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1.  The Australian preventive health agenda: what will this mean for workforce development? 
The formation of the National Health and Hospitals Reform Commission (NHHRC) and the National Preventative Task Force in 2008, demonstrate a renewed Australian Government commitment to health reform. The re-focus on prevention, bringing it to the centre of health care has significant implications for health service delivery in the primary health care setting, supportive organisational structures and continuing professional development for the existing clinical and public health workforce. It is an opportune time, therefore, to consider new approaches to workforce development aligned to health policy reform. Regardless of the actual recommendations from the NHHRC in June 2009, there will be an emphasis on performance improvements which are accountable and aligned to new preventive health policy, organisational priorites and anticipated improved health outcomes.
To achieve this objective there will be a need for the existing population health workforce, primary health care and non-government sectors to increase their knowledge and understanding of prevention, promotion and protection theory and practice within new organisational frameworks and linked to the community. This shift needs to be part of a national health services research agenda, infrastructure and funding which is supportive of quality continuing professional development.
This paper discusses policy and practice issues related to workforce development as part of an integrated response to the preventive agenda.
doi:10.1186/1743-8462-6-14
PMCID: PMC2696455  PMID: 19463159
2.  “Working the System”—British American Tobacco's Influence on the European Union Treaty and Its Implications for Policy: An Analysis of Internal Tobacco Industry Documents 
PLoS Medicine  2010;7(1):e1000202.
Katherine Smith and colleagues investigate the ways in which British American Tobacco influenced the European Union Treaty so that new EU policies advance the interests of major corporations, including those that produce products damaging to health.
Background
Impact assessment (IA) of all major European Union (EU) policies is now mandatory. The form of IA used has been criticised for favouring corporate interests by overemphasising economic impacts and failing to adequately assess health impacts. Our study sought to assess how, why, and in what ways corporations, and particularly the tobacco industry, influenced the EU's approach to IA.
Methods and Findings
In order to identify whether industry played a role in promoting this system of IA within the EU, we analysed internal documents from British American Tobacco (BAT) that were disclosed following a series of litigation cases in the United States. We combined this analysis with one of related literature and interviews with key informants. Our analysis demonstrates that from 1995 onwards BAT actively worked with other corporate actors to successfully promote a business-oriented form of IA that favoured large corporations. It appears that BAT favoured this form of IA because it could advance the company's European interests by establishing ground rules for policymaking that would: (i) provide an economic framework for evaluating all policy decisions, implicitly prioritising costs to businesses; (ii) secure early corporate involvement in policy discussions; (iii) bestow the corporate sector with a long-term advantage over other actors by increasing policymakers' dependence on information they supplied; and (iv) provide businesses with a persuasive means of challenging potential and existing legislation. The data reveal that an ensuing lobbying campaign, largely driven by BAT, helped secure binding changes to the EU Treaty via the Treaty of Amsterdam that required EU policymakers to minimise legislative burdens on businesses. Efforts subsequently focused on ensuring that these Treaty changes were translated into the application of a business orientated form of IA (cost–benefit analysis [CBA]) within EU policymaking procedures. Both the tobacco and chemical industries have since employed IA in apparent attempts to undermine key aspects of European policies designed to protect public health.
Conclusions
Our findings suggest that BAT and its corporate allies have fundamentally altered the way in which all EU policy is made by making a business-oriented form of IA mandatory. This increases the likelihood that the EU will produce policies that advance the interests of major corporations, including those that produce products damaging to health, rather than in the interests of its citizens. Given that the public health community, focusing on health IA, has largely welcomed the increasing policy interest in IA, this suggests that urgent consideration is required of the ways in which IA can be employed to undermine, as well as support, effective public health policies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
The primary goal of public health, the branch of medicine concerned with the health of communities, is to improve lives by preventing disease. Public-health groups do this by assessing and monitoring the health of communities, by ensuring that populations have access to appropriate and cost-effective health care, and by helping to formulate public policies that safeguard human health. Until recently, most of the world's major public-health concerns related to infectious diseases. Nowadays, however, many major public-health concerns are linked to the goods made and marketed by large corporations such as fast food, alcohol, tobacco, and chemicals. In Europe, these corporations are regulated by policies drawn up both by member states and by the European Commission, the executive organ of the European Union (EU; an economic and political partnership among 27 democratic European countries). Thus, for example, the tobacco industry, which is widely recognized as a driver of the smoking epidemic, is regulated by Europe-wide tobacco control policies and member state level policies.
Why Was This Study Done?
Since 1997, the European Commission has been required by law to assess the economic, social (including health), and environmental consequences of new policy initiatives using a process called an “impact assessment” (IA). Because different types of IA examine the likely effects of policies on different aspects of daily life—a health impact assessment, for example, focuses on a policy's effect on health—the choice of IA can lead to different decisions being taken about new policies. Although the IA tool adopted by the European Commission aims to assess economic, environmental and social impacts, independent experts suggest this tool does not adequately assess health impacts. Instead, economic impacts receive the most attention, a situation that may favour the interests of large businesses. In this study, the researchers seek to identify how and why the EU's approach to IA developed. More specifically, the researchers analyze internal documents from British American Tobacco (BAT), which have been disclosed because of US litigation cases, to find out whether industry has played a role in promoting the EU's system of IA.
What Did the Researchers Do and Find?
The researchers analyzed 714 BAT internal documents (identified by searching the Legacy Tobacco Documents Library, which contains more than 10 million internal tobacco company documents) that concerned attempts made by BAT to influence regulatory reforms in Europe. They also analyzed related literature from other sources (for example, academic publications) and interviewed 16 relevant people (including people who had worked at the European Commission). This analysis shows that from 1995, BAT worked with other businesses to promote European regulatory reforms (in particular, the establishment of a business-orientated form of IA) that favor large corporations. A lobbying campaign, initiated by BAT but involving a “policy network” of other companies, first helped to secure binding changes to the EU Treaty that require policymakers to minimize legislative burdens on businesses. The analysis shows that after achieving this goal, which BAT described as an “important victory,” further lobbying ensured that these treaty changes were translated into the implementation of a business-orientated form of IA within the EU. Both the tobacco industry and the chemical industry, the researchers argue, have since used the IA to delay and/or weaken EU legislation intended to protect public health.
What Do These Findings Mean?
These findings suggest that BAT and its corporate allies have fundamentally altered the way in which EU policy is made by ensuring that all significant EU policy decisions have to be assessed using a business-orientated IA. As the authors note, this situation increases the likelihood that the EU will produce policies that favor big business rather than the health of its citizens. Furthermore, these findings suggest that by establishing a network of other industries to help in lobbying for EU Treaty changes, BAT was able to distance itself from the push to establish a business-orientated IA to the extent that Commission officials were unaware of the involvement of the tobacco industry in campaigns for IA. Thus, in future, to safeguard public health, policymakers and public-health groups must pay more attention to corporate efforts to shape decision-making processes. In addition, public-health groups must take account of the ways in which IA can be used to undermine as well as support effective public-health policies and they must collaborate more closely in their efforts to ensure effective national and international policy.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/0.1371/journal.pmed.1000202.
Wikipedia has a page on public health (note that Wikipedia is a free online encyclopedia that anyone can edit; available in several languages)
More information on the European Union (in several languages), on public health in the European Union, and on impact assessment by the European Commission is available
The Legacy Tobacco Documents Library is a public, searchable database of tobacco company internal documents detailing their advertising, manufacturing, marketing, sales, and scientific activities
The World Health Organization provides information about the dangers of tobacco (in several languages)
The Smoke Free Partnership contains more information about smoking prevalence in Europe and about European policies to tackle the public health issues associated with tobacco use
For more information about tobacco industry influence on policy see the 2009 World Health Organization report on tobacco industry interference with tobacco control
doi:10.1371/journal.pmed.1000202
PMCID: PMC2797088  PMID: 20084098
3.  Mental health research and evaluation in multicultural Australia: developing a culture of inclusion 
Introduction
Cultural and linguistic diversity is a core feature of the Australian population and a valued element of national identity. The proportion of the population that will be overseas-born is projected to be 32% by 2050. While a very active process of mental health system reform has been occurring for more than two decades - at national and state and territory levels - the challenges presented by cultural and linguistic diversity have not been effectively met. A key area in which this is particularly an issue is in the collection, analysis and reporting of mental health data that reflect the reality of population diversity. The purpose of this study was to examine: what is known about the mental health of immigrant and refugee communities in Australia; whether Australian mental health research pays adequate attention to the fact of cultural and linguistic diversity in the Australian population; and whether national mental health data collections support evidence-informed mental health policy and practice and mental health reform in multicultural Australia.
Methods
The study consisted of three components – a brief review of what is known about mental health in, and mental health service use by, immigrant and refugee communities; an examination of national data collections to determine the extent to which relevant cultural variables are included in the collections; and an examination of Australian research to determine the extent to which immigrant and refugee communities are included as participants in such research.
Results
The review of Australian research on mental health of immigrant and refugee communities and their patterns of mental health service use generated findings that are highly variable. The work is fragmented and usually small-scale. There are multiple studies of some immigrant and refugee communities and there are no studies of others. Although there is a broadly consistent pattern of lower rates of utilisation of specialist public mental health services by immigrants and refugees the absence of adequate population epidemiological data prevents judgments about whether the observed patterns constitute under-utilisation. There are virtually no data on quality of service outcomes. The examination of national data collections revealed multiple gaps in these data collections. The review of papers published in four key Australian journals to determine whether immigrants and refugees are included in mental health research studies revealed a high rate (9.1%) of specific exclusion from studies (usually due to low English fluency) and a much higher rate of general neglect of the issue of population diversity in study design and reporting.
Conclusions
While there are many positive statements of policy intent in relation to immigrant and refugee communities in national mental health policies and strategies there is virtually no reporting by Commonwealth or State and Territory governments of whether policies that are relevant to immigrant and refugee communities are effectively implemented. It is not possible, on the basis of the data collected, to determine whether immigrant and refugee communities are benefiting from the mental health system reforms that are being actively carried out. The majority of Australian mental health research does not adequately include immigrant and refugee samples. On the basis of the findings of this study eight strategies have been recommended that will contribute to the development of a culture of inclusion of all Australians in the national mental health research enterprise.
doi:10.1186/1752-4458-7-23
PMCID: PMC3852843  PMID: 24093216
4.  How evidence-based workforce planning in Australia is informing policy development in the retention and distribution of the health workforce 
Background
Australia’s health workforce is facing significant challenges now and into the future. Health Workforce Australia (HWA) was established by the Council of Australian Governments as the national agency to progress health workforce reform to address the challenges of providing a skilled, innovative and flexible health workforce in Australia. HWA developed Australia’s first major, long-term national workforce projections for doctors, nurses and midwives over a planning horizon to 2025 (called Health Workforce 2025; HW 2025), which provided a national platform for developing policies to help ensure Australia’s health workforce meets the community’s needs.
Methods
A review of existing workforce planning methodologies, in concert with the project brief and an examination of data availability, identified that the best fit-for-purpose workforce planning methodology was the stock and flow model for estimating workforce supply and the utilisation method for estimating workforce demand. Scenario modelling was conducted to explore the implications of possible alternative futures, and to demonstrate the sensitivity of the model to various input parameters. Extensive consultation was conducted to test the methodology, data and assumptions used, and also influenced the scenarios selected for modelling. Additionally, a number of other key principles were adopted in developing HW 2025 to ensure the workforce projections were robust and able to be applied nationally.
Results
The findings from HW 2025 highlighted that a ‘business as usual’ approach to Australia’s health workforce is not sustainable over the next 10 years, with a need for co-ordinated, long-term reforms by government, professions and the higher education and training sector for a sustainable and affordable health workforce. The main policy levers identified to achieve change were innovation and reform, immigration, training capacity and efficiency and workforce distribution.
Conclusion
While HW 2025 has provided a national platform for health workforce policy development, it is not a one-off project. It is an ongoing process where HWA will continue to develop and improve health workforce projections incorporating data and methodology improvements to support incremental health workforce changes.
doi:10.1186/1478-4491-12-7
PMCID: PMC3922608  PMID: 24490586
Workforce planning; Workforce projections
5.  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
6.  (Re)form with Substance? Restructuring and governance in the Australian health system 2004/05 
The Australian health system has been the subject of multiple reviews and reorganisations over the last twenty years or more. The year 2004–2005 was no different.
This paper reviews the reforms, (re)structures and governance arrangements in place at both the national and state/territory levels in the last year. At the national level some progress has been made in 2004/05 through the Australian Health Ministers' Council and there is now a national health reform agenda, albeit not a comprehensive one, endorsed by the Council of Australian Governments (COAG) in June 2005. Quality and safety was an increasing focus in 2004–2005 at both the national and jurisdictional levels, as was the need for workforce reform. Although renewed policy attention was given to the need to better integrate and coordinate health care, there is little evidence of any real progress this last year. More progress was made on a national approach to workforce reform.
At the jurisdictional level, the usual rounds of reviews and restructuring occurred in several jurisdictions and, in 2005, they are organisationally very different from each other. The structure and effectiveness of jurisdictional health authorities are now more important. All health authorities are being expected to drive an ambitious set of national and local reforms. At the same time, most have now blurred the boundary between policy and service delivery and are devoting significant resources to centrally 'crisis managing' their service systems. These same reasons led to decentralisation in previous restructuring cycles. While there were many changes in 2004–2005, and a new national report to COAG on health reform is expected at the end of 2005, based on current evidence there is little room for optimism about the prospects for real progress.
doi:10.1186/1743-8462-2-19
PMCID: PMC1208850  PMID: 16120207
7.  Nursing education reform in South Africa – lessons from a policy analysis study 
Global Health Action  2014;7:10.3402/gha.v7.26401.
Background
Nursing education reform is identified as an important strategy for enhancing health workforce performance, and thereby improving the functioning of health systems. Globally, a predominant trend in such reform is towards greater professionalisation and university-based education. Related nursing education reform in South Africa culminated in a new Framework for Nursing Qualifications in 2013.
Objective
We undertook a policy analysis study of the development of the new Nursing Qualifications Framework in South Africa.
Design
We used a policy analysis framework derived from Walt and Gilson that interrogated the context, content, actors, and processes of policy development and implementation. Following informed consent, in-depth interviews were conducted with 28 key informants from national and provincial government; the South African Nursing Council; the national nursing association; nursing academics, managers, and educators; and other nursing organisations. The interviews were complemented with a review of relevant legislation and policy documents. Documents and interview transcripts were coded thematically using Atlas-ti software.
Results
The revision of nursing qualifications was part of the post-apartheid transformation of nursing, but was also influenced by changes in the education sector. The policy process took more than 10 years to complete and the final Regulations were promulgated in 2013. The two most important changes are the requirement for a baccalaureate degree to qualify as a professional nurse and abolishing the enrolled nurse with 2 years training in favour of a staff nurse with a 3-year college diploma. Respondents criticised slow progress, weak governance by the Nursing Council and the Department of Health, limited planning for implementation, and the inappropriateness of the proposals for South Africa.
Conclusions
The study found significant weaknesses in the policy capacity of the main institutions responsible for the leadership and governance of nursing in South Africa, which will need to be addressed if important nursing education reforms are to be realised.
doi:10.3402/gha.v7.26401
PMCID: PMC4275647  PMID: 25537941
nursing; nursing education; professionalisation; policy analysis; education reform; South Africa
8.  Culture, class, and service delivery: The politics of welfare reform and an urban bioethics Agenda 
Conclusion
Culture and class remain contested terrains in policy narratives about the right of the urban poor to access health and social services delivery systems under welfare reform. An urban bioethics agenda is needed to address these dilemmas that have arisen in the context of PRWORA and had an impact on access to health and social services in the urban environment.2;18 Such efforts, however, must address the intellectual framing of the urban poor, as well as the public policies that inscribe deterministic and stereotypical ideas about the poor alongside incomplete portraits of barriers to greater social and occupational mobility.
The focus of social science researchers on the delineation of behavioral characteristics among an urban “underclass” in some instances further marginalizes and stigmatizes an already isolated urban poor. Even though Wilson, the Harvard sociologist who popularized the term “underclass” in his earlier research, has now largely disowned it, tales and stories a bound in the social policy and health literature. The media also commonly underscore perceptions that establish rumor as social science and promote stereotypes that the poor are lazy and unwilling to work. Wilson, who has analyzed contextual and neighborhood factors such as the migration of jobs to the suburbs, has also declared stance that is in opposition to those, such as New York University political science professor Lawrence Mead, who embrace a “culture of poverty” thesis and have set the tone for some welfare reform initiatives by arguing that behavior, and not joblessness, is the key, “My guess,” Mead stated after welfare reform was enacted in 1996, ”is that culture came first, and drove away the economy or the good jobs, rather than the other way around,” 21(p3)These statements continue to have dramatic impacts on the stigmas attached to public programs by promoting the idea that those in spatially concentrated radical and ethnic groups in urban areas are not members of the working class. Such perceptions have also contributed to a belief that those who participate in publicly subsidized social welfare and health insurance programs do not work.
Whether one accepts that the denial of health care to citizens and noncitizens in contemporary America derives in large part from the promotion of images of the poor as pathological, states have moved steadily to institute a variety of policies under welfare reform that continue to prescribe narrower eligibility criteria for access to service delivery systems. This is occurring as the US Congress hesitates to restore excluded populations, and there are reports of questionable practices targeted at those who are eligible based on current legislation. On several occasions, for example, the Civil Rights Division of the US Department of Health and Human Services has made inquiries (and issued sanctions) in cases for which state and local governments have discriminated against potential Medicaid and TANF applicants by ignoring regulations that stipulate that applications be delivered to applicants on request in a timely manner.3
While it is the explicit responsibility under welfare reform of the US Congress to pass legislation restoring eligibility to excluded populations, an urban bioethics agenda framed in a historical context has much to offer prevailing policy discourses. If, as political theorist Stone notes, a policy alternative is to be judged “by the company that it keeps,” then urban bioethicists can offer human rights paradigms and additional policy alternatives based an assessments of earlier historical experiences of stigmatization that embodied similar forms of evil.23
doi:10.1093/jurban/78.1.81
PMCID: PMC3456202  PMID: 11368206
9.  How Does Medical Device Regulation Perform in the United States and the European Union? A Systematic Review 
PLoS Medicine  2012;9(7):e1001276.
Aaron Kesselheim and colleagues conduct a systematic review to examine the strengths and weaknesses associated with approaches to medical device regulation in the US and EU.
Background
Policymakers and regulators in the United States (US) and the European Union (EU) are weighing reforms to their medical device approval and post-market surveillance systems. Data may be available that identify strengths and weakness of the approaches to medical device regulation in these settings.
Methods and Findings
We performed a systematic review to find empirical studies evaluating medical device regulation in the US or EU. We searched Medline using two nested categories that included medical devices and glossary terms attributable to the US Food and Drug Administration and the EU, following PRISMA guidelines for systematic reviews. We supplemented this search with a review of the US Government Accountability Office online database for reports on US Food and Drug Administration device regulation, consultations with local experts in the field, manual reference mining of selected articles, and Google searches using the same key terms used in the Medline search. We found studies of premarket evaluation and timing (n = 9), studies of device recalls (n = 8), and surveys of device manufacturers (n = 3). These studies provide evidence of quality problems in pre-market submissions in the US, provide conflicting views of device safety based largely on recall data, and relay perceptions of some industry leaders from self-surveys.
Conclusions
Few studies have quantitatively assessed medical device regulation in either the US or EU. Existing studies of US and EU device approval and post-market evaluation performance suggest that policy reforms are necessary for both systems, including improving classification of devices in the US and promoting transparency and post-market oversight in the EU. Assessment of regulatory performance in both settings is limited by lack of data on post-approval safety outcomes. Changes to these device approval and post-marketing systems must be accompanied by ongoing research to ensure that there is better assessment of what works in either setting.
Please see later in the article for the Editors' Summary.
Editors' Summary
Background
Medical devices—health technologies that are not medicines, vaccines, or clinical procedures—cover a vast range of equipment from the simple to the more complex. Medical devices are essential for patient care, and in the past decade, new devices have offered improved treatment alternatives for many diseases and conditions, leading to substantial growth in the US$350 billion medical device industry. However, new medical devices also pose substantial risks to patients, as shown in recent high-profile product recalls involving breast implants and artificial hip implants.
Why Was This Study Done?
Concerns about the safety of new medical devices have led to calls for greater testing of the safety and effectiveness of new devices before they come on the market and for improved monitoring of their performance after new devices have been approved for use by a regulatory body. In this study, the researchers systematically reviewed evidence about the performance of medical device approval and post-market surveillance systems in two of the most important world markets for medical devices—the United States and the European Union.
What Did the Researchers Do and Find?
The researchers performed a keyword search in Medline (a database of published biomedical literature) for all relevant articles, and supplemented this search with a review of reports on Food and Drug Administration (FDA) device regulation in the US Government Accountability Office's online database. Then they consulted with both US and EU experts and also conducted Google searches to capture reports by management consultant firms. The researchers included only those studies that reported empirical data, either qualitative or quantitative, about the characteristics, performance metrics, or effectiveness of device evaluation or post-market oversight in the US or EU.
Using these methods the researchers identified nine studies that focused on pre-market evaluation and timing, eight studies of device recalls, and three surveys of device manufacturers. Because of the variable quality and lack of outcomes from these studies and reports, the researchers concluded that these studies offered only limited insights into either the US or EU systems. But the available evidence does suggest that in the US, the FDA could improve oversight of device approval, for example, by following up on its commitment to reclassify high-risk medical devices and improve post-market surveillance of devices that are approved on the basis of limited data. The researchers also suggest that using recalls to measure the safety record of individual devices or classes of devices is flawed, as particular devices may be over- or underrepresented in recall data depending on the frequency of their use, design complexity, and the clinical manifestations of malfunction. In the EU, apart from a few studies addressing the timing of approval, the researchers found almost no robust data on device regulation. Some case reports suggested substantial dangers to patients in the EU from devices approved on the basis of limited data, but the researchers could not systematically compare the quality of studies used for device approval or post-approval safety outcomes between the EU and US, mainly because of the lack of transparency among the EU regulators (Notified Bodies).
What Do These Findings Mean?
These findings show that few studies have quantitatively assessed medical device regulation in either the US or EU, but the existing studies examined in this review suggest that policy reforms are necessary for both device approval and post-market evaluation of performance, including improving classification of devices in the US and promoting transparency and postmarket oversight in the EU. However, assessment of regulatory performance in both the US and EU is limited by lack of data on post-approval safety outcomes. Any changes to medical device approval and post-marketing systems should be accompanied by ongoing research and evaluation to ensure that there is an improved assessment of what works in either setting.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001276.
This study is further discussed in a PLoS Medicine Perspective by Sanket Dhruva and Rita Redberg
The WHO website has a comprehensive topic section on medical devices
Information on medical devices is also available from the FDA and the European Commission
doi:10.1371/journal.pmed.1001276
PMCID: PMC3418047  PMID: 22912563
10.  Human resources for health challenges of public health system reform in Georgia 
Background
Human resources (HR) are one of the most important components determining performance of public health system. The aim of this study was to assess adequacy of HR of local public health agencies to meet the needs emerging from health care reforms in Georgia.
Methods
We used the Human Resources for Health Action Framework, which includes six components: HR management, policy, finance, education, partnerships and leadership. The study employed: (a) quantitative methods: from September to November 2004, 30 randomly selected district Centers of Public Health (CPH) were surveyed through face-to-face interviews with the CPH director and one public health worker randomly selected from all professional staff; and (b) qualitative methods: in November 2004, Focus Group Discussions (FGD) were held among 3 groups: a) 12 district public health professionals, b) 11 directors of district public health centers, and c) 10 policy makers at central level.
Results
There was an unequal distribution of public health workers across selected institutions, with lack of professionals in remote rural district centers and overstaffing in urban centers. Survey respondents disagreed or were uncertain that public health workers possess adequate skills and knowledge necessary for delivery of public health programs. FGDs shed additional light on the survey findings that there is no clear vision and plans on HR development. Limited budget, poor planning, and ignorance from the local government were mentioned as main reasons for inadequate staffing. FGD participants were concerned with lack of good training institutions and training programs, lack of adequate legislation for HR issues, and lack of necessary resources for HR development from the government.
Conclusion
After ten years of public health system reforms in Georgia, the public health workforce still has major problems such as irrational distribution and inadequate knowledge and skills. There is an urgent need for re-training and training programs and development of conducive policy environment with sufficient resources to address these problems and assure adequate functionality of public health programs.
doi:10.1186/1478-4491-6-8
PMCID: PMC2429907  PMID: 18505585
11.  Clinical Benefits, Costs, and Cost-Effectiveness of Neonatal Intensive Care in Mexico 
PLoS Medicine  2010;7(12):e1000379.
Joshua Salomon and colleagues performed a cost-effectiveness analysis using health and economic outcomes following preterm birth in Mexico and showed that neonatal intensive care provided high value for the money in this setting.
Background
Neonatal intensive care improves survival, but is associated with high costs and disability amongst survivors. Recent health reform in Mexico launched a new subsidized insurance program, necessitating informed choices on the different interventions that might be covered by the program, including neonatal intensive care. The purpose of this study was to estimate the clinical outcomes, costs, and cost-effectiveness of neonatal intensive care in Mexico.
Methods and Findings
A cost-effectiveness analysis was conducted using a decision analytic model of health and economic outcomes following preterm birth. Model parameters governing health outcomes were estimated from Mexican vital registration and hospital discharge databases, supplemented with meta-analyses and systematic reviews from the published literature. Costs were estimated on the basis of data provided by the Ministry of Health in Mexico and World Health Organization price lists, supplemented with published studies from other countries as needed. The model estimated changes in clinical outcomes, life expectancy, disability-free life expectancy, lifetime costs, disability-adjusted life years (DALYs), and incremental cost-effectiveness ratios (ICERs) for neonatal intensive care compared to no intensive care. Uncertainty around the results was characterized using one-way sensitivity analyses and a multivariate probabilistic sensitivity analysis. In the base-case analysis, neonatal intensive care for infants born at 24–26, 27–29, and 30–33 weeks gestational age prolonged life expectancy by 28, 43, and 34 years and averted 9, 15, and 12 DALYs, at incremental costs per infant of US$11,400, US$9,500, and US$3,000, respectively, compared to an alternative of no intensive care. The ICERs of neonatal intensive care at 24–26, 27–29, and 30–33 weeks were US$1,200, US$650, and US$240, per DALY averted, respectively. The findings were robust to variation in parameter values over wide ranges in sensitivity analyses.
Conclusions
Incremental cost-effectiveness ratios for neonatal intensive care imply very high value for money on the basis of conventional benchmarks for cost-effectiveness analysis.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Most pregnancies last about 40 weeks but increasing numbers of babies are being born preterm, before they reach 37 weeks of gestation (the period during which a baby develops in its mother). In developed countries and some middle-income countries such as Mexico, improvements in the care of newborn babies (neonatal intensive care) mean that more preterm babies survive now than in the past. Nevertheless, preterm birth is still a major cause of infant death worldwide that challenges attainment of Target 5 of Millennium Development Goal 4—the reduction of the global under-five mortality rate by two-thirds of the 1990 rate by 2015 (the Millennium Development Goals, which were agreed by world leaders in 2000, aim to reduce world poverty). Furthermore, many preterm babies who survive have long-term health problems and disabilities such as cerebral palsy, deafness, or learning difficulties. The severity of these disabilities and their long-term costs to families and to society depend on the baby's degree of prematurity.
Why Was This Study Done?
Mexico recently reformed its health system in an effort to improve access to care, particularly for the poorest sections of its population, and to improve the quality of its health care. The central component of this health care reform is the System of Social Protection of Health (SSPH). The SSPH contains a family health insurance program—Seguro Popular—that aims to provide the 50 million uninsured people living in Mexico with free access to an explicit set of health care interventions. As with any insurance program, decisions have to be made about which interventions Seguro Poplar should cover. Should neonatal intensive care be covered, for example? Do the benefits of this intervention (increased survival of babies) outweigh the costs of neonatal care and of long-term care for survivors with disabilities? In other words, is neonatal intensive care cost-effective? In this study, the researchers investigate this question by estimating the clinical benefits, costs, and cost-effectiveness of neonatal intensive care in Mexico.
What Did the Researchers Do and Find?
The researchers built a decision analytic model, a mathematical model that combines evidence on the outcomes and costs of alternative treatments to help inform decisions about health care policy. They gathered data about the health outcomes of preterm births in Mexico from registers of births and deaths and from hospital discharge databases, and estimated the costs of neonatal intensive care and long-term care for disabled survivors using data from the Mexican Ministry of Health and the World Health Organization. They then applied their model, which estimates changes in parameters such as life expectancy, lifetime costs, disability-adjusted life years (DALYs; one DALY represents the loss of a year of healthy life), and incremental cost-effectiveness ratios (ICERs; the additional cost expended for each DALY averted) for neonatal intensive care compared to no intensive care, to a group of 2 million infants. Neonatal intensive care for infants born at 24–26, 27–29, and 30–33 weeks gestation prolonged life expectancy by 28, 43, and 34 years and averted 9, 15, and 12 DALYs at incremental costs of US$11,000, US$10,000, and US$3000, respectively, compared to no intensive care. The ICERs of neonatal intensive care for babies born at these times were US$1200, US$700, and US$300 per DALY averted, respectively.
What Do These Findings Mean?
Interventions with ICERs of less than a country's per capita gross domestic product (GDP) are highly cost-effective; those with ICERs of 1–3 times the per capita GDP are potentially cost-effective. Mexico's per capita GDP in 2005 was approximately US$8,200. Thus, neonatal intensive care could provide exceptional value for money in Mexico (and maybe in other middle-income countries), even for very premature babies. The accuracy of these findings inevitably depends on the assumptions used to build the decision analytic model and on the accuracy of the data fed into it, but the findings were little changed by a wide range of alterations that the researchers made to the model. Importantly, however, this cost-effectiveness analysis focuses on health and economic consequences of different intervention choices, and does not capture all aspects of well-being. Decisions regarding neonatal intensive care will need to be based on a full consideration of all relevant factors, including ethical issues, and cost-effectiveness analyses should continue to be updated as new data emerge on health outcomes and costs associated with neonatal intensive care.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1000379.
The March of Dimes, a nonprofit organization for pregnancy and baby health, provides information on preterm birth (in English and Spanish)
The Nemours Foundation, another nonprofit organization for child health, also provides information on premature babies (in English and Spanish)
MedlinePlus provides links to other information on premature babies (in English and Spanish)
The United Nations Childrens Fund (UNICEF) works for children's rights, survival, development and protection around the world; it provides information on Millennium Development Goal 4 and its Childinfo website provides detailed statistics about child survival and health (some information in several languages)
A PLoS Medicine Policy Forum by Núria Homedes and Antonio Ugalde discusses health care reforms in Mexico
doi:10.1371/journal.pmed.1000379
PMCID: PMC3001895  PMID: 21179496
12.  Who needs what from a national health research system: lessons from reforms to the English Department of Health's R&D system 
Health research systems consist of diverse groups who have some role in health research, but the boundaries around such a system are not clear-cut. To explore what various stakeholders need we reviewed the literature including that on the history of English health R&D reforms, and we also applied some relevant conceptual frameworks.
We first describe the needs and capabilities of the main groups of stakeholders in health research systems, and explain key features of policymaking systems within which these stakeholders operate in the UK. The five groups are policymakers (and health care managers), health professionals, patients and the general public, industry, and researchers. As individuals and as organisations they have a range of needs from the health research system, but should also develop specific capabilities in order to contribute effectively to the system and benefit from it.
Second, we discuss key phases of reform in the development of the English health research system over four decades - especially that of the English Department of Health's R&D system - and identify how far legitimate demands of key stakeholder interests were addressed.
Third, in drawing lessons we highlight points emerging from contemporary reports, but also attempt to identify issues through application of relevant conceptual frameworks. The main lessons are: the importance of comprehensively addressing the diverse needs of various interacting institutions and stakeholders; the desirability of developing facilitating mechanisms at interfaces between the health research system and its various stakeholders; and the importance of additional money in being able to expand the scope of the health research system whilst maintaining support for basic science.
We conclude that the latest health R&D strategy in England builds on recent progress and tackles acknowledged weaknesses. The strategy goes a considerable way to identifying and more effectively meeting the needs of key groups such as medical academics, patients and industry, and has been remarkably successful in increasing the funding for health research. There are still areas that might benefit from further recognition and resourcing, but the lessons identified, and progress made by the reforms are relevant for the design and coordination of national health research systems beyond England.
doi:10.1186/1478-4505-8-11
PMCID: PMC2881918  PMID: 20465789
13.  Universal Health Coverage for India by 2022: A Utopia or Reality? 
It is the obligation of the state to provide free and universal access to quality health-care services to its citizens. India continues to be among the countries of the world that have a high burden of diseases. The various health program and policies in the past have not been able to achieve the desired goals and objectives. 65th World Health Assembly in Geneva identified universal health coverage (UHC) as the key imperative for all countries to consolidate the public health advances. Accordingly, Planning Commission of India constituted a high level expert group (HLEG) on UHC in October 2010. HLEG submitted its report in Nov 2011 to Planning Commission on UHC for India by 2022. The recommendations for the provision of UHC pertain to the critical areas such as health financing, health infrastructure, health services norms, skilled human resources, access to medicines and vaccines, management and institutional reforms, and community participation. India faces enormous challenges to achieve UHC by 2022 such as high disease prevalence, issues of gender equality, unregulated and fragmented health-care delivery system, non-availability of adequate skilled human resource, vast social determinants of health, inadequate finances, lack of inter-sectoral co-ordination and various political pull and push of different forces, and interests. These challenges can be met by a paradigm shift in health policies and programs in favor of vulnerable population groups, restructuring of public health cadres, reorientation of undergraduate medical education, more emphasis on public health research, and extensive education campaigns. There are still areas of concern in fulfilling the objectives of achieving UHC by 2022 regarding financing model for health-care delivery, entitlement package, cost of health-care interventions and declining state budgets. However, the Government's commitment to provide adequate finances, recent bold social policy initiatives and enactments such as food security bill, enhanced participation by civil society in all health matters, major initiative by some states such as Tamil Nadu to improve health, water, and sanitation services are good enough reasons for hope that UHC can be achieved by 2022. However, in the absence of sustained financial support, strong political will and leadership, dedicated involvement of all stakeholders and community participation, attainment of UHC by 2022 will remain a Utopia.
doi:10.4103/0970-0218.112430
PMCID: PMC3714944  PMID: 23878417
Management reforms; public health; reality; universal health care; utopia
14.  Health systems research in the time of health system reform in India: a review 
Background
Research on health systems is an important contributor to improving health system performance. Importantly, research on program and policy implementation can also create a culture of public accountability. In the last decade, significant health system reforms have been implemented in India. These include strengthening the public sector health system through the National Rural Health Mission (NRHM), and expansion of government-sponsored insurance schemes for the poor. This paper provides a situation analysis of health systems research during the reform period.
Methods
We reviewed 9,477 publications between 2005 and 2013 in two online databases, PubMed and IndMED. Articles were classified according to the WHO classification of health systems building blocks.
Results
Our findings indicate the number of publications on health systems progressively increased every year from 92 in 2006 to 314 in 2012. The majority of papers were on service delivery (40%), with fewer on information (16%), medical technology and vaccines (15%), human resources (11%), governance (5%), and financing (8%). Around 70% of articles were lead by an author based in India, the majority by authors located in only four states. Several states, particularly in eastern and northeastern India, did not have a single paper published by a lead author located in a local institution. Moreover, many of these states were not the subject of a single published paper. Further, a few select institutions produced the bulk of research. Of the foreign author lead papers, 77% came from five countries (USA, UK, Canada, Australia, and Switzerland).
Conclusions
The growth of published research during the reform period in India is a positive development. However, bulk of this research is produced in a few states and by a few select institutions Further strengthening health systems research requires attention to neglected health systems domains like human resources, financing, and governance. Importantly, research capacity needs to be strengthened in states and institutions that have a scarcity of researchers, as well as states that have been the focus of little research. While more funding for health systems research is required, this funding needs to be targeted at deficient health systems domains, geographical areas, and institutions.
doi:10.1186/1478-4505-12-37
PMCID: PMC4134119  PMID: 25106759
15.  Integration of care systems in Portugal: anatomy of recent reforms 
Background
Integrated care is increasingly present in the agenda of policy-makers, health professionals and researchers as a way to improve care services in relation to access, quality, user satisfaction and efficiency. These are overarching objectives of most sectoral reforms. However, health care and social care services and systems are more and more dependent on the performance of each other, imposing the logic of network. Demographic, epidemiologic and cultural changes result in pressure to increase efficiency and efficacy of services and organisations in both sectors and that is why integrated care has become so relevant in the last years.
Methods
We first used concept maps to organise and systematise information that we had gathered through deep literature review in order to set a framework where to base the subsequent work. Then, we interviewed informants at several levels of the health and social care systems and we built a list of major recent reforms addressing integrated care in Portugal. In a third step, we conducted two independent focus groups where those reforms were discussed and evaluated within the context of the concepts and frameworks identified from the literature. Results were confronted and reconciled, giving place to a list of requisites and guidelines that oriented further search for documentation on those reforms.
Results
Several important health reforms are in course in primary and hospital care in Portugal, while a so-called third level of care has been introduced with the launch of the National Network of Long-Term Integrated Care (RNCCI – Rede Nacional de Cuidados Continuados Integrados). The social care sector has itself been a subject of alternative models springing from opposite political orientations. All these changes are having repercussions on the way the systems work with each other as they are leading to ongoing and ill-evaluated reformulations on the way they are governed, financed, structured and operated.
Conclusions
Care integration is not absent from policy-making and implementation endeavour in Portugal. However, recurrent issues seem to be consistently hampering the efforts regarding the integration of care in the country. It is urgent to assess current situation as experienced by those closely involved and directly affected.
PMCID: PMC4113913  PMID: 25114663
care systems integration; health care reform; social care reform; Portugal
16.  Political determinants of Health: Lessons for Pakistan 
There is much concern about the capacity of the health system of Pakistan to meet its goals and obligations. Historically, the political thrust has been absent from the health policy formulation and this is reflected in the low and stagnant public allocations to health. Successive political leaderships have averred from considering healthcare is a common good rather than a market commodity and health has not been recognized as a constitutional right. Over 120 of world’s nation states have accepted health as a constitutional right but the 1973 Constitution of Pakistan does not mandate health or education as a fundamental right and the recently adopted 18th constitutional amendment missed the opportunity to extend access to primary health care as an obligation of the State. It is argued in this communication that missing from the calculations of policy formulation and agenda setting is the political benefits of providing health and other social services to underserved populations. Across the developing world, many examples are presented of governments undertaking progressive health reforms that bring services where none existed and subsequently reaping electoral benefit. The political determinant of healthcare will be realized when the political leaders of poorly performing countries can be convinced that embracing distributive policies and successfully bringing healthcare to the poor can be major factors in their re-elections.
doi:10.12669/pjms.303.5487
PMCID: PMC4048485  PMID: 24948958
Politics; Social Determinants of Health; Policy; Pakistan
17.  General practice and the New Zealand health reforms – lessons for Australia? 
New Zealand's health sector has undergone three significant restructures within 10 years. The most recent has involved a Primary Health Care Strategy, launched in 2001. Primary Health Organisations (PHOs), administered by 21 District Health Boards, are the local structures for implementing the Primary Health Care Strategy. Ninety-three percent of the New Zealand population is now enrolled within 79 PHOs, which pose a challenge to the well-established Independent Practitioner Associations (IPAs).
Although there was initial widespread support for the philosophy underlying the Primary Health Care Strategy, there are concerns amongst general practitioners (GPs) and their professional organisations relating to its implementation. These centre around 6 main issues:
1. Loss of autonomy
2. Inadequate management funding and support
3. Inconsistency and variations in contracting processes
4. Lack of publicity and advice around enrolment issues
5. Workforce and workload issues
6. Financial risks
On the other hand, many GPs are feeling positive regarding the opportunities for PHOs, particularly for being involved in the provision of a wider range of community health services. Australia has much to learn from New Zealand's latest health sector and primary health care reforms.
The key lessons concern:
• the need for a national primary health care strategy
• active engagement of general practitioners and their professional organisations
• recognition of implementation costs
• the need for infrastructural support, including information technology and quality systems
• robust management and governance arrangements
• issues related to critical mass and population/distance trade offs in service delivery models
doi:10.1186/1743-8462-2-26
PMCID: PMC1291356  PMID: 16262908
18.  Human resources for health policies: a critical component in health policies 
In the last few years, increasing attention has been paid to the development of health policies. But side by side with the presumed benefits of policy, many analysts share the opinion that a major drawback of health policies is their failure to make room for issues of human resources. Current approaches in human resources suggest a number of weaknesses: a reactive, ad hoc attitude towards problems of human resources; dispersal of accountability within human resources management (HRM); a limited notion of personnel administration that fails to encompass all aspects of HRM; and finally the short-term perspective of HRM.
There are three broad arguments for modernizing the ways in which human resources for health are managed:
• the central role of the workforce in the health sector;
• the various challenges thrown up by health system reforms;
• the need to anticipate the effect on the health workforce (and consequently on service provision) arising from various macroscopic social trends impinging on health systems.
The absence of appropriate human resources policies is responsible, in many countries, for a chronic imbalance with multifaceted effects on the health workforce: quantitative mismatch, qualitative disparity, unequal distribution and a lack of coordination between HRM actions and health policy needs.
Four proposals have been put forward to modernize how the policy process is conducted in the development of human resources for health (HRH):
• to move beyond the traditional approach of personnel administration to a more global concept of HRM;
• to give more weight to the integrated, interdependent and systemic nature of the different components of HRM when preparing and implementing policy;
• to foster a more proactive attitude among human resources (HR) policy-makers and managers;
• to promote the full commitment of all professionals and sectors in all phases of the process.
The development of explicit human resources policies is a crucial link in health policies and is needed both to address the imbalances of the health workforce and to foster implementation of the health services reforms.
doi:10.1186/1478-4491-1-1
PMCID: PMC166115  PMID: 12904254
19.  Shaping public opinion on the issue of childbirth; a critical analysis of articles published in an Australian newspaper 
Background
The Australian government has announced a major program of reform with the move to primary maternity care, a program of change that appears to be at odds with current general public perceptions regarding how maternity care is delivered.
Methods
A critical discourse analysis of articles published in 'The Age', a newspaper with national distribution, subsequent to the release of the discussion paper by the Australian Government in 2008 was undertaken. The purpose was to identify how Australian maternity services are portrayed and what purpose is served by this representation to the general public.
Results
Findings from this critical discourse analysis revealed that Australian maternity services are being portrayed to the general public as an inflexible outdated service struggling to meets the needs of pregnant women and in desperate need of reform. The style of reporting employed in this newspaper involved presenting to the reader the range of expert opinion relevant to each topic, frequently involving polarised positions of the experts on the issue.
Conclusions
The general public are presented with a conflict, caught between the need for changes that come with the primary maternity model of care and fear that these change will undermine safe standards. The discourse; 'Australia is one of the safest countries in which to give birth or be born, what is must be best', represents the situation where despite major deficiencies in the system the general public may be too fearful of the consequences to consider a move away from reliance on traditional medical-led maternity care.
doi:10.1186/1471-2393-11-47
PMCID: PMC3149596  PMID: 21708041
20.  Interactions between Non-Physician Clinicians and Industry: A Systematic Review 
PLoS Medicine  2013;10(11):e1001561.
In a systematic review of studies of interactions between non-physician clinicians and industry, Quinn Grundy and colleagues found that many of the issues identified for physicians' industry interactions exist for non-physician clinicians.
Please see later in the article for the Editors' Summary
Background
With increasing restrictions placed on physician–industry interactions, industry marketing may target other health professionals. Recent health policy developments confer even greater importance on the decision making of non-physician clinicians. The purpose of this systematic review is to examine the types and implications of non-physician clinician–industry interactions in clinical practice.
Methods and Findings
We searched MEDLINE and Web of Science from January 1, 1946, through June 24, 2013, according to PRISMA guidelines. Non-physician clinicians eligible for inclusion were: Registered Nurses, nurse prescribers, Physician Assistants, pharmacists, dieticians, and physical or occupational therapists; trainee samples were excluded. Fifteen studies met inclusion criteria. Data were synthesized qualitatively into eight outcome domains: nature and frequency of industry interactions; attitudes toward industry; perceived ethical acceptability of interactions; perceived marketing influence; perceived reliability of industry information; preparation for industry interactions; reactions to industry relations policy; and management of industry interactions. Non-physician clinicians reported interacting with the pharmaceutical and infant formula industries. Clinicians across disciplines met with pharmaceutical representatives regularly and relied on them for practice information. Clinicians frequently received industry “information,” attended sponsored “education,” and acted as distributors for similar materials targeted at patients. Clinicians generally regarded this as an ethical use of industry resources, and felt they could detect “promotion” while benefiting from industry “information.” Free samples were among the most approved and common ways that clinicians interacted with industry. Included studies were observational and of varying methodological rigor; thus, these findings may not be generalizable. This review is, however, the first to our knowledge to provide a descriptive analysis of this literature.
Conclusions
Non-physician clinicians' generally positive attitudes toward industry interactions, despite their recognition of issues related to bias, suggest that industry interactions are normalized in clinical practice across non-physician disciplines. Industry relations policy should address all disciplines and be implemented consistently in order to mitigate conflicts of interest and address such interactions' potential to affect patient care.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling health care goods (including drugs and devices) and services is big business. To maximize the profits they make for their shareholders, companies involved in health care build relationships with physicians by providing information on new drugs, organizing educational meetings, providing samples of their products, giving gifts, and holding sponsored events. These relationships help to keep physicians informed about new developments in health care but also create the potential for causing harm to patients and health care systems. These relationships may, for example, result in increased prescription rates of new, heavily marketed medications, which are often more expensive than their generic counterparts (similar unbranded drugs) and that are more likely to be recalled for safety reasons than long-established drugs. They may also affect the provision of health care services. Industry is providing an increasingly large proportion of routine health care services in many countries, so relationships built up with physicians have the potential to influence the commissioning of the services that are central to the treatment and well-being of patients.
Why Was This Study Done?
As a result of concerns about the tension between industry's need to make profits and the ethics underlying professional practice, restrictions are increasingly being placed on physician–industry interactions. In the US, for example, the Physician Payments Sunshine Act now requires US manufacturers of drugs, devices, and medical supplies that participate in federal health care programs to disclose all payments and gifts made to physicians and teaching hospitals. However, other health professionals, including those with authority to prescribe drugs such as pharmacists, Physician Assistants, and nurse practitioners are not covered by this legislation or by similar legislation in other settings, even though the restructuring of health care to prioritize primary care and multidisciplinary care models means that “non-physician clinicians” are becoming more numerous and more involved in decision-making and medication management. In this systematic review (a study that uses predefined criteria to identify all the research on a given topic), the researchers examine the nature and implications of the interactions between non-physician clinicians and industry.
What Did the Researchers Do and Find?
The researchers identified 15 published studies that examined interactions between non-physician clinicians (Registered Nurses, nurse prescribers, midwives, pharmacists, Physician Assistants, and dieticians) and industry (corporations that produce health care goods and services). They extracted the data from 16 publications (representing 15 different studies) and synthesized them qualitatively (combined the data and reached word-based, rather than numerical, conclusions) into eight outcome domains, including the nature and frequency of interactions, non-physician clinicians' attitudes toward industry, and the perceived ethical acceptability of interactions. In the research the authors identified, non-physician clinicians reported frequent interactions with the pharmaceutical and infant formula industries. Most non-physician clinicians met industry representatives regularly, received gifts and samples, and attended educational events or received educational materials (some of which they distributed to patients). In these studies, non-physician clinicians generally regarded these interactions positively and felt they were an ethical and appropriate use of industry resources. Only a minority of non-physician clinicians felt that marketing influenced their own practice, although a larger percentage felt that their colleagues would be influenced. A sizeable proportion of non-physician clinicians questioned the reliability of industry information, but most were confident that they could detect biased information and therefore rated this information as reliable, valuable, or useful.
What Do These Findings Mean?
These and other findings suggest that non-physician clinicians generally have positive attitudes toward industry interactions but recognize issues related to bias and conflict of interest. Because these findings are based on a small number of studies, most of which were undertaken in the US, they may not be generalizable to other countries. Moreover, they provide no quantitative assessment of the interaction between non-physician clinicians and industry and no information about whether industry interactions affect patient care outcomes. Nevertheless, these findings suggest that industry interactions are normalized (seen as standard) in clinical practice across non-physician disciplines. This normalization creates the potential for serious risks to patients and health care systems. The researchers suggest that it may be unrealistic to expect that non-physician clinicians can be taught individually how to interact with industry ethically or how to detect and avert bias, particularly given the ubiquitous nature of marketing and promotional materials. Instead, they suggest, the environment in which non-physician clinicians practice should be structured to mitigate the potentially harmful effects of interactions with industry.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001561.
This study is further discussed in a PLOS Medicine Perspective by James S. Yeh and Aaron S. Kesselheim
The American Medical Association provides guidance for physicians on interactions with pharmaceutical industry representatives, information about the Physician Payments Sunshine Act, and a toolkit for preparing Physician Payments Sunshine Act reports
The International Council of Nurses provides some guidance on industry interactions in its position statement on nurse-industry relations
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice website, which describes what is required of all registered doctors in the UK
Understanding and Responding to Pharmaceutical Promotion: A Practical Guide is a manual prepared by Health Action International and the World Health Organization that schools of medicine and pharmacy can use to train students how to recognize and respond to pharmaceutical promotion.
The Institute of Medicine's Report on Conflict of Interest in Medical Research, Education, and Practice recommends steps to identify, limit, and manage conflicts of interest
The University of California, San Francisco, Office of Continuing Medical Education offers a course called Marketing of Medicines
doi:10.1371/journal.pmed.1001561
PMCID: PMC3841103  PMID: 24302892
21.  Policy and the Re-Formation of Hospice: Lessons from the Past for the Future of Palliative Care 
During the twentieth-century, dramatic changes in the manner and location of care for the dying resulted in the conception and birth of the modern American hospice movement. Idealistic nurses, clergy, and others concerned about the plight of terminally ill cancer patients launched hospice as a necessary health care reform. As new hospice programs opened across the country, the idealism of the early leaders gave way to more pragmatic issues such as program viability. As hospice was studied and integrated into the health care system, it came to be redefined by the politics of health policy and the health care industry. As a result, there is a disarticulation between the needs of seriously ill persons and their families and the health care that is available to them. Important lessons can be learned from the history of the Medicare hospice benefit to help guide current palliative care policy initiatives. While formalized reimbursement for hospice enhanced organizational sustainability, many critical issues remain.
doi:10.1097/NJH.0b013e3182331160
PMCID: PMC3241009  PMID: 22184500
policy; hospice; Medicare; nursing; outcomes
22.  Prospects for progress on health inequalities in England in the post-primary care trust era: professional views on challenges, risks and opportunities 
BMC Public Health  2013;13:274.
Background
Addressing health inequalities remains a prominent policy objective of the current UK government, but current NHS reforms involve a significant shift in roles and responsibilities. Clinicians are now placed at the heart of healthcare commissioning through which significant inequalities in access, uptake and impact of healthcare services must be addressed. Questions arise as to whether these new arrangements will help or hinder progress on health inequalities. This paper explores the perspectives of experienced healthcare professionals working within the commissioning arena; many of whom are likely to remain key actors in this unfolding scenario.
Methods
Semi-structured interviews were conducted with 42 professionals involved with health and social care commissioning at national and local levels. These included representatives from the Department of Health, Primary Care Trusts, Strategic Health Authorities, Local Authorities, and third sector organisations.
Results
In general, respondents lamented the lack of progress on health inequalities during the PCT commissioning era, where strong policy had not resulted in measurable improvements. However, there was concern that GP-led commissioning will fare little better, particularly in a time of reduced spending. Specific concerns centred on: reduced commitment to a health inequalities agenda; inadequate skills and loss of expertise; and weakened partnership working and engagement. There were more mixed opinions as to whether GP commissioners would be better able than their predecessors to challenge large provider trusts and shift spend towards prevention and early intervention, and whether GPs’ clinical experience would support commissioning action on inequalities. Though largely pessimistic, respondents highlighted some opportunities, including the potential for greater accountability of healthcare commissioners to the public and more influential needs assessments via emergent Health & Wellbeing Boards.
Conclusions
There is doubt about the ability of GP commissioners to take clearer action on health inequalities than PCTs have historically achieved. Key actors expect the contribution from commissioning to address health inequalities to become even more piecemeal in the new arrangements, as it will be dependent upon the interest and agency of particular individuals within the new commissioning groups to engage and influence a wider range of stakeholders.
doi:10.1186/1471-2458-13-274
PMCID: PMC3621701  PMID: 23530661
Commissioning; Health inequalities; NHS; General practitioners; CCG; Restructuring
23.  Caregivers’ acceptance of alternatives to long-term psychiatric hospitalization; lessons and debates from the South Korean situation 
Background
A political movement towards building alternatives to long-term hospitalization of psychiatric patients in Korea has gained momentum. We aimed to provide sturdy foundation needed to formulate the most rational policy by review of caregiver’s opinion to the political alternatives under discussion for facilitating discharge of long-term stayed psychiatric patients in Korea.
Discussion
Caregivers in Korea, whose family members had been hospitalized longer than 6 months and all of whom applied to the Mental Health Review Board (MHRB) for an examination required for extended stay, have shown reluctance to take their patients back home. Especially, a half of them answered that if MHRB would order compulsory discharge, they would take their patients to another hospital instead of living together. Despite of those pessimistic attitudes, one of the promising solutions might be residential care as an alternative to the long-term hospital care, which is most preferred by caregivers.
Conclusion
After all, the issue of who should take an accountability of the psychiatric patients is essential in establishing mental health policy. Korean government should analyze and reform mental health delivery systems such as residential service system, community-based case management programs and hospital treatment systems including payment program which can facilitate reasonable decision by professionals as well as caregivers for the appropriate admission rather than longer term hospitalizations.
doi:10.1186/1752-4458-8-4
PMCID: PMC3898570  PMID: 24433522
24.  Urban health insurance reform and coverage in China using data from National Health Services Surveys in 1998 and 2003 
Background
In 1997 there was a major reform of the government run urban health insurance system in China. The principal aims of the reform were to widen coverage of health insurance for the urban employed and contain medical costs. Following this reform there has been a transition from the dual system of the Government Insurance Scheme (GIS) and Labour Insurance Scheme (LIS) to the new Urban Employee Basic Health Insurance Scheme (BHIS).
Methods
This paper uses data from the National Health Services Surveys of 1998 and 2003 to examine the impact of the reform on population coverage. Particular attention is paid to coverage in terms of gender, age, employment status, and income levels. Following a description of the data between the two years, the paper will discuss the relationship between the insurance reform and the growing inequities in population coverage.
Results
An examination of the data reveals a number of key points:
a) The overall coverage of the newly established scheme has decreased from 1998 to 2003.
b) The proportion of the urban population without any type of health insurance arrangement remained almost the same between 1998 and 2003 in spite of the aim of the 1997 reform to increase the population coverage.
c) Higher levels of participation in mainstream insurance schemes (i.e. GIS-LIS and BHIS) were identified among older age groups, males and high income groups. In some cases, the inequities in the system are increasing.
d) There has been an increase in coverage of the urban population by non-mainstream health insurance schemes, including non-commercial and commercial ones.
The paper discusses three important issues in relation to urban insurance coverage: institutional diversity in the forms of insurance, labour force policy and the non-mainstream forms of commercial and non-commercial forms of insurance.
Conclusion
The paper concludes that the huge economic development and expansion has not resulted in a reduced disparity in health insurance coverage, and that limited cross-group subsidy and regional inequality is possible. Unless effective measures are taken, vulnerable groups such as women, low income groups, employees based on short-term contracts and rural-urban migrant workers may well be left out of sharing the social and economic development.
doi:10.1186/1472-6963-7-37
PMCID: PMC1828155  PMID: 17335584
25.  Lithuanian health care in transitional state: ethical problems 
BMC Public Health  2005;5:117.
Background
Throughout the economic and political reforms in post-communist countries, significant changes have also occurred in public morality. One of the tasks of the Lithuanian health policy is to create mechanisms for strengthening the significance of ethical considerations in the decision-making processes concerning health care of individuals and groups of individuals, as well as considering the positions of physicians and the health care system itself in a general way. Thus, health care ethics could be analyzed at two levels: the micro level (the ethics of doctor-patient relationships) and the macro level (the ethics of health policy-making, which can be realized by applying the principles of equal access, reasonable quality, affordable care and shared responsibilities). To date, the first level remains dominant, but the need arises for our attention to refocus now from the micro level to the patterns of managing and delivering care, managing the health care resources, and conducting business practices.
Discussion
In attempting to increase the efficiency of health services in Lithuania, a common strategy has been in place for the last fifteen years. Decentralization and privatization have been implemented as part of its policy to achieve greater efficiency. Although decentralization in theory is supposed to improve efficiency, in practice the reform of decentralization has still to be completely implemented in Lithuania. Debates on health policy in Lithuania also include the issue of private versus public health care. Although the approach of private health care is changing in a positive way, it is obvious that reduced access to health services is the most vulnerable aspect. In the Lithuanian Health Program adopted in July 1998, the target of equity was stressed, stating that by 2010, differences in health and health care between various socio-economic groups should be reduced by 25%.
Summary
The restructuring of health care system in Lithuania should be based on a balance between decentralization and centralization, and between public and private health care sectors. Successful transition requires a balanced role of the government. Today it is obvious in Lithuania that continuous encouragement to make sacrifices was not enough to induce the system to function well, and in an ethical manner.
doi:10.1186/1471-2458-5-117
PMCID: PMC1310618  PMID: 16281969

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