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Litigation and public health policy making: the case of tobacco control.

Many tobacco control advocates, believing that legislators and regulators have failed to enact and implement sufficiently stringent tobacco control laws, have supported litigation as a means of achieving public health policy goals. In this article, we examine the relationship between litigation and public health policy formulation in the context of the debate over tobacco control policy. The fundamental questions are how social policy should be made regarding the use of tobacco products, and which institutions should be responsible for controlling tobacco use: the market, the political system (i.e., the legislative and regulatory branches of government), or the courts. On balance we conclude that litigation is a second-best solution. We see a distinct role for litigation as a complement to a broader, comprehensive approach to tobacco control policy making, rather than as an alternative to the traditional political apparatus of formulating and implementing public health policy. Our analysis suggests that, in general, public health goals are more directly achievable through the political process than through litigation, though situations such as those concerning tobacco control blur the bounds between litigation and the politics of public health. Litigation has stimulated a national debate over the role of smoking in society and may well move the policy agenda. But we conclude that a sustained legislative and regulatory presence ought to be the foundation of meaningful policy changes.

Humans↗

Oklahoma tobacco policy-making.

OBJECTIVES: To document and analyze comprehensive Oklahoma state tobacco policy-making trends and their link to public health trends. METHODS: A historical qualitative and archival content overview and analysis from 1985 to the present of previously secret tobacco industry documents. RESULTS: The 2002 Oklahoma State Plan for Tobacco Use Prevention and Cessation indicated tobacco use was the largest cause of annual preventable death in Oklahoma. The Oklahoma State Plan recommended a variety of proposals, including sales restrictions, youth access enforcement, repealing state preemption of stricter local tobacco control laws, adopting clean indoor air laws, increasing tobacco taxes, cessation programs, and anti-tobacco education efforts. CONCLUSIONS: Since 1985, the powerful tobacco lobby in Oklahoma has been highly successful in maintaining lower tobacco taxes and reduced regulations, which is a major impediment to the anti-tobacco public health goals of the Oklahoma State Plan and enhanced public health.

Adolescent↗

Implications of the Precautionary Principle in research and policy-making.

The Precautionary Principle (PP) has recently been formally introduced into national and international law. The key element is the justification for acting in the face of uncertainty. The PP is thereby a tool for avoiding possible future harm associated with suspected, but not conclusive, environmental risks. Under the PP, the burden of proof is shifted from demonstrating the presence of risk to demonstrating the absence of risk and it is the responsibility of the producer of a technology to demonstrate its safety rather than the responsibility of public authorities to show harm. Past experiences show the costly consequences of disregarding early warnings about environmental hazards. Today, the need for applying the PP is even greater. New research is needed to expand current insight into disease causation, to elucidate the full scope of potential adverse implications resulting from environmental pollutants, and to identify opportunities for prevention. Research approaches should be developed and strengthened to counteract innate ideological biases and to support our confidence in applying the PP for decision-making in the public policy arena.

Environmental Exposure↗

Systematically reviewing qualitative and quantitative evidence to inform management and policy-making in the health field.

Policy-makers and managers have always used a wide range of sources of evidence in making decisions about policy and the organization of services. However, they are under increasing pressure to adopt a more systematic approach to the utilization of the complex evidence base. Decision-makers must address complicated questions about the nature and significance of the problem to be addressed; the nature of proposed interventions; their differential impact; cost-effectiveness; acceptability and so on. This means that Cochrane-style reviews alone are not sufficient. Rather, they require access to syntheses of high-quality evidence that include research and non-research sources, and both qualitative and quantitative research findings. There is no single, agreed framework for synthesizing such diverse forms of evidence and many of the approaches potentially applicable to such an endeavour were devised for either qualitative or quantitative synthesis and/or for analysing primary data. This paper describes the key stages in reviewing and synthesizing qualitative and quantitative evidence for decision-making and looks at various strategies that could offer a way forward. We identify four basic approaches: narrative (including traditional 'literature reviews' and more methodologically explicit approaches such as 'thematic analysis', 'narrative synthesis', 'realist synthesis' and 'meta-narrative mapping'), qualitative (which convert all available evidence into qualitative form using techniques such as 'meta-ethnography' and 'qualitative cross-case analysis'), quantitative (which convert all evidence into quantitative form using techniques such as 'quantitative case survey' or 'content analysis') and Bayesian meta-analysis and decision analysis (which can convert qualitative evidence such as preferences about different outcomes into quantitative form or 'weights' to use in quantitative synthesis). The choice of approach will be contingent on the aim of the review and nature of the available evidence, and often more than one approach will be required.

Delivery of Health Care↗

Breast cancer patients' attitudes about rationing postlumpectomy radiation therapy: applicability of trade-off methods to policy-making.

PURPOSE: Along with evidence, clinical policies must take patients' values into account. Particularly where evidence is limited and where assumptions of utility-maximizing behavior may not be valid, new methods such as trade-off techniques (TOTs), which allow elicitation of patients' treatment alternatives, might be useful in policy formulation. We used TOTs to assess breast cancer patients' attitudes toward two clinical policies designed to ration adjuvant postlumpectomy breast radiation therapy. METHODS: Cross-sectional interviews were performed in a tertiary cancer center. A total of 102 patients were presented with information about the side effects and benefits associated with two hypothetical decisions: (1) willingness to receive treatment elsewhere to shorten the wait for radiation therapy, and (2) foregoing radiation therapy in the face of small marginal benefits. For each scenario, a TOT was used to identify the maximal acceptable wait time (MAWT) for therapy and the benefit threshold at which the patient would forego therapy. Associations of clinical and demographic factors with these decisions were determined by regression analysis. RESULTS: Patients would be willing to wait, on average, 7 weeks before wanting to leave their city for radiation therapy, less than the 13-week delay our patients actually faced. Older patients were less willing to wait (P = .013); 46% of patients would not give up radiation therapy, even in the face of no stated benefit. Willingness to give up radiation therapy was predicted by willingness to accept delay (odds ratio [OR], 1.84; 95% confidence interval [CI], 1.05 to 3.37) and being employed (OR, 2.61; 95% CI, 1.08 to 6.54). Patients with larger tumors were less willing to give up radiation therapy (OR, 0.57; 95% CI, 0.31 to 0.97). CONCLUSION: Even in difficult decisions such as rationing postlumpectomy breast cancer radiation therapy, TOTs can inform policy formulation by indicating the distributions of patients' preferences.

Adult↗

How are policy makers using evidence? Models of research utilisation and local NHS policy making.

STUDY OBJECTIVE: This paper is based on a qualitative study that aimed to identify factors that facilitate or impede evidence-based policy making at a local level in the UK National Health Service (NHS). It considers how models of research utilisation drawn from the social sciences map onto empirical evidence from this study. DESIGN: A literature review and case studies of social research projects that were initiated by NHS health authority managers or GP fundholders in one region of the NHS. In depth interviews and document analysis were used. SETTING: One NHS region in England. PARTICIPANTS: Policy makers, GPs and researchers working on each of the social research projects selected as case studies. MAIN RESULTS: The direct influence of research evidence on decision making was tempered by factors such as financial constraints, shifting timescales and decision makers' own experiential knowledge. Research was more likely to impact on policy in indirect ways, including shaping policy debate and mediating dialogue between service providers and users. CONCLUSIONS: The study highlights the role of sustained dialogue between researchers and the users of research in improving the utilisation of research-based evidence in the policy process.

England↗

Health research, the MDGs and policy making in Mozambique.

Health research can play an important part in achieving the goals of improving health, economic development and reducing poverty, even though a review of the literature suggests that little attention is given to the subject. Mozambique as a developing country has scarce resources for health research and so its health research efforts need targeted at pressing concerns and be capable of influencing policy-making. A way forward is being developed so that position of policy-makers and researchers is clarified and co-ordination better organised. This will also involve a review of financing, formulation of agendas, the avoidance of wasted resources and improving management skills.

Health Policy↗

Improving the use of research-based evidence in policy making: effective care in pregnancy and childbirth in the United States.

The rigorous syntheses in Effective Care in Pregnancy and Childbirth (ECPC) raise the question of how these and future recommendations can effectively be used to influence the decisions of policy makers and to improve the care we receive. The fragmentation of U.S. health care is especially striking for pregnancy and childbirth care. Although the U.S. context does not contain an obvious focal point for ECPC, several organizations have leverage or influence over different facets of policy making in this area: professional associations, consumer advocates, regulatory bodies, and third-party payers. An alternative to current independent activities is the organization of a network to facilitate implementation of ECPC. The intention would be that, through interaction, members would strengthen their interest and improve their effectiveness in implementing ECPC. An initial activity might be to evaluate alternative methods for implementing a specific recommendation.

Health Education↗

Towards systematic reviews that inform health care management and policy-making.

OBJECTIVES: To identify ways to improve the usefulness of systematic reviews for health care managers and policy-makers that could then be evaluated prospectively. METHODS: We systematically reviewed studies of decision-making by health care managers and policy-makers, conducted interviews with a purposive sample of them in Canada and the United Kingdom (n = 29), and reviewed the websites of research funders, producers/purveyors of research, and journals that include them among their target audiences (n = 45). RESULTS: Our systematic review identified that factors such as interactions between researchers and health care policy-makers and timing/timeliness appear to increase the prospects for research use among policy-makers. Our interviews with health care managers and policy-makers suggest that they would benefit from having information that is relevant for decisions highlighted for them (e.g. contextual factors that affect a review's local applicability and information about the benefits, harms/risks and costs of interventions) and having reviews presented in a way that allows for rapid scanning for relevance and then graded entry (such as one page of take-home messages, a three-page executive summary and a 25-page report). Managers and policy-makers have mixed views about the helpfulness of recommendations. Our analysis of websites found that contextual factors were rarely highlighted, recommendations were often provided and graded entry formats were rarely used. CONCLUSIONS: Researchers could help to ensure that the future flow of systematic reviews will better inform health care management and policy-making by involving health care managers and policy-makers in their production and better highlighting information that is relevant for decisions. Research funders could help to ensure that the global stock of systematic reviews will better inform health care management and policy-making by supporting and evaluating local adaptation processes such as developing and making available online more user-friendly 'front ends' for potentially relevant systematic reviews.

Canada↗

Anticipating the consequences for the primary therapy of breast cancer after introducing screening. A more global picture for health care policy making.

A breast cancer screening program mainly aims at reducing mortality. However, it also has an effect, often not assessed, on the utilization of health care resources that is relevant to health care policy making. Using a simulation model, this paper forecasts the impact of introducing a breast cancer screening program on the utilization of resources for the primary therapy of breast cancer. The most important consequences from a health care point of view will be an increased use of breast-conserving therapy and an increased need for postoperative radiotherapy; there will also be a higher number of women diagnosed with noninvasive breast cancer. The results of this study could provide support for health care decision making by showing the consequences of policy decisions on the introduction of screening programs for health care utilization.

Adult↗

Measuring the extent of gerontological home care staff participation in agency policy making and planning.

A survey study of the work experience and views of administrative and direct service program staff (N = 91) in both small scale and large scale Older Americans Act-funded home care programs in New York City sheds light on the extent to which various categories of personnel in the field of community home care have opportunities to participate in a range of agency policy making and planning functions. Findings reveal that home care staff in small scale programs were more directly involved in both client-centered and program-centered policy/making activities. In particular, these workers felt they were significantly more active in: changing service plans; discussing changes that need to be made in how the agency operates; planning new services and programs at the agency; and helping to train or orient new workers in the program. A strong negative correlation between level of organizational complexity and worker participation rates was discovered. Additional data suggest that all staff, regardless of their status or work responsibility, would like to be granted more of a voice in planning decision. Those who participate least in such activities were most adamant over being given a greater role in this aspect of program life. Heightened levels of job satisfaction were also associated with greater measures of worker involvement in organizational decision-making. Study findings are seen to have implications for the design of more equitable decision-making mechanisms in gerontological home care specifically and human service programs generally.

Aged↗

Computer simulation to support policy making in the control of pseudorabies.

A further integration of international markets makes a coordinated policy against contagious animal infections increasingly important. In the future, stricter demands are to be expected concerning the control and eradication of such infections. To anticipate these demands, a computer simulation model is created in which scenarios can be evaluated with respect to epidemiological and economic effects of the infections and control strategies. In this paper, the simulation model is described for Pseudorabies in swine. In the model, the population of herds is subdivided into two main herd types: breeding and finishing. Each herd is in one of 24 states per herd type. The states are based on (1) the reproduction ratio R which is the number of secondary cases caused by one infectious herd, (2) the prevalence for each value of R and (3) the expected number of infectious animals in an infectious herd within each prevalence range and for each R. The different values of R are based on experiments and field data in which different vaccination strategies were used. The transition matrix with the probabilities of every transition from one state to another is calculated on a weekly base. With this matrix the distribution of herds over states from week to week is derived. To include a dynamic element in the transition probabilities, the number of newly infectious herds per week is a function of animal and other contacts, including aerial, material and personal contacts. Calculations show that the infection in the Dutch swine population will not disappear without vaccination. With a vaccination scheme in which sows are vaccinated 3 times per year and fattening pigs 1 time per cycle the infection will ultimately be eradicated, but 2 vaccinations per cycle for fattening pigs are needed to eradicate the infection within an acceptable timespan (i.e. 2 to 3 years). The latter strategy will become compulsory in the Netherlands from October 1st 1995.

Animals↗

Healthcare technology assessment: methods, framework, and role in policy making.

UNLABELLED: This activity is designed for healthcare organization managers and clinicians, particularly those involved in technology-related decisions, including coverage decisions, technology acquisition, practice guideline development, and evidence-based medicine. GOAL: To provide a basic understanding of the principles, methods, and systematic framework of healthcare technology assessment. OBJECTIVES: 1. Understand the role of healthcare technology assessment in policy making and the technical properties and impact assessed. 2. Become familiar with the categories and basic attributes of methods used in healthcare technology assessment. 3. Comprehend the ten-step framework for conducting a healthcare technology assessment.

Data Collection↗

[Value of cost-utility analysis; evidence-based policy making].

In this issue of the Journal a review on the present state of science regarding cost-utility analysis is presented. The article can be regarded as a laudable enumeration of the points of academic discussion still associated with cost-utility analyses. Indeed, various schools of researchers with different positions on specific points contribute to these discussions. However, it would be incorrect to conclude that cost-utility analyses are therefore not useful. If performed according to current insights and clearly presented, they are transparent and can be assessed and reproduced. Thus they can contribute to a scientific underpinning of policy decisions. Notably, the alternative of 'opinion'-based policy making should be kept in mind when assessing cost-utility analyses.

Cost-Benefit Analysis↗

Network analysis of Korean health insurance policy-making process.

This study examines how the decision-making process evolved in Korea during the initial phases of introduction and implementation of National Health Insurance. This study analyses the official documents and interviews views made with government officials and related personnel. We used the method of network analysis and multidimensional scaling in order to demonstrate how the major participants in the decision-making process developed and changed under the contemporary political situations. In the pre-implementation stage around 1976, major concerns were concentrated around the issues of financial support for social insurance, the fee schedule and who ought to be covered first. The total number of participants of the health or health-related organization was 61, which included the President, the Minister of Health and Social Affairs, representatives of special interest groups, etc. In the actual implementation period of 1982, different issues were brought up by the major participants. The number of participants in this period declined to 44 with the deletion of 19 and with the addition of two newly formed health insurance organizations. By 1988, as the implementation reached its final decision period, disagreements were centered on progressive premium rating and the administration of National Health Insurance. The number of participants increased to 60 after the addition of 16 participants. The analysis of this paper may provide some insight for other countries which wish to establish National Health Insurance; as reference to the policy-making process, it may provide some suggestions for when to initiate and how to formulate National Health Insurance policies.

Humans↗

Implications for social security policy-making of research in mortality.

"The main purpose of this article is to outline the relationship between mortality research and policy-making in social security. Reasons are first discussed as to why more information is needed for social security purposes on how and why mortality varies over time periods and across population groups. There follows a synopsis of the correspondence between the type of policy question asked and the kind of research required to answer it. The paper concludes with a discussion of the incorporation of mortality research into policy models." The geographic focus is on the United States.

Americas↗

Public health expenditures: developing estimates for improved policy making.

The Public Health Foundation (PHF), under contract to the U.S. Department of Health and Human Services, Public Health Service (PHS), worked with federal, state, and local public health, mental health, substance abuse, and environmental agencies in nine states to develop and successfully test a methodology for estimating investments in essential public health services. Estimates from the nine-state sample revealed the predominance of personal health expenditures in the public health system. Of total state health care dollars, only 1 percent was spent on population-based health services by participating agencies. This pilot provides a rational starting point toward a uniform methodology for highlighting public health expenditures that may be critical in revealing the effects of a changing health care environment on the nation's health. In combination with other data, results are expected to lead to a more informed policy-making process.

Financing, Government↗