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1.  Implementing the 2009 Institute of Medicine recommendations on resident physician work hours, supervision, and safety 
Long working hours and sleep deprivation have been a facet of physician training in the US since the advent of the modern residency system. However, the scientific evidence linking fatigue with deficits in human performance, accidents and errors in industries from aeronautics to medicine, nuclear power, and transportation has mounted over the last 40 years. This evidence has also spawned regulations to help ensure public safety across safety-sensitive industries, with the notable exception of medicine.
In late 2007, at the behest of the US Congress, the Institute of Medicine embarked on a year-long examination of the scientific evidence linking resident physician sleep deprivation with clinical performance deficits and medical errors. The Institute of Medicine’s report, entitled “Resident duty hours: Enhancing sleep, supervision and safety”, published in January 2009, recommended new limits on resident physician work hours and workload, increased supervision, a heightened focus on resident physician safety, training in structured handovers and quality improvement, more rigorous external oversight of work hours and other aspects of residency training, and the identification of expanded funding sources necessary to implement the recommended reforms successfully and protect the public and resident physicians themselves from preventable harm.
Given that resident physicians comprise almost a quarter of all physicians who work in hospitals, and that taxpayers, through Medicare and Medicaid, fund graduate medical education, the public has a deep investment in physician training. Patients expect to receive safe, high-quality care in the nation’s teaching hospitals. Because it is their safety that is at issue, their voices should be central in policy decisions affecting patient safety. It is likewise important to integrate the perspectives of resident physicians, policy makers, and other constituencies in designing new policies. However, since its release, discussion of the Institute of Medicine report has been largely confined to the medical education community, led by the Accreditation Council for Graduate Medical Education (ACGME).
To begin gathering these perspectives and developing a plan to implement safer work hours for resident physicians, a conference entitled “Enhancing sleep, supervision and safety: What will it take to implement the Institute of Medicine recommendations?” was held at Harvard Medical School on June 17–18, 2010. This White Paper is a product of a diverse group of 26 representative stakeholders bringing relevant new information and innovative practices to bear on a critical patient safety problem. Given that our conference included experts from across disciplines with diverse perspectives and interests, not every recommendation was endorsed by each invited conference participant. However, every recommendation made here was endorsed by the majority of the group, and many were endorsed unanimously. Conference members participated in the process, reviewed the final product, and provided input before publication. Participants provided their individual perspectives, which do not necessarily represent the formal views of any organization.
In September 2010 the ACGME issued new rules to go into effect on July 1, 2011. Unfortunately, they stop considerably short of the Institute of Medicine’s recommendations and those endorsed by this conference. In particular, the ACGME only applied the limitation of 16 hours to first-year resident physicans. Thus, it is clear that policymakers, hospital administrators, and residency program directors who wish to implement safer health care systems must go far beyond what the ACGME will require. We hope this White Paper will serve as a guide and provide encouragement for that effort.
Resident physician workload and supervision
By the end of training, a resident physician should be able to practice independently. Yet much of resident physicians’ time is dominated by tasks with little educational value. The caseload can be so great that inadequate reflective time is left for learning based on clinical experiences. In addition, supervision is often vaguely defined and discontinuous. Medical malpractice data indicate that resident physicians are frequently named in lawsuits, most often for lack of supervision. The recommendations are: The ACGME should adjust resident physicians workload requirements to optimize educational value. Resident physicians as well as faculty should be involved in work redesign that eliminates nonessential and noneducational activity from resident physician dutiesMechanisms should be developed for identifying in real time when a resident physician’s workload is excessive, and processes developed to activate additional providersTeamwork should be actively encouraged in delivery of patient care. Historically, much of medical training has focused on individual knowledge, skills, and responsibility. As health care delivery has become more complex, it will be essential to train resident and attending physicians in effective teamwork that emphasizes collective responsibility for patient care and recognizes the signs, both individual and systemic, of a schedule and working conditions that are too demanding to be safeHospitals should embrace the opportunities that resident physician training redesign offers. Hospitals should recognize and act on the potential benefits of work redesign, eg, increased efficiency, reduced costs, improved quality of care, and resident physician and attending job satisfactionAttending physicians should supervise all hospital admissions. Resident physicians should directly discuss all admissions with attending physicians. Attending physicians should be both cognizant of and have input into the care patients are to receive upon admission to the hospitalInhouse supervision should be required for all critical care services, including emergency rooms, intensive care units, and trauma services. Resident physicians should not be left unsupervised to care for critically ill patients. In settings in which the acuity is high, physicians who have completed residency should provide direct supervision for resident physicians. Supervising physicians should always be physically in the hospital for supervision of resident physicians who care for critically ill patientsThe ACGME should explicitly define “good” supervision by specialty and by year of training. Explicit requirements for intensity and level of training for supervision of specific clinical scenarios should be providedCenters for Medicare and Medicaid Services (CMS) should use graduate medical education funding to provide incentives to programs with proven, effective levels of supervision. Although this action would require federal legislation, reimbursement rules would help to ensure that hospitals pay attention to the importance of good supervision and require it from their training programs
Resident physician work hours
Although the IOM “Sleep, supervision and safety” report provides a comprehensive review and discussion of all aspects of graduate medical education training, the report’s focal point is its recommendations regarding the hours that resident physicians are currently required to work. A considerable body of scientific evidence, much of it cited by the Institute of Medicine report, describes deteriorating performance in fatigued humans, as well as specific studies on resident physician fatigue and preventable medical errors.
The question before this conference was what work redesign and cultural changes are needed to reform work hours as recommended by the Institute of Medicine’s evidence-based report? Extensive scientific data demonstrate that shifts exceeding 12–16 hours without sleep are unsafe. Several principles should be followed in efforts to reduce consecutive hours below this level and achieve safer work schedules. The recommendations are: Limit resident physician work hours to 12–16 hour maximum shiftsA minimum of 10 hours off duty should be scheduled between shiftsResident physician input into work redesign should be actively solicitedSchedules should be designed that adhere to principles of sleep and circadian science; this includes careful consideration of the effects of multiple consecutive night shifts, and provision of adequate time off after night work, as specified in the IOM reportResident physicians should not be scheduled up to the maximum permissible limits; emergencies frequently occur that require resident physicians to stay longer than their scheduled shifts, and this should be anticipated in scheduling resident physicians’ work shiftsHospitals should anticipate the need for iterative improvement as new schedules are initiated; be prepared to learn from the initial phase-in, and change the plan as neededAs resident physician work hours are redesigned, attending physicians should also be considered; a potential consequence of resident physician work hour reduction and increased supervisory requirements may be an increase in work for attending physicians; this should be carefully monitored, and adjustments to attending physician work schedules made as needed to prevent unsafe work hours or working conditions for this group“Home call” should be brought under the overall limits of working hours; work load and hours should be monitored in each residency program to ensure that resident physicians and fellows on home call are getting sufficient sleepMedicare funding for graduate medical education in each hospital should be linked with adherence to the Institute of Medicine limits on resident physician work hours
Moonlighting by resident physicians
The Institute of Medicine report recommended including external as well as internal moonlighting in working hour limits. The recommendation is: All moonlighting work hours should be included in the ACGME working hour limits and actively monitored. Hospitals should formalize a moonlighting policy and establish systems for actively monitoring resident physician moonlighting
Safety of resident physicians
The “Sleep, supervision and safety” report also addresses fatigue-related harm done to resident physicians themselves. The report focuses on two main sources of physical injury to resident physicians impaired by fatigue, ie, needle-stick exposure to blood-borne pathogens and motor vehicle crashes. Providing safe transportation home for resident physicians is a logistical and financial challenge for hospitals. Educating physicians at all levels on the dangers of fatigue is clearly required to change driving behavior so that safe hospital-funded transport home is used effectively. Fatigue-related injury prevention (including not driving while drowsy) should be taught in medical school and during residency, and reinforced with attending physicians; hospitals and residency programs must be informed that resident physicians’ ability to judge their own level of impairment is impaired when they are sleep deprived; hence, leaving decisions about the capacity to drive to impaired resident physicians is not recommendedHospitals should provide transportation to all resident physicians who report feeling too tired to drive safely; in addition, although consecutive work should not exceed 16 hours, hospitals should provide transportation for all resident physicians who, because of unforeseen reasons or emergencies, work for longer than consecutive 24 hours; transportation under these circumstances should be automatically provided to house staff, and should not rely on self-identification or request
Training in effective handovers and quality improvement
Handover practice for resident physicians, attendings, and other health care providers has long been identified as a weak link in patient safety throughout health care settings. Policies to improve handovers of care must be tailored to fit the appropriate clinical scenario, recognizing that information overload can also be a problem. At the heart of improving handovers is the organizational effort to improve quality, an effort in which resident physicians have typically been insufficiently engaged. The recommendations are: Hospitals should train attending and resident physicians in effective handovers of careHospitals should create uniform processes for handovers that are tailored to meet each clinical setting; all handovers should be done verbally and face-to-face, but should also utilize written toolsWhen possible, hospitals should integrate hand-over tools into their electronic medical records (EMR) systems; these systems should be standardized to the extent possible across residency programs in a hospital, but may be tailored to the needs of specific programs and services; federal government should help subsidize adoption of electronic medical records by hospitals to improve signoutWhen feasible, handovers should be a team effort including nurses, patients, and familiesHospitals should include residents in their quality improvement and patient safety efforts; the ACGME should specify in their core competency requirements that resident physicians work on quality improvement projects; likewise, the Joint Commission should require that resident physicians be included in quality improvement and patient safety programs at teaching hospitals; hospital administrators and residency program directors should create opportunities for resident physicians to become involved in ongoing quality improvement projects and root cause analysis teams; feedback on successful quality improvement interventions should be shared with resident physicians and broadly disseminatedQuality improvement/patient safety concepts should be integral to the medical school curriculum; medical school deans should elevate the topics of patient safety, quality improvement, and teamwork; these concepts should be integrated throughout the medical school curriculum and reinforced throughout residency; mastery of these concepts by medical students should be tested on the United States Medical Licensing Examination (USMLE) stepsFederal government should support involvement of resident physicians in quality improvement efforts; initiatives to improve quality by including resident physicians in quality improvement projects should be financially supported by the Department of Health and Human Services
Monitoring and oversight of the ACGME
While the ACGME is a key stakeholder in residency training, external voices are essential to ensure that public interests are heard in the development and monitoring of standards. Consequently, the Institute of Medicine report recommended external oversight and monitoring through the Joint Commission and Centers for Medicare and Medicaid Services (CMS). The recommendations are: Make comprehensive fatigue management a Joint Commission National Patient Safety Goal; fatigue is a safety concern not only for resident physicians, but also for nurses, attending physicians, and other health care workers; the Joint Commission should seek to ensure that all health care workers, not just resident physicians, are working as safely as possibleFederal government, including the Centers for Medicare and Medicaid Services and the Agency for Healthcare Research and Quality, should encourage development of comprehensive fatigue management programs which all health systems would eventually be required to implementMake ACGME compliance with working hours a “ condition of participation” for reimbursement of direct and indirect graduate medical education costs; financial incentives will greatly increase the adoption of and compliance with ACGME standards
Future financial support for implementation
The Institute of Medicine’s report estimates that $1.7 billion (in 2008 dollars) would be needed to implement its recommendations. Twenty-five percent of that amount ($376 million) will be required just to bring hospitals into compliance with the existing 2003 ACGME rules. Downstream savings to the health care system could potentially result from safer care, but these benefits typically do not accrue to hospitals and residency programs, who have been asked historically to bear the burden of residency reform costs. The recommendations are: The Institute of Medicine should convene a panel of stakeholders, including private and public funders of health care and graduate medical education, to lay down the concrete steps necessary to identify and allocate the resources needed to implement the recommendations contained in the IOM “Resident duty hours: Enhancing sleep, supervision and safety” report. Conference participants suggested several approaches to engage public and private support for this initiativeEfforts to find additional funding to implement the Institute of Medicine recommendations should focus more broadly on patient safety and health care delivery reform; policy efforts focused narrowly upon resident physician work hours are less likely to succeed than broad patient safety initiatives that include residency redesign as a key componentHospitals should view the Institute of Medicine recommendations as an opportunity to begin resident physician work redesign projects as the core of a business model that embraces safety and ultimately saves resourcesBoth the Secretary of Health and Human Services and the Director of the Centers for Medicare and Medicaid Services should take the Institute of Medicine recommendations into consideration when promulgating rules for innovation grantsThe National Health Care Workforce Commission should consider the Institute of Medicine recommendations when analyzing the nation’s physician workforce needs
Recommendations for future research
Conference participants concurred that convening the stakeholders and agreeing on a research agenda was key. Some observed that some sectors within the medical education community have been reluctant to act on the data. Several logical funders for future research were identified. But above all agencies, Centers for Medicare and Medicaid Services is the only stakeholder that funds graduate medical education upstream and will reap savings downstream if preventable medical errors are reduced as a result of reform of resident physician work hours.
doi:10.2147/NSS.S19649
PMCID: PMC3630963  PMID: 23616719
resident; hospital; working hours; safety
2.  Place and Cause of Death in Centenarians: A Population-Based Observational Study in England, 2001 to 2010 
PLoS Medicine  2014;11(6):e1001653.
Catherine J. Evans and colleagues studied how many and where centenarians in England die, their causes of death, and how these measures have changed from 2001 to 2010.
Please see later in the article for the Editors' Summary
Background
Centenarians are a rapidly growing demographic group worldwide, yet their health and social care needs are seldom considered. This study aims to examine trends in place of death and associations for centenarians in England over 10 years to consider policy implications of extreme longevity.
Methods and Findings
This is a population-based observational study using death registration data linked with area-level indices of multiple deprivations for people aged ≥100 years who died 2001 to 2010 in England, compared with those dying at ages 80-99. We used linear regression to examine the time trends in number of deaths and place of death, and Poisson regression to evaluate factors associated with centenarians’ place of death. The cohort totalled 35,867 people with a median age at death of 101 years (range: 100–115 years). Centenarian deaths increased 56% (95% CI 53.8%–57.4%) in 10 years. Most died in a care home with (26.7%, 95% CI 26.3%–27.2%) or without nursing (34.5%, 95% CI 34.0%–35.0%) or in hospital (27.2%, 95% CI 26.7%–27.6%). The proportion of deaths in nursing homes decreased over 10 years (−0.36% annually, 95% CI −0.63% to −0.09%, p = 0.014), while hospital deaths changed little (0.25% annually, 95% CI −0.06% to 0.57%, p = 0.09). Dying with frailty was common with “old age” stated in 75.6% of death certifications. Centenarians were more likely to die of pneumonia (e.g., 17.7% [95% CI 17.3%–18.1%] versus 6.0% [5.9%–6.0%] for those aged 80–84 years) and old age/frailty (28.1% [27.6%–28.5%] versus 0.9% [0.9%–0.9%] for those aged 80–84 years) and less likely to die of cancer (4.4% [4.2%–4.6%] versus 24.5% [24.6%–25.4%] for those aged 80–84 years) and ischemic heart disease (8.6% [8.3%–8.9%] versus 19.0% [18.9%–19.0%] for those aged 80–84 years) than were younger elderly patients. More care home beds available per 1,000 population were associated with fewer deaths in hospital (PR 0.98, 95% CI 0.98–0.99, p<0.001).
Conclusions
Centenarians are more likely to have causes of death certified as pneumonia and frailty and less likely to have causes of death of cancer or ischemic heart disease, compared with younger elderly patients. To reduce reliance on hospital care at the end of life requires recognition of centenarians’ increased likelihood to “acute” decline, notably from pneumonia, and wider provision of anticipatory care to enable people to remain in their usual residence, and increasing care home bed capacity.
Please see later in the article for the Editors' Summary
Editors’ Summary
Background
People who live to be more than 100 years old—centenarians—are congratulated and honored in many countries. In the UK, for example, the Queen sends a personal greeting to individuals on their 100th birthday. The number of UK residents who reach this notable milestone is increasing steadily, roughly doubling every 10 years. The latest Office of National Statistics (ONS) figures indicate that 13,350 centenarians were living in the UK in 2012 (20 centenarians per 100,000 people in the population) compared to only 7,740 in 2002. If current trends continue, by 2066 there may be more than half a million centenarians living in the UK. And similar increases in the numbers of centenarians are being seen in many other countries. The exact number of centenarians living worldwide is uncertain but is thought to be around 317,000 and is projected to rise to about 18 million by the end of this century.
Why Was This Study Done?
Traditional blessings often include the wish that the blessing’s recipient lives to be at least 100 years old. However, extreme longevity is associated with increasing frailty—declining physical function, increasing disability, and increasing vulnerability to a poor clinical outcome following, for example, an infection. Consequently, many centenarians require 24-hour per day care in a nursing home or a residential care home. Moreover, although elderly people, including centenarians, generally prefer to die in a home environment rather than a clinical environment, many centenarians end up dying in a hospital. To ensure that centenarians get their preferred end-of-life care, policy makers and clinicians need to know as much as possible about the health and social needs of this specific and unique group of elderly people. In this population-based observational study, the researchers examine trends in the place of death and factors associated with the place of death among centenarians in England over a 10-year period.
What Did the Researchers Do and Find?
The researchers extracted information about the place and cause of death of centenarians in England between 2001 and 2010 from the ONS death registration database, linked these data with area level information on deprivation and care-home bed capacity, and analyzed the data statistically. Over the 10-year study period, 35,867 centenarians (mainly women, average age 101 years) died in England. The annual number of centenarian deaths increased from 2,823 in 2001 to 4,393 in 2010. Overall, three-quarters of centenarian death certificates stated “old age” as the cause of death. About a quarter of centenarians died in the hospital, a quarter died in a nursing home, and a third died in a care home without nursing; only one in ten centenarians died at home. The proportion of deaths in a nursing home increased slightly over the study period but there was little change in the number of hospital deaths. Compared with younger age groups (80–84 year olds), centenarians were more likely to die from pneumonia and “old age” and less likely to die from cancer and heart disease. Among centenarians, dying in the hospital was more likely to be reported to be associated with pneumonia or heart disease than with dementia; death in the hospital was also associated with having four or more contributing causes of death and with living in a deprived area. Finally, living in an area with a higher care-home bed capacity was associated with a lower risk of dying in the hospital.
What Do These Findings Mean?
These findings suggest that many centenarians have outlived death from the chronic diseases that are the common causes of death among younger groups of elderly people and that dying in the hospital is often associated with pneumonia. Overall, these findings suggest that centenarians are a group of people living with a risk of death from increasing frailty that is exacerbated by acute lung infection. The accuracy of these findings is likely to be affected by the quality of UK death certification data. Although this is generally high, the strength of some of the reported associations may be affected, for example, by the tendency of clinicians to record the cause of death in the very elderly as “old age” to provide some comfort to surviving relatives. Importantly, however, these findings suggest that care-home capacity and the provision of anticipatory care should be increased in England (and possibly in other countries) to ensure that more of the growing number of centenarians can end their long lives outside hospital.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001653.
The US National Institute on Aging provides information about healthy aging, including information on longevity (in English and Spanish)
The National End of Life Care Intelligence Network, England is a government organization that gathers data on care provided to adults approaching the end of life to improve service quality and productivity
The Worldwide Palliative Care Alliance promotes universal access to affordable palliative care through the support of regional and national palliative care organizations
The non-for-profit organization AgeUK provides information about all aspects of aging
Wikipedia has a page on centenarians (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The International Longevity Centre-UK is an independent, non-partisan think tank dedicated to addressing issues of longevity, ageing and population; its “Living Beyond 100” report examines the research base on centenarians and calls for policy to reflect the ongoing UK increase in extreme longevity
This study is part of GUIDE_Care, a project initiated by the Cicely Saunders Institute to investigate patterns in place of death and the factors that affect these patterns
doi:10.1371/journal.pmed.1001653
PMCID: PMC4043499  PMID: 24892645
3.  Proceedings of the 3rd IPLeiria’s International Health Congress 
Tomás, Catarina Cardoso | Oliveira, Emanuel | Sousa, D. | Uba-Chupel, M. | Furtado, G. | Rocha, C. | Teixeira, A. | Ferreira, P. | Alves, Celeste | Gisin, Stefan | Catarino, Elisabete | Carvalho, Nelma | Coucelo, Tiago | Bonfim, Luís | Silva, Carina | Franco, Débora | González, Jesús Alcoba | Jardim, Helena G. | Silva, Rita | Baixinho, Cristina L. | Presado, Mª Helena | Marques, Mª Fátima | Cardoso, Mário E. | Cunha, Marina | Mendes, Joana | Xavier, Ana | Galhardo, Ana | Couto, Margarida | Frade, João G. | Nunes, Carla | Mesquita, João R. | Nascimento, Maria S. | Gonçalves, Guilherme | Castro, Conceição | Mártires, Alice | Monteiro, Mª João | Rainho, Conceição | Caballero, Francisco P. | Monago, Fatima M. | Guerrero, Jose T. | Monago, Rocio M. | Trigo, Africa P. | Gutierrez, Milagros L. | Milanés, Gemma M. | Reina, Mercedes G. | Villanueva, Ana G. | Piñero, Ana S. | Aliseda, Isabel R. | Ramirez, Francisco B. | Ribeiro, Andrea | Quelhas, Ana | Manso, Conceição | Caballero, Francisco P. | Guerrero, Jose T. | Monago, Fatima M. | Santos, Rafael B. | Jimenez, Nuria R. | Nuñez, Cristina G. | Gomez, Inmaculada R. | Fernandez, Mª Jose L. | Marquez, Laura A. | Moreno, Ana L. | Huertas, Mª Jesus Tena | Ramirez, Francisco B. | Seabra, Daniel | Salvador, Mª Céu | Braga, Luciene | Parreira, Pedro | Salgueiro-Oliveira, Anabela | Arreguy-Sena, Cristina | Oliveira, Bibiana F. | Henriques, Mª Adriana | Santos, Joana | Lebre, Sara | Marques, Alda | Festas, Clarinda | Rodrigues, Sandra | Ribeiro, Andrea | Lumini, José | Figueiredo, Ana G. | Hernandez-Martinez, Francisco J. | Campi, Liliana | Quintana-Montesdeoca, Mª Pino | Jimenez-Diaz, Juan F. | Rodriguez-De-Vera, Bienvenida C. | Parente, Alexandra | Mata, Mª Augusta | Pereira, Ana Mª | Fernandes, Adília | Brás, Manuel | Pinto, Mª Rosário | Parreira, Pedro | Basto, Marta L. | Rei, Ana C. | Mónico, Lisete M. | Sousa, Gilberta | Morna, Clementina | Freitas, Otília | Freitas, Gregório | Jardim, Ana | Vasconcelos, Rita | Horta, Lina G. | Rosa, Roger S. | Kranz, Luís F. | Nugem, Rita C. | Siqueira, Mariana S. | Bordin, Ronaldo | Kniess, Rosiane | Lacerda, Josimari T. | Guedes, Joana | Machado, Idalina | Almeida, Sidalina | Zilhão, Adriano | Alves, Helder | Ribeiro, Óscar | Amaral, Ana P. | Santos, Ana | Monteiro, Joana | Rocha, Mª Clara | Cruz, Rui | Amaral, Ana P. | Lourenço, Marina | Rocha, Mª Clara | Cruz, Rui | Antunes, Sandra | Mendonça, Verónica | Andrade, Isabel | Osório, Nádia | Valado, Ana | Caseiro, Armando | Gabriel, António | Martins, Anabela C. | Mendes, Fernando | Cabral, Lídia | Ferreira, Manuela | Gonçalves, Amadeu | Luz, Tatiana D. | Luz, Leonardo | Martins, Raul | Morgado, Alice | Vale-Dias, Maria L. | Porta-Nova, Rui | Fleig, Tânia C. | Reuter, Éboni M. | Froemming, Miriam B. | Guerreiro, Sabrina L. | Carvalho, Lisiane L. | Guedelha, Daniel | Coelho, P. | Pereira, A. | Calha, António | Cordeiro, Raul | Gonçalves, Ana | Certo, Ana | Galvão, Ana | Mata, Mª Augusta | Welter, Aline | Pereira, Elayne | Ribeiro, Sandra | Kretzer, Marcia | Jiménez-Díaz, Juan-Fernando | Jiménez-Rodríguez, Carla | Hernández-Martínez, Francisco-José | Rodríguez-De-Vera, Bienvenida-Del-Carmen | Marques-Rodrigues, Alexandre | Coelho, Patrícia | Bernardes, Tiago | Pereira, Alexandre | Sousa, Patrícia | Filho, João G. | Nazario, Nazare | Kretzer, Marcia | Amaral, Odete | Garrido, António | Veiga, Nélio | Nunes, Carla | Pedro, Ana R. | Pereira, Carlos | Almeia, António | Fernandes, Helder M. | Vasconcelos, Carlos | Sousa, Nelson | Reis, Victor M. | Monteiro, M. João | Mendes, Romeu | Pinto, Isabel C. | Pires, Tânia | Gama, João | Preto, Vera | Silva, Norberto | Magalhães, Carlos | Martins, Matilde | Duarte, Mafalda | Paúl, Constança | Martín, Ignácio | Pinheiro, Arminda A. | Xavier, Sandra | Azevedo, Julieta | Bento, Elisabete | Marques, Cristiana | Marques, Mariana | Macedo, António | Pereira, Ana T. | Almeida, José P. | Almeida, António | Alves, Josiane | Sousa, Nelson | Saavedra, Francisco | Mendes, Romeu | Maia, Ana S. | Oliveira, Michelle T. | Sousa, Anderson R. | Ferreira, Paulo P. | Lopes, Luci S. | Santiago, Eujcely C. | Monteiro, Sílvia | Jesus, Ângelo | Colaço, Armanda | Carvalho, António | Silva, Rita P. | Cruz, Agostinho | Ferreira, Ana | Marques, Catarina | Figueiredo, João P. | Paixão, Susana | Ferreira, Ana | Lopes, Carla | Moreira, Fernando | Figueiredo, João P. | Ferreira, Ana | Ribeiro, Diana | Moreira, Fernando | Figueiredo, João P. | Paixão, Susana | Fernandes, Telma | Amado, Diogo | Leal, Jéssica | Azevedo, Marcelo | Ramalho, Sónia | Mangas, Catarina | Ribeiro, Jaime | Gonçalves, Rita | Nunes, Amélia F | Tuna, Ana R. | Martins, Carlos R. | Forte, Henriqueta D. | Costa, Cláudia | Tenedório, José A. | Santana, Paula | Andrade, J. A. | Pinto, J. L. | Campofiorito, C. | Nunes, S. | Carmo, A. | Kaliniczenco, A. | Alves, B. | Mendes, F. | Jesus, C. | Fonseca, F. | Gehrke, F. | Albuquerque, Carlos | Batista, Rita | Cunha, Madalena | Madureira, António | Ribeiro, Olivério | Martins, Rosa | Madeira, Teresa | Peixoto-Plácido, Catarina | Santos, Nuno | Santos, Osvaldo | Bergland, Astrid | Bye, Asta | Lopes, Carla | Alarcão, Violeta | Goulão, Beatriz | Mendonça, Nuno | Nicola, Paulo | Clara, João G. | Gomes, João | Querido, Ana | Tomás, Catarina | Carvalho, Daniel | Cordeiro, Marina | Rosa, Marlene C. | Marques, Alda | Brandão, Daniela | Ribeiro, Óscar | Araújo, Lia | Paúl, Constança | Minghelli, Beatriz | Richaud, Sylvina | Mendes, Ana L. | Marta-Simões, Joana | Trindade, Inês A. | Ferreira, Cláudia | Carvalho, Teresa | Cunha, Marina | Pinto-Gouveia, José | Fernandes, Morgana C. | Rosa, Roger S. | Nugem, Rita C. | Kranz, Luís F. | Siqueira, Mariana S. | Bordin, Ronaldo | Martins, Anabela C. | Medeiros, Anabela | Pimentel, Rafaela | Fernandes, Andreia | Mendonça, Carlos | Andrade, Isabel | Andrade, Susana | Menezes, Ruth L. | Bravo, Rafael | Miranda, Marta | Ugartemendia, Lierni | Tena, José Mª | Pérez-Caballero, Francisco L. | Fuentes-Broto, Lorena | Rodríguez, Ana B. | Carmen, Barriga | Carneiro, M. A. | Domingues, J. N. | Paixão, S. | Figueiredo, J. | Nascimento, V. B. | Jesus, C. | Mendes, F | Gehrke, F. | Alves, B. | Azzalis, L. | Fonseca, F. | Martins, Ana R. | Nunes, Amélia | Jorge, Arminda | Veiga, Nélio | Amorim, Ana | Silva, André | Martinho, Liliana | Monteiro, Luís | Silva, Rafael | Coelho, Carina | Amaral, Odete | Coelho, Inês | Pereira, Carlos | Correia, André | Rodrigues, Diana | Marante, Nídia | Silva, Pedro | Carvalho, Sara | Araujo, André Rts | Ribeiro, Maximiano | Coutinho, Paula | Ventura, Sandra | Roque, Fátima | Calvo, Cristina | Reses, Manoela | Conde, Jorge | Ferreira, Ana | Figueiredo, João | Silva, David | Seiça, Luís | Soares, Raquel | Mourão, Ricardo | Kraus, Teresa | Abreu, Ana C. | Padilha, José M. | Alves, Júlia M. | Sousa, Paulino | Oliveira, Manuel | Sousa, Joana | Novais, Sónia | Mendes, Felismina | Pinto, Joana | Cruz, Joana | Marques, Alda | Duarte, Hugo | Dixe, Maria Dos Anjos | Sousa, Pedro | Cruz, Inês | Bastos, Fernanda | Pereira, Filipe | Carvalho, Francisco L. | Oliveira, Teresa T. | Raposo, Vítor R. | Rainho, Conceição | Ribeiro, José C. | Barroso, Isabel | Rodrigues, Vítor | Neves, Carmo | Oliveira, Teresa C. | Oliveira, Bárbara | Morais, Mª Carminda | Baylina, Pilar | Rodrigues, Rogério | Azeredo, Zaida | Vicente, Corália | Dias, Hélia | Sim-Sim, Margarida | Parreira, Pedro | Salgueiro-Oliveira, Anabela | Castilho, Amélia | Melo, Rosa | Graveto, João | Gomes, José | Vaquinhas, Marina | Carvalho, Carla | Mónico, Lisete | Brito, Nuno | Sarroeira, Cassilda | Amendoeira, José | Cunha, Fátima | Cândido, Anabela | Fernandes, Patrícia | Silva, Helena R. | Silva, Elsa | Barroso, Isabel | Lapa, Leila | Antunes, Cristina | Gonçalves, Ana | Galvão, Ana | Gomes, Mª José | Escanciano, Susana R. | Freitas, Maria | Parreira, Pedro | Marôco, João | Fernandes, Ana R. | Cabral, Cremilde | Alves, Samuel | Sousa, Pedro | Ferreira, António | Príncipe, Fernanda | Seppänen, Ulla-Maija | Ferreira, Margarida | Carvalhais, Maribel | Silva, Marilene | Ferreira, Manuela | Silva, Joana | Neves, Jéssica | Costa, Diana | Santos, Bruno | Duarte, Soraia | Marques, Sílvia | Ramalho, Sónia | Mendes, Isabel | Louro, Clarisse | Menino, Eva | Dixe, Maria | Dias, Sara S. | Cordeiro, Marina | Tomás, Catarina | Querido, Ana | Carvalho, Daniel | Gomes, João | Valim, Frederico C. | Costa, Joyce O. | Bernardes, Lúcia G. | Prebianchi, Helena | Rosa, Marlene Cristina | Gonçalves, Narcisa | Martins, Maria M. | Kurcgant, Paulina | Vieira, André | Bento, Sandrina | Deodato, Sérgio | Rabiais, Isabel | Reis, Laura | Torres, Ana | Soares, Sérgio | Ferreira, Margarida | Graça, Pedro | Leitão, Céu | Abreu, Renato | Bellém, Fernando | Almeida, Ana | Ribeiro-Varandas, Edna | Tavares, Ana | Frade, João G. | Henriques, Carolina | Menino, Eva | Louro, Clarisse | Jordão, Célia | Neco, Sofia | Morais, Carminda | Ferreira, Pedro | Silva, Carla R. | Brito, Alice | Silva, Antónia | Duarte, Hugo | Dixe, Maria Dos Anjos | Sousa, Pedro | Postolache, Gabriela | Oliveira, Raul | Moreira, Isabel | Pedro, Luísa | Vicente, Sónia | Domingos, Samuel | Postolache, Octavian | Silva, Darlen | Filho, João G. | Nazario, Nazare | Kretzer, Marcia | Schneider, Dulcineia | Marques, Fátima M. | Parreira, Pedro | Carvalho, Carla | Mónico, Lisete M. | Pinto, Carlos | Vicente, Sara | Breda, São João | Gomes, José H. | Melo, Rosa | Parreira, Pedro | Salgueiro, Anabela | Graveto, João | Vaquinhas, Marina | Castilho, Amélia | Jesus, Ângelo | Duarte, Nuno | Lopes, José C. | Nunes, Hélder | Cruz, Agostinho | Salgueiro-Oliveira, Anabela | Parreira, Pedro | Basto, Marta L. | Braga, Luciene M. | Ferreira, António | Araújo, Beatriz | Alves, José M. | Ferreira, Margarida | Carvalhais, Maribel | Silva, Marilene | Novais, Sónia | Sousa, Ana S. | Ferrito, Cândida | Ferreira, Pedro L. | Rodrigues, Alexandre | Ferreira, Margarida | Oliveira, Isabel | Ferreira, Manuela | Neves, Jéssica | Costa, Diana | Duarte, Soraia | Silva, Joana | Santos, Bruno | Martins, Cristina | Macedo, Ana P. | Araújo, Odete | Augusto, Cláudia | Braga, Fátima | Gomes, Lisa | Silva, Maria A. | Rosário, Rafaela | Pimenta, Luís | Carreira, Diana | Teles, Patrícia | Barros, Teresa | Tomás, Catarina | Querido, Ana | Carvalho, Daniel | Gomes, João | Cordeiro, Marina | Carvalho, Daniel | Querido, Ana | Tomás, Catarina | Gomes, João | Cordeiro, Marina | Jácome, Cristina | Marques, Alda | Capelas, Sylvie | Hall, Andreia | Alves, Dina | Lousada, Marisa | Loureiro, Mª Helena | Camarneiro, Ana | Silva, Margarida | Mendes, Aida | Pedreiro, Ana | G.Silva, Anne | Coelho, Elza S. | Melo, Flávio | Ribeiro, Fernando | Torres, Rui | Costa, Rui | Pinho, Tânia | Jácome, Cristina | Marques, Alda | Cruz, Bárbara | Seabra, Daniel | Carreiras, Diogo | Ventura, Maria | Cruz, x | Brooks, Dina | Marques, Alda | Pinto, M Rosário | Parreira, Pedro | Lima-Basto, Marta | Neves, Miguel | Mónico, Lisete M. | Bizarro, Carla | Cunha, Marina | Galhardo, Ana | Margarida, Couto | Amorim, Ana P. | Silva, Eduardo | Cruz, Susana | Padilha, José M. | Valente, Jorge | Guerrero, José T. | Caballero, Francisco P. | Santos, Rafael B. | Gonzalez, Estefania P. | Monago, Fátima M. | Ugalde, Lierni U. | Vélez, Marta M. | Tena, Maria J. | Guerrero, José T. | Bravo, Rafael | Pérez-Caballero, Francisco L. | Becerra, Isabel A. | Agudelo, Mª Elizabeth | Acedo, Guadalupe | Bajo, Roberto | Malheiro, Isabel | Gaspar, Filomena | Barros, Luísa | Furtado, Guilherme | Uba-Chupel, Mateus | Marques, Mariana | Rama, Luís | Braga, Margarida | Ferreira, José P. | Teixeira, Ana Mª | Cruz, João | Barbosa, Tiago | Simões, Ângela | Coelho, Luís | Rodrigues, Alexandre | Jiménez-Díaz, Juan-Fernando | Martinez-Hernandez, Francisco | Rodriguez-De-Vera, Bienvenida | Ferreira, Pedro | Rodrigues, Alexandrina | Ramalho, André | Petrica, João | Mendes, Pedro | Serrano, João | Santo, Inês | Rosado, António | Mendonça, Paula | Freitas, Kátia | Ferreira, Dora | Brito, António | Fernandes, Renato | Gomes, Sofia | Moreira, Fernando | Pinho, Cláudia | Oliveira, Rita | Oliveira, Ana I. | Mendonça, Paula | Casimiro, Ana P. | Martins, Patrícia | Silva, Iryna | Evangelista, Diana | Leitão, Catarina | Velosa, Fábia | Carecho, Nélio | Coelho, Luís | Menino, Eva | Dixe, Anjos | Catarino, Helena | Soares, Fátima | Gama, Ester | Gordo, Clementina | Moreira, Eliana | Midões, Cristiana | Santos, Marlene | Machado, Sara | Oliveira, Vânia P. | Santos, Marlene | Querido, Ana | Dixe, Anjos | Marques, Rita | Charepe, Zaida | Antunes, Ana | Santos, Sofia | Rosa, Marlene C. | Rosa, Marlene C. | Marques, Silvana F. | Minghelli, Beatriz | CaroMinghelli, Eulália | Luís, Mª José | Brandão, Teresa | Mendes, Pedro | Marinho, Daniel | Petrica, João | Monteiro, Diogo | Paulo, Rui | Serrano, João | Santo, Inês | Monteiro, Lina | Ramalho, Fátima | Santos-Rocha, Rita | Morgado, Sónia | Bento, Teresa | Sousa, Gilberta | Freitas, Otília | Silva, Isabel | Freitas, Gregório | Morna, Clementina | Vasconcelos, Rita | Azevedo, Tatiana | Soares, Salete | Pisco, Jacinta | Ferreira, Paulo P. | Olszewer, Efrain O. | Oliveira, Michelle T. | Sousa, Anderson R. | Maia, Ana S. | Oliveira, Sebastião T. | Santos, Erica | Oliveira, Ana I. | Maia, Carla | Moreira, Fernando | Santos, Joana | Mendes, Maria F. | Oliveira, Rita F. | Pinho, Cláudia | Barreira, Eduarda | Pereira, Ana | Vaz, Josiana A. | Novo, André | Silva, Luís D. | Maia, Bruno | Ferreira, Eduardo | Pires, Filipa | Andrade, Renato | Camarinha, Luís | Silva, Luís D. | Maia, Bruno | Ferreira, Eduardo | Pires, Filipa | Andrade, Renato | Camarinha, Luís | César, Ana F. | Poço, Mariana | Ventura, David | Loura, Raquel | Gomes, Pedro | Gomes, Catarina | Silva, Cláudia | Melo, Elsa | Lindo, João | Domingos, Joana | Mendes, Zaida | Poeta, Susana | Carvalho, Tiago | Tomás, Catarina | Catarino, Helena | Dixe, Mª Anjos | Ramalho, André | Rosado, António | Mendes, Pedro | Paulo, Rui | Garcia, Inês | Petrica, João | Rodrigues, Sandra | Meneses, Rui | Afonso, Carlos | Faria, Luís | Seixas, Adérito | Cordeiro, Marina | Granjo, Paulo | Gomes, José C. | Souza, Nelba R. | Furtado, Guilherme E. | Rocha, Saulo V. | Silva, Paula | Carvalho, Joana | Morais, Marina Ana | Santos, Sofia | Lebre, Paula | Antunes, Ana | Calha, António | Xavier, Ana | Cunha, Marina | Pinto-Gouveia, José | Alencar, Liana | Cunha, Madalena | Madureira, António | Cardoso, Ilda | Galhardo, Ana | Daniel, Fernanda | Rodrigues, Vítor | Luz, Leonardo | Luz, Tatiana | Ramos, Maurício R. | Medeiros, Dayse C. | Carmo, Bruno M. | Seabra, André | Padez, Cristina | Silva, Manuel C. | Rodrigues, António | Coelho, Patrícia | Coelho, Alexandre | Caminha, Madson | Matheus, Filipe | Mendes, Elenice | Correia, Jony | Kretzer, Marcia | Hernandez-Martinez, Francisco J. | Jimenez-Diaz, Juan F. | Rodriguez-De-Vera, Bienvendida C. | Jimenez-Rodriguez, Carla | Armas-Gonzalez, Yadira | Rodrigues, Cátia | Pedroso, Rosa | Apolinário-Hagen, Jennifer | Vehreschild, Viktor | Veloso, Milene | Magalhães, Celina | Cabral, Isabel | Ferraz, Maira | Nave, Filipe | Costa, Emília | Matos, Filomena | Pacheco, José | Dias, António | Pereira, Carlos | Duarte, João | Cunha, Madalena | Silva, Daniel | Mónico, Lisete M. | Alferes, Valentim R. | Brêda, Mª São João | Carvalho, Carla | Parreira, Pedro M. | Morais, Mª Carminda | Ferreira, Pedro | Pimenta, Rui | Boavida, José | Pinto, Isabel C. | Pires, Tânia | Silva, Catarina | Ribeiro, Maria | Viega-Branco, Maria | Pereira, Filomena | Pereira, Ana Mª | Almeida, Fabrícia M. | Estevez, Gustavo L. | Ribeiro, Sandra | Kretzer, Marcia R. | João, Paulo V. | Nogueira, Paulo | Novais, Sandra | Pereira, Ana | Carneiro, Lara | Mota, Maria | Cruz, Rui | Santiago, Luiz | Fontes-Ribeiro, Carlos | Furtado, Guilherme | Rocha, Saulo V. | Coutinho, André P. | Neto, João S. | Vasconcelos, Lélia R. | Souza, Nelba R. | Dantas, Estélio | Dinis, Alexandra | Carvalho, Sérgio | Castilho, Paula | Pinto-Gouveia, José | Sarreira-Santos, Alexandra | Figueiredo, Amélia | Medeiros-Garcia, Lurdes | Seabra, Paulo | Rodrigues, Rosa | Morais, Mª Carminda | Fernandes, Paula O. | Santiago, Conceição | Figueiredo, Mª Henriqueta | Basto, Marta L. | Guimarães, Teresa | Coelho, André | Graça, Anabela | Silva, Ana M. | Fonseca, Ana R. | Vale-Dias, Luz | Minas, Bárbara | Franco-Borges, Graciete | Simões, Cristina | Santos, Sofia | Serra, Ana | Matos, Maria | Jesus, Luís | Tavares, Ana S. | Almeida, Ana | Leitão, Céu | Varandas, Edna | Abreu, Renato | Bellém, Fernando | Trindade, Inês A. | Ferreira, Cláudia | Pinto-Gouveia, José | Marta-Simões, Joana | Amaral, Odete | Miranda, Cristiana | Guimarães, Pedro | Gonçalves, Rodrigo | Veiga, Nélio | Pereira, Carlos | Fleig, Tânia C. | San-Martin, Elisabete A. | Goulart, Cássia L. | Schneiders, Paloma B. | Miranda, Natacha F. | Carvalho, Lisiane L. | Silva, Andrea G. | Topa, Joana | Nogueira, Conceição | Neves, Sofia | Ventura, Rita | Nazaré, Cristina | Brandão, Daniela | Freitas, Alberto | Ribeiro, Óscar | Paúl, Constança | Mercê, Cristiana | Branco, Marco | Almeida, Pedro | Nascimento, Daniela | Pereira, Juliana | Catela, David | Rafael, Helga | Reis, Alcinda C. | Mendes, Ana | Valente, Ana R. | Lousada, Marisa | Sousa, Diana | Baltazar, Ana L. | Loureiro, Mª Helena | Oliveira, Ana | Aparício, José | Marques, Alda | Marques, Alda | Oliveira, Ana | Neves, Joana | Ayoub, Rodrigo | Sousa, Luís | Marques-Vieira, Cristina | Severino, Sandy | José, Helena | Cadorio, Inês | Lousada, Marisa | Cunha, Marina | Andrade, Diogo | Galhardo, Ana | Couto, Margarida | Mendes, Fernando | Domingues, Cátia | Schukg, Susann | Abrantes, Ana M. | Gonçalves, Ana C. | Sales, Tiago | Teixo, Ricardo | Silva, Rita | Estrela, Jéssica | Laranjo, Mafalda | Casalta-Lopes, João | Rocha, Clara | Simões, Paulo C. | Sarmento-Ribeiro, Ana B. | Botelho, Mª Filomena | Rosa, Manuel S. | Fonseca, Virgínia | Colaço, Diogo | Neves, Vanessa | Jesus, Carlos | Hesse, Camilla | Rocha, Clara | Osório, Nádia | Valado, Ana | Caseiro, Armando | Gabriel, António | Svensson, Lola | Mendes, Fernando | Siba, Wafa A. | Pereira, Cristina | Tomaz, Jorge | Carvalho, Teresa | Pinto-Gouveia, José | Cunha, Marina | Duarte, Diana | Lopes, Nuno V. | Fonseca-Pinto, Rui | Duarte, Diana | Lopes, Nuno V. | Fonseca-Pinto, Rui | Martins, Anabela C. | Brandão, Piedade | Martins, Laura | Cardoso, Margarida | Morais, Nuno | Cruz, Joana | Alves, Nuno | Faria, Paula | Mateus, Artur | Morouço, Pedro | Alves, Nuno | Ferreira, Nelson | Mateus, Artur | Faria, Paula | Morouço, Pedro | Malheiro, Isabel | Gaspar, Filomena | Barros, Luísa | Parreira, Pedro | Cardoso, Andreia | Mónico, Lisete | Carvalho, Carla | Lopes, Albino | Salgueiro-Oliveira, Anabela | Seixas, Adérito | Soares, Valter | Dias, Tiago | Vardasca, Ricardo | Gabriel, Joaquim | Rodrigues, Sandra | Paredes, Hugo | Reis, Arsénio | Marinho, Sara | Filipe, Vítor | Lains, Jorge | Barroso, João | Da Motta, Carolina | Carvalho, Célia B. | Pinto-Gouveia, José | Peixoto, Ermelindo | Gomes, Ana A. | Costa, Vanessa | Couto, Diana | Marques, Daniel R. | Leitão, José A. | Tavares, José | Azevedo, Maria H. | Silva, Carlos F. | Freitas, João | Parreira, Pedro | Marôco, João | Garcia-Gordillo, Miguel A. | Collado-Mateo, Daniel | Chen, Gang | Iezzi, Angelo | Sala, José A. | Parraça, José A. | Gusi, Narcis | Sousa, Jani | Marques, Mariana | Jardim, Jacinto | Pereira, Anabela | Simões, Sónia | Cunha, Marina | Sardo, Pedro | Guedes, Jenifer | Lindo, João | Machado, Paulo | Melo, Elsa | Carvalho, Célia B. | Benevides, Joana | Sousa, Marina | Cabral, Joana | Da Motta, Carolina | Pereira, Ana T. | Xavier, Sandra | Azevedo, Julieta | Bento, Elisabete | Marques, Cristiana | Carvalho, Rosa | Marques, Mariana | Macedo, António | Silva, Ana M. | Alves, Juliana | Gomes, Ana A. | Marques, Daniel R. | Azevedo, Mª Helena | Silva, Carlos | Mendes, Ana | Lee, Huei D. | Spolaôr, Newton | Oliva, Jefferson T. | Chung, Wu F. | Fonseca-Pinto, Rui | Bairros, Keila | Silva, Cláudia D. | Souza, Clóvis A. | Schroeder, Silvana S. | Araújo, Elsa | Monteiro, Helena | Costa, Ricardo | Dias, Sara S. | Torgal, Jorge | Henriques, Carolina G. | Santos, Luísa | Caceiro, Elisa F. | Ramalho, Sónia A. | Oliveira, Rita | Afreixo, Vera | Santos, João | Mota, Priscilla | Cruz, Agostinho | Pimentel, Francisco | Marques, Rita | Dixe, Mª Anjos | Querido, Ana | Sousa, Patrícia | Benevides, Joana | Da Motta, Carolina | Sousa, Marina | Caldeira, Suzana N. | Carvalho, Célia B. | Querido, Ana | Tomás, Catarina | Carvalho, Daniel | Gomes, João | Cordeiro, Marina | Costa, Joyce O. | Valim, Frederico C. | Ribeiro, Lígia C. | Charepe, Zaida | Querido, Ana | Figueiredo, Mª Henriqueta | Aquino, Priscila S. | Ribeiro, Samila G. | Pinheiro, Ana B. | Lessa, Paula A. | Oliveira, Mirna F. | Brito, Luísa S. | Pinto, Ítalo N. | Furtado, Alessandra S. | Castro, Régia B. | Aquino, Caroline Q. | Martins, Eveliny S. | Pinheiro, Ana B | Aquino, Priscila S. | Oliveira, Lara L. | Pinheiro, Patrícia C. | Sousa, Caroline R. | Freitas, Vívien A. | Silva, Tatiane M. | Lima, Adman S. | Aquino, Caroline Q. | Andrade, Karizia V. | Oliveira, Camila A. | Vidal, Eglidia F. | Ganho-Ávila, Ana | Moura-Ramos, Mariana | Gonçalves, Óscar | Almeida, Jorge | Silva, Armando | Brito, Irma | Amado, João | Rodrigo, António | Santos, Sofia | Gomes, Fernando | Rosa, Marlene C. | Marques, Silvana F. | Luís, Sara | Cavalheiro, Luís | Ferreira, Pedro | Gonçalves, Rui | Lopes, Rui S. | Cavalheiro, Luís | Ferreira, Pedro | Gonçalves, Rui | Fiorin, Bruno H. | Santos, Marina S. | Oliveira, Edmar S. | Moreira, Rita L. | Oliveira, Elizabete A. | Filho, Braulio L. | Palmeira, Lara | Garcia, Teresa | Pinto-Gouveia, José | Cunha, Marina | Cardoso, Sara | Palmeira, Lara | Cunha, Marina | Pinto-Gouveia, José | Marta-Simões, Joana | Mendes, Ana L. | Trindade, Inês A. | Oliveira, Sara | Ferreira, Cláudia | Mendes, Ana L. | Marta-Simões, Joana | Trindade, Inês A. | Ferreira, Cláudia | Nave, Filipe | Campos, Mariana | Gaudêncio, Iris | Martins, Fernando | Ferreira, Lino | Lopes, Nuno | Fonseca-Pinto, Rui | Rodrigues, Rogério | Azeredo, Zaida | Vicente, Corália | Silva, Joana | Sousa, Patrícia | Marques, Rita | Mendes, Isabel | Rodrigues, Rogério | Azeredo, Zaida | Vicente, Corália | Vardasca, Ricardo | Marques, Ana R. | Seixas, Adérito | Carvalho, Rui | Gabriel, Joaquim | Ferreira, Paulo P. | Oliveira, Michelle T. | Sousa, Anderson R. | Maia, Ana S. | Oliveira, Sebastião T. | Costa, Pablo O. | Silva, Maiza M. | Arreguy-Sena, Cristina | Alvarenga-Martins, Nathália | Pinto, Paulo F. | Oliveira, Denize C. | Parreira, Pedro D. | Gomes, Antônio T. | Braga, Luciene M. | Araújo, Odete | Lage, Isabel | Cabrita, José | Teixeira, Laetitia | Marques, Rita | Dixe, Mª Anjos | Querido, Ana | Sousa, Patrícia | Silva, Sara | Cordeiro, Eugénio | Pimentel, João | Ferro-Lebres, Vera | Souza, Juliana A. | Tavares, Mariline | Dixe, Mª Anjos | Sousa, Pedro | Passadouro, Rui | Peralta, Teresa | Ferreira, Carlos | Lourenço, Georgina | Serrano, João | Petrica, João | Paulo, Rui | Honório, Samuel | Mendes, Pedro | Simões, Alexandra | Carvalho, Lucinda | Pereira, Alexandre | Silva, Sara | Sousa, Paulino | Padilha, José M. | Figueiredo, Daniela | Valente, Carolina | Marques, Alda | Ribas, Patrícia | Sousa, Joana | Brandão, Frederico | Sousa, Cesar | Martins, Matilde | Sousa, Patrícia | Marques, Rita | Mendes, Francisco | Fernandes, Rosina | Martins, Emília | Magalhães, Cátia | Araújo, Patrícia | Grande, Carla | Mata, Mª Augusta | Vieitez, Juan G. | Bianchini, Bruna | Nazario, Nazare | Filho, João G. | Kretzer, Marcia | Costa, Tânia | Almeida, Armando | Baffour, Gabriel | Almeida, Armando | Costa, Tânia | Baffour, Gabriel | Azeredo, Zaida | Laranjeira, Carlos | Guerra, Magda | Barbeiro, Ana P. | Ferreira, Regina | Lopes, Sara | Nunes, Liliana | Mendes, Ana | Martins, Julian | Schneider, Dulcineia | Kretzer, Marcia | Magajewski, Flávio | Soares, Célia | Marques, António | Batista, Marco | Castuera, Ruth J. | Mesquita, Helena | Faustino, António | Santos, Jorge | Honório, Samuel | Vizzotto, Betina P. | Frigo, Leticia | Pivetta, Hedioneia F. | Sardo, Dolores | Martins, Cristina | Abreu, Wilson | Figueiredo, Mª Céu | Batista, Marco | Jimenez-Castuera, Ruth | Petrica, João | Serrano, João | Honório, Samuel | Paulo, Rui | Mendes, Pedro | Sousa, Patrícia | Marques, Rita | Faustino, António | Silveira, Paulo | Serrano, João | Paulo, Rui | Mendes, Pedro | Honório, Samuel | Oliveira, Catarina | Bastos, Fernanda | Cruz, Inês | Rodriguez, Cláudia K. | Kretzer, Márcia R. | Nazário, Nazaré O. | Cruz, Pedro | Vaz, Daniela C. | Ruben, Rui B. | Avelelas, Francisco | Silva, Susana | Campos, Mª Jorge | Almeida, Maria | Gonçalves, Liliana | Antunes, Lígia | Sardo, Pedro | Guedes, Jenifer | Simões, João | Machado, Paulo | Melo, Elsa | Cardoso, Susana | Santos, Osvaldo | Nunes, Carla | Loureiro, Isabel | Santos, Flávia | Alves, Gilberto | Soar, Cláudia | Marsi, Teresa O. | Silva, Ernestina | Pedrosa, Dora | Leça, Andrea | Silva, Daniel | Galvão, Ana | Gomes, Maria | Fernandes, Paula | Noné, Ana | Combadão, Jaime | Ramalhete, Cátia | Figueiredo, Paulo | Caeiro, Patrícia | Fontana, Karine C. | Lacerda, Josimari T. | Machado, Patrícia O. | Borges, Raphaelle | Barbosa, Flávio | Sá, Dayse | Brunhoso, Germana | Aparício, Graça | Carvalho, Amâncio | Garcia, Ana P. | Fernandes, Paula O. | Santos, Adriana | Veiga, Nélio | Brás, Carina | Carvalho, Inês | Batalha, Joana | Glória, Margarida | Bexiga, Filipa | Coelho, Inês | Amaral, Odete | Pereira, Carlos | Pinho, Cláudia | Paraíso, Nilson | Oliveira, Ana I. | Lima, Cristóvão F. | Dias, Alberto P. | Silva, Pedro | Espada, Mário | Marques, Mário | Pereira, Ana | Pereira, Ana Mª | Veiga-Branco, Mª | Pereira, Filomena | Ribeiro, Maria | Lima, Vera | Oliveira, Ana I. | Pinho, Cláudia | Cruz, Graça | Oliveira, Rita F. | Barreiros, Luísa | Moreira, Fernando | Camarneiro, Ana | Loureiro, Mª Helena | Silva, Margarida | Duarte, Catarina | Jesus, Ângelo | Cruz, Agostinho | Mota, Maria | Novais, Sandra | Nogueira, Paulo | Pereira, Ana | Carneiro, Lara | João, Paulo V. | Lima, Teresa Maneca | Salgueiro-Oliveira, Anabela | Vaquinhas, Marina | Parreira, Pedro | Melo, Rosa | Graveto, João | Castilho, Amélia | Gomes, José H. | Medina, María S. | Blanco, Valeriana G. | Santos, Osvaldo | Lopes, Elisa | Virgolino, Ana | Dinis, Alexandra | Ambrósio, Sara | Almeida, Inês | Marques, Tatiana | Heitor, Mª João | Garcia-Gordillo, Miguel A. | Collado-Mateo, Daniel | Olivares, Pedro R. | Parraça, José A. | Sala, José A. | Castilho, Amélia | Graveto, João | Parreira, Pedro | Oliveira, Anabela | Gomes, José H. | Melo, Rosa | Vaquinhas, Marina | Cheio, Mónica | Cruz, Agostinho | Pereira, Olívia R. | Pinto, Sara | Oliveira, Adriana | Manso, M. Conceição | Sousa, Carla | Vinha, Ana F. | Machado, Mª Manuela | Vieira, Margarida | Fernandes, Beatriz | Tomás, Teresa | Quirino, Diogo | Desouzart, Gustavo | Matos, Rui | Bordini, Magali | Mouroço, Pedro | Matos, Ana R. | Serapioni, Mauro | Guimarães, Teresa | Fonseca, Virgínia | Costa, André | Ribeiro, João | Lobato, João | Martin, Inmaculada Z. | Björklund, Anita | Tavares, Aida I. | Ferreira, Pedro | Passadouro, Rui | Morgado, Sónia | Tavares, Nuno | Valente, João | Martins, Anabela C. | Araújo, Patrícia | Fernandes, Rosina | Mendes, Francisco | Magalhães, Cátia | Martins, Emília | Mendes, Pedro | Paulo, Rui | Faustino, António | Mesquita, Helena | Honório, Samuel | Batista, Marco | Lacerda, Josimari T. | Ortiga, Angela B. | Calvo, Mª Cristina | Natal, Sônia | Pereira, Marta | Ferreira, Manuela | Prata, Ana R. | Nelas, Paula | Duarte, João | Carneiro, Juliana | Oliveira, Ana I. | Pinho, Cláudia | Couto, Cristina | Oliveira, Rita F. | Moreira, Fernando | Maia, Ana S. | Oliveira, Michelle T. | Sousa, Anderson R. | Ferreira, Paulo P. | Souza, Géssica M. | Almada, Lívia F. | Conceição, Milena A. | Santiago, Eujcely C. | Rodrigues, Sandra | Domingues, Gabriela | Ferreira, Irina | Faria, Luís | Seixas, Adérito | Costa, Ana R. | Jesus, Ângelo | Cardoso, Américo | Meireles, Alexandra | Colaço, Armanda | Cruz, Agostinho | Vieira, Viviane L. | Vincha, Kellem R. | Cervato-Mancuso, Ana Mª | Faria, Melissa | Reis, Cláudia | Cova, Marco P. | Ascenso, Rita T. | Almeida, Henrique A. | Oliveira, Eunice G. | Santana, Miguel | Pereira, Rafael | Oliveira, Eunice G. | Almeida, Henrique A. | Ascenso, Rita T. | Jesus, Rita | Tapadas, Rodrigo | Tim-Tim, Carolina | Cezanne, Catarina | Lagoa, Matilde | Dias, Sara S. | Torgal, Jorge | Lopes, João | Almeida, Henrique | Amado, Sandra | Carrão, Luís | Cunha, Madalena | Saboga-Nunes, Luís | Albuquerque, Carlos | Ribeiro, Olivério | Oliveira, Suzete | Morais, Mª Carminda | Martins, Emília | Mendes, Francisco | Fernandes, Rosina | Magalhães, Cátia | Araújo, Patrícia | Pedro, Ana R. | Amaral, Odete | Escoval, Ana | Assunção, Victor | Luís, Henrique | Luís, Luís | Apolinário-Hagen, Jennifer | Vehreschild, Viktor | Fotschl, Ulrike | Lirk, Gerald | Martins, Anabela C. | Andrade, Isabel | Mendes, Fernando | Mendonça, Verónica | Antunes, Sandra | Andrade, Isabel | Osório, Nádia | Valado, Ana | Caseiro, Armando | Gabriel, António | Martins, Anabela C. | Mendes, Fernando | Silva, Paula A. | Mónico, Lisete M. | Parreira, Pedro M. | Carvalho, Carla | Carvalho, Carla | Parreira, Pedro M. | Mónico, Lisete M. | Ruivo, Joana | Silva, Vânia | Sousa, Paulino | Padilha, José M. | Ferraz, Vera | Aparício, Graça | Duarte, João | Vasconcelos, Carlos | Almeida, António | Neves, Joel | Correia, Telma | Amorim, Helena | Mendes, Romeu | Saboga-Nunes, Luís | Cunha, Madalena | Albuquerque, Carlos | Pereira, Elsa S. | Santos, Leonino S. | Reis, Ana S. | Silva, Helena R. | Rombo, João | Fernandes, Jorge C. | Fernandes, Patrícia | Ribeiro, Jaime | Mangas, Catarina | Freire, Ana | Silva, Sara | Francisco, Irene | Oliveira, Ana | Catarino, Helena | Dixe, Mª Anjos | Louro, Mª Clarisse | Lopes, Saudade | Dixe, Anjos | Dixe, Mª Anjos | Menino, Eva | Catarino, Helena | Soares, Fátima | Oliveira, Ana P. | Gordo, Sara | Kraus, Teresa | Tomás, Catarina | Queirós, Paulo | Rodrigues, Teresa | Sousa, Pedro | Frade, João G. | Lobão, Catarina | Moura, Cynthia B. | Dreyer, Laysa C. | Meneghetti, Vanize | Cabral, Priscila P. | Pinto, Francisca | Sousa, Paulino | Esteves, Mª Raquel | Galvão, Sofia | Tytgat, Ite | Andrade, Isabel | Osório, Nádia | Valado, Ana | Caseiro, Armando | Gabriel, António | Martins, Anabela C. | Mendes, Fernando | Casas-Novas, Mónica | Bernardo, Helena | Andrade, Isabel | Sousa, Gracinda | Sousa, Ana P. | Rocha, Clara | Belo, Pedro | Osório, Nádia | Valado, Ana | Caseiro, Armando | Gabriel, António | Martins, Anabela C. | Mendes, Fernando | Martins, Fátima | Pulido-Fuentes, Montserrat | Barroso, Isabel | Cabral, Gil | Monteiro, M. João | Rainho, Conceição | Prado, Alessandro | Carvalho, Yara M. | Campos, Maria | Moreira, Liliana | Ferreira, José | Teixeira, Ana | Rama, Luís | Campos, Maria | Moreira, Liliana | Ferreira, José | Teixeira, Ana | Rama, Luís
BMC Health Services Research  2016;16(Suppl 3):200.
Table of contents
S1 Health literacy and health education in adolescence
Catarina Cardoso Tomás
S2 The effect of a walking program on the quality of life and well-being of people with schizophrenia
Emanuel Oliveira, D. Sousa, M. Uba-Chupel, G. Furtado, C. Rocha, A. Teixeira, P. Ferreira
S3 Diagnosis and innovative treatments - the way to a better medical practice
Celeste Alves
S4 Simulation-based learning and how it is a high contribution
Stefan Gisin
S5 Formative research about acceptability, utilization and promotion of a home fortification programme with micronutrient powders (MNP) in the Autonomous Region of Príncipe, São Tomé and Príncipe
Elisabete Catarino, Nelma Carvalho, Tiago Coucelo, Luís Bonfim, Carina Silva
S6 Safety culture of the patient: a reflexion about the therapeutic approach on the patient with vocal pathology
Débora Franco
S7 About wine, fortune cookies and patient experience
Jesús Alcoba González
O1 The psychological impact on the emergency crews after the disaster event on February 20, 2010
Helena G. Jardim, Rita Silva
O2 Musculoskeletal disorders in midwives
Cristina L. Baixinho, Mª Helena Presado, Mª Fátima Marques, Mário E. Cardoso
O3 Negative childhood experiences and fears of compassion: Implications for psychological difficulties in adolescence
Marina Cunha, Joana Mendes, Ana Xavier, Ana Galhardo, Margarida Couto
O4 Optimal age to give the first dose of measles vaccine in Portugal
João G. Frade, Carla Nunes, João R. Mesquita, Maria S. Nascimento, Guilherme Gonçalves
O5 Functional assessment of elderly in primary care
Conceição Castro, Alice Mártires, Mª João Monteiro, Conceição Rainho
O6 Smoking and coronary events in a population of Spanish health-care centre: An observational study
Francisco P. Caballero, Fatima M. Monago, Jose T. Guerrero, Rocio M. Monago, Africa P. Trigo, Milagros L. Gutierrez, Gemma M. Milanés, Mercedes G. Reina, Ana G. Villanueva, Ana S. Piñero, Isabel R. Aliseda, Francisco B. Ramirez
O7 Prevalence of musculoskeletal injuries in Portuguese musicians
Andrea Ribeiro, Ana Quelhas, Conceição Manso
O8 Hip fractures, psychotropic drug consumption and comorbidity in patients of a primary care practice in Spain
Francisco P. Caballero, Jose T. Guerrero, Fatima M. Monago, Rafael B. Santos, Nuria R. Jimenez, Cristina G. Nuñez, Inmaculada R. Gomez, Mª Jose L. Fernandez, Laura A. Marquez, Ana L. Moreno, Mª Jesus Tena Huertas, Francisco B. Ramirez
O9 The role of self-criticism and shame in social anxiety in a clinical SAD sample
Daniel Seabra, Mª Céu Salvador
O10 Obstruction and infiltration: a proposal of a quality indicator
Luciene Braga, Pedro Parreira, Anabela Salgueiro-Oliveira, Cristina Arreguy-Sena, Bibiana F. Oliveira, Mª Adriana Henriques
O11 Balance and anxiety and depression symptoms in old age people
Joana Santos, Sara Lebre, Alda Marques
O12 Prevalence of postural changes and risk factors in school children and adolescents in a northern region (Porto)
Clarinda Festas, Sandra Rodrigues, Andrea Ribeiro, José Lumini
O13 Ischemic stroke vs. haemorrhagic stroke survival rate
Ana G. Figueiredo
O14 Chronobiological factors as responsible for the appearance of locomotor pathology in adolescents
Francisco J. Hernandez-Martinez, Liliana Campi, Mª Pino Quintana-Montesdeoca, Juan F. Jimenez-Diaz, Bienvenida C. Rodriguez-De-Vera
O15 Risk of malnutrition in the elderly of Bragança
Alexandra Parente, Mª Augusta Mata, Ana Mª Pereira, Adília Fernandes, Manuel Brás
O16 A Lifestyle Educational Programme for primary care diabetic patients: the design of a complex nursing intervention
Mª Rosário Pinto, Pedro Parreira, Marta L. Basto, Ana C. Rei, Lisete M. Mónico
O17 Medication adherence in elderly people
Gilberta Sousa, Clementina Morna, Otília Freitas, Gregório Freitas, Ana Jardim, Rita Vasconcelos
O18 Hospitalization for cervical cancer of residents in the metropolitan region of Porto Alegre, Southern Brazil, 2012 to 2014
Lina G. Horta, Roger S. Rosa, Luís F. Kranz, Rita C. Nugem, Mariana S. Siqueira, Ronaldo Bordin
O19 Oncologic assistance of high complexity: evaluation of regulating accesses
Rosiane Kniess, Josimari T. Lacerda
O20 Perceived barriers for using health care services by the older population as seen by the social sector: findings from the Vila Nova de Gaia Gerontological Plan
Joana Guedes, Idalina Machado, Sidalina Almeida, Adriano Zilhão, Helder Alves, Óscar Ribeiro
O21 Sleep difficulties and depressive symptoms in college students
Ana P. Amaral, Ana Santos, Joana Monteiro, Mª Clara Rocha, Rui Cruz
O22 Psychopathological symptoms and medication use in higher education
Ana P. Amaral, Marina Lourenço, Mª Clara Rocha, Rui Cruz
O23 Sexually transmitted diseases in higher education institutions
Sandra Antunes, Verónica Mendonça, Isabel Andrade, Nádia Osório, Ana Valado, Armando Caseiro, António Gabriel, Anabela C. Martins, Fernando Mendes
O24 Alcohol consumption and suicide ideation in higher education students
Lídia Cabral, Manuela Ferreira, Amadeu Gonçalves
O25 Quality of life in university students
Tatiana D. Luz, Leonardo Luz, Raul Martins
O26 Male and female adolescent antisocial behaviour: characterizing vulnerabilities in a Portuguese sample
Alice Morgado, Maria L. Vale-Dias
O27 Risk factors for mental health in higher education students of health sciences
Rui Porta-Nova
O28 International classification of functioning disability and health as reflexive reasoning in primary attention in health
Tânia C. Fleig, Éboni M. Reuter, Miriam B. Froemming, Sabrina L. Guerreiro, Lisiane L. Carvalho
O29 Risk factors and cardiovascular disease in Portalegre
Daniel Guedelha, P. Coelho, A. Pereira
O30 Health status of the elderly population living in Portalegre historic city centre: A longitudinal study
António Calha, Raul Cordeiro
O31 Student’s sleep in higher education: sleep quality among students of the IPB
Ana Gonçalves, Ana Certo, Ana Galvão, Mª Augusta Mata
O32 Trend in mortality from cervical cancer in the metropolitan area of Florianópolis, state of Santa Catarina, Brazil, 2000 to 2013
Aline Welter, Elayne Pereira, Sandra Ribeiro, Marcia Kretzer
O33 Adherence to treatment in the elderly in an urban environment in Spain
Juan-Fernando Jiménez-Díaz, Carla Jiménez-Rodríguez, Francisco-José Hernández-Martínez, Bienvenida-Del-Carmen Rodríguez-De-Vera, Alexandre Marques-Rodrigues
O34 Beira Baixa Blood Pressure Study (Study PABB)
Patrícia Coelho, Tiago Bernardes, Alexandre Pereira
O35 Trends in cervical cancer mortality statistics in Santa Catarina State, Brazil, by age group and macro-region, from 2000 to 2013
Patrícia Sousa, João G. Filho, Nazare Nazario, Marcia Kretzer
O36 Sleep problems among Portuguese adolescents: a public health issue
Odete Amaral, António Garrido, Nélio Veiga, Carla Nunes, Ana R. Pedro, Carlos Pereira
O37 Association between body fat and health-related quality of life in patients with type 2 diabetes
António Almeia, Helder M. Fernandes, Carlos Vasconcelos, Nelson Sousa, Victor M. Reis, M. João Monteiro, Romeu Mendes
O38 Therapy adherence and polypharmacy in non-institutionalized elderly from Amares county, Portugal
Isabel C. Pinto, Tânia Pires, João Gama
O39 Prevalence of surgical site infection in adults at a hospital unit in the North of Portugal
Vera Preto, Norberto Silva, Carlos Magalhães, Matilde Martins
O40 Frailty phenotype in old age: implications to intervention
Mafalda Duarte, Constança Paúl, Ignácio Martín
O41 Portuguese women: sexual symptoms in perimenopause
Arminda A. Pinheiro
O42 Predictive ability of the Perinatal Depression Screening and Prevention Tool – preliminary results of the categorical approach
Sandra Xavier, Julieta Azevedo, Elisabete Bento, Cristiana Marques, Mariana Marques, António Macedo, Ana T. Pereira
O43 Aging and muscle strength in patients with type 2 diabetes: cross sectional analysis
José P. Almeida, António Almeida, Josiane Alves, Nelson Sousa, Francisco Saavedra, Romeu Mendes
O44 Accessibility of the elderly in the prevention of hypertension in a family health unit
Ana S. Maia, Michelle T. Oliveira, Anderson R. Sousa, Paulo P. Ferreira, Luci S. Lopes, Eujcely C. Santiago
O45 Community Health screenings and self-reported chronic diseases
Sílvia Monteiro, Ângelo Jesus, Armanda Colaço, António Carvalho, Rita P. Silva, Agostinho Cruz
O46 Evaluation of indoor air quality in Kindergartens
Ana Ferreira, Catarina Marques, João P. Figueiredo, Susana Paixão
O47 Atmospheric exposure to chemical agents under the occupational activity of pathology technicians
Ana Ferreira, Carla Lopes, Fernando Moreira, João P. Figueiredo
O48 Occupational exposure to air pollutants in night entertainment venues workers
Ana Ferreira, Diana Ribeiro, Fernando Moreira, João P. Figueiredo, Susana Paixão
O49 Beliefs and attitudes of young people towards breastfeeding
Telma Fernandes, Diogo Amado, Jéssica Leal, Marcelo Azevedo, Sónia Ramalho
O50 Profiling informal caregivers: surveying needs in the care of the elderly
Catarina Mangas, Jaime Ribeiro, Rita Gonçalves
O51 Visual health in teenagers
Amélia F Nunes, Ana R. Tuna, Carlos R. Martins, Henriqueta D. Forte
O52 Amenable mortality and the geographic accessibility to healthcare in Portugal
Cláudia Costa, José A. Tenedório, Paula Santana
O53 Bacterial contamination of door handles in a São Paulo See Metropolitan Cathedral public restrooms in Brazil
J. A. Andrade, J. L. Pinto, C. Campofiorito, S. Nunes, A. Carmo, A. Kaliniczenco, B. Alves, F. Mendes, C. Jesus, F. Fonseca, F. Gehrke
O54 Adherence of patients to rehabilitation programmes
Carlos Albuquerque, Rita Batista, Madalena Cunha, António Madureira, Olivério Ribeiro, Rosa Martins
O55 Prevalence of malnutrition among Portuguese elderly living in nursing homes: preliminary results of the PEN-3S project
Teresa Madeira, Catarina Peixoto-Plácido, Nuno Santos, Osvaldo Santos, Astrid Bergland, Asta Bye, Carla Lopes, Violeta Alarcão, Beatriz Goulão, Nuno Mendonça, Paulo Nicola, João G. Clara
O56 Relation between emotional intelligence and mental illness in health students
João Gomes, Ana Querido, Catarina Tomás, Daniel Carvalho, Marina Cordeiro
P1 Fall risk factors in people older than 50 years old – a pilot report
Marlene C. Rosa, Alda Marques
P2 What about the Portuguese oldest old? A global overview using census data
Daniela Brandão, Óscar Ribeiro, Lia Araújo, Constança Paúl
P3 Prevalence of injuries in senior amateur volleyball athletes in Alentejo and Algarve clubs, Portugal: factors associated
Beatriz Minghelli, Sylvina Richaud
P4 Shame feelings and quality of life: the role of acceptance and decentring
Ana L. Mendes, Joana Marta-Simões, Inês A. Trindade, Cláudia Ferreira
P5 Assessment of social support during deployment in portuguese colonial war veterans
Teresa Carvalho, Marina Cunha, José Pinto-Gouveia
P6 Hospitalization for acute viral bronchiolitis of residents in the metropolitan region of Porto Alegre, Southern Brazil, 2012 to 2014
Morgana C. Fernandes, Roger S. Rosa, Rita C. Nugem, Luís F. Kranz, Mariana S. Siqueira, Ronaldo Bordin
P7 Falls-risk screening – an opportunity for preventing falls in the elderly from Nordeste
Anabela C. Martins, Anabela Medeiros, Rafaela Pimentel, Andreia Fernandes, Carlos Mendonça, Isabel Andrade, Susana Andrade, Ruth L. Menezes
P8 Aging provokes chronodisruption in mature people in temperature circadian rhythm
Rafael Bravo, Marta Miranda, Lierni Ugartemendia, José Mª Tena, Francisco L. Pérez-Caballero, Lorena Fuentes-Broto, Ana B. Rodríguez, Barriga Carmen
P9 The influence of climate and pollution factors in dengue cases of great ABC region, São Paulo
M. A. Carneiro, J. N. Domingues, S. Paixão, J. Figueiredo, V. B. Nascimento, C. Jesus, F Mendes, F. Gehrke, B. Alves, L. Azzalis, F. Fonseca
P10 Visual function and impact of visual therapy in children with learning disabilities: a pilot study
Ana R. Martins, Amélia Nunes, Arminda Jorge
P11 Edentulism and the need of oral rehabilitation among institutionalized elderly
Nélio Veiga, Ana Amorim, André Silva, Liliana Martinho, Luís Monteiro, Rafael Silva, Carina Coelho, Odete Amaral, Inês Coelho, Carlos Pereira, André Correia
P12 Therapy adherence of outpatients in the pharmacy services of a hospital unit
Diana Rodrigues, Nídia Marante, Pedro Silva, Sara Carvalho, André Rts Araujo, Maximiano Ribeiro, Paula Coutinho, Sandra Ventura, Fátima Roque
P13 Universal access and comprehensive care of oral health: an availability study
Cristina Calvo, Manoela Reses
P14 Is the respiratory function of children a predictor of air quality? Coimbra as a case study
Jorge Conde, Ana Ferreira, João Figueiredo
P15 Meaning-in-life of college students
David Silva, Luís Seiça, Raquel Soares, Ricardo Mourão, Teresa Kraus
O57 Training needs for nurses in palliative care
Ana C. Abreu, José M. Padilha, Júlia M. Alves
O58 Impact of computerized information systems in the global nurses’ workload: nurses’ perceptions and real-time
Paulino Sousa, Manuel Oliveira, Joana Sousa
O59 The perspective of health care professionals on self-care in hereditary neurodegenerative disease: a qualitative study
Sónia Novais, Felismina Mendes
O60 Contribution for health-related physical fitness reference values in healthy adolescents
Joana Pinto, Joana Cruz, Alda Marques
School of Health Sciences, University of Aveiro, 3810-193 Aveiro, Portugal
O61 Perception of learning, satisfaction and self-efficacy of nursing students about High-Fidelity Simulation
Hugo Duarte, Maria Dos Anjos Dixe, Pedro Sousa
O62 Analysis of statements of diagnosis about health deviation in self-care requisites customized in a Nursing Practice Support System (SAPE®): Management of therapeutic regimen
Inês Cruz, Fernanda Bastos, Filipe Pereira
O63 Hybrid management and hospital governance: doctors and nurses as managers
Francisco L. Carvalho, Teresa T. Oliveira, Vítor R. Raposo
O64 Time management in health professionals
Conceição Rainho, José C. Ribeiro, Isabel Barroso, Vítor Rodrigues
O65 Financial rewards and wellbeing in primary health care
Carmo Neves, Teresa C. Oliveira
O66 Patient safety promotion in the operating room
Bárbara Oliveira, Mª Carminda Morais, Pilar Baylina
O67 Difficulties and needs of pre-graduate nursing students in the area of Geriatrics/Gerontology
Rogério Rodrigues, Zaida Azeredo, Corália Vicente
O68 Teaching and learning sexuality in nursing education
Hélia Dias, Margarida Sim-Sim
O69 Entrepreneurial Motivations Questionnaire: AFC and CFA in academy
Pedro Parreira, Anabela Salgueiro-Oliveira, Amélia Castilho, Rosa Melo, João Graveto, José Gomes, Marina Vaquinhas, Carla Carvalho, Lisete Mónico, Nuno Brito
O70 Nursing intervention to patient with Permanent Pacemakers and Implantable Cardioverter Defibrillators: a qualitative analysis
Cassilda Sarroeira, José Amendoeira, Fátima Cunha, Anabela Cândido, Patrícia Fernandes, Helena R. Silva, Elsa Silva
O71 Alcohol consumption among nursing students: where does education fail?
Isabel Barroso, Leila Lapa, Cristina Antunes
O72 Labour stress in nursing
Ana Gonçalves, Ana Galvão, Mª José Gomes, Susana R. Escanciano
O73 The influence of safe staff nursing in patient satisfaction with nursing care
Maria Freitas, Pedro Parreira, João Marôco
O74 Intention to use eHealth strategies with nursing students
Ana R. Fernandes, Cremilde Cabral, Samuel Alves, Pedro Sousa
O75 Community Based Mental Health: contributions of an interdisciplinary international program for students in higher health education
António Ferreira, Fernanda Príncipe, Ulla-Maija Seppänen, Margarida Ferreira, Maribel Carvalhais, Marilene Silva
O76 Study of satisfaction at work of graduates in nursing: 2002-2014
Manuela Ferreira, Joana Silva, Jéssica Neves, Diana Costa, Bruno Santos, Soraia Duarte
O77 Health professionals’ attitudes towards breastfeeding
Sílvia Marques, Sónia Ramalho, Isabel Mendes
O78 Continuity of nursing care to person with type 2 diabetes
Clarisse Louro, Eva Menino, Maria Dixe, Sara S. Dias
O79 Stigma toward mental illness among future health professionals
Marina Cordeiro, Catarina Tomás, Ana Querido, Daniel Carvalho, João Gomes
O80 Working with fears and anxieties of medical students in search of a humanized care
Frederico C. Valim, Joyce O. Costa, Lúcia G. Bernardes
P16 Surgical paediatrics patients’ psycho prophylaxis at a teaching hospital
Helena Prebianchi
P17 Patient-perceived outcomes in physiotherapy – a pilot study
Marlene Cristina Rosa
P18 Building competencies for managers in nursing
Narcisa Gonçalves, Maria M. Martins, Paulina Kurcgant
P19 Theoretical basis underlying physiotherapy practice in stroke rehabilitation
André Vieira
P20 When the life-cycle ends: the nurse’s confrontation with death
Sandrina Bento, Sérgio Deodato, Isabel Rabiais
P21 Nursing students’ opinion about the supervision relationship during their first clinical experience
Laura Reis
P22 Nursing Relational Laboratory: Pedagogical, dialogic and critical project
Ana Torres, Sérgio Soares, Margarida Ferreira, Pedro Graça
P23 Job satisfaction of bioscientists at a Lisbon hospital
Céu Leitão, Renato Abreu, Fernando Bellém, Ana Almeida, Edna Ribeiro-Varandas, Ana Tavares
P24 Sociodemographic and professional profile of nurses and its relation with the importance of family in nursing practices
João G. Frade, Carolina Henriques, Eva Menino, Clarisse Louro, Célia Jordão
P25 Professional satisfaction of rehabilitation nurses
Sofia Neco, Carminda Morais, Pedro Ferreira
P26 The person living with a stoma: the formalization of knowledge in nursing
Carla R. Silva, Alice Brito, Antónia Silva
P27 Validation of the Portuguese versions of the nursing students’ perceptions of learning and learner satisfaction with simulation tool
Hugo Duarte, Maria Dos Anjos Dixe, Pedro Sousa
P28 Physiotherapists’ perceived knowledge on technologies for electronic health records for physiotherapy
Gabriela Postolache, Raul Oliveira, Isabel Moreira, Luísa Pedro, Sónia Vicente, Samuel Domingos, Octavian Postolache
P29 Quality of life and physical activity of medicine undergraduate students in the University of Southern Santa Catarina, Brazil
Darlen Silva, João G. Filho, Nazare Nazario, Marcia Kretzer, Dulcineia Schneider
P30 The curricular skills for decision making education in a Nursing Degree
Fátima M. Marques
P31 Effect of nurses’ mobilization in satisfaction at work and turnover: An empirical study in the hospital setting
Pedro Parreira, Carla Carvalho, Lisete M. Mónico, Carlos Pinto, Sara Vicente, São João Breda
P32 Entrepreneurial skills of students of polytechnic higher education in Portugal: Business influences
José H. Gomes, Rosa Melo, Pedro Parreira, Anabela Salgueiro, João Graveto, Marina Vaquinhas, Amélia Castilho
P33 Design and assessment of e-learning modules for Pharmacology
Ângelo Jesus, Nuno Duarte, José C. Lopes, Hélder Nunes, Agostinho Cruz
P34 Perspective of nurses involved in an action-research study on the changes observed in care provision: results from a focus group
Anabela Salgueiro-Oliveira, Pedro Parreira, Marta L. Basto, Luciene M. Braga
P35 Use of peer feedback by nursing students during clinical training: teacher’s perception
António Ferreira, Beatriz Araújo, José M. Alves, Margarida Ferreira, Maribel Carvalhais, Marilene Silva, Sónia Novais
P36 What’s new on endotracheal suctioning recommendations
Ana S. Sousa, Cândida Ferrito
P37 Assessment of the nurses satisfaction on the Central Region of Portugal
Pedro L. Ferreira, Alexandre Rodrigues, Margarida Ferreira, Isabel Oliveira
P38 Study of graduate’s satisfaction with the school of nursing
Manuela Ferreira, Jéssica Neves, Diana Costa, Soraia Duarte, Joana Silva, Bruno Santos
P39 Partnership between the school of nursing and the hospital: Supervisors´ perspectives
Cristina Martins, Ana P. Macedo, Odete Araújo, Cláudia Augusto, Fátima Braga, Lisa Gomes, Maria A. Silva, Rafaela Rosário
P40 Coping strategies of college students
Luís Pimenta, Diana Carreira, Patrícia Teles, Teresa Barros
P41 Emotional intelligence and mental health stigma in health students
Catarina Tomás, Ana Querido, Daniel Carvalho, João Gomes, Marina Cordeiro
P42 Stigma of mental health assessment: Comparison between health courses
Daniel Carvalho, Ana Querido, Catarina Tomás, João Gomes, Marina Cordeiro
O81 Short- and long-term effects of pulmonary rehabilitation in mild COPD
Cristina Jácome, Alda Marques
O82 Phonological awareness programme for preschool children
Sylvie Capelas, Andreia Hall, Dina Alves, Marisa Lousada
O83 REforma ATIVA: An efficient health promotion program to be implemented during retirement
Mª Helena Loureiro, Ana Camarneiro, Margarida Silva, Aida Mendes, Ana Pedreiro
O84 Intervention for men who batter women, a case report
Anne G.Silva, Elza S. Coelho
O85 Immediate effects of Bowen Therapy on muscle tone and flexibility
Flávio Melo, Fernando Ribeiro, Rui Torres, Rui Costa
O86 Predictive equation for incremental shuttle walk test in adolescents
Tânia Pinho, Cristina Jácome, Alda Marques
O87 Life satisfaction and psychopathology in institutionalized elderly people: The results of an adapted Mindfulness-Based Stress Reduction program
Bárbara Cruz, Daniel Seabra, Diogo Carreira, Maria Ventura
O88 Outcome changes in COPD rehabilitation: exploring the relationship between physical activity and health-related outcomes
Joana Cruz, Dina Brooks, Alda Marques
O89 Assessing the effectiveness of a Complex Nursing Intervention
M Rosário Pinto, Pedro Parreira, Marta Lima-Basto, Miguel Neves, Lisete M. Mónico
O90 Psychotherapeutic intervention in addiction disorders: Change in psychopathological symptoms and emotional states
Carla Bizarro, Marina Cunha, Ana Galhardo, Couto Margarida, Ana P. Amorim, Eduardo Silva
O91 Economic impact of a nursing intervention program to promote self-management in COPD
Susana Cruz, José M. Padilha, Jorge Valente
O92 Multimodal acute pain management during uterine artery embolization in treatment of uterine myomas
José T. Guerrero, Francisco P. Caballero, Rafael B. Santos, Estefania P. Gonzalez, Fátima M. Monago, Lierni U. Ugalde, Marta M. Vélez, Maria J. Tena
O93 Fluid administration strategies in major surgery: Goal-directed therapy
José T. Guerrero, Rafael Bravo, Francisco L. Pérez-Caballero, Isabel A. Becerra, Mª Elizabeth Agudelo, Guadalupe Acedo, Roberto Bajo
O94 Development and implementation of a self-management educational programme using lay-led’s in adolescents Spina Bifida: A pilot study
Isabel Malheiro, Filomena Gaspar, Luísa Barros
O95 Influence of chair-based yoga exercises on salivary anti-microbial proteins in institutionalized frail-elderly women: a preliminary study
Guilherme Furtado, Mateus Uba-Chupel, Mariana Marques, Luís Rama, Margarida Braga, José P. Ferreira, Ana Mª Teixeira
O96 High intensity interval training vs moderate intensity continuous training impact on diabetes 2
João Cruz, Tiago Barbosa, Ângela Simões, Luís Coelho
O97 Family caregiver of people with pressure ulcer: Nursing intervention plan
Alexandre Rodrigues, Juan-Fernando Jiménez-Díaz, Francisco Martinez-Hernández, Bienvenida Rodriguez-De-Vera, Pedro Ferreira, Alexandrina Rodrigues
O98 Chronic effects of exercise on motor memory consolidation in elderly people
André Ramalho, João Petrica, Pedro Mendes, João Serrano, Inês Santo, António Rosado
O99 Impression cytology of the ocular surface: Collection technique and sample processing
Paula Mendonça, Kátia Freitas
O100 Does sport practice affect the reaction time in neuromuscular activity?
Dora Ferreira, António Brito, Renato Fernandes
O101 Efficiency of the enteral administration of fibbers in the treatment of chronic obstipation
Sofia Gomes, Fernando Moreira, Cláudia Pinho, Rita Oliveira, Ana I. Oliveira
O102 Fast decalcifier in compact bone and spongy bone
Paula Mendonça, Ana P. Casimiro, Patrícia Martins, Iryna Silva
O103 Health promotion in the elderly – Intervention project in dementia
Diana Evangelista
O104 Prevention of musculoskeletal disorders through an exercise protocol held in labour context
Catarina Leitão, Fábia Velosa, Nélio Carecho, Luís Coelho
O105 Knowledge of teachers and other education agents on diabetes type 1: Effectiveness of an intervention program
Eva Menino, Anjos Dixe, Helena Catarino, Fátima Soares, Ester Gama, Clementina Gordo
O106 Treatment of diabetic peripheral neuropathic pain: a systematic review of clinical trials of phase II and III
Eliana Moreira, Cristiana Midões, Marlene Santos
O107 New drugs for osteoporosis treatment: Systematic review of clinical trials of phase II and III
Sara Machado, Vânia P. Oliveira, Marlene Santos
O108 Promoting hope at the end of life: Effectiveness of an Intervention Programme
Ana Querido, Anjos Dixe, Rita Marques, Zaida Charepe
P43 Psychomotor therapy effects on adaptive behaviour and motor proficiency of adults with intellectual disability
Ana Antunes, Sofia Santos
P44 The effect of exercise therapy in multiple sclerosis – a single study case
Marlene C. Rosa
P45 Physical condition and self-efficacy in people with fall risk – a preliminary study
Marlene C. Rosa, Silvana F. Marques
P46 Shock waves: their effectiveness in improving the symptoms of calcifying tendinitis of the shoulder
Beatriz Minghelli, Eulália Caro
P47 Pacifier – construction and pilot application of a parenting intervention for parents of babies until six months in primary health care
Mª José Luís, Teresa Brandão
P48 The influence of Motor Imagery in fine motor skills of individuals with disabilities
Pedro Mendes, Daniel Marinho, João Petrica, Diogo Monteiro, Rui Paulo, João Serrano, Inês Santo
P49 Evaluation of the effects of a walking programme on the fall risk factors in older people – a longitudinal pilot study
Lina Monteiro, Fátima Ramalho, Rita Santos-Rocha, Sónia Morgado, Teresa Bento
P50 Nursing intervention programme in lifestyles of adolescents
Gilberta Sousa, Otília Freitas, Isabel Silva, Gregório Freitas, Clementina Morna, Rita Vasconcelos
P51 The person submitted to hip replacement rehabilitation, at home
Tatiana Azevedo, Salete Soares, Jacinta Pisco
P52 Effects of Melatonin use in the treatment of neurovegetative diseases
Paulo P. Ferreira, Efrain O. Olszewer, Michelle T. Oliveira, Anderson R. Sousa, Ana S. Maia, Sebastião T. Oliveira
P53 Review of Phytotherapy and other natural substances in alcohol abuse and alcoholism
Erica Santos, Ana I. Oliveira, Carla Maia, Fernando Moreira, Joana Santos, Maria F. Mendes, Rita F. Oliveira, Cláudia Pinho
P54 Dietary programme impact on biochemical markers in diabetics: systematic review
Eduarda Barreira, Ana Pereira, Josiana A. Vaz, André Novo
P55 Biological approaches to knee osteoarthritis: platelet-rich plasma and hyaluronic acid
Luís D. Silva, Bruno Maia, Eduardo Ferreira, Filipa Pires, Renato Andrade, Luís Camarinha
P56 Platelet-rich plasma and hyaluronic acid intra-articular injections for the treatment of ankle osteoarthritis
Luís D. Silva, Bruno Maia, Eduardo Ferreira, Filipa Pires, Renato Andrade, Luís Camarinha
P57 The impact of preventive measures in the incidence of diabetic foot ulcers: a systematic review
Ana F. César, Mariana Poço, David Ventura, Raquel Loura, Pedro Gomes, Catarina Gomes, Cláudia Silva, Elsa Melo, João Lindo
P58 Dating violence among young adolescents
Joana Domingos, Zaida Mendes, Susana Poeta, Tiago Carvalho, Catarina Tomás, Helena Catarino, Mª Anjos Dixe
P59 Physical activity and motor memory in pedal dexterity
André Ramalho, António Rosado, Pedro Mendes, Rui Paulo, Inês Garcia, João Petrica
P60 The effects of whole body vibration on the electromyographic activity of thigh muscles
Sandra Rodrigues, Rui Meneses, Carlos Afonso, Luís Faria, Adérito Seixas
P61 Mental health promotion in the workplace
Marina Cordeiro, Paulo Granjo, José C. Gomes
P62 Influence of physical exercise on the self-perception of body image in elderly women: A systematic review of qualitative studies
Nelba R. Souza, Guilherme E. Furtado, Saulo V. Rocha, Paula Silva, Joana Carvalho
O109 Psychometric properties of the Portuguese version of the Éxamen Geronto-Psychomoteur (P-EGP)
Marina Ana Morais, Sofia Santos, Paula Lebre, Ana Antunes
O110 Symptoms of depression in the elderly population of Portugal, Spain and Italy
António Calha
O111 Emotion regulation strategies and psychopathology symptoms: A comparison between adolescents with and without deliberate self-harm
Ana Xavier, Marina Cunha, José Pinto-Gouveia
O112 Prevalence of physical disability in people with leprosy
Liana Alencar, Madalena Cunha, António Madureira
O113 Quality of life and self-esteem in type 1 and type 2 diabetes mellitus patients
Ilda Cardoso, Ana Galhardo, Fernanda Daniel, Vítor Rodrigues
O114 Cross-cultural comparison of gross motor coordination in children from Brazil and Portugal
Leonardo Luz, Tatiana Luz, Maurício R. Ramos, Dayse C. Medeiros, Bruno M. Carmo, André Seabra, Cristina Padez, Manuel C. Silva
O115 Electrocardiographic differences between African and Caucasian people
António Rodrigues, Patrícia Coelho, Alexandre Coelho
O116 Factors associated with domestic, sexual and other types of violence in the city of Palhoça - Brazil
Madson Caminha, Filipe Matheus, Elenice Mendes, Jony Correia, Marcia Kretzer
O117 Tinnitus prevalence study of users of a hospital of public management - Spain
Francisco J. Hernandez-Martinez, Juan F. Jimenez-Diaz, Bienvendida C. Rodriguez-De-Vera, Carla Jimenez-Rodriguez, Yadira Armas-Gonzalez
O118 Difficulties experienced by parents of children with diabetes mellitus of preschool age in therapeutic and nutritional management
Cátia Rodrigues, Rosa Pedroso
O119 E-mental health - “nice to have” or “must have”? Exploring the attitudes towards e-mental health in the general population
Jennifer Apolinário-Hagen, Viktor Vehreschild
O120 Violence against children and adolescents and the role of health professionals: Knowing how to identify and care
Milene Veloso, Celina Magalhães, Isabel Cabral, Maira Ferraz
O121 Marital violence. A study in the Algarve population
Filipe Nave, Emília Costa, Filomena Matos, José Pacheco
O122 Clinical factors and adherence to treatment in ischemic heart disease
António Dias, Carlos Pereira, João Duarte, Madalena Cunha, Daniel Silva
O123 Can religiosity improve optimism in participants in states of illness, when controlling for life satisfaction?
Lisete M. Mónico, Valentim R. Alferes, Mª São João Brêda, Carla Carvalho, Pedro M. Parreira
O124 Empowerment, knowledge and quality of life of people with diabetes type 2 in the Alto Minho Health Local Unit
Mª Carminda Morais, Pedro Ferreira, Rui Pimenta, José Boavida
O125 Antihypertensive therapy adherence among hypertensive patients from Bragança county, Portugal
Isabel C. Pinto, Tânia Pires, Catarina Silva
O126 Subjective perception of sexual achievement - An exploratory study on people with overweight
Maria Ribeiro, Maria Viega-Branco, Filomena Pereira, Ana Mª Pereira
O127 Physical activity level and associated factors in hypertensive individuals registered in the family health strategy of a basic health unit from the city of Palhoça, Santa Catarina, Brazil
Fabrícia M. Almeida, Gustavo L. Estevez, Sandra Ribeiro, Marcia R. Kretzer
O128 Perception of functional fitness and health in non-institutionalised elderly from rural areas
Paulo V. João, Paulo Nogueira, Sandra Novais, Ana Pereira, Lara Carneiro, Maria Mota
O129 Medication adherence in patients with type 2 diabetes mellitus treated at primary health care in Coimbra
Rui Cruz, Luiz Santiago, Carlos Fontes-Ribeiro
O130 Multivariate association between body mass index and multi-comorbidities in elderly people living in low socio-economic status context
Guilherme Furtado, Saulo V. Rocha, André P. Coutinho, João S. Neto, Lélia R. Vasconcelos, Nelba R. Souza, Estélio Dantas
O131 Metacognition, rumination and experiential avoidance in Borderline Personality Disorder
Alexandra Dinis, Sérgio Carvalho, Paula Castilho, José Pinto-Gouveia
O132 Health issues in a vulnerable population: nursing consultation in a public bathhouse in Lisbon
Alexandra Sarreira-Santos, Amélia Figueiredo, Lurdes Medeiros-Garcia, Paulo Seabra
O133 The perception of quality of life in people with multiple sclerosis accompanied in External Consultation of the Local Health Unit of Alto Minho
Rosa Rodrigues, Mª Carminda Morais, Paula O. Fernandes
O134 Representation of interaction established between immigrant women and nurse during pregnancy to postpartum, from the perspective of immigrant women
Conceição Santiago, Mª Henriqueta Figueiredo, Marta L. Basto
O135 Illness perceptions and medication adherence in hypertension
Teresa Guimarães, André Coelho, Anabela Graça, Ana M. Silva, Ana R. Fonseca
O136 A Portuguese study on adults’ intimate partner violence, interpersonal trust and hope
Luz Vale-Dias, Bárbara Minas, Graciete Franco-Borges
P63 QOL’ predictors of people with intellectual disability and general population
Cristina Simões, Sofia Santos
P64 Content validation of the Communication Disability Profile (CDP) - Portuguese Version
Ana Serra, Maria Matos, Luís Jesus
P65 Study of biochemical and haematological changes in football players
Ana S. Tavares, Ana Almeida, Céu Leitão, Edna Varandas, Renato Abreu, Fernando Bellém
P66 Body image dissatisfaction in inflammatory bowel disease: exploring the role of chronic illness-related shame
Inês A. Trindade, Cláudia Ferreira, José Pinto-Gouveia, Joana Marta-Simões
P67 Obesity and sleep in the adult population - a systematic review
Odete Amaral, Cristiana Miranda, Pedro Guimarães, Rodrigo Gonçalves, Nélio Veiga, Carlos Pereira
P68 Frequency of daytime sleepiness and obstructive sleep apnea risk in COPD patients
Tânia C. Fleig, Elisabete A. San-Martin, Cássia L. Goulart, Paloma B. Schneiders, Natacha F. Miranda, Lisiane L. Carvalho, Andrea G. Silva
P69 Working with immigrant-origin clients: discourses and practices of health professionals
Joana Topa, Conceição Nogueira, Sofia Neves
P70 Systemic Lupus Erythematosus – what are audiovestibular changes?
Rita Ventura, Cristina Nazaré
P71 Mental disorders in the oldest old: findings from the Portuguese national hospitalization database
Daniela Brandão, Alberto Freitas, Óscar Ribeiro, Constança Paúl
P72 Recurrence analysis in postural control in children with cerebral palsy
Cristiana Mercê, Marco Branco, Pedro Almeida, Daniela Nascimento, Juliana Pereira, David Catela
P73 The experience of self-care in the elderly with COPD: contributions to reflect proximity care
Helga Rafael
P74 Culturally competent nurses: managing unpredictability in clinical practice with immigrants
Alcinda C. Reis
O137 Paediatric speech and language screening: An instrument for health professionals
Ana Mendes, Ana R. Valente, Marisa Lousada
O138 Anthropometric and nutritional assessment in bodybuilders
Diana Sousa, Ana L. Baltazar, Mª Helena Loureiro
O139 Computerized adventitious respiratory sounds in children with lower respiratory tract infections
Ana Oliveira, José Aparício, Alda Marques
O140 Role of computerized respiratory sounds as a marker in LRTI
Alda Marques, Ana Oliveira, Joana Neves, Rodrigo Ayoub
O141 Confirmatory factor analysis of the Personal Wellbeing Index in people with chronic kidney disease
Luís Sousa, Cristina Marques-Vieira, Sandy Severino, Helena José
O142 Phonological awareness skills in school aged children
Inês Cadorio, Marisa Lousada
O143 Assessment of early memories of warmth and safeness in interaction with peers: its relationship with psychopathology in adolescence
Marina Cunha, Diogo Andrade, Ana Galhardo, Margarida Couto
O144 The molecular effects induced by single shot irradiation on a diffuse large B cell lymphoma cell line
Fernando Mendes, Cátia Domingues, Susann Schukg, Ana M. Abrantes, Ana C. Gonçalves, Tiago Sales, Ricardo Teixo, Rita Silva, Jéssica Estrela, Mafalda Laranjo, João Casalta-Lopes, Clara Rocha, Paulo C. Simões, Ana B. Sarmento-Ribeiro, Mª Filomena Botelho, Manuel S. Rosa
O145 Morpho-functional characterization of cardiac chambers by Transthoracic Echocardiography, in young athletes of gymnastics competition
Virgínia Fonseca, Diogo Colaço, Vanessa Neves
O146 Prevalence of the antibodies of the new histo-blood system – FORS system
Carlos Jesus, Camilla Hesse, Clara Rocha, Nádia Osório, Ana Valado, Armando Caseiro, António Gabriel, Lola Svensson, Fernando Mendes, Wafa A. Siba, Cristina Pereira, Jorge Tomaz
O147 Assessment of the war-related perceived threat in Portuguese Colonial War Veterans
Teresa Carvalho, José Pinto-Gouveia, Marina Cunha
O148 Pulse transit time estimation for continuous blood pressure measurement: A comparative study
Diana Duarte, Nuno V. Lopes, Rui Fonseca-Pinto
O149 Blood pressure assessment during standard clinical manoeuvres: A non-invasive PPT based approach
Diana Duarte, Nuno V. Lopes, Rui Fonseca-Pinto
O150 Development and initial validation of the Activities and Participation Profile related to Mobility (APPM)
Anabela C. Martins
O151 MEASYCare-2010 Standard–A geriatric evaluation system in primary health care: Reliability and validity of the latest version in Portugal
Piedade Brandão, Laura Martins, Margarida Cardoso
O152 Interrater and intrarater reliability and agreement of the range of shoulder flexion in the standing upright position through photographic assessment
Nuno Morais, Joana Cruz
O153 Three-dimensional biofabrication techniques for tissue regeneration
Nuno Alves, Paula Faria, Artur Mateus, Pedro Morouço
O154 A new computer tool for biofabrication applied to tissue engineering
Nuno Alves, Nelson Ferreira, Artur Mateus, Paula Faria, Pedro Morouço
O155 Development and psychometric qualities of a scale to measure the functional independence of adolescents with motor impairment
Isabel Malheiro, Filomena Gaspar, Luísa Barros
O156 Organizational Trust in Health services: Exploratory and Confirmatory factor analysis of the Organizational Trust Inventory- Short Form (OTI-SF)
Pedro Parreira, Andreia Cardoso, Lisete Mónico, Carla Carvalho, Albino Lopes, Anabela Salgueiro-Oliveira
O157 Thermal symmetry: An indicator of occupational task asymmetries in physiotherapy
Adérito Seixas, Valter Soares, Tiago Dias, Ricardo Vardasca, Joaquim Gabriel, Sandra Rodrigues
O158 A study of ICT active monitoring adoption in stroke rehabilitation
Hugo Paredes, Arsénio Reis, Sara Marinho, Vítor Filipe, João Barroso
O159 Paranoia Checklist (Portuguese Version): Preliminary studies in a mixed sample of patients and healthy controls
Carolina Da Motta, Célia B. Carvalho, José Pinto-Gouveia, Ermelindo Peixoto
O160 Reliability and validity of the Composite Scale on Morningness: European Portuguese version, in adolescents and young adults
Ana A. Gomes, Vanessa Costa, Diana Couto, Daniel R. Marques, José A. Leitão, José Tavares, Maria H. Azevedo, Carlos F. Silva
O161 Evaluation scale of patient satisfaction with nursing care: Psychometric properties evaluation
João Freitas, Pedro Parreira, João Marôco
O162 Impact of fibromyalgia on quality of life: Comparing results from generic instruments and FIQR
Miguel A. Garcia-Gordillo, Daniel Collado-Mateo, Gang Chen, Angelo Iezzi, José A. Sala, José A. Parraça, Narcis Gusi
O163 Preliminary study of the adaptation and validation of the Rating Scale of Resilient Self: Resilience, self-harm and suicidal ideation in adolescents
Jani Sousa, Mariana Marques, Jacinto Jardim, Anabela Pereira, Sónia Simões, Marina Cunha
O164 Development of the first pressure ulcer in inpatient setting: Focus on length of stay
Pedro Sardo, Jenifer Guedes, João Lindo, Paulo Machado, Elsa Melo
O165 Forms of Self-Criticizing and Self-Reassuring Scale: Adaptation and early findings in a sample of Portuguese children
Célia B. Carvalho, Joana Benevides, Marina Sousa, Joana Cabral, Carolina Da Motta
O166 Predictive ability of the Perinatal Depression Screening and Prevention Tool – Preliminary results of the dimensional approach
Ana T. Pereira, Sandra Xavier, Julieta Azevedo, Elisabete Bento, Cristiana Marques, Rosa Carvalho, Mariana Marques, António Macedo
O167 Psychometric properties of the BaSIQS-Basic Scale on insomnia symptoms and quality of sleep, in adults and in the elderly
Ana M. Silva, Juliana Alves, Ana A. Gomes, Daniel R. Marques, Mª Helena Azevedo, Carlos Silva
O168 Enlightening the human decision in health: The skin melanocytic classification challenge
Ana Mendes, Huei D. Lee, Newton Spolaôr, Jefferson T. Oliva, Wu F. Chung, Rui Fonseca-Pinto
O169 Test-retest reliability household life study and health questionnaire Pomerode (SHIP-BRAZIL)
Keila Bairros, Cláudia D. Silva, Clóvis A. Souza, Silvana S. Schroeder
O170 Characterization of sun exposure behaviours among medical students from Nova Medical School
Elsa Araújo, Helena Monteiro, Ricardo Costa, Sara S. Dias, Jorge Torgal
O171 Spirituality in pregnant women
Carolina G. Henriques, Luísa Santos, Elisa F. Caceiro, Sónia A. Ramalho
O172 Polypharmacy in older patients with cancer
Rita Oliveira, Vera Afreixo, João Santos, Priscilla Mota, Agostinho Cruz, Francisco Pimentel
O173 Quality of life of caregivers of people with advanced chronic disease: Translation and validation of the quality of life in life threatening illness - family carer version (QOLLTI-C-PT)
Rita Marques, Mª Anjos Dixe, Ana Querido, Patrícia Sousa
O174 The psychometric properties of the brief Other as Shamer Scale for Children (OAS-C): preliminary validation studies in a sample of Portuguese children
Joana Benevides, Carolina Da Motta, Marina Sousa, Suzana N. Caldeira, Célia B. Carvalho
O175 Measuring emotional intelligence in health care students – Revalidation of WLEIS-P
Ana Querido, Catarina Tomás, Daniel Carvalho, João Gomes, Marina Cordeiro
O176 Health indicators in prenatal assistance: The impact of computerization and of under-production in basic health centres
Joyce O. Costa, Frederico C. Valim, Lígia C. Ribeiro
O177 Hope genogram: Assessment of resources and interaction patterns in the family of the child with cerebral palsy
Zaida Charepe, Ana Querido, Mª Henriqueta Figueiredo
O178 The influence of childbirth type in postpartum quality of life
Priscila S. Aquino, Samila G. Ribeiro, Ana B. Pinheiro, Paula A. Lessa, Mirna F. Oliveira, Luísa S. Brito, Ítalo N. Pinto, Alessandra S. Furtado, Régia B. Castro, Caroline Q. Aquino, Eveliny S. Martins
O179 Women’s beliefs about pap smear test and cervical cancer: influence of social determinants
Ana B Pinheiro, Priscila S. Aquino, Lara L. Oliveira, Patrícia C. Pinheiro, Caroline R. Sousa, Vívien A. Freitas, Tatiane M. Silva, Adman S. Lima, Caroline Q. Aquino, Karizia V. Andrade, Camila A. Oliveira, Eglidia F. Vidal
O180 Validity of the Portuguese version of the ASI-3: Is anxiety sensitivity a unidimensional or multidimensional construct?
Ana Ganho-Ávila, Mariana Moura-Ramos, Óscar Gonçalves, Jorge Almeida
O181 Lifestyles of higher education students: the influence of self-esteem and psychological well-being
Armando Silva, Irma Brito, João Amado
P75 Assessing the quality of life of persons with significant intellectual disability: Portuguese version of Escala de San Martín
António Rodrigo, Sofia Santos, Fernando Gomes
P76 Childhood obesity and breastfeeding - A systematic review
Marlene C. Rosa, Silvana F. Marques
P77 Cross-cultural adaptation of the Foot and Ankle Ability Measure (FAAM) for the Portuguese population
Sara Luís, Luís Cavalheiro, Pedro Ferreira, Rui Gonçalves
P78 Cross-cultural adaptation of the Patient-Rated Wrist Evaluation score (PRWE) for the Portuguese population
Rui S. Lopes, Luís Cavalheiro, Pedro Ferreira, Rui Gonçalves
P79 Cross-cultural adaptation of the Myocardial Infraction Dimensional Assessment Scale (MIDAS) for Brazilian Portuguese language
Bruno H. Fiorin, Marina S. Santos, Edmar S. Oliveira, Rita L. Moreira, Elizabete A. Oliveira, Braulio L. Filho
P80 The revised Portuguese version of the Three-Factor Eating Questionnaire: A confirmatory factor analysis
Lara Palmeira, Teresa Garcia, José Pinto-Gouveia, Marina Cunha
P81 Assessing weight-related psychological inflexibility: An exploratory factor analysis of the AAQW’s Portuguese version
Sara Cardoso, Lara Palmeira, Marina Cunha; José Pinto-Gouveia
P82 Validation of the Body Appreciation Scale-2 for Portuguese women
Joana Marta-Simões, Ana L. Mendes, Inês A. Trindade, Sara Oliveira, Cláudia Ferreira
P83 The Portuguese validation of the Dietary Intent Scale
Ana L. Mendes, Joana Marta-Simões, Inês A. Trindade, Cláudia Ferreira
P84 Construction and validation of the Inventory of Marital Violence (IVC)
Filipe Nave
P85 Portable continuous blood pressure monitor system
Mariana Campos, Iris Gaudêncio, Fernando Martins, Lino Ferreira, Nuno Lopes, Rui Fonseca-Pinto
P86 Construction and validation of the Scale of Perception of the Difficulties in Caring for the Elderly (SPDCE)
Rogério Rodrigues, Zaida Azeredo, Corália Vicente
P87 Development and validation of a comfort rating scale for the elderly hospitalized with chronic illness
Joana Silva, Patrícia Sousa, Rita Marques
P88 Construction and validation of the Postpartum Paternal Quality of Life Questionnaire (PP-QOL)
Isabel Mendes, Rogério Rodrigues, Zaida Azeredo, Corália Vicente
P89 Infrared thermal imaging: A tool for assessing diabetic foot ulcers
Ricardo Vardasca, Ana R. Marques, Adérito Seixas, Rui Carvalho, Joaquim Gabriel
P90 Pressure ulcers in an intensive care unit: An experience report
Paulo P. Ferreira, Michelle T. Oliveira, Anderson R. Sousa, Ana S. Maia, Sebastião T. Oliveira, Pablo O. Costa, Maiza M. Silva
P91 Validation of figures used in evocations: instrument to capture representations
Cristina Arreguy-Sena, Nathália Alvarenga-Martins, Paulo F. Pinto, Denize C. Oliveira, Pedro D. Parreira, Antônio T. Gomes, Luciene M. Braga
P92 Telephone assistance to decrease burden in informal caregivers of stroke older people: Monitoring and diagnostic evaluation
Odete Araújo, Isabel Lage, José Cabrita, Laetitia Teixeira
P93 Hope of informal caregivers of people with chronic and advanced disease
Rita Marques, Mª Anjos Dixe, Ana Querido, Patrícia Sousa
P94 Functionality and quality information from the Portuguese National Epidemiological Surveillance System
Sara Silva, Eugénio Cordeiro, João Pimentel
P95 Resting metabolic rate objectively measured vs. Harris and Benedict formula
Vera Ferro-Lebres, Juliana A. Souza, Mariline Tavares
O182 Characteristics of non-urgent patients: Cross-sectional study of an emergency department
Mª Anjos Dixe, Pedro Sousa, Rui Passadouro, Teresa Peralta, Carlos Ferreira, Georgina Lourenço
O183 Physical fitness and health in children of the 1st Cycle of Education
João Serrano, João Petrica, Rui Paulo, Samuel Honório, Pedro Mendes
O184 The impact of physical activity on sleep quality, in children
Alexandra Simões, Lucinda Carvalho, Alexandre Pereira
O185 What is the potential for using Information and Communication Technologies in Arterial Hypertension self-management?
Sara Silva, Paulino Sousa, José M. Padilha
O186 Exploring psychosocial factors associated with risk of falling in older patients undergoing haemodialysis
Daniela Figueiredo, Carolina Valente, Alda Marques
O187 Development of pressure ulcers on the face in patients undergoing non-invasive ventilation
Patrícia Ribas, Joana Sousa, Frederico Brandão, Cesar Sousa, Matilde Martins
O188 The elder hospitalized: Limiting factors of comfort
Patrícia Sousa, Rita Marques
O189 Physical activity and health state self-perception by Portuguese adults
Francisco Mendes, Rosina Fernandes, Emília Martins, Cátia Magalhães, Patrícia Araújo
O190 Satisfaction with social support in the elderly of the district of Bragança
Carla Grande, Mª Augusta Mata, Juan G. Vieitez
O191 Prevalence of death by traumatic brain injury and associated factors in intensive care unit of a general hospital, Brazil
Bruna Bianchini, Nazare Nazario, João G. Filho, Marcia Kretzer
O192 Relation between family caregivers burden and health status of elderly dependents
Tânia Costa, Armando Almeida, Gabriel Baffour
O193 Phenomena sensitive to nursing care in day centre
Armando Almeida, Tânia Costa, Gabriel Baffour
O194 Frailty: what do the elderly think?
Zaida Azeredo, Carlos Laranjeira, Magda Guerra, Ana P. Barbeiro
O195 The therapeutic self-care as a nursing-sensitive outcome: A correlational study
Regina Ferreira
O196 Phonetic-phonological acquisition for the European Portuguese from 18 months to 6 years and 12 months
Sara Lopes, Liliana Nunes, Ana Mendes
O197 Quality of life of patients undergoing liver transplant surgery
Julian Martins, Dulcineia Schneider, Marcia Kretzer, Flávio Magajewski
O198 Professional competences in health: views of older people from different European Countries
Célia Soares, António Marques
O199 Life satisfaction of working adults due to the number of hours of weekly exercise
Marco Batista, Ruth J. Castuera, Helena Mesquita, António Faustino, Jorge Santos, Samuel Honório
O200 Therapeutic itinerary of women with breast cancer in Santa Maria City/RS
Betina P. Vizzotto, Leticia Frigo, Hedioneia F. Pivetta
O201 The breastfeeding prevalence at 4 months: Maternal experience as a determining factor
Dolores Sardo
O202 The impact of the transition to parenthood in health and well-being
Cristina Martins, Wilson Abreu, Mª Céu Figueiredo
P96 Self-determined motivation and well-being in Portuguese active adults of both genders
Marco Batista, Ruth Jimenez-Castuera, João Petrica, João Serrano, Samuel Honório, Rui Paulo, Pedro Mendes
P97 The geriatric care: ways and means of comforting
Patrícia Sousa, Rita Marques
P98 The influence of relative age, subcutaneous adiposity and physical growth on Castelo Branco under-15 soccer players 2015
António Faustino, Paulo Silveira, João Serrano, Rui Paulo, Pedro Mendes, Samuel Honório
P99 Data for the diagnostic process focused on self-care – managing medication regime: An integrative literature review
Catarina Oliveira, Fernanda Bastos, Inês Cruz
P100 Art therapy as mental health promotion for children
Cláudia K. Rodriguez, Márcia R. Kretzer, Nazaré O. Nazário
P101 Chemical characterization of fungal chitosan for industrial applications
Pedro Cruz, Daniela C. Vaz, Rui B. Ruben, Francisco Avelelas, Susana Silva, Mª Jorge Campos
P102 The impact of caring older people at home
Maria Almeida, Liliana Gonçalves, Lígia Antunes
P103 Development of the first pressure ulcer in an inpatient setting: Focus on patients’ characteristics
Pedro Sardo, Jenifer Guedes, João Simões, Paulo Machado, Elsa Melo
P104 Association between General Self-efficacy and Physical Activity among Adolescents
Susana Cardoso, Osvaldo Santos, Carla Nunes, Isabel Loureiro
O203 Characterization of the habits of online acquisition of medicinal products in Portugal
Flávia Santos, Gilberto Alves
O204 Waiting room – A space for health education
Cláudia Soar, Teresa O. Marsi
O205 Safey culture evaluation in hospitalized children
Ernestina Silva, Dora Pedrosa, Andrea Leça, Daniel Silva
O206 Sexual Self-awareness and Body Image
Ana Galvão, Maria Gomes, Paula Fernandes, Ana Noné
O207 Perception of a Portuguese population regarding the acquisition and consumption of functional foods
Jaime Combadão, Cátia Ramalhete, Paulo Figueiredo, Patrícia Caeiro
O208 The work process in primary health care: evaluation in municipalities of southern Brazil
Karine C. Fontana, Josimari T. Lacerda, Patrícia O. Machado
O209 Exploration and evaluation of potential probiotic lactic acid bacteria isolated from Amazon buffalo milk
Raphaelle Borges, Flávio Barbosa, Dayse Sá
O210 Road safety for children: Using children’s observation, as a passenger
Germana Brunhoso, Graça Aparício, Amâncio Carvalho
O211 Perception and application of quality-by-design by the Pharmaceutical industry in Portugal
Ana P. Garcia, Paula O. Fernandes, Adriana Santos
O212 Oral health among Portuguese children and adolescents: a public health issue
Nélio Veiga, Carina Brás, Inês Carvalho, Joana Batalha, Margarida Glória, Filipa Bexiga, Inês Coelho, Odete Amaral, Carlos Pereira
O213 Plant species as a medicinal resource in Igatu-Chapada Diamantina (Bahia, Brazil)
Cláudia Pinho, Nilson Paraíso, Ana I. Oliveira, Cristóvão F. Lima, Alberto P. Dias
O214 Characterization of cognitive and functional performance in everyday tasks: Implications for health in institutionalised older adults
Pedro Silva, Mário Espada, Mário Marques, Ana Pereira
O215 BMI and the perception of the importance given to sexuality in obese and overweight people
Ana Mª Pereira, Mª Veiga-Branco, Filomena Pereira, Maria Ribeiro
O216 Analysis and comparison of microbiological contaminations of two different composition pacifiers
Vera Lima, Ana I. Oliveira, Cláudia Pinho, Graça Cruz, Rita F. Oliveira, Luísa Barreiros, Fernando Moreira
O217 Experiences of couple relationships in the transition to retirement
Ana Camarneiro, Mª Helena Loureiro, Margarida Silva
O218 Preventive and corrective treatment of drug-induced calcium deficiency: an analysis in a community pharmacy setting
Catarina Duarte, Ângelo Jesus, Agostinho Cruz
O219 Profile of mood states in physically active elderly subjects: Is there a relation with health perception?
Maria Mota, Sandra Novais, Paulo Nogueira, Ana Pereira, Lara Carneiro, Paulo V. João
O220 (Un)Safety behaviour at work: the role of education towards a health and safety culture
Teresa Maneca Lima
O221 Analysis of the entrepreneurial profile of students attending higher education in Portugal: the Carland Entrepreneurship Index application
Anabela Salgueiro-Oliveira, Marina Vaquinhas, Pedro Parreira, Rosa Melo, João Graveto, Amélia Castilho, José H. Gomes
O222 Evaluation of welfare and quality of life of pregnant working women regarding the age of the pregnant
María S. Medina, Valeriana G. Blanco
O223 Psychological wellbeing protection among unemployed and temporary workers: Uncovering effective community-based interventions with a Delphi panel
Osvaldo Santos, Elisa Lopes, Ana Virgolino, Alexandra Dinis, Sara Ambrósio, Inês Almeida, Tatiana Marques, Mª João Heitor
O224 Chilean population norms derived from the Health-related quality of life SF-6D
Miguel A. Garcia-Gordillo, Daniel Collado-Mateo, Pedro R. Olivares, José A. Parraça, José A. Sala
O225 Motivation of college students toward Entrepreneurship: The influence of social and economic instability
Amélia Castilho, João Graveto, Pedro Parreira, Anabela Oliveira, José H. Gomes, Rosa Melo, Marina Vaquinhas
O226 Use of aromatic and medicinal plants, drugs and herbal products in Bragança city
Mónia Cheio, Agostinho Cruz, Olívia R. Pereira
O227 Edible flowers as new novel foods concept for health promotion
Sara Pinto, Adriana Oliveira, M. Conceição Manso, Carla Sousa, Ana F. Vinha
O228 The influence of leisure activities on the health and welfare of older people living in nursing homes
Mª Manuela Machado, Margarida Vieira
O229 Risk of falling, fear of falling and functionality in community-dwelling older adults
Beatriz Fernandes, Teresa Tomás, Diogo Quirino
O230 Musculoskeletal pain and postural habits in children and teenage students
Gustavo Desouzart, Rui Matos, Magali Bordini, Pedro Mouroço
O231 What's different in Southern Europe? The question of citizens’ participation in health systems
Ana R. Matos, Mauro Serapioni
O232 Occupational stress in Portuguese police officers
Teresa Guimarães, Virgínia Fonseca, André Costa, João Ribeiro, João Lobato
O233 Is occupational therapy culturally relevant to promote mental health in Burkina Faso?
Inmaculada Z. Martin, Anita Björklund
P105 Pay-for-performance satisfaction and quality in primary care
Aida I. Tavares, Pedro Ferreira, Rui Passadouro
P106 Economic development through life expectancy lenses
Sónia Morgado
P107 What is the effectiveness of exercise on smoking cessation to prevent clinical complications of smoking?
Nuno Tavares, João Valente, Anabela C. Martins
P108 A systematic review of the effects of yoga on mental health
Patrícia Araújo, Rosina Fernandes, Francisco Mendes, Cátia Magalhães, Emília Martins
P109 Healthy lifestyle: comparison between higher education students that lived until adult age in rural and urban environment
Pedro Mendes, Rui Paulo, António Faustino, Helena Mesquita, Samuel Honório, Marco Batista
P110 Evaluation of the Mobile Emergency Care Service (SAMU) in Brazil
Josimari T. Lacerda, Angela B. Ortiga, Mª Cristina Calvo, Sônia Natal
P111 Bioactive compounds - antioxidant activity of tropical fruits
Marta Pereira
P112 Use of non-pharmacological methods to relieve pain in labour
Manuela Ferreira, Ana R. Prata, Paula Nelas, João Duarte
P113 Mechanical safety of pacifiers sold in Portuguese pharmacies and childcare stores
Juliana Carneiro, Ana I. Oliveira, Cláudia Pinho, Cristina Couto, Rita F. Oliveira, Fernando Moreira
P114 The importance of prenatal consultation: Information to pregnant women given on a unit of primary care
Ana S. Maia, Michelle T. Oliveira, Anderson R. Sousa, Paulo P. Ferreira, Géssica M. Souza, Lívia F. Almada, Milena A. Conceição, Eujcely C. Santiago
P115 Influence of different backpack loading conditions on neck and lumbar muscles activity of elementary school children
Sandra Rodrigues, Gabriela Domingues, Irina Ferreira, Luís Faria, Adérito Seixas
P116 Efficacy and safety of dry extract Hedera helix in the treatment of productive cough
Ana R. Costa, Ângelo Jesus, Américo Cardoso, Alexandra Meireles, Armanda Colaço, Agostinho Cruz
P117 A portrait of the evaluation processes of education groups in primary health care
Viviane L. Vieira, Kellem R. Vincha, Ana Mª Cervato-Mancuso
P118 Benefits of vitamins C and E in sensorineural hearing loss: a review
Melissa Faria, Cláudia Reis
P119 BODY SNAPSHOT – a web-integrated anthropometric evaluation system
Marco P. Cova, Rita T. Ascenso, Henrique A. Almeida, Eunice G. Oliveira
P120 Anthropometric evaluation and variation during pregnancy
Miguel Santana, Rafael Pereira, Eunice G. Oliveira, Henrique A. Almeida, Rita T. Ascenso
P121 Knowledge of college students on the amendments of their eating habits and physical activity index in the transition to higher education
Rita Jesus, Rodrigo Tapadas, Carolina Tim-Tim, Catarina Cezanne, Matilde Lagoa, Sara S. Dias, Jorge Torgal
P122 Muscular activity of a rally race car driver
João Lopes, Henrique Almeida, Sandra Amado, Luís Carrão
O234 Literacy and results in health
Madalena Cunha, Luís Saboga-Nunes, Carlos Albuquerque, Olivério Ribeiro
O235 Literacy promotion and empowerment of type 2 diabetics elderly in four family health units of the group of health centers of Dão Lafões
Suzete Oliveira, Mª Carminda Morais
O236 Mediterranean diet, health and life quality among Portuguese children
Emília Martins, Francisco Mendes, Rosina Fernandes, Cátia Magalhães, Patrícia Araújo
O237 Health literacy, from data to action - translation, validation and application of the European Health Literacy Survey in Portugal (HLS-EU-PT)
Ana R. Pedro, Odete Amaral, Ana Escoval
O238 Oral health literacy evaluation in a Portuguese military population
Victor Assunção, Henrique Luís, Luís Luís
O239 Preferences to Internet-based cognitive behavioural therapy – do attachment orientations matter?
Jennifer Apolinário-Hagen, Viktor Vehreschild
O240 A comparative transnational study in health literacy between Austria and Portugal
Ulrike Fotschl, Gerald Lirk, Anabela C. Martins, Isabel Andrade, Fernando Mendes
O241 Health literacy and social behaviours: relationship with sexually transmitted diseases?
Verónica Mendonça, Sandra Antunes, Isabel Andrade, Nádia Osório, Ana Valado, Armando Caseiro, António Gabriel, Anabela C. Martins, Fernando Mendes
O242 Parenting styles and attachment to parents: what relationships?
Paula A. Silva, Lisete M. Mónico, Pedro M. Parreira, Carla Carvalho
O243 Work-life balance in health professionals and professors: comparative study of workers with shift work and fixed schedule
Carla Carvalho, Pedro M. Parreira, Lisete M. Mónico, Joana Ruivo
O244 Technology literacy in self-management of diabetes
Vânia Silva, Paulino Sousa, José M. Padilha
O245 Satisfaction with therapeutic education and its relationship with clinical variables in children with type 1 diabetes
Vera Ferraz, Graça Aparício, João Duarte
O246 Nutrition-related knowledge in middle-age and older patients with type 2 diabetes
Carlos Vasconcelos, António Almeida, Joel Neves, Telma Correia, Helena Amorim, Romeu Mendes
O247 Validating the HLS-EU-(PT) questionnaire to measure health literacy in adolescents (CrAdLiSa project: HLS-EU-PT)
Luís Saboga-Nunes, Madalena Cunha, Carlos Albuquerque
O248 Health education in people with coronary heart disease: Experience of the cardiology department of a hospital on the outskirts of Lisbon
Elsa S. Pereira, Leonino S. Santos, Ana S. Reis, Helena R. Silva, João Rombo, Jorge C. Fernandes, Patrícia Fernandes
O249 Information and training needs of informal caregivers of individuals with stroke sequelae: a qualitative survey
Jaime Ribeiro, Catarina Mangas, Ana Freire
O250 Prevention of psychoactive substances consumption in students from 6th grade of Albergaria-a-Velha´s School Group
Sara Silva, Irene Francisco, Ana Oliveira
O251 Promoting healthy sexuality: shared responsibility for family, youth and educators
Helena Catarino, Mª Anjos Dixe, Mª Clarisse Louro
O252 Sexual risk behaviour in adolescents and young people
Saudade Lopes, Anjos Dixe
O253 Knowledge of school staff on type 1 diabetes
Mª Anjos Dixe, Eva Menino, Helena Catarino, Fátima Soares, Ana P. Oliveira, Sara Gordo, Teresa Kraus
O254 Sexual health in adolescents: the impact of information search in literacy
Catarina Tomás, Paulo Queirós, Teresa Rodrigues
P123 Improving basic life support skills in adolescents through a training programme
Pedro Sousa, João G. Frade, Catarina Lobão
P124 Difficulties in sexual education reported by basic education teachers in the city of Foz do Iguaçu - Brazil
Cynthia B. Moura, Laysa C. Dreyer, Vanize Meneghetti, Priscila P. Cabral
P125 Breast cancer survivors: subjects and resources for information. A qualitative systematic review
Francisca Pinto, Paulino Sousa, Mª Raquel Esteves
P126 Relationship between health literacy and prevalence of STI in Biomedical Laboratory Science students
Sofia Galvão, Ite Tytgat, Isabel Andrade, Nádia Osório, Ana Valado, Armando Caseiro, António Gabriel, Anabela C. Martins, Fernando Mendes
P127 Health literacy, risk behaviours and sexually transmitted diseases among blood donors
Mónica Casas-Novas, Helena Bernardo, Isabel Andrade, Gracinda Sousa, Ana P. Sousa, Clara Rocha, Pedro Belo, Nádia Osório, Ana Valado, Armando Caseiro, António Gabriel, Anabela C. Martins, Fernando Mendes
P128 Promoting literacy in pregnancy health-care
Fátima Martins, Montserrat Pulido-Fuentes
P129 The lifestyles of the operating assistants of education
Isabel Barroso, Gil Cabral, M. João Monteiro, Conceição Rainho
P130 Experiences of service-learning health and the literary art: reflections about the health education
Alessandro Prado, Yara M. Carvalho
P131 Life long swimming – a European Erasmus + project
Maria Campos, Liliana Moreira, José Ferreira, Ana Teixeira, Luís Rama
doi:10.1186/s12913-016-1423-5
PMCID: PMC4943498  PMID: 27409075
4.  Caregiver- and Patient-Directed Interventions for Dementia 
Executive Summary
In early August 2007, the Medical Advisory Secretariat began work on the Aging in the Community project, an evidence-based review of the literature surrounding healthy aging in the community. The Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the ministry’s newly released Aging at Home Strategy.
After a broad literature review and consultation with experts, the secretariat identified 4 key areas that strongly predict an elderly person’s transition from independent community living to a long-term care home. Evidence-based analyses have been prepared for each of these 4 areas: falls and fall-related injuries, urinary incontinence, dementia, and social isolation. For the first area, falls and fall-related injuries, an economic model is described in a separate report.
Please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html, to review these titles within the Aging in the Community series.
Aging in the Community: Summary of Evidence-Based Analyses
Prevention of Falls and Fall-Related Injuries in Community-Dwelling Seniors: An Evidence-Based Analysis
Behavioural Interventions for Urinary Incontinence in Community-Dwelling Seniors: An Evidence-Based Analysis
Caregiver- and Patient-Directed Interventions for Dementia: An Evidence-Based Analysis
Social Isolation in Community-Dwelling Seniors: An Evidence-Based Analysis
The Falls/Fractures Economic Model in Ontario Residents Aged 65 Years and Over (FEMOR)
This report features the evidence-based analysis on caregiver- and patient-directed interventions for dementia and is broken down into 4 sections:
Introduction
Caregiver-Directed Interventions for Dementia
Patient-Directed Interventions for Dementia
Economic Analysis of Caregiver- and Patient-Directed Interventions for Dementia
Caregiver-Directed Interventions for Dementia
Objective
To identify interventions that may be effective in supporting the well-being of unpaid caregivers of seniors with dementia living in the community.
Clinical Need: Target Population and Condition
Dementia is a progressive and largely irreversible syndrome that is characterized by a loss of cognitive function severe enough to impact social or occupational functioning. The components of cognitive function affected include memory and learning, attention, concentration and orientation, problem-solving, calculation, language, and geographic orientation. Dementia was identified as one of the key predictors in a senior’s transition from independent community living to admission to a long-term care (LTC) home, in that approximately 90% of individuals diagnosed with dementia will be institutionalized before death. In addition, cognitive decline linked to dementia is one of the most commonly cited reasons for institutionalization.
Prevalence estimates of dementia in the Ontario population have largely been extrapolated from the Canadian Study of Health and Aging conducted in 1991. Based on these estimates, it is projected that there will be approximately 165,000 dementia cases in Ontario in the year 2008, and by 2010 the number of cases will increase by nearly 17% over 2005 levels. By 2020 the number of cases is expected to increase by nearly 55%, due to a rise in the number of people in the age categories with the highest prevalence (85+). With the increase in the aging population, dementia will continue to have a significant economic impact on the Canadian health care system. In 1991, the total costs associated with dementia in Canada were $3.9 billion (Cdn) with $2.18 billion coming from LTC.
Caregivers play a crucial role in the management of individuals with dementia because of the high level of dependency and morbidity associated with the condition. It has been documented that a greater demand is faced by dementia caregivers compared with caregivers of persons with other chronic diseases. The increased burden of caregiving contributes to a host of chronic health problems seen among many informal caregivers of persons with dementia. Much of this burden results from managing the behavioural and psychological symptoms of dementia (BPSD), which have been established as a predictor of institutionalization for elderly patients with dementia.
It is recognized that for some patients with dementia, an LTC facility can provide the most appropriate care; however, many patients move into LTC unnecessarily. For individuals with dementia to remain in the community longer, caregivers require many types of formal and informal support services to alleviate the stress of caregiving. These include both respite care and psychosocial interventions. Psychosocial interventions encompass a broad range of interventions such as psychoeducational interventions, counseling, supportive therapy, and behavioural interventions.
Assuming that 50% of persons with dementia live in the community, a conservative estimate of the number of informal caregivers in Ontario is 82,500. Accounting for the fact that 29% of people with dementia live alone, this leaves a remaining estimate of 58,575 Ontarians providing care for a person with dementia with whom they reside.
Description of Interventions
The 2 main categories of caregiver-directed interventions examined in this review are respite care and psychosocial interventions. Respite care is defined as a break or relief for the caregiver. In most cases, respite is provided in the home, through day programs, or at institutions (usually 30 days or less). Depending on a caregiver’s needs, respite services will vary in delivery and duration. Respite care is carried out by a variety of individuals, including paid staff, volunteers, family, or friends.
Psychosocial interventions encompass a broad range of interventions and have been classified in various ways in the literature. This review will examine educational, behavioural, dementia-specific, supportive, and coping interventions. The analysis focuses on behavioural interventions, that is, those designed to help the caregiver manage BPSD. As described earlier, BPSD are one of the most challenging aspects of caring for a senior with dementia, causing an increase in caregiver burden. The analysis also examines multicomponent interventions, which include at least 2 of the above-mentioned interventions.
Methods of Evidence-Based Analysis
A comprehensive search strategy was used to identify systematic reviews and randomized controlled trials (RCTs) that examined the effectiveness of interventions for caregivers of dementia patients.
Questions
Section 2.1
Are respite care services effective in supporting the well-being of unpaid caregivers of seniors with dementia in the community?
Do respite care services impact on rates of institutionalization of these seniors?
Section 2.2
Which psychosocial interventions are effective in supporting the well-being of unpaid caregivers of seniors with dementia in the community?
Which interventions reduce the risk for institutionalization of seniors with dementia?
Outcomes of Interest
any quantitative measure of caregiver psychological health, including caregiver burden, depression, quality of life, well-being, strain, mastery (taking control of one’s situation), reactivity to behaviour problems, etc.;
rate of institutionalization; and
cost-effectiveness.
Assessment of Quality of Evidence
The quality of the evidence was assessed as High, Moderate, Low, or Very low according to the GRADE methodology and GRADE Working Group. As per GRADE the following definitions apply:
Summary of Findings
Conclusions in Table 1 are drawn from Sections 2.1 and 2.2 of the report.
Summary of Conclusions on Caregiver-Directed Interventions
There is limited evidence from RCTs that respite care is effective in improving outcomes for those caring for seniors with dementia.
There is considerable qualitative evidence of the perceived benefits of respite care.
Respite care is known as one of the key formal support services for alleviating caregiver burden in those caring for dementia patients.
Respite care services need to be tailored to individual caregiver needs as there are vast differences among caregivers and patients with dementia (severity, type of dementia, amount of informal/formal support available, housing situation, etc.)
There is moderate- to high-quality evidence that individual behavioural interventions (≥ 6 sessions), directed towards the caregiver (or combined with the patient) are effective in improving psychological health in dementia caregivers.
There is moderate- to high-quality evidence that multicomponent interventions improve caregiver psychosocial health and may affect rates of institutionalization of dementia patients.
RCT indicates randomized controlled trial.
Patient-Directed Interventions for Dementia
Objective
The section on patient-directed interventions for dementia is broken down into 4 subsections with the following questions:
3.1 Physical Exercise for Seniors with Dementia – Secondary Prevention
What is the effectiveness of physical exercise for the improvement or maintenance of basic activities of daily living (ADLs), such as eating, bathing, toileting, and functional ability, in seniors with mild to moderate dementia?
3.2 Nonpharmacologic and Nonexercise Interventions to Improve Cognitive Functioning in Seniors With Dementia – Secondary Prevention
What is the effectiveness of nonpharmacologic interventions to improve cognitive functioning in seniors with mild to moderate dementia?
3.3 Physical Exercise for Delaying the Onset of Dementia – Primary Prevention
Can exercise decrease the risk of subsequent cognitive decline/dementia?
3.4 Cognitive Interventions for Delaying the Onset of Dementia – Primary Prevention
Does cognitive training decrease the risk of cognitive impairment, deterioration in the performance of basic ADLs or instrumental activities of daily living (IADLs),1 or incidence of dementia in seniors with good cognitive and physical functioning?
Clinical Need: Target Population and Condition
Secondary Prevention2
Exercise
Physical deterioration is linked to dementia. This is thought to be due to reduced muscle mass leading to decreased activity levels and muscle atrophy, increasing the potential for unsafe mobility while performing basic ADLs such as eating, bathing, toileting, and functional ability.
Improved physical conditioning for seniors with dementia may extend their independent mobility and maintain performance of ADL.
Nonpharmacologic and Nonexercise Interventions
Cognitive impairments, including memory problems, are a defining feature of dementia. These impairments can lead to anxiety, depression, and withdrawal from activities. The impact of these cognitive problems on daily activities increases pressure on caregivers.
Cognitive interventions aim to improve these impairments in people with mild to moderate dementia.
Primary Prevention3
Exercise
Various vascular risk factors have been found to contribute to the development of dementia (e.g., hypertension, hypercholesterolemia, diabetes, overweight).
Physical exercise is important in promoting overall and vascular health. However, it is unclear whether physical exercise can decrease the risk of cognitive decline/dementia.
Nonpharmacologic and Nonexercise Interventions
Having more years of education (i.e., a higher cognitive reserve) is associated with a lower prevalence of dementia in crossectional population-based studies and a lower incidence of dementia in cohorts followed longitudinally. However, it is unclear whether cognitive training can increase cognitive reserve or decrease the risk of cognitive impairment, prevent or delay deterioration in the performance of ADLs or IADLs or reduce the incidence of dementia.
Description of Interventions
Physical exercise and nonpharmacologic/nonexercise interventions (e.g., cognitive training) for the primary and secondary prevention of dementia are assessed in this review.
Evidence-Based Analysis Methods
A comprehensive search strategy was used to identify systematic reviews and RCTs that examined the effectiveness, safety and cost effectiveness of exercise and cognitive interventions for the primary and secondary prevention of dementia.
Questions
Section 3.1: What is the effectiveness of physical exercise for the improvement or maintenance of ADLs in seniors with mild to moderate dementia?
Section 3.2: What is the effectiveness of nonpharmacologic/nonexercise interventions to improve cognitive functioning in seniors with mild to moderate dementia?
Section 3.3: Can exercise decrease the risk of subsequent cognitive decline/dementia?
Section 3.4: Does cognitive training decrease the risk of cognitive impairment, prevent or delay deterioration in the performance of ADLs or IADLs, or reduce the incidence of dementia in seniors with good cognitive and physical functioning?
Assessment of Quality of Evidence
The quality of the evidence was assessed as High, Moderate, Low, or Very low according to the GRADE methodology. As per GRADE the following definitions apply:
Summary of Findings
Table 2 summarizes the conclusions from Sections 3.1 through 3.4.
Summary of Conclusions on Patient-Directed Interventions*
Previous systematic review indicated that “cognitive training” is not effective in patients with dementia.
A recent RCT suggests that CST (up to 7 weeks) is effective for improving cognitive function and quality of life in patients with dementia.
Regular leisure time physical activity in midlife is associated with a reduced risk of dementia in later life (mean follow-up 21 years).
Regular physical activity in seniors is associated with a reduced risk of cognitive decline (mean follow-up 2 years).
Regular physical activity in seniors is associated with a reduced risk of dementia (mean follow-up 6–7 years).
Evidence that cognitive training for specific functions (memory, reasoning, and speed of processing) produces improvements in these specific domains.
Limited inconclusive evidence that cognitive training can offset deterioration in the performance of self-reported IADL scores and performance assessments.
1° indicates primary; 2°, secondary; CST, cognitive stimulation therapy; IADL, instrumental activities of daily living; RCT, randomized controlled trial.
Benefit/Risk Analysis
As per the GRADE Working Group, the overall recommendations consider 4 main factors:
the trade-offs, taking into account the estimated size of the effect for the main outcome, the confidence limits around those estimates, and the relative value placed on the outcome;
the quality of the evidence;
translation of the evidence into practice in a specific setting, taking into consideration important factors that could be expected to modify the size of the expected effects such as proximity to a hospital or availability of necessary expertise; and
uncertainty about the baseline risk for the population of interest.
The GRADE Working Group also recommends that incremental costs of health care alternatives should be considered explicitly alongside the expected health benefits and harms. Recommendations rely on judgments about the value of the incremental health benefits in relation to the incremental costs. The last column in Table 3 reflects the overall trade-off between benefits and harms (adverse events) and incorporates any risk/uncertainty (cost-effectiveness).
Overall Summary Statement of the Benefit and Risk for Patient-Directed Interventions*
Economic Analysis
Budget Impact Analysis of Effective Interventions for Dementia
Caregiver-directed behavioural techniques and patient-directed exercise programs were found to be effective when assessing mild to moderate dementia outcomes in seniors living in the community. Therefore, an annual budget impact was calculated based on eligible seniors in the community with mild and moderate dementia and their respective caregivers who were willing to participate in interventional home sessions. Table 4 describes the annual budget impact for these interventions.
Annual Budget Impact (2008 Canadian Dollars)
Assumed 7% prevalence of dementia aged 65+ in Ontario.
Assumed 8 weekly sessions plus 4 monthly phone calls.
Assumed 12 weekly sessions plus biweekly sessions thereafter (total of 20).
Assumed 2 sessions per week for first 5 weeks. Assumed 90% of seniors in the community with dementia have mild to moderate disease. Assumed 4.5% of seniors 65+ are in long-term care, and the remainder are in the community. Assumed a rate of participation of 60% for both patients and caregivers and of 41% for patient-directed exercise. Assumed 100% compliance since intervention administered at the home. Cost for trained staff from Ministry of Health and Long-Term Care data source. Assumed cost of personal support worker to be equivalent to in-home support. Cost for recreation therapist from Alberta government Website.
Note: This budget impact analysis was calculated for the first year after introducing the interventions from the Ministry of Health and Long-Term Care perspective using prevalence data only. Prevalence estimates are for seniors in the community with mild to moderate dementia and their respective caregivers who are willing to participate in an interventional session administered at the home setting. Incidence and mortality rates were not factored in. Current expenditures in the province are unknown and therefore were not included in the analysis. Numbers may change based on population trends, rate of intervention uptake, trends in current programs in place in the province, and assumptions on costs. The number of patients was based on patients likely to access these interventions in Ontario based on assumptions stated below from the literature. An expert panel confirmed resource consumption.
PMCID: PMC3377513  PMID: 23074509
5.  Public stewardship of private for-profit healthcare providers in low- and middle-income countries 
Background
Governments use different approaches to ensure that private for-profit healthcare services meet certain quality standards. Such government guidance, referred to as public stewardship, encompasses government policies, regulatory mechanisms, and implementation strategies for ensuring accountability in the delivery of services. However, the effectiveness of these strategies in low- and middle-income countries (LMICs) have not been the subject of a systematic review.
Objectives
To assess the effects of public sector regulation, training, or co-ordination of the private for-profit health sector in low- and middle-income countries.
Search methods
For related systematic reviews, we searched the Cochrane Database of Systematic Reviews (CDSR) 2015, Issue 4; Database of Abstracts of Reviews of Effectiveness (DARE) 2015, Issue 1; Health Technology Assessment Database (HTA) 2015, Issue 1; all part of The Cochrane Library, and searched 28 April 2015. For primary studies, we searched MEDLINE, Epub Ahead of Print, In-Process & Other Non-Indexed Citations, MEDLINE Daily and MEDLINE 1946 to Present, OvidSP (searched 16 June 2016); Science Citation Index and Social Sciences Citation Index 1987 to present, and Emerging Sources Citation Index 2015 to present, ISI Web of Science (searched 3 May 2016 for papers citing included studies); Cochrane Central Register of Controlled Trials (CENTRAL), 2015, Issue 3, part of The Cochrane Library (including the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register) (searched 28 April 2015); Embase 1980 to 2015 Week 17, OvidSP (searched 28 April 2015); Global Health 1973 to 2015 Week 16, OvidSP (searched 30 April 2015); WHOLIS, WHO (searched 30 April 2015); Science Citation Index and Social Sciences Citation Index 1975 to present, ISI Web of Science (searched 30 April 2015); Health Management, ProQuest (searched 22 November 2013). In addition, in April 2016, we searched the reference lists of relevant articles, WHO International Clinical Trials Registry Platform, Clinicaltrials.gov, and various electronic databases of grey literature.
Selection criteria
Randomised trials, non-randomised trials, interrupted time series studies, or controlled before-after studies.
Data collection and analysis
Two authors independently assessed study eligibility and extracted data, comparing their results and resolving discrepancies by consensus. We expressed study results as risk ratios (RR) or mean differences (MD) with 95% confidence intervals (CI), where appropriate, and assessed the certainty of the evidence using Grades of Recommendation, Assessment, Development and Evaluation (GRADE). We did not conduct meta-analysis because of heterogeneity of interventions and study designs.
Main results
We identified 20,177 records, 50 of them potentially eligible. We excluded 39 potentially eligible studies because they did not involve a rigorous evaluation of training, regulation, or co-ordination of private for-profit healthcare providers in LMICs; five studies identified after the review was submitted are awaiting assessment; and six studies met our inclusion criteria. Two included studies assessed training alone; one assessed regulation alone; three assessed a multifaceted intervention involving training and regulation; and none assessed co-ordination. All six included studies targeted private for-profit pharmacy workers in Africa and Asia.
Three studies found that training probably increases sale of oral rehydration solution (one trial in Kenya, 106 pharmacies: RR 3.04, 95% CI 1.37 to 6.75; and one trial in Indonesia, 87 pharmacies: RR 1.41, 95% CI 1.03 to 1.93) and dispensing of anti-malarial drugs (one trial in Kenya, 293 pharmacies: RR 8.76, 95% CI 0.94 to 81.81); moderate-certainty evidence.
One study conducted in the Lao People's Democratic Republic shows that regulation of the distribution and sale of registered pharmaceutical products may improve composite pharmacy indicators (one trial, 115 pharmacies: improvements in four of six pharmacy indicators; low-certainty evidence).
The outcome in three multifaceted intervention studies was the quality of pharmacy practice; including the ability to ask questions, give advice, and provide appropriate treatment. The trials applied regulation, training, and peer influence in sequence; and the study design does not permit separation of the effects of the different interventions. Two trials conducted among 136 pharmacies in Vietnam found that the multifaceted intervention may improve the quality of pharmacy practice; but the third study, involving 146 pharmacies in Vietnam and Thailand, found that the intervention may have little or no effects on the quality of pharmacy practice (low-certainty evidence).
Only two studies (both conducted in Vietnam) reported cost data, with no rigorous assessment of the economic implications of implementing the interventions in resource-constrained settings. No study reported data on equity, mortality, morbidity, adverse effects, satisfaction, or attitudes.
Authors' conclusions
Training probably improves quality of care (i.e. adherence to recommended practice), regulation may improve quality of care, and we are uncertain about the effects of co-ordination on quality of private for-profit healthcare services in LMICs. The likelihood that further research will find the effect of training to be substantially different from the results of this review is moderate; implying that monitoring of the impact is likely to be needed if training is implemented. The low certainty of the evidence for regulation implies that the likelihood of further research finding the effect of regulation to be substantially different from the results of this review is high. Therefore, an impact evaluation is warranted if government regulation of private for-profit providers is implemented in LMICs. Rigorous evaluations of these interventions should also assess other outcomes such as impacts on equity, cost implications, mortality, morbidity, and adverse effects.
Government regulation, training, or co-ordination of private for-profit health care in low- and middle-income countries
What is the aim of this review?
The aim of this Cochrane review was to evaluate the effect of government regulation, training, or co-ordination of private for-profit health care in low- and middle-income countries.
We collected and analysed all relevant studies to answer this question and included six studies in the review.
Why do governments regulate, train or co-ordinate private healthcare providers?
In many low- and middle-income countries, the public sector is not able to provide high quality healthcare services to all citizens, and private healthcare providers therefore play a major role. However, there is concern that health care provided by the private sector is not always of high quality and that recommended practices and guidelines are not always followed. Governments therefore use different approaches to ensure that private for-profit healthcare services meet certain quality standards. This type of government guidance is referred to as 'public stewardship' and can for instance involve training and education for private for-profit healthcare providers; introduction of regulations where quality standards are set and enforced; and co-ordination between private for-profit and public sector healthcare providers, for instance, creating referral systems between the private for-profit and public sectors.
What happens when governments regulate, train or co-ordinate private, for-profit health care providers?
Training In two studies in Kenya and Indonesia, the Ministry of Health offered private drug sellers short training sessions on prescribing and dispensing drugs. These sellers were compared to drug sellers who were not offered training. The studies suggested that training probably improves the quality of healthcare services.
Regulation In one study in the Lao People's Democratic Republic, the Ministry of Health supervised private pharmacy services in certain districts over a three-month period, applied sanctions when rules were broken, and offered information about areas needing improvement. These districts were compared to districts without this enhanced supervision. The study suggested that this enhanced regulation may make little or no difference to quality of care.
Training and regulation In three studies in Vietnam and Thailand, private pharmacies in some districts received educational visits as well as visits from pharmacy inspectors to enforce regulations. These districts were compared to districts that did not receive any visits. The studies suggested that these types of visits may improve quality of care.
Co-ordination The review did not find any eligible study that assessed the effects of co-ordination on quality of care.
How up-to-date is this review?
The review authors searched for studies that had been published up to June 2016.
doi:10.1002/14651858.CD009855.pub2
PMCID: PMC5014877  PMID: 27510030
6.  Continuous Subcutaneous Insulin Infusion (CSII) Pumps for Type 1 and Type 2 Adult Diabetic Populations 
Executive Summary
In June 2008, the Medical Advisory Secretariat began work on the Diabetes Strategy Evidence Project, an evidence-based review of the literature surrounding strategies for successful management and treatment of diabetes. This project came about when the Health System Strategy Division at the Ministry of Health and Long-Term Care subsequently asked the secretariat to provide an evidentiary platform for the Ministry’s newly released Diabetes Strategy.
After an initial review of the strategy and consultation with experts, the secretariat identified five key areas in which evidence was needed. Evidence-based analyses have been prepared for each of these five areas: insulin pumps, behavioural interventions, bariatric surgery, home telemonitoring, and community based care. For each area, an economic analysis was completed where appropriate and is described in a separate report.
To review these titles within the Diabetes Strategy Evidence series, please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/mas_about.html,
Diabetes Strategy Evidence Platform: Summary of Evidence-Based Analyses
Continuous Subcutaneous Insulin Infusion Pumps for Type 1 and Type 2 Adult Diabetics: An Evidence-Based Analysis
Behavioural Interventions for Type 2 Diabetes: An Evidence-Based Analysis
Bariatric Surgery for People with Diabetes and Morbid Obesity: An Evidence-Based Summary
Community-Based Care for the Management of Type 2 Diabetes: An Evidence-Based Analysis
Home Telemonitoring for Type 2 Diabetes: An Evidence-Based Analysis
Application of the Ontario Diabetes Economic Model (ODEM) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario
Objective
The objective of this analysis is to review the efficacy of continuous subcutaneous insulin infusion (CSII) pumps as compared to multiple daily injections (MDI) for the type 1 and type 2 adult diabetics.
Clinical Need and Target Population
Insulin therapy is an integral component of the treatment of many individuals with diabetes. Type 1, or juvenile-onset diabetes, is a life-long disorder that commonly manifests in children and adolescents, but onset can occur at any age. It represents about 10% of the total diabetes population and involves immune-mediated destruction of insulin producing cells in the pancreas. The loss of these cells results in a decrease in insulin production, which in turn necessitates exogenous insulin therapy.
Type 2, or ‘maturity-onset’ diabetes represents about 90% of the total diabetes population and is marked by a resistance to insulin or insufficient insulin secretion. The risk of developing type 2 diabetes increases with age, obesity, and lack of physical activity. The condition tends to develop gradually and may remain undiagnosed for many years. Approximately 30% of patients with type 2 diabetes eventually require insulin therapy.
CSII Pumps
In conventional therapy programs for diabetes, insulin is injected once or twice a day in some combination of short- and long-acting insulin preparations. Some patients require intensive therapy regimes known as multiple daily injection (MDI) programs, in which insulin is injected three or more times a day. It’s a time consuming process and usually requires an injection of slow acting basal insulin in the morning or evening and frequent doses of short-acting insulin prior to eating. The most common form of slower acting insulin used is neutral protamine gagedorn (NPH), which reaches peak activity 3 to 5 hours after injection. There are some concerns surrounding the use of NPH at night-time as, if injected immediately before bed, nocturnal hypoglycemia may occur. To combat nocturnal hypoglycemia and other issues related to absorption, alternative insulins have been developed, such as the slow-acting insulin glargine. Glargine has no peak action time and instead acts consistently over a twenty-four hour period, helping reduce the frequency of hypoglycemic episodes.
Alternatively, intensive therapy regimes can be administered by continuous insulin infusion (CSII) pumps. These devices attempt to closely mimic the behaviour of the pancreas, continuously providing a basal level insulin to the body with additional boluses at meal times. Modern CSII pumps are comprised of a small battery-driven pump that is designed to administer insulin subcutaneously through the abdominal wall via butterfly needle. The insulin dose is adjusted in response to measured capillary glucose values in a fashion similar to MDI and is thus often seen as a preferred method to multiple injection therapy. There are, however, still risks associated with the use of CSII pumps. Despite the increased use of CSII pumps, there is uncertainty around their effectiveness as compared to MDI for improving glycemic control.
Part A: Type 1 Diabetic Adults (≥19 years)
An evidence-based analysis on the efficacy of CSII pumps compared to MDI was carried out on both type 1 and type 2 adult diabetic populations.
Research Questions
Are CSII pumps more effective than MDI for improving glycemic control in adults (≥19 years) with type 1 diabetes?
Are CSII pumps more effective than MDI for improving additional outcomes related to diabetes such as quality of life (QoL)?
Literature Search
Inclusion Criteria
Randomized controlled trials, systematic reviews, meta-analysis and/or health technology assessments from MEDLINE, EMBASE, CINAHL
Adults (≥ 19 years)
Type 1 diabetes
Study evaluates CSII vs. MDI
Published between January 1, 2002 – March 24, 2009
Patient currently on intensive insulin therapy
Exclusion Criteria
Studies with <20 patients
Studies <5 weeks in duration
CSII applied only at night time and not 24 hours/day
Mixed group of diabetes patients (children, adults, type 1, type 2)
Pregnancy studies
Outcomes of Interest
The primary outcomes of interest were glycosylated hemoglobin (HbA1c) levels, mean daily blood glucose, glucose variability, and frequency of hypoglycaemic events. Other outcomes of interest were insulin requirements, adverse events, and quality of life.
Search Strategy
The literature search strategy employed keywords and subject headings to capture the concepts of:
1) insulin pumps, and
2) type 1 diabetes.
The search was run on July 6, 2008 in the following databases: Ovid MEDLINE (1996 to June Week 4 2008), OVID MEDLINE In-Process and Other Non-Indexed Citations, EMBASE (1980 to 2008 Week 26), OVID CINAHL (1982 to June Week 4 2008) the Cochrane Library, and the Centre for Reviews and Dissemination/International Agency for Health Technology Assessment. A search update was run on March 24, 2009 and studies published prior to 2002 were also examined for inclusion into the review. Parallel search strategies were developed for the remaining databases. Search results were limited to human and English-language published between January 2002 and March 24, 2009. Abstracts were reviewed, and studies meeting the inclusion criteria outlined above were obtained. Reference lists were also checked for relevant studies.
Summary of Findings
The database search identified 519 relevant citations published between 1996 and March 24, 2009. Of the 519 abstracts reviewed, four RCTs and one abstract met the inclusion criteria outlined above. While efficacy outcomes were reported in each of the trials, a meta-analysis was not possible due to missing data around standard deviations of change values as well as missing data for the first period of the crossover arm of the trial. Meta-analysis was not possible on other outcomes (quality of life, insulin requirements, frequency of hypoglycemia) due to differences in reporting.
HbA1c
In studies where no baseline data was reported, the final values were used. Two studies (Hanaire-Broutin et al. 2000, Hoogma et al. 2005) reported a slight reduction in HbA1c of 0.35% and 0.22% respectively for CSII pumps in comparison to MDI. A slightly larger reduction in HbA1c of 0.84% was reported by DeVries et al.; however, this study was the only study to include patients with poor glycemic control marked by higher baseline HbA1c levels. One study (Bruttomesso et al. 2008) showed no difference between CSII pumps and MDI on Hba1c levels and was the only study using insulin glargine (consistent with results of parallel RCT in abstract by Bolli 2004). While there is statistically significant reduction in HbA1c in three of four trials, there is no evidence to suggest these results are clinically significant.
Mean Blood Glucose
Three of four studies reported a statistically significant reduction in the mean daily blood glucose for patients using CSII pump, though these results were not clinically significant. One study (DeVries et al. 2002) did not report study data on mean blood glucose but noted that the differences were not statistically significant. There is difficulty with interpreting study findings as blood glucose was measured differently across studies. Three of four studies used a glucose diary, while one study used a memory meter. In addition, frequency of self monitoring of blood glucose (SMBG) varied from four to nine times per day. Measurements used to determine differences in mean daily blood glucose between the CSII pump group and MDI group at clinic visits were collected at varying time points. Two studies use measurements from the last day prior to the final visit (Hoogma et al. 2005, DeVries et al. 2002), while one study used measurements taken during the last 30 days and another study used measurements taken during the 14 days prior to the final visit of each treatment period.
Glucose Variability
All four studies showed a statistically significant reduction in glucose variability for patients using CSII pumps compared to those using MDI, though one, Bruttomesso et al. 2008, only showed a significant reduction at the morning time point. Brutomesso et al. also used alternate measures of glucose variability and found that both the Lability index and mean amplitude of glycemic excursions (MAGE) were in concordance with the findings using the standard deviation (SD) values of mean blood glucose, but the average daily risk range (ADRR) showed no difference between the CSII pump and MDI groups.
Hypoglycemic Events
There is conflicting evidence concerning the efficacy of CSII pumps in decreasing both mild and severe hypoglycemic events. For mild hypoglycemic events, DeVries et al. observed a higher number of events per patient week in the CSII pump group than the MDI group, while Hoogma et al. observed a higher number of events per patient year in the MDI group. The remaining two studies found no differences between the two groups in the frequency of mild hypoglycemic events. For severe hypoglycemic events, Hoogma et al. found an increase in events per patient year among MDI patients, however, all of the other RCTs showed no difference between the patient groups in this aspect.
Insulin Requirements and Adverse Events
In all four studies, insulin requirements were significantly lower in patients receiving CSII pump treatment in comparison to MDI. This difference was statistically significant in all studies. Adverse events were reported in three studies. Devries et al. found no difference in ketoacidotic episodes between CSII pump and MDI users. Bruttomesso et al. reported no adverse events during the study. Hanaire-Broutin et al. found that 30 patients experienced 58 serious adverse events (SAEs) during MDI and 23 patients had 33 SAEs during treatment out of a total of 256 patients. Most events were related to severe hypoglycemia and diabetic ketoacidosis.
Quality of Life and Patient Preference
QoL was measured in three studies and patient preference was measured in one. All three studies found an improvement in QoL for CSII users compared to those using MDI, although various instruments were used among the studies and possible reporting bias was evident as non-positive outcomes were not consistently reported. Moreover, there was also conflicting results in two of the studies using the Diabetes Treatment Satisfaction Questionnaire (DTSQ). DeVries et al. reported no difference in treatment satisfaction between CSII pump users and MDI users while Brutomesso et al. reported that treatment satisfaction improved among CSII pump users.
Patient preference for CSII pumps was demonstrated in just one study (Hanaire-Broutin et al. 2000) and there are considerable limitations with interpreting this data as it was gathered through interview and 72% of patients that preferred CSII pumps were previously on CSII pump therapy prior to the study. As all studies were industry sponsored, findings on QoL and patient preference must be interpreted with caution.
Quality of Evidence
Overall, the body of evidence was downgraded from high to low due to study quality and issues with directness as identified using the GRADE quality assessment tool (see Table 1) While blinding of patient to intervention/control was not feasible in these studies, blinding of study personnel during outcome assessment and allocation concealment were generally lacking. Trials reported consistent results for the outcomes HbA1c, mean blood glucose and glucose variability, but the directness or generalizability of studies, particularly with respect to the generalizability of the diabetic population, was questionable as most trials used highly motivated populations with fairly good glycemic control. In addition, the populations in each of the studies varied with respect to prior treatment regimens, which may not be generalizable to the population eligible for pumps in Ontario. For the outcome of hypoglycaemic events the evidence was further downgraded to very low since there was conflicting evidence between studies with respect to the frequency of mild and severe hypoglycaemic events in patients using CSII pumps as compared to CSII (see Table 2). The GRADE quality of evidence for the use of CSII in adults with type 1 diabetes is therefore low to very low and any estimate of effect is, therefore, uncertain.
GRADE Quality Assessment for CSII pumps vs. MDI on HbA1c, Mean Blood Glucose, and Glucose Variability for Adults with Type 1 Diabetes
Inadequate or unknown allocation concealment (3/4 studies); Unblinded assessment (all studies) however lack of blinding due to the nature of the study; No ITT analysis (2/4 studies); possible bias SMBG (all studies)
HbA1c: 3/4 studies show consistency however magnitude of effect varies greatly; Single study uses insulin glargine instead of NPH; Mean Blood Glucose: 3/4 studies show consistency however magnitude of effect varies between studies; Glucose Variability: All studies show consistency but 1 study only showed a significant effect in the morning
Generalizability in question due to varying populations: highly motivated populations, educational component of interventions/ run-in phases, insulin pen use in 2/4 studies and varying levels of baseline glycemic control and experience with intensified insulin therapy, pumps and MDI.
GRADE Quality Assessment for CSII pumps vs. MDI on Frequency of Hypoglycemic
Inadequate or unknown allocation concealment (3/4 studies); Unblinded assessment (all studies) however lack of blinding due to the nature of the study; No ITT analysis (2/4 studies); possible bias SMBG (all studies)
Conflicting evidence with respect to mild and severe hypoglycemic events reported in studies
Generalizability in question due to varying populations: highly motivated populations, educational component of interventions/ run-in phases, insulin pen use in 2/4 studies and varying levels of baseline glycemic control and experience with intensified insulin therapy, pumps and MDI.
Economic Analysis
One article was included in the analysis from the economic literature scan. Four other economic evaluations were identified but did not meet our inclusion criteria. Two of these articles did not compare CSII with MDI and the other two articles used summary estimates from a mixed population with Type 1 and 2 diabetes in their economic microsimulation to estimate costs and effects over time. Included were English articles that conducted comparisons between CSII and MDI with the outcome of Quality Adjusted Life Years (QALY) in an adult population with type 1 diabetes.
From one study, a subset of the population with type 1 diabetes was identified that may be suitable and benefit from using insulin pumps. There is, however, limited data in the literature addressing the cost-effectiveness of insulin pumps versus MDI in type 1 diabetes. Longer term models are required to estimate the long term costs and effects of pumps compared to MDI in this population.
Conclusions
CSII pumps for the treatment of adults with type 1 diabetes
Based on low-quality evidence, CSII pumps confer a statistically significant but not clinically significant reduction in HbA1c and mean daily blood glucose as compared to MDI in adults with type 1 diabetes (>19 years).
CSII pumps also confer a statistically significant reduction in glucose variability as compared to MDI in adults with type 1 diabetes (>19 years) however the clinical significance is unknown.
There is indirect evidence that the use of newer long-acting insulins (e.g. insulin glargine) in MDI regimens result in less of a difference between MDI and CSII compared to differences between MDI and CSII in which older insulins are used.
There is conflicting evidence regarding both mild and severe hypoglycemic events in this population when using CSII pumps as compared to MDI. These findings are based on very low-quality evidence.
There is an improved quality of life for patients using CSII pumps as compared to MDI however, limitations exist with this evidence.
Significant limitations of the literature exist specifically:
All studies sponsored by insulin pump manufacturers
All studies used crossover design
Prior treatment regimens varied
Types of insulins used in study varied (NPH vs. glargine)
Generalizability of studies in question as populations were highly motivated and half of studies used insulin pens as the mode of delivery for MDI
One short-term study concluded that pumps are cost-effective, although this was based on limited data and longer term models are required to estimate the long-term costs and effects of pumps compared to MDI in adults with type 1 diabetes.
Part B: Type 2 Diabetic Adults
Research Questions
Are CSII pumps more effective than MDI for improving glycemic control in adults (≥19 years) with type 2 diabetes?
Are CSII pumps more effective than MDI for improving other outcomes related to diabetes such as quality of life?
Literature Search
Inclusion Criteria
Randomized controlled trials, systematic reviews, meta-analysis and/or health technology assessments from MEDLINE, Excerpta Medica Database (EMBASE), Cumulative Index to Nursing & Allied Health Literature (CINAHL)
Any person with type 2 diabetes requiring insulin treatment intensive
Published between January 1, 2000 – August 2008
Exclusion Criteria
Studies with <10 patients
Studies <5 weeks in duration
CSII applied only at night time and not 24 hours/day
Mixed group of diabetes patients (children, adults, type 1, type 2)
Pregnancy studies
Outcomes of Interest
The primary outcome of interest was a reduction in glycosylated hemoglobin (HbA1c) levels. Other outcomes of interest were mean blood glucose level, glucose variability, insulin requirements, frequency of hypoglycemic events, adverse events, and quality of life.
Search Strategy
A comprehensive literature search was performed in OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, CINAHL, The Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published between January 1, 2000 and August 15, 2008. Studies meeting the inclusion criteria were selected from the search results. Data on the study characteristics, patient characteristics, primary and secondary treatment outcomes, and adverse events were abstracted. Reference lists of selected articles were also checked for relevant studies. The quality of the evidence was assessed as high, moderate, low, or very low according to the GRADE methodology.
Summary of Findings
The database search identified 286 relevant citations published between 1996 and August 2008. Of the 286 abstracts reviewed, four RCTs met the inclusion criteria outlined above. Upon examination, two studies were subsequently excluded from the meta-analysis due to small sample size and missing data (Berthe et al.), as well as outlier status and high drop out rate (Wainstein et al) which is consistent with previously reported meta-analyses on this topic (Jeitler et al 2008, and Fatourechi M et al. 2009).
HbA1c
The primary outcome in this analysis was reduction in HbA1c. Both studies demonstrated that both CSII pumps and MDI reduce HbA1c, but neither treatment modality was found to be superior to the other. The results of a random effects model meta-analysis showed a mean difference in HbA1c of -0.14 (-0.40, 0.13) between the two groups, which was found not to be statistically or clinically significant. There was no statistical heterogeneity observed between the two studies (I2=0%).
Forrest plot of two parallel, RCTs comparing CSII to MDI in type 2 diabetes
Secondary Outcomes
Mean Blood Glucose and Glucose Variability
Mean blood glucose was only used as an efficacy outcome in one study (Raskin et al. 2003). The authors found that the only time point in which there were consistently lower blood glucose values for the CSII group compared to the MDI group was 90 minutes after breakfast. Glucose variability was not examined in either study and the authors reported no difference in weight gain between the CSII pump group and MDI groups at the end of study. Conflicting results were reported regarding injection site reactions between the two studies. Herman et al. reported no difference in the number of subjects experiencing site problems between the two groups, while Raskin et al. reported that there were no injection site reactions in the MDI group but 15 such episodes among 8 participants in the CSII pump group.
Frequency of Hypoglycemic Events and Insulin Requirements
All studies reported that there were no differences in the number of mild hypoglycemic events in patients on CSII pumps versus MDI. Herman et al. also reported no differences in the number of severe hypoglycemic events in patients using CSII pumps compared to those on MDI. Raskin et al. reported that there were no severe hypoglycemic events in either group throughout the study duration. Insulin requirements were only examined in Herman et al., who found that daily insulin requirements were equal between the CSII pump and MDI treatment groups.
Quality of Life
QoL was measured by Herman et al. using the Diabetes Quality of Life Clinical Trial Questionnaire (DQOLCTQ). There were no differences reported between CSII users and MDI users for treatment satisfaction, diabetes impact, and worry-related scores. Patient satisfaction was measured in Raskin et al. using a patient satisfaction questionnaire, whose results indicated that patients in the CSII pump group had significantly greater improvement in overall treatment satisfaction at the end of the study compared to the MDI group. Although patient preference was also reported, it was only examined in the CSII pump group, thus results indicating a greater preference for CSII pumps in this groups (as compared to prior injectable insulin regimens) are biased and must be interpreted with caution.
Quality of Evidence
Overall, the body of evidence was downgraded from high to low according to study quality and issues with directness as identified using the GRADE quality assessment tool (see Table 3). While blinding of patient to intervention/control is not feasible in these studies, blinding of study personnel during outcome assessment and allocation concealment were generally lacking. ITT was not clearly explained in one study and heterogeneity between study populations was evident from participants’ treatment regimens prior to study initiation. Although trials reported consistent results for HbA1c outcomes, the directness or generalizability of studies, particularly with respect to the generalizability of the diabetic population, was questionable as trials required patients to adhere to an intense SMBG regimen. This suggests that patients were highly motivated. In addition, since prior treatment regimens varied between participants (no requirement for patients to be on MDI), study findings may not be generalizable to the population eligible for a pump in Ontario. The GRADE quality of evidence for the use of CSII in adults with type 2 diabetes is, therefore, low and any estimate of effect is uncertain.
GRADE Quality Assessment for CSII pumps vs. MDI on HbA1c Adults with Type 2 Diabetes
Inadequate or unknown allocation concealment (all studies); Unblinded assessment (all studies) however lack of blinding due to the nature of the study; ITT not well explained in 1 of 2 studies
Indirect due to lack of generalizability of findings since participants varied with respect to prior treatment regimens and intensive SMBG suggests highly motivated populations used in trials.
Economic Analysis
An economic analysis of CSII pumps was carried out using the Ontario Diabetes Economic Model (ODEM) and has been previously described in the report entitled “Application of the Ontario Diabetes Economic Model (ODEM) to Determine the Cost-effectiveness and Budget Impact of Selected Type 2 Diabetes Interventions in Ontario”, part of the diabetes strategy evidence series. Based on the analysis, CSII pumps are not cost-effective for adults with type 2 diabetes, either for the age 65+ sub-group or for all patients in general. Details of the analysis can be found in the full report.
Conclusions
CSII pumps for the treatment of adults with type 2 diabetes
There is low quality evidence demonstrating that the efficacy of CSII pumps is not superior to MDI for adult type 2 diabetics.
There were no differences in the number of mild and severe hypoglycemic events in patients on CSII pumps versus MDI.
There are conflicting findings with respect to an improved quality of life for patients using CSII pumps as compared to MDI.
Significant limitations of the literature exist specifically:
All studies sponsored by insulin pump manufacturers
Prior treatment regimens varied
Types of insulins used in study varied (NPH vs. glargine)
Generalizability of studies in question as populations may not reflect eligible patient population in Ontario (participants not necessarily on MDI prior to study initiation, pen used in one study and frequency of SMBG required during study was high suggesting highly motivated participants)
Based on ODEM, insulin pumps are not cost-effective for adults with type 2 diabetes either for the age 65+ sub-group or for all patients in general.
PMCID: PMC3377523  PMID: 23074525
7.  Eurocan plus report: feasibility study for coordination of national cancer research activities 
Summary
The EUROCAN+PLUS Project, called for by the European Parliament, was launched in October 2005 as a feasibility study for coordination of national cancer research activities in Europe. Over the course of the next two years, the Project process organized over 60 large meetings and countless smaller meetings that gathered in total over a thousand people, the largest Europe–wide consultation ever conducted in the field of cancer research.
Despite a strong tradition in biomedical science in Europe, fragmentation and lack of sustainability remain formidable challenges for implementing innovative cancer research and cancer care improvement. There is an enormous duplication of research effort in the Member States, which wastes time, wastes money and severely limits the total intellectual concentration on the wide cancer problem. There is a striking lack of communication between some of the biggest actors on the European scene, and there are palpable tensions between funders and those researchers seeking funds.
It is essential to include the patients’ voice in the establishment of priority areas in cancer research at the present time. The necessity to have dialogue between funders and scientists to establish the best mechanisms to meet the needs of the entire community is evident. A top priority should be the development of translational research (in its widest form), leading to the development of effective and innovative cancer treatments and preventive strategies. Translational research ranges from bench–to–bedside innovative cancer therapies and extends to include bringing about changes in population behaviours when a risk factor is established.
The EUROCAN+PLUS Project recommends the creation of a small, permanent and independent European Cancer Initiative (ECI). This should be a model structure and was widely supported at both General Assemblies of the project. The ECI should assume responsibility for stimulating innovative cancer research and facilitating processes, becoming the common voice of the cancer research community and serving as an interface between the cancer research community and European citizens, patients’ organizations, European institutions, Member States, industry and small and medium enterprises (SMEs), putting into practice solutions aimed at alleviating barriers to collaboration and coordination of cancer research activities in the European Union, and dealing with legal and regulatory issues. The development of an effective ECI will require time, but this entity should be established immediately. As an initial step, coordination efforts should be directed towards the creation of a platform on translational research that could encompass (1) coordination between basic, clinical and epidemiological research; (2) formal agreements of co–operation between comprehensive cancer centres and basic research laboratories throughout Europe and (3) networking between funding bodies at the European level.
The European Parliament and its instruments have had a major influence in cancer control in Europe, notably in tobacco control and in the implementation of effective population–based screening. To make further progress there is a need for novelty and innovation in cancer research and prevention in Europe, and having a platform such as the ECI, where those involved in all aspects of cancer research can meet, discuss and interact, is a decisive development for Europe.
Executive Summary
Cancer is one of the biggest public health crises facing Europe in the 21st century—one for which Europe is currently not prepared nor preparing itself. Cancer is a major cause of death in Europe with two million casualties and three million new cases diagnosed annually, and the situation is set to worsen as the population ages.
These facts led the European Parliament, through the Research Directorate-General of the European Commission, to call for initiatives for better coordination of cancer research efforts in the European Union. The EUROCAN+PLUS Project was launched in October 2005 as a feasibility study for coordination of national cancer research activities. Over the course of the next two years, the Project process organized over 60 large meetings and countless smaller meetings that gathered in total over a thousand people. In this respect, the Project became the largest Europe-wide consultation ever conducted in the field of cancer research, implicating researchers, cancer centres and hospitals, administrators, healthcare professionals, funding agencies, industry, patients’ organizations and patients.
The Project first identified barriers impeding research and collaboration in research in Europe. Despite a strong tradition in biomedical science in Europe, fragmentation and lack of sustainability remain the formidable challenges for implementing innovative cancer research and cancer care improvement. There is an enormous duplication of research effort in the Member States, which wastes time, wastes money and severely limits the total intellectual concentration on the wide cancer problem. There is a striking lack of communication between some of the biggest actors on the European scene, and there are palpable tensions between funders and those researchers seeking funds.
In addition, there is a shortage of leadership, a multiplicity of institutions each focusing on its own agenda, sub–optimal contact with industry, inadequate training, non–existent career paths, low personnel mobility in research especially among clinicians and inefficient funding—all conspiring against efficient collaboration in cancer care and research. European cancer research today does not have a functional translational research continuum, that is the process that exploits biomedical research innovations and converts them into prevention methods, diagnostic tools and therapies. Moreover, epidemiological research is not integrated with other types of cancer research, and the implementation of the European Directives on Clinical Trials 1 and on Personal Data Protection 2 has further slowed the innovation process in Europe. Furthermore, large inequalities in health and research exist between the EU–15 and the New Member States.
The picture is not entirely bleak, however, as the European cancer research scene presents several strengths, such as excellent basic research and clinical research and innovative etiological research that should be better exploited.
When considering recommendations, several priority dimensions had to be retained. It is essential that proposals include actions and recommendations that can benefit all Member States of the European Union and not just States with the elite centres. It is also essential to have a broader patient orientation to help provide the knowledge to establish cancer control possibilities when we exhaust what can be achieved by the implementation of current knowledge. It is vital that the actions proposed can contribute to the Lisbon Strategy to make Europe more innovative and competitive in (cancer) research.
The Project participants identified six areas for which consensus solutions should be implemented in order to obtain better coordination of cancer research activities. The required solutions are as follows. The proactive management of innovation, detection, facilitation of collaborations and maintenance of healthy competition within the European cancer research community.The establishment of an exchange portal of information for health professionals, patients and policy makers.The provision of guidance for translational and clinical research including the establishment of a translational research platform involving comprehensive cancer centres and cancer research centres.The coordination of calls and financial management of cancer research projects.The construction of a ‘one–stop shop’ as a contact interface between the industry, small and medium enterprises, scientists and other stakeholders.The support of greater involvement of healthcare professionals in translational research and multidisciplinary training.
In the course of the EUROCAN+PLUS consultative process, several key collaborative projects emerged between the various groups and institutes engaged in the consultation. There was a collaboration network established with Europe’s leading Comprehensive Cancer Centres; funding was awarded for a closer collaboration of Owners of Cancer Registries in Europe (EUROCOURSE); there was funding received from FP7 for an extensive network of leading Biological Resource Centres in Europe (BBMRI); a Working Group identified the special needs of Central, Eastern and South–eastern Europe and proposed a remedy (‘Warsaw Declaration’), and the concept of developing a one–stop shop for dealing with academia and industry including the Innovative Medicines Initiative (IMI) was discussed in detail.
Several other dimensions currently lacking were identified. There is an absolute necessity to include the patients’ voice in the establishment of priority areas in cancer research at the present time. It was a salutary lesson when it was recognized that all that is known about the quality of life of the cancer patient comes from the experience of a tiny proportion of cancer patients included in a few clinical trials. The necessity to have dialogue between funders and scientists to establish the best mechanisms to meet the needs of the entire community was evident. A top priority should be the development of translational research (in its widest form) and the development of effective and innovative cancer treatments and preventative strategies in the European Union. Translational research ranges from bench-to-bedside innovative cancer therapies and extends to include bringing about changes in population behaviours when a risk factor is established.
Having taken note of the barriers and the solutions and having examined relevant examples of existing European organizations in the field, it was agreed during the General Assembly of 19 November 2007 that the EUROCAN+PLUS Project had to recommend the creation of a small, permanent and neutral ECI. This should be a model structure and was widely supported at both General Assemblies of the project. The proposal is based on the successful model of the European Molecular Biology Organisation (EMBO), and its principal aims include providing a forum where researchers from all backgrounds and from all countries can meet with members of other specialities including patients, nurses, clinicians, funders and scientific administrators to develop priority programmes to make Europe more competitive in research and more focused on the cancer patient.
The ECI should assume responsibility for: stimulating innovative cancer research and facilitating processes;becoming the common voice of the cancer research community and serving as an interface between the cancer research community and European citizens, patients’ and organizations;European institutions, Member States, industry and small and medium enterprises;putting into practice the aforementioned solutions aimed at alleviating barriers and coordinating cancer research activities in the EU;dealing with legal and regulatory issues.
Solutions implemented through the ECI will lead to better coordination and collaboration throughout Europe, more efficient use of resources, an increase in Europe’s attractiveness to the biomedical industry and better quality of cancer research and education of health professionals.
The Project considered that European legal instruments currently available were inadequate for addressing many aspects of the barriers identified and for the implementation of effective, lasting solutions. Therefore, the legal environment that could shelter an idea like the ECI remains to be defined but should be done so as a priority. In this context, the initiative of the European Commission for a new legal entity for research infrastructure might be a step in this direction. The development of an effective ECI will require time, but this should be established immediately. As an initial step, coordination efforts should be directed towards the creation of a platform on translational research that could encompass: (1) coordination between basic, clinical and epidemiological research; (2) formal agreements of co-operation between comprehensive cancer centres and basic research laboratories throughout Europe; (3) networking between funding bodies at the European level. Another topic deserving immediate attention is the creation of a European database on cancer research projects and cancer research facilities.
Despite enormous progress in cancer control in Europe during the past two decades, there was an increase of 300,000 in the number of new cases of cancer diagnosed between 2004 and 2006. The European Parliament and its instruments have had a major influence in cancer control, notably in tobacco control and in the implementation of effective population–based screening. To make further progress there is a need for novelty and innovation in cancer research and prevention in Europe, and having a platform such as the ECI, where those involved in all aspects of cancer research can meet, discuss and interact, is a decisive development for Europe.
doi:10.3332/ecancer.2011.84
PMCID: PMC3234055  PMID: 22274749
8.  Developing an efficient scheduling template of a chemotherapy treatment unit 
The Australasian Medical Journal  2011;4(10):575-588.
This study was undertaken to improve the performance of a Chemotherapy Treatment Unit by increasing the throughput and reducing the average patient’s waiting time. In order to achieve this objective, a scheduling template has been built. The scheduling template is a simple tool that can be used to schedule patients' arrival to the clinic. A simulation model of this system was built and several scenarios, that target match the arrival pattern of the patients and resources availability, were designed and evaluated. After performing detailed analysis, one scenario provide the best system’s performance. A scheduling template has been developed based on this scenario. After implementing the new scheduling template, 22.5% more patients can be served.
Introduction
CancerCare Manitoba is a provincially mandated cancer care agency. It is dedicated to provide quality care to those who have been diagnosed and are living with cancer. MacCharles Chemotherapy unit is specially built to provide chemotherapy treatment to the cancer patients of Winnipeg. In order to maintain an excellent service, it tries to ensure that patients get their treatment in a timely manner. It is challenging to maintain that goal because of the lack of a proper roster, the workload distribution and inefficient resource allotment. In order to maintain the satisfaction of the patients and the healthcare providers, by serving the maximum number of patients in a timely manner, it is necessary to develop an efficient scheduling template that matches the required demand with the availability of resources. This goal can be reached using simulation modelling. Simulation has proven to be an excellent modelling tool. It can be defined as building computer models that represent real world or hypothetical systems, and hence experimenting with these models to study system behaviour under different scenarios.1, 2
A study was undertaken at the Children's Hospital of Eastern Ontario to identify the issues behind the long waiting time of a emergency room.3 A 20-­‐day field observation revealed that the availability of the staff physician and interaction affects the patient wait time. Jyväskylä et al.4 used simulation to test different process scenarios, allocate resources and perform activity-­‐based cost analysis in the Emergency Department (ED) at the Central Hospital. The simulation also supported the study of a new operational method, named "triage-team" method without interrupting the main system. The proposed triage team method categorises the entire patient according to the urgency to see the doctor and allows the patient to complete the necessary test before being seen by the doctor for the first time. The simulation study showed that it will decrease the throughput time of the patient and reduce the utilisation of the specialist and enable the ordering all the tests the patient needs right after arrival, thus quickening the referral to treatment.
Santibáñez et al.5 developed a discrete event simulation model of British Columbia Cancer Agency"s ambulatory care unit which was used to study the impact of scenarios considering different operational factors (delay in starting clinic), appointment schedule (appointment order, appointment adjustment, add-­‐ons to the schedule) and resource allocation. It was found that the best outcomes were obtained when not one but multiple changes were implemented simultaneously. Sepúlveda et al.6 studied the M. D. Anderson Cancer Centre Orlando, which is a cancer treatment facility and built a simulation model to analyse and improve flow process and increase capacity in the main facility. Different scenarios were considered like, transferring laboratory and pharmacy areas, adding an extra blood draw room and applying different scheduling techniques of patients. The study shows that by increasing the number of short-­‐term (four hours or less) patients in the morning could increase chair utilisation.
Discrete event simulation also helps improve a service where staff are ignorant about the behaviour of the system as a whole; which can also be described as a real professional system. Niranjon et al.7 used simulation successfully where they had to face such constraints and lack of accessible data. Carlos et al. 8 used Total quality management and simulation – animation to improve the quality of the emergency room. Simulation was used to cover the key point of the emergency room and animation was used to indicate the areas of opportunity required. This study revealed that a long waiting time, overload personnel and increasing withdrawal rate of patients are caused by the lack of capacity in the emergency room.
Baesler et al.9 developed a methodology for a cancer treatment facility to find stochastically a global optimum point for the control variables. A simulation model generated the output using a goal programming framework for all the objectives involved in the analysis. Later a genetic algorithm was responsible for performing the search for an improved solution. The control variables that were considered in this research are number of treatment chairs, number of drawing blood nurses, laboratory personnel, and pharmacy personnel. Guo et al. 10 presented a simulation framework considering demand for appointment, patient flow logic, distribution of resources, scheduling rules followed by the scheduler. The objective of the study was to develop a scheduling rule which will ensure that 95% of all the appointment requests should be seen within one week after the request is made to increase the level of patient satisfaction and balance the schedule of each doctor to maintain a fine harmony between "busy clinic" and "quiet clinic".
Huschka et al.11 studied a healthcare system which was about to change their facility layout. In this case a simulation model study helped them to design a new healthcare practice by evaluating the change in layout before implementation. Historical data like the arrival rate of the patients, number of patients visited each day, patient flow logic, was used to build the current system model. Later, different scenarios were designed which measured the changes in the current layout and performance.
Wijewickrama et al.12 developed a simulation model to evaluate appointment schedule (AS) for second time consultations and patient appointment sequence (PSEQ) in a multi-­‐facility system. Five different appointment rule (ARULE) were considered: i) Baily; ii) 3Baily; iii) Individual (Ind); iv) two patients at a time (2AtaTime); v) Variable Interval and (V-­‐I) rule. PSEQ is based on type of patients: Appointment patients (APs) and new patients (NPs). The different PSEQ that were studied in this study were: i) first-­‐ come first-­‐serve; ii) appointment patient at the beginning of the clinic (APBEG); iii) new patient at the beginning of the clinic (NPBEG); iv) assigning appointed and new patients in an alternating manner (ALTER); v) assigning a new patient after every five-­‐appointment patients. Also patient no show (0% and 5%) and patient punctuality (PUNCT) (on-­‐time and 10 minutes early) were also considered. The study found that ALTER-­‐Ind. and ALTER5-­‐Ind. performed best on 0% NOSHOW, on-­‐time PUNCT and 5% NOSHOW, on-­‐time PUNCT situation to reduce WT and IT per patient. As NOSHOW created slack time for waiting patients, their WT tends to reduce while IT increases due to unexpected cancellation. Earliness increases congestion whichin turn increases waiting time.
Ramis et al.13 conducted a study of a Medical Imaging Center (MIC) to build a simulation model which was used to improve the patient journey through an imaging centre by reducing the wait time and making better use of the resources. The simulation model also used a Graphic User Interface (GUI) to provide the parameters of the centre, such as arrival rates, distances, processing times, resources and schedule. The simulation was used to measure the waiting time of the patients in different case scenarios. The study found that assigning a common function to the resource personnel could improve the waiting time of the patients.
The objective of this study is to develop an efficient scheduling template that maximises the number of served patients and minimises the average patient's waiting time at the given resources availability. To accomplish this objective, we will build a simulation model which mimics the working conditions of the clinic. Then we will suggest different scenarios of matching the arrival pattern of the patients with the availability of the resources. Full experiments will be performed to evaluate these scenarios. Hence, a simple and practical scheduling template will be built based on the indentified best scenario. The developed simulation model is described in section 2, which consists of a description of the treatment room, and a description of the types of patients and treatment durations. In section 3, different improvement scenarios are described and their analysis is presented in section 4. Section 5 illustrates a scheduling template based on one of the improvement scenarios. Finally, the conclusion and future direction of our work is exhibited in section 6.
Simulation Model
A simulation model represents the actual system and assists in visualising and evaluating the performance of the system under different scenarios without interrupting the actual system. Building a proper simulation model of a system consists of the following steps.
Observing the system to understand the flow of the entities, key players, availability of resources and overall generic framework.
Collecting the data on the number and type of entities, time consumed by the entities at each step of their journey, and availability of resources.
After building the simulation model it is necessary to confirm that the model is valid. This can be done by confirming that each entity flows as it is supposed to and the statistical data generated by the simulation model is similar to the collected data.
Figure 1 shows the patient flow process in the treatment room. On the patient's first appointment, the oncologist comes up with the treatment plan. The treatment time varies according to the patient’s condition, which may be 1 hour to 10 hours. Based on the type of the treatment, the physician or the clinical clerk books an available treatment chair for that time period.
On the day of the appointment, the patient will wait until the booked chair is free. When the chair is free a nurse from that station comes to the patient, verifies the name and date of birth and takes the patient to a treatment chair. Afterwards, the nurse flushes the chemotherapy drug line to the patient's body which takes about five minutes and sets up the treatment. Then the nurse leaves to serve another patient. Chemotherapy treatment lengths vary from less than an hour to 10 hour infusions. At the end of the treatment, the nurse returns, removes the line and notifies the patient about the next appointment date and time which also takes about five minutes. Most of the patients visit the clinic to take care of their PICC line (a peripherally inserted central catheter). A PICC is a line that is used to inject the patient with the chemical. This PICC line should be regularly cleaned, flushed to maintain patency and the insertion site checked for signs of infection. It takes approximately 10–15 minutes to take care of a PICC line by a nurse.
Cancer Care Manitoba provided access to the electronic scheduling system, also known as "ARIA" which is comprehensive information and image management system that aggregates patient data into a fully-­‐electronic medical chart, provided by VARIAN Medical System. This system was used to find out how many patients are booked in every clinic day. It also reveals which chair is used for how many hours. It was necessary to search a patient's history to find out how long the patient spends on which chair. Collecting the snapshot of each patient gives the complete picture of a one day clinic schedule.
The treatment room consists of the following two main limited resources:
Treatment Chairs: Chairs that are used to seat the patients during the treatment.
Nurses: Nurses are required to inject the treatment line into the patient and remove it at the end of the treatment. They also take care of the patients when they feel uncomfortable.
Mc Charles Chemotherapy unit consists of 11 nurses, and 5 stations with the following description:
Station 1: Station 1 has six chairs (numbered 1 to 6) and two nurses. The two nurses work from 8:00 to 16:00.
Station 2: Station 2 has six chairs (7 to 12) and three nurses. Two nurses work from 8:00 to 16:00 and one nurse works from 12:00 to 20:00.
Station 3: Station 4 has six chairs (13 to 18) and two nurses. The two nurses work from 8:00 to 16:00.
Station 4: Station 4 has six chairs (19 to 24) and three nurses. One nurse works from 8:00 to 16:00. Another nurse works from 10:00 to 18:00.
Solarium Station: Solarium Station has six chairs (Solarium Stretcher 1, Solarium Stretcher 2, Isolation, Isolation emergency, Fire Place 1, Fire Place 2). There is only one nurse assigned to this station that works from 12:00 to 20:00. The nurses from other stations can help when need arises.
There is one more nurse known as the "float nurse" who works from 11:00 to 19:00. This nurse can work at any station. Table 1 summarises the working hours of chairs and nurses. All treatment stations start at 8:00 and continue until the assigned nurse for that station completes her shift.
Currently, the clinic uses a scheduling template to assign the patients' appointments. But due to high demand of patient appointment it is not followed any more. We believe that this template can be improved based on the availability of nurses and chairs. Clinic workload was collected from 21 days of field observation. The current scheduling template has 10 types of appointment time slot: 15-­‐minute, 1-­‐hour, 1.5-­‐hour, 2-­‐hour, 3-­‐hour, 4-­‐hour, 5-­‐hour, 6-­‐hour, 8-­‐hour and 10-­‐hour and it is designed to serve 95 patients. But when the scheduling template was compared with the 21 days observations, it was found that the clinic is serving more patients than it is designed for. Therefore, the providers do not usually follow the scheduling template. Indeed they very often break the time slots to accommodate slots that do not exist in the template. Hence, we find that some of the stations are very busy (mostly station 2) and others are underused. If the scheduling template can be improved, it will be possible to bring more patients to the clinic and reduce their waiting time without adding more resources.
In order to build or develop a simulation model of the existing system, it is necessary to collect the following data:
Types of treatment durations.
Numbers of patients in each treatment type.
Arrival pattern of the patients.
Steps that the patients have to go through in their treatment journey and required time of each step.
Using the observations of 2,155 patients over 21 days of historical data, the types of treatment durations and the number of patients in each type were estimated. This data also assisted in determining the arrival rate and the frequency distribution of the patients. The patients were categorised into six types. The percentage of these types and their associated service times distributions are determined too.
ARENA Rockwell Simulation Software (v13) was used to build the simulation model. Entities of the model were tracked to verify that the patients move as intended. The model was run for 30 replications and statistical data was collected to validate the model. The total number of patients that go though the model was compared with the actual number of served patients during the 21 days of observations.
Improvement Scenarios
After verifying and validating the simulation model, different scenarios were designed and analysed to identify the best scenario that can handle more patients and reduces the average patient's waiting time. Based on the clinic observation and discussion with the healthcare providers, the following constraints have been stated:
The stations are filled up with treatment chairs. Therefore, it is literally impossible to fit any more chairs in the clinic. Moreover, the stakeholders are not interested in adding extra chairs.
The stakeholders and the caregivers are not interested in changing the layout of the treatment room.
Given these constraints the options that can be considered to design alternative scenarios are:
Changing the arrival pattern of the patients: that will fit over the nurses' availability.
Changing the nurses' schedule.
Adding one full time nurse at different starting times of the day.
Figure 2 compares the available number of nurses and the number of patients' arrival during different hours of a day. It can be noticed that there is a rapid growth in the arrival of patients (from 13 to 17) between 8:00 to 10:00 even though the clinic has the equal number of nurses during this time period. At 12:00 there is a sudden drop of patient arrival even though there are more available nurses. It is clear that there is an imbalance in the number of available nurses and the number of patient arrivals over different hours of the day. Consequently, balancing the demand (arrival rate of patients) and resources (available number of nurses) will reduce the patients' waiting time and increases the number of served patients. The alternative scenarios that satisfy the above three constraints are listed in Table 2. These scenarios respect the following rules:
Long treatments (between 4hr to 11hr) have to be scheduled early in the morning to avoid working overtime.
Patients of type 1 (15 minutes to 1hr treatment) are the most common. They can be fitted in at any time of the day because they take short treatment time. Hence, it is recommended to bring these patients in at the middle of the day when there are more nurses.
Nurses get tired at the end of the clinic day. Therefore, fewer patients should be scheduled at the late hours of the day.
In Scenario 1, the arrival pattern of the patient was changed so that it can fit with the nurse schedule. This arrival pattern is shown Table 3. Figure 3 shows the new patients' arrival pattern compared with the current arrival pattern. Similar patterns can be developed for the remaining scenarios too.
Analysis of Results
ARENA Rockwell Simulation software (v13) was used to develop the simulation model. There is no warm-­‐up period because the model simulates day-­‐to-­‐day scenarios. The patients of any day are supposed to be served in the same day. The model was run for 30 days (replications) and statistical data was collected to evaluate each scenario. Tables 4 and 5 show the detailed comparison of the system performance between the current scenario and Scenario 1. The results are quite interesting. The average throughput rate of the system has increased from 103 to 125 patients per day. The maximum throughput rate can reach 135 patients. Although the average waiting time has increased, the utilisation of the treatment station has increased by 15.6%. Similar analysis has been performed for the rest of the other scenarios. Due to the space limitation the detailed results are not given. However, Table 6 exhibits a summary of the results and comparison between the different scenarios. Scenario 1 was able to significantly increase the throughput of the system (by 21%) while it still results in an acceptable low average waiting time (13.4 minutes). In addition, it is worth noting that adding a nurse (Scenarios 3, 4, and 5) does not significantly reduce the average wait time or increase the system's throughput. The reason behind this is that when all the chairs are busy, the nurses have to wait until some patients finish the treatment. As a consequence, the other patients have to wait for the commencement of their treatment too. Therefore, hiring a nurse, without adding more chairs, will not reduce the waiting time or increase the throughput of the system. In this case, the only way to increase the throughput of the system is by adjusting the arrival pattern of patients over the nurses' schedule.
Developing a Scheduling Template based on Scenario 1
Scenario 1 provides the best performance. However a scheduling template is necessary for the care provider to book the patients. Therefore, a brief description is provided below on how scheduling the template is developed based on this scenario.
Table 3 gives the number of patients that arrive hourly, following Scenario 1. The distribution of each type of patient is shown in Table 7. This distribution is based on the percentage of each type of patient from the collected data. For example, in between 8:00-­‐9:00, 12 patients will come where 54.85% are of Type 1, 34.55% are of Type 2, 15.163% are of Type 3, 4.32% are of Type 4, 2.58% are of Type 5 and the rest are of Type 6. It is worth noting that, we assume that the patients of each type arrive as a group at the beginning of the hourly time slot. For example, all of the six patients of Type 1 from 8:00 to 9:00 time slot arrive at 8:00.
The numbers of patients from each type is distributed in such a way that it respects all the constraints described in Section 1.3. Most of the patients of the clinic are from type 1, 2 and 3 and they take less amount of treatment time compared with the patients of other types. Therefore, they are distributed all over the day. Patients of type 4, 5 and 6 take a longer treatment time. Hence, they are scheduled at the beginning of the day to avoid overtime. Because patients of type 4, 5 and 6 come at the beginning of the day, most of type 1 and 2 patients come at mid-­‐day (12:00 to 16:00). Another reason to make the treatment room more crowded in between 12:00 to 16:00 is because the clinic has the maximum number of nurses during this time period. Nurses become tired at the end of the clinic which is a reason not to schedule any patient after 19:00.
Based on the patient arrival schedule and nurse availability a scheduling template is built and shown in Figure 4. In order to build the template, if a nurse is available and there are patients waiting for service, a priority list of these patients will be developed. They are prioritised in a descending order based on their estimated slack time and secondarily based on the shortest service time. The secondary rule is used to break the tie if two patients have the same slack. The slack time is calculated using the following equation:
Slack time = Due time - (Arrival time + Treatment time)
Due time is the clinic closing time. To explain how the process works, assume at hour 8:00 (in between 8:00 to 8:15) two patients in station 1 (one 8-­‐hour and one 15-­‐ minute patient), two patients in station 2 (two 12-­‐hour patients), two patients in station 3 (one 2-­‐hour and one 15-­‐ minute patient) and one patient in station 4 (one 3-­‐hour patient) in total seven patients are scheduled. According to Figure 2, there are seven nurses who are available at 8:00 and it takes 15 minutes to set-­‐up a patient. Therefore, it is not possible to schedule more than seven patients in between 8:00 to 8:15 and the current scheduling is also serving seven patients by this time. The rest of the template can be justified similarly.
doi:10.4066/AMJ.2011.837
PMCID: PMC3562880  PMID: 23386870
9.  Point-of-Care International Normalized Ratio (INR) Monitoring Devices for Patients on Long-term Oral Anticoagulation Therapy 
Executive Summary
Subject of the Evidence-Based Analysis
The purpose of this evidence based analysis report is to examine the safety and effectiveness of point-of-care (POC) international normalized ratio (INR) monitoring devices for patients on long-term oral anticoagulation therapy (OAT).
Clinical Need: Target Population and Condition
Long-term OAT is typically required by patients with mechanical heart valves, chronic atrial fibrillation, venous thromboembolism, myocardial infarction, stroke, and/or peripheral arterial occlusion. It is estimated that approximately 1% of the population receives anticoagulation treatment and, by applying this value to Ontario, there are an estimated 132,000 patients on OAT in the province, a figure that is expected to increase with the aging population.
Patients on OAT are regularly monitored and their medications adjusted to ensure that their INR scores remain in the therapeutic range. This can be challenging due to the narrow therapeutic window of warfarin and variation in individual responses. Optimal INR scores depend on the underlying indication for treatment and patient level characteristics, but for most patients the therapeutic range is an INR score of between 2.0 and 3.0.
The current standard of care in Ontario for patients on long-term OAT is laboratory-based INR determination with management carried out by primary care physicians or anticoagulation clinics (ACCs). Patients also regularly visit a hospital or community-based facility to provide a venous blood samples (venipuncture) that are then sent to a laboratory for INR analysis.
Experts, however, have commented that there may be under-utilization of OAT due to patient factors, physician factors, or regional practice variations and that sub-optimal patient management may also occur. There is currently no population-based Ontario data to permit the assessment of patient care, but recent systematic reviews have estimated that less that 50% of patients receive OAT on a routine basis and that patients are in the therapeutic range only 64% of the time.
Overview of POC INR Devices
POC INR devices offer an alternative to laboratory-based testing and venipuncture, enabling INR determination from a fingerstick sample of whole blood. Independent evaluations have shown POC devices to have an acceptable level of precision. They permit INR results to be determined immediately, allowing for more rapid medication adjustments.
POC devices can be used in a variety of settings including physician offices, ACCs, long-term care facilities, pharmacies, or by the patients themselves through self-testing (PST) or self-management (PSM) techniques. With PST, patients measure their INR values and then contact their physician for instructions on dose adjustment, whereas with PSM, patients adjust the medication themselves based on pre-set algorithms. These models are not suitable for all patients and require the identification and education of suitable candidates.
Potential advantages of POC devices include improved convenience to patients, better treatment compliance and satisfaction, more frequent monitoring and fewer thromboembolic and hemorrhagic complications. Potential disadvantages of the device include the tendency to underestimate high INR values and overestimate low INR values, low thromboplastin sensitivity, inability to calculate a mean normal PT, and errors in INR determination in patients with antiphospholipid antibodies with certain instruments. Although treatment satisfaction and quality of life (QoL) may improve with POC INR monitoring, some patients may experience increased anxiety or preoccupation with their disease with these strategies.
Evidence-Based Analysis Methods
Research Questions
1. Effectiveness
Does POC INR monitoring improve clinical outcomes in various settings compared to standard laboratory-based testing?
Does POC INR monitoring impact patient satisfaction, QoL, compliance, acceptability, convenience compared to standard laboratory-based INR determination?
Settings include primary care settings with use of POC INR devices by general practitioners or nurses, ACCs, pharmacies, long-term care homes, and use by the patient either for PST or PSM.
2. Cost-effectiveness
What is the cost-effectiveness of POC INR monitoring devices in various settings compared to standard laboratory-based INR determination?
Inclusion Criteria
English-language RCTs, systematic reviews, and meta-analyses
Publication dates: 1996 to November 25, 2008
Population: patients on OAT
Intervention: anticoagulation monitoring by POC INR device in any setting including anticoagulation clinic, primary care (general practitioner or nurse), pharmacy, long-term care facility, PST, PSM or any other POC INR strategy
Minimum sample size: 50 patients Minimum follow-up period: 3 months
Comparator: usual care defined as venipuncture blood draw for an INR laboratory test and management provided by an ACC or individual practitioner
Outcomes: Hemorrhagic events, thromboembolic events, all-cause mortality, anticoagulation control as assessed by proportion of time or values in the therapeutic range, patient reported outcomes including satisfaction, QoL, compliance, acceptability, convenience
Exclusion criteria
Non-RCTs, before-after studies, quasi-experimental studies, observational studies, case reports, case series, editorials, letters, non-systematic reviews, conference proceedings, abstracts, non-English articles, duplicate publications
Studies where POC INR devices were compared to laboratory testing to assess test accuracy
Studies where the POC INR results were not used to guide patient management
Method of Review
A search of electronic databases (OVID MEDLINE, MEDLINE In-Process & Other Non-Indexed Citations, EMBASE, The Cochrane Library, and the International Agency for Health Technology Assessment [INAHTA] database) was undertaken to identify evidence published from January 1, 1998 to November 25, 2008. Studies meeting the inclusion criteria were selected from the search results. Reference lists of selected articles were also checked for relevant studies.
Summary of Findings
Five existing reviews and 22 articles describing 17 unique RCTs met the inclusion criteria. Three RCTs examined POC INR monitoring devices with PST strategies, 11 RCTs examined PSM strategies, one RCT included both PST and PSM strategies and two RCTs examined the use of POC INR monitoring devices by health care professionals.
Anticoagulation Control
Anticoagulation control is measured by the percentage of time INR is within the therapeutic range or by the percentage of INR values in the therapeutic range. Due to the differing methodologies and reporting structures used, it was deemed inappropriate to combine the data and estimate whether the difference between groups would be significant. Instead, the results of individual studies were weighted by the number of person-years of observation and then pooled to calculate a summary measure.
Across most studies, patients in the intervention groups tended to have a higher percentage of time and values in the therapeutic target range in comparison to control patients. When the percentage of time in the therapeutic range was pooled across studies and weighted by the number of person-years of observation, the difference between the intervention and control groups was 4.2% for PSM, 7.2% for PST and 6.1% for POC use by health care practitioners. Overall, intervention patients were in the target range 69% of the time and control patients were in the therapeutic target range 64% of the time leading to an overall difference between groups of roughly 5%.
Major Complications and Deaths
There was no statistically significant difference in the number of major hemorrhagic events between patients managed with POC INR monitoring devices and patients managed with standard laboratory testing (OR =0.74; 95% CI: 0.52- 1.04). This difference was non-significant for all POC strategies (PSM, PST, health care practitioner).
Patients managed with POC INR monitoring devices had significantly fewer thromboembolic events than usual care patients (OR =0.52; 95% CI: 0.37 - 0.74). When divided by POC strategy, PSM resulted in significantly fewer thromboembolic events than usual care (OR =0.46.; 95% CI: 0.29 - 0.72). The observed difference in thromboembolic events for PSM remained significant when the analysis was limited to major thromboembolic events (OR =0.40; 95% CI: 0.17 - 0.93), but was non-significant when the analysis was limited to minor thromboembolic events (OR =0.73; 95% CI: 0.08 - 7.01). PST and GP/Nurse strategies did not result in significant differences in thromboembolic events, however there were only a limited number of studies examining these interventions.
No statistically significant difference was observed in the number of deaths between POC intervention and usual care control groups (OR =0.67; 95% CI: 0.41 - 1.10). This difference was non-significant for all POC strategies. Only one study reported on survival with 10-year survival rate of 76.1% in the usual care control group compared to 84.5% in the PSM group (P=0.05).
Summary Results of Meta-Analyses of Major Complications and Deaths in POC INR Monitoring Studies
Patient Satisfaction and Quality of Life
Quality of life measures were reported in eight studies comparing POC INR monitoring to standard laboratory testing using a variety of measurement tools. It was thus not possible to calculate a quantitative summary measure. The majority of studies reported favourable impacts of POC INR monitoring on QoL and found better treatment satisfaction with POC monitoring. Results from a pre-analysis patient and caregiver focus group conducted in Ontario also indicated improved patient QoL with POC monitoring.
Quality of the Evidence
Studies varied with regard to patient eligibility, baseline patient characteristics, follow-up duration, and withdrawal rates. Differential drop-out rates were observed such that the POC intervention groups tended to have a larger number of patients who withdrew. There was a lack of consistency in the definitions and reporting for OAT control and definitions of adverse events. In most studies, the intervention group received more education on the use of warfarin and performed more frequent INR testing, which may have overestimated the effect of the POC intervention. Patient selection and eligibility criteria were not always fully described and it is likely that the majority of the PST/PSM trials included a highly motivated patient population. Lastly, a large number of trials were also sponsored by industry.
Despite the observed heterogeneity among studies, there was a general consensus in findings that POC INR monitoring devices have beneficial impacts on the risk of thromboembolic events, anticoagulation control and patient satisfaction and QoL (ES Table 2).
GRADE Quality of the Evidence on POC INR Monitoring Studies
CI refers to confidence interval; Interv, intervention; OR, odds ratio; RCT, randomized controlled trial.
Economic Analysis
Using a 5-year Markov model, the health and economic outcomes associated with four different anticoagulation management approaches were evaluated:
Standard care: consisting of a laboratory test with a venipuncture blood draw for an INR;
Healthcare staff testing: consisting of a test with a POC INR device in a medical clinic comprised of healthcare staff such as pharmacists, nurses, and physicians following protocol to manage OAT;
PST: patient self-testing using a POC INR device and phoning in results to an ACC or family physician; and
PSM: patient self-managing using a POC INR device and self-adjustment of OAT according to a standardized protocol. Patients may also phone in to a medical office for guidance.
The primary analytic perspective was that of the MOHLTC. Only direct medical costs were considered and the time horizon of the model was five years - the serviceable life of a POC device.
From the results of the economic analysis, it was found that POC strategies are cost-effective compared to traditional INR laboratory testing. In particular, the healthcare staff testing strategy can derive potential cost savings from the use of one device for multiple patients. The PSM strategy, however, seems to be the most cost-effective method i.e. patients are more inclined to adjust their INRs more readily (as opposed to allowing INRs to fall out of range).
Considerations for Ontario Health System
Although the use of POC devices continues to diffuse throughout Ontario, not all OAT patients are suitable or have the ability to practice PST/PSM. The use of POC is currently concentrated at the institutional setting, including hospitals, ACCs, long-term care facilities, physician offices and pharmacies, and is much less commonly used at the patient level. It is, however, estimated that 24% of OAT patients (representing approximately 32,000 patients in Ontario), would be suitable candidates for PST/PSM strategies and willing to use a POC device.
There are several barriers to the use and implementation of POC INR monitoring devices, including factors such as lack of physician familiarity with the devices, resistance to changing established laboratory-based methods, lack of an approach for identifying suitable patients and inadequate resources for effective patient education and training. Issues of cost and insufficient reimbursement strategies may also hinder implementation and effective quality assurance programs would need to be developed to ensure that INR measurements are accurate and precise.
Conclusions
For a select group of patients who are highly motivated and trained, PSM resulted in significantly fewer thromboembolic events compared to conventional laboratory-based INR testing. No significant differences were observed for major hemorrhages or all-cause mortality. PST and GP/Nurse use of POC strategies are just as effective as conventional laboratory-based INR testing for thromboembolic events, major hemorrhages, and all-cause mortality. POC strategies may also result in better OAT control as measured by the proportion of time INR is in the therapeutic range and there appears to be beneficial impacts on patient satisfaction and QoL. The use of POC devices should factor in patient suitability, patient education and training, health system constraints, and affordability.
Keywords
anticoagulants, International Normalized Ratio, point-of-care, self-monitoring, warfarin.
PMCID: PMC3377545  PMID: 23074516
10.  A region-based palliative care intervention trial using the mixed-method approach: Japan OPTIM study 
BMC Palliative Care  2012;11:2.
Background
Disseminating palliative care is a critical task throughout the world. Several outcome studies explored the effects of regional palliative care programs on a variety of end-points, and some qualitative studies investigated the process of developing community palliative care networks. These studies provide important insights into the potential benefits of regional palliative care programs, but the clinical implications are still limited, because: 1) many interventions included fundamental changes in the structure of the health care system, and, thus, the results would not be applicable for many regions where structural changes are difficult or unfeasible; 2) patient-oriented outcomes were not measured or explored only in a small number of populations, and interpretation of the results from a patient's view is difficult; and 3) no studies adopted a mixed-method approach using both quantitative and qualitative methodologies to interpret the complex phenomenon from multidimensional perspectives.
Methods/designs
This is a mixed-method regional intervention trial, consisting of a pre-post outcome study and qualitative process studies. The primary aim of the pre-post outcome study is to evaluate the change in the number of home deaths, use of specialized palliative care services, patient-reported quality of palliative care, and family-reported quality of palliative care after regional palliative care intervention. The secondary aim is to explore the changes in a variety of outcomes, including patients' quality of life, pain intensity, family care burden, and physicians' and nurses' knowledge, difficulties, and self-perceived practice. Outcome measurements used in this study include the Care Evaluation Scale, Good Death Inventory, Brief pain Inventory, Caregiving Consequence Inventory, Sense of Security Scale, Palliative Care Knowledge test, Palliative Care Difficulties Scale, and Palliative Care Self-reported Practice Scale. Study populations are a nearly representative sample of advanced cancer patients, bereaved family members, physicians, and nurses in the region.
Qualitative process studies consist of 3 studies with each aim: 1) to describe the process in developing regional palliative care in each local context, 2) to understand how and why the regional palliative care program led to changes in the region and to propose a model for shaping regional palliative care, and 3) to systemically collect the barriers of palliative care at a regional level and potential resolutions. The study methodology is a case descriptive study, a grounded theory approach based on interviews, and a content analysis based on systemically collected data, respectively.
Discussion
This study is, to our knowledge, one of the most comprehensive evaluations of a region-based palliative care intervention program. This study has 3 unique aspects: 1) it measures a wide range of outcomes, including quality of care and quality of life measures specifically designed for palliative care populations, whether patients died where they actually preferred, the changes in physicians and nurses at a regional level; 2) adopts qualitative studies along with quantitative evaluations; and 3) the intervention is without a fundamental change in health care systems. A comprehensive understanding of the findings in this study will contribute to a deeper insight into how to develop community palliative care.
Trial Registration
UMIN Clinical Trials Registry (UMIN-CTR), Japan, UMIN000001274.
doi:10.1186/1472-684X-11-2
PMCID: PMC3349547  PMID: 22233691
11.  Clinical Utility of Vitamin D Testing 
Executive Summary
This report from the Medical Advisory Secretariat (MAS) was intended to evaluate the clinical utility of vitamin D testing in average risk Canadians and in those with kidney disease. As a separate analysis, this report also includes a systematic literature review of the prevalence of vitamin D deficiency in these two subgroups.
This evaluation did not set out to determine the serum vitamin D thresholds that might apply to non-bone health outcomes. For bone health outcomes, no high or moderate quality evidence could be found to support a target serum level above 50 nmol/L. Similarly, no high or moderate quality evidence could be found to support vitamin D’s effects in non-bone health outcomes, other than falls.
Vitamin D
Vitamin D is a lipid soluble vitamin that acts as a hormone. It stimulates intestinal calcium absorption and is important in maintaining adequate phosphate levels for bone mineralization, bone growth, and remodelling. It’s also believed to be involved in the regulation of cell growth proliferation and apoptosis (programmed cell death), as well as modulation of the immune system and other functions. Alone or in combination with calcium, Vitamin D has also been shown to reduce the risk of fractures in elderly men (≥ 65 years), postmenopausal women, and the risk of falls in community-dwelling seniors. However, in a comprehensive systematic review, inconsistent results were found concerning the effects of vitamin D in conditions such as cancer, all-cause mortality, and cardiovascular disease. In fact, no high or moderate quality evidence could be found concerning the effects of vitamin D in such non-bone health outcomes. Given the uncertainties surrounding the effects of vitamin D in non-bone health related outcomes, it was decided that this evaluation should focus on falls and the effects of vitamin D in bone health and exclusively within average-risk individuals and patients with kidney disease.
Synthesis of vitamin D occurs naturally in the skin through exposure to ultraviolet B (UVB) radiation from sunlight, but it can also be obtained from dietary sources including fortified foods, and supplements. Foods rich in vitamin D include fatty fish, egg yolks, fish liver oil, and some types of mushrooms. Since it is usually difficult to obtain sufficient vitamin D from non-fortified foods, either due to low content or infrequent use, most vitamin D is obtained from fortified foods, exposure to sunlight, and supplements.
Clinical Need: Condition and Target Population
Vitamin D deficiency may lead to rickets in infants and osteomalacia in adults. Factors believed to be associated with vitamin D deficiency include:
darker skin pigmentation,
winter season,
living at higher latitudes,
skin coverage,
kidney disease,
malabsorption syndromes such as Crohn’s disease, cystic fibrosis, and
genetic factors.
Patients with chronic kidney disease (CKD) are at a higher risk of vitamin D deficiency due to either renal losses or decreased synthesis of 1,25-dihydroxyvitamin D.
Health Canada currently recommends that, until the daily recommended intakes (DRI) for vitamin D are updated, Canada’s Food Guide (Eating Well with Canada’s Food Guide) should be followed with respect to vitamin D intake. Issued in 2007, the Guide recommends that Canadians consume two cups (500 ml) of fortified milk or fortified soy beverages daily in order to obtain a daily intake of 200 IU. In addition, men and women over the age of 50 should take 400 IU of vitamin D supplements daily. Additional recommendations were made for breastfed infants.
A Canadian survey evaluated the median vitamin D intake derived from diet alone (excluding supplements) among 35,000 Canadians, 10,900 of which were from Ontario. Among Ontarian males ages 9 and up, the median daily dietary vitamin D intake ranged between 196 IU and 272 IU per day. Among females, it varied from 152 IU to 196 IU per day. In boys and girls ages 1 to 3, the median daily dietary vitamin D intake was 248 IU, while among those 4 to 8 years it was 224 IU.
Vitamin D Testing
Two laboratory tests for vitamin D are available, 25-hydroxy vitamin D, referred to as 25(OH)D, and 1,25-dihydroxyvitamin D. Vitamin D status is assessed by measuring the serum 25(OH)D levels, which can be assayed using radioimmunoassays, competitive protein-binding assays (CPBA), high pressure liquid chromatography (HPLC), and liquid chromatography-tandem mass spectrometry (LC-MS/MS). These may yield different results with inter-assay variation reaching up to 25% (at lower serum levels) and intra-assay variation reaching 10%.
The optimal serum concentration of vitamin D has not been established and it may change across different stages of life. Similarly, there is currently no consensus on target serum vitamin D levels. There does, however, appear to be a consensus on the definition of vitamin D deficiency at 25(OH)D < 25 nmol/l, which is based on the risk of diseases such as rickets and osteomalacia. Higher target serum levels have also been proposed based on subclinical endpoints such as parathyroid hormone (PTH). Therefore, in this report, two conservative target serum levels have been adopted, 25 nmol/L (based on the risk of rickets and osteomalacia), and 40 to 50 nmol/L (based on vitamin D’s interaction with PTH).
Ontario Context
Volume & Cost
The volume of vitamin D tests done in Ontario has been increasing over the past 5 years with a steep increase of 169,000 tests in 2007 to more than 393,400 tests in 2008. The number of tests continues to rise with the projected number of tests for 2009 exceeding 731,000. According to the Ontario Schedule of Benefits, the billing cost of each test is $51.7 for 25(OH)D (L606, 100 LMS units, $0.517/unit) and $77.6 for 1,25-dihydroxyvitamin D (L605, 150 LMS units, $0.517/unit). Province wide, the total annual cost of vitamin D testing has increased from approximately $1.7M in 2004 to over $21.0M in 2008. The projected annual cost for 2009 is approximately $38.8M.
Evidence-Based Analysis
The objective of this report is to evaluate the clinical utility of vitamin D testing in the average risk population and in those with kidney disease. As a separate analysis, the report also sought to evaluate the prevalence of vitamin D deficiency in Canada. The specific research questions addressed were thus:
What is the clinical utility of vitamin D testing in the average risk population and in subjects with kidney disease?
What is the prevalence of vitamin D deficiency in the average risk population in Canada?
What is the prevalence of vitamin D deficiency in patients with kidney disease in Canada?
Clinical utility was defined as the ability to improve bone health outcomes with the focus on the average risk population (excluding those with osteoporosis) and patients with kidney disease.
Literature Search
A literature search was performed on July 17th, 2009 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 1998 until July 17th, 2009. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.
Observational studies that evaluated the prevalence of vitamin D deficiency in Canada in the population of interest were included based on the inclusion and exclusion criteria listed below. The baseline values were used in this report in the case of interventional studies that evaluated the effect of vitamin D intake on serum levels. Studies published in grey literature were included if no studies published in the peer-reviewed literature were identified for specific outcomes or subgroups.
Considering that vitamin D status may be affected by factors such as latitude, sun exposure, food fortification, among others, the search focused on prevalence studies published in Canada. In cases where no Canadian prevalence studies were identified, the decision was made to include studies from the United States, given the similar policies in vitamin D food fortification and recommended daily intake.
Inclusion Criteria
Studies published in English
Publications that reported the prevalence of vitamin D deficiency in Canada
Studies that included subjects from the general population or with kidney disease
Studies in children or adults
Studies published between January 1998 and July 17th 2009
Exclusion Criteria
Studies that included subjects defined according to a specific disease other than kidney disease
Letters, comments, and editorials
Studies that measured the serum vitamin D levels but did not report the percentage of subjects with serum levels below a given threshold
Outcomes of Interest
Prevalence of serum vitamin D less than 25 nmol/L
Prevalence of serum vitamin D less than 40 to 50 nmol/L
Serum 25-hydroxyvitamin D was the metabolite used to assess vitamin D status. Results from adult and children studies were reported separately. Subgroup analyses according to factors that affect serum vitamin D levels (e.g., seasonal effects, skin pigmentation, and vitamin D intake) were reported if enough information was provided in the studies
Quality of Evidence
The quality of the prevalence studies was based on the method of subject recruitment and sampling, possibility of selection bias, and generalizability to the source population. The overall quality of the trials was examined according to the GRADE Working Group criteria.
Summary of Findings
Fourteen prevalence studies examining Canadian adults and children met the eligibility criteria. With the exception of one longitudinal study, the studies had a cross-sectional design. Two studies were conducted among Canadian adults with renal disease but none studied Canadian children with renal disease (though three such US studies were included). No systematic reviews or health technology assessments that evaluated the prevalence of vitamin D deficiency in Canada were identified. Two studies were published in grey literature, consisting of a Canadian survey designed to measure serum vitamin D levels and a study in infants presented as an abstract at a conference. Also included were the results of vitamin D tests performed in community laboratories in Ontario between October 2008 and September 2009 (provided by the Ontario Association of Medical Laboratories).
Different threshold levels were used in the studies, thus we reported the percentage of subjects with serum levels of between 25 and 30 nmol/L and between 37.5 and 50 nmol/L. Some studies stratified the results according to factors affecting vitamin D status and two used multivariate models to investigate the effects of these characteristics (including age, season, BMI, vitamin D intake, skin pigmentation, and season) on serum 25(OH)D levels. It’s unclear, however, if these studies were adequately powered for these subgroup analyses.
Study participants generally consisted of healthy, community-dwelling subjects and most excluded individuals with conditions or medications that alter vitamin D or bone metabolism, such as kidney or liver disease. Although the studies were conducted in different parts of Canada, fewer were performed in Northern latitudes, i.e. above 53°N, which is equivalent to the city of Edmonton.
Adults
Serum vitamin D levels of < 25 to 30 nmol/L were observed in 0% to 25.5% of the subjects included in five studies; the weighted average was 3.8% (95% CI: 3.0, 4.6). The preliminary results of the Canadian survey showed that approximately 5% of the subjects had serum levels below 29.5 nmol/L. The results of over 600,000 vitamin D tests performed in Ontarian community laboratories between October 2008 and September 2009 showed that 2.6% of adults (> 18 years) had serum levels < 25 nmol/L.
The prevalence of serum vitamin D levels below 37.5-50 nmol/L reported among studies varied widely, ranging from 8% to 73.6% with a weighted average of 22.5%. The preliminary results of the CHMS survey showed that between 10% and 25% of subjects had serum levels below 37 to 48 nmol/L. The results of the vitamin D tests performed in community laboratories showed that 10% to 25% of the individuals had serum levels between 39 and 50 nmol/L.
In an attempt to explain this inter-study variation, the study results were stratified according to factors affecting serum vitamin D levels, as summarized below. These results should be interpreted with caution as none were adjusted for other potential confounders. Adequately powered multivariate analyses would be necessary to determine the contribution of risk factors to lower serum 25(OH)D levels.
Seasonal variation
Three adult studies evaluating serum vitamin D levels in different seasons observed a trend towards a higher prevalence of serum levels < 37.5 to 50 nmol/L during the winter and spring months, specifically 21% to 39%, compared to 8% to 14% in the summer. The weighted average was 23.6% over the winter/spring months and 9.6% over summer. The difference between the seasons was not statistically significant in one study and not reported in the other two studies.
Skin Pigmentation
Four studies observed a trend toward a higher prevalence of serum vitamin D levels < 37.5 to 50 nmol/L in subjects with darker skin pigmentation compared to those with lighter skin pigmentation, with weighted averages of 46.8% among adults with darker skin colour and 15.9% among those with fairer skin.
Vitamin D intake and serum levels
Four adult studies evaluated serum vitamin D levels according to vitamin D intake and showed an overall trend toward a lower prevalence of serum levels < 37.5 to 50 nmol/L with higher levels of vitamin D intake. One study observed a dose-response relationship between higher vitamin D intake from supplements, diet (milk), and sun exposure (results not adjusted for other variables). It was observed that subjects taking 50 to 400 IU or > 400 IU of vitamin D per day had a 6% and 3% prevalence of serum vitamin D level < 40 nmol/L, respectively, versus 29% in subjects not on vitamin D supplementation. Similarly, among subjects drinking one or two glasses of milk per day, the prevalence of serum vitamin D levels < 40 nmol/L was found to be 15%, versus 6% in those who drink more than two glasses of milk per day and 21% among those who do not drink milk. On the other hand, one study observed little variation in serum vitamin D levels during winter according to milk intake, with the proportion of subjects exhibiting vitamin D levels of < 40 nmol/L being 21% among those drinking 0-2 glasses per day, 26% among those drinking > 2 glasses, and 20% among non-milk drinkers.
The overall quality of evidence for the studies conducted among adults was deemed to be low, although it was considered moderate for the subgroups of skin pigmentation and seasonal variation.
Newborn, Children and Adolescents
Five Canadian studies evaluated serum vitamin D levels in newborns, children, and adolescents. In four of these, it was found that between 0 and 36% of children exhibited deficiency across age groups with a weighted average of 6.4%. The results of over 28,000 vitamin D tests performed in children 0 to 18 years old in Ontario laboratories (Oct. 2008 to Sept. 2009) showed that 4.4% had serum levels of < 25 nmol/L.
According to two studies, 32% of infants 24 to 30 months old and 35.3% of newborns had serum vitamin D levels of < 50 nmol/L. Two studies of children 2 to 16 years old reported that 24.5% and 34% had serum vitamin D levels below 37.5 to 40 nmol/L. In both studies, older children exhibited a higher prevalence than younger children, with weighted averages 34.4% and 10.3%, respectively. The overall weighted average of the prevalence of serum vitamin D levels < 37.5 to 50 nmol/L among pediatric studies was 25.8%. The preliminary results of the Canadian survey showed that between 10% and 25% of subjects between 6 and 11 years (N= 435) had serum levels below 50 nmol/L, while for those 12 to 19 years, 25% to 50% exhibited serum vitamin D levels below 50 nmol/L.
The effects of season, skin pigmentation, and vitamin D intake were not explored in Canadian pediatric studies. A Canadian surveillance study did, however, report 104 confirmed cases1 (2.9 cases per 100,000 children) of vitamin D-deficient rickets among Canadian children age 1 to 18 between 2002 and 2004, 57 (55%) of which from Ontario. The highest incidence occurred among children living in the North, i.e., the Yukon, Northwest Territories, and Nunavut. In 92 (89%) cases, skin pigmentation was categorized as intermediate to dark, 98 (94%) had been breastfed, and 25 (24%) were offspring of immigrants to Canada. There were no cases of rickets in children receiving ≥ 400 IU VD supplementation/day.
Overall, the quality of evidence of the studies of children was considered very low.
Kidney Disease
Adults
Two studies evaluated serum vitamin D levels in Canadian adults with kidney disease. The first included 128 patients with chronic kidney disease stages 3 to 5, 38% of which had serum vitamin D levels of < 37.5 nmol/L (measured between April and July). This is higher than what was reported in Canadian studies of the general population during the summer months (i.e. between 8% and 14%). In the second, which examined 419 subjects who had received a renal transplantation (mean time since transplantation: 7.2 ± 6.4 years), the prevalence of serum vitamin D levels < 40 nmol/L was 27.3%. The authors concluded that the prevalence observed in the study population was similar to what is expected in the general population.
Children
No studies evaluating serum vitamin D levels in Canadian pediatric patients with kidney disease could be identified, although three such US studies among children with chronic kidney disease stages 1 to 5 were. The mean age varied between 10.7 and 12.5 years in two studies but was not reported in the third. Across all three studies, the prevalence of serum vitamin D levels below the range of 37.5 to 50 nmol/L varied between 21% and 39%, which is not considerably different from what was observed in studies of healthy Canadian children (24% to 35%).
Overall, the quality of evidence in adults and children with kidney disease was considered very low.
Clinical Utility of Vitamin D Testing
A high quality comprehensive systematic review published in August 2007 evaluated the association between serum vitamin D levels and different bone health outcomes in different age groups. A total of 72 studies were included. The authors observed that there was a trend towards improvement in some bone health outcomes with higher serum vitamin D levels. Nevertheless, precise thresholds for improved bone health outcomes could not be defined across age groups. Further, no new studies on the association were identified during an updated systematic review on vitamin D published in July 2009.
With regards to non-bone health outcomes, there is no high or even moderate quality evidence that supports the effectiveness of vitamin D in outcomes such as cancer, cardiovascular outcomes, and all-cause mortality. Even if there is any residual uncertainty, there is no evidence that testing vitamin D levels encourages adherence to Health Canada’s guidelines for vitamin D intake. A normal serum vitamin D threshold required to prevent non-bone health related conditions cannot be resolved until a causal effect or correlation has been demonstrated between vitamin D levels and these conditions. This is as an ongoing research issue around which there is currently too much uncertainty to base any conclusions that would support routine vitamin D testing.
For patients with chronic kidney disease (CKD), there is again no high or moderate quality evidence supporting improved outcomes through the use of calcitriol or vitamin D analogs. In the absence of such data, the authors of the guidelines for CKD patients consider it best practice to maintain serum calcium and phosphate at normal levels, while supplementation with active vitamin D should be considered if serum PTH levels are elevated. As previously stated, the authors of guidelines for CKD patients believe that there is not enough evidence to support routine vitamin D [25(OH)D] testing. According to what is stated in the guidelines, decisions regarding the commencement or discontinuation of treatment with calcitriol or vitamin D analogs should be based on serum PTH, calcium, and phosphate levels.
Limitations associated with the evidence of vitamin D testing include ambiguities in the definition of an ‘adequate threshold level’ and both inter- and intra- assay variability. The MAS considers both the lack of a consensus on the target serum vitamin D levels and assay limitations directly affect and undermine the clinical utility of testing. The evidence supporting the clinical utility of vitamin D testing is thus considered to be of very low quality.
Daily vitamin D intake, either through diet or supplementation, should follow Health Canada’s recommendations for healthy individuals of different age groups. For those with medical conditions such as renal disease, liver disease, and malabsorption syndromes, and for those taking medications that may affect vitamin D absorption/metabolism, physician guidance should be followed with respect to both vitamin D testing and supplementation.
Conclusions
Studies indicate that vitamin D, alone or in combination with calcium, may decrease the risk of fractures and falls among older adults.
There is no high or moderate quality evidence to support the effectiveness of vitamin D in other outcomes such as cancer, cardiovascular outcomes, and all-cause mortality.
Studies suggest that the prevalence of vitamin D deficiency in Canadian adults and children is relatively low (approximately 5%), and between 10% and 25% have serum levels below 40 to 50 nmol/L (based on very low to low grade evidence).
Given the limitations associated with serum vitamin D measurement, ambiguities in the definition of a ‘target serum level’, and the availability of clear guidelines on vitamin D supplementation from Health Canada, vitamin D testing is not warranted for the average risk population.
Health Canada has issued recommendations regarding the adequate daily intake of vitamin D, but current studies suggest that the mean dietary intake is below these recommendations. Accordingly, Health Canada’s guidelines and recommendations should be promoted.
Based on a moderate level of evidence, individuals with darker skin pigmentation appear to have a higher risk of low serum vitamin D levels than those with lighter skin pigmentation and therefore may need to be specially targeted with respect to optimum vitamin D intake. The cause-effect of this association is currently unclear.
Individuals with medical conditions such as renal and liver disease, osteoporosis, and malabsorption syndromes, as well as those taking medications that may affect vitamin D absorption/metabolism, should follow their physician’s guidance concerning both vitamin D testing and supplementation.
PMCID: PMC3377517  PMID: 23074397
12.  Quality of Private and Public Ambulatory Health Care in Low and Middle Income Countries: Systematic Review of Comparative Studies 
PLoS Medicine  2011;8(4):e1000433.
Paul Garner and colleagues conducted a systematic review of 80 studies to compare the quality of private versus public ambulatory health care in low- and middle-income countries.
Background
In developing countries, the private sector provides a substantial proportion of primary health care to low income groups for communicable and non-communicable diseases. These providers are therefore central to improving health outcomes. We need to know how their services compare to those of the public sector to inform policy options.
Methods and Findings
We summarised reliable research comparing the quality of formal private versus public ambulatory health care in low and middle income countries. We selected studies against inclusion criteria following a comprehensive search, yielding 80 studies. We compared quality under standard categories, converted values to a linear 100% scale, calculated differences between providers within studies, and summarised median values of the differences across studies. As the results for for-profit and not-for-profit providers were similar, we combined them. Overall, median values indicated that many services, irrespective of whether public or private, scored low on infrastructure, clinical competence, and practice. Overall, the private sector performed better in relation to drug supply, responsiveness, and effort. No difference between provider groups was detected for patient satisfaction or competence. Synthesis of qualitative components indicates the private sector is more client centred.
Conclusions
Although data are limited, quality in both provider groups seems poor, with the private sector performing better in drug availability and aspects of delivery of care, including responsiveness and effort, and possibly being more client orientated. Strategies seeking to influence quality in both groups are needed to improve care delivery and outcomes for the poor, including managing the increasing burden of non-communicable diseases.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The provision of private (“for-profit” hospitals and self-employed practitioners, and “not-for-profit” non-government providers, including faith-based organizations) versus public health care services in low and middle income countries raises considerable ideological debate. Ideological arguments aside—which can be very passionate on both sides—there is general agreement that improving the quality of both public and private health care could have a major impact on improved health outcomes, especially as the private sector is so widely used in low and middle income countries. For example, almost three quarters and half of children from the poorest households of South Asia and sub-Saharan Africa, respectively, seek health care from a private provider when they are ill. Private providers are also increasingly responsible for outpatient care for non-communicable diseases.
As a result of the mixed health care system in many low and middle income countries, adequate oversight and stewardship of the mixed system from the national government is essential yet often missing.
Why Was This Study Done?
An understanding of how quality and performance in the private sector compares with that in the public sector would help governments to prioritize where they need to concentrate their efforts. So, for example, if the private sector is generally providing poorer quality care than the public sector, then there is an imperative to improve the quality and outcomes; on the other hand, if the quality of care offered by the private sector is good, the policy priority is to influence the market to further improve access to such health care for low income groups.
In order to help with this comparison, the researchers wanted to systematically identify and summarize the results of studies that directly compared the quality of care offered by public providers with the one offered by “formal” private providers (recognized by law) and “informal” private providers (providers that are not legally recognized, such as lay health workers and shop keepers). For the purposes of this study the researchers focused their comparison on the private and public provision of outpatient care in low and middle income countries.
What Did the Researchers Do and Find?
In their literature review, the researchers searched for relevant studies reported in English, French, or German and published between January 1970 and April 2009. Only studies that compared private and public outpatient medical services in the same country, at the same time, using the same methods, and which met particular quality criteria, were included in the analysis. The researchers also had strict criteria for including qualitative studies, and they retrieved the full text of articles, contacted study authors where appropriate, and verified with a second researcher most (80%) of the extracted study data. In order to evaluate and compare the studies, the researchers converted study values to a linear 100% scale, calculated differences between providers within studies, and summarized the median values of the differences across studies.
The researchers identified a total of 8,812 relevant titles and abstracts and found 80 studies that included direct quantitative comparisons of public and private formal providers. Ten studies included qualitative data. Most studies were conducted after 1990, and mainly in sub-Saharan Africa (n = 39) and Asia and the Pacific (n = 23). Most studies did not report socio-economic status of public and private service users, and only five studies presented data by different income groups. No study compared the same individual providers working in public and private care settings. Only two studies compared public providers and private informal providers, so the authors excluded these from subsequent analysis.
For the formal sector, since the results for “for-profit” and “not-for-profit” providers were similar, the researchers decided to combine the results. Overall, the researchers found that the median values indicated that many services, irrespective of whether public or private, scored low (less than 50%) on infrastructure, clinical competence, and practice. Generally, the private sector performed better in relation to drug supply, responsiveness, and effort, but there was no detectable difference between provider groups for patient satisfaction. Furthermore, a synthesis of qualitative data suggested that the private sector may be more client-centered.
What Do These Findings Mean?
Based on the findings of this review, there is a clear need to consider the quality of primary health services in both the public and private sector in order to improve health outcomes in low and middle income countries. These findings also indicate that, for some aspects of care, on average the private sector provided better quality services. The overall low quality of care in both the formal private and public sector found in this review is worrying, and calls for the governments of low and middle income countries to find and implement effective strategies to improve the quality in both sectors. This is particularly important given the increasing volume of conditions that require relatively sophisticated, long-term ambulatory medical care, such as non-communicable diseases.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000433.
This study is further discussed in a PLoS Medicine Perspective by Jishnu Das
WHO has more information on health service delivery in low- and middle-income countries
WHO has more information on noncommunicable diseases
The World Bank's World Development Report for 2004 addresses health care for poor people
doi:10.1371/journal.pmed.1000433
PMCID: PMC3075233  PMID: 21532746
13.  Internet-Based Device-Assisted Remote Monitoring of Cardiovascular Implantable Electronic Devices 
Executive Summary
Objective
The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions.
Clinical Need: Condition and Target Population
Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD.
Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities.
Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs.
Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices.
With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications.
In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs.
Technology
In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings.
Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system.
Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented.
Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians.
The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers—Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.—which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices.
All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience.
Research Questions
The research directions and specific research questions for this evidence review were as follows:
To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices.
To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs.
To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices.
To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies.
To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada.
Research Methods
Literature Search
The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices.
Search Strategy
A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
published between 1950 and September 2010;
English language full-reports and human studies;
original reports including clinical evaluations of Internet-based device-assisted RMSs for CIEDs in clinical settings;
reports including standardized measurements on outcome events such as technical success, safety, effectiveness, cost, measures of health care utilization, morbidity, mortality, quality of life or patient satisfaction;
randomized controlled trials (RCTs), systematic reviews and meta-analyses, cohort and controlled clinical studies.
Exclusion Criteria
non-systematic reviews, letters, comments and editorials;
reports not involving standardized outcome events;
clinical reports not involving Internet-based device assisted RM systems for CIEDs in clinical settings;
reports involving studies testing or validating algorithms without RM;
studies with small samples (<10 subjects).
Outcomes of Interest
The outcomes of interest included: technical outcomes, emergency department visits, complications, major adverse events, symptoms, hospital admissions, clinic visits (scheduled and/or unscheduled), survival, morbidity (disease progression, stroke, etc.), patient satisfaction, and quality of life.
Summary of Findings
The MAS evidence review was performed to review available evidence on Internet-based device-assisted RMSs for CIEDs published until September 2010. The search identified 6 systematic reviews, 7 randomized controlled trials, and 19 reports for 16 cohort studies—3 of these being registry-based and 4 being multi-centered. The evidence is summarized in the 3 sections that follow.
1. Effectiveness of Remote Monitoring Systems of CIEDs for Cardiac Arrhythmia and Device Functioning
In total, 15 reports on 13 cohort studies involving investigations with 4 different RMSs for CIEDs in cardiology implant clinic groups were identified in the review. The 4 RMSs were: Care Link Network® (Medtronic Inc,, Minneapolis, MN, USA); Home Monitoring® (Biotronic, Berlin, Germany); House Call 11® (St Jude Medical Inc., St Pauls, MN, USA); and a manufacturer-independent RMS. Eight of these reports were with the Home Monitoring® RMS (12,949 patients), 3 were with the Care Link® RMS (167 patients), 1 was with the House Call 11® RMS (124 patients), and 1 was with a manufacturer-independent RMS (44 patients). All of the studies, except for 2 in the United States, (1 with Home Monitoring® and 1 with House Call 11®), were performed in European countries.
The RMSs in the studies were evaluated with different cardiac implant device populations: ICDs only (6 studies), ICD and CRT devices (3 studies), PM and ICD and CRT devices (4 studies), and PMs only (2 studies). The patient populations were predominately male (range, 52%–87%) in all studies, with mean ages ranging from 58 to 76 years. One study population was unique in that RMSs were evaluated for ICDs implanted solely for primary prevention in young patients (mean age, 44 years) with Brugada syndrome, which carries an inherited increased genetic risk for sudden heart attack in young adults.
Most of the cohort studies reported on the feasibility of RMSs in clinical settings with limited follow-up. In the short follow-up periods of the studies, the majority of the events were related to detection of medical events rather than system configuration or device abnormalities. The results of the studies are summarized below:
The interrogation of devices on the web platform, both for continuous and scheduled transmissions, was significantly quicker with remote follow-up, both for nurses and physicians.
In a case-control study focusing on a Brugada population–based registry with patients followed-up remotely, there were significantly fewer outpatient visits and greater detection of inappropriate shocks. One death occurred in the control group not followed remotely and post-mortem analysis indicated early signs of lead failure prior to the event.
Two studies examined the role of RMSs in following ICD leads under regulatory advisory in a European clinical setting and noted:
– Fewer inappropriate shocks were administered in the RM group.
– Urgent in-office interrogations and surgical revisions were performed within 12 days of remote alerts.
– No signs of lead fracture were detected at in-office follow-up; all were detected at remote follow-up.
Only 1 study reported evaluating quality of life in patients followed up remotely at 3 and 6 months; no values were reported.
Patient satisfaction was evaluated in 5 cohort studies, all in short term follow-up: 1 for the Home Monitoring® RMS, 3 for the Care Link® RMS, and 1 for the House Call 11® RMS.
– Patients reported receiving a sense of security from the transmitter, a good relationship with nurses and physicians, positive implications for their health, and satisfaction with RM and organization of services.
– Although patients reported that the system was easy to implement and required less than 10 minutes to transmit information, a variable proportion of patients (range, 9% 39%) reported that they needed the assistance of a caregiver for their transmission.
– The majority of patients would recommend RM to other ICD patients.
– Patients with hearing or other physical or mental conditions hindering the use of the system were excluded from studies, but the frequency of this was not reported.
Physician satisfaction was evaluated in 3 studies, all with the Care Link® RMS:
– Physicians reported an ease of use and high satisfaction with a generally short-term use of the RMS.
– Physicians reported being able to address the problems in unscheduled patient transmissions or physician initiated transmissions remotely, and were able to handle the majority of the troubleshooting calls remotely.
– Both nurses and physicians reported a high level of satisfaction with the web registry system.
2. Effectiveness of Remote Monitoring Systems in Heart Failure Patients for Cardiac Arrhythmia and Heart Failure Episodes
Remote follow-up of HF patients implanted with ICD or CRT devices, generally managed in specialized HF clinics, was evaluated in 3 cohort studies: 1 involved the Home Monitoring® RMS and 2 involved the Care Link® RMS. In these RMSs, in addition to the standard diagnostic features, the cardiac devices continuously assess other variables such as patient activity, mean heart rate, and heart rate variability. Intra-thoracic impedance, a proxy measure for lung fluid overload, was also measured in the Care Link® studies. The overall diagnostic performance of these measures cannot be evaluated, as the information was not reported for patients who did not experience intra-thoracic impedance threshold crossings or did not undergo interventions. The trial results involved descriptive information on transmissions and alerts in patients experiencing high morbidity and hospitalization in the short study periods.
3. Comparative Effectiveness of Remote Monitoring Systems for CIEDs
Seven RCTs were identified evaluating RMSs for CIEDs: 2 were for PMs (1276 patients) and 5 were for ICD/CRT devices (3733 patients). Studies performed in the clinical setting in the United States involved both the Care Link® RMS and the Home Monitoring® RMS, whereas all studies performed in European countries involved only the Home Monitoring® RMS.
3A. Randomized Controlled Trials of Remote Monitoring Systems for Pacemakers
Two trials, both multicenter RCTs, were conducted in different countries with different RMSs and study objectives. The PREFER trial was a large trial (897 patients) performed in the United States examining the ability of Care Link®, an Internet-based remote PM interrogation system, to detect clinically actionable events (CAEs) sooner than the current in-office follow-up supplemented with transtelephonic monitoring transmissions, a limited form of remote device interrogation. The trial results are summarized below:
In the 375-day mean follow-up, 382 patients were identified with at least 1 CAE—111 patients in the control arm and 271 in the remote arm.
The event rate detected per patient for every type of CAE, except for loss of atrial capture, was higher in the remote arm than the control arm.
The median time to first detection of CAEs (4.9 vs. 6.3 months) was significantly shorter in the RMS group compared to the control group (P < 0.0001).
Additionally, only 2% (3/190) of the CAEs in the control arm were detected during a transtelephonic monitoring transmission (the rest were detected at in-office follow-ups), whereas 66% (446/676) of the CAEs were detected during remote interrogation.
The second study, the OEDIPE trial, was a smaller trial (379 patients) performed in France evaluating the ability of the Home Monitoring® RMS to shorten PM post-operative hospitalization while preserving the safety of conventional management of longer hospital stays.
Implementation and operationalization of the RMS was reported to be successful in 91% (346/379) of the patients and represented 8144 transmissions.
In the RM group 6.5% of patients failed to send messages (10 due to improper use of the transmitter, 2 with unmanageable stress). Of the 172 patients transmitting, 108 patients sent a total of 167 warnings during the trial, with a greater proportion of warnings being attributed to medical rather than technical causes.
Forty percent had no warning message transmission and among these, 6 patients experienced a major adverse event and 1 patient experienced a non-major adverse event. Of the 6 patients having a major adverse event, 5 contacted their physician.
The mean medical reaction time was faster in the RM group (6.5 ± 7.6 days vs. 11.4 ± 11.6 days).
The mean duration of hospitalization was significantly shorter (P < 0.001) for the RM group than the control group (3.2 ± 3.2 days vs. 4.8 ± 3.7 days).
Quality of life estimates by the SF-36 questionnaire were similar for the 2 groups at 1-month follow-up.
3B. Randomized Controlled Trials Evaluating Remote Monitoring Systems for ICD or CRT Devices
The 5 studies evaluating the impact of RMSs with ICD/CRT devices were conducted in the United States and in European countries and involved 2 RMSs—Care Link® and Home Monitoring ®. The objectives of the trials varied and 3 of the trials were smaller pilot investigations.
The first of the smaller studies (151 patients) evaluated patient satisfaction, achievement of patient outcomes, and the cost-effectiveness of the Care Link® RMS compared to quarterly in-office device interrogations with 1-year follow-up.
Individual outcomes such as hospitalizations, emergency department visits, and unscheduled clinic visits were not significantly different between the study groups.
Except for a significantly higher detection of atrial fibrillation in the RM group, data on ICD detection and therapy were similar in the study groups.
Health-related quality of life evaluated by the EuroQoL at 6-month or 12-month follow-up was not different between study groups.
Patients were more satisfied with their ICD care in the clinic follow-up group than in the remote follow-up group at 6-month follow-up, but were equally satisfied at 12- month follow-up.
The second small pilot trial (20 patients) examined the impact of RM follow-up with the House Call 11® system on work schedules and cost savings in patients randomized to 2 study arms varying in the degree of remote follow-up.
The total time including device interrogation, transmission time, data analysis, and physician time required was significantly shorter for the RM follow-up group.
The in-clinic waiting time was eliminated for patients in the RM follow-up group.
The physician talk time was significantly reduced in the RM follow-up group (P < 0.05).
The time for the actual device interrogation did not differ in the study groups.
The third small trial (115 patients) examined the impact of RM with the Home Monitoring® system compared to scheduled trimonthly in-clinic visits on the number of unplanned visits, total costs, health-related quality of life (SF-36), and overall mortality.
There was a 63.2% reduction in in-office visits in the RM group.
Hospitalizations or overall mortality (values not stated) were not significantly different between the study groups.
Patient-induced visits were higher in the RM group than the in-clinic follow-up group.
The TRUST Trial
The TRUST trial was a large multicenter RCT conducted at 102 centers in the United States involving the Home Monitoring® RMS for ICD devices for 1450 patients. The primary objectives of the trial were to determine if remote follow-up could be safely substituted for in-office clinic follow-up (3 in-office visits replaced) and still enable earlier physician detection of clinically actionable events.
Adherence to the protocol follow-up schedule was significantly higher in the RM group than the in-office follow-up group (93.5% vs. 88.7%, P < 0.001).
Actionability of trimonthly scheduled checks was low (6.6%) in both study groups. Overall, actionable causes were reprogramming (76.2%), medication changes (24.8%), and lead/system revisions (4%), and these were not different between the 2 study groups.
The overall mean number of in-clinic and hospital visits was significantly lower in the RM group than the in-office follow-up group (2.1 per patient-year vs. 3.8 per patient-year, P < 0.001), representing a 45% visit reduction at 12 months.
The median time from onset of first arrhythmia to physician evaluation was significantly shorter (P < 0.001) in the RM group than in the in-office follow-up group for all arrhythmias (1 day vs. 35.5 days).
The median time to detect clinically asymptomatic arrhythmia events—atrial fibrillation (AF), ventricular fibrillation (VF), ventricular tachycardia (VT), and supra-ventricular tachycardia (SVT)—was also significantly shorter (P < 0.001) in the RM group compared to the in-office follow-up group (1 day vs. 41.5 days) and was significantly quicker for each of the clinical arrhythmia events—AF (5.5 days vs. 40 days), VT (1 day vs. 28 days), VF (1 day vs. 36 days), and SVT (2 days vs. 39 days).
System-related problems occurred infrequently in both groups—in 1.5% of patients (14/908) in the RM group and in 0.7% of patients (3/432) in the in-office follow-up group.
The overall adverse event rate over 12 months was not significantly different between the 2 groups and individual adverse events were also not significantly different between the RM group and the in-office follow-up group: death (3.4% vs. 4.9%), stroke (0.3% vs. 1.2%), and surgical intervention (6.6% vs. 4.9%), respectively.
The 12-month cumulative survival was 96.4% (95% confidence interval [CI], 95.5%–97.6%) in the RM group and 94.2% (95% confidence interval [CI], 91.8%–96.6%) in the in-office follow-up group, and was not significantly different between the 2 groups (P = 0.174).
The CONNECT Trial
The CONNECT trial, another major multicenter RCT, involved the Care Link® RMS for ICD/CRT devices in a15-month follow-up study of 1,997 patients at 133 sites in the United States. The primary objective of the trial was to determine whether automatically transmitted physician alerts decreased the time from the occurrence of clinically relevant events to medical decisions. The trial results are summarized below:
Of the 575 clinical alerts sent in the study, 246 did not trigger an automatic physician alert. Transmission failures were related to technical issues such as the alert not being programmed or not being reset, and/or a variety of patient factors such as not being at home and the monitor not being plugged in or set up.
The overall mean time from the clinically relevant event to the clinical decision was significantly shorter (P < 0.001) by 17.4 days in the remote follow-up group (4.6 days for 172 patients) than the in-office follow-up group (22 days for 145 patients).
– The median time to a clinical decision was shorter in the remote follow-up group than in the in-office follow-up group for an AT/AF burden greater than or equal to 12 hours (3 days vs. 24 days) and a fast VF rate greater than or equal to 120 beats per minute (4 days vs. 23 days).
Although infrequent, similar low numbers of events involving low battery and VF detection/therapy turned off were noted in both groups. More alerts, however, were noted for out-of-range lead impedance in the RM group (18 vs. 6 patients), and the time to detect these critical events was significantly shorter in the RM group (same day vs. 17 days).
Total in-office clinic visits were reduced by 38% from 6.27 visits per patient-year in the in-office follow-up group to 3.29 visits per patient-year in the remote follow-up group.
Health care utilization visits (N = 6,227) that included cardiovascular-related hospitalization, emergency department visits, and unscheduled clinic visits were not significantly higher in the remote follow-up group.
The overall mean length of hospitalization was significantly shorter (P = 0.002) for those in the remote follow-up group (3.3 days vs. 4.0 days) and was shorter both for patients with ICD (3.0 days vs. 3.6 days) and CRT (3.8 days vs. 4.7 days) implants.
The mortality rate between the study arms was not significantly different between the follow-up groups for the ICDs (P = 0.31) or the CRT devices with defribillator (P = 0.46).
Conclusions
There is limited clinical trial information on the effectiveness of RMSs for PMs. However, for RMSs for ICD devices, multiple cohort studies and 2 large multicenter RCTs demonstrated feasibility and significant reductions in in-office clinic follow-ups with RMSs in the first year post implantation. The detection rates of clinically significant events (and asymptomatic events) were higher, and the time to a clinical decision for these events was significantly shorter, in the remote follow-up groups than in the in-office follow-up groups. The earlier detection of clinical events in the remote follow-up groups, however, was not associated with lower morbidity or mortality rates in the 1-year follow-up. The substitution of almost all the first year in-office clinic follow-ups with RM was also not associated with an increased health care utilization such as emergency department visits or hospitalizations.
The follow-up in the trials was generally short-term, up to 1 year, and was a more limited assessment of potential longer term device/lead integrity complications or issues. None of the studies compared the different RMSs, particularly the different RMSs involving patient-scheduled transmissions or automatic transmissions. Patients’ acceptance of and satisfaction with RM were reported to be high, but the impact of RM on patients’ health-related quality of life, particularly the psychological aspects, was not evaluated thoroughly. Patients who are not technologically competent, having hearing or other physical/mental impairments, were identified as potentially disadvantaged with remote surveillance. Cohort studies consistently identified subgroups of patients who preferred in-office follow-up. The evaluation of costs and workflow impact to the health care system were evaluated in European or American clinical settings, and only in a limited way.
Internet-based device-assisted RMSs involve a new approach to monitoring patients, their disease progression, and their CIEDs. Remote monitoring also has the potential to improve the current postmarket surveillance systems of evolving CIEDs and their ongoing hardware and software modifications. At this point, however, there is insufficient information to evaluate the overall impact to the health care system, although the time saving and convenience to patients and physicians associated with a substitution of in-office follow-up by RM is more certain. The broader issues surrounding infrastructure, impacts on existing clinical care systems, and regulatory concerns need to be considered for the implementation of Internet-based RMSs in jurisdictions involving different clinical practices.
PMCID: PMC3377571  PMID: 23074419
14.  Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD) 
Executive Summary
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.
After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.
The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.
Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework
Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model
Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature
For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm.
For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx.
The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.
Objective
The objective of this analysis was to conduct an evidence-based assessment of home telehealth technologies for patients with chronic obstructive pulmonary disease (COPD) in order to inform recommendations regarding the access and provision of these services in Ontario. This analysis was one of several analyses undertaken to evaluate interventions for COPD. The perspective of this assessment was that of the Ontario Ministry of Health and Long-Term Care, a provincial payer of medically necessary health care services.
Clinical Need: Condition and Target Population
Canada is facing an increase in chronic respiratory diseases due in part to its aging demographic. The projected increase in COPD will put a strain on health care payers and providers. There is therefore an increasing demand for telehealth services that improve access to health care services while maintaining or improving quality and equality of care. Many telehealth technologies however are in the early stages of development or diffusion and thus require study to define their application and potential harms or benefits. The Medical Advisory Secretariat (MAS) therefore sought to evaluate telehealth technologies for COPD.
Technology
Telemedicine (or telehealth) refers to using advanced information and communication technologies and electronic medical devices to support the delivery of clinical care, professional education, and health-related administrative services.
Generally there are 4 broad functions of home telehealth interventions for COPD:
to monitor vital signs or biological health data (e.g., oxygen saturation),
to monitor symptoms, medication, or other non-biologic endpoints (e.g., exercise adherence),
to provide information (education) and/or other support services (such as reminders to exercise or positive reinforcement), and
to establish a communication link between patient and provider.
These functions often require distinct technologies, although some devices can perform a number of these diverse functions. For the purposes of this review, MAS focused on home telemonitoring and telephone only support technologies.
Telemonitoring (or remote monitoring) refers to the use of medical devices to remotely collect a patient’s vital signs and/or other biologic health data and the transmission of those data to a monitoring station for interpretation by a health care provider.
Telephone only support refers to disease/disorder management support provided by a health care provider to a patient who is at home via telephone or videoconferencing technology in the absence of transmission of patient biologic data.
Research Questions
What is the effectiveness, cost-effectiveness, and safety of home telemonitoring compared with usual care for patients with COPD?
What is the effectiveness, cost-effectiveness, and safety of telephone only support programs compared with usual care for patients with COPD?
Research Methods
Literature Search
Search Strategy
A literature search was performed on November 3, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 2000 until November 3, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, and then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low, or very low according to GRADE methodology.
Inclusion Criteria – Question #1
frequent transmission of a patient’s physiological data collected at home and without a health care professional physically present to health care professionals for routine monitoring through the use of a communication technology;
monitoring combined with a coordinated management and feedback system based on transmitted data;
telemonitoring as a key component of the intervention (subjective determination);
usual care as provided by the usual care provider for the control group;
randomized controlled trials (RCTs), controlled clinical trials (CCTs), systematic reviews, and/or meta-analyses;
published between January 1, 2000 and November 3, 2010.
Inclusion Criteria – Question #2
scheduled or frequent contact between patient and a health care professional via telephone or videoconferencing technology in the absence of transmission of patient physiological data;
monitoring combined with a coordinated management and feedback system based on transmitted data;
telephone support as a key component of the intervention (subjective determination);
usual care as provided by the usual care provider for the control group;
RCTs, CCTs, systematic reviews, and/or meta-analyses;
published between January 1, 2000 and November 3, 2010.
Exclusion Criteria
published in a language other than English;
intervention group (and not control) receiving some form of home visits by a medical professional, typically a nurse (i.e., telenursing) beyond initial technology set-up and education, to collect physiological data, or to somehow manage or treat the patient;
not recording patient or health system outcomes (e.g., technical reports testing accuracy, reliability or other development-related outcomes of a device, acceptability/feasibility studies, etc.);
not using an independent control group that received usual care (e.g., studies employing historical or periodic controls).
Outcomes of Interest
hospitalizations (primary outcome)
mortality
emergency department visits
length of stay
quality of life
other […]
Subgroup Analyses (a priori)
length of intervention (primary)
severity of COPD (primary)
Quality of Evidence
The quality of evidence assigned to individual studies was determined using a modified CONSORT Statement Checklist for Randomized Controlled Trials. (1) The CONSORT Statement was adapted to include 3 additional quality measures: the adequacy of control group description, significant differential loss to follow-up between groups, and greater than or equal to 30% study attrition. Individual study quality was defined based on total scores according to the CONSORT Statement checklist: very low (0 to < 40%), low (≥ 40 to < 60%), moderate (≥ 60 to < 80%), and high (≥ 80 to 100%).
The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence:
Summary of Findings
Six publications, representing 5 independent trials, met the eligibility criteria for Research Question #1. Three trials were RCTs reported across 4 publications, whereby patients were randomized to home telemonitoring or usual care, and 2 trials were CCTs, whereby patients or health care centers were nonrandomly assigned to intervention or usual care.
A total of 310 participants were studied across the 5 included trials. The mean age of study participants in the included trials ranged from 61.2 to 74.5 years for the intervention group and 61.1 to 74.5 years for the usual care group. The percentage of men ranged from 40% to 64% in the intervention group and 46% to 72% in the control group.
All 5 trials were performed in a moderate to severe COPD patient population. Three trials initiated the intervention following discharge from hospital. One trial initiated the intervention following a pulmonary rehabilitation program. The final trial initiated the intervention during management of patients at an outpatient clinic.
Four of the 5 trials included oxygen saturation (i.e., pulse oximetry) as one of the biological patient parameters being monitored. Additional parameters monitored included forced expiratory volume in one second, peak expiratory flow, and temperature.
There was considerable clinical heterogeneity between trials in study design, methods, and intervention/control. In relation to the telemonitoring intervention, 3 of the 5 included studies used an electronic health hub that performed multiple functions beyond the monitoring of biological parameters. One study used only a pulse oximeter device alone with modem capabilities. Finally, in 1 study, patients measured and then forwarded biological data to a nurse during a televideo consultation. Usual care varied considerably between studies.
Only one trial met the eligibility criteria for Research Question #2. The included trial was an RCT that randomized 60 patients to nurse telephone follow-up or usual care (no telephone follow-up). Participants were recruited from the medical department of an acute-care hospital in Hong Kong and began receiving follow-up after discharge from the hospital with a diagnosis of COPD (no severity restriction). The intervention itself consisted of only two 10-to 20-minute telephone calls, once between days 3 to 7 and once between days 14 to 20, involving a structured, individualized educational and supportive programme led by a nurse that focused on 3 components: assessment, management options, and evaluation.
Regarding Research Question #1:
Low to very low quality evidence (according to GRADE) finds non-significant effects or conflicting effects (of significant or non-significant benefit) for all outcomes examined when comparing home telemonitoring to usual care.
There is a trend towards significant increase in time free of hospitalization and use of other health care services with home telemonitoring, but these findings need to be confirmed further in randomized trials of high quality.
There is severe clinical heterogeneity between studies that limits summary conclusions.
The economic impact of home telemonitoring is uncertain and requires further study.
Home telemonitoring is largely dependent on local information technologies, infrastructure, and personnel, and thus the generalizability of external findings may be low. Jurisdictions wishing to replicate home telemonitoring interventions should likely test those interventions within their jurisdictional framework before adoption, or should focus on home-grown interventions that are subjected to appropriate evaluation and proven effective.
Regarding Research Question #2:
Low quality evidence finds significant benefit in favour of telephone-only support for self-efficacy and emergency department visits when compared to usual care, but non-significant results for hospitalizations and hospital length of stay.
There are very serious issues with the generalizability of the evidence and thus additional research is required.
PMCID: PMC3384362  PMID: 23074421
15.  Assessing the quality of healthcare provided to children. 
Health Services Research  1998;33(4 Pt 2):1059-1090.
OBJECTIVE: To present a conceptual framework for evaluating quality of care for children and adolescents, summarize the key issues related to developing measures to assess pediatric quality of care, examine some existing measures, and present evidence about their current level of performance. PRINCIPAL FINDINGS: Assessing the quality of care for children poses many challenges not encountered when making these measurements in the adult population. Children and adolescents (from this point forward referred to collectively as children unless differentiation is necessary) differ from adults in two clinically important ways (Jameson and Wehr 1993): (1) their normal developmental trajectory is characterized by change, and (2) they have differential morbidity. These factors contribute to the limitations encountered when developing measures to assess the quality of care for children. The movement of a child through the various stages of development makes it difficult to establish what constitutes a "normal" outcome and by extension what constitutes a poor outcome. Additionally, salient developmental outcomes that result from poor quality of care may not be observed for several years. This implies that poor outcomes may be observed when the child is receiving care from a delivery system other than the one that provided the low-quality care. Attributing the suboptimal outcome to the new delivery system would be inappropriate. Differential morbidity refers to the fact that the type, prevalence, and severity of illness experienced by children is measurably different from that observed in adults. Most children experience numerous self-limited illness of mild severity. A minority of children suffer from markedly more severe diseases. Thus, condition-specific measures in children are problematic to implement for routine assessments because of the extremely low incidence and prevalence of most severe pediatric diseases (Halfon 1996). However, children with these conditions are potentially the segment of the pediatric population that can be most affected by variations in the quality of care. Improving the care provided to these children is likely to have the largest impact on quality of life and longevity. The low prevalence of most severe pediatric diseases also makes it difficult to evaluate the effectiveness of new treatment modalities; multi-center trials or long enrollment periods are usually required to obtain a large enough patient sample to conduct the necessary randomized controlled trials or cohort studies. Another challenge encountered when measuring quality of care for children is that, in most cases, they depend on adults to both obtain care and to report on the outcomes of that care. Parents and their children may have different perceptions of what defines health or have different levels of satisfaction with the care they receive. Children, particularly those with special needs, also depend on a broad range of services including the medical system, community intervention programs, social programs, and school-based services. Dependency on these various services adds to the difficulty of measuring and appropriately attributing health outcomes observed in children to a particular service delivery entity. Adolescents also depend on adults for access to some of their care; however, they have special needs related to confidentiality and parent-child information sharing. Adolescents commonly seek care at facilities, such as school-based clinics, that allow them to obtain confidential care. These facilities usually provide out-of-health plan care for these children, which raises special issues related to information availability for quality assessments and for assessing utilization patterns in this population. If the source of poor health outcomes is not known, quality improvement is not possible. The many challenges faced when constructing pediatric (this term will be used to refer to both children and adolescents) quality of care measures have resulted in few of these instruments being developed specifically for children. Most of the measures developed to date have either a very limited pediatric component or still require the process or outcome validation step. Although several practice guidelines and indicators of quality have been constructed, a conceptual framework to guide the development of such tools for quality assessment in the pediatric population is lacking. CONCLUSIONS. Pediatric health services researchers and the organizations that fund this work need to focus on developing a set of quality assessment tools that will address several challenging issues. Working within the context of the conceptual framework presented, we draw several conclusions related to issues that should be considered in developing quality of care measures for children.
PMCID: PMC1070304  PMID: 9776949
16.  Balloon Kyphoplasty 
Executive Summary
Objective
To review the evidence on the effectiveness and cost-effectiveness of balloon kyphoplasty for the treatment of vertebral compression fractures (VCFs).
Clinical Need
Vertebral compression fractures are one of the most common types of osteoporotic fractures. They can lead to chronic pain and spinal deformity. They are caused when the vertebral body (the thick block of bone at the front of each vertebra) is too weak to support the loads of activities of daily living. Spinal deformity due to a collapsed vertebral body can substantially affect the quality of life of elderly people, who are especially at risk for osteoporotic fractures due to decreasing bone mass with age. A population-based study across 12 European centres recently found that VCFs have a negative impact on health-related quality of life. Complications associated with VCFs are pulmonary dysfunction, eating disorders, loss of independence, and mental status change due to pain and the use of medications. Osteoporotic VCFs also are associated with a higher rate of death.
VCFs affect an estimated 25% of women over age 50 years and 40% of women over age 80 years. Only about 30% of these fractures are diagnosed in clinical practice. A Canadian multicentre osteoporosis study reported on the prevalence of vertebral deformity in Canada in people over 50 years of age. To define the limit of normality, they plotted a normal distribution, including mean and standard deviations (SDs) derived from a reference population without any deformity. They reported a prevalence rate of 23.5% in women and a rate of 21.5% in men, using 3 SDs from the mean as the limit of normality. When they used 4 SDs, the prevalence was 9.3% and 7.3%, respectively. They also found the prevalence of vertebral deformity increased with age. For people older than 80 years of age, the prevalence for women and men was 45% and 36%, respectively, using 3 SDs as the limit of normality.
About 85% of VCFs are due to primary osteoporosis. Secondary osteoporosis and neoplasms account for the remaining 15%. A VCF is operationally defined as a reduction in vertebral body height of at least 20% from the initial measurement. It is considered mild if the reduction in height is between 20% and 25%; moderate, if it is between 25% and 40%; and severs, if it is more than 40%. The most frequently fractured locations are the third-lower part of the thorax and the superior lumbar levels. The cervical vertebrae and the upper third of the thorax are rarely involved.
Traditionally, bed rest, medication, and bracing are used to treat painful VCFs. However, anti-inflammatory and narcotic medications are often poorly tolerated by the elderly and may harm the gastrointestinal tract. Bed rest and inactivity may accelerate bone loss, and bracing may restrict diaphragmatic movement. Furthermore, medical treatment does not treat the fracture in a way that ameliorates the pain and spinal deformity.
Over the past decade, the injection of bone cement through the skin into a fractured vertebral body has been used to treat VCFs. The goal of cement injection is to reduce pain by stabilizing the fracture. The secondary indication of these procedures is management of painful vertebral fractures caused by benign or malignant neoplasms (e.g., hemangioma, multiple myeloma, and metastatic cancer).
The Technology
Balloon kyphoplasty is a modified vertebroplasty technique. It is a minimally invasive procedure that aims to relieve pain, restore vertebral height, and correct kyphosis. During this procedure, an inflatable bone tamp is inserted into the collapsed vertebral body. Once inflated, the balloon elevates the end plates and thereby restores the height of the vertebral body. The balloon is deflated and removed, and the space is filled with bone cement. Creating a space in the vertebral body enables the application of more viscous cement and at a much lower pressure than is needed for vertebroplasty. This may result in less cement leakage and fewer complications. Balloons typically are inserted bilaterally, into each fractured vertebral body. Kyphoplasty usually is done under general anesthesia in about 1.5 hours. Patients typically are observed for only a few hours after the surgery, but some may require an overnight hospital stay.
Health Canada has licensed KyphX Xpander Inflatable Bone Tamp (Kyphon Inc., Sunnyvale, CA), for kyphoplasty in patients with VCFs. KyphX is the only commercially available device for percutaneous kyphoplasty. The KyphX kit uses a series of bone filler device tubes. Each bone filler device must be loaded manually with cement. The cement is injected into the cavity by pressing an inner stylet.
In the United States, the Food and Drug Administration cleared the KyphX Inflatable Bone Tamp for marketing in July 1998. CE (Conformité European) marketing was obtained in February 2000 for the reduction of fracture and/or creation of a void in cancellous bone.
Review Strategy
The aim of this literature review was to evaluate the safety and effectiveness of balloon kyphoplasty in the treatment of painful VCFs.
INAHTA, Cochrane CCTR (formerly Cochrane Controlled Trials Register), and DSR were searched for health technology assessment reports. In addition, MEDLINE, EMBASE, and MEDLINE In-Process & Other Non-Indexed Citations were searched from January 1, 2000 to September 21, 2004. The search was limited to English-language articles and human studies.
The positive end points selected for this assessment were as follows:
Reduction in pain scores
Reduction in vertebral height loss
Reduction in kyphotic (Cobb) angle
Improvement in quality of life scores
The search did not yield any health technology assessments on balloon kyphoplasty. The search yielded 152 citations, including those for review articles. No randomized controlled trials (RCTs) on balloon kyphoplasty were identified. All of the published studies were either prospective cohort studies or retrospective studies with no controls. Eleven studies (all case series) met the inclusion criteria. There was also a comparative study published in German that had been translated into English.
Summary of Findings
The results of the 1 comparative study (level 3a evidence) that was included in this review showed that, compared with conservative medical care, balloon kyphoplasty significantly improved patient outcomes.
Patients who had balloon kyphoplasty reported a significant reduction in pain that was maintained throughout follow-up (6 months), whereas pain scores did not change in the control group. Patients in the balloon kyphoplasty group did not need pain medication after 3 days. In the control group, about one-half of the patients needed more pain medication in the first 4 weeks after the procedure. After 6 weeks, 82% of the patients in the control group were still taking pain medication regularly.
Adjacent fractures were more frequent in the control group than in the balloon kyphoplasty group.
The case series reported on several important clinical outcomes.
Pain: Four studies on osteoporosis patients and 1 study on patients with multiple myeloma/primary cancers used the Visual Analogue Scale (VAS) to measure pain before and after balloon kyphoplasty. All of these studies reported that patients had significantly less pain after the procedure. This was maintained during follow-up. Two other studies on patients with osteoporosis also used the VAS to measure pain and found a significant improvement in pain scores; however, they did not provide follow-up data.
Vertebral body height: All 5 studies that assessed vertebral body height in patients with osteoporosis reported a significant improvement in vertebral body height after balloon kyphoplasty. One study had 1-year follow-up data for 26 patients. Vertebral body height was significantly better at 6 months and 1 year for both the anterior and midline measurements.
Two studies reported that vertebral body height was restored significantly after balloon kyphoplasty for patients with multiple myeloma or metastatic disease. In another study, the researchers reported complete height restoration in 9% of patients, a mean 56% height restoration in 60% of patients, and no appreciable height restoration in 31% of the patients who received balloon kyphoplasty.
Kyphosis correction: Four studies that assessed Cobb angle before and after balloon kyphoplasty in patients with osteoporosis found a significant reduction in degree of kyphosis after the procedure. In these studies, the differences between preoperative and postoperative Cobb angles were 3.4°, 7°, 8.8°, and 9.9°.
Only 1 study investigated kyphosis correction in patients with multiple myeloma or metastatic disease. The authors reported a significant improvement (5.2°) in local kyphosis.
Quality of life: Four studies used the Short Form 36 (SF-36) Health Survey Questionnaire to measure the quality of life in patients with osteoporosis after they had balloon kyphoplasty. A significant improvement in most of the domains of the SF-36 (bodily pain, social functioning, vitality, physical functioning, mental health, and role functioning) was observed in 2 studies. One study found that general health declined, although not significantly, and another found that role emotional declined.
Both studies that used the Oswestry Disability Index found that patients had a better quality of life after balloon kyphoplasty. In one study, this improvement was statistically significant. In another study, researchers found that quality of life after kyphoplasty improved significantly, as measured with the Roland-Morris Disability Questionnaire. Yet another study used a quality of life questionnaire and found that 62% of the patients that had balloon kyphoplasty had returned to normal activities, whereas 2 patients had reduced mobility.
To measure quality of life in patients with multiple myeloma or metastatic disease, one group of researchers used the SF-36 and found significantly better scores on bodily pain, physical functioning, vitality, and social functioning after kyphoplasty. However, the scores for general health, mental health, role physical, and role emotional had not improved. A study that used the Oswestry Disability Index reported that patients’ scores were better postoperatively and at 3 months follow-up.
These were the main findings on complications in patients with osteoporosis:
The bone cement leaked in 37 (6%) of 620 treated fractures.
There were no reports of neurological deficits.
There were no reports of pulmonary embolism due to cement leakage.
There were 6 cases of cardiovascular events in 362 patients:
3 (0.8%) patients had myocardial infarction.
3 (0.8%) patients had cardiac arrhythmias.
There was 1 (0.27%) case of pulmonary embolism due to deep venous thrombosis.
There were 20 (8.4%) cases of new fractures in 238 patients.
For patients with multiple myeloma or metastatic disease, these were the main findings:
The bone cement leaked in 12 (9.6%) of 125 procedures.
There were no reports of neurological deficits.
Economic Analysis
Balloon kyphoplasty requires anesthesia. Standard vertebroplasty requires sedation and an analgesic. Based on these considerations, the professional fees (Cdn) for each procedure is shown in Table 1.
Professional Fees for Standard Vertebroplasty and Balloon Kyphoplasty
Balloon kyphoplasty has a sizable device cost add-on of $3,578 (the device cost per case) that standard vertebroplasty does not have. Therefore, the up-front cost (i.e., physician’s fees and device costs) is $187 for standard vertebroplasty and $3,812 for balloon kyphoplasty. (All costs are in Canadian currency.)
There are also “downstream costs” of the procedures, based on the different adverse outcomes associated with each. This includes the risk of developing new fractures (21% for vertebroplasty vs. 8.4% for balloon kyphoplasty), neurological complications (3.9% for vertebroplasty vs. 0% for balloon kyphoplasty), pulmonary embolism (0.1% for vertebroplasty vs. 0% for balloon kyphoplasty), and cement leakage (26.5% for vertebroplasty vs. 6.0% for balloon kyphoplasty). Accounting for these risks, and the base costs to treat each of these complications, the expected downstream costs are estimated at less than $500 per case. Therefore, the expected total direct medical cost per patient is about $700 for standard vertebroplasty and $4,300 for balloon kyphoplasty.
Kyphon, the manufacturer of the inflatable bone tamps has stated that the predicted Canadian incidence of osteoporosis in 2005 is about 29,000. The predicted incidence of cancer-related vertebral fractures in 2005 is 6,731. Based on Ontario having about 38% of the Canadian population, the incidence in the province is likely to be about 11,000 for osteoporosis and 2,500 for cancer-related vertebral fractures. This means there could be as many as 13,500 procedures per year in Ontario; however, this is highly unlikely because most of the cancer-related fractures likely would be treated with medication. Given a $3,600 incremental direct medical cost associated with balloon kyphoplasty, the budget impact of adopting this technology could be as high as $48.6 million per year; however, based on data from the Provider Services Branch, about 120 standard vertebroplasties are done in Ontario annually. Given these current utilization patterns, the budget impact is likely to be in the range of $430,000 per year. This is because of the sizable device cost add-on of $3,578 (per case) for balloon kyphoplasty that standard vertebroplasty does not have.
Policy Considerations
Other treatments for osteoporotic VCFs are medical management and open surgery. In cases without neurological involvement, the medical treatment of osteoporotic VCFs comprises bed rest, orthotic management, and pain medication. However, these treatments are not free of side effects. Bed rest over time can result in more bone and muscle loss, and can speed the deterioration of the underlying condition. Medication can lead to altered mood or mental status. Surgery in these patients has been limited because of its inherent risks and invasiveness, and the poor quality of osteoporotic bones. However, it may be indicated in patients with neurological deficits.
Neither of these vertebral augmentation procedures eliminates the need for aggressive treatment of osteoporosis. Osteoporotic VCFs are often under-diagnosed and under-treated. A survey of physicians in Ontario (1) who treated elderly patients living in long-term care homes found that although these physicians were aware of the rates of osteoporosis in these patients, 45% did not routinely assess them for osteoporosis, and 26% did not routinely treat them for osteoporosis.
Management of the underlying condition that weakens the vertebral bodies should be part of the treatment plan. All patients with osteoporosis should be in a medical therapy program to treat the underlying condition, and the referring health care provider should monitor the clinical progress of the patient.
The main complication associated with vertebroplasty and balloon kyphoplasty is cement leakage (extravertebral or vascular). This may result in more patient morbidity, longer hospitalizations, the need for open surgery, and the use of pain medications, all of which have related costs. Extravertebral cement leakage can cause neurological complications, like spinal cord compression, nerve root compression, and radiculopathy. In some cases, surgery is required to remove the cement and release the nerve. The rate of cement leakage is much lower after balloon kyphoplasty than after vertebroplasty. Furthermore, the neurological complications seen with vertebroplasty have not seen in the studies of balloon kyphoplasty. Rarely, cement leakage into the venous system will cause a pulmonary embolism. Finally, compared with vertebroplasty, the rate of new fractures is lower after balloon kyphoplasty.
Diffusion – International, National, Provincial
In Canada, balloon kyphoplasty has not yet been funded in any of the provinces. The first balloon kyphoplasty performed in Canada was in July 2004 in Ontario.
In the United States, the technology is considered by some states as medically reasonable and necessary for the treatment of painful vertebral body compression fractures.
Conclusion
There is level 4 evidence that balloon kyphoplasty to treat pain associated with VCFs due to osteoporosis is as effective as vertebroplasty at relieving pain. Furthermore, the evidence suggests that it restores the height of the affected vertebra. It also results in lower fracture rates in other vertebrae compared with vertebroplasty, and in fewer neurological complications due to cement leakage compared with vertebroplasty. Balloon kyphoplasty is a reasonable alternative to vertebroplasty, although it must be reiterated that this conclusion is based on evidence from level 4 studies.
Balloon kyphoplasty should be restricted to facilities that have sufficient volumes to develop and maintain the expertise required to maximize good quality outcomes. Therefore, consideration should be given to limiting the number of facilities in the province that can do balloon kyphoplasty.
PMCID: PMC3387743  PMID: 23074451
17.  Optimal Management of High-Risk T1G3 Bladder Cancer: A Decision Analysis 
PLoS Medicine  2007;4(9):e284.
Background
Controversy exists about the most appropriate treatment for high-risk superficial (stage T1; grade G3) bladder cancer. Immediate cystectomy offers the best chance for survival but may be associated with an impaired quality of life compared with conservative therapy. We estimated life expectancy (LE) and quality-adjusted life expectancy (QALE) for both of these treatments for men and women of different ages and comorbidity levels.
Methods and Findings
We evaluated two treatment strategies for high-risk, T1G3 bladder cancer using a decision-analytic Markov model: (1) Immediate cystectomy with neobladder creation versus (2) conservative management with intravesical bacillus Calmette-Guérin (BCG) and delayed cystectomy in individuals with resistant or progressive disease. Probabilities and utilities were derived from published literature where available, and otherwise from expert opinion. Extensive sensitivity analyses were conducted to identify variables most likely to influence the decision. Structural sensitivity analyses modifying the base case definition and the triggers for cystectomy in the conservative therapy arm were also explored. Probabilistic sensitivity analysis was used to assess the joint uncertainty of all variables simultaneously and the uncertainty in the base case results. External validation of model outputs was performed by comparing model-predicted survival rates with independent published literature. The mean LE of a 60-y-old male was 14.3 y for immediate cystectomy and 13.6 y with conservative management. With the addition of utilities, the immediate cystectomy strategy yielded a mean QALE of 12.32 y and remained preferred over conservative therapy by 0.35 y. Worsening patient comorbidity diminished the benefit of early cystectomy but altered the LE-based preferred treatment only for patients over age 70 y and the QALE-based preferred treatment for patients over age 65 y. Sensitivity analyses revealed that patients over the age of 70 y or those strongly averse to loss of sexual function, gastrointestinal dysfunction, or life without a bladder have a higher QALE with conservative therapy. The results of structural or probabilistic sensitivity analyses did not change the preferred treatment option. Model-predicted overall and disease-specific survival rates were similar to those reported in published studies, suggesting external validity.
Conclusions
Our model is, to our knowledge, the first of its kind in bladder cancer, and demonstrated that younger patients with high-risk T1G3 bladder had a higher LE and QALE with immediate cystectomy. The decision to pursue immediate cystectomy versus conservative therapy should be based on discussions that consider patient age, comorbid status, and an individual's preference for particular postcystectomy health states. Patients over the age of 70 y or those who place high value on sexual function, gastrointestinal function, or bladder preservation may benefit from a more conservative initial therapeutic approach.
Using a Markov model, Shabbir Alibhai and colleagues develop a decision analysis comparing cystectomy with conservative treatment for high-risk superficial bladder cancer depending on patient age, comorbid conditions, and preferences.
Editors' Summary
Background.
Every year, about 67,000 people in the US develop bladder cancer. Like all cancers, bladder cancer arises when a single cell begins to grow faster than normal, loses its characteristic shape, and moves into surrounding tissues. Most bladder cancers develop from cells that line the bladder (“transitional” cells) and most are detected before they spread out of this lining. These superficial or T1 stage cancers can be removed by transurethral resection of bladder tumor (TURBT). The urologist (a specialist who treats urinary tract problems) passes a small telescope into the bladder through the urethra (the tube through which urine leaves the body) and removes the tumor. If the tumor cells look normal under a microscope (so-called normal histology), the cancer is unlikely to return; if they have lost their normal appearance, the tumor is given a “G3” histological grade, which indicates a high risk of recurrence.
Why Was This Study Done?
The best treatment for T1G3 bladder cancer remains controversial. Some urologists recommend immediate radical cystectomy— surgical removal of the bladder, the urethra, and other nearby organs. This treatment often provides a complete cure but can cause serious short-term health problems and affects long-term quality of life. Patients often develop sexual dysfunction or intestinal (gut) problems and sometimes find it hard to live with a reconstructed bladder. The other recommended treatment is immunotherapy with bacillus Calmette-Guérin (BCG, bacteria that are also used to vaccinate against tuberculosis). Long-term survival is not always as good with this conservative treatment but it is less likely than surgery to cause short-term illness or to reduce quality of life. In this study, the researchers have used decision analysis (a systematic evaluation of the important factors affecting a decision) to determine whether immediate cystectomy or conservative therapy is the optimal treatment for patients with T1G3 bladder cancer. Decision analysis allowed the researchers to account for quality-of-life factors while comparing the health benefits of each treatment for T1G3 bladder cancer.
What Did the Researchers Do and Find?
Using a decision analysis model called a Markov model, the researchers calculated the months of life gained, and the quality of life expected to result, from each of the two treatments. To estimate the life expectancy (LE) associated with each treatment, the researchers incorporated the published probabilities of various outcomes of each treatment into their model. To estimate quality-adjusted life expectancy (QALE, the number of years of good quality life), they incorporated “utilities,” measures of relative satisfaction with outcomes. (A utility of 1 represents perfect health; death is assigned a value of 0, and outcomes considered less than ideal, but better than death, fall in between). For a sexually potent 60-year-old man with bladder cancer but no other illnesses, the average LE predicted by the model was nearly eight months longer with immediate cystectomy than with conservative treatment (both LEs predicted by this model matched those seen in clinical trials); the average QALE with cystectomy was 4.2 months longer than with conservative treatment. Having additional diseases decreased the benefit of immediate cystectomy but the treatment still gave a longer LE until the patient reached 70 years old, when conservative treatment became better. For QALE, this change in optimal treatment appeared at age 65. Finally, conservative treatment gave a higher QALE than immediate cystectomy for patients concerned about preserving sexual function or averse to living with intestinal problems or a reconstructed bladder.
What Do These Findings Mean?
As with all mathematical models, these results depend on the assumptions included in the model. In particular, because published probability and utility values are not available for some of the possible outcomes of the two treatments, the LE and QALE calculations could be inaccurate. Also, assigning numerical ratings to life experiences is generally something of a simplification, which could affect the reliability of the QALE (but not the LE) results. Nevertheless, these findings provide useful guidance for urologists trying to balance the benefits of immediate cystectomy or conservative treatment against the potential short-term and long-term effects of these treatments on patients' quality of life. Specifically, the results indicate that decisions on treatment for T1G3 bladder cancer should be based on a consideration of the patient's age and any coexisting disease coupled with detailed discussions with the patient about their attitudes regarding the possible health-related effects of cystectomy.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040284.
MedlinePlus encyclopedia page on bladder cancer (in English and Spanish)
Information for patients and professionals from the US National Cancer Institute on bladder cancer (in English and Spanish)
Information for patients on bladder cancer from the UK charity Cancerbackup
Online course on Decision Analysis in Health Care from George Mason University
doi:10.1371/journal.pmed.0040284
PMCID: PMC1989749  PMID: 17896857
18.  Beyond MQSA: Measuring the quality of breast cancer screening programs 
OBJECTIVE
A high quality screening mammography program should find breast cancer when it exists, when it’s small, and ensure that suspicious findings receive prompt follow-up. The Mammography Quality Standards Act (MQSA) guidelines related to tracking outcomes are insufficient for assessing quality of care. We used data from a quality improvement project to determine whether mammography screening facilities could show that they met certain quality benchmarks beyond those required by MQSA.
METHODS
Participating facilities (N=52) provided aggregate data on screening mammograms conducted in calendar year 2009 and corresponding diagnostic follow-up, including lost to follow-up and timing of diagnostic imaging and biopsy, cancer detection rates, and the proportion of cancers detected as minimal and early stage tumors.
RESULTS
The percentage of institutions meeting each benchmark varied from 27% to 83%. Facilities with American College of Surgeons or National Comprehensive Cancer Network designation were more likely to meet benchmarks pertaining to cancer detection and early detection, and Disproportionate Share facilities were less likely to meet benchmarks pertaining to timeliness of care.
CONCLUSIONS
Results suggest a combination of care quality issues and incomplete tracking of patients. To accurately measure quality of the breast cancer screening process, it is critical that there be complete tracking of patients with abnormal screening mammograms so that results can be interpreted solely in terms of quality of care. The Mammography Quality Standards Act guidelines for tracking outcomes and measuring quality indicators should be strengthened to better assess quality of care.
doi:10.2214/AJR.13.10806
PMCID: PMC4113079  PMID: 24261339
19.  Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD) 
Executive Summary
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.
After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.
The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.
Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework
Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model
Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature
For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm.
For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx.
The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.
Objective
The objective of this evidence-based analysis was to determine the effectiveness and cost-effectiveness of multidisciplinary care (MDC) compared with usual care (UC, single health care provider) for the treatment of stable chronic obstructive pulmonary disease (COPD).
Clinical Need: Condition and Target Population
Chronic obstructive pulmonary disease is a progressive disorder with episodes of acute exacerbations associated with significant morbidity and mortality. Cigarette smoking is linked causally to COPD in more than 80% of cases. Chronic obstructive pulmonary disease is among the most common chronic diseases worldwide and has an enormous impact on individuals, families, and societies through reduced quality of life and increased health resource utilization and mortality.
The estimated prevalence of COPD in Ontario in 2007 was 708,743 persons.
Technology
Multidisciplinary care involves professionals from a range of disciplines, working together to deliver comprehensive care that addresses as many of the patient’s health care and psychosocial needs as possible.
Two variables are inherent in the concept of a multidisciplinary team: i) the multidisciplinary components such as an enriched knowledge base and a range of clinical skills and experiences, and ii) the team components, which include but are not limited to, communication and support measures. However, the most effective number of team members and which disciplines should comprise the team for optimal effect is not yet known.
Research Question
What is the effectiveness and cost-effectiveness of MDC compared with UC (single health care provider) for the treatment of stable COPD?
Research Methods
Literature Search
Search Strategy
A literature search was performed on July 19, 2010 using OVID MEDLINE, OVID MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, EBSCO Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Wiley Cochrane Library, and the Centre for Reviews and Dissemination database, for studies published from January 1, 1995 until July 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search.
Inclusion Criteria
health technology assessments, systematic reviews, or randomized controlled trials
studies published between January 1995 and July 2010;
COPD study population
studies comparing MDC (2 or more health care disciplines participating in care) compared with UC (single health care provider)
Exclusion Criteria
grey literature
duplicate publications
non-English language publications
study population less than 18 years of age
Outcomes of Interest
hospital admissions
emergency department (ED) visits
mortality
health-related quality of life
lung function
Quality of Evidence
The quality of each included study was assessed, taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses.
The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence:
Summary of Findings
Six randomized controlled trials were obtained from the literature search. Four of the 6 studies were completed in the United States. The sample size of the 6 studies ranged from 40 to 743 participants, with a mean study sample between 66 and 71 years of age. Only 2 studies characterized the study sample in terms of the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD stage criteria, and in general the description of the study population in the other 4 studies was limited. The mean percent predicted forced expiratory volume in 1 second (% predicted FEV1) among study populations was between 32% and 59%. Using this criterion, 3 studies included persons with severe COPD and 2 with moderate COPD. Information was not available to classify the population in the sixth study.
Four studies had MDC treatment groups which included a physician. All studies except 1 reported a respiratory specialist (i.e., respiratory therapist, specialist nurse, or physician) as part of the multidisciplinary team. The UC group was comprised of a single health care practitioner who may or may not have been a respiratory specialist.
A meta-analysis was completed for 5 of the 7 outcome measures of interest including:
health-related quality of life,
lung function,
all-cause hospitalization,
COPD-specific hospitalization, and
mortality.
There was only 1 study contributing to the outcome of all-cause and COPD-specific ED visits which precluded pooling data for these outcomes. Subgroup analyses were not completed either because heterogeneity was not significant or there were a small number of studies that were meta-analysed for the outcome.
Quality of Life
Three studies reported results of quality of life assessment based on the St. George’s Respiratory Questionnaire (SGRQ). A mean decrease in the SGRQ indicates an improvement in quality of life while a mean increase indicates deterioration in quality of life. In all studies the mean change score from baseline to the end time point in the MDC treatment group showed either an improvement compared with the control group or less deterioration compared with the control group. The mean difference in change scores between MDC and UC groups was statistically significant in all 3 studies. The pooled weighted mean difference in total SGRQ score was −4.05 (95% confidence interval [CI], −6.47 to 1.63; P = 0.001). The GRADE quality of evidence was assessed as low for this outcome.
Lung Function
Two studies reported results of the FEV1 % predicted as a measure of lung function. A negative change from baseline infers deterioration in lung function and a positive change from baseline infers an improvement in lung function. The MDC group showed a statistically significant improvement in lung function up to 12 months compared with the UC group (P = 0.01). However this effect is not maintained at 2-year follow-up (P = 0.24). The pooled weighted mean difference in FEV1 percent predicted was 2.78 (95% CI, −1.82 to −7.37). The GRADE quality of evidence was assessed as very low for this outcome indicating that an estimate of effect is uncertain.
Hospital Admissions
All-Cause
Four studies reported results of all-cause hospital admissions in terms of number of persons with at least 1 admission during the follow-up period. Estimates from these 4 studies were pooled to determine a summary estimate. There is a statistically significant 25% relative risk (RR) reduction in all-cause hospitalizations in the MDC group compared with the UC group (P < 0.001). The index of heterogeneity (I2) value is 0%, indicating no statistical heterogeneity between studies. The GRADE quality of evidence was assessed as moderate for this outcome, indicating that further research may change the estimate of effect.
COPD-Specific Hospitalization
Three studies reported results of COPD-specific hospital admissions in terms of number of persons with at least 1 admission during the follow-up period. Estimates from these 3 studies were pooled to determine a summary estimate. There is a statistically significant 33% RR reduction in all-cause hospitalizations in the MDC group compared with the UC group (P = 0.002). The I2 value is 0%, indicating no statistical heterogeneity between studies. The GRADE quality of evidence was assessed as moderate for this outcome, indicating that further research may change the estimate of effect.
Emergency Department Visits
All-Cause
Two studies reported results of all-cause ED visits in terms of number of persons with at least 1 visit during the follow-up period. There is a statistically nonsignificant reduction in all-cause ED visits when data from these 2 studies are pooled (RR, 0.64; 95% CI, 0.31 to −1.33; P = 0.24). The GRADE quality of evidence was assessed as very low for this outcome indicating that an estimate of effect is uncertain.
COPD-Specific
One study reported results of COPD-specific ED visits in terms of number of persons with at least 1 visit during the follow-up period. There is a statistically significant 41% reduction in COPD-specific ED visits when the data from these 2 studies are pooled (RR, 0.59; 95% CI, 0.43−0.81; P < 0.001). The GRADE quality of evidence was assessed as moderate for this outcome.
Mortality
Three studies reported the mortality during the study follow-up period. Estimates from these 3 studies were pooled to determine a summary estimate. There is a statistically nonsignificant reduction in mortality between treatment groups (RR, 0.81; 95% CI, 0.52−1.27; P = 0.36). The I2 value is 19%, indicating low statistical heterogeneity between studies. All studies had a 12-month follow-up period. The GRADE quality of evidence was assessed as low for this outcome.
Conclusions
Significant effect estimates with moderate quality of evidence were found for all-cause hospitalization, COPD-specific hospitalization, and COPD-specific ED visits (Table ES1). A significant estimate with low quality evidence was found for the outcome of quality of life (Table ES2). All other outcome measures were nonsignificant and supported by low or very low quality of evidence.
Summary of Dichotomous Data
Abbreviations: CI, confidence intervals; COPD, chronic obstructive pulmonary disease; n, number.
Summary of Continuous Data
Abbreviations: CI, confidence intervals; FEV1, forced expiratory volume in 1 second; n, number; SGRQ, St. George’s Respiratory Questionnaire.
PMCID: PMC3384374  PMID: 23074433
20.  Is Immediate Imaging Important in Managing Low Back Pain? 
Journal of Athletic Training  2011;46(1):99-102.
Abstract
Reference:
Chou R, Fu R, Carrino JA, Deyo RA. Imaging strategies for low-back pain: systematic review and meta-analysis. Lancet. 2009;373(9662):463–472.
Clinical Questions:
In patients with low back pain (LBP) who do not have indications of a serious underlying condition, does routine, immediate lumbar imaging result in improved patient outcomes when compared with clinical care without immediate imaging?
Data Sources:
Studies were identified by searching MEDLINE (1966 through first week of August 2008) and the Cochrane Central Register of Controlled Trials (third quarter of 2008). The reference lists of identified studies were manually reviewed for additional citations. The search terms spine, low-back pain, diagnostic imaging, and randomized controlled trials were used in both databases. The complete search strategy was made available as an online supplement.
Study Selection:
The search criteria were applied to the articles obtained from the electronic searches and the subsequent manual searches with no language restrictions. This systematic review and meta-analysis included randomized, controlled trials that compared immediate, routine lumbar imaging (or routine provision of imaging findings) with usual clinical care without immediate lumbar imaging (or not routinely providing results of imaging) for LBP without indications of serious underlying conditions.
Data Extraction:
Data extraction and assessment of study quality were well described. The trials assessed one or more of the following outcomes: pain, function, mental health, quality of life, patient satisfaction, and overall patient-reported improvement. Two reviewers independently appraised citations considered potentially relevant, with disagreements between reviewers resolved by consensus. Two independent reviewers abstracted data from the trials and assessed quality with modified Cochrane Back Review Group criteria. The criterion for blinding of patients and providers was excluded because of lack of applicability to imaging studies. In addition, the criterion of co-intervention similarity was excluded because a potential effect of different imaging strategies is to alter subsequent treatment decisions. As a result of excluding these criteria, quality ratings were based on the remaining 8 criteria. The authors resolved disagreements about quality ratings through discussion and consensus. Trials that met 4 or more of the 8 criteria were classified as higher quality, whereas those that met 3 or fewer of the 8 criteria were classified as lower quality. In addition, the authors categorized duration of symptoms as acute (<4 weeks), subacute (4–12 weeks), or chronic (>12 weeks). The investigators also contacted the study authors for additional data if included outcomes were not published or if median (rather than mean) outcomes were reported. Statistical analysis was conducted on the primary outcomes of improvement in pain or function. Secondary outcomes of improvement in mental health, quality of life, patient satisfaction, and overall improvement were also analyzed. Outcomes were categorized as short term (≤3 months), long term (>6 months to ≤1 year), or extended (>1 year). For continuous outcomes, standardized mean differences (SMDs) of interventions for change between baseline and follow-up measurements were calculated. In studies reporting the same pain (visual analog scale [VAS] or Short Form-36 bodily pain score) or function (Roland-Morris Disability Questionnaire [RDQ]) outcomes, weighted mean differences (WMDs) were calculated. In all analyses, lower pain and function scores indicated better outcomes. For quality-of-life and mental health outcomes, higher scores indicated improved outcomes. All statistical analyses were performed with Stata 10.0. For outcomes in which SMDs were calculated, values of 0.2 to 0.5 were considered small, 0.5 to 0.8 were considered moderate, and values greater than 0.8 were considered large. For WMDs, mean improvements of 5 to 10 points on a 100-point scale (or equivalent) were considered small, 10-point to 20-point changes were considered moderate, and changes greater than 20 points were considered large. For the RDQ, mean improvements of 1 to 2 points were termed small, and improvements of 2 to 5 points were termed moderate.
Main Results:
The total number of citations identified using the search criteria was 479 articles and abstracts. Of these, 466 were excluded because either they were not randomized trials or they did not use imaging strategies for LBP. At this step, 13 articles were retrieved for further analysis. This analysis resulted in 3 additional articles being excluded (1 was not a randomized trial and the other 2 compared 2 imaging techniques rather than immediate imaging versus no imaging). The final step resulted in the inclusion of 6 trials reported in 10 publications for the meta-analysis. In the studies meeting the inclusion criteria, 4 assessed lumbar radiography and 2 assessed magnetic resonance imaging (MRI) or computed tomography (CT) scans. In these 6 trials, 1804 patients were randomly assigned to the intervention group. The duration of patient follow-up ranged from 3 weeks to 2 years. In addition, 1 trial excluded patients with sciatica or other radiculopathy symptoms, whereas another did not report the proportion of patients with these symptoms. In the other 4 studies, the proportion of patients with sciatica or radiculopathy ranged from 24% to 44%. Of the included trials, 3 compared immediate lumbar radiography with usual clinical care without immediate radiography, and a fourth study compared immediate lumbar radiography and a brief educational intervention with lumbar radiography if no improvement was seen by 3 weeks. The final 2 studies assessed advanced imaging modalities. Specifically, one group compared immediate MRI or CT with usual clinical care without advanced imaging in patients with primarily chronic LBP (82% with LBP for >3 months) who were referred to a surgeon. In the other advanced imaging study, all patients with LBP for <3 weeks underwent MRI and were then randomized to routine notification of results or to notification of results only if clinically indicated. With respect to study quality, 5 trials met at least 4 of the 8 predetermined quality criteria, leading to a classification of higher quality. In addition, 5 trials were included in the primary meta-analysis on pain or function improvement at 1 or more follow-up periods. With regard to short-term and long-term improvements in pain, no differences were noted between routine, immediate lumbar imaging and usual clinical care without immediate imaging (Table 1). In studies using the VAS pain score, the WMD (0.62, 95% confidence interval [CI]  =  0.03, 1.21) at short-term follow-up slightly favored no immediate imaging. No differences in outcome were seen in studies using the Short Form-36 bodily pain score. No improvements in function at short-term or long-term follow-up were noted between imaging strategies. Specifically, short-term function measured with the RDQ in 3 studies showed a WMD of 0.48 points (95% CI  =  −1.39, 2.35) between imaging strategies, whereas long-term function in 3 studies, also measured with the RDQ, showed a WMD of 0.33 points (95% CI  =  −0.65, 1.32). One included trial reported pain outcomes at extended (2-year) follow-up and found no differences between imaging strategies for pain (Short Form-36 bodily pain or Aberdeen pain score), with SMDs of −2.7 (95% CI  =  −6.17, 0.79) and −1.6 (−4.04, 0.84), respectively. The outcomes between immediate imaging and usual clinical care without immediate imaging did not differ for short-term follow-up in those studies reporting quality of life (SMD  =  −0.10, 95% CI  =  −0.53, 0.34), mental health (SMD  =  0.12, 95% CI  =  −0.37, 0.62), or overall improvement (mean risk ratio  =  0.83, 95% CI  =  0.65, 1.06). In those studies reporting long-term follow-up periods, similar results can be seen for quality of life (SMD  =  −0.15, 95% CI  =  −0.33, 0.04) and mental health (SMD  =  0.01, 95% CI  =  −0.32, 0.34). In the study reporting extended follow-up, immediate imaging was not better in terms of improving quality of life (SMD  =  0.02, 95% CI  =  −0.02, 0.07) or mental health (SMD  =  −1.50, 95% CI  =  −4.09, 1.09) when compared with usual clinical care without immediate imaging. In the included studies, no cases of cancer, infection, cauda equina syndrome, or other serious diagnoses were reported in patients randomly assigned to either imaging strategy.
Conclusions:
Available evidence indicates that immediate, routine lumbar spine imaging in patients with LBP and without features indicating a serious underlying condition did not improve outcomes compared with usual clinical care without immediate imaging. Clinical care without immediate imaging seems to result in no increased odds of failure in identifying serious underlying conditions in patients without risk factors for these conditions. In addition to lacking clinical benefit, routine lumbar imaging is associated with radiation exposure (radiography and CT) and increased direct expenses for patients and may lead to unnecessary procedures. This evidence confirms that clinicians should refrain from routine, immediate lumbar imaging in primary care patients with nonspecific, acute or subacute LBP and no indications of underlying serious conditions. Specific consideration of patient expectations about the value of imaging was not addressed here; however, this aspect must be considered to avoid unnecessary imaging while also meeting patient expectations and increasing patient satisfaction.
doi:10.4085/1062-6050-46.1.99
PMCID: PMC3017496  PMID: 21214357
spine; assessment; outcomes
21.  Health system and community level interventions for improving antenatal care coverage and health outcomes 
Background
The World Health Organization (WHO) recommends at least four antenatal care (ANC) visits for all pregnant women. Almost half of pregnant women worldwide, and especially in developing countries do not receive this amount of care. Poor attendance of ANC is associated with delivery of low birthweight babies and more neonatal deaths. ANC may include education on nutrition, potential problems with pregnancy or childbirth, child care and prevention or detection of disease during pregnancy.
This review focused on community-based interventions and health systems-related interventions.
Objectives
To assess the effects of health system and community interventions for improving coverage of antenatal care and other perinatal health outcomes.
Search methods
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (7 June 2015) and reference lists of retrieved studies.
Selection criteria
We included randomised controlled trials (RCTs), quasi-randomised trials and cluster-randomised trials. Trials of any interventions to improve ANC coverage were eligible for inclusion. Trials were also eligible if they targeted specific and related outcomes, such as maternal or perinatal death, but also reported ANC coverage.
Data collection and analysis
Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy.
Main results
We included 34 trials involving approximately 400,000 women. Some trials tested community-based interventions to improve uptake of antenatal care (media campaigns, education or financial incentives for pregnant women), while other trials looked at health systems interventions (home visits for pregnant women or equipment for clinics). Most trials took place in low- and middle-income countries, and 29 of the 34 trials used a cluster-randomised design. We assessed 30 of the 34 trials as of low or unclear overall risk of bias.
Comparison 1: One intervention versus no intervention
We found marginal improvements in ANC coverage of at least four visits (average odds ratio (OR) 1.11, 95% confidence interval (CI) 1.01 to 1.22; participants = 45,022; studies = 10; Heterogeneity: Tau² = 0.01; I² = 52%; high quality evidence). Sensitivity analysis with a more conservative intra-cluster correlation co-efficient (ICC) gave similar marginal results. Excluding one study at high risk of bias shifted the marginal pooled estimate towards no effect. There was no effect on pregnancy-related deaths (average OR 0.69, 95% CI 0.45 to 1.08; participants = 114,930; studies = 10; Heterogeneity: Tau² = 0.00; I² = 0%; low quality evidence), perinatal mortality (average OR 0.98, 95% CI 0.90 to 1.07; studies = 15; Heterogeneity: Tau² = 0.01; I² = 58%; moderate quality evidence) or low birthweight (average OR 0.94, 95% CI 0.82 to 1.06; studies = five; Heterogeneity: Tau² = 0.00; I² = 5%; high quality evidence). Single interventions led to marginal improvements in the number of women who delivered in health facilities (average OR 1.08, 95% CI 1.02 to 1.15; studies = 10; Heterogeneity: Tau² = 0.00; I² = 0%; high quality evidence), and in the proportion of women who had at least one ANC visit (average OR 1.68, 95% CI 1.02 to 2.79; studies = six; Heterogeneity: Tau² = 0.24; I² = 76%; moderate quality evidence). Results for ANC coverage (at least four and at least one visit) and for perinatal mortality had substantial statistical heterogeneity. Single interventions did not improve the proportion of women receiving tetanus protection (average OR 1.03, 95% CI 0.92 to 1.15; studies = 8; Heterogeneity: Tau² = 0.01; I² = 57%). No study reported onintermittent prophylactic treatment for malaria.
Comparison 2: Two or more interventions versus no intervention
We found no improvements in ANC coverage of four or more visits (average OR 1.48, 95% CI 0.99 to 2.21; participants = 7840; studies = six; Heterogeneity: Tau² = 0.10; I² = 48%; low quality evidence) or pregnancy-related deaths (average OR 0.70, 95% CI 0.39 to 1.26; participants = 13,756; studies = three; Heterogeneity: Tau² = 0.00; I² = 0%; moderate quality evidence). However, combined interventions led to improvements in ANC coverage of at least one visit (average OR 1.79, 95% CI 1.47 to 2.17; studies = five; Heterogeneity: Tau² = 0.00; I² = 0%; moderate quality evidence), perinatal mortality (average OR 0.74, 95% CI 0.57 to 0.95; studies = five; Heterogeneity: Tau² = 0.06; I² = 83%; moderate quality evidence) and low birthweight (average OR 0.61, 95% CI 0.46 to 0.80; studies = two; Heterogeneity: Tau² = 0.00; I² = 0%; moderate quality evidence). Meta-analyses for both ANC coverage four or more visits and perinatal mortality had substantial statistical heterogeneity. Combined interventions improved the proportion of women who had tetanus protection (average OR 1.48, 95% CI 1.18 to 1.87; studies = 3; Heterogeneity: Tau² = 0.01; I² = 33%). No trial in this comparison reported on intermittent prophylactic treatment for malaria.
Comparison 3: Two interventions compared head to head. No trials found.
Comparison 4: One intervention versus a combination of interventions
There was no difference in ANC coverage (four or more visits and at least one visit), pregnancy-related deaths, deliveries in a health facility or perinatal mortality. No trials in this comparison reported on low birthweight orintermittent prophylactic treatment of malaria.
Authors' conclusions
Implications for practice - Single interventions may improve ANC coverage (at least one visit and four or more visits) and deliveries in health facilities. Combined interventions may improve ANC coverage (at least one visit), reduce perinatal mortality and reduce the occurrence of low birthweight. The effects of the interventions are unrelated to whether they are community or health system interventions.
Implications for research - More details should be provided in reporting numbers of events, group totals and the ICCs used to adjust for cluster effects. Outcomes should be reported uniformly so that they are comparable to commonly-used population indicators. We recommend further cluster-RCTs of pregnant women and women in their reproductive years, using combinations of interventions and looking at outcomes that are important to pregnant women, such as maternal and perinatal morbidity and mortality, alongside the explanatory outcomes along the pathway of care: ANC coverage, the services provided during ANC and deliveries in health facilities.
PLAIN LANGUAGE SUMMARY
Health system and community level interventions for improving antenatal care coverage and health outcomes
What is the issue?
The World Health Organization recommends at least four antenatal visits for all pregnant women. Almost half of pregnant women worldwide miss out on this level of care, and this is more problematic in low- and middle-income countries.
Why is this important?
Healthcare during pregnancy is a priority because poor antenatal attendance is associated with delivery of low birthweight babies and more newborn deaths. Antenatal care also provides opportunity for nutritional and health checks, such as whether a woman has a disease like malaria or has been exposed to infectious diseases such as HIV (human immunodeficiency virus) or syphilis.
What evidence did we find?
We reviewed randomised controlled trials that tested ways to improve the uptake of antenatal care during pregnancy. Some trials tested community-based interventions (media campaigns, education on self and infant care or financial incentives for pregnant women to attend antenatal care), while other trials looked at health systems interventions (home visits for pregnant women or provision of equipment for clinics). We included 34 trials with approximately 400,000 women. Most trials took place in low- and middle-income countries, and most trials were conducted in a way that made us feel confident about trusting the published reports. We assessed 30 of the 34 trials as of low or unclear overall risk of bias. The quality rating (high, moderate or low) shows our level of confidence that the result is robust and meaningful.
Trials comparing one intervention with no intervention
Single interventions only marginally improved the numbers of women attending four antenatal visits (high quality). Interventions did not improve rates of maternal death (low quality), baby deaths (moderate quality) or low birthweight (high quality). Even so, interventions led to modest improvements in the number of women who had at least one antenatal visit (moderate quality) and who delivered in a health facility (high quality). The number of women who received intermittent preventive treatment for malaria was not reported.
Trials comparing two or more interventions with no intervention
Combined interventions did not improve the number of women with four or more visits (low quality), or reduce maternal deaths (moderate quality). Nor did it increase the number of women who delivered in a health facility (moderate quality). However, more women who received combined interventions had one or more antenatal visits (moderate quality); there were also fewer baby deaths (moderate quality) and fewer low birthweight babies (moderate quality). The number of women who received intermittent preventive treatment for malaria was not reported.
We found no evidence that trials of community interventions worked differently from trials of health systems interventions.
Trials comparing one intervention with another intervention - there were no trials for this comparison.
Trials comparing one intervention with a combination of interventions - There was no difference in the number of women attending four or more antenatal visits (and at least one visit), maternal deaths, baby deaths, the number of deliveries in a health facility or the number of women who received intermittent preventive treatment for malaria.
What does this mean?
Single interventions may improve antenatal care coverage (women attending at least one visit and women attending four or more visits) and encourage women to give birth to their babies in health facilities. Combined interventions may also improve antenatal care coverage (at least one visit), reduce baby deaths and reduce the number of babies born with low birthweight.
We recommend that further studies of pregnant women and women in their reproductive years use combinations of interventions to maximise impact and look at outcomes that are important to the women themselves, such as maternal and baby deaths or ill health and the use of healthcare services.
doi:10.1002/14651858.CD010994.pub2
PMCID: PMC4676908  PMID: 26621223
22.  Extracorporeal Photophoresis 
Executive Summary
Objective
To assess the effectiveness, safety and cost-effectiveness of extracorporeal photophoresis (ECP) for the treatment of refractory erythrodermic cutaneous T cell lymphoma (CTCL) and refractory chronic graft versus host disease (cGvHD).
Background
Cutaneous T Cell Lymphoma
Cutaneous T cell lymphoma (CTCL) is a general name for a group of skin affecting disorders caused by malignant white blood cells (T lymphocytes). Cutaneous T cell lymphoma is relatively uncommon and represents slightly more than 2% of all lymphomas in the United States. The most frequently diagnosed form of CTCL is mycosis fungoides (MF) and its leukemic variant Sezary syndrome (SS). The relative frequency and disease-specific 5-year survival of 1,905 primary cutaneous lymphomas classified according to the World Health Organization-European Organization for Research and Treatment of Cancer (WHO-EORTC) classification (Appendix 1). Mycosis fungoides had a frequency of 44% and a disease specific 5-year survival of 88%. Sezary syndrome had a frequency of 3% and a disease specific 5-year survival of 24%.
Cutaneous T cell lymphoma has an annual incidence of approximately 0.4 per 100,000 and it mainly occurs in the 5th to 6th decade of life, with a male/female ratio of 2:1. Mycosis fungoides is an indolent lymphoma with patients often having several years of eczematous or dermatitic skin lesions before the diagnosis is finally established. Mycosis fungoides commonly presents as chronic eczematous patches or plaques and can remain stable for many years. Early in the disease biopsies are often difficult to interpret and the diagnosis may only become apparent by observing the patient over time.
The clinical course of MF is unpredictable. Most patients will live normal lives and experience skin symptoms without serious complications. Approximately 10% of MF patients will experience progressive disease involving lymph nodes, peripheral blood, bone marrow and visceral organs. A particular syndrome in these patients involves erythroderma (intense and usually widespread reddening of the skin from dilation of blood vessels, often preceding or associated with exfoliation), and circulating tumour cells. This is known as SS. It has been estimated that approximately 5-10% of CTCL patients have SS. Patients with SS have a median survival of approximately 30 months.
Chronic Graft Versus Host Disease
Allogeneic hematopoietic cell transplantation (HCT) is a treatment used for a variety of malignant and nonmalignant disease of the bone marrow and immune system. The procedure is often associated with serious immunological complications, particularly graft versus host disease (GvHD). A chronic form of GvHD (cGvHD) afflicts many allogeneic HCT recipients, which results in dysfunction of numerous organ systems or even a profound state of immunodeficiency. Chronic GVHD is the most frequent cause of poor long-term outcome and quality of life after allogeneic HCT. The syndrome typically develops several months after transplantation, when the patient may no longer be under the direct care of the transplant team.
Approximately 50% of patients with cGvHD have limited disease and a good prognosis. Of the patients with extensive disease, approximately 60% will respond to treatment and eventually be able to discontinue immunosuppressive therapy. The remaining patients will develop opportunistic infection, or require prolonged treatment with immunosuppressive agents.
Chronic GvHD occurs in at least 30% to 50% of recipients of transplants from human leukocyte antigen matched siblings and at least 60% to 70% of recipients of transplants from unrelated donors. Risk factors include older age of patient or donor, higher degree of histoincompatibility, unrelated versus related donor, use of hematopoietic cells obtained from the blood rather than the marrow, and previous acute GvHD. Bhushan and Collins estimated that the incidence of severe cGvHD has probably increased in recent years because of the use of more unrelated transplants, donor leukocyte infusions, nonmyeloablative transplants and stem cells obtained from the blood rather than the marrow. The syndrome typically occurs 4 to 7 months after transplantation but may begin as early as 2 months or as late as 2 or more years after transplantation. Chronic GvHD may occur by itself, evolve from acute GvHD, or occur after resolution of acute GvHD.
The onset of the syndrome may be abrupt but is frequently insidious with manifestations evolving gradually for several weeks. The extent of involvement varies significantly from mild involvement limited to a few patches of skin to severe involvement of numerous organ systems and profound immunodeficiency. The most commonly involved tissues are the skin, liver, mouth, and eyes. Patients with limited disease have localized skin involvement, evidence of liver dysfunction, or both, whereas those with more involvement of the skin or involvement of other organs have extensive disease.
Treatment
 
Cutaneous T Cell Lymphoma
The optimal management of MF is undetermined because of its low prevalence, and its highly variable natural history, with frequent spontaneous remissions and exacerbations and often prolonged survival.
Nonaggressive approaches to therapy are usually warranted with treatment aimed at improving symptoms and physical appearance while limiting toxicity. Given that multiple skin sites are usually involved, the initial treatment choices are usually topical or intralesional corticosteroids or phototherapy using psoralen (a compound found in plants which make the skin temporarily sensitive to ultraviolet A) (PUVA). PUVA is not curative and its influence on disease progression remains uncertain. Repeated courses are usually required which may lead to an increased risk of both melanoma and nonmelanoma skin cancer. For thicker plaques, particularly if localized, radiotherapy with superficial electrons is an option.
“Second line” therapy for early stage disease is often topical chemotherapy, radiotherapy or total skin electron beam radiation (TSEB).
Treatment of advanced stage (IIB-IV) MF usually consists of topical or systemic therapy in refractory or rapidly progressive SS.
Bone marrow transplantation and peripheral blood stem cell transplantation have been used to treat many malignant hematologic disorders (e.g., leukemias) that are refractory to conventional treatment. Reports on the use of these procedures for the treatment of CTCL are limited and mostly consist of case reports or small case series.
Chronic Graft Versus Host Disease
Patients who develop cGvHD require reinstitution of immunosuppressive medication (if already discontinued) or an increase in dosage and possibly addition of other agents. The current literature regarding cGvHD therapy is less than optimal and many recommendations about therapy are based on common practices that await definitive testing. Patients with disease that is extensive by definition but is indolent in clinical appearance may respond to prednisone. However, patients with more aggressive disease are treated with higher doses of corticosteroids and/or cyclosporine.
Numerous salvage therapies have been considered in patients with refractory cGvHD, including ECP. Due to uncertainty around salvage therapies, Bhushan and Collins suggested that ideally, patients with refractory cGvHD should be entered into clinical trials.
Two Ontario expert consultants jointly estimated that there may be approximately 30 new erythrodermic treatment resistant CTCL patients and 30 new treatment resistant cGvHD patients per year who are unresponsive to other forms of therapy and may be candidates for ECP.
Extracorporeal photopheresis is a procedure that was initially developed as a treatment for CTCL, particularly SS.
Current Technique
Extracorporeal photopheresis is an immunomodulatory technique based on pheresis of light sensitive cells. Whole blood is removed from patients followed by pheresis. Lymphocytes are separated by centrifugation to create a concentrated layer of white blood cells. The lymphocyte layer is treated with methoxsalen (a drug that sensitizes the lymphocytes to light) and exposed to UVA, following which the lymphocytes are returned to the patient. Red blood cells and plasma are returned to the patient between each cycle.
Photosensitization is achieved by administering methoxsalen to the patient orally 2 hours before the procedure, or by injecting methoxsalen directly ino the leucocyte rich fraction. The latter approach avoids potential side effects such as nausea, and provides a more consistent drug level within the machine.
In general, from the time the intravenous line is inserted until the white blood cells are returned to the patient takes approximately 2.5-3.5 hours.
For CTCL, the treatment schedule is generally 2 consecutive days every 4 weeks for a median of 6 months. For cGvHD, an expert in the field estimated that the treatment schedule would be 3 times a week for the 1st month, then 2 consecutive days every 2 weeks after that (i.e., 4 treatments a month) for a median of 6 to 9 months.
Regulatory Status
The UVAR XTS Photopheresis System is licensed by Health Canada as a Class 3 medical device (license # 7703) for the “palliative treatment of skin manifestations of CTCL.” It is not licensed for the treatment of cGvHD.
UVADEX (sterile solution methoxsalen) is not licensed by Health Canada, but can be used in Canada via the Special Access Program. (Personal communication, Therakos, February 16, 2006)
According to the manufacturer, the UVAR XTS photopheresis system licensed by Health Canada can also be used with oral methoxsalen. (Personal communication, Therakos, February 16, 2006) However, oral methoxsalen is associated with side effects, must be taken by the patient in advance of ECP, and has variable absorption in the gastrointestinal tract.
According to Health Canada, UVADEX is not approved for use in Canada. In addition, a review of the Product Monographs of the methoxsalen products that have been approved in Canada showed that none of them have been approved for oral administration in combination with the UVAR XTS photophoresis system for “the palliative treatment of the skin manifestations of cutaneous T-cell Lymphoma”.
In the United States, the UVAR XTS Photopheresis System is approved by the Food and Drug Administration (FDA) for “use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug methoxsalen of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestations of CTCL in persons who have not been responsive to other therapy.”
UVADEX is approved by the FDA for use in conjunction with UVR XTS photopheresis system for “use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug methoxsalen of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestations of CTCL in persons who have not been responsive to other therapy.”
The use of the UVAR XTS photopheresis system or UVADEX for cGvHD is an off-label use of a FDA approved device/drug.
Summary of Findings
The quality of the trials was examined.
As stated by the GRADE Working Group, the following definitions were used in grading the quality of the evidence.
Cutaneous T Cell Lymphoma
Overall, there is low-quality evidence that ECP improves response rates and survival in patients with refractory erythrodermic CTCL (Table 1).
Limitations in the literature related to ECP for the treatment of refractory erythrodermic CTCL include the following:
Different treatment regimens.
Variety of forms of CTCL (and not necessarily treatment resistant) - MF, erythrodermic MF, SS.
SS with peripheral blood involvement → role of T cell clonality reporting?
Case series (1 small crossover RCT with several limitations)
Small sample sizes.
Retrospective.
Response criteria not clearly defined/consistent.
Unclear how concomitant therapy contributed to responses.
Variation in definitions of concomitant therapy
Comparison to historical controls.
Some patients were excluded from analysis because of progression of disease, toxicity and other reasons.
Unclear/strange statistics
Quality of life not reported as an outcome of interest.
The reported CR range is ~ 16% to 23% and the overall reported CR/PR range is ~ 33% to 80%.
The wide range in reported responses to ECP appears to be due to the variability of the patients treated and the way in which the data were presented and analyzed.
Many patients, in mostly retrospective case series, were concurrently on other therapies and were not assessed for comparability of diagnosis or disease stage (MF versus SS; erythrodermic versus not erythrodermic). Blood involvement in patients receiving ECP (e.g., T cell clonality) was not consistently reported, especially in earlier studies. The definitions of partial and complete response also are not standardized or consistent between studies.
Quality of life was reported in one study; however, the scale was developed by the authors and is not a standard validated scale.
Adverse events associated with ECP appear to be uncommon and most involve catheter related infections and hypotension caused by volume depletion.
GRADE Quality of Studies – Extracorporeal Photopheresis for Refractory Erythrodermic Cutaneous T-Cell Lymphoma
Chronic Graft-Versus-Host Disease
Overall, there is low-quality evidence that ECP improves response rates and survival in patients with refractory cGvHD (Table 2).
Patients in the studies had stem cell transplants due to a variety of hematological disorders (e.g., leukemias, aplastic anemia, thalassemia major, Hodgkin’s lymphoma, non Hodgkin’s lymphoma).
In 2001, The Blue Cross Blue Shield Technology Evaluation Centre concluded that ECP meets the TEC criteria as treatment of cGvHD that is refractory to established therapy.
The Catalan health technology assessment (also published in 2001) concluded that ECP is a new but experimental therapeutic alternative for the treatment of the erythrodermal phase of CTCL and cGvHD in allogenic HPTC and that this therapy should be evaluated in the framework of a RCT.
Quality of life (Lansky/Karnofsky play performance score) was reported in 1 study.
The patients in the studies were all refractory to steroids and other immunosuppressive agents, and these drugs were frequently continued concomitantly with ECP.
Criteria for assessment of organ improvement in cGvHD are variable, but PR was typically defined as >50% improvement from baseline parameters and CR as complete resolution of organ involvement.
Followup was variable and incomplete among the studies.
GRADE Quality of Studies – ECP for Refractory cGvHD
Conclusion
As per the GRADE Working Group, overall recommendations consider 4 main factors.
The tradeoffs, taking into account the estimated size of the effect for the main outcome, the confidence limits around those estimates and the relative value placed on the outcome.
The quality of the evidence (Tables 1 and 2).
Translation of the evidence into practice in a specific setting, taking into consideration important factors that could be expected to modify the size of the expected effects such as proximity to a hospital or availability of necessary expertise.
Uncertainty about the baseline risk for the population of interest.
The GRADE Working Group also recommends that incremental costs of healthcare alternatives should be considered explicitly alongside the expected health benefits and harms. Recommendations rely on judgments about the value of the incremental health benefits in relation to the incremental costs. The last column in Table 3 is the overall trade-off between benefits and harms and incorporates any risk/uncertainty.
For refractory erythrodermic CTCL, the overall GRADE and strength of the recommendation is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality and directness), and the corresponding risk/uncertainty is increased due to an annual budget impact of approximately $1.5M Cdn (based on 30 patients) while the cost-effectiveness of ECP is unknown and difficult to estimate considering that there are no high quality studies of effectiveness. The device is licensed by Health Canada, but the sterile solution of methoxsalen is not licensed.
With an annual budget impact of $1.5 M Cdn (based on 30 patients), and the current expenditure is $1.3M Cdn (for out of country for 7 patients), the potential cost savings based on 30 patients with refractory erythrodermic CTCL is about $3.8 M Cdn (annual).
For refractory cGvHD, the overall GRADE and strength of the recommendation is “weak” – the quality of the evidence is “low” (uncertainties due to methodological limitations in the study design in terms of study quality and directness), and the corresponding risk/uncertainty is increased due to a budget impact of approximately $1.5M Cdn while the cost-effectiveness of ECP is unknown and difficult to estimate considering that there are no high quality studies of effectiveness. Both the device and sterile solution are not licensed by Health Canada for the treatment of cGvHD.
If all the ECP procedures for patients with refractory erythrodermic CTCL and refractory cGvHD were performed in Ontario, the annual budget impact would be approximately $3M Cdn.
Overall GRADE and Strength of Recommendation (Including Uncertainty)
PMCID: PMC3379535  PMID: 23074497
23.  The Effectiveness of Mobile-Health Technologies to Improve Health Care Service Delivery Processes: A Systematic Review and Meta-Analysis 
PLoS Medicine  2013;10(1):e1001363.
Caroline Free and colleagues systematically review controlled trials of mobile technology interventions to improve health care delivery processes and show that current interventions give only modest benefits and that high-quality trials measuring clinical outcomes are needed.
Background
Mobile health interventions could have beneficial effects on health care delivery processes. We aimed to conduct a systematic review of controlled trials of mobile technology interventions to improve health care delivery processes.
Methods and Findings
We searched for all controlled trials of mobile technology based health interventions using MEDLINE, EMBASE, PsycINFO, Global Health, Web of Science, Cochrane Library, UK NHS HTA (Jan 1990–Sept 2010). Two authors independently extracted data on allocation concealment, allocation sequence, blinding, completeness of follow-up, and measures of effect. We calculated effect estimates and we used random effects meta-analysis to give pooled estimates.
We identified 42 trials. None of the trials had low risk of bias. Seven trials of health care provider support reported 25 outcomes regarding appropriate disease management, of which 11 showed statistically significant benefits. One trial reported a statistically significant improvement in nurse/surgeon communication using mobile phones. Two trials reported statistically significant reductions in correct diagnoses using mobile technology photos compared to gold standard. The pooled effect on appointment attendance using text message (short message service or SMS) reminders versus no reminder was increased, with a relative risk (RR) of 1.06 (95% CI 1.05–1.07, I2 = 6%). The pooled effects on the number of cancelled appointments was not significantly increased RR 1.08 (95% CI 0.89–1.30). There was no difference in attendance using SMS reminders versus other reminders (RR 0.98, 95% CI 0.94–1.02, respectively). To address the limitation of the older search, we also reviewed more recent literature.
Conclusions
The results for health care provider support interventions on diagnosis and management outcomes are generally consistent with modest benefits. Trials using mobile technology-based photos reported reductions in correct diagnoses when compared to the gold standard. SMS appointment reminders have modest benefits and may be appropriate for implementation. High quality trials measuring clinical outcomes are needed.
Please see later in the article for the Editors' Summary
Editors’ Summary
Background
Over the past few decades, computing and communication technologies have changed dramatically. Bulky, slow computers have been replaced by portable devices that can complete increasingly complex tasks in less and less time. Similarly, landlines have been replaced by mobile phones and other mobile communication technologies that can connect people anytime and anywhere, and that can transmit text messages (short message service; SMS), photographs, and data at the touch of a button. These advances have led to the development of mobile-health (mHealth)—the use of mobile computing and communication technologies in health care and public health. mHealth has many applications. It can be used to facilitate data collection and to encourage health-care consumers to adopt healthy lifestyles or to self-manage chronic conditions. It can also be used to improve health-care service delivery processes by targeting health-care providers or communication between these providers and their patients. So, for example, mobile technologies can be used to provide clinical management support in settings where there are no specialist clinicians, and they can be used to send patients test results and timely reminders of appointments.
Why Was This Study Done?
Many experts believe that mHealth interventions could greatly improve health-care delivery processes, particularly in resource-poor settings. The results of several controlled trials (studies that compare the outcomes of people who do or do not receive an intervention) of mHealth interventions designed to improve health-care delivery processes have been published. However, these data have not been comprehensively reviewed, and the effectiveness of this type of mHealth intervention has not been quantified. Here, the researchers rectify this situation by undertaking a systematic review and meta-analysis of controlled trials of mobile technology-based interventions designed to improve health-care service delivery processes. A systematic review is a study that uses predefined criteria to identify all the research on a given topic; a meta-analysis is a statistical approach that is used to pool the results of several independent studies.
What Did the Researchers Do and Find?
The researchers identified 42 controlled trials that investigated mobile technology-based interventions designed to improve health-care service delivery processes. None of the trials were of high quality—many had methodological problems likely to affect the accuracy of their findings—and nearly all were undertaken in high-income countries. Thirty-two of the trials tested interventions directed at health-care providers. Of these trials, seven investigated interventions providing health-care provider education, 18 investigated interventions supporting clinical diagnosis and treatment, and seven investigated interventions to facilitate communication between health-care providers. Several of the trials reported that the tested intervention led to statistically significant improvements (improvements unlikely to have happened by chance) in outcomes related to disease management. However, two trials that used mobile phones to transmit photos to off-site clinicians for diagnosis reported significant reductions in correct diagnoses compared to diagnosis by an on-site specialist. Ten of the 42 trials investigated interventions targeting communication between health-care providers and patients. Eight of these trials investigated SMS-based appointment reminders. Meta-analyses of the results of these trials indicated that using SMS appointment reminders significantly but modestly increased patient attendance compared to no reminders. However, SMS reminders were no more effective than postal or phone call reminders, and texting reminders to patients who persistently missed appointments did not significantly change the number of cancelled appointments.
What Do These Findings Mean?
These findings indicate that some mHealth interventions designed to improve health-care service delivery processes are modestly effective, but they also highlight the need for more trials of these interventions. Specifically, these findings show that although some interventions designed to provide support for health-care providers modestly improved some aspects of clinical diagnosis and management, other interventions had deleterious effects—most notably, the use of mobile technology–based photos for diagnosis. In terms of mHealth interventions targeting communication between health-care providers and patients, the finding that SMS appointment reminders have modest benefits suggests that implementation of this intervention should be considered, at least in high-income settings. However, the researchers stress that more trials are needed to robustly establish the ability of mobile technology-based interventions to improve health-care delivery processes. These trials need to be of high quality, they should be undertaken in resource-limited settings as well as in high-income countries, and, ideally, they should consider interventions that combine mHealth and conventional approaches.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001363.
A related PLOS Medicine Research Article by Free et al. investigates the effectiveness of mHealth technology-based health behavior change and disease management interventions for health-care consumers
Wikipedia has a page on mHealth (note: Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
mHealth: New horizons for health through mobile technologies is a global survey of mHealth prepared by the World Health Organization’s Global Observatory for eHealth (eHealth is health-care practice supported by electronic processes and communication)
The mHealth in Low-Resource Settings website, which is maintained by the Netherlands Royal Tropical Institute, provides information on the current use, potential, and limitations of mHealth in low-resource settings
The US National Institutes of Health Fogarty International Center provides links to resources and information about mHealth
doi:10.1371/journal.pmed.1001363
PMCID: PMC3566926  PMID: 23458994
24.  Cancer Screening with Digital Mammography for Women at Average Risk for Breast Cancer, Magnetic Resonance Imaging (MRI) for Women at High Risk 
Executive Summary
Objective
The purpose of this review is to determine the effectiveness of 2 separate modalities, digital mammography (DM) and magnetic resonance imaging (MRI), relative to film mammography (FM), in the screening of women asymptomatic for breast cancer. A third analysis assesses the effectiveness and safety of the combination of MRI plus mammography (MRI plus FM) in screening of women at high risk. An economic analysis was also conducted.
Research Questions
How does the sensitivity and specificity of DM compare to FM?
How does the sensitivity and specificity of MRI compare to FM?
How do the recall rates compare among these screening modalities, and what effect might this have on radiation exposure? What are the risks associated with radiation exposure?
How does the sensitivity and specificity of the combination of MRI plus FM compare to either MRI or FM alone?
What are the economic considerations?
Clinical Need
The effectiveness of FM with respect to breast cancer mortality in the screening of asymptomatic average- risk women over the age of 50 has been established. However, based on a Medical Advisory Secretariat review completed in March 2006, screening is not recommended for women between the ages of 40 and 49 years. Guidelines published by the Canadian Task Force on Preventive Care recommend mammography screening every 1 to 2 years for women aged 50 years and over, hence, the inclusion of such women in organized breast cancer screening programs. In addition to the uncertainty of the effectiveness of mammography screening from the age of 40 years, there is concern over the risks associated with mammographic screening for the 10 years between the ages of 40 and 49 years.
The lack of effectiveness of mammography screening starting at the age of 40 years (with respect to breast cancer mortality) is based on the assumption that the ability to detect cancer decreases with increased breast tissue density. As breast density is highest in the premenopausal years (approximately 23% of postmenopausal and 53% of premenopausal women having at least 50% of the breast occupied by high density), mammography screening is not promoted in Canada nor in many other countries for women under the age of 50 at average risk for breast cancer. It is important to note, however, that screening of premenopausal women (i.e., younger than 50 years of age) at high risk for breast cancer by virtue of a family history of cancer or a known genetic predisposition (e.g., having tested positive for the breast cancer genes BRCA1 and/or BRCA2) is appropriate. Thus, this review will assess the effectiveness of breast cancer screening with modalities other than film mammography, specifically DM and MRI, for both pre/perimenopausal and postmenopausal age groups.
International estimates of the epidemiology of breast cancer show that the incidence of breast cancer is increasing for all ages combined whereas mortality is decreasing, though at a slower rate. The observed decreases in mortality rates may be attributable to screening, in addition to advances in breast cancer therapy over time. Decreases in mortality attributable to screening may be a result of the earlier detection and treatment of invasive cancers, in addition to the increased detection of ductal carcinoma in situ (DCIS), of which certain subpathologies are less lethal. Evidence from the Surveillance, Epidemiology and End Results (better known as SEER) cancer registry in the United States, indicates that the age-adjusted incidence of DCIS has increased almost 10-fold over a 20 year period, from 2.7 to 25 per 100,000.
There is a 4-fold lower incidence of breast cancer in the 40 to 49 year age group than in the 50 to 69 year age group (approximately 140 per 100,000 versus 500 per 100,000 women, respectively). The sensitivity of FM is also lower among younger women (approximately 75%) than for women aged over 50 years (approximately 85%). Specificity is approximately 80% for younger women versus 90% for women over 50 years. The increased density of breast tissue in younger women is likely responsible for the decreased accuracy of FM.
Treatment options for breast cancer vary with the stage of disease (based on tumor size, involvement of surrounding tissue, and number of affected axillary lymph nodes) and its pathology, and may include a combination of surgery, chemotherapy and/or radiotherapy. Surgery is the first-line intervention for biopsy-confirmed tumors. The subsequent use of radiation, chemotherapy or hormonal treatments is dependent on the histopathologic characteristics of the tumor and the type of surgery. There is controversy regarding the optimal treatment of DCIS, which is considered a noninvasive tumour.
Women at high risk for breast cancer are defined as genetic carriers of the more commonly known breast cancer genes (BRCA1, BRCA2 TP53), first degree relatives of carriers, women with varying degrees of high risk family histories, and/or women with greater than 20% lifetime risk for breast cancer based on existing risk models. Genetic carriers for this disease, primarily women with BRCA1 or BRCA2 mutations, have a lifetime probability of approximately 85% of developing breast cancer. Preventive options for these women include surgical interventions such as prophylactic mastectomy and/or oophorectomy, i.e., removal of the breasts and/or ovaries. Therefore, it is important to evaluate the benefits and risks of different screening modalities, to identify additional options for these women.
This Medical Advisory Secretariat review is the second of 2 parts on breast cancer screening, and concentrates on the evaluation of both DM and MRI relative to FM, the standard of care. Part I of this review (March 2006) addressed the effectiveness of screening mammography in 40 to 49 year old average-risk women. The overall objective of the present review is to determine the optimal screening modality based on the evidence.
Evidence Review Strategy
The Medical Advisory Secretariat followed its standard procedures and searched the following electronic databases: Ovid MEDLINE, EMBASE, Ovid MEDLINE In-Process & Other Non-Indexed Citations, Cochrane Central Register of Controlled Trials, Cochrane Database of Systematic Reviews and The International Network of Agencies for Health Technology Assessment database. The subject headings and keywords searched included breast cancer, breast neoplasms, mass screening, digital mammography, magnetic resonance imaging. The detailed search strategies can be viewed in Appendix 1.
Included in this review are articles specific to screening and do not include evidence on diagnostic mammography. The search was further restricted to English-language articles published between January 1996 and April 2006. Excluded were case reports, comments, editorials, nonsystematic reviews, and letters.
Digital Mammography: In total, 224 articles specific to DM screening were identified. These were examined against the inclusion/exclusion criteria described below, resulting in the selection and review of 5 health technology assessments (HTAs) (plus 1 update) and 4 articles specific to screening with DM.
Magnetic Resonance Imaging: In total, 193 articles specific to MRI were identified. These were examined against the inclusion/exclusion criteria described below, resulting in the selection and review of 2 HTAs and 7 articles specific to screening with MRI.
The evaluation of the addition of FM to MRI in the screening of women at high risk for breast cancer was also conducted within the context of standard search procedures of the Medical Advisory Secretariat. as outlined above. The subject headings and keywords searched included the concepts of breast cancer, magnetic resonance imaging, mass screening, and high risk/predisposition to breast cancer. The search was further restricted to English-language articles published between September 2007 and January 15, 2010. Case reports, comments, editorials, nonsystematic reviews, and letters were not excluded.
MRI plus mammography: In total, 243 articles specific to MRI plus FM screening were identified. These were examined against the inclusion/exclusion criteria described below, resulting in the selection and review of 2 previous HTAs, and 1 systematic review of 11 paired design studies.
Inclusion Criteria
English-language articles, and English or French-language HTAs published from January 1996 to April 2006, inclusive.
Articles specific to screening of women with no personal history of breast cancer.
Studies in which DM or MRI were compared with FM, and where the specific outcomes of interest were reported.
Randomized controlled trials (RCTs) or paired studies only for assessment of DM.
Prospective, paired studies only for assessment of MRI.
Exclusion Criteria
Studies in which outcomes were not specific to those of interest in this report.
Studies in which women had been previously diagnosed with breast cancer.
Studies in which the intervention (DM or MRI) was not compared with FM.
Studies assessing DM with a sample size of less than 500.
Intervention
Digital mammography.
Magnetic resonance imaging.
Comparator
Screening with film mammography.
Outcomes of Interest
Breast cancer mortality (although no studies were found with such long follow-up).
Sensitivity.
Specificity.
Recall rates.
Summary of Findings
Digital Mammography
There is moderate quality evidence that DM is significantly more sensitive than FM in the screening of asymptomatic women aged less than 50 years, those who are premenopausal or perimenopausal, and those with heterogeneously or extremely dense breast tissue (regardless of age).
It is not known what effect these differences in sensitivity will have on the more important effectiveness outcome measure of breast cancer mortality, as there was no evidence of such an assessment.
Other factors have been set out to promote DM, for example, issues of recall rates and reading and examination times. Our analysis did not show that recall rates were necessarily improved in DM, though examination times were lower than for FM. Other factors including storage and retrieval of screens were not the subject of this analysis.
Magnetic Resonance Imaging
There is moderate quality evidence that the sensitivity of MRI is significantly higher than that of FM in the screening of women at high risk for breast cancer based on genetic or familial factors, regardless of age.
Radiation Risk Review
Cancer Care Ontario conducted a review of the evidence on radiation risk in screening with mammography women at high risk for breast cancer. From this review of recent literature and risk assessment that considered the potential impact of screening mammography in cohorts of women who start screening at an earlier age or who are at increased risk of developing breast cancer due to genetic susceptibility, the following conclusions can be drawn:
For women over 50 years of age, the benefits of mammography greatly outweigh the risk of radiation-induced breast cancer irrespective of the level of a woman’s inherent breast cancer risk.
Annual mammography for women aged 30 – 39 years who carry a breast cancer susceptibility gene or who have a strong family breast cancer history (defined as a first degree relative diagnosed in their thirties) has a favourable benefit:risk ratio. Mammography is estimated to detect 16 to 18 breast cancer cases for every one induced by radiation (Table 1). Initiation of screening at age 35 for this same group would increase the benefit:risk ratio to an even more favourable level of 34-50 cases detected for each one potentially induced.
Mammography for women under 30 years of age has an unfavourable benefit:risk ratio due to the challenges of detecting cancer in younger breasts, the aggressiveness of cancers at this age, the potential for radiation susceptibility at younger ages and a greater cumulative radiation exposure.
Mammography when used in combination with MRI for women who carry a strong breast cancer susceptibility (e.g., BRCA1/2 carriers), which if begun at age 35 and continued for 35 years, may confer greatly improved benefit:risk ratios which were estimated to be about 220 to one.
While there is considerable uncertainty in the risk of radiation-induced breast cancer, the risk expressed in published studies is almost certainly conservative as the radiation dose absorbed by women receiving mammography recently has been substantially reduced by newer technology.
A CCO update of the mammography radiation risk literature for 2008 and 2009 gave rise to one article by Barrington de Gonzales et al. published in 2009 (Barrington de Gonzales et al., 2009, JNCI, vol. 101: 205-209). This article focuses on estimating the risk of radiation-induced breast cancer for mammographic screening of young women at high risk for breast cancer (with BRCA gene mutations). Based on an assumption of a 15% to 25% or less reduction in mortality from mammography in these high risk women, the authors conclude that such a reduction is not substantially greater than the risk of radiation-induced breast cancer mortality when screening before the age of 34 years. That is, there would be no net benefit from annual mammographic screening of BRCA mutation carriers at ages 25-29 years; the net benefit would be zero or small if screening occurs in 30-34 year olds, and there would be some net benefit at age 35 years or older.
The Addition of Mammography to Magnetic Resonance Imaging
The effects of the addition of FM to MRI screening of high risk women was also assessed, with inclusion and exclusion criteria as follows:
Inclusion Criteria
English-language articles and English or French-language HTAs published from September 2007 to January 15, 2010.
Articles specific to screening of women at high risk for breast cancer, regardless of the definition of high risk.
Studies in which accuracy data for the combination of MRI plus FM are available to be compared to that of MRI and FM alone.
RCTs or prospective, paired studies only.
Studies in which women were previously diagnosed with breast cancer were also included.
Exclusion Criteria
Studies in which outcomes were not specific to those of interest in this report.
Studies in which there was insufficient data on the accuracy of MRI plus FM.
Intervention
Both MRI and FM.
Comparators
Screening with MRI alone and FM alone.
Outcomes of Interest
Sensitivity.
Specificity.
Summary of Findings
Magnetic Resonance Imaging Plus Mammography
Moderate GRADE Level Evidence that the sensitivity of MRI plus mammography is significantly higher than that of MRI or FM alone, although the specificity remains either unchanged or decreases in the screening of women at high risk for breast cancer based on genetic/familial factors, regardless of age.
These studies include women at high risk defined as BRCA1/2 or TP53 carriers, first degree relatives of carriers, women with varying degrees of high risk family histories, and/or >20% lifetime risk based on existing risk models. This definition of high risk accounts for approximately 2% of the female adult population in Ontario.
PMCID: PMC3377503  PMID: 23074406
25.  Robotic-Assisted Minimally Invasive Surgery for Gynecologic and Urologic Oncology 
Executive Summary
Objective
An application was received to review the evidence on the ‘The Da Vinci Surgical System’ for the treatment of gynecologic malignancies (e.g. endometrial and cervical cancers). Limitations to the current standard of care include the lack of trained physicians on minimally invasive surgery and limited access to minimally invasive surgery for patients. The potential benefits of ‘The Da Vinci Surgical System’ include improved technical manipulation and physician uptake leading to increased surgeries, and treatment and management of these cancers.
The demand for robotic surgery for the treatment and management of prostate cancer has been increasing due to its alleged benefits of recovery of erectile function and urinary continence, two important factors of men’s health. The potential technical benefits of robotic surgery leading to improved patient functional outcomes are surgical precision and vision.
Clinical Need
Uterine and cervical cancers represent 5.4% (4,400 of 81,700) and 1.6% (1,300 of 81,700), respectively, of incident cases of cancer among female cancers in Canada. Uterine cancer, otherwise referred to as endometrial cancer is cancer of the lining of the uterus. The most common treatment option for endometrial cancer is removing the cancer through surgery. A surgical option is the removal of the uterus and cervix through a small incision in the abdomen using a laparoscope which is referred to as total laparoscopic hysterectomy. Risk factors that increase the risk of endometrial cancer include taking estrogen replacement therapy after menopause, being obese, early age at menarche, late age at menopause, being nulliparous, having had high-dose radiation to the pelvis, and use of tamoxifen.
Cervical cancer occurs at the lower narrow end of the uterus. There are more treatment options for cervical cancer compared to endometrial cancer, however total laparoscopic hysterectomy is also a treatment option. Risk factors that increase the risk for cervical cancer are multiple sexual partners, early sexual activity, infection with the human papillomavirus, and cigarette smoking, whereas barrier-type of contraception as a risk factor decreases the risk of cervical cancer.
Prostate cancer is ranked first in men in Canada in terms of the number of new cases among all male cancers (25,500 of 89,300 or 28.6%). The impact on men who develop prostate cancer is substantial given the potential for erectile dysfunction and urinary incontinence. Prostate cancer arises within the prostate gland, which resides in the male reproductive system and near the bladder. Radical retropubic prostatectomy is the gold standard treatment for localized prostate cancer. Prostate cancer affects men above 60 years of age. Other risk factors include a family history of prostate cancer, being of African descent, being obese, consuming a diet high in fat, physical inactivity, and working with cadium.
The Da Vinci Surgical System
The Da Vinci Surgical System is a robotic device. There are four main components to the system: 1) the surgeon’s console, where the surgeon sits and views a magnified three-dimensional image of the surgical field; 2) patient side-cart, which sits beside the patient and consists of three instrument arms and one endoscope arm; 3) detachable instruments (endowrist instruments and intuitive masters), which simulate fine motor human movements. The hand movements of the surgeon’s hands at the surgeon’s console are translated into smaller ones by the robotic device and are acted out by the attached instruments; 4) three-dimensional vision system: the camera unit or endoscope arm. The main advantages of use of the robotic device are: 1) the precision of the instrument and improved dexterity due to the use of “wristed” instruments; 2) three-dimensional imaging, with improved ability to locate blood vessels, nerves and tissues; 3) the surgeon’s console, which reduces fatigue accompanied with conventional laparoscopy surgery and allows for tremor-free manipulation. The main disadvantages of use of the robotic device are the costs including instrument costs ($2.6 million in US dollars), cost per use ($200 per use), the costs associated with training surgeons and operating room personnel, and the lack of tactile feedback, with the trade-off being increased visual feedback.
Research Questions
For endometrial and cervical cancers,
1. What is the effectiveness of the Da Vinci Surgical System vs. laparoscopy and laparotomy for women undergoing any hysterectomy for the surgical treatment and management of their endometrial and cervical cancers?
2. What are the incremental costs of the Da Vinci Surgical System vs. laparoscopy and laparotomy for women undergoing any hysterectomy for the surgical treatment and management of their endometrial and cervical cancers?
For prostate cancer,
3. What is the effectiveness of robotically-assisted radical prostatectomy using the Da Vinci Surgical System vs. laparoscopic radical prostatectomy and retropubic radical prostatectomy for the surgical treatment and management of prostate cancer?
4. What are the incremental costs of robotically-assisted radical prostatectomy using the Da Vinci Surgical System vs. laparoscopic radical prostatectomy and retropubic radical prostatectomy for the surgical treatment and management of prostate cancer?
Research Methods
Literature Search
Search Strategy
A literature search was performed on May 12, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, OVID EMBASE, Wiley Cochrane, CINAHL, Centre for Reviews and Dissemination/International Agency for Health Technology Assessment for studies published from January 1, 2000 until May 12, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist, then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low or very low according to GRADE methodology.
Inclusion Criteria
English language articles (January 1, 2000-May 12, 2010)
Journal articles that report on the effectiveness or cost-effectiveness for the comparisons of interest using a primary data source (e.g. obtained in a clinical setting)
Journal articles that report on the effectiveness or cost-effectiveness for the comparisons of interest using a secondary data source (e.g. hospital- or population-based registries)
Study design and methods must be clearly described
Health technology assessments, systematic reviews, randomized controlled trials, non-randomized controlled trials and/or cohort studies, case-case studies, regardless of sample size, cost-effectiveness studies
Exclusion Criteria
Duplicate publications (with the more recent publication on the same study population included)
Non-English papers
Animal or in-vitro studies
Case reports or case series without a referent or comparison group
Studies on long-term survival which may be affected by treatment
Studies that do not examine the cancers (e.g. advanced disease) or outcomes of interest
Outcomes of Interest
For endometrial and cervical cancers,
Primary outcomes:
Morbidity factors
- Length of hospitalization
- Number of complications*
Peri-operative factors
- Operation time
- Amount of blood loss*
- Number of conversions to laparotomy*
Number of lymph nodes recovered
For prostate cancer,
Primary outcomes:
Morbidity factors
- Length of hospitalization
- Amount of morphine use/pain*
Peri-operative factors
- Operation time
- Amount of blood loss*
- Number of transfusions*
- Duration of catheterization
- Number of complications*
- Number of anastomotic strictures*
Number of lymph nodes recovered
Oncologic factors
- Proportion of positive surgical margins
Long-term outcomes
- Urinary continence
- Erectile function
Summary of Findings
Robotic use for gynecologic oncology compared to:
Laparotomy: benefits of robotic surgery in terms of shorter length of hospitalization and less blood loss. These results indicate clinical effectiveness in terms of reduced morbidity and safety, respectively, in the context of study design limitations.
The beneficial effect of robotic surgery was shown in pooled analysis for complications, owing to increased sample size.
More work is needed to clarify the role of complications in terms of safety, including improved study designs, analysis and measurement.
Laparoscopy: benefits of robotic surgery in terms of shorter length of hospitalization, less blood loss and fewer conversions to laparotomy likely owing to the technical difficulty of conventional laparoscopy, in the context of study design limitations.
Clinical significance of significant findings for length of hospitalizations and blood loss is low.
Fewer conversions to laparotomy indicate clinical effectiveness in terms of reduced morbidity.
Robotic use for urologic oncology, specifically prostate cancer, compared to:
Retropubic surgery: benefits of robotic surgery in terms of shorter length of hospitalization and less blood loss/fewer individuals requiring transfusions. These results indicate clinical effectiveness in terms of reduced morbidity and safety, respectively, in the context of study design limitations. There was a beneficial effect in terms of decreased positive surgical margins and erectile dysfunction. These results indicate clinical effectiveness in terms of improved cancer control and functional outcomes, respectively, in the context of study design limitations.
Surgeon skill had an impact on cancer control and functional outcomes.
The results for complications were inconsistent when measured as either total number of complications, pain management or anastomosis. There is some suggestion that robotic surgery is safe with respect to less post-operative pain management required compared to retropubic surgery, however improved study design and measurement of complications need to be further addressed.
Clinical significance of significant findings for length of hospitalizations is low.
Laparoscopy: benefits of robotic surgery in terms of less blood loss and fewer individuals requiring transfusions likely owing to the technical difficulty of conventional laparoscopy, in the context of study design limitations.
Clinical significance of significant findings for blood loss is low.
The potential link between less blood loss, improved visualization and improved functional outcomes is an important consideration for use of robotics.
All studies included were observational in nature and therefore the results must be interpreted cautiously.
Economic Analysis
The objective of this project was to assess the economic impact of robotic-assisted laparoscopy (RAL) for endometrial, cervical, and prostate cancers in the province of Ontario.
A budget impact analysis was undertaken to report direct costs associated with open surgery (OS), endoscopic laparoscopy (EL) and robotic-assisted laparoscopy (RAL) based on clinical literature review outcomes, to report a budget impact in the province based on volumes and costs from administrative data sets, and to project a future impact of RAL in Ontario. A cost-effectiveness analysis was not conducted because of the low quality evidence from the clinical literature review.
Hospital costs were obtained from the Ontario Case Costing Initiative (OCCI) for the appropriate Canadian Classification of Health Intervention (CCI) codes restricted to selective ICD-10 diagnostic codes after consultation with experts in the field. Physician fees were obtained from the Ontario Schedule of Benefits (OSB) after consultation with experts in the field. Fees were costed based on operation times reported in the clinical literature for the procedures being investigated. Volumes of procedures were obtained from the Ministry of Health and Long-Term Care (MOHLTC) administrative databases.
Direct costs associated with RAL, EL and OS included professional fees, hospital costs (including disposable instruments), radiotherapy costs associated with positive surgical margins in prostate cancer and conversion to OS in gynecological cancer. The total cost per case was higher for RAL than EL and OS for both gynecological and prostate cancers. There is also an acquisition cost associated with RAL. After conversation with the only supplier in Canada, hospitals are looking to spend an initial 3.6M to acquire the robotic surgical system
Previous volumes of OS and EL procedures were used to project volumes into Years 1-3 using a linear mathematical expression. Burden of OS and EL hysterectomies and prostatectomies was calculated by multiplying the number of cases for that year by the cost/case of the procedure.
The number of procedures is expected to increase in the next three years based on historical data. RAL is expected to capture this market by 65% after consultation with experts. If it’s assumed that RAL will capture the current market in Ontario by 65%, the net impact is expected to be by Year 3, 3.1M for hysterectomy and 6.7M for prostatectomy procedures respectively in the province.
RAL has diffused in the province with four surgical systems in place in Ontario, two in Toronto and two in London. RAL is a more expensive technology on a per case basis due to more expensive robot specific instrumentation and physician labour reflected by increased OR time reported in the clinical literature. There is also an upfront cost to acquire the machine and maintenance contract. RAL is expected to capture the market at 65% with project net impacts by Year 3 of 3.1M and 6.7M for hysterectomy and prostatectomy respectively.
PMCID: PMC3382308  PMID: 23074405

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