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1.  The path dependency theory: analytical framework to study institutional integration. The case of France 
Background
The literature on integration indicates the need for an enhanced theorization of institutional integration. This article proposes path dependence as an analytical framework to study the systems in which integration takes place.
Purpose
PRISMA proposes a model for integrating health and social care services for older adults. This model was initially tested in Quebec. The PRISMA France study gave us an opportunity to analyze institutional integration in France.
Methods
A qualitative approach was used. Analyses were based on semi-structured interviews with actors of all levels of decision-making, observations of advisory board meetings, and administrative documents.
Results
Our analyses revealed the complexity and fragmentation of institutional integration. The path dependency theory, which analyzes the change capacity of institutions by taking into account their historic structures, allows analysis of this situation. The path dependency to the Bismarckian system and the incomplete reforms of gerontological policies generate the coexistence and juxtaposition of institutional systems. In such a context, no institution has sufficient ability to determine gerontology policy and build institutional integration by itself.
Conclusion
Using path dependence as an analytical framework helps to understand the reasons why institutional integration is critical to organizational and clinical integration, and the complex construction of institutional integration in France.
PMCID: PMC2916113  PMID: 20689740
integrated care; institutional integration; path dependence; gerontology
2.  PRISMA in Québec and France: implementation and impact of a coordination-type integrated service delivery (ISD) system for frail older people 
Introduction
Several models of integrated service delivery (ISD) networks are presently experimented in Canada and elsewhere, but most of them are designed according to a full integration model (PACE, S-HMO, SIPA). PRISMA is the only example of a coordinated-type model to be developed and fully implemented with a process and outcome evaluation.
The PRISMA model includes the following components to enhance the integration: 1) co-operation between decision-makers and managers of all services and institutions, 2) the use of a single entry point, 3) case management process, 4) individualized service plans, 5) a unique disability-based assessment tool (SMAF) with a case-mix system (Iso-SMAF profiles) and case-finding tool (PRISMA-7), and 6) a computerized system for communicating between institutions and professionals.
The PRISMA model
The PRISMA model was implemented in three areas (urban, rural with or without a local hospital) in Québec, Canada and research was carried out using both qualitative and quantitative data to evaluate its process and impact. An efficiency study was carried out, considering societal costs and all population impacts.
Based on the population impact demonstration, the PRISMA model has also been adapted and implemented in France. This symposium will present the implementation, impact and efficiency of the Québec experimentation, and the implementation transfer in France.
The 4 abstracts related to this project presentation:
1. Description and implementation of the PRISMA ISD system in Québec
Hébert R, Veil A, Raîche M, Dubois M-F, Dubuc N, Tousignant M
Components: The six components of the PRISMA model will be presented. The model was implemented in three areas (urban, rural with or without a local hospital) in Québec, Canada and the implementation evaluation was carried out using mixed (qualitative and quantitative) methods. Over four years, the implementation rates went from 22% to 79%. The perception of integration by managers and clinicians working in the different organizations of the network shows that most interactions are perceived at the cooperation level and some getting to the highest collaboration level. The perception of efficacy of case managers was very high. Implementing such model is feasible and decision to generalize it was made in Québec.
2. Population impact of PRISMA on frail older people and utilization of health and social services
Hébert R, Raîche M, Dubois M-F, Gueye NR, Dubuc N, Tousignant M
Objective: The objective of the population impact study was to evaluate the impact of the PRISMA model on health, satisfaction and services utilization of frail older people. It was a population-based study with a quasi-experimental design. From a random selection of people over 75 years old, a sample of 1501 persons identified at risk of functional decline was recruited in the three experimental areas (n=751) and three comparison zones (n=800). Subjects were measured at baseline and yearly for four years on functional autonomy, satisfaction with services and empowerment. Functional decline was defined as a loss of five points on the SMAF disability scale, institutionalization or death. Information on utilization of health and social services (public, private and community) was collected by bi-monthly phone questionnaires.
Results: When the last two years (where implementation rate was over 75%) were compared with first two years, the experimental group presented a difference of 6.3% on functional decline prevalence (p=0.03). Satisfaction and empowerment were significantly higher (both p<0.001) in the experimental group. For health services utilization, a 20% reduction of visits to emergency room (p<0.001) was observed in the experimental cohort. The hospitalization rate was also lower in the experimental group but the difference was not statistically significant (p=0.19). No significant effect was observed on other services.
3. Efficiency of the PRISMA model regarding population impacts
Durand S, Hébert R, Blanchette D, Buteau M
Efficiency: Assessing the efficiency of PRISMA is based on a comprehensive economic evaluation, with a societal approach. Given the implementation complexity of the six components in this innovative integration model, a micro-analysis was performed to assess its implementation and operational costs for the three experimental areas. The impact on residential, health and social services expenditures was also valued, based on use data collected during bimonthly interviews. Unit costs of these numerous services were estimated according to the opportunity cost approach. All these economic data were compared with the results of the population impact study through a cost-consequences analysis in order to measure PRISMA efficiency.
Results: The overall cost was not higher in the experimental group. It seems that implementation and operational costs of the PRISMA were offset relatively quickly by the savings likely stemming from better-adapted services. Also, the PRISMA had no effect on the mix of public, private and community costs. The population impact study showed positive impacts on functional decline prevalence, on handicaps, and on older people's satisfaction and empowerment. The only negative impact on the population is caregiver burden. Overall, these findings add evidence in support of increased efficiency under PRISMA.
4. Poster abstract: the PRISMA France study: implementation rate and factors influencing this rate
Somme D, Trouve H, Etheridge F, Gagnon D, Couturier Y, Balard F, Saint-Jean O
See elsewhere in this supplement.
PMCID: PMC2807086
PRISMA model; integrated service delivery
3.  Institutional integration in France: Health Regional Agencies and integrated services delivery 
Introduction
The PRISMA France pilot project is ongoing since 2006. This project aims to implement an integrated services delivery (ISD) for elderly people, based on the PRISMA methodology. The experimentation is coupled with an implementation study to identify factors that facilitate and hinder the implementation. The fragmentation of public authorities represents one of the first barriers identified.
In 2009, a large-scale institutional reform has been initiated. It consists of merging various structures having strategic authorities on medical and social care within a single entity: the Health Regional Agencies (HRA). One could anticipate that this reform should facilitate the implementation of ISD.
Aims
To analyze the influence of institutional reforms on a pilot program aiming to implement an ISD. In the framework of our qualitative study we analyze the way the actors conceive the HRA.
Conclusions
The potential to facilitate ISD of the HRA has been identified. It is hope that they should reduce the institutional fragmentation. Nonetheless, the link between these agencies and the implementation of ISD in the pilot project was rarely made.
The extent of institutional change is bought into question by the past of the French system of social welfare.
PMCID: PMC3031844
integrated networks; PRISMA; implementation study; institutional fragmentation; Regional Agencies of Health
4.  The PRISMA France study: implementation rate and factors influencing this rate 
Introduction
The PRISMA integration model is a promising method to implement integration in health and social services for elderly people. In the PRISMA-France study, we qualitatively studied the implementation process of this model in French settings.
Method
Our analyses were based on in-depth interviews, meeting observations and the documentation produced.
Results
We adapted the implementation scale inherent to the PRISMA model to fit the French context and, using this scale, were able to appreciate a 15% progression of implementation, from 5% to 20%, in the first 18 months of the study. The factors that contributed to this rate of progression are of three main types. To begin with, contextual factors intrinsic to the French setting complexified the incorporation of integration into the public policy agenda and the means to achieve this feat. Secondly, factors related to the background of the concerned managers and professionals were identified. Thirdly, factors related to the particularities of the PRISMA-Experiment's governance were noted. Our experience leads to consider time as the answer to these hindering contextual, professional and governance issues.
Conclusion
These observations hold an important strategic value in a time where a wider integration experimentation is planned by the ‘plan-Alzheimer’ in France.
PMCID: PMC2807061
integration measurement; factors influencing implementation; integrated health care networks; France
5.  Is there a way to measure implementation of integration in different countries? The case of the PRISMA implementation qualitative methodology 
Introduction
The PRISMA implementation research has used an innovative tool: the penetration rate of integrated model in the system. The experimentation in France of the PRISMA adopts and adapts this methodology.
Aims and objective
This measurement relates to the functions of the 6 tools and mechanisms of the model: coordination boards, single entry point, case-management, single assessment instrument, individualised services plan and information system. In contrast with Quebec, no public policy in France incites to move towards this model of integration. In addition, in the French system the construction of coordination boards is complex because there is as much as ten supervision authorities and about fifteen organisation managers involved in each experimental site.
Methods of adaptation of the tool in France
The measurement was not only the absence, partial existence or existence of the 6 components but takes into account the appropriation process for each one, the administrative time and the new definition of thresholds to reach as compared to the model.
Results
This research tool presents two advantages. The measurement scale enables also the partners to appropriate the function of each model component and more precisely the global model of the integration. Actors do not feel evaluated but accompanied.
PMCID: PMC2430309
care for the elderly; qualitative research; implementation; Canada
6.  “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
7.  Insights into the Management of Emerging Infections: Regulating Variant Creutzfeldt-Jakob Disease Transfusion Risk in the UK and the US 
PLoS Medicine  2006;3(10):e342.
Background
Variant Creutzfeldt-Jakob disease (vCJD) is a human prion disease caused by infection with the agent of bovine spongiform encephalopathy. After the recognition of vCJD in the UK in 1996, many nations implemented policies intended to reduce the hypothetical risk of transfusion transmission of vCJD. This was despite the fact that no cases of transfusion transmission had yet been identified. In December 2003, however, the first case of vCJD in a recipient of blood from a vCJD-infected donor was announced. The aim of this study is to ascertain and compare the factors that influenced the motivation for and the design of regulations to prevent transfusion transmission of vCJD in the UK and US prior to the recognition of this case.
Methods and Findings
A document search was conducted to identify US and UK governmental policy statements and guidance, transcripts (or minutes when transcripts were not available) of scientific advisory committee meetings, research articles, and editorials published in medical and scientific journals on the topic of vCJD and blood transfusion transmission between March 1996 and December 2003. In addition, 40 interviews were conducted with individuals familiar with the decision-making process and/or the science involved. All documents and transcripts were coded and analyzed according to the methods and principles of grounded theory. Data showed that while resulting policies were based on the available science, social and historical factors played a major role in the motivation for and the design of regulations to protect against transfusion transmission of vCJD. First, recent experience with and collective guilt resulting from the transfusion-transmitted epidemics of HIV/AIDS in both countries served as a major, historically specific impetus for such policies. This history was brought to bear both by hemophilia activists and those charged with regulating blood products in the US and UK. Second, local specificities, such as the recall of blood products for possible vCJD contamination in the UK, contributed to a greater sense of urgency and a speedier implementation of regulations in that country. Third, while the results of scientific studies played a prominent role in the construction of regulations in both nations, this role was shaped by existing social and professional networks. In the UK, early focus on a European study implicating B-lymphocytes as the carrier of prion infectivity in blood led to the introduction of a policy that requires universal leukoreduction of blood components. In the US, early focus on an American study highlighting the ability of plasma to serve as a reservoir of prion infectivity led the FDA and its advisory panel to eschew similar measures.
Conclusions
The results of this study yield three important theoretical insights that pertain to the global management of emerging infectious diseases. First, because the perception and management of disease may be shaped by previous experience with disease, especially catastrophic experience, there is always the possibility for over-management of some possible routes of transmission and relative neglect of others. Second, local specificities within a given nation may influence the temporality of decision making, which in turn may influence the choice of disease management policies. Third, a preference for science-based risk management among nations will not necessarily lead to homogeneous policies. This is because the exposure to and interpretation of scientific results depends on the existing social and professional networks within a given nation. Together, these theoretical insights provide a framework for analyzing and anticipating potential conflicts in the international management of emerging infectious diseases. In addition, this study illustrates the utility of qualitative methods in investigating research questions that are difficult to assess through quantitative means.
A qualitative study of US and UK governmental policy statements on the topic of vCJD and blood transfusion transmission identified factors responsible for differences in the policies adopted.
Editors' Summary
Background.
In 1996 in the UK, a new type of human prion disease was seen for the first time. This is now known as variant Creutzfeldt-Jakob disease (vCJD). Prion diseases are rare brain diseases passed from individual to individual (or between animals) by a particular type of wrongly folded protein, and they are fatal. It was suspected that vCJD had passed to humans from cattle, and that the agent causing vCJD was the same as that causing bovine spongiform encephalopathy (or “mad cow disease”). Shortly after vCJD was recognized, authorities in many countries became concerned about the possibility that it could be transmitted from one person to another through contaminated blood supplies used for transfusion in hospitals. Even though there wasn't any evidence of actual transmission of the disease through blood before December 2003, authorities in the UK, US, and elsewhere set up regulations designed to reduce the chance of that happening. At this early stage in the epidemic, there was little in the way of scientific information about the transmission properties of the disease. Both the UK and US, however, sought to make decisions in a scientific manner. They made use of evidence as it was being produced, often before it had been published. Despite this, the UK and US decided on very different changes to their respective regulations on blood donation. Both countries chose to prevent certain people (who they thought would be at greater risk of having vCJD) from donating blood. In the UK, however, the decision was made to remove white blood cells from donated blood to reduce the risk of transmitting vCJD, while the US decided that such a step was not merited by the evidence.
Why Was This Study Done?
This researcher wanted to understand more clearly why the UK and US ended up with different policies: what role was played by science, and what role was played by non-scientific factors? She hoped that insights from this investigation would also be relevant to similar challenges in the future—for example, as many countries try to work out how to control the threat of avian flu.
What Did the Researcher Do and Find?
The researcher searched for all relevant official government documents from the US and UK, as well as scientific papers, published between the time vCJD was first identified (March 1996) and the first instance of vCJD carried through blood (December 2003). She also interviewed people who knew about vCJD management in the US and UK—for example, members of government agencies and the relevant advisory committees. From the documents and interviews, the researcher picked out and grouped shared ideas. Although these documents and interviews suggested that policy making was rooted in scientific evidence, many non-scientific factors were also important. The researcher found substantial uncertainty in the scientific evidence available at the time. The document search and interviews showed that policy makers felt guilty about a previous experience in which people had become infected with HIV/AIDS through contaminated blood and were concerned about repeating this experience. Finally, in the UK, the possibility of blood contamination was seen as a much more urgent problem than in the US, because BSE and vCJD were found there first and there were far more cases. This meant that when the UK made its decision about whether to remove white blood cells from donated blood, there was less scientific evidence available. In fact, the main study that was relied on at the time would later be questioned.
What Do These Findings Mean?
These findings show that for this particular case, science was not the only factor affecting government policies. Historical and social factors such as previous experience, sense of urgency, public pressure, and the relative importance of different scientific networks were also very important. The study predicts that in the future, infectious disease–related policy decisions are unlikely to be the same across different countries because the interpretation of scientific evidence depends, to a large extent, on social factors.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0030342.
National Creutzfeldt-Jakob Disease Surveillance Unit, Edinburgh, UK
US Centers for Disease Control and Prevention pages about prion diseases
World Health Organization variant Creutzfeldt-Jakob disease fact sheet
US National Institute of Neurological Disorders and Stroke information about prion diseases
doi:10.1371/journal.pmed.0030342
PMCID: PMC1621089  PMID: 17076547
8.  Successfully integrating aged care services: a review of the evidence and tools emerging from a long-term care program 
Background
Providing efficient and effective aged care services is one of the greatest public policy concerns currently facing governments. Increasing the integration of care services has the potential to provide many benefits including increased access, promoting greater efficiency, and improving care outcomes. There is little research, however, investigating how integrated aged care can be successfully achieved. The PRISMA (Program of Research to Integrate Services for the Maintenance of Autonomy) project, from Quebec, Canada, is one of the most systematic and sustained bodies of research investigating the translation and outcomes of an integrated care policy into practice. The PRISMA research program has run since 1988, yet there has been no independent systematic review of this work to draw out the lessons learnt.
Methods
Narrative review of all literature emanating from the PRISMA project between 1988 and 2012. Researchers accessed an online list of all published papers from the program website. The reference lists of papers were hand searched to identify additional literature. Finally, Medline, Pubmed, EMBASE and Google Scholar indexing databases were searched using key terms and author names. Results were extracted into specially designed spread sheets for analysis.
Results
Forty-five journal articles and two books authored or co-authored by the PRISMA team were identified. Research was primarily concerned with: the design, development and validation of screening and assessment tools; and results generated from their application. Both quasi-experimental and cross sectional analytic designs were used extensively. Contextually appropriate expert opinion was obtained using variations on the Delphi Method. Literature analysis revealed the structures, processes and outcomes which underpinned the implementation. PRISMA provides evidence that integrating care for older persons is beneficial to individuals through reducing incidence of functional decline and handicap levels, and improving feelings of empowerment and satisfaction with care provided. The research also demonstrated benefits to the health system, including a more appropriate use of emergency rooms, and decreased consultations with medical specialists.
Discussion
Reviewing the body of research reveals the importance of both designing programs with an eye to local context, and building in flexibility allowing the program to be adapted to changing circumstances. Creating partnerships between policy designers, project implementers, and academic teams is an important element in achieving these goals. Partnerships are also valuable for achieving effective monitoring and evaluation, and support to ‘evidence-based’ policy-making processes. Despite a shared electronic health record being a key component of the service model, there was an under-investigation of the impact this technology on facilitating and enabling integration and the outcomes achieved.
Conclusions
PRISMA provides evidence of the benefits that can arise from integrating care for older persons, particularly in terms of increased feelings of personal empowerment, and improved client satisfaction with the care provided. Taken alongside other integrated care experiments, PRISMA provides further evidentiary support to policy-makers pursuing integrated care programs. The scale and scope of the research body highlights the long-term and complex nature of program evaluations, but underscores the benefits of evaluation, review and subsequent adaptation of programs. The role of information technology in supporting integration of services is likely to substantially expand in the future and the potential this technology offers should be investigated and harnessed.
PMCID: PMC3653282  PMID: 23687475
integrated care; aged care; integrated delivery systems; literature review; PRISMA; Canada
9.  Why integrated care? Conclusions from an international expert survey 
Purpose
Exploring the indicators most crucial for actors in health and social care services and identifying those which lead up to the initiation and implementation of integrated care. By analysing the reasons why integrated care is chosen and initiated, the underlying mechanisms and decision-making processes of integrated care are highlighted.
Theory
Even though integrated care projects and programmes are implemented in very different settings and health systems one can find the same main actors everywhere. They share similar goals and principles which are universal and not unique to one specific country or system. Hence, it is likely that the type of actor, i.e. health insurance, is more influential on the decision-making process than the health system and surrounding setting. In other words, it was stipulated that a health insurer in the Netherlands will have similar priorities for integrated care as a health insurer in Singapore and hence will choose similar integrated care approaches.
On the other hand, system administrators can strongly incentivise or discourage innovation and cooperation within the health and social care dominions, i.e. by passing laws or (re)organising the financing system. It is suggested that integrated care is implemented more widely in countries where stakeholders receive targeted incentives and fragmentation within the system is less pronounced.
Methods
The hypotheses were tested using an international expert questionnaire, contacting integrated care managers and decision-makers in Europe, North America and Australasia. The results were quantitatively analyzed using SPSS.
Results and conclusions
Integrated care is stipulated to offer solutions to the demographic changes, the concurring increase of chronic disease and the pressures on restricted resources experienced in the modern health systems of today. The survey conducted suggested a more diversified picture regarding the expectations and priorities set into the concept by health care decision-makers. While all of these challenges are perceived by them, their undisputed priority is on the introduction and enhancement of management structures on all levels. They do not value financial restrictions as severely as may have been anticipated and they revealed that neither active patient participation nor the introduction of outcome measurement are high priorities when introducing integrated care. The findings also suggest that the same stakeholders follow similar priorities disregarding the different health systems they act in.
In conclusion, two levels of priority setting have been identified as highly important for integrated care initiation: on the policy level, prioritisation of integrated care along with specific promotion measures influence decision-making; on the organisational level, the need for clear structures and better management tools both in the organisation itself and in the management of the targeted patient population, reflect the highest priorities for the decision-making process.
The response rate was 18% with the majority of responses coming from Germany, The Netherlands, UK and the USA.
Discussion
Integrated care has come a long way from the first projects implemented by health insurance organisations to a colourful array of projects and permanent programmes, spanning from local to national level and from very targeted to very broad inclusion criteria, initiated, owned and financed by a mix of all stakeholders and agents in the system. Hence, integrated care developed into a ‘Jack-of-all-trades’ approach, stimulating change and confusion at the same time. Still, in most countries, it has not entered mainstream health care organisation and management and continues to struggle in proving its value. Asking why integrated care is initiated and implemented in the first place helps understand the priorities and objectives of decision-makers in health care, and hence can lead to a more targeted development and application of integrated care models.
PMCID: PMC3184810
decision-making; priority setting in integrated care; stakeholder-specific differences
10.  The right to health, health systems development and public health policy challenges in Chad 
Background
There is increasing consensus that the right to health can provide ethical, policy and practical groundings for health systems development. The goals of the right to health are congruent with those of health systems development, which are about strengthening health promotion organizations and actions so as to improve public health. The poor shape and performance of health systems in Chad question the extent of realization of the right to health. Due to its comprehensiveness and inclusiveness, the right to health has the potential of being an organizational and a normative backbone for public health policy and practice. It can then be understood and studied as an integral component of health systems development.
Method
This paper uses a secondary data analysis of existing documents by the Ministry of Public Health, Institut National de la Statistique, des Etudes Economiques et Démographiques (INSEED), the Ministry of Economy and Agence Française de Cooperation to analyze critically the shape and performance of health systems in Chad based on key concepts and components of the right to health contained in article 12 of the International Covenant on Economic, Social and Cultural Rights, and on General Comment 14.
Results
The non-realization of the right to health, even in a consistently progressive manner, raises concerns about the political commitment of state officials to public health, about the justice of social institutions in ensuring social well-being and about individual and public values that shape decision-making processes. Social justice, democratic rule, transparency, accountability and subsidiarity are important groundings for ensuring community participation in public affairs and for monitoring the performance of public institutions.
Conclusion
The normative ideals of health systems development are essentially democratic in nature and are rooted in human rights and in ethical principles of human dignity, equality, non-discrimination and social justice. These ideals are grounded in an integrated vision of society as a place for multi-level interactions, where government plays its role by equitably providing institutions and services that ensure people’s welfare. Inter-sectoral collaboration, which calls for a conceptual shift in health and public policy, can be instrumental in improving health systems through concerted efforts of various governmental institutions and civil society.
doi:10.1186/s13010-015-0023-z
PMCID: PMC4336701
The right to health; Health systems development; Social justice; Health policy; Intersectoral collaboration; Public health and democratic governance; Community agency; Social participation; Accountability and transparency
11.  Is the PRISMA-France glass half-full or half-empty? The emergence and management of polarized views regarding an integrative change process 
Aim
The PRISMA-France pilot project is aimed at implementing an innovative case management type integration model in the 20th district of Paris. This paper apprehends the emergence of two polarized views regarding the progression of the model's spread in order to analyze the change management enacted during the process and its effects.
Method
A qualitative analysis was conducted based on an institutional change model.
Results
Our results suggest that, according to one view, the path followed to reach the study's current level of progress was efficient and necessary to lay the foundation of a new health and social services system while according to the other, change management shortcomings were responsible for the lack of progress.
Discussion
While neither of these two views appears entirely justified, analyzing the factors underlying their differences pinpoints some of the challenges involved in managing the spread of an integrated service delivery network. Meticulous preparation for the change management role and communication of the time and effort required for a wholesale institutional change process may be significant factors for a successful integrative endeavor.
PMCID: PMC2807121  PMID: 20087426
change management; institutional change; integrated care; networks
12.  Institutional change and Institutional Integration in France: Health Regional Agencies what consequences for the development of integrated services delivery? 
Purpose
In France, the development of integrated services delivery for elderly (ISDE) has been hindered by the fragmentation of the decision-making institutions. By merging the healthcare and medicosocial institutions, the Health Regional Agencies (HRA), responsible for developing ISDE, theoretically constitutes a solution. The study examines how the HRA received and implemented the legislative mandate of the development of the ISDE.
Theory
We used the model of “receptivity to change strategic” developed by A.M. Pettigrew in the context of reforms of the National Health Service (NHS).
Method
An empirical study was conducted in 2011 in two phases: 1) 10 case studies of HRA, 2) questionnaire sent to all 26 HRAs.
Results and conclusion
The concentration of the decision powers in HRAs favors the deployment of ISDE. Three considerations limit this consideration: 1) lack of legislative instruments allows the HRA to reproduce a fragmented internal organization; 2) lack of prerogative on the social institutions; these institutions can develop contradictory policies; 3) new definition of norms and governance may slow down the deployment of ISDE.
Discussion
The deployment of ISDE relies on regional institutions that are subjected to changes. The on-going analysis will determine whether the new frames of reference and governance comply with the principles of services integration.
PMCID: PMC3617741
integrated networks; institutional integration; institutional change; Social healthcare system
13.  Institutional change and Institutional Integration in France: Health Regional Agencies. What consequences for the development integrated services delivery? 
Purpose
In France, the development of integrated services delivery for elderly (ISDE) has been hindered by the fragmentation of the decision-making institutions. By merging the healthcare and medicosocial institutions, the Health Regional Agencies (HRA), responsible for developing ISDE, theoretically constitutes a solution. The study examines how the HRA received and implemented the legislative mandate of the development of the ISDE.
Theory
We used the model of “receptivity to change strategic” developed by A.M Pettigrew in the context of reforms of the National Health Service (NHS).
Method
An empirical study was conducted in 2011 in two phases: 1) 10 case studies of HRA, 2) questionnaire sent to all 26 HRAs.
Results and conclusion
The concentration of the decision powers in HRAs favors the deployment of ISDE. Three considerations limit this consideration: 1) lack of legislative instruments allows the HRA to reproduce a fragmented internal organization; 2) lack of prerogative on the social institutions; these institutions can develop contradictory policies; 3) new definition of norms and governance may slow down the deployment of ISDE.
Discussion
The deployment of ISDE relies on regional institutions that are subjected to changes. The on-going analysis will determine whether the new frames of reference and governance comply with the principles of services integration.
PMCID: PMC3617774
integrated networks; institutional integration; institutional change; social healthcare system
14.  Global Health Governance and the Commercial Sector: A Documentary Analysis of Tobacco Company Strategies to Influence the WHO Framework Convention on Tobacco Control 
PLoS Medicine  2012;9(6):e1001249.
Heide Weishaar and colleagues did an analysis of internal tobacco industry documents together with other data and describe the industry's strategic response to the proposed World Health Organization Framework Convention on Tobacco Control.
Background
In successfully negotiating the Framework Convention on Tobacco Control (FCTC), the World Health Organization (WHO) has led a significant innovation in global health governance, helping to transform international tobacco control. This article provides the first comprehensive review of the diverse campaign initiated by transnational tobacco corporations (TTCs) to try to undermine the proposed convention.
Methods and Findings
The article is primarily based on an analysis of internal tobacco industry documents made public through litigation, triangulated with data from official documentation relating to the FCTC process and websites of relevant organisations. It is also informed by a comprehensive review of previous studies concerning tobacco industry efforts to influence the FCTC. The findings demonstrate that the industry's strategic response to the proposed WHO convention was two-fold. First, arguments and frames were developed to challenge the FCTC, including: claiming there would be damaging economic consequences; depicting tobacco control as an agenda promoted by high-income countries; alleging the treaty conflicted with trade agreements, “good governance,” and national sovereignty; questioning WHO's mandate; claiming the FCTC would set a precedent for issues beyond tobacco; and presenting corporate social responsibility (CSR) as an alternative. Second, multiple tactics were employed to promote and increase the impact of these arguments, including: directly targeting FCTC delegations and relevant political actors, enlisting diverse allies (e.g., mass media outlets and scientists), and using stakeholder consultation to delay decisions and secure industry participation.
Conclusions
TTCs' efforts to undermine the FCTC were comprehensive, demonstrating the global application of tactics that TTCs have previously been found to have employed nationally and further included arguments against the FCTC as a key initiative in global health governance. Awareness of these strategies can help guard against industry efforts to disrupt the implementation of the FCTC and support the development of future, comparable initiatives in global health.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 5 million people die worldwide from tobacco-related causes and, if current trends continue, annual deaths from tobacco-related causes will increase to 10 million by 2030. In response to this global tobacco epidemic, the World Health Organization (WHO) has developed an international instrument for tobacco control called the Framework Convention on Tobacco Control (FCTC). Negotiations on the FCTC began in 1999, and the international treaty—the first to be negotiated under the auspices of WHO—entered into force on 27 February 2005. To date, 174 countries have become parties to the FCTC. As such, they agree to implement comprehensive bans on tobacco advertising, promotion, and sponsorship; to ban misleading and deceptive terms on cigarette packaging; to implement health warnings on tobacco packaging; to protect people from tobacco smoke exposure in public spaces and indoor workplaces; to implement taxation policies aimed at reducing tobacco consumption; and to combat illicit trade in tobacco products.
Why Was This Study Done?
Transnational tobacco corporations (TTCs) are sometimes described as “vectors” of the global tobacco epidemic because of their drive to maximize shareholder value and tobacco consumption. Just like conventional disease vectors (agents that carry or transmit infectious organisms), TTCs employ a variety of tactics to ensure the spread of tobacco consumption. For example, various studies have shown that TTCs have developed strategies that attempt to limit the impact of tobacco control measures such as the FCTC. However, to date, studies investigating the influence of TTCs on the FCTC have concentrated on specific countries or documented specific tactics. Here, the researchers undertake a comprehensive review of the diverse tactics employed by TTCs to undermine the development of the FCTC. Such a review is important because its results should facilitate the effective implementation of FCTC measures and could support the development of future tobacco control initiatives and of global initiatives designed to control alcohol-related and food-related disease and death.
What Did the Researchers Do and Find?
The researchers analyzed documents retrieved from the Legacy Tobacco Documents Library (a collection of internal tobacco industry documents released as a result of US litigation cases) dealing with the strategies employed by TTCs to influence the FCTC alongside data from the websites of industry, consultancy, and other organizations cited in the documents; the official records of the FCTC process; and previous studies of tobacco industry efforts to influence the FCTC. Their analysis reveals that the strategic response of the major TTCs to the proposed FCTC was two-fold. First, the TTCs developed a series of arguments and “frames” (beliefs and ideas that provide a framework for thinking about an issue) to challenge the FCTC. Core frames included claiming that the FCTC would have damaging economic consequences, questioning WHO's mandate to develop a legally binding international treaty by claiming that tobacco was not a cross-border problem, and presenting corporate social responsibility (the commitment by business to affect the environment, consumers, employees, and society positively in addition to making money for shareholders) as an alternative to the FCTC. Second, the TTCs employed multiple strategies to promote and increase the impact of these arguments and frames, such as targeting FCTC delegations and enlisting the help of diverse allies including media outlets and scientists.
What Do These Findings Mean?
These findings illustrate the variety and complexity of the tobacco industry's efforts to undermine the FCTC and show the extent to which TTCs combined and coordinated tactics on a global stage that they had previously used on a national stage. Indeed, “the comprehensiveness and scale of the tobacco industry's response to the FCTC suggests that it is reasonable to speak of a ‘globalisation of tobacco industry strategy’ in combating the development of effective tobacco control policies,” write the researchers. Awareness of the strategies employed by TTCs to influence the FCTC should help guard against industry efforts to disrupt the implementation of the FCTC and should support the development of future global tobacco control initiatives. More generally, these findings should support the development of global health initiatives designed to tackle cardiovascular disease, cancer, chronic respiratory diseases and diabetes – non-communicable diseases that together account for 60% of global deaths and are partly driven by the commercial activities of food, alcohol, and tobacco corporations.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001249.
The World Health Organization provides information about the dangers of tobacco (in several languages) and about the Framework Convention on Tobacco Control
For information about the tobacco industry's influence on policy, see the 2009 World Health Organization report Tobacco interference with tobacco control
The Framework Convention Alliance provides more information about the FCTC
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 UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking and not start again
doi:10.1371/journal.pmed.1001249
PMCID: PMC3383743  PMID: 22745607
15.  Developing integrated health and social care services for older persons in Europe 
Abstract
Purpose
This paper is to distribute first results of the EU Fifth Framework Project ‘Providing integrated health and social care for older persons—issues, problems and solutions’ (PROCARE—http://www.euro.centre.org/procare/). The project's first phase was to identify different approaches to integration as well as structural, organisational, economic and social-cultural factors and actors that constitute integrated and sustainable care systems. It also served to retrieve a number of experiences, model ways of working and demonstration projects in the participating countries which are currently being analysed in order to learn from success—or failure—and to develop policy recommendations for the local, national and European level.
Theory
The paper draws on existing definitions of integrated care in various countries and by various scholars. Given the context of an international comparative study it tries to avoid providing a single, ready-made definition but underlines the role of social care as part and parcel of this type of integrated care in the participating countries.
Methods
The paper is based on national reports from researchers representing ten organisations (university institutes, consultancy firms, research institutes, the public and the NGO sector) from 9 European countries: Austria, Denmark, Finland, France, Germany, Greece, Italy, the Netherlands, and the UK. Literature reviews made intensive use of grey literature and evaluation studies in the context of at least five model ways of working in each country.
Results
As a result of the cross-national overview an attempt to classify different approaches and definitions is made and indicators of relative importance of the different instruments used in integrating health and social care services are provided.
Conclusions
The cross-national overview shows that issues concerning co-ordination and integration of services are high on the agenda in most countries. Depending on the state of service development, various approaches and instruments can be observed. Different national frameworks, in particular with respect to financing and organisation, systemic development, professionalisation and professional cultures, basic societal values (family ethics), and political approaches have to be taken into account during the second phase of PROCARE during which transversal and transnational analysis will be undertaken based on an in-depth analysis of two model ways of working in each country.
Discussion
Far from a European vision concerning integrated care, national health and social care systems remain—at best—loosely coupled systems that are facing increasing difficulties, given the current challenges, in particular in long-term care for older persons: increasing marketisation, lack of managerial knowledge (co-operation, co-ordination), shortage of care workers and a general trend towards down-sizing of social care services continue to hamper the first tentative pathways towards integrated care systems.
PMCID: PMC1393267  PMID: 16773149
health and social care; integrated service delivery; older persons in need of care; European overview
16.  Serological Testing Versus Other Strategies for Diagnosis of Active Tuberculosis in India: A Cost-Effectiveness Analysis 
PLoS Medicine  2011;8(8):e1001074.
This cost-effectiveness study shows that sputum smear microscopy is the most cost-effective test for active tuberculosis (TB) in India, and liquid culture plus microscopy is more cost-effective for TB diagnosis than serological tests.
Background
Undiagnosed and misdiagnosed tuberculosis (TB) drives the epidemic in India. Serological (antibody detection) TB tests are not recommended by any agency, but widely used in many countries, including the Indian private sector. The cost and impact of using serology compared with other diagnostic techniques is unknown.
Methods and Findings
Taking a patient cohort conservatively equal to the annual number of serological tests done in India (1.5 million adults suspected of having active TB), we used decision analysis to estimate costs and effectiveness of sputum smear microscopy (US$3.62 for two smears), microscopy plus automated liquid culture (mycobacterium growth indicator tube [MGIT], US$20/test), and serological testing (anda-tb ELISA, US$20/test). Data on test accuracy and costs were obtained from published literature. We adopted the perspective of the Indian TB control sector and an analysis frame of 1 year. Our primary outcome was the incremental cost per disability-adjusted life year (DALY) averted. We performed one-way sensitivity analysis on all model parameters, with multiway sensitivity analysis on variables to which the model was most sensitive.
If used instead of sputum microscopy, serology generated an estimated 14,000 more TB diagnoses, but also 121,000 more false-positive diagnoses, 102,000 fewer DALYs averted, and 32,000 more secondary TB cases than microscopy, at approximately four times the incremental cost (US$47.5 million versus US$11.9 million). When added to high-quality sputum smears, MGIT culture was estimated to avert 130,000 incremental DALYs at an incremental cost of US$213 per DALY averted. Serology was dominated by (i.e., more costly and less effective than) MGIT culture and remained less economically favorable than sputum smear or TB culture in one-way and multiway sensitivity analyses.
Conclusions
In India, sputum smear microscopy remains the most cost-effective diagnostic test available for active TB; efforts to increase access to quality-assured microscopy should take priority. In areas where high-quality microscopy exists and resources are sufficient, MGIT culture is more cost-effective than serology as an additional diagnostic test for TB. These data informed a recently published World Health Organization policy statement against serological tests.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 2 million people develop tuberculosis in India—a fifth of the global incidence of this highly contagious bacterial infection. Mycobacterium tuberculosis, the bacterium that causes tuberculosis, is spread in airborne droplets when people with the disease cough or sneeze and usually infects the lungs although it can also infect other organs. The characteristic symptoms of tuberculosis are a persistent cough, weight loss, and night sweats. Diagnostic tests for tuberculosis include sputum smear microscopy (microscopic analysis of mucus brought up from the lungs by coughing), culture (growth) of M. tuberculosis from sputum samples in liquid media (using, for example, a commercial product called the mycobacteria growth indicator tube or MGIT), and nucleic acid amplification tests (which detect the bacterium's genome in patient samples) such as the Xpert MTB/RIF system. Tuberculosis can usually be cured by taking several powerful antibiotics daily for at least 6 months.
Why Was This Study Done?
In India, as elsewhere, undiagnosed and misdiagnosed tuberculosis drives the tuberculosis epidemic by increasing the transmission of M. tuberculosis. Unfortunately, sputum smear microscopy, the current mainstay of tuberculosis diagnosis worldwide, detects only half of tuberculosis cases, mycobacterial culture can take weeks to provide a diagnosis, and rapid techniques such as nucleic acid amplification require infrastructure that is often not available in developing countries. Consequently, in India and other developing countries, serological tests are widely used for the diagnosis of tuberculosis. Serological tests detect antibodies against M. tuberculosis in the blood (antibodies are proteins made by the immune system in response to infections). Serological tests are fast and simple to perform, but they are not recommended for clinical use, and the available evidence suggests that they do not diagnose tuberculosis accurately. Even so, and in the absence of information about the cost and impact (cost-effectiveness) of serological testing, about 1.5 million serological tests for tuberculosis are conducted every year in India at a cost of more than US$15 million. Here, the researchers analyze the cost-effectiveness of serological tests compared to other diagnostic tests from the perspective of tuberculosis control in India.
What Did the Researchers Do and Find?
The researchers used “decision analysis” to estimate the cost-effectiveness of sputum smear microscopy, microscopy plus liquid culture using the MGIT system, and serological testing using the widely used anda-tb ELISA commercial test in a hypothetical group of 1.5 million people suspected of having tuberculosis. Decision analysis formally assesses the decision-making process by using models that evaluate outcomes under different scenarios. By feeding data on the costs and accuracy of different diagnostic tests into their decision-analysis model, the researchers estimate that, over a year, serology would generate 14,000 more tuberculosis diagnoses than sputum microscopy. However, it would also generate 121,000 more false-positive diagnoses and 32,000 more tuberculosis transmissions to other people (secondary transmissions), and avert 102,000 fewer disability-adjusted life years (DALYs; a DALY is a year of healthy life lost because of premature death or disability) at four times the incremental cost of sputum microscopy. MGIT culture added to sputum smear microscopy would avert 130,000 DALYs at an incremental cost of US$213 per DALY averted. Finally, sensitivity analyses (reruns of the decision-analysis model using different values for test costs and accuracy) identified no scenario in which serology was either less costly or more effective than sputum smear microscopy alone or in which serology plus sputum microscopy was more cost-effective than MGIT culture plus sputum microscopy.
What Do These Findings Mean?
These findings identify sputum smear microscopy as the most cost-effective existing diagnostic test for tuberculosis in India. Moreover, they suggest that in areas where high-quality microscopy is available, resources are sufficient, and infrastructure to effectively use culture exists, the addition of MGIT culture to sputum smear microscopy would be more cost-effective than the addition of serology. Importantly, these findings suggest that, if used as an initial test for tuberculosis in India, serology would result in more DALYs, more secondary infections, and more false-positive diagnoses than sputum smear microscopy while increasing per-patient costs to the Indian tuberculosis control sector. Given these findings and the results of a recent updated systematic review on the accuracy of serological tests, the World Health Organization's Strategic and Technical Advisory Group for Tuberculosis recently advised against the use of currently available serological tests for the diagnosis of tuberculosis. The WHO negative policy against serological tests must now be implemented in India.
Additional Information
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001074.
Details of the recent systematic review of serological tests for tuberculosis diagnosis are available in a PLoS Medicine Research Article by Steingart et al.
The World Health Organization provides information on all aspects of tuberculosis, including tuberculosis diagnostics and the Stop TB Partnership (some information is in several languages); its Strategic and Technical Advisory Group for Tuberculosis recommendations on tuberculosis diagnosis are available
The Evidence-based TB Diagnosis Web site by the Stop TB Partnership's New Diagnostics Working Group provides evidence syntheses on various TB tests, along with guidelines, resources, and training materials
The US Centers for Disease Control and Prevention has information about tuberculosis, including information on the diagnosis of tuberculosis disease
The US National Institute of Allergy and Infectious Diseases also has information on all aspects of tuberculosis
MedlinePlus has links to further information about tuberculosis (in English and Spanish)
doi:10.1371/journal.pmed.1001074
PMCID: PMC3153451  PMID: 21857810
17.  Experiences of Living and Dying With COPD 
Executive Summary
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.
After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.
The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.
Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework
Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Long-Term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Hospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model
Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature
For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm.
For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx.
The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.
Objective of Analysis
The objective of this analysis was to review empirical qualitative research on the experiences of patients with chronic obstructive pulmonary disease (COPD), informal caregivers (“carers”), and health care providers—from the point of diagnosis, through daily living and exacerbation episodes, to the end of life.
Clinical Need and Target Population
Qualitative empirical studies (from social sciences, clinical, and related fields) can offer important information about how patients experience their condition. This exploration of the qualitative literature offers insights into patients’ perspectives on COPD, their needs, and how interventions might affect their experiences. The experiences of caregivers are also explored.
Research Question
What do patients with COPD, their informal caregivers (“carers”), and health care providers experience over the course of COPD?
Research Methods
Literature Search
Search Strategy
Literature searches for studies published from January 1, 2000, to November 2010 were performed on November 29, 2010, using OVID MEDLINE; on November 26, 2010, using ISI Web of Science; and on November 28, 2010, using EBSCO Cumulative Index to Nursing and Allied Health Literature (CINAHL). Titles and abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. One additional report, highly relevant to the synthesis, appeared in early 2011 during the drafting of this analysis and was included post hoc.
Inclusion Criteria
English-language full reports
studies published between January 1, 2000, and November 2010
primary qualitative empirical research (using any descriptive or interpretive qualitative methodology, including the qualitative component of mixed-methods studies) and secondary syntheses of primary qualitative empirical research
studies addressing any aspect of the experiences of living or dying with COPD from the perspective of persons at risk, patients, health care providers, or informal carers; studies addressing multiple conditions were included if COPD was addressed explicitly
Exclusion Criteria
studies addressing topics other than the experiences of living or dying with COPD from the perspective of persons at risk, patients, health care providers, or informal carers
studies labelled “qualitative” but not using a qualitative descriptive or interpretive methodology (e.g., case studies, experiments, or observational analysis using qualitative categorical variables)
quantitative research (i.e., using statistical hypothesis testing, using primarily quantitative data or analyses, or expressing results in quantitative or statistical terms)
studies that did not pose an empirical research objective or question, or involve the primary or secondary analysis of empirical data
Outcomes of Interest
qualitative descriptions and interpretations (narrative or theoretical) of personal and social experiences of COPD
Summary of Findings
Experiences at Diagnosis
Patients typically seek initial treatment for an acute episode rather than for chronic early symptoms of COPD.
Many patients initially misunderstand terms such as COPD, chronic obstructive pulmonary disease, or exacerbation.
Patients may not realize that COPD is incurable and fatal; some physicians themselves do not consider early COPD to be a fatal disease.
Smokers may not readily understand or agree with the idea that smoking caused or worsens their COPD. Those who believe there is a causal link may feel regret or shame.
Experiences of Living Day to Day
COPD patients experience alternating good days and bad days. A roller-coaster pattern of ups and downs becomes apparent, and COPD becomes a way of life.
Patients use many means (social, psychological, medical, organizational) to control what they can, and to cope with what they cannot. Economic hardship, comorbidities, language barriers, and low health literacy can make coping more difficult.
Increasing vulnerability and unpredictable setbacks make patients dependent on others for practical assistance, but functional limitations, institutional living or self-consciousness can isolate patients from the people they need.
For smokers, medical advice to quit can conflict with increased desire to smoke as a coping strategy.
Many of the factors that isolate COPD patients from social contact also isolate them from health care.
Experiences of Exacerbations
Patients may not always attribute repeated exacerbations to advancing disease, instead seeing them as temporary setbacks caused by activities, environmental factors, faltering self-management, or infection.
Lack of confidence in community-based services leads some patients to seek hospital admission, but patients also feel vulnerable when hospitalized. They may feel dependent on others for care or traumatized by hospital care routines.
Upon hospital discharge following an exacerbation, patients may face new levels of uncertainty about their illness, prognosis, care providers, and supports.
Experiences of the End of Life
Patients tend to be poorly informed about the long-term prognosis of COPD and what to expect toward the end of life; this lack of understanding impairs quality of life as the disease progresses.
As the end of life approaches, COPD patients face the usual challenges of daily living, but in a context of increasing exacerbations and deepening dependency. Activities and mobility decrease, and life may become confined.
Some clinicians have difficulty identifying the beginning of “the end of life,” given the unpredictable course of COPD. Long-term physician-patient relationships, familiarity and understanding, trust, good communication skills, sensitivity, and secure discussion settings can help facilitate end-of-life discussions.
Divergent meanings and goals of palliative care in COPD lead to confusion about whether such services are the responsibility of home care, primary care, specialty care, or even critical care. Palliative end-of-life care may not be anticipated prior to referral for such care. A palliative care referral can convey the demoralizing message that providers have “given up.”
Experiences of Carers
Carers’ challenges often echo patients’ challenges, and include anxiety, uncertainty about the future, helplessness, powerlessness, depression, difficulties maintaining employment, loss of mobility and freedoms, strained relationships, and growing social isolation.
Carers feel pressured by their many roles, struggling to maintain patience when they feel overwhelmed, and often feeling guilty about not doing enough.
Carers often face their own health problems and may have difficulty sustaining employment.
Synthesis: A Disease Trajectory Reflecting Patient Experiences
The flux of needs in COPD calls for service continuity and flexibility to allow both health care providers and patients to respond to the unpredictable yet increasing demands of the disease over time.
PMCID: PMC3384365  PMID: 23074423
18.  Eurocan plus report: feasibility study for coordination of national cancer research activities 
Summary
The EUROCAN+PLUS Project, called for by the European Parliament, was launched in October 2005 as a feasibility study for coordination of national cancer research activities in Europe. Over the course of the next two years, the Project process organized over 60 large meetings and countless smaller meetings that gathered in total over a thousand people, the largest Europe–wide consultation ever conducted in the field of cancer research.
Despite a strong tradition in biomedical science in Europe, fragmentation and lack of sustainability remain formidable challenges for implementing innovative cancer research and cancer care improvement. There is an enormous duplication of research effort in the Member States, which wastes time, wastes money and severely limits the total intellectual concentration on the wide cancer problem. There is a striking lack of communication between some of the biggest actors on the European scene, and there are palpable tensions between funders and those researchers seeking funds.
It is essential to include the patients’ voice in the establishment of priority areas in cancer research at the present time. The necessity to have dialogue between funders and scientists to establish the best mechanisms to meet the needs of the entire community is evident. A top priority should be the development of translational research (in its widest form), leading to the development of effective and innovative cancer treatments and preventive strategies. Translational research ranges from bench–to–bedside innovative cancer therapies and extends to include bringing about changes in population behaviours when a risk factor is established.
The EUROCAN+PLUS Project recommends the creation of a small, permanent and independent European Cancer Initiative (ECI). This should be a model structure and was widely supported at both General Assemblies of the project. The ECI should assume responsibility for stimulating innovative cancer research and facilitating processes, becoming the common voice of the cancer research community and serving as an interface between the cancer research community and European citizens, patients’ organizations, European institutions, Member States, industry and small and medium enterprises (SMEs), putting into practice solutions aimed at alleviating barriers to collaboration and coordination of cancer research activities in the European Union, and dealing with legal and regulatory issues. The development of an effective ECI will require time, but this entity should be established immediately. As an initial step, coordination efforts should be directed towards the creation of a platform on translational research that could encompass (1) coordination between basic, clinical and epidemiological research; (2) formal agreements of co–operation between comprehensive cancer centres and basic research laboratories throughout Europe and (3) networking between funding bodies at the European level.
The European Parliament and its instruments have had a major influence in cancer control in Europe, notably in tobacco control and in the implementation of effective population–based screening. To make further progress there is a need for novelty and innovation in cancer research and prevention in Europe, and having a platform such as the ECI, where those involved in all aspects of cancer research can meet, discuss and interact, is a decisive development for Europe.
Executive Summary
Cancer is one of the biggest public health crises facing Europe in the 21st century—one for which Europe is currently not prepared nor preparing itself. Cancer is a major cause of death in Europe with two million casualties and three million new cases diagnosed annually, and the situation is set to worsen as the population ages.
These facts led the European Parliament, through the Research Directorate-General of the European Commission, to call for initiatives for better coordination of cancer research efforts in the European Union. The EUROCAN+PLUS Project was launched in October 2005 as a feasibility study for coordination of national cancer research activities. Over the course of the next two years, the Project process organized over 60 large meetings and countless smaller meetings that gathered in total over a thousand people. In this respect, the Project became the largest Europe-wide consultation ever conducted in the field of cancer research, implicating researchers, cancer centres and hospitals, administrators, healthcare professionals, funding agencies, industry, patients’ organizations and patients.
The Project first identified barriers impeding research and collaboration in research in Europe. Despite a strong tradition in biomedical science in Europe, fragmentation and lack of sustainability remain the formidable challenges for implementing innovative cancer research and cancer care improvement. There is an enormous duplication of research effort in the Member States, which wastes time, wastes money and severely limits the total intellectual concentration on the wide cancer problem. There is a striking lack of communication between some of the biggest actors on the European scene, and there are palpable tensions between funders and those researchers seeking funds.
In addition, there is a shortage of leadership, a multiplicity of institutions each focusing on its own agenda, sub–optimal contact with industry, inadequate training, non–existent career paths, low personnel mobility in research especially among clinicians and inefficient funding—all conspiring against efficient collaboration in cancer care and research. European cancer research today does not have a functional translational research continuum, that is the process that exploits biomedical research innovations and converts them into prevention methods, diagnostic tools and therapies. Moreover, epidemiological research is not integrated with other types of cancer research, and the implementation of the European Directives on Clinical Trials 1 and on Personal Data Protection 2 has further slowed the innovation process in Europe. Furthermore, large inequalities in health and research exist between the EU–15 and the New Member States.
The picture is not entirely bleak, however, as the European cancer research scene presents several strengths, such as excellent basic research and clinical research and innovative etiological research that should be better exploited.
When considering recommendations, several priority dimensions had to be retained. It is essential that proposals include actions and recommendations that can benefit all Member States of the European Union and not just States with the elite centres. It is also essential to have a broader patient orientation to help provide the knowledge to establish cancer control possibilities when we exhaust what can be achieved by the implementation of current knowledge. It is vital that the actions proposed can contribute to the Lisbon Strategy to make Europe more innovative and competitive in (cancer) research.
The Project participants identified six areas for which consensus solutions should be implemented in order to obtain better coordination of cancer research activities. The required solutions are as follows. The proactive management of innovation, detection, facilitation of collaborations and maintenance of healthy competition within the European cancer research community.The establishment of an exchange portal of information for health professionals, patients and policy makers.The provision of guidance for translational and clinical research including the establishment of a translational research platform involving comprehensive cancer centres and cancer research centres.The coordination of calls and financial management of cancer research projects.The construction of a ‘one–stop shop’ as a contact interface between the industry, small and medium enterprises, scientists and other stakeholders.The support of greater involvement of healthcare professionals in translational research and multidisciplinary training.
In the course of the EUROCAN+PLUS consultative process, several key collaborative projects emerged between the various groups and institutes engaged in the consultation. There was a collaboration network established with Europe’s leading Comprehensive Cancer Centres; funding was awarded for a closer collaboration of Owners of Cancer Registries in Europe (EUROCOURSE); there was funding received from FP7 for an extensive network of leading Biological Resource Centres in Europe (BBMRI); a Working Group identified the special needs of Central, Eastern and South–eastern Europe and proposed a remedy (‘Warsaw Declaration’), and the concept of developing a one–stop shop for dealing with academia and industry including the Innovative Medicines Initiative (IMI) was discussed in detail.
Several other dimensions currently lacking were identified. There is an absolute necessity to include the patients’ voice in the establishment of priority areas in cancer research at the present time. It was a salutary lesson when it was recognized that all that is known about the quality of life of the cancer patient comes from the experience of a tiny proportion of cancer patients included in a few clinical trials. The necessity to have dialogue between funders and scientists to establish the best mechanisms to meet the needs of the entire community was evident. A top priority should be the development of translational research (in its widest form) and the development of effective and innovative cancer treatments and preventative strategies in the European Union. Translational research ranges from bench-to-bedside innovative cancer therapies and extends to include bringing about changes in population behaviours when a risk factor is established.
Having taken note of the barriers and the solutions and having examined relevant examples of existing European organizations in the field, it was agreed during the General Assembly of 19 November 2007 that the EUROCAN+PLUS Project had to recommend the creation of a small, permanent and neutral ECI. This should be a model structure and was widely supported at both General Assemblies of the project. The proposal is based on the successful model of the European Molecular Biology Organisation (EMBO), and its principal aims include providing a forum where researchers from all backgrounds and from all countries can meet with members of other specialities including patients, nurses, clinicians, funders and scientific administrators to develop priority programmes to make Europe more competitive in research and more focused on the cancer patient.
The ECI should assume responsibility for: stimulating innovative cancer research and facilitating processes;becoming the common voice of the cancer research community and serving as an interface between the cancer research community and European citizens, patients’ and organizations;European institutions, Member States, industry and small and medium enterprises;putting into practice the aforementioned solutions aimed at alleviating barriers and coordinating cancer research activities in the EU;dealing with legal and regulatory issues.
Solutions implemented through the ECI will lead to better coordination and collaboration throughout Europe, more efficient use of resources, an increase in Europe’s attractiveness to the biomedical industry and better quality of cancer research and education of health professionals.
The Project considered that European legal instruments currently available were inadequate for addressing many aspects of the barriers identified and for the implementation of effective, lasting solutions. Therefore, the legal environment that could shelter an idea like the ECI remains to be defined but should be done so as a priority. In this context, the initiative of the European Commission for a new legal entity for research infrastructure might be a step in this direction. The development of an effective ECI will require time, but this should be established immediately. As an initial step, coordination efforts should be directed towards the creation of a platform on translational research that could encompass: (1) coordination between basic, clinical and epidemiological research; (2) formal agreements of co-operation between comprehensive cancer centres and basic research laboratories throughout Europe; (3) networking between funding bodies at the European level. Another topic deserving immediate attention is the creation of a European database on cancer research projects and cancer research facilities.
Despite enormous progress in cancer control in Europe during the past two decades, there was an increase of 300,000 in the number of new cases of cancer diagnosed between 2004 and 2006. The European Parliament and its instruments have had a major influence in cancer control, notably in tobacco control and in the implementation of effective population–based screening. To make further progress there is a need for novelty and innovation in cancer research and prevention in Europe, and having a platform such as the ECI, where those involved in all aspects of cancer research can meet, discuss and interact, is a decisive development for Europe.
doi:10.3332/ecancer.2011.84
PMCID: PMC3234055  PMID: 22274749
19.  Strategy for care for the elderly persons in Slovenia 
Introduction
The size and age-structure of Europe’s population is undergoing dramatic changes due to low fertility rates, continuous increases in life expectancy and the retirement of the baby-boom generation. ‘The Strategy for care for the elderly till 2010—Solidarity, good intergenerational relations and quality ageing of the population’, prepared by Ministry of Labour, Family and Social Affairs, is the response of the Republic of Slovenia to the ageing society and to the European demands for new solidarity between the generations. The main purpose of the strategy is to create good conditions for preserving and strengthening solidarity, for good intergenerational relations and to ensure quality ageing and care for the fast growing third generation. Special attention is given to the long-term care and the implementation of the new insurance for it.
Description of care
Slovenia was 40 years ago one of the first countries with an efficient gerontological institute. The social welfare system in Slovenia today is based on the welfare system of public social insurance implemented in former Yugoslavia, which for elderly primarily developed nursing homes. Nursing homes in Slovenia are fully occupied at the moment. There are approximately 3.8% of people older than 65 live in nursing homes. The number of applications has been growing and waiting list for a bed to become available has been prolonging.
Discussion
Like in other European countries, there are also in Slovenia trends toward developing specific services for the elderly, adjusted to their needs and preferences. However, to a large share of the elderly population these services are not accessible—partly due to their small number and partly due to their high price. Furthermore, the majority of the elderly people wish to live in their current dwelling and familiar environment.
Conclusion
In developed societies the quality of life of the elderly population is coming to the forefront of research, as well as political agendas. This strategy is the only Slovenian document of this kind, in which different ministries took part in setting goals regarding ageing population. The strategy covers work of the governmental departments of work, employment, social care, health care, education, economy, traffic, science and other relevant areas and the civil society of the Third sector.
PMCID: PMC2707533
elderly; services; ageing; strategy for long-term care
20.  Association of Medical Students' Reports of Interactions with the Pharmaceutical and Medical Device Industries and Medical School Policies and Characteristics: A Cross-Sectional Study 
PLoS Medicine  2014;11(10):e1001743.
Aaron Kesselheim and colleagues compared US medical students' survey responses regarding pharmaceutical company interactions with the schools' AMSA PharmFree scorecard and Institute on Medicine as a Profession's (IMAP) scores.
Please see later in the article for the Editors' Summary
Background
Professional societies use metrics to evaluate medical schools' policies regarding interactions of students and faculty with the pharmaceutical and medical device industries. We compared these metrics and determined which US medical schools' industry interaction policies were associated with student behaviors.
Methods and Findings
Using survey responses from a national sample of 1,610 US medical students, we compared their reported industry interactions with their schools' American Medical Student Association (AMSA) PharmFree Scorecard and average Institute on Medicine as a Profession (IMAP) Conflicts of Interest Policy Database score. We used hierarchical logistic regression models to determine the association between policies and students' gift acceptance, interactions with marketing representatives, and perceived adequacy of faculty–industry separation. We adjusted for year in training, medical school size, and level of US National Institutes of Health (NIH) funding. We used LASSO regression models to identify specific policies associated with the outcomes. We found that IMAP and AMSA scores had similar median values (1.75 [interquartile range 1.50–2.00] versus 1.77 [1.50–2.18], adjusted to compare scores on the same scale). Scores on AMSA and IMAP shared policy dimensions were not closely correlated (gift policies, r = 0.28, 95% CI 0.11–0.44; marketing representative access policies, r = 0.51, 95% CI 0.36–0.63). Students from schools with the most stringent industry interaction policies were less likely to report receiving gifts (AMSA score, odds ratio [OR]: 0.37, 95% CI 0.19–0.72; IMAP score, OR 0.45, 95% CI 0.19–1.04) and less likely to interact with marketing representatives (AMSA score, OR 0.33, 95% CI 0.15–0.69; IMAP score, OR 0.37, 95% CI 0.14–0.95) than students from schools with the lowest ranked policy scores. The association became nonsignificant when fully adjusted for NIH funding level, whereas adjusting for year of education, size of school, and publicly versus privately funded school did not alter the association. Policies limiting gifts, meals, and speaking bureaus were associated with students reporting having not received gifts and having not interacted with marketing representatives. Policy dimensions reflecting the regulation of industry involvement in educational activities (e.g., continuing medical education, travel compensation, and scholarships) were associated with perceived separation between faculty and industry. The study is limited by potential for recall bias and the cross-sectional nature of the survey, as school curricula and industry interaction policies may have changed since the time of the survey administration and study analysis.
Conclusions
As medical schools review policies regulating medical students' industry interactions, limitations on receipt of gifts and meals and participation of faculty in speaking bureaus should be emphasized, and policy makers should pay greater attention to less research-intensive institutions.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Making and selling prescription drugs and medical devices is big business. To promote their products, pharmaceutical and medical device companies build relationships with physicians by providing information on new drugs, by organizing educational meetings and sponsored events, and by giving gifts. Financial relationships begin early in physicians' careers, with companies providing textbooks and other gifts to first-year medical students. In medical school settings, manufacturers may help to inform trainees and physicians about developments in health care, but they also create the potential for harm to patients and health care systems. These interactions may, for example, reduce trainees' and trained physicians' skepticism about potentially misleading promotional claims and may encourage physicians to prescribe new medications, which are often more expensive than similar unbranded (generic) drugs and more likely to be recalled for safety reasons than older drugs. To address these and other concerns about the potential career-long effects of interactions between medical trainees and industry, many teaching hospitals and medical schools have introduced policies to limit such interactions. The development of these policies has been supported by expert professional groups and medical societies, some of which have created scales to evaluate the strength of the implemented industry interaction policies.
Why Was This Study Done?
The impact of policies designed to limit interactions between students and industry on student behavior is unclear, and it is not known which aspects of the policies are most predictive of student behavior. This information is needed to ensure that the policies are working and to identify ways to improve them. Here, the researchers investigate which medical school characteristics and which aspects of industry interaction policies are most predictive of students' reported behaviors and beliefs by comparing information collected in a national survey of US medical students with the strength of their schools' industry interaction policies measured on two scales—the American Medical Student Association (AMSA) PharmFree Scorecard and the Institute on Medicine as a Profession (IMAP) Conflicts of Interest Policy Database.
What Did the Researchers Do and Find?
The researchers compared information about reported gift acceptance, interactions with marketing representatives, and the perceived adequacy of faculty–industry separation collected from 1,610 medical students at 121 US medical schools with AMSA and IMAP scores for the schools evaluated a year earlier. Students at schools with the highest ranked interaction policies based on the AMSA score were 63% less likely to accept gifts as students at the lowest ranked schools. Students at the highest ranked schools based on the IMAP score were about half as likely to accept gifts as students at the lowest ranked schools, although this finding was not statistically significant (it could be a chance finding). Similarly, students at the highest ranked schools were 70% less likely to interact with sales representatives as students at the lowest ranked schools. These associations became statistically nonsignificant after controlling for the amount of research funding each school received from the US National Institutes of Health (NIH). Policies limiting gifts, meals, and being a part of speaking bureaus (where companies pay speakers to present information about the drugs for dinners and other events) were associated with students' reports of receiving no gifts and of non-interaction with sales representatives. Finally, policies regulating industry involvement in educational activities were associated with the perceived separation between faculty and industry, which was regarded as adequate by most of the students at schools with such policies.
What Do These Findings Mean?
These findings suggest that policies designed to limit industry interactions with medical students need to address multiple aspects of these interactions to achieve changes in the behavior and attitudes of trainees, but that policies limiting gifts, meals, and speaking bureaus may be particularly important. These findings also suggest that the level of NIH funding plays an important role in students' self-reported behaviors and their perceptions of industry, possibly because institutions with greater NIH funding have the resources needed to implement effective policies. The accuracy of these findings may be limited by recall bias (students may have reported their experiences inaccurately), and by the possibility that industry interaction policies may have changed in the year that elapsed between policy grading and the student survey. Nevertheless, these findings suggest that limitations on gifts should be emphasized when academic medical centers refine their policies on interactions between medical students and industry and that particular attention should be paid to the design and implementation of policies that regulate industry interactions in institutions with lower levels of NIH funding.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001743.
The UK General Medical Council provides guidance on financial and commercial arrangements and conflicts of interest as part of its good medical practice document, which describes what is required of all registered doctors in the UK
Information about the American Medical Student Association (AMSA) Just Medicine campaign (formerly the PharmFree campaign) and about the AMSA Scorecard is available
Information about the Institute on Medicine as a Profession (IMAP) and about its Conflicts of Interest Policy Database is also available
“Understanding and Responding to Pharmaceutical Promotion: A Practical Guide” is a manual prepared by Health Action International and the World Health Organization that medical schools can use to train students how to recognize and respond to pharmaceutical promotion
The US Institute of Medicine's report “Conflict of Interest in Medical Research, Education, and Practice” recommends steps to identify, limit, and manage conflicts of interest
The ALOSA Foundation provides evidence-based, non-industry-funded education about treating common conditions and using prescription drugs
doi:10.1371/journal.pmed.1001743
PMCID: PMC4196737  PMID: 25314155
21.  Methods for the comparative evaluation of pharmaceuticals 
Political background
As a German novelty, the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen; IGWiG) was established in 2004 to, among other tasks, evaluate the benefit of pharmaceuticals. In this context it is of importance that patented pharmaceuticals are only excluded from the reference pricing system if they offer a therapeutic improvement.
The institute is commissioned by the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) or by the Ministry of Health and Social Security. The German policy objective expressed by the latest health care reform (Gesetz zur Modernisierung der Gesetzlichen Krankenversicherung, GMG) is to base decisions on a scientific assessment of pharmaceuticals in comparison to already available treatments. However, procedures and methods are still to be established.
Research questions and methods
This health technology assessment (HTA) report was commissioned by the German Agency for HTA at the Institute for Medical Documentation and Information (DAHTA@DIMDI). It analysed criteria, procedures, and methods of comparative drug assessment in other EU-/OECD-countries. The research question was the following: How do national public institutions compare medicines in connection with pharmaceutical regulation, i.e. licensing, reimbursement and pricing of drugs?
Institutions as well as documents concerning comparative drug evaluation (e.g. regulations, guidelines) were identified through internet, systematic literature, and hand searches. Publications were selected according to pre-defined inclusion and exclusion criteria. Documents were analysed in a qualitative matter following an analytic framework that had been developed in advance. Results were summarised narratively and presented in evidence tables.
Results and discussion
Currently licensing agencies do not systematically assess a new drug's added value for patients and society. This is why many countries made post-licensing evaluation of pharmaceuticals a requirement for reimbursement or pricing decisions. Typically an explicitly designated drug review body is involved.
In all eleven countries included (Austria, Australia, Canada, Switzerland, Finland, France, the Netherlands, Norway, New Zealand, Sweden, and the United Kingdom) a drug's therapeutic benefit in comparison to treatment alternatives is leading the evaluation. A medicine is classified as a therapeutic improvement if it demonstrates an improved benefit-/risk-profile compared to treatment alternatives. However, evidence of superiority to a relevant degree is requested.
Health related quality of life is considered as the most appropriate criterion for a drug's added value from patients' perspective. Review bodies in Australia, New Zealand, and the United Kingdom have committed themselves to include this outcome measure whenever possible.
Pharmacological or innovative characteristics (e.g. administration route, dosage regime, new acting principle) and other advantages (e.g. taste, appearance) are considered in about half of the countries. However, in most cases these aspects rank as second line criteria for a drug's added value.
All countries except France and Switzerland perform a comparative pharmacoeconomic evaluation to analyse costs caused by a drug intervention in relation to its benefit (preferably by cost utility analysis). However, the question if a medicine is cost effective in relation to treatment alternatives is answered in a political and social context. A range of remarkably varying criteria are considered.
Countries agree that randomised controlled head-to-head trials (head-to-head RCT) with a high degree of internal and external validity provide the most reliable and least biased evidence of a drug's relative treatment effects (as do systematic reviews and meta-analyses of these RCT). Final outcome parameters reflecting long-term treatment objectives (mortality, morbidity, quality of life) are preferred to surrogate parameters. Following the concept of community effectiveness, drug review institutions also explicitly favour RCT in a "natural" design, i.e. in daily routine and country specific care settings.
The countries' requirements for pharmacoeconomic studies are similar despite some methodological inconsistencies, e.g. concerning cost calculation.
Outcomes of clinical and pharmacoeconomic analyses are largely determined by the choice of comparator. Selecting an appropriate comparative treatment is therefore crucial. In theory, the best or most cost effective therapy is regarded as appropriate comparator for clinical and economic studies. Pragmatically however, institutions accept that the drug is compared to the treatment of daily routine or to the least expensive therapy.
If a pharmaceutical offers several approved indications, in some countries all of them are assessed. Others only evaluate a drug's main indication. Canada is the only country which also considers a medicine's off-label use.
It is well known that clinical trials and pharmacoeconomic studies directly comparing a drug with adequate competitors are lacking - in quantitative as well as in qualitative terms. This is specifically the case before or shortly after marketing authorisation. Yet there is the need to support reimbursement or pricing decisions by scientific evidence. In this situation review bodies are often forced to rely on observational studies or on other internally less valid data (including expert and consensus opinions). As a second option they use statistical approaches like indirect adjusted comparisons (in Australia and the United Kingdom) and, commonly, economic modelling. However, there is consensus that results provided by these techniques need to be verified by valid head-to-head comparisons as soon as possible.
Conclusions
In the majority of countries reimbursement and pricing decisions are based on systematic and evidence-based evaluation comparing a drug's clinical and economic characteristics to daily treatment routine. However, further evaluation criteria, requirements and specific methodological issues still lack internationally consented standards.
PMCID: PMC3011319  PMID: 21289930
22.  How research funding agencies support science integration into policy and practice: An international overview 
Background
Funding agencies constitute one essential pillar for policy makers, researchers and health service delivery institutions. Such agencies are increasingly providing support for science implementation. In this paper, we investigate health research funding agencies and how they support the integration of science into policy, and of science into practice, and vice versa.
Methods
We selected six countries: Australia, The Netherlands, France, Canada, England and the United States. For 13 funding agencies, we compared their intentions to support, their actions related to science integration into policy and practice, and the reported benefits of this integration. We did a qualitative content analysis of the reports and information provided on the funding agencies’ websites.
Results
Most funding agencies emphasized the importance of science integration into policy and practice in their strategic orientation, and stated how this integration was structured. Their funding activities were embedded in the push, pull, or linkage/exchange knowledge transfer model. However, few program funding efforts were based on all three models. The agencies reported more often on the benefits of integration on practice, rather than on policy. External programs that were funded largely covered science integration into policy and practice at the end of grant stage, while overlooking the initial stages. Finally, external funding actions were more prominent than internally initiated bridging activities and training activities on such integration.
Conclusions
This paper contributes to research on science implementation because it goes beyond the two community model of researchers versus end users, to include funding agencies. Users of knowledge may be end users in health organizations like hospitals; civil servants assigned to decision making positions within funding agencies; civil servants outside of the Ministry of Health, such as the Ministry of the Environment; politicians deciding on health-related legislation; or even university researchers whose work builds on previous research. This heterogeneous sample of users may require different user-specific mechanisms for research initiation, development and dissemination. This paper builds the foundation for further discussion on science implementation from the perspective of funding agencies in the health field. In general, case studies can help in identifying best practices for evidence-informed decision making.
doi:10.1186/1748-5908-9-28
PMCID: PMC3939639  PMID: 24565209
Knowledge management system; Knowledge funding agencies; Knowledge use/utilization; International; Science; Policy; Funding agency
23.  Gender policies and advertising and marketing practices that affect women's health 
Global Health Action  2013;6:10.3402/gha.v6i0.20372.
Background
The three papers of this doctoral thesis are based on the social construction of reality through the analysis of communication relating to health issues. We have analysed the contents of parliamentary, institutional, and mass media to uncover whether their communications create, transmit, and perpetuate gender biases and/or stereotypes, which may have an impact on people's health, with a particular focus on women.
Objective
To analyse decision making and the creation of gender awareness policies and actions affecting women's health: (1) political debates about abortion, (2) gender awareness communication campaigns and educational actions, and (3) pharmaceutical advertising strategies.
Design
Quantitative and qualitative methods were employed, and the research included observational studies and systematic reviews. To apply a gender perspective, we used the level of gender observation proposed by S. Harding, which states that: (1) gender is the basis of social norms and (2) gender is one of the organisers of the social structure.
Results
Sixty percentage of the bills concerning abortion introduced in the Spanish Parliament were initiated and led by pro-choice women's groups. Seventy-nine percent of institutional initiatives aimed at promoting equality awareness and were in the form of educational actions, while unconventional advertising accounted for 6 percent. Both initiatives focused on occupational equality, and very few actions addressed issues such as shared responsibility or public policy. With regard to pharmaceutical advertising, similar traditional male–female gender roles were used between 1975 and 2005.
Conclusions
Gender sensitivity continues to be essential in changing the established gender system in Spanish institutions, which has a direct and indirect impact on health. Greater participation of women in public policy and decision-making are critical for womens’ health, such as the issue of abortion. The predominance of women as the target group of institutional gender awareness campaigns proves that the gender perspective still lacks the promotion of shared responsibilities between men and women. There is a need for institutions that act as ‘policy watchdogs’ to control the gender biases in mass media and pharmaceutical marketing as well as to ensure the proper implementation and maintenance of Spanish equality laws.
doi:10.3402/gha.v6i0.20372
PMCID: PMC3695283  PMID: 23806207
abortion; public policy; work-family reconciliation; pharmaceutical advertising; gender awareness communication campaigns; gender bias
24.  Representation and Misrepresentation of Scientific Evidence in Contemporary Tobacco Regulation: A Review of Tobacco Industry Submissions to the UK Government Consultation on Standardised Packaging 
PLoS Medicine  2014;11(3):e1001629.
Selda Ulucanlar and colleagues analyze submissions by two tobacco companies to the UK government consultation on standardized packaging.
Please see later in the article for the Editors' Summary
Background
Standardised packaging (SP) of tobacco products is an innovative tobacco control measure opposed by transnational tobacco companies (TTCs) whose responses to the UK government's public consultation on SP argued that evidence was inadequate to support implementing the measure. The government's initial decision, announced 11 months after the consultation closed, was to wait for ‘more evidence’, but four months later a second ‘independent review’ was launched. In view of the centrality of evidence to debates over SP and TTCs' history of denying harms and manufacturing uncertainty about scientific evidence, we analysed their submissions to examine how they used evidence to oppose SP.
Methods and Findings
We purposively selected and analysed two TTC submissions using a verification-oriented cross-documentary method to ascertain how published studies were used and interpretive analysis with a constructivist grounded theory approach to examine the conceptual significance of TTC critiques. The companies' overall argument was that the SP evidence base was seriously flawed and did not warrant the introduction of SP. However, this argument was underpinned by three complementary techniques that misrepresented the evidence base. First, published studies were repeatedly misquoted, distorting the main messages. Second, ‘mimicked scientific critique’ was used to undermine evidence; this form of critique insisted on methodological perfection, rejected methodological pluralism, adopted a litigation (not scientific) model, and was not rigorous. Third, TTCs engaged in ‘evidential landscaping’, promoting a parallel evidence base to deflect attention from SP and excluding company-held evidence relevant to SP. The study's sample was limited to sub-sections of two out of four submissions, but leaked industry documents suggest at least one other company used a similar approach.
Conclusions
The TTCs' claim that SP will not lead to public health benefits is largely without foundation. The tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for highly resourced corporations to slow, weaken, or prevent public health policies.
Please see later in the article for the Editors' Summary
Editors' Summary
Background
Every year, about 6 million people die from tobacco-related diseases and, if current trends continue, annual tobacco-related deaths will increase to more than 8 million by 2030. To reduce this loss of life, national and international bodies have drawn up various conventions and directives designed to implement tobacco control measures such as the adoption of taxation policies aimed at reducing tobacco consumption and bans on tobacco advertising, promotion, and sponsorship. One innovative but largely unused tobacco control measure is standardised packaging of tobacco products. Standardised packaging aims to prevent the use of packaging as a marketing tool by removing all brand imagery and text (other than name) and by introducing packs of a standard shape and colour that include prominent pictorial health warnings. Standardised packaging was first suggested as a tobacco control measure in 1986 but has been consistently opposed by the tobacco industry.
Why Was This Study Done?
The UK is currently considering standardised packaging of tobacco products. In the UK, Better Regulation guidance obliges officials to seek the views of stakeholders, including corporations, on the government's cost and benefit estimates of regulatory measures such as standardised packaging and on the evidence underlying these estimates. In response to a public consultation about standardised packaging in July 2013, which considered submissions from several transnational tobacco companies (TTCs), the UK government announced that it would wait for the results of the standardised packaging legislation that Australia adopted in December 2012 before making its final decision about this tobacco control measure. Parliamentary debates and media statements have suggested that doubt over the adequacy of the evidence was the main reason for this ‘wait and see’ decision. Notably, TTCs have a history of manufacturing uncertainty about the scientific evidence related to the harms of tobacco. Given the centrality of evidence to the debate about standardised packaging, in this study, the researchers analyse submissions made by two TTCs, British American Tobacco (BAT) and Japan Tobacco International (JTI), to the first UK consultation on standardised packaging (a second review is currently underway and will report shortly) to examine how TTCs used evidence to oppose standardised packaging.
What Did the Researchers Do and Find?
The researchers analysed sub-sections of two of the four TTC submissions (those submitted by BAT and JTI) made to the public consultation using verification-oriented cross-documentary analysis, which compared references made to published sources with the original sources to ascertain how these sources had been used, and interpretative analysis to examine the conceptual significance of TTC critiques of the evidence on standardised packaging. The researchers report that the companies' overall argument was that the evidence base in support of standardised packaging was seriously flawed and did not warrant the introduction of such packaging. The researchers identified three ways in which the TTC reports misrepresented the evidence base. First, the TTCs misquoted published studies, thereby distorting the main messages of these studies. For example, the TTCs sometimes omitted important qualifying information when quoting from published studies. Second, the TTCs undermined evidence by employing experts to review published studies for methodological rigor and value in ways that did not conform to normal scientific critique approaches (‘mimicked scientific critique’). So, for example, the experts considered each piece of evidence in isolation for its ability to support standardised packaging rather than considering the cumulative weight of the evidence. Finally, the TTCs engaged in ‘evidential landscaping’. That is, they promoted research that deflected attention from standardised packaging (for example, research into social explanations of smoking behaviour) and omitted internal industry research on the role of packaging in marketing.
What Do These Findings Mean?
These findings suggest that the TTC critique of the evidence in favour of standardised packaging that was presented to the UK public consultation on this tobacco control measure is highly misleading. However, because the researchers' analysis only considered subsections of the submissions from two TTCs, these findings may not be applicable to the other submissions or to other TTCs. Moreover, their analysis only considered the efforts made by TTCs to influence public health policy and not the effectiveness of these efforts. Nevertheless, these findings suggest that the claim of TTCs that standardised packaging will not lead to public health benefits is largely without foundation. More generally, these findings highlight the possibility that the tools of Better Regulation, particularly stakeholder consultation, provide an opportunity for wealthy corporations to slow, weaken, or prevent the implementation of public health policies.
Additional Information
Please access these websites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.1001629.
The World Health Organization provides information about the dangers of tobacco (in several languages) and an article about first experiences with Australia's tobacco plain packaging law; for information about the tobacco industry's influence on policy, see the 2009 World Health Organization report ‘Tobacco industry interference with tobacco control’
A UK parliamentary briefing on standardised packaging of tobacco products, a press release about the consultation, and a summary report of the consultation are available; the ideas behind the UK's Better Regulation guidance are described in a leaflet produced by the Better Regulation Task Force
Cancer Research UK (CRUK) has a web page with information on standardised packaging and includes videos
Wikipedia has a page on standardised packaging of tobacco products (note: Wikipedia is a free online encyclopaedia that anyone can edit; available in several languages)
The UK Centre for Tobacco Control Studies is a network of UK universities that undertakes original research, policy development, advocacy, and teaching and training in the field of tobacco control
TobaccoTactics.org, an online resource managed by the University of Bath, provides up-to-date information on the tobacco industry and the tactics it uses to influence tobacco regulation
SmokeFree, a website provided by the UK National Health Service, offers advice on quitting smoking and includes personal stories from people who have stopped smoking
Smokefree.gov, from the US National Cancer Institute, offers online tools and resources to help people quit smoking
doi:10.1371/journal.pmed.1001629
PMCID: PMC3965396  PMID: 24667150
25.  Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD) 
Executive Summary
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.
After an initial review of health technology assessments and systematic reviews of COPD literature, and consultation with experts, MAS identified the following topics for analysis: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.
The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.
Chronic Obstructive Pulmonary Disease (COPD) Evidentiary Framework
Influenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Smoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Community-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Pulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Long-term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Noninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Hospital-at-Home Programs for Patients with Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Home Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based Analysis
Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy Model
Experiences of Living and Dying With COPD: A Systematic Review and Synthesis of the Qualitative Empirical Literature
For more information on the qualitative review, please contact Mita Giacomini at: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm.
For more information on the economic analysis, please visit the PATH website: http://www.path-hta.ca/About-Us/Contact-Us.aspx.
The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.
Objective
The objective of this analysis was to determine the effectiveness of the influenza vaccination and the pneumococcal vaccination in patients with chronic obstructive pulmonary disease (COPD) in reducing the incidence of influenza-related illness or pneumococcal pneumonia.
Clinical Need: Condition and Target Population
Influenza Disease
Influenza is a global threat. It is believed that the risk of a pandemic of influenza still exists. Three pandemics occurred in the 20th century which resulted in millions of deaths worldwide. The fourth pandemic of H1N1 influenza occurred in 2009 and affected countries in all continents.
Rates of serious illness due to influenza viruses are high among older people and patients with chronic conditions such as COPD. The influenza viruses spread from person to person through sneezing and coughing. Infected persons can transfer the virus even a day before their symptoms start. The incubation period is 1 to 4 days with a mean of 2 days. Symptoms of influenza infection include fever, shivering, dry cough, headache, runny or stuffy nose, muscle ache, and sore throat. Other symptoms such as nausea, vomiting, and diarrhea can occur.
Complications of influenza infection include viral pneumonia, secondary bacterial pneumonia, and other secondary bacterial infections such as bronchitis, sinusitis, and otitis media. In viral pneumonia, patients develop acute fever and dyspnea, and may further show signs and symptoms of hypoxia. The organisms involved in bacterial pneumonia are commonly identified as Staphylococcus aureus and Hemophilus influenza. The incidence of secondary bacterial pneumonia is most common in the elderly and those with underlying conditions such as congestive heart disease and chronic bronchitis.
Healthy people usually recover within one week but in very young or very old people and those with underlying medical conditions such as COPD, heart disease, diabetes, and cancer, influenza is associated with higher risks and may lead to hospitalization and in some cases death. The cause of hospitalization or death in many cases is viral pneumonia or secondary bacterial pneumonia. Influenza infection can lead to the exacerbation of COPD or an underlying heart disease.
Streptococcal Pneumonia
Streptococcus pneumoniae, also known as pneumococcus, is an encapsulated Gram-positive bacterium that often colonizes in the nasopharynx of healthy children and adults. Pneumococcus can be transmitted from person to person during close contact. The bacteria can cause illnesses such as otitis media and sinusitis, and may become more aggressive and affect other areas of the body such as the lungs, brain, joints, and blood stream. More severe infections caused by pneumococcus are pneumonia, bacterial sepsis, meningitis, peritonitis, arthritis, osteomyelitis, and in rare cases, endocarditis and pericarditis.
People with impaired immune systems are susceptible to pneumococcal infection. Young children, elderly people, patients with underlying medical conditions including chronic lung or heart disease, human immunodeficiency virus (HIV) infection, sickle cell disease, and people who have undergone a splenectomy are at a higher risk for acquiring pneumococcal pneumonia.
Technology
Influenza and Pneumococcal Vaccines
Trivalent Influenza Vaccines in Canada
In Canada, 5 trivalent influenza vaccines are currently authorized for use by injection. Four of these are formulated for intramuscular use and the fifth product (Intanza®) is formulated for intradermal use.
The 4 vaccines for intramuscular use are:
Fluviral (GlaxoSmithKline), split virus, inactivated vaccine, for use in adults and children ≥ 6 months;
Vaxigrip (Sanofi Pasteur), split virus inactivated vaccine, for use in adults and children ≥ 6 months;
Agriflu (Novartis), surface antigen inactivated vaccine, for use in adults and children ≥ 6 months; and
Influvac (Abbott), surface antigen inactivated vaccine, for use in persons ≥ 18 years of age.
FluMist is a live attenuated virus in the form of an intranasal spray for persons aged 2 to 59 years. Immunization with current available influenza vaccines is not recommended for infants less than 6 months of age.
Pneumococcal Vaccine
Pneumococcal polysaccharide vaccines were developed more than 50 years ago and have progressed from 2-valent vaccines to the current 23-valent vaccines to prevent diseases caused by 23 of the most common serotypes of S pneumoniae. Canada-wide estimates suggest that approximately 90% of cases of pneumococcal bacteremia and meningitis are caused by these 23 serotypes. Health Canada has issued licenses for 2 types of 23-valent vaccines to be injected intramuscularly or subcutaneously:
Pneumovax 23® (Merck & Co Inc. Whitehouse Station, NJ, USA), and
Pneumo 23® (Sanofi Pasteur SA, Lion, France) for persons 2 years of age and older.
Other types of pneumococcal vaccines licensed in Canada are for pediatric use. Pneumococcal polysaccharide vaccine is injected only once. A second dose is applied only in some conditions.
Research Questions
What is the effectiveness of the influenza vaccination and the pneumococcal vaccination compared with no vaccination in COPD patients?
What is the safety of these 2 vaccines in COPD patients?
What is the budget impact and cost-effectiveness of these 2 vaccines in COPD patients?
Research Methods
Literature search
Search Strategy
A literature search was performed on July 5, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 2000 to July 5, 2010. The search was updated monthly through the AutoAlert function of the search up to January 31, 2011. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria, full-text articles were obtained. Articles with an unknown eligibility were reviewed with a second clinical epidemiologist and then a group of epidemiologists until consensus was established. Data extraction was carried out by the author.
Inclusion Criteria
studies comparing clinical efficacy of the influenza vaccine or the pneumococcal vaccine with no vaccine or placebo;
randomized controlled trials published between January 1, 2000 and January 31, 2011;
studies including patients with COPD only;
studies investigating the efficacy of types of vaccines approved by Health Canada;
English language studies.
Exclusion Criteria
non-randomized controlled trials;
studies investigating vaccines for other diseases;
studies comparing different variations of vaccines;
studies in which patients received 2 or more types of vaccines;
studies comparing different routes of administering vaccines;
studies not reporting clinical efficacy of the vaccine or reporting immune response only;
studies investigating the efficacy of vaccines not approved by Health Canada.
Outcomes of Interest
Primary Outcomes
Influenza vaccination: Episodes of acute respiratory illness due to the influenza virus.
Pneumococcal vaccination: Time to the first episode of community-acquired pneumonia either due to pneumococcus or of unknown etiology.
Secondary Outcomes
rate of hospitalization and mechanical ventilation
mortality rate
adverse events
Quality of Evidence
The quality of each included study was assessed taking into consideration allocation concealment, randomization, blinding, power/sample size, withdrawals/dropouts, and intention-to-treat analyses. The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. The following definitions of quality were used in grading the quality of the evidence:
Summary of Efficacy of the Influenza Vaccination in Immunocompetent Patients With COPD
Clinical Effectiveness
The influenza vaccination was associated with significantly fewer episodes of influenza-related acute respiratory illness (ARI). The incidence density of influenza-related ARI was:
All patients: vaccine group: (total of 4 cases) = 6.8 episodes per 100 person-years; placebo group: (total of 17 cases) = 28.1 episodes per 100 person-years, (relative risk [RR], 0.2; 95% confidence interval [CI], 0.06−0.70; P = 0.005).
Patients with severe airflow obstruction (forced expiratory volume in 1 second [FEV1] < 50% predicted): vaccine group: (total of 1 case) = 4.6 episodes per 100 person-years; placebo group: (total of 7 cases) = 31.2 episodes per 100 person-years, (RR, 0.1; 95% CI, 0.003−1.1; P = 0.04).
Patients with moderate airflow obstruction (FEV1 50%−69% predicted): vaccine group: (total of 2 cases) = 13.2 episodes per 100 person-years; placebo group: (total of 4 cases) = 23.8 episodes per 100 person-years, (RR, 0.5; 95% CI, 0.05−3.8; P = 0.5).
Patients with mild airflow obstruction (FEV1 ≥ 70% predicted): vaccine group: (total of 1 case) = 4.5 episodes per 100 person-years; placebo group: (total of 6 cases) = 28.2 episodes per 100 person-years, (RR, 0.2; 95% CI, 0.003−1.3; P = 0.06).
The Kaplan-Meier survival analysis showed a significant difference between the vaccinated group and the placebo group regarding the probability of not acquiring influenza-related ARI (log-rank test P value = 0.003). Overall, the vaccine effectiveness was 76%. For categories of mild, moderate, or severe COPD the vaccine effectiveness was 84%, 45%, and 85% respectively.
With respect to hospitalization, fewer patients in the vaccine group compared with the placebo group were hospitalized due to influenza-related ARIs, although these differences were not statistically significant. The incidence density of influenza-related ARIs that required hospitalization was 3.4 episodes per 100 person-years in the vaccine group and 8.3 episodes per 100 person-years in the placebo group (RR, 0.4; 95% CI, 0.04−2.5; P = 0.3; log-rank test P value = 0.2). Also, no statistically significant differences between the 2 groups were observed for the 3 categories of severity of COPD.
Fewer patients in the vaccine group compared with the placebo group required mechanical ventilation due to influenza-related ARIs. However, these differences were not statistically significant. The incidence density of influenza-related ARIs that required mechanical ventilation was 0 episodes per 100 person-years in the vaccine group and 5 episodes per 100 person-years in the placebo group (RR, 0.0; 95% CI, 0−2.5; P = 0.1; log-rank test P value = 0.4). In addition, no statistically significant differences between the 2 groups were observed for the 3 categories of severity of COPD. The effectiveness of the influenza vaccine in preventing influenza-related ARIs and influenza-related hospitalization was not related to age, sex, severity of COPD, smoking status, or comorbid diseases.
safety
Overall, significantly more patients in the vaccine group than the placebo group experienced local adverse reactions (vaccine: 17 [27%], placebo: 4 [6%]; P = 0.002). Significantly more patients in the vaccine group than the placebo group experienced swelling (vaccine 4, placebo 0; P = 0.04) and itching (vaccine 4, placebo 0; P = 0.04). Systemic reactions included headache, myalgia, fever, and skin rash and there were no significant differences between the 2 groups for these reactions (vaccine: 47 [76%], placebo: 51 [81%], P = 0.5).
With respect to lung function, dyspneic symptoms, and exercise capacity, there were no significant differences between the 2 groups at 1 week and at 4 weeks in: FEV1, maximum inspiratory pressure at residual volume, oxygen saturation level of arterial blood, visual analogue scale for dyspneic symptoms, and the 6 Minute Walking Test for exercise capacity.
There was no significant difference between the 2 groups with regard to the probability of not acquiring total ARIs (influenza-related and/or non-influenza-related); (log-rank test P value = 0.6).
Summary of Efficacy of the Pneumococcal Vaccination in Immunocompetent Patients With COPD
Clinical Effectiveness
The Kaplan-Meier survival analysis showed no significant differences between the group receiving the penumoccocal vaccination and the control group for time to the first episode of community-acquired pneumonia due to pneumococcus or of unknown etiology (log-rank test 1.15; P = 0.28). Overall, vaccine efficacy was 24% (95% CI, −24 to 54; P = 0.33).
With respect to the incidence of pneumococcal pneumonia, the Kaplan-Meier survival analysis showed a significant difference between the 2 groups (vaccine: 0/298; control: 5/298; log-rank test 5.03; P = 0.03).
Hospital admission rates and median length of hospital stays were lower in the vaccine group, but the difference was not statistically significant. The mortality rate was not different between the 2 groups.
Subgroup Analysis
The Kaplan-Meier survival analysis showed significant differences between the vaccine and control groups for pneumonia due to pneumococcus and pneumonia of unknown etiology, and when data were analyzed according to subgroups of patients (age < 65 years, and severe airflow obstruction FEV1 < 40% predicted). The accumulated percentage of patients without pneumonia (due to pneumococcus and of unknown etiology) across time was significantly lower in the vaccine group than in the control group in patients younger than 65 years of age (log-rank test 6.68; P = 0.0097) and patients with a FEV1 less than 40% predicted (log-rank test 3.85; P = 0.0498).
Vaccine effectiveness was 76% (95% CI, 20−93; P = 0.01) for patients who were less than 65 years of age and −14% (95% CI, −107 to 38; P = 0.8) for those who were 65 years of age or older. Vaccine effectiveness for patients with a FEV1 less than 40% predicted and FEV1 greater than or equal to 40% predicted was 48% (95% CI, −7 to 80; P = 0.08) and −11% (95% CI, −132 to 47; P = 0.95), respectively. For patients who were less than 65 years of age (FEV1 < 40% predicted), vaccine effectiveness was 91% (95% CI, 35−99; P = 0.002).
Cox modelling showed that the effectiveness of the vaccine was dependent on the age of the patient. The vaccine was not effective in patients 65 years of age or older (hazard ratio, 1.53; 95% CI, 0.61−a2.17; P = 0.66) but it reduced the risk of acquiring pneumonia by 80% in patients less than 65 years of age (hazard ratio, 0.19; 95% CI, 0.06−0.66; P = 0.01).
safety
No patients reported any local or systemic adverse reactions to the vaccine.
PMCID: PMC3384373  PMID: 23074431

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