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1.  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
2.  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
3.  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
4.  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
5.  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
6.  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
7.  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
8.  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
9.  Hospital Performance, the Local Economy, and the Local Workforce: Findings from a US National Longitudinal Study 
PLoS Medicine  2010;7(6):e1000297.
Blustein and colleagues examine the associations between changes in hospital performance and their local economic resources. Locationally disadvantaged hospitals perform poorly on key indicators, raising concerns that pay-for-performance models may not reduce inequality.
Background
Pay-for-performance is an increasingly popular approach to improving health care quality, and the US government will soon implement pay-for-performance in hospitals nationwide. Yet hospital capacity to perform (and improve performance) likely depends on local resources. In this study, we quantify the association between hospital performance and local economic and human resources, and describe possible implications of pay-for-performance for socioeconomic equity.
Methods and Findings
We applied county-level measures of local economic and workforce resources to a national sample of US hospitals (n = 2,705), during the period 2004–2007. We analyzed performance for two common cardiac conditions (acute myocardial infarction [AMI] and heart failure [HF]), using process-of-care measures from the Hospital Quality Alliance [HQA], and isolated temporal trends and the contributions of individual resource dimensions on performance, using multivariable mixed models. Performance scores were translated into net scores for hospitals using the Performance Assessment Model, which has been suggested as a basis for reimbursement under Medicare's “Value-Based Purchasing” program. Our analyses showed that hospital performance is substantially associated with local economic and workforce resources. For example, for HF in 2004, hospitals located in counties with longstanding poverty had mean HQA composite scores of 73.0, compared with a mean of 84.1 for hospitals in counties without longstanding poverty (p<0.001). Hospitals located in counties in the lowest quartile with respect to college graduates in the workforce had mean HQA composite scores of 76.7, compared with a mean of 86.2 for hospitals in the highest quartile (p<0.001). Performance on AMI measures showed similar patterns. Performance improved generally over the study period. Nevertheless, by 2007—4 years after public reporting began—hospitals in locationally disadvantaged areas still lagged behind their locationally advantaged counterparts. This lag translated into substantially lower net scores under the Performance Assessment Model for hospital reimbursement.
Conclusions
Hospital performance on clinical process measures is associated with the quantity and quality of local economic and human resources. Medicare's hospital pay-for-performance program may exacerbate inequalities across regions, if implemented as currently proposed. Policymakers in the US and beyond may need to take into consideration the balance between greater efficiency through pay-for-performance and socioeconomic equity.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
These days, many people are rewarded for working hard and efficiently by being given bonuses when they reach preset performance targets. With a rapidly aging population and rising health care costs, policy makers in many developed countries are considering ways of maximizing value for money, including rewarding health care providers when they meet targets, under “pay-for-performance.” In the UK, for example, a major pay-for-performance initiative—the Quality and Outcomes Framework—began in 2004. All the country's general practices (primary health care facilities that deal with all medical ailments) now detail their achievements in terms of numerous clinical quality indicators for common chronic conditions (for example, the regularity of blood sugar checks for people with diabetes). They are then rewarded on the basis of these results.
Why Was This Study Done?
In the US, the government is poised to implement a nationwide pay-for-performance program in hospitals within Medicare, the government program that provides health insurance to Americans aged 65 years or older, as well as people with disabilities. However, some observers are concerned about the effect that the proposed pay-for-performance program might have on the distribution of health care resources in the US. Pay-for-performance assumes that health care providers have the economic and human resources that they need to perform or to improve their performance. But, if a hospital's capacity to perform depends on local resources, payment based on performance might worsen existing health care inequalities because hospitals in under-resourced areas might lose funds to hospitals in more affluent regions. In other words, the government might act as a reverse Robin Hood, taking from the poor and giving to the rich. In this study, the researchers examine the association between hospital performance and local economic and human resources, to explore whether this scenario is a plausible result of the pending change in US hospital reimbursement.
What Did the Researchers Do and Find?
US hospitals have voluntarily reported their performance on indicators of clinical care (“process-of-care measures”) for acute myocardial infarction (AMI, heart attack), heart failure (HF), and pneumonia under the Hospital Quality Alliance (HQA) program since 2004. The researchers identified 2,705 hospitals that had fully reported process-of-care measures for AMI and HF in both 2004 and 2007. They then used the “Performance Assessment Model” (a methodology developed by the US Centers for Medicare and Medicaid Services to score hospital performance) to calculate scores for each hospital. Finally, they looked for associations between these scores and measures of the hospital's local economic and human resources such as population poverty levels and the percentage of college graduates in the workforce. Hospital performance was associated with local and economic workforce capacity, they report. Thus, hospitals in counties with longstanding poverty had lower average performance scores for HF and AMI than hospitals in affluent counties. Similarly, hospitals in counties with a low percentage of college graduates in the workforce had lower average performance scores than hospitals in counties where more of the workforce had been to college. Finally, although performance improved generally over the study period, hospitals in disadvantaged areas still lagged behind hospitals in advantaged areas in 2007.
What Do These Findings Mean?
These findings indicate that hospital performance (as measured by the clinical process measures considered here) is associated with the quantity and quality of local human and economic resources. Thus, the proposed Medicare hospital pay-for-performance program may exacerbate existing US health care inequalities by leading to the transfer of funds from hospitals in disadvantaged locations to those in advantaged locations. Although further studies are needed to confirm this conclusion, these findings have important implications for pay-for-performance programs in health care. They suggest that US policy makers may need to modify how they measure performance improvement—the current Performance Assessment Model gives hospitals that start from a low baseline less credit for improvements than those that start from a high baseline. This works against hospitals in disadvantaged locations, which start at a low baseline. Second and more generally, they suggest that there may be a tension between the efficiency goals of pay-for-performance and other equity goals of health care systems. In a world where resources vary across regions, the expectation that regions can perform equally may not be realistic.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000297.
KaiserEDU.org is an online resource for learning about the US health care system. It includes educational modules on such topics as the Medicare program and efforts to improve the quality of care
The Hospital Quality Alliance provides information on the quality of care in US hospitals
Information about the UK National Health Service Quality and Outcomes Framework pay-for-performance initiative for general practice surgeries is available
doi:10.1371/journal.pmed.1000297
PMCID: PMC2893955  PMID: 20613863
10.  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
11.  Ethnic Disparities in Diabetes Management and Pay-for-Performance in the UK: The Wandsworth Prospective Diabetes Study 
PLoS Medicine  2007;4(6):e191.
Background
Pay-for-performance rewards health-care providers by paying them more if they succeed in meeting performance targets. A new contract for general practitioners in the United Kingdom represents the most radical shift towards pay-for-performance seen in any health-care system. The contract provides an important opportunity to address disparities in chronic disease management between ethnic and socioeconomic groups. We examined disparities in management of people with diabetes and intermediate clinical outcomes within a multiethnic population in primary care before and after the introduction of the new contract in April 2004.
Methods and Findings
We conducted a population-based longitudinal survey, using electronic general practice records, in an ethnically diverse part of southwest London. Outcome measures were prescribing levels and achievement of national treatment targets (HbA1c ≤ 7.0%; blood pressure [BP] < 140/80 mm Hg; total cholesterol ≤ 5 mmol/l or 193 mg/dl). The proportion of patients reaching treatment targets for HbA1c, BP, and total cholesterol increased significantly after the implementation of the new contract. The extents of these increases were broadly uniform across ethnic groups, with the exception of the black Caribbean patient group, which had a significantly lower improvement in HbA1c (adjusted odds ratio [AOR] 0.75, 95% confidence interval [CI] 0.57–0.97) and BP control (AOR 0.65, 95% CI 0.53–0.81) relative to the white British patient group. Variations in prescribing and achievement of treatment targets between ethnic groups present in 2003 were not attenuated in 2005.
Conclusions
Pay-for-performance incentives have not addressed disparities in the management and control of diabetes between ethnic groups. Quality improvement initiatives must place greater emphasis on minority communities to avoid continued disparities in mortality from cardiovascular disease and the other major complications of diabetes.
Based on a population-based longitudinal survey, Christopher Millett and colleagues concluded that pay-for-performance incentives for UK general practitioners had not addressed disparities in the management and control of diabetes between ethnic groups.
Editors' Summary
Background.
When used in health care, the term “pay-for-performance” means rewarding health-care providers by paying them more if they succeed in meeting performance targets set by the government and other commissioners of health care. It is an approach to health service management that is becoming common, particularly in the US and the UK. For example, the UK's general practitioners (family doctors) agreed with the government in 2004 that they would receive increases to their income that would depend on how well they were judged to be performing according to 146 quality indicators that cover clinical care for ten chronic diseases, as well as “organization of care,” and “patient experience.” One of the chronic diseases is diabetes, a condition that has reached epidemic proportions in the UK, as it has also in many other countries.
  Ethnic minorities often suffer more from health problems than the majority population of the country they live in. They are also likely to be served less well by the health services. Diabetes is a case in point; in many countries—including the US and UK—the condition is much more common in minority groups. In addition, their diabetes is usually less well “managed”—i.e., it becomes more severe more rapidly and there are more complications. In the UK, the government recognizes the need to ensure that its health policies are applied to all sectors of the population, including minority ethnic communities. Nevertheless, the advances that have been made in the management of diabetes have not benefited the UK's ethnic minorities to the same extent as they have the majority population. It is hoped that the use of pay-for-performance management by the UK National Health Service will lead to more efficient delivery of health care, and that one consequence will be that different communities will be more equally served.
Why Was This Study Done?
The researchers wanted to find out whether the introduction of pay-for-performance management in general medical practice in the UK was leading to a reduction in the gap in the quality of care provided to people with diabetes who belonged to ethnic minorities and other people with diabetes.
What Did the Researchers Do and Find?
The research was carried out in Wandsworth, an area of southwest London that is considered to be “ethnically diverse.” Over 4,200 people with diabetes are registered with general practitioners in this area. The researchers used the electronic records kept by these doctors and they focused on diabetes “treatment targets” set by the government, according to which the blood pressure and cholesterol levels of people with diabetes should be kept below defined levels. There is also a target level for glycated hemoglobin (HbA1c), which is a substance that can be used to measure the extent to which a patient's diabetes is under control. The researchers calculated the percentage of patients who were meeting these treatment targets. Overall, more patients met their treatment targets after the introduction of pay-for-performance management than were doing so before. All ethnic groups seemed to have benefited, but the black Caribbean group did not benefit as much as the other groups; the number of these patients who met the targets did improve, but the gap between them and patients with diabetes from other ethnic groups remained about the same.
What Do These Findings Mean?
The researchers concluded that, while the introduction of pay-for-performance did seem to have been beneficial, it had not addressed disparities in the management and control of diabetes between ethnic groups. They say that, in all initiatives to improve the quality of health care, special efforts must be made to reduce such gaps. The UK's use of pay-for-performance in general practice is regarded internationally as a very bold step, but, as other countries are also considering moving in this direction, the lessons from the study will be relevant in many other parts of the world.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040191.
Wikipedia has an entry on pay-for-performance in health care (note: Wikipedia is a free online encyclopedia that anyone can edit)
Information about how the NHS works in England
Diabetes UK is the largest organization in the UK working for people with diabetes and its website includes a useful Guide to Diabetes
The London Health Observatory is one of nine health observatories set up by the NHS to monitor health and health care in England. There is a page devoted to “ethnic health intelligence”
Introductory information about diabetes as a medical condition may be found on the MedlinePlus website; there are several MedlinePlus pages on diabetes as well
doi:10.1371/journal.pmed.0040191
PMCID: PMC1891316  PMID: 17564486
12.  Alternative Strategies to Reduce Maternal Mortality in India: A Cost-Effectiveness Analysis 
PLoS Medicine  2010;7(4):e1000264.
A cost-effectiveness study by Sue Goldie and colleagues finds that better family planning, provision of safe abortion, and improved intrapartum and emergency obstetrical care could reduce maternal mortality in India by 75% in 5 years.
Background
Approximately one-quarter of all pregnancy- and delivery-related maternal deaths worldwide occur in India. Taking into account the costs, feasibility, and operational complexity of alternative interventions, we estimate the clinical and population-level benefits associated with strategies to improve the safety of pregnancy and childbirth in India.
Methods and Findings
Country- and region-specific data were synthesized using a computer-based model that simulates the natural history of pregnancy (both planned and unintended) and pregnancy- and childbirth-associated complications in individual women; and considers delivery location, attendant, and facility level. Model outcomes included clinical events, population measures, costs, and cost-effectiveness ratios. Separate models were adapted to urban and rural India using survey-based data (e.g., unmet need for birth spacing/limiting, facility births, skilled birth attendants). Model validation compared projected maternal indicators with empiric data. Strategies consisted of improving coverage of effective interventions that could be provided individually or packaged as integrated services, could reduce the incidence of a complication or its case fatality rate, and could include improved logistics such as reliable transport to an appropriate referral facility as well as recognition of referral need and quality of care. Increasing family planning was the most effective individual intervention to reduce pregnancy-related mortality. If over the next 5 y the unmet need for spacing and limiting births was met, more than 150,000 maternal deaths would be prevented; more than US$1 billion saved; and at least one of every two abortion-related deaths averted. Still, reductions in maternal mortality reached a threshold (∼23%–35%) without including strategies that ensured reliable access to intrapartum and emergency obstetrical care (EmOC). An integrated and stepwise approach was identified that would ultimately prevent four of five maternal deaths; this approach coupled stepwise improvements in family planning and safe abortion with consecutively implemented strategies that incrementally increased skilled attendants, improved antenatal/postpartum care, shifted births away from home, and improved recognition of referral need, transport, and availability/quality of EmOC. The strategies in this approach ranged from being cost-saving to having incremental cost-effectiveness ratios less than US$500 per year of life saved (YLS), well below India's per capita gross domestic product (GDP), a common benchmark for cost-effectiveness.
Conclusions
Early intensive efforts to improve family planning and control of fertility choices and to provide safe abortion, accompanied by a paced systematic and stepwise effort to scale up capacity for integrated maternal health services over several years, is as cost-effective as childhood immunization or treatment of malaria, tuberculosis, or HIV. In just 5 y, more than 150,000 maternal deaths would be averted through increasing contraception rates to meet women's needs for spacing and limiting births; nearly US$1.5 billion would be saved by coupling safe abortion to aggressive family planning efforts; and with stepwise investments to improve access to pregnancy-related health services and to high-quality facility-based intrapartum care, more than 75% of maternal deaths could be prevented. If accomplished over the next decade, the lives of more than one million women would be saved.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, more than half a million women—most of them living in developing countries—die from pregnancy- or childbirth-related complications. About a quarter of these “maternal” deaths occur in India. In 2005, a woman's lifetime risk of maternal death in India was 1 in 70; in the UK, it was only one in 8,200. Similarly, the maternal mortality ratio (MMR; number of maternal deaths per 100,000 live births) in India was 450, whereas in the UK it was eight. Faced with the enormous maternal death toll in India and other developing countries, in September 2000, the United Nations pledged, as its fifth Millennium Development Goal (MDG 5), that the global MMR would be reduced to a quarter of its 1990 level by 2015. Currently, it seems unlikely that this target will be met. Between 1990 and 2005, global maternal deaths decreased by only 1% per annum instead of the 5% needed to reach MDG 5; in India, the decrease in maternal deaths between 1990 and 2005 was about 1.8% per annum.
Why Was This Study Done?
Most maternal deaths in developing countries are caused by severe bleeding after childbirth, infections soon after delivery, blood pressure disorders during pregnancy, and obstructed (difficult) labors. Consequently, experts agree that universal access to high-quality routine care during labor (“obstetric” care) and to emergency obstetrical care is needed to reduce maternal deaths. However, there is less agreement about how to adapt these “ideal recommendations” to specific situations. In developing countries with weak health systems and predominantly rural populations, it is unlikely that all women will have access to emergency obstetric care in the near future—so would beginning with improved access to family planning and to safe abortions (unsafe abortion is another major cause of maternal death) be a more achievable, more cost-effective way of reducing maternal deaths? How would family planning and safe abortion be coupled efficiently and cost-effectively with improved access to intrapartum care? In this study, the researchers investigate these questions by estimating the health and economic outcomes of various strategies to reduce maternal mortality in India.
What Did the Researchers Do and Find?
The researchers used a computer-based model that simulates women through pregnancy and childbirth to estimate the effect of different strategies (for example, increased family planning or increased access to obstetric care) on clinical outcomes (pregnancies, live births, or deaths), costs, and cost-effectiveness (the cost of saving one year of life) in India. Increased family planning was the most effective single intervention for the reduction of pregnancy-related mortality. If the current unmet need for family planning in India could be fulfilled over the next 5 years, more than 150,000 maternal deaths would be prevented, more than US$1 billion saved, and at least half of abortion-related deaths averted. However, increased family planning alone would reduce maternal deaths by 35% at most, so the researchers also used their model to test the effect of combinations of strategies on maternal death. They found that an integrated and stepwise approach (increased family planning and safe abortion combined with consecutively increased skilled birth attendants, improved care before and after birth, reduced home births, and improved emergency obstetric care) could eventually prevent nearly 80% of maternal deaths. All the steps in this strategy either saved money or involved an additional cost per year of life saved of less than US$500; given one suggested threshold for cost-effectiveness in India of the per capita GDP (US$1,068) per year of life saved, these strategies would be considered very cost-effective.
What Do These Findings Mean?
The accuracy of these findings depends on the assumptions used to build the model and the quality of the data fed into it. Nevertheless, these findings suggest that early intensive efforts to improve family planning and to provide safe abortion accompanied by a systematic, stepwise effort to improve integrated maternal health services could reduce maternal deaths in India by more than 75% in less than a decade. Furthermore, such a strategy would be cost-effective. Indeed, note the researchers, the cost savings from an initial focus on family planning and safe abortion provision would partly offset the resources needed to assure that every woman had access to high quality routine and emergency obstetric care. Thus, overall, these findings suggest that MDG 5 may be within reach in India, a conclusion that should help to mobilize political support for this worthy goal.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000264.
UNICEF (the United Nations Children's Fund) provides information on maternal mortality, including the WHO/UNICEF/UNFPA/The World Bank 2005 country estimates of maternal mortality
The World Health Organization also provides information on maternal health and about MDG 5 (in several languages)
The United Nations Millennium Development Goals Web site provides detailed information about the Millennium Declaration, the MDGs, their targets and their indicators, and about MDG 5.
The Millennium Development Goals Report 2009 and its progress chart provide an up-to-date assessment of progress toward all the MDGs
Computer simulation modeling as applied to health is further discussed at the Center for Health Decision Science at Harvard University
doi:10.1371/journal.pmed.1000264
PMCID: PMC2857650  PMID: 20421922
13.  Changing Patterns in Place of Cancer Death in England: A Population-Based Study 
PLoS Medicine  2013;10(3):e1001410.
Wei Gao and colleagues describe how location of death has changed for patients with cancer in England between 1993 and 2010.
Background
Most patients with cancer prefer to die at home or in a hospice, but hospitals remain the most common place of death (PoD).This study aims to explore the changing time trends of PoD and the associated factors, which are essential for end-of-life care improvement.
Methods and Findings
The study analysed all cancer deaths in England collected by the Office for National Statistics during 1993–2010 (n = 2,281,223). Time trends of age- and gender-standardised proportion of deaths in individual PoDs were evaluated using weighted piecewise linear regression. Variables associated with PoD (home or hospice versus hospital) were determined using proportion ratio (PR) derived from the log-binomial regression, adjusting for clustering effects. Hospital remained the most common PoD throughout the study period (48.0%; 95% CI 47.9%–48.0%), followed by home (24.5%; 95% CI 24.4%–24.5%), and hospice (16.4%; 95% CI 16.3%–16.4%). Home and hospice deaths increased since 2005 (0.87%; 95% CI 0.74%–0.99%/year, 0.24%; 95% CI 0.17%–0.32%/year, respectively, p<0.001), while hospital deaths declined (−1.20%; 95% CI −1.41 to −0.99/year, p<0.001). Patients who died from haematological cancer (PRs 0.46–0.52), who were single, widowed, or divorced (PRs 0.75–0.88), and aged over 75 (PRs 0.81–0.84 for 75–84; 0.66–0.72 for 85+) were less likely to die in home or hospice (p<0.001; reference groups: colorectal cancer, married, age 25–54). There was little improvement in patients with lung cancer of dying in home or hospice (PRs 0.87–0.88). Marital status became the second most important factor associated with PoD, after cancer type. Patients from less deprived areas (higher quintile of the deprivation index) were more likely to die at home or in a hospice than those from more deprived areas (lower quintile of the deprivation index; PRs 1.02–1.12). The analysis is limited by a lack of data on individual patients' preferences for PoD or a clinical indication of the most appropriate PoD.
Conclusions
More efforts are needed to reduce hospital deaths. Health care facilities should be improved and enhanced to support the increased home and hospice deaths. People who are single, widowed, or divorced should be a focus for end-of-life care improvement, along with known at risk groups such as haematological cancer, lung cancer, older age, and deprivation.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Death is the only certain event in our lives. Consequently, end-of-life care is an issue that is relevant to everyone, and everyone hopes for a “good death” (a death that is free from avoidable distress and suffering) for themselves and for their loved ones. Many factors contribute to a good death, including the place of death. When asked, most people say they would rather die at home or in a hospice (a care facility that gives supportive care to people in the final phase of a terminal illness and that focuses on comfort and quality of life rather than on cure) than in a hospital. Importantly, patients who die at home or in a hospice often have a better quality of life than those who die in hospital, and caring for terminally ill patients in the community is less expensive than caring for them in hospital.
Why Was This Study Done?
Many countries have introduced end-of-life care policies that are designed to enable more people to die at home or in hospices. England, for example, implemented its National End of Life Care Programme in 2004. However, to improve end-of-life care services and to enable more people to die in their preferred place, we need to understand how the patterns of place of death and the factors that affect the place of death are changing over time. In this population-based study, the researchers examine the changing pattern of place of death of people with cancer and the factors associated with place of death in England between 1993 and 2010. Cancer is a leading cause of death globally and is responsible for 8 million deaths annually. Deaths from cancer still occur most commonly in hospitals, which are the least preferred place of death for people with cancer; home and hospices are the first and second preferred places of death, respectively, for such people.
What Did the Researchers Do and Find?
The researchers used death registration data collected by the Office of National Statistics to identify all the adult cancer deaths in England between 1993 and 2010 (2.28 million deaths) and to determine where these deaths occurred, time trends in place of death, and the factors associated with place of death. Hospital was the commonest place of death throughout the study period—48% of cancer deaths occurred in hospital, 24.5% at home, and 16.4% in hospices. The proportion of home deaths increased after 2005 whereas the proportion of hospital deaths declined. The proportion of deaths in hospices also increased over the study period. The most important factor associated with place of death was cancer site. For example, patients who died from a blood (hematological) cancer were more likely to die in hospital than patients with colorectal cancer throughout the study period although the proportion dying at home or in a hospice increased over time. Being single, widowed, or divorced was associated with a higher likelihood of dying in hospital than being married. Being over 75 was associated with a higher likelihood of dying in hospital than being 25–54 although elderly people were more likely to die at home or in a hospice after 2006 than in earlier periods.
What Do These Findings Mean?
These findings show that the hospital is still the commonest place of death for patients with cancer in England. However, the increase in home and hospice deaths since 2005 suggests that the National End of Life Care Programme has enabled more people to die at their preferred place of death. These findings identify cancer site, marital status, and age as the three most important factors associated with place of death for patients with cancer. Because the study is a large-scale, population-based study, these findings are likely to be generalizable to other high-income settings. However, because the study did not include data on individual patient preferences for place of death, these findings should be applied with care to individual patients. Importantly, these findings indicate that more needs to be done to support people with cancer (and other terminal illnesses) who wish to die at home or in a hospice. Moreover, they identify groups of people—single, widowed or divorced individuals, older people, and people with specific types of cancer—who need extra help to ensure that they are able to choose where they die.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001410.
The Cicely Saunders International, a not-for-profit organization, promotes research to improve the care and treatment of all patients with terminal illnesses at home, in hospices and in hospital; its website includes information on end-of-life care and on Cicely Saunders, the founder of the hospice movement in England
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
Information on the National End of Life Care Programme is available
The UK National Health Service Choices website provides information (including videos of personal experiences) on end-of-life issues for carers, information on end-of-life care for patients with cancer, and an end-of-life care guide for people approaching the end of their life
The US National Cancer Institute has a fact sheet on end-of-life care for people who have cancer and provides information on hospice care and home care for patients with cancer (in English and Spanish)
The not-for-profit organization HealthTalkOnline provides personal stories about living with dying
The NHS National End of Life Intelligence Network (NEoLCIN) provides information on broad issues about end-of-life care
The South West Public Health Observatory (SWPHO) aims to improve the health of the population through producing evidence to inform decision making on health issues at local, regional, and national levels. SWPHO also produces specific end-of-life care resources (e.g., specialised reports, end-of-life care profiles) and disseminates it via the NEoLCIN website
doi:10.1371/journal.pmed.1001410
PMCID: PMC3608543  PMID: 23555201
14.  Health systems and long-term care for older people in Europe. Modelling the interfaces between prevention, rehabilitation, quality of services and informal care—an action research project 
Objective
The objective of INTERLINKS, a project that is co-financed by the 7th Framework Programme of DG Research, is to construct and validate a general model to describe, analyse and improve long-term care (LTC) systems for older people from a European perspective. The project is co-ordinated by the European Centre for Social Welfare Policy and Research (Vienna) and carried out by 14 research agencies from 16 European countries. This 3-year project will complete in October 2011.
Method
Since LTC exists at the boundaries of health and social care systems and is often undefined and underspecified as a discrete system, INTERLINKS is conceived as an interactive study of applied social research. A methodology based on some principles of action research was chosen, in order to facilitate cross-national comparisons and enable individual Member States to compare their developmental status and to identify future areas for national development.
In three cyclical rounds of investigation, production and eventual validation (see Figure 1), key research questions have been tested and reviewed by groups of participating countries, in such a way that a model in the form of an analytical toolbox is currently evolving out of the process. Key to the process is a validation procedure that will ensure a robust outcome in terms of methods and tools, carried out in close cooperation with many parties, such as: researchers, health professionals, politicians, economists, users and other experts on LTC, including those at EU level.
First, the national research teams prepared vignettes to describe the pathway of a stroke or dementia patient through their country’s system(s), from the perspective of the roles of informal care, quality assurance and assessment, prevention and rehabilitation, considering also regulation and financing issues (see Figures 2 and 3). In focusing on gaps and interfaces between services and organisations involved, problems and difficulties perceived were highlighted visually in posters. In a second phase, national and European overview papers were compiled, focusing on ‘Informal Care’, ‘Prevention and Rehabilitation’, ‘Quality Management and Quality Assurance’ as well as on ‘Governance and Financing’.
Model
These elements informed and influenced the ongoing development of the evolving INTERLINKS model which is currently being validated by National Expert Panels and a European Sounding Board. During the final cyclical phase of the project the web-based model will cover all themes and key-issues necessary to describe and analyse LTC systems, including practice examples. From these examples interested stakeholders should be able to gather and reflect upon issues that relate to their own national context and find answers from how other countries have solved similar challenges at different developmental stages.
While developing solutions to above-mentioned issues the model will also emphasise links, gaps and interfaces addressed by the practice examples. An interactive database for all EU countries will thus be available to which interested stakeholders may refer to, but to which they may also add pertinent examples from their national experiences and/or use them to generate ideas for improving future LTC practice for older people.
Results
Selected results of this process, such as highlighted findings from specific research foci and the draft web-based model to describe, analyse and improve LTC, will be presented at the conference.
Kai Leichsenring will introduce the project and some key findings from emerging LTC systems in Europe concerning links and interfaces between health and social care with a view on informal care, quality management and governance and financing.
Lis Wagner will show examples for embedding prevention and rehabilitation also in the context of LTC for older people, with a specific focus on Danish experiences.
Lorna Campbell will show how interested stakeholders can navigate through the INTERLINKS model—from vignettes describing gaps and bottlenecks to practice examples showing solutions and answers to pertinent key-issues in improving emerging LTC systems in Europe.
PMCID: PMC3184821
INTERLINKS; older people; long-term care; Europe
15.  Health-related quality of life in breast cancer patients: A bibliographic review of the literature from 1974 to 2007 
Background
Quality of life in patients with breast cancer is an important outcome. This paper presents an extensive overview on the topic ranging from descriptive findings to clinical trials.
Methods
This was a bibliographic review of the literature covering all full publications that appeared in English language biomedical journals between 1974 and 2007. The search strategy included a combination of key words 'quality of life' and 'breast cancer' or 'breast carcinoma' in titles. A total of 971 citations were identified and after exclusion of duplicates, the abstracts of 606 citations were reviewed. Of these, meetings abstracts, editorials, brief commentaries, letters, errata and dissertation abstracts and papers that appeared online and were indexed ahead of publication were also excluded. The remaining 477 papers were examined. The major findings are summarized and presented under several headings: instruments used, validation studies, measurement issues, surgical treatment, systemic therapies, quality of life as predictor of survival, psychological distress, supportive care, symptoms and sexual functioning.
Results
Instruments-Several valid instruments were used to measure quality of life in breast cancer patients. The European Organization for Research and Treatment of Cancer Core Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and its breast cancer specific complementary measure (EORTC QLQ-BR23) and the Functional Assessment Chronic Illness Therapy General questionnaire (FACIT-G) and its breast cancer module (FACIT-B) were found to be the most common and well developed instruments to measure quality of life in breast cancer patients. Surgery-different surgical procedures led to relatively similar results in terms of quality of life assessments, although mastectomy patients compared to conserving surgery patients usually reported a lower body image and sexual functioning. Systemic therapies-almost all studies indicated that breast cancer patients receiving chemotherapy might experience several side-effects and symptoms that negatively affect their quality of life. Adjuvant hormonal therapies also were found to have similar negative impact on quality of life, although in general they were associated with improved survival. Quality of life as predictor of survival-similar to known medical factors, quality of life data in metastatic breast cancer patients was found to be prognostic and predictive of survival time. Psychological distress-anxiety and depression were found to be common among breast cancer patients even years after the disease diagnosis and treatment. Psychological factors also were found to predict subsequent quality of life or even overall survival in breast cancer patients. Supportive care-clinical treatments to control emesis, or interventions such as counseling, providing social support and exercise could improve quality of life. Symptoms-Pain, fatigue, arm morbidity and postmenopausal symptoms were among the most common symptoms reported by breast cancer patients. As recommended, recognition and management of these symptoms is an important issue since such symptoms impair health-related quality of life. Sexual functioning-breast cancer patients especially younger patients suffer from poor sexual functioning that negatively affect quality of life.
Conclusion
There was quite an extensive body of the literature on quality of life in breast cancer patients. These papers have made a considerable contribution to improving breast cancer care, although their exact benefit was hard to define. However, quality of life data provided scientific evidence for clinical decision-making and conveyed helpful information concerning breast cancer patients' experiences during the course of the disease diagnosis, treatment, disease-free survival time, and recurrences; otherwise finding patient-centered solutions for evidence-based selection of optimal treatments, psychosocial interventions, patient-physician communications, allocation of resources, and indicating research priorities were impossible. It seems that more qualitative research is needed for a better understanding of the topic. In addition, issues related to the disease, its treatment side effects and symptoms, and sexual functioning should receive more attention when studying quality of life in breast cancer patients.
doi:10.1186/1756-9966-27-32
PMCID: PMC2543010  PMID: 18759983
16.  A self-evaluation tool for integrated care services: the Development Model for Integrated Care applied in practice 
Purpose
The purpose of the workshop is to show the applications of the Development Model for Integrated Care (DMIC) in practice. This relatively new and validated model, can be used by integrated care practices to evaluate their integrated care, to assess their phase of development and reveal improvement areas. In the workshop the results of the use of the model in three types of integrated care settings in the Netherlands will be presented. Participants are offered practical instruments based on the validated DMIC to use in their own setting and will be introduced to the webbased tool.
Context
To integrate care from multiple providers into a coherent and streamlined client-focused service, a large number of activities and agreements have to be implemented like streamlining information flows and adequate transfers of clients. In the large range of possible activities it is often not clear what essential activities are and where to start or continue. Also, knowledge about how to further develop integrated care services is needed. The Development Model for Integrated Care (DMIC), based on PhD research of Mirella Minkman, describes nine clusters containing in total 89 elements that contribute to the integration of care. The clusters are named: ‘client-centeredness’, ‘delivery system’, ‘performance management’, ‘quality of care’, ‘result-focused learning’, ‘interprofessional teamwork’, ‘roles and tasks’, ‘commitment’, and ‘transparant entrepreneurship’ [1–3]. In 2011 a new digital webbased self-evolution tool which contains the 89 elements grouped in nine clusters was developed. The DMIC also describes four phases of development [4]. The model is empirically validated in practice by assessing the relevance and implementation of the elements and development phases in 84 integrated care services in The Netherlands: in stroke, acute myocardial infarct (AMI), and dementia services. The validation studies are recently published [5, 6]. In 2011 also other integrated care services started using the model [7]. Vilans developed a digital web-based self-evaluation tool for integrated care services based on the DMIC. A palliative care network, four diabetes services, a youth care service and a network for autism used the self-evaluation tool to evaluate the development of their integrated care service. Because of its generic character, the model and tool are believed to be also interesting internationally.
Data sources
In the workshop we will present the results of three studies in integrated diabetes, youth and palliative care. The three projects consist of multiple steps, see below. Workshop participants could also work with the DMIC following these steps.
One: Preparation of the digital self-evolution tool for integrated care services
Although they are very different, the three integrated care services all wanted to gain insight in their development and improvement opportunities. We tailored the digital self-evaluation tool for each specific integrated care services, but for all the basis was the DMIC. Personal accounts for the digital DMIC self-evalution survey were sent to multiple partners working in each integrated care service (4–16 partners).
Two: Use of the online self-evaluation tool each partner of the local integrated care setting evaluated the integrated care by filling in the web-based questionnaire. The tool consists of three parts (A-C) named: general information about the integrated care practice (A); the clusters and elements of the DMIC (B); and the four phases of development (C). The respondents rated the relevance and presence of each element in their integrated care practice. Respondents were asked to estimate in which phase of development their thought their service was.
Three: Analysing the results
Advisers from Vilans, the Centre of excellence for long-term care in the Netherlands, analysed the self-evolution results in cooperation with the integrated care coordinators. The results show the total amount of implemented integrated care elements per cluster in spider graphs and the development phase as calculated by the DMIC model. Suggestions for further development of the integrated care services were analysed and reported.
Four: Discussing the implications for further development
In a workshop with the local integrated care partners the results of the self-evaluation were presented and discussed. We noticed remarkable results and highlight elements for further development. In addition, we gave advice for further development appropriate to the development phase of the integrated care service. Furthermore, the professionals prioritized the elements and decided which elements to start working on. This resulted in a (quality improvement) plan for the further development of the integrated care service.
Five: Reporting results
In a report all the results of the survey (including consensus scores) and the workshops came together. The integrated care coordinators stated that the reports really helped them to assess their improvement strategy. Also, there was insight in the development phase of their service which gave tools for further development.
Case description
The three cases presented are a palliative network, an integrated diabetes services and an integrated care network for youth in the Netherlands. The palliative care network wanted to reflect on their current development, to build a guiding framework for further development of the network. About sixteen professionals within the network worked with the digital self-evaluation tool and the DMIC: home care organisations, welfare organizations, hospice centres, health care organisations, community organizations.
For diabetes care, a Dutch health care insurance company wished to gain insight in the development of the contracted integrated care services to stimulate further development of the services. Professionals of three diabetes integrated care services were invited to fill in the digital self-evaluation tool. Of each integrated care service professionals like a general practitioner, a diabetes nurse, a medical specialist, a dietician and a podiatrist were invited. In youth care, a local health organisation wondered whether the DMIC could be helpful to visualize the results of youth integrated care services at process- and organisational level. The goal of the project was to define indicators at a process- and organisational level for youth care services based on the DMIC. In the future, these indicators might be used to evaluate youth care integrated care services and improve the quality of youth care within the Netherlands.
Conclusions and discussion
It is important for the quality of integrated care services that the involved coordinators, managers and professionals are aware of the development process of the integrated care service and that they focus on elements which can further develop and improve their integrated care. However, we noticed that integrated care services in the Netherlands experience difficulties in developing their integrated care service. It is often not clear what essential activities are to work on and how to further develop the integrated care service. A guiding framework for the development of integrated care was missing. The DMIC model has been developed for that reason and offers a useful tool for assessment, self-evaluation or improvement of integrated care services in practice. The model has been validated for AMI, dementia and stroke services. The latest new studies in diabetes, palliative care and youth care gave further insight in the generic character of the DMIC. Based on these studies it can be assumed that the DMIC can be used for multiple types of integrated care services. The model is assumed to be interesting for an international audience. Improving integrated care is a complex topic in a large number of countries; the DMIC is also based on the international literature. Dutch integrated care coordinators stated that the DMIC helped them to assess their integrated care development in practice and supported them in obtaining ideas for expanding and improving their integrated care activities.
The web-based self-evaluation tool focuses on a process- and organisational level of integrated care. Also, the self assessed development phase can be compared to the development phase as calculated by the DMIC tool. The cases showed this is fruitful input for discussions. When using the tool, the results can also be used in quality policy reports and improvement plans. The web-based tool is being tested at this moment in practice, but in San Marino we can present the latest webversion and demonstrate with a short video how to use the tool and model. During practical exercises in the workshop the participants will experience how the application of the DMIC can work for them in practice or in research. For integrated care researchers and policy makers, the DMIC questionnaire and tool is a promising method for further research and policy plans in integrated care.
PMCID: PMC3617779
development model for integrated care; development of integrated care services; implementation and improvement of integrated care; self evaluation
17.  Implantable Cardioverter Defibrillators. Prophylactic Use 
Executive Summary
Objective
The use of implantable cardiac defibrillators (ICDs) to prevent sudden cardiac death (SCD) in patients resuscitated from cardiac arrest or documented dangerous ventricular arrhythmias (secondary prevention of SCD) is an insured service. In 2003 (before the establishment of the Ontario Health Technology Advisory Committee), the Medical Advisory Secretariat conducted a health technology policy assessment on the prophylactic use (primary prevention of SCD) of ICDs for patients at high risk of SCD. The Medical Advisory Secretariat concluded that ICDs are effective for the primary prevention of SCD. Moreover, it found that a more clearly defined target population at risk for SCD that would be likely to benefit from ICDs is needed, given that the number needed to treat (NNT) from recent studies is 13 to 18, and given that the per-unit cost of ICDs is $32,000, which means that the projected cost to Ontario is $770 million (Cdn).
Accordingly, as part of an annual review and publication of more recent articles, the Medical Advisory Secretariat updated its health technology policy assessment of ICDs.
Clinical Need
Sudden cardiac death is caused by the sudden onset of fatal arrhythmias, or abnormal heart rhythms: ventricular tachycardia (VT), a rhythm abnormality in which the ventricles cause the heart to beat too fast, and ventricular fibrillation (VF), an abnormal, rapid and erratic heart rhythm. About 80% of fatal arrhythmias are associated with ischemic heart disease, which is caused by insufficient blood flow to the heart.
Management of VT and VF with antiarrhythmic drugs is not very effective; for this reason, nonpharmacological treatments have been explored. One such treatment is the ICD.
The Technology
An ICD is a battery-powered device that, once implanted, monitors heart rhythm and can deliver an electric shock to restore normal rhythm when potentially fatal arrhythmias are detected. The use of ICDs to prevent SCD in patients resuscitated from cardiac arrest or documented dangerous ventricular arrhythmias (secondary prevention) is an insured service in Ontario.
Primary prevention of SCD involves identification of and preventive therapy for patients who are at high risk for SCD. Most of the studies in the literature that have examined the prevention of fatal ventricular arrhythmias have focused on patients with ischemic heart disease, in particular, those with heart failure (HF), which has been shown to increase the risk of SCD. The risk of HF is determined by left ventricular ejection fraction (LVEF); most studies have focused on patients with an LVEF under 0.35 or 0.30. While most studies have found ICDs to reduce significantly the risk for SCD in patients with an LVEF less than 0.35, a more recent study (Sudden Cardiac Death in Heart Failure Trial [SCD-HeFT]) reported that patients with HF with nonischemic heart disease could also benefit from this technology. Based on the generalization of the SCD-HeFT study, the Centers for Medicare and Medicaid in the United States recently announced that it would allocate $10 billion (US) annually toward the primary prevention of SCD for patients with ischemic and nonischemic heart disease and an LVEF under 0.35.
Review Strategy
The aim of this literature review was to assess the effectiveness, safety, and cost effectiveness of ICDs for the primary prevention of SCD.
The standard search strategy used by the Medical Advisory Secretariat was used. This included a search of all international health technology assessments as well as a search of the medical literature from January 2003–May 2005.
A modification of the GRADE approach (1) was used to make judgments about the quality of evidence and strength of recommendations systematically and explicitly. GRADE provides a framework for structured reflection and can help to ensure that appropriate judgments are made. GRADE takes into account a study’s design, quality, consistency, and directness in judging the quality of evidence for each outcome. The balance between benefits and harms, quality of evidence, applicability, and the certainty of the baseline risks are considered in judgments about the strength of recommendations.
Summary of Findings
Overall, ICDs are effective for the primary prevention of SCD. Three studies – the Multicentre Automatic Defibrillator Implantation Trial I (MADIT I), the Multicentre Automatic Defibrillator Implantation Trial II (MADIT II), and SCD-HeFT – showed there was a statistically significant decrease in total mortality for patients who prophylactically received an ICD compared with those who received conventional therapy (Table 1).
Results of Key Studies on the Use of Implantable Cardioverter Defibrillators for the Primary Prevention of Sudden Cardiac Death – All-Cause Mortality
MADIT I: Multicentre Automatic Defibrillator Implantation Trial I; MADIT II: Multicentre Automatic Defibrillator Implantation Trial II; SCD-HeFT: Sudden Cardiac Death in Heart Failure Trial.
EP indicates electrophysiology; ICD, implantable cardioverter defibrillator; NNT, number needed to treat; NSVT, nonsustained ventricular tachycardia. The NNT will appear higher if follow-up is short. For ICDs, the absolute benefit increases over time for at least a 5-year period; the NNT declines, often substantially, in studies with a longer follow-up. When the NNT are equalized for a similar period as the SCD-HeFT duration (5 years), the NNT for MADIT-I is 2.2; for MADIT-II, it is 6.3.
GRADE Quality of the Evidence
Using the GRADE Working Group criteria, the quality of these 3 trials was examined (Table 2).
Quality refers to the criteria such as the adequacy of allocation concealment, blinding and follow-up.
Consistency refers to the similarity of estimates of effect across studies. If there is important unexplained inconsistency in the results, our confidence in the estimate of effect for that outcome decreases. Differences in the direction of effect, the size of the differences in effect, and the significance of the differences guide the decision about whether important inconsistency exists.
Directness refers to the extent to which the people interventions and outcome measures are similar to those of interest. For example, there may be uncertainty about the directness of the evidence if the people of interest are older, sicker or have more comorbidity than those in the studies.
As stated by the GRADE Working Group, the following definitions were used to grade the quality of the evidence:
High: Further research is very unlikely to change our confidence n the estimate of effect.
Moderate: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low: Any estimate of effect is very uncertain.
Quality of Evidence – MADIT I, MADIT II, and SCD-HeFT*
MADIT I: Multicentre Automatic Defibrillator Implantation Trial I; MADIT II: Multicentre Automatic Defibrillator Implantation Trial II; SCD-HeFT: Sudden Cardiac Death in Heart Failure Trial.
The 3 trials had 3 different sets of eligibility criteria for implantation of an ICD for primary prevention of SCD. Conclusions
Conclusions
Overall, there is evidence that ICDs are effective for the primary prevention of SCD. Three trials have found a statistically significant decrease in total mortality for patients who prophylactically received an ICD compared with those who received conventional therapy in their respective study populations.
As per the GRADE Working Group, 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 (Table 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; 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 with 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 or uncertainty.
For MADIT I, the overall GRADE and strength of the recommendation is “moderate” – the quality of the evidence is “moderate” (uncertainty due to methodological limitations in the study design), and risk/uncertainty in cost and budget impact was mitigated by the use of filters to help target the prevalent population at risk (Table 3).
For MADIT II, the overall GRADE and strength of the recommendation is “very weak” – the quality of the evidence is “weak” (uncertainty due to methodological limitations in the study design), but there is risk or uncertainty regarding the high prevalence, cost, and budget impact. It is not clear why screening for high-risk patients was dropped, given that in MADIT II the absolute reduction in mortality was small (5.6%) compared to MADIT I, which used electrophysiological screening (23%) (Table 3).
For SCD-HeFT, the overall GRADE and strength of the recommendation is “weak” – the study quality is “moderate,” but there is also risk/uncertainty due to a high NNT at 5 years (13 compared to the MADIT II NNT of 6 and MADIT I NNT of 2 at 5 years), high prevalent population (N = 23,700), and a high budget impact ($770 million). A filter (as demonstrated in MADIT 1) is required to help target the prevalent population at risk and mitigate the risk or uncertainty relating to the high NNT, prevalence, and budget impact (Table 3).
The results of the most recent ICD trial (SCD-HeFT) are not generalizable to the prevalent population in Ontario (Table 3). Given that the current funding rate of an ICD is $32,500 (Cdn), the estimated budget impact for Ontario would be as high as $770 million (Cdn). The uncertainty around the cost estimate of treating the prevalent population with LVEF < 0.30 in Ontario, the lack of human resources to implement such a strategy and the high number of patients required to prevent one SCD (NNT = 13) calls for an alternative strategy that allows the appropriate uptake and diffusion of ICDs for primary prevention for patients at maximum risk for SCD within the SCD-HeFT population.
The uptake and diffusion of ICDs for primary prevention of SCD should therefore be based on risk stratification through the use of appropriate screen(s) that would identify patients at highest risk who could derive the most benefit from this technology.
Overall GRADE and Strength of Recommendation for the Use of Implantable Cardioverter Defibrillators for the Primary Prevention of Sudden Cardiac Death
MADIT I: Multicentre Automatic Defibrillator Implantation Trial I; MADIT II: Multicentre Automatic Defibrillator Implantation Trial II; SCD-HeFT: Sudden Cardiac Death in Heart Failure Trial.
NNT indicates number needed to treat. The NNT will appear higher if follow-up is short. For ICDs, the absolute benefit increases over time for at least a 5-year period; the NNT declines, often substantially, in studies with a longer follow-up. When the NNT are equalized for a similar period as the SCD-HeFT duration (5 years), the NNT for MADIT-I is 2.2; for MADIT-II, it is 6.3.
NSVT indicates nonsustained ventricular tachycardia; VT, ventricular tachycardia.
PMCID: PMC3382404  PMID: 23074465
18.  Community-Based Care for the Specialized Management of Heart Failure 
Executive Summary
In August 2008, the Medical Advisory Secretariat (MAS) presented a vignette to the Ontario Health Technology Advisory Committee (OHTAC) on a proposed targeted health care delivery model for chronic care. The proposed model was defined as multidisciplinary, ambulatory, community-based care that bridged the gap between primary and tertiary care, and was intended for individuals with a chronic disease who were at risk of a hospital admission or emergency department visit. The goals of this care model were thought to include: the prevention of emergency department visits, a reduction in hospital admissions and re-admissions, facilitation of earlier hospital discharge, a reduction or delay in long-term care admissions, and an improvement in mortality and other disease-specific patient outcomes.
OHTAC approved the development of an evidence-based assessment to determine the effectiveness of specialized community based care for the management of heart failure, Type 2 diabetes and chronic wounds.
Please visit the Medical Advisory Secretariat Web site at: www.health.gov.on.ca/ohtas to review the following reports associated with the Specialized Multidisciplinary Community-Based care series.
Specialized multidisciplinary community-based care series: a summary of evidence-based analyses
Community-based care for the specialized management of heart failure: an evidence-based analysis
Community-based care for chronic wound management: an evidence-based analysis
Please note that the evidence-based analysis of specialized community-based care for the management of diabetes titled: “Community-based care for the management of type 2 diabetes: an evidence-based analysis” has been published as part of the Diabetes Strategy Evidence Platform at this URL: http://www.health.gov.on.ca/english/providers/program/mas/tech/ohtas/tech_diabetes_20091020.html
Please visit the Toronto Health Economics and Technology Assessment Collaborative Web site at: http://theta.utoronto.ca/papers/MAS_CHF_Clinics_Report.pdf to review the following economic project associated with this series:
Community-based Care for the specialized management of heart failure: a cost-effectiveness and budget impact analysis.
Objective
The objective of this evidence-based analysis was to determine the effectiveness of specialized multidisciplinary care in the management of heart failure (HF).
Clinical Need: Target Population and Condition
HF is a progressive, chronic condition in which the heart becomes unable to sufficiently pump blood throughout the body. There are several risk factors for developing the condition including hypertension, diabetes, obesity, previous myocardial infarction, and valvular heart disease.(1) Based on data from a 2005 study of the Canadian Community Health Survey (CCHS), the prevalence of congestive heart failure in Canada is approximately 1% of the population over the age of 12.(2) This figure rises sharply after the age of 45, with prevalence reports ranging from 2.2% to 12%.(3) Extrapolating this to the Ontario population, an estimated 98,000 residents in Ontario are believed to have HF.
Disease management programs are multidisciplinary approaches to care for chronic disease that coordinate comprehensive care strategies along the disease continuum and across healthcare delivery systems.(4) Evidence for the effectiveness of disease management programs for HF has been provided by seven systematic reviews completed between 2004 and 2007 (Table 1) with consistency of effect demonstrated across four main outcomes measures: all cause mortality and hospitalization, and heart-failure specific mortality and hospitalization. (4-10)
However, while disease management programs are multidisciplinary by definition, the published evidence lacks consistency and clarity as to the exact nature of each program and usual care comparators are generally ill defined. Consequently, the effectiveness of multidisciplinary care for the management of persons with HF is still uncertain. Therefore, MAS has completed a systematic review of specialized, multidisciplinary, community-based care disease management programs compared to a well-defined usual care group for persons with HF.
Evidence-Based Analysis Methods
Research Questions
What is the effectiveness of specialized, multidisciplinary, community-based care (SMCCC) compared with usual care for persons with HF?
Literature Search Strategy
A comprehensive literature search was completed of electronic databases including MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, Cochrane Library and Cumulative Index to Nursing & Allied Health Literature. Bibliographic references of selected studies were also searched. After a review of the title and abstracts, relevant studies were obtained and the full reports evaluated. All studies meeting explicit inclusion and exclusion criteria were retained. Where appropriate, a meta-analysis was undertaken to determine the pooled estimate of effect of specialized multidisciplinary community-based care for explicit outcomes. The quality of the body of evidence, defined as one or more relevant studies was determined using GRADE Working Group criteria. (11)
Inclusion Criteria
Randomized controlled trial
Systematic review with meta analysis
Population includes persons with New York Heart Association (NYHA) classification 1-IV HF
The intervention includes a team consisting of a nurse and physician one of which is a specialist in HF management.
The control group receives care by a single practitioner (e.g. primary care physician (PCP) or cardiologist)
The intervention begins after discharge from the hospital
The study reports 1-year outcomes
Exclusion Criteria
The intervention is delivered predominately through home-visits
Studies with mixed populations where discrete data for HF is not reported
Outcomes of Interest
All cause mortality
All cause hospitalization
HF specific mortality
HF specific hospitalization
All cause duration of hospital stay
HF specific duration of hospital stay
Emergency room visits
Quality of Life
Summary of Findings
One large and seven small randomized controlled trials were obtained from the literature search.
A meta-analysis was completed for four of the seven outcomes including:
All cause mortality
HF-specific mortality
All cause hospitalization
HF-specific hospitalization.
Where the pooled analysis was associated with significant heterogeneity, subgroup analyses were completed using two primary categories:
direct and indirect model of care; and
type of control group (PCP or cardiologist).
The direct model of care was a clinic-based multidisciplinary HF program and the indirect model of care was a physician supervised, nurse-led telephonic HF program.
All studies, except one, were completed in jurisdictions outside North America. (12-19) Similarly, all but one study had a sample size of less than 250. The mean age in the studies ranged from 65 to 77 years. Six of the studies(12;14-18) included populations with a NYHA classification of II-III. In two studies, the control treatment was a cardiologist (12;15) and two studies reported the inclusion of a dietitian, physiotherapist and psychologist as members of the multidisciplinary team (12;19).
All Cause Mortality
Eight studies reported all cause mortality (number of persons) at 1 year follow-up. (12-19) When the results of all eight studies were pooled, there was a statistically significant RRR of 29% with moderate heterogeneity (I2 of 38%). The results of the subgroup analyses indicated a significant RRR of 40% in all cause mortality when SMCCC is delivered through a direct team model (clinic) and a 35% RRR when SMCCC was compared with a primary care practitioner.
HF-Specific Mortality
Three studies reported HF-specific mortality (number of persons) at 1 year follow-up. (15;18;19) When the results of these were pooled, there was an insignificant RRR of 42% with high statistical heterogeneity (I2 of 60%). The GRADE quality of evidence is moderate for the pooled analysis of all studies.
All Cause Hospitalization
Seven studies reported all cause hospitalization at 1-year follow-up (13-15;17-19). When pooled, their results showed a statistically insignificant 12% increase in hospitalizations in the SMCCC group with high statistical heterogeneity (I2 of 81%). A significant RRR of 12% in all cause hospitalization in favour of the SMCCC care group was achieved when SMCCC was delivered using an indirect model (telephonic) with an associated (I2 of 0%). The Grade quality of evidence was found to be low for the pooled analysis of all studies and moderate for the subgroup analysis of the indirect team care model.
HF-Specific Hospitalization
Six studies reported HF-specific hospitalization at 1-year follow-up. (13-15;17;19) When pooled, the results of these studies showed an insignificant RRR of 14% with high statistical heterogeneity (I2 of 60%); however, the quality of evidence for the pooled analysis of was low.
Duration of Hospital Stay
Seven studies reported duration of hospital stay, four in terms of mean duration of stay in days (14;16;17;19) and three in terms of total hospital bed days (12;13;18). Most studies reported all cause duration of hospital stay while two also reported HF-specific duration of hospital stay. These data were not amenable to meta-analyses as standard deviations were not provided in the reports. However, in general (and in all but one study) it appears that persons receiving SMCCC had shorter hospital stays, whether measured as mean days in hospital or total hospital bed days.
Emergency Room Visits
Only one study reported emergency room visits. (14) This was presented as a composite of readmissions and ER visits, where the authors reported that 77% (59/76) of the SMCCC group and 84% (63/75) of the usual care group were either readmitted or had an ER visit within the 1 year of follow-up (P=0.029).
Quality of Life
Quality of life was reported in five studies using the Minnesota Living with HF Questionnaire (MLHFQ) (12-15;19) and in one study using the Nottingham Health Profile Questionnaire(16). The MLHFQ results are reported in our analysis. Two studies reported the mean score at 1 year follow-up, although did not provide the standard deviation of the mean in their report. One study reported the median and range scores at 1 year follow-up in each group. Two studies reported the change scores of the physical and emotional subscales of the MLHFQ of which only one study reported a statistically significant change from baseline to 1 year follow-up between treatment groups in favour of the SMCCC group in the physical sub-scale. A significant change in the emotional subscale scores from baseline to 1 year follow-up in the treatment groups was not reported in either study.
Conclusion
There is moderate quality evidence that SMCCC reduces all cause mortality by 29%. There is low quality evidence that SMCCC contributes to a shorter duration of hospital stay and improves quality of life compared to usual care. The evidence supports that SMCCC is effective when compared to usual care provided by either a primary care practitioner or a cardiologist. It does not, however, suggest an optimal model of care or discern what the effective program components are. A field evaluation could address this uncertainty.
PMCID: PMC3377506  PMID: 23074521
19.  Preventing and Treating Lower Extremity Stress Reactions and Fractures in Adults 
Journal of Athletic Training  2006;41(4):466-469.
Reference/Citation: Rome K, Handoll HH, Ashford R. Interventions for preventing and treating stress fractures and stress reactions of bone of the lower limbs in young adults. Cochrane Database Syst Rev.20052:CD000450. Update from Gillespie WJ, Grant I. Interventions for preventing and treating stress fractures and stress reactions of bone of the lower limbs in young adults. Cochrane Database Syst Rev.20002: CD000450.
Clinical Question: Do evidence-based interventions exist for the prevention and treatment of stress reactions and stress fractures in young active adults?
Data Sources: This systematic review is an update of the original article, which was published in 2000. The authors conducted a literature review of computerized databases that included the Cochrane Musculoskeletal Injuries Group Specialized Register (April 2004), the Cochrane Central Register of Controlled Trials, MEDLINE (1966 to September 2004), EMBASE (1988 to 2004, week 36), CINAHL (1982 to 2004, September, week 1), Index to Theses (1990 to 2004), and Dissertation Abstracts (1990 to 2004). In addition, the authors searched the Current Controlled Trials at http://www.controlled-trials.com (June 2004, week 1) and the United Kingdom National Research Registrar at http://www.update-software.com/national/ (to issue 1, 2004) for current or recently completed studies. They also reviewed the British Journal of Podiatry, International Journal of Podiatric Biomechanics, Physiotherapy, and the Australian Journal of Podiatric Medicine for relevant studies. Furthermore, they contacted the Medical Departments of Defense Forces in Europe and North America to identify unpublished or unlisted military studies. Reference lists of all identified studies and Cochrane reviews were also investigated. The computer search strategy included 61 separate entries and included such terms as stress fractures, stress reactions, shin splints, overuse, athletic injuries, cumulative trauma disorders, running, and randomized controlled trial. The 3 authors of this updated review independently selected new articles for inclusion. Furthermore, the 12 articles that were included in the original systematic review were also reevaluated to ensure they met the defined inclusion criteria.
Study Selection: To qualify for inclusion, studies had to be randomized or quasirandomized control trials, involve interventions to prevent or treat lower extremity stress reactions and fractures, and include physically active adults (adolescence to middle age) who were involved in athletics or military training. Clinical and radiographic (bone scan or x-ray) evidence of a lower extremity stress reaction or stress fracture was also required for inclusion of treatment-based studies. Specifically, skeletal overuse injuries are considered the result of a cumulative and repetitive process that produces initial microstructural changes or stress reactions that are identified by bone scans or magnetic resonance imaging but not conventional radiographs. If cumulative stresses continue, structural changes are visualized on radiographs and are referred to as stress fractures. In addition, research studies involving the treatment of medial tibial stress syndrome or shin splints were excluded. Desired outcome measures for treatment studies included return to training time, return to normal physical activity, functional performance, quality of life measures, resource management (eg, costs, health care visits, diagnostic procedures), adverse effects, and compliance.
The inclusion criteria for stress fracture prevention studies were similar, except that the authors did not have to provide radiographic evidence of a stress fracture or stress reaction. Prevention studies included a combination of the following outcome measures: occurrence and location of stress fracture, stratification of diagnosis, incidence of other lower limb injuries, complications and adverse effects of prevention techniques, resource management, and compliance with the prevention strategy.
Data Extraction: At least 2 reviewers independently extracted the demographic and outcome data from the newly identified studies, and 1 author verified the data and results from the 12 studies included in the 2000 Cochrane review. Inconsistencies from the original review and data from all new studies were also checked by an additional reviewer. All 3 reviewers then independently evaluated the quality of inclusion studies using a quality scoring scheme ( Table). The categories considered included randomization or group allocation (A), intention-to-treat analysis (B), examiner blinding (C), comparison of experimental and control groups at baseline (D), use of a placebo treatment (E), clearly defined subject inclusion and exclusion criteria (F), and methods of outcome assessments (G). Items A through F were scored from 0 to 2 and item G from 0 to 3, for a total “best” quality assessment score (QAS) of 15. Inconsistencies among reviewers' QAS scores were resolved by discussion and with the aid of a discrepancies form.
Main Results: Search criteria identified 24 new studies since the previous review, 8 of which fulfilled the inclusion criteria. In addition, 4 of the 12 studies included in the original 2000 review were excluded. Three were excluded as a result of insufficient indication of subject or group randomization or quasirandomization, and the fourth excluded study included subjects with the diagnosis of medial tibial stress syndrome. Overall, 16 studies were included.
The authors of 13 studies focused on prevention, and 3 groups evaluated the treatment of stress fractures and reactions. The average number of subjects for prevention and treatment studies, respectively, was 1091 (range = 206 to 3025) and 34 (range = 21 to 60). All 13 prevention studies involved military personnel who performed physical training over a 9-to-14–week period. Quality assessment scores for prevention studies ranged from 4 to 10 (mean score = 7). In 9 prevention studies, the effectiveness of insoles or orthoses was evaluated, and the QAS for these studies ranged from 4 to 9 (mean = 6.2). The investigators in 4 studies assessed “shock-absorbing” insoles or orthoses in shoes or boots versus a control (shoes or boots alone), and an additional 5 groups compared insoles and orthoses against one another. One study's authors also evaluated military training in a modified high-top shoe versus standard military boots (QAS = 8). Two groups assessed the influence of pre-exercise stretching (QAS = 8 and 9, respectively), and one investigated the effects of calcium supplementation (QAS = 10).
In none of the prevention studies were adequate randomization and concealment of treatment before group allocation (item A) accomplished, and the researchers in 3 studies randomized groups (team or platoon) instead of individual participants. Attrition rates exceeded 50% in 2 studies, and missing subjects' data were unaccounted for in the final analysis of 3 studies (item B, intention-to-treat analysis). Also, in only 2 of 13 studies were examiners blinded to group assignment (item C). Radiographic (bone scan or x-ray) evidence for diagnostic confirmation of a stress reaction or fracture was used in 12 studies. The method of diagnosis (item G) was based solely on clinical examination or a self-report questionnaire in 2 studies, and diagnostic methods were not described in 2 studies.
Overall fewer osseous stress injuries were reported in the experimental groups for all 4 studies comparing military personnel in “shock absorbing insoles” with controls (no insoles). However, none of these 4 studies demonstrated a statistically significant reduction in lower extremity overuse osseous injuries. In addition, statistically significant results were reported in only 1 of 5 studies that compared various orthoses and insoles. The authors reported a significant reduction in tibial stress fractures for soldiers wearing custom-made semirigid or soft-foot orthoses versus those wearing standard insoles (relative risk = 0.46, 95% confidence interval = 0.22 to 0.93). In a follow-up study, no significant difference in stress fracture rates was seen between subjects who wore custom-made semirigid orthoses and those who wore biomechanical soft orthoses, thus precluding the ability to identify one best design for stress fracture reduction. No significant stress fracture or lower extremity injury rate differences were seen between the control and experimental groups involved in lower extremity stretching studies. Participants taking calcium supplements did not demonstrate a significant reduction in stress fractures (tibial only) versus controls. The differences among the prevention studies prohibited pooling of the data and subsequent meta-analysis. Authors of all 3 treatment studies investigated the effects of a pneumatic ankle foot orthosis (Aircast Corp, Summit, NJ). Follow-up for outcome measures ranged from 78 days to 6 months. Two studies were conducted with military recruits, and the other was conducted with competitive and recreational athletes (n = 18, age range = 18 to 45 years). Treatment QASs ranged from 7/15 to 11/ 15, with an average score of 9.3/15. Proper randomization (item A) and evaluator blinding (item C) were confirmed in 1 of the 3 treatment studies. Data pooled from all 3 studies reached statistical significance for mean number of days until returning to full activities (weighted mean difference with brace versus without brace = −33.39 days, 95% confidence interval = −44.18 to −22.59 days).
Conclusions: Currently, no solid evidence-based interventions to prevent lower extremity stress reactions or fractures exist. Limited evidence suggests that “shock absorbing” insoles may reduce the overall incidence of lower extremity osseous injuries in military personnel. Unfortunately, research does not support the best design for inserts or footwear modifications. There is also insufficient evidence to determine if pre-performance stretching or calcium supplementation offers added protection from lower extremity osseous overuse injuries. Initial evidence supports the use of a pneumatic brace and early mobilization for the treatment of tibal stress reactions and fractures, but additional studies are required to validate these findings. Further investigation concerning the prevention and treatment of lower extremity stress fractures is needed and would assist researchers in establishing and clarifying evidence-based intervention guidelines. Future randomized control trials that clearly define (ie, provide clinical and radiographic evidence for) the diagnosis of a stress fracture or reaction, implement appropriate randomization, and use intervention and outcome measures (functional and performance measurements) that are appropriate for active adults would assist this ongoing and necessary process.
PMCID: PMC1748425  PMID: 17273474
athletic injuries; outcomes assessment
20.  Pressure Ulcer Prevention 
Executive Summary
In April 2008, the Medical Advisory Secretariat began an evidence-based review of the literature concerning pressure ulcers.
Please visit the Medical Advisory Secretariat Web site, http://www.health.gov.on.ca/english/providers/program/mas/tech/tech_mn.html to review these titles that are currently available within the Pressure Ulcers series.
Pressure ulcer prevention: an evidence based analysis
The cost-effectiveness of prevention strategies for pressure ulcers in long-term care homes in Ontario: projections of the Ontario Pressure Ulcer Model (field evaluation)
Management of chronic pressure ulcers: an evidence-based analysis (anticipated pubicstion date - mid-2009)
Purpose
A pressure ulcer, also known as a pressure sore, decubitus ulcer, or bedsore, is defined as a localized injury to the skin/and or underlying tissue occurring most often over a bony prominence and caused by pressure, shear, or friction, alone or in combination. (1) Those at risk for developing pressure ulcers include the elderly and critically ill as well as persons with neurological impairments and those who suffer conditions associated with immobility. Pressure ulcers are graded or staged with a 4-point classification system denoting severity. Stage I represents the beginnings of a pressure ulcer and stage IV, the severest grade, consists of full thickness tissue loss with exposed bone, tendon, and or muscle. (1)
In a 2004 survey of Canadian health care settings, Woodbury and Houghton (2) estimated that the prevalence of pressure ulcers at a stage 1 or greater in Ontario ranged between 13.1% and 53% with nonacute health care settings having the highest prevalence rate (Table 1).
Executive Summary Table 1: Prevalence of Pressure Ulcers*
CI indicates confidence interval.
Nonacute care included sub-acute care, chronic care, complex continuing care, long-term care, and nursing home care.
Mixed health care includes a mixture of acute, nonacute, and/or community care health care delivery settings.
Pressure ulcers have a considerable economic impact on health care systems. In Australia, the cost of treating a single stage IV ulcer has been estimated to be greater than $61,000 (AUD) (approximately $54,000 CDN), (3) while in the United Kingdom the total cost of pressure ulcers has been estimated at £1.4–£2.1 billion annually or 4% of the National Health Service expenditure. (4)
Because of the high physical and economic burden of pressure ulcers, this review was undertaken to determine which interventions are effective at preventing the development of pressure ulcers in an at-risk population.
Review Strategy
The main objective of this systematic review is to determine the effectiveness of pressure ulcer preventive interventions including Risk Assessment, Distribution Devices, Nutritional Supplementation, Repositioning, and Incontinence Management.
A comprehensive literature search was completed for each of the above 5 preventive interventions. The electronic databases searched included MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cochrane Library, and the Cumulative Index to Nursing and Allied Health Literature. As well, the bibliographic references of selected studies were searched. All studies meeting explicit inclusion and exclusion criteria for each systematic review section were retained and the quality of the body of evidence was determined using the Grading of Recommendation Assessment, Development, and Evaluation (GRADE) system. (5) Where appropriate, a meta-analysis was undertaken to determine the overall estimate of effect of the preventive intervention under review.
Summary of Findings
Risk Assessment
There is very low quality evidence to support the hypothesis that allocating the type of pressure-relieving equipment according to the person’s level of pressure ulcer risk statistically decreases the incidence of pressure ulcer development. Similarly, there is very low quality evidence to support the hypothesis that incorporating a risk assessment into nursing practice increases the number of preventative measures used per person and that these interventions are initiated earlier in the care continuum.
Pressure Redistribution Devices
There is moderate quality evidence that the use of an alternative foam mattress produces a relative risk reduction (RRR) of 69% in the incidence of pressure ulcers compared with a standard hospital mattress. The evidence does not support the superiority of one particular type of alternative foam mattress.
There is very low quality evidence that the use of an alternating pressure mattress is associated with an RRR of 71% in the incidence of grade 1 or 2 pressure ulcers. Similarly, there is low quality evidence that the use of an alternating pressure mattress is associated with an RRR of 68% in the incidence of deteriorating skin changes.
There is moderate quality evidence that there is a statistically nonsignificant difference in the incidence of grade 2 pressure ulcers between persons using an alternating pressure mattress and those using an alternating pressure overlay.
There is moderate quality evidence that the use of an Australian sheepskin produces an RRR of 58% in the incidence of pressure ulcers grade 1 or greater. There is also evidence that sheepskins are uncomfortable to use. The Pressure Ulcer Advisory Panel noted that, in general, sheepskins are not a useful preventive intervention because they bunch up in a patient’s bed and may contribute to wound infection if not properly cleaned, and this reduces their acceptability as a preventive intervention.
There is very low quality evidence that the use of a Micropulse System alternating pressure mattress used intra operatively and postoperatively produces an RRR of 79% in the incidence of pressure ulcers compared with a gel-pad used intraoperatively and a standard hospital mattress used postoperatively (standard care). It is unclear if this effect is due to the use of the alternating pressure mattress intraoperatively or postoperatively or if indeed it must be used in both patient care areas.
There is low quality evidence that the use of a vesico-elastic polymer pad (gel pad) on the operating table for surgeries of at least 90 minutes’ duration produces a statistically significant RRR of 47% in the incidence of pressure ulcers grade 1 or greater compared with a standard operating table foam mattress.
There is low quality evidence that the use of an air suspension bed in the intensive care unit (ICU) for stays of at least 3 days produces a statistically significant RRR of 76% in the incidence of pressure ulcers compared with a standard ICU bed.
There is very low quality evidence that the use of an alternating pressure mattress does not statistically reduce the incidence of pressure ulcers compared with an alternative foam mattress.
Nutritional Supplementation
There is very low quality evidence supporting an RRR of 15% in the incidence of pressure ulcers when nutritional supplementation is added to a standard hospital diet.
Repositioning
There is low quality evidence supporting the superiority of a 4-hourly turning schedule with a vesico-elastic polyurethane foam mattress compared with a 2-hourly or 3-hourly turning schedule and a standard foam mattress to reduce the incidence of grade 1 or 2 pressure ulcers.
Incontinence Management
There is very low quality evidence supporting the benefit of a structured skin care protocol to reduce the incidence of grade 1 or 2 pressure ulcers in persons with urinary and/or fecal incontinence.
There is low quality evidence supporting the benefit of a pH-balanced cleanser compared with soap and water to reduce the incidence of grade 1 or 2 pressure ulcers in persons with urinary and fecal incontinence.
Conclusions
There is moderate quality evidence that an alternative foam mattress is effective in preventing the development of pressure ulcers compared with a standard hospital foam mattress.
However, overall there remains a paucity of moderate or higher quality evidence in the literature to support many of the preventive interventions. Until better quality evidence is available, pressure ulcer preventive care must be guided by expert opinion for those interventions where low or very low quality evidence supports the effectiveness of such interventions.
Abbreviations
Confidence interval
Grading of Recommendation Assessment, Development, and Evaluation
Intensive care unit
Medical Advisory Secretariat
National Pressure Ulcer Advisory Panel
Risk assessment scale
Randomized controlled trial
Registered Nurses Association of Ontario
Relative risk
Relative risk reduction
PMCID: PMC3377566  PMID: 23074524
21.  Configuring Balanced Scorecards for Measuring Health System Performance: Evidence from 5 Years' Evaluation in Afghanistan 
PLoS Medicine  2011;8(7):e1001066.
Anbrasi Edward and colleagues report the results of a balanced scorecard performance system used to examine 29 key performance indicators over a 5-year period in Afghanistan, between 2004 and 2008.
Background
In 2004, Afghanistan pioneered a balanced scorecard (BSC) performance system to manage the delivery of primary health care services. This study examines the trends of 29 key performance indicators over a 5-year period between 2004 and 2008.
Methods and Findings
Independent evaluations of performance in six domains were conducted annually through 5,500 patient observations and exit interviews and 1,500 provider interviews in >600 facilities selected by stratified random sampling in each province. Generalized estimating equation (GEE) models were used to assess trends in BSC parameters. There was a progressive improvement in the national median scores scaled from 0–100 between 2004 and 2008 in all six domains: patient and community satisfaction of services (65.3–84.5, p<0.0001); provider satisfaction (65.4–79.2, p<0.01); capacity for service provision (47.4–76.4, p<0.0001); quality of services (40.5–67.4, p<0.0001); and overall vision for pro-poor and pro-female health services (52.0–52.6). The financial domain also showed improvement until 2007 (84.4–95.7, p<0.01), after which user fees were eliminated. By 2008, all provinces achieved the upper benchmark of national median set in 2004.
Conclusions
The BSC has been successfully employed to assess and improve health service capacity and service delivery using performance benchmarking during the 5-year period. However, scorecard reconfigurations are needed to integrate effectiveness and efficiency measures and accommodate changes in health systems policy and strategy architecture to ensure its continued relevance and effectiveness as a comprehensive health system performance measure. The process of BSC design and implementation can serve as a valuable prototype for health policy planners managing performance in similar health care contexts.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Traditionally, the performance of a health system (the complete network of health care agencies, facilities, and providers in a defined geographical region) has been measured in terms of health outcomes: how many people have been treated, how many got better, and how many died. But, nowadays, with increased demand for improved governance and accountability, policy makers are seeking comprehensive performance measures that show in detail how innovations designed to strengthen health systems are affecting service delivery and health outcomes. One such performance measure is the “balanced scorecard,” an integrated management and measurement tool that enables organizations to clarify their vision and strategy and translate them into action. The balanced scorecard—essentially a list of key performance indicators and performance benchmarks in several domains—was originally developed for industry but is now becoming a popular strategic management tool in the health sector. For example, balanced scorecards have been successfully integrated into the Dutch and Italian public health care systems.
Why Was This Study Done?
Little is known about the use of balanced scorecards in the national public health care systems of developing countries but the introduction of performance management into health system reform in fragile states in particular (developing countries where the state fails to perform the fundamental functions necessary to meet its citizens' basic needs and expectations) could help to promote governance and leadership, and facilitate essential policy changes. One fragile state that has introduced the balanced scorecard system for public health care management is Afghanistan, which emerged from decades of conflict in 2002 with some of the world's worst health indicators. To deal with an extremely high burden of disease, the Ministry of Public Health (MOPH) designed a Basic Package of Health Services (BPHS), which is delivered by nongovernmental organizations and MOPH agencies. In 2004, the MOPH introduced the National Health Service Performance Assessment (NHSPA), an annual country-wide assessment of service provision and patient satisfaction and pioneered a balanced scorecard, which uses data collected in the NHSPA, to manage the delivery of primary health care services. In this study, the researchers examine the trends between 2004 and 2008 of the 29 key performance indicators in six domains included in this balanced scorecard, and consider the potential and limitations of the scorecard as a management tool to measure and improve health service delivery in Afghanistan and other similar countries.
What Did the Researchers Do and Find?
Each year of the study, a random sample of 25 facilities (district hospitals and comprehensive and basic health centers) in 28 of Afghanistan's 34 provinces was chosen (one province did not have functional facilities in 2004 and the other five missing provinces were inaccessible because of ongoing conflicts). NHSPA surveyors collected approximately 5,000 patient observations, 5,000 exit interviews with patients or their caregivers, and 1,500 health provider interviews by observing consultations involving five children under 5 years old and five patients over 5 years old in each facility. The researchers then used this information to evaluate the key performance indicators in the balanced scorecard and a statistical method called generalized estimating equation modeling to assess trends in these indicators. They report that there was a progressive improvement in national average scores in all six domains (patients and community satisfaction with services, provider satisfaction, capacity for service provision, quality of services, overall vision for pro-poor and pro-female health services, and financial systems) between 2004 and 2008.
What Do These Findings Mean?
These findings suggest that the balanced scorecard was successfully used to improve health system capacity and service delivery through performance benchmarking over the 5-year study period. Importantly, the use of the balanced scorecard helped to show the effects of investments, facilitate policy change, and create a more evidence-based decision-making culture in Afghanistan's primary health care system. However, the researchers warn that the continuing success of the balanced scorecard in Afghanistan will depend on its ability to accommodate changes in health systems policy. Furthermore, reconfigurations of the scorecard are needed to include measures of the overall effectiveness and efficiency of the health system such as mortality rates. More generally, the researchers conclude that the balanced scorecard offers a promising measure of health system performance that could be used to examine the effectiveness of health care strategies and innovations in other fragile and developing countries.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001066.
A 2010 article entitled An Afghan Success Story: The Balanced Scorecard and Improved Health Services in The Globe, a newsletter produced by the Department of International Health at the John Hopkins Bloomberg School of Public Health, provides a detailed description of the balanced scorecard used in this study
Wikipedia has a page on health systems and on balanced scorecards (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
The World Health Organization country profile of Afghanistan provides information on the country's health system and burden of disease (in several languages)
doi:10.1371/journal.pmed.1001066
PMCID: PMC3144209  PMID: 21814499
22.  Primary Care Research Team Assessment (PCRTA): development and evaluation. 
BACKGROUND: Since the early 1990s the United Kingdom (UK) Department of Health has explicitly promoted a research and development (R&D) strategy for the National Health Service (NHS). General practitioners (GPs) and other members of the primary care team are in a unique position to undertake research activity that will complement and inform the research undertaken by basic scientists and hospital-based colleagues and lead directly to a better evidence base for decision making by primary care professionals. Opportunities to engage in R&D in primary care are growing and the scope for those wishing to become involved is finally widening. Infrastructure funding for research-active practices and the establishment of a range of support networks have helped to improve the research capacity and blur some of the boundaries between academic departments and clinical practice. This is leading to a supportive environment for primary care research. There is thus a need to develop and validate nationally accepted quality standards and accreditation of performance to ensure that funders, collaborators and primary care professionals can deliver high quality primary care research. Several strategies have been described in national policy documents in order to achieve an improvement in teaching and clinical care, as well as enhancing research capacity in primary care. The development of both research practices and primary care research networks has been recognised as having an important contribution to make in enabling health professionals to devote more protected time to undertake research methods training and to undertake research in a service setting. The recognition and development of primary care research has also brought with it an emphasis on quality and standards, including an approach to the new research governance framework. PRIMARY CARE RESEARCH TEAM ASSESSMENT: In 1998, the NHS Executive South and West, and later the London Research and Development Directorate, provided funding for a pilot project based at the Royal College of General Practitioners (RCGP) to develop a scheme to accredit UK general practices undertaking primary care R&D. The pilot began with initial consultation on the development of the process, as well as the standards and criteria for assessment. The resulting assessment schedule allowed for assessment at one of two levels: Collaborative Research Practice (Level I), with little direct experience of gaining project or infrastructure funding Established Research Practice (Level II), with more experience of research funding and activity and a sound infrastructure to allow for growth in capacity. The process for assessment of practices involved the assessment of written documentation, followed by a half-day assessment visit by a multidisciplinary team of three assessors. IMPLEMENTATION--THE PILOT PROJECT: Pilot practices were sampled in two regions. Firstly, in the NHS Executive South West Region, where over 150 practices expressed an interest in participating. From these a purposive sample of 21 practices was selected, providing a range of research and service activity. A further seven practices were identified and included within the project through the East London and Essex Network of Researchers (ELENoR). Many in this latter group received funding and administrative support and advice from ELENoR in order to prepare written submissions for assessment. Some sample loss was encountered within the pilot project, which was attributable largely to conflicting demands on participants' time. Indeed, the preparation of written submissions within the South West coincided with the introduction of primary care groups (PCGs) in April 1999, which several practices cited as having a major impact on their participation in the pilot project. A final sample of 15 practices (nine in the South West and six through ELENoR) underwent assessment through the pilot project. EVALUATION: A formal evaluation of the Primary Care Research Team Assessment (PCRTA) pilot was undertaken by an independent researcher (FM). This was supplemented with feedback from the assessment team members. The qualitative aspect of the evaluation, which included face-to-face and telephone interviews with assessors, lead researchers and other practice staff within the pilot research practices, as well as members of the project management group, demonstrated a positive view of the pilot scheme. Several key areas were identified in relation to particular strengths of research practices and areas for development including: Strengths Level II practices were found to have a strong primary care team ethos in research. Level II practices tended to have a greater degree of strategic thinking in relation to research. Development areas Level I practices were found to lack a clear and explicit research strategy. Practices at both levels had scope to develop their communication processes for dissemination of research and also for patient involvement. Practices at both levels needed mechanisms for supporting professional development in research methodology. The evaluation demonstrated that practices felt that they had gained from their participation and assessors felt that the scheme had worked well. Some specific issues were raised by different respondents within the qualitative evaluation relating to consistency of interpretation of standards and also the possible overlap of the assessment scheme with other RCGP quality initiatives. NATIONAL IMPLEMENTATION OF THE PRIMARY CARE RESEARCH TEAM ASSESSMENT: The pilot project has been very successful and recommendations have been made to progress to a UK scheme. Management and review of the scheme will remain largely the same, with a few changes focusing on the assessment process and support for practices entering the scheme. Specific changes include: development of the support and mentoring role of the primary care research networks increased peer and external support and mentoring for research practices undergoing assessment development of assessor training in line with other schemes within the RCGP Assessment Network work to ensure consistency across RCGP accreditation schemes in relation to key criteria, thereby facilitating comparable assessment processes refinement of the definition of the two groups, with Level I practices referred to as Collaborators and Level II practices as Investigator-Led. The project has continued to generate much enthusiasm and support and continues to reflect current policy. Indeed, recent developments include the proposed new funding arrangements for primary care R&D, which refer to the RCGP assessment scheme and recognise it as a key component in the future R&D agenda. The assessment scheme will help primary care trusts (PCTs) and individual practices to prepare and demonstrate their approach to research governance in a systematic way. It will also provide a more explicit avenue for primary care trusts to explore local service and development priorities identified within health improvement programmes and the research priorities set nationally for the NHS.
PMCID: PMC2560501  PMID: 12049028
23.  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
24.  A Multifaceted Intervention to Implement Guidelines and Improve Admission Paediatric Care in Kenyan District Hospitals: A Cluster Randomised Trial 
PLoS Medicine  2011;8(4):e1001018.
Philip Ayieko and colleagues report the outcomes of a cluster-randomized trial carried out in eight Kenyan district hospitals evaluating the effects of a complex intervention involving improved training and supervision for clinicians. They found a higher performance of hospitals assigned to the complex intervention on a variety of process of care measures, as compared to those receiving the control intervention.
Background
In developing countries referral of severely ill children from primary care to district hospitals is common, but hospital care is often of poor quality. However, strategies to change multiple paediatric care practices in rural hospitals have rarely been evaluated.
Methods and Findings
This cluster randomized trial was conducted in eight rural Kenyan district hospitals, four of which were randomly assigned to a full intervention aimed at improving quality of clinical care (evidence-based guidelines, training, job aides, local facilitation, supervision, and face-to-face feedback; n = 4) and the remaining four to control intervention (guidelines, didactic training, job aides, and written feedback; n = 4). Prespecified structure, process, and outcome indicators were measured at baseline and during three and five 6-monthly surveys in control and intervention hospitals, respectively. Primary outcomes were process of care measures, assessed at 18 months postbaseline.
In both groups performance improved from baseline. Completion of admission assessment tasks was higher in intervention sites at 18 months (mean = 0.94 versus 0.65, adjusted difference 0.54 [95% confidence interval 0.05–0.29]). Uptake of guideline recommended therapeutic practices was also higher within intervention hospitals: adoption of once daily gentamicin (89.2% versus 74.4%; 17.1% [8.04%–26.1%]); loading dose quinine (91.9% versus 66.7%, 26.3% [−3.66% to 56.3%]); and adequate prescriptions of intravenous fluids for severe dehydration (67.2% versus 40.6%; 29.9% [10.9%–48.9%]). The proportion of children receiving inappropriate doses of drugs in intervention hospitals was lower (quinine dose >40 mg/kg/day; 1.0% versus 7.5%; −6.5% [−12.9% to 0.20%]), and inadequate gentamicin dose (2.2% versus 9.0%; −6.8% [−11.9% to −1.6%]).
Conclusions
Specific efforts are needed to improve hospital care in developing countries. A full, multifaceted intervention was associated with greater changes in practice spanning multiple, high mortality conditions in rural Kenyan hospitals than a partial intervention, providing one model for bridging the evidence to practice gap and improving admission care in similar settings.
Trial registration
Current Controlled Trials ISRCTN42996612
Please see later in the article for the Editors' Summary
Editors' Summary
Background
In 2008, nearly 10 million children died in early childhood. Nearly all these deaths were in low- and middle-income countries—half were in Africa. In Kenya, for example, 74 out every 1,000 children born died before they reached their fifth birthday. About half of all childhood (pediatric) deaths in developing countries are caused by pneumonia, diarrhea, and malaria. Deaths from these common diseases could be prevented if all sick children had access to quality health care in the community (“primary” health care provided by health centers, pharmacists, family doctors, and traditional healers) and in district hospitals (“secondary” health care). Unfortunately, primary health care facilities in developing countries often lack essential diagnostic capabilities and drugs, and pediatric hospital care is frequently inadequate with many deaths occurring soon after admission. Consequently, in 1996, as part of global efforts to reduce childhood illnesses and deaths, the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) introduced the Integrated Management of Childhood Illnesses (IMCI) strategy. This approach to child health focuses on the well-being of the whole child and aims to improve the case management skills of health care staff at all levels, health systems, and family and community health practices.
Why Was This Study Done?
The implementation of IMCI has been evaluated at the primary health care level, but its implementation in district hospitals has not been evaluated. So, for example, interventions designed to encourage the routine use of WHO disease-specific guidelines in rural pediatric hospitals have not been tested. In this cluster randomized trial, the researchers develop and test a multifaceted intervention designed to improve the implementation of treatment guidelines and admission pediatric care in district hospitals in Kenya. In a cluster randomized trial, groups of patients rather than individual patients are randomly assigned to receive alternative interventions and the outcomes in different “clusters” of patients are compared. In this trial, each cluster is a district hospital.
What Did the Researchers Do and Find?
The researchers randomly assigned eight Kenyan district hospitals to the “full” or “control” intervention, interventions that differed in intensity but that both included more strategies to promote implementation of best practice than are usually applied in Kenyan rural hospitals. The full intervention included provision of clinical practice guidelines and training in their use, six-monthly survey-based hospital assessments followed by face-to-face feedback of survey findings, 5.5 days training for health care workers, provision of job aids such as structured pediatric admission records, external supervision, and the identification of a local facilitator to promote guideline use and to provide on-site problem solving. The control intervention included the provision of clinical practice guidelines (without training in their use) and job aids, six-monthly surveys with written feedback, and a 1.5-day lecture-based seminar to explain the guidelines. The researchers compared the implementation of various processes of care (activities of patients and doctors undertaken to ensure delivery of care) in the intervention and control hospitals at baseline and 18 months later. The performance of both groups of hospitals improved during the trial but more markedly in the intervention hospitals than in the control hospitals. At 18 months, the completion of admission assessment tasks and the uptake of guideline-recommended clinical practices were both higher in the intervention hospitals than in the control hospitals. Moreover, a lower proportion of children received inappropriate doses of drugs such as quinine for malaria in the intervention hospitals than in the control hospitals.
What Do These Findings Mean?
These findings show that specific efforts are needed to improve pediatric care in rural Kenya and suggest that interventions that include more approaches to changing clinical practice may be more effective than interventions that include fewer approaches. These findings are limited by certain aspects of the trial design, such as the small number of participating hospitals, and may not be generalizable to other hospitals in Kenya or to hospitals in other developing countries. Thus, although these findings seem to suggest that efforts to implement and scale up improved secondary pediatric health care will need to include more than the production and dissemination of printed materials, further research including trials or evaluation of test programs are necessary before widespread adoption of any multifaceted approach (which will need to be tailored to local conditions and available resources) can be contemplated.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001018.
WHO provides information on efforts to reduce global child mortality and on Integrated Management of Childhood Illness (IMCI); the WHO pocket book “Hospital care for children contains guidelines for the management of common illnesses with limited resources (available in several languages)
UNICEF also provides information on efforts to reduce child mortality and detailed statistics on child mortality
The iDOC Africa Web site, which is dedicated to improving the delivery of hospital care for children and newborns in Africa, provides links to the clinical guidelines and other resources used in this study
doi:10.1371/journal.pmed.1001018
PMCID: PMC3071366  PMID: 21483712
25.  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

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