Perspectives of California Legislators on Institutional Barriers and Facilitators to Non-Partisan Research Evidence Use in State Health Policymaking.

BACKGROUND: Bridging the translational gap between research evidence and health policy in state legislatures requires understanding the institutional barriers and facilitators to non-partisan research evidence use. Previous studies have identified individual-level barriers and facilitators to research evidence use, but limited perspectives exist on institutional factors within legislatures that influence non-partisan research evidence use in health policymaking. OBJECTIVE: We describe the perspectives of California state legislators and legislative staff on institutional barriers and facilitators of non-partisan research evidence use in health policymaking and explore potential solutions for enhancing use. DESIGN: Case study design involving qualitative interviews. PARTICIPANTS: We interviewed 24 California state legislators, legislative office staff, and legislative research staff. APPROACH: Semi-structured recorded interviews were conducted in person or by phone to identify opportunities for enhancing non-partisan research evidence use within state legislatures. We conducted thematic analyses of interview transcripts to identify (1) when research evidence is used during the policymaking process, (2) barriers and facilitators operating at the institutional level, and (3) potential solutions for enhancing evidence use. RESULTS: Institutional barriers to non-partisan research evidence use in health policymaking were grouped into three themes: institutional policies, practices, and priorities. Interviews also revealed institutional-level facilitators of research evidence use, including (1) access and capacity to engage with research evidence, and (2) perceived credibility of research evidence. The most widely supported institutional-level solution for enhancing evidence-based health policymaking in state legislatures involved establishing independent, impartial research entities to provide legislators with trusted evidence to inform decision-making. CONCLUSIONS: Potential institutional-level changes within state legislatures may enhance evidence use in health policymaking, leading to improved health outcomes and lower healthcare costs for states.

Lawmakers' use of scientific evidence can be improved.

Core to the goal of scientific exploration is the opportunity to guide future decision-making. Yet, elected officials often miss opportunities to use science in their policymaking. This work reports on an experiment with the US Congress-evaluating the effects of a randomized, dual-population (i.e., researchers and congressional offices) outreach model for supporting legislative use of research evidence regarding child and family policy issues. In this experiment, we found that congressional offices randomized to the intervention reported greater value of research for understanding issues than the control group following implementation. More research use was also observed in legislation introduced by the intervention group. Further, we found that researchers randomized to the intervention advanced their own policy knowledge and engagement as well as reported benefits for their research following implementation.

Government policy interventions to reduce human antimicrobial use: A systematic review and evidence map.

BACKGROUND: Growing political attention to antimicrobial resistance (AMR) offers a rare opportunity for achieving meaningful action. Many governments have developed national AMR action plans, but most have not yet implemented policy interventions to reduce antimicrobial overuse. A systematic evidence map can support governments in making evidence-informed decisions about implementing programs to reduce AMR, by identifying, describing, and assessing the full range of evaluated government policy options to reduce antimicrobial use in humans. METHODS AND FINDINGS: Seven databases were searched from inception to January 28, 2019, (MEDLINE, CINAHL, EMBASE, PAIS Index, Cochrane Central Register of Controlled Trials, Web of Science, and PubMed). We identified studies that (1) clearly described a government policy intervention aimed at reducing human antimicrobial use, and (2) applied a quantitative design to measure the impact. We found 69 unique evaluations of government policy interventions carried out across 4 of the 6 WHO regions. These evaluations included randomized controlled trials (n = 4), non-randomized controlled trials (n = 3), controlled before-and-after designs (n = 7), interrupted time series designs (n = 25), uncontrolled before-and-after designs (n = 18), descriptive designs (n = 10), and cohort designs (n = 2). From these we identified 17 unique policy options for governments to reduce the human use of antimicrobials. Many studies evaluated public awareness campaigns (n = 17) and antimicrobial guidelines (n = 13); however, others offered different policy options such as professional regulation, restricted reimbursement, pay for performance, and prescription requirements. Identifying these policies can inform the development of future policies and evaluations in different contexts and health systems. Limitations of our study include the possible omission of unpublished initiatives, and that policies not evaluated with respect to antimicrobial use have not been captured in this review. CONCLUSIONS: To our knowledge this is the first study to provide policy makers with synthesized evidence on specific government policy interventions addressing AMR. In the future, governments should ensure that AMR policy interventions are evaluated using rigorous study designs and that study results are published. PROTOCOL REGISTRATION: PROSPERO CRD42017067514.

ISPOR, the FDA, and the Evolving Regulatory Science of Medical Device Products.

The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) is a key venue for members from private industry, government, and academia to collaborate and share advances in regulatory, clinical, and reimbursement science for drugs, devices, and diagnostics. In parallel, the US Food and Drug Administration (FDA) "is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable." In 2012, the Medical Device Innovation Consortium (MDIC) was formed as a public-private partnership bringing together government, industry, and nonprofit organizations to advance approaches that promote patient access to safe, innovative medical technologies. With a focus on regulatory science, the MDIC has been assessing how to apply real-world evidence (RWE) regulatory science to medical devices. A key goal of this project is to review the history of RWE regulatory science, define terms, and explain why and how RWE is being considered across the total product life cycle, including regulatory assessment. Unique considerations of real-world data for in vitro diagnostics are also taken into account. We envision that these activities will help ensure a high level of rigor and integrity of RWE necessary for regulatory use cases and demonstrate where RWE can be successfully used for regulatory decision making. The ISPOR, FDA, and MDIC are providing the needed leadership in ensuring that diverse stakeholders share a meaningful voice in determining RWE use and, by so doing, are improving the quality and efficiency of care, enhancing health outcomes, and addressing broader societal concerns of reducing health disparities and costs.

Limitations for health research with restricted data collection from UK primary care.

PURPOSE: UK primary care provides a rich data source for research. The impact of proposed data collection restrictions is unknown. This study aimed to assess the impact of restricting the scope of electronic health record (EHR) data collection on the ability to conduct research. The study estimated the consequences of restricted data collection on published Clinical Practice Research Datalink studies from high impact journals or referenced in clinical guidelines. METHODS: A structured form was used to systematically analyse the extent to which individual studies would have been possible using a database with data collection restrictions in place: (1) retrospective collection of specified diseases only; (2) retrospective collection restricted to a 6- or 12-year period; (3) prospective and retrospective collection restricted to non-sensitive data. Outcomes were categorised as unfeasible (not reproducible without major bias); compromised (feasible with design modification); or unaffected. RESULTS: Overall, 91% studies were compromised with all restrictions in place; 56% studies were unfeasible even with design modification. With restrictions on diseases alone, 74% studies were compromised; 51% were unfeasible. Restricting collection to 6/12 years had a major impact, with 67 and 22% of studies compromised, respectively. Restricting collection of sensitive data had a lesser but marked impact with 10% studies compromised. CONCLUSION: EHR data collection restrictions can profoundly reduce the capacity for public health research that underpins evidence-based medicine and clinical guidance. National initiatives seeking to collect EHRs should consider the implications of restricting data collection on the ability to address vital public health questions.

Balancing early access with uncertainties in evidence for drugs authorized by prospective case series - systematic review of reimbursement decisions.

AIMS: To review clinical and cost-effectiveness evidence underlying reimbursement decisions relating to drugs whose authorization mainly is based on evidence from prospective case series. METHODS: A systematic review of all new drugs evaluated in 2011-2016 within a health care profession-driven resource prioritization process, with a market approval based on prospective case series, and a reimbursement decision by the Swedish Dental and Pharmaceutical Benefits Agency (TLV). Public assessment reports from the European Medicines Agency, published pivotal studies, and TLV, Scottish Medicines Consortium and National Institute of Health and Care Excellence decisions and guidance documents were reviewed. RESULTS: Six drug cases were assessed (brentuximab vedotin, bosutinib, ponatinib, idelalisib, vismodegib, ceritinib). The validity of the pivotal studies was hampered by the use of surrogate primary outcomes and the absence of recruitment information. To quantify drug treatment effect sizes, the reimbursement agencies primarily used data from another source in indirect comparisons. TLV granted reimbursement in five cases, compared with five in five cases for Scottish Medicines Consortium and four in five cases for National Institute of Health and Care Excellence. Decision modifiers, contributing to granted reimbursement despite hugely uncertain cost-effectiveness ratios, were, for example, small population size, occasionally linked to budget impact, severity of disease, end of life and improved life expectancy. CONCLUSION: For drugs whose authorization is based on prospective case series, most applications for reimbursement within public health care are granted. The underlying evidence has limitations over and above the design per se, and decision modifiers are frequently referred to in the value-based pricing decision making.

State Tobacco Policies as Predictors of Evidence-Based Cessation Method Usage: Results From a Large, Nationally Representative Dataset.

Introduction: Evidence-based cessation methods including nicotine replacement therapy (NRT), non-NRT medications, quitlines, and behavioral treatments are underutilized by smokers attempting to quit. Although a number of studies have demonstrated a relationship between state-level tobacco policies (eg, taxation, appropriations) and cessation, whether such state-level factors influence likelihood of using an evidence-based treatment is unclear. Accordingly, the aims of the present study were: (1) to describe evidence-based cessation method utilization by state and (2) to examine the effect of state-level factors on cessation method utilization above and beyond individual-level predictors. Methods: Data were utilized from the 2010-2011 Tobacco Use Supplement to the Current Population Survey (TUS-CPS). Participants included 9232 smokers who reported a past-year quit attempt. Data on 11 state-level predictors were collated from national datasets. Analyses were based on: (1) descriptive characterization of quit method usage, (2) logistic regression models to determine state-level factors as predictors of quit method utilization, controlling for individual-level predictors, (3) cluster analyses grouping states with similar state-level factors, and (4) examination of cluster as a predictor of cessation method. Results: Tobacco control appropriations significantly predicted NRT, quitline, and behavioral treatment utilization. Additional state-level factors that demonstrated significant relationships included Medicaid coverage of non-NRT medications and behavioral treatment, tobacco tax rate, smoking prevalence, and percentage of population uninsured. State clustering significantly predicted quit method across all four methods. Conclusions: State-level factors influence the likelihood of residents utilizing evidence-based quit methods. Results are discussed in terms of implications for tobacco policy at the state level. Implications: Results from the present study highlight state tobacco control appropriations as a robust predictor of evidence-based cessation method utilization. Other significant state-level predictors of evidence-based cessation method utilization included Medicaid coverage of non-NRT medications and behavioral treatment, tobacco tax rate, smoking prevalence, and percentage of population uninsured. Moreover, state-level predictors clustered together to significantly predict evidence-based cessation method utilization. Thus, increasing tobacco control appropriations, extending health insurance coverage, maximizing revenue from tobacco taxation and tobacco settlements, and ultimately decreasing smoking prevalence are important targets for individual states to promote utilization of evidence-based cessation methods.

Legitimacy in bioethics: challenging the orthodoxy.

Several prominent writers including Norman Daniels, James Sabin, Amy Gutmann, Dennis Thompson and Leonard Fleck advance a view of legitimacy according to which, roughly, policies are legitimate if and only if they result from democratic deliberation, which employs only public reasons that are publicised to stakeholders. Yet, the process described by this view contrasts with the actual processes involved in creating the Affordable Care Act (ACA) and in attempting to pass the Health Securities Act (HSA). Since the ACA seems to be legitimate, as the HSA would have been had it passed, there seem to be counterexamples to this view. In this essay, I clarify the concept of legitimacy as employed in bioethics discourse. I then use that clarification to develop these examples into a criticism of the orthodox view-that it implies that legitimacy requires counterintuitively large sacrifices of justice in cases where important advancement of healthcare rights depends on violations of publicity. Finally, I reply to three responses to this challenge: (1) that some revision to the orthodox view salvages its core commitments, (2) that its views of publicity and substantive considerations do not have the implications that I claim and (3) that arguments for it are strong enough to support even counterintuitive results. My arguments suggest a greater role for substantive considerations than the orthodox view allows.

Integrative medicine or infiltrative pseudoscience?

Evidence-based medicine, first described in 1992, offers a clear, systematic, and scientific approach to the practice of medicine. Recently, the non-evidence-based practice of complementary and alternative medicine (CAM) has been increasing in the United States and around the world, particularly at medical institutions known for providing rigorous evidence-based care. The use of CAM may cause harm to patients through interactions with evidence-based medications or if patients choose to forego evidence-based care. CAM may also put financial strain on patients as most CAM expenditures are paid out-of-pocket. Despite these drawbacks, patients continue to use CAM due to media promotion of CAM therapies, dissatisfaction with conventional healthcare, and a desire for more holistic care. Given the increasing demand for CAM, many medical institutions now offer CAM services. Recently, there has been controversy surrounding the leaders of several CAM centres based at a highly respected academic medical institution, as they publicly expressed anti-vaccination views. These controversies demonstrate the non-evidence-based philosophies that run deep within CAM that are contrary to the evidence-based care that academic medical institutions should provide. Although there are financial incentives for institutions to provide CAM, it is important to recognize that this legitimizes CAM and may cause harm to patients. The poor regulation of CAM allows for the continued distribution of products and services that have not been rigorously tested for safety and efficacy. Governments in Australia and England have successfully improved regulation of CAM and can serve as a model to other countries.

Medical immobilization as impairment of bodily organ functions within the meaning of the Polish Penal Code - consultative problems and a proposal for a method of judicial and medical evaluation.

AIM OF THE STUDY: The aim of the paper is analysis of the impact of immobilization treatment of "less severe" motor organ injuries affecting soft tissues on the position of medical experts and court decisions in crimes against health. We also analysed the attitude of courts to expert opinions and present a proposal for a model of judicial and medical opinion in such cases. MATERIAL AND METHODS: In the study, we analysed judgments of the criminal divisions of common courts, in which the use of medical immobilization of a given part of the body or lack thereof could have an impact on the degree of health impairment determined by the medical expert. RESULTS: Some experts consider medical immobilization to be tantamount to an impairment of the function of a body organ, and the courts rarely reject such opinions. For some experts, the key is not the actual function of the immobilized part of the musculoskeletal system after 7 days from injury, but the immobilization treatment itself, and not the time it takes. In addition, experts determine the severity of injuries when immobilization is/is not used. CONCLUSIONS: The degree of health impairment, as defined in the Penal Code, should be determined by a medical check-up carried out 7 days after the injury, with an assessment of its "biological" effects, and not by the use of immobilization treatment and the time for which it is maintained.

Policies for Use of Real-World Data in Health Technology Assessment (HTA): A Comparative Study of Six HTA Agencies.

BACKGROUND: Randomized controlled trials provide robust data on the efficacy of interventions rather than on effectiveness. Health technology assessment (HTA) agencies worldwide are thus exploring whether real-world data (RWD) may provide alternative sources of data on effectiveness of interventions. Presently, an overview of HTA agencies' policies for RWD use in relative effectiveness assessments (REA) is lacking. OBJECTIVES: To review policies of six European HTA agencies on RWD use in REA of drugs. A literature review and stakeholder interviews were conducted to collect information on RWD policies for six agencies: the Dental and Pharmaceutical Benefits Agency (Sweden), the National Institute for Health and Care Excellence (United Kingdom), the Institute for Quality and Efficiency in Healthcare (Germany), the High Authority for Health (France), the Italian Medicines Agency (Italy), and the National Healthcare Institute (The Netherlands). The following contexts for RWD use in REA of drugs were reviewed: initial reimbursement discussions, pharmacoeconomic analyses, and conditional reimbursement schemes. We identified 13 policy documents and 9 academic publications, and conducted 6 interviews. RESULTS: Policies for RWD use in REA of drugs notably differed across contexts. Moreover, policies differed between HTA agencies. Such variations might discourage the use of RWD for HTA. CONCLUSIONS: To facilitate the use of RWD for HTA across Europe, more alignment of policies seems necessary. Recent articles and project proposals of the European network of HTA may provide a starting point to achieve this.

Corporate political activity of the dairy industry in France: an analysis of publicly available information.

OBJECTIVE: In the present study, we used a structured approach based on publicly available information to identify the corporate political activity (CPA) strategies of three major actors in the dairy industry in France. DESIGN: We collected publicly available information from the industry, government and other sources over a 6-month period, from March to August 2015. Data collection and analysis were informed by an existing framework for classifying the CPA of the food industry. Setting/Subjects Our study included three major actors in the dairy industry in France: Danone, Lactalis and the Centre National Interprofessionnel de l'Economie Laitière (CNIEL), a trade association. RESULTS: During the period of data collection, the dairy industry employed CPA practices on numerous occasions by using three strategies: the 'information and messaging', the 'constituency building' and the 'policy substitution' strategies. The most common practice was the shaping of evidence in ways that suited the industry. The industry also sought involvement in the community, establishing relationships with public health professionals, academics and the government. CONCLUSIONS: Our study shows that the dairy industry used several CPA practices, even during periods when there was no specific policy debate on the role of dairy products in dietary guidelines. The information provided here could inform public health advocates and policy makers and help them ensure that commercial interests of industry do not impede public health policies and programmes.

Complementary medicine products: interpreting the evidence base.

Many patients use complementary medicine (CM) products, such as vitamins, minerals and herbs as part of self-care without professional advice or disclosure to their doctors. While use of CM products is gaining awareness by the medical community and there is mounting evidence for their safety, efficacy and cost-effectiveness, there is also the potential for adverse events from inappropriate use and/or withdrawal, as well as interactions with other medicines. Due to the unique and complex properties of many CM products, research evidence is specific to individual preparations and this can lead to confusion when assessing label claims and interpreting the results of clinical trials and systematic reviews. While the Australian regulatory environment for CM products is the same as for prescription medicines and is based on risk, there is a great need for consumers and clinicians to have access to easily understood, evidence-based information to facilitate informed decision-making.

Observational Evidence of For-Profit Delivery and Inferior Nursing Home Care: When Is There Enough Evidence for Policy Change?

Margaret McGregor and colleagues consider Bradford Hill's framework for examining causation in observational research for the association between nursing home care quality and for-profit ownership.

Knowledge of and Attitudes Toward Evidence-Based Guidelines for and Against Clinical Preventive Services: Results from a National Survey.

POLICY POINTS: Both the underuse and overuse of clinical preventive services relative to evidence-based guidelines are a public health concern. Informed consumers are an important foundation of many components of the Affordable Care Act, including coverage mandates for proven clinical preventive services recommended by the US Preventive Services Task Force. Across sociodemographic groups, however, knowledge of and positive attitudes toward evidence-based guidelines for preventive care are extremely low. Given the demonstrated low levels of consumers' knowledge of and trust in guidelines, coupled with their strong preference for involvement in preventive care decisions, better education and decision-making support for evidence-based preventive services are greatly needed. CONTEXT: Both the underuse and overuse of clinical preventive services are a serious public health problem. The goal of our study was to produce population-based national data that could assist in the design of communication strategies to increase knowledge of and positive attitudes toward evidence-based guidelines for clinical preventive services (including the US Preventive Services Task Force, USPSTF) and to reduce uncertainty among patients when guidelines change or are controversial. METHODS: In late 2013 we implemented an Internet-based survey of a nationally representative sample of 2,529 adults via KnowledgePanel, a probability-based survey panel of approximately 60,000 adults, statistically representative of the US noninstitutionalized population. African Americans, Hispanics, and those with less than a high school education were oversampled. We then conducted descriptive statistics and multivariable logistic regression analysis to identify the prevalence of and sociodemographic characteristics associated with key knowledge and attitudinal variables. FINDINGS: While 36.4% of adults reported knowing that the Affordable Care Act requires insurance companies to cover proven preventive services without cost sharing, only 7.7% had heard of the USPSTF. Approximately 1 in 3 (32.6%) reported trusting that a government task force would make fair guidelines for preventive services, and 38.2% believed that the government uses guidelines to ration health care. Most of the respondents endorsed the notion that research/scientific evidence and expert medical opinion are important for the creation of guidelines and that clinicians should follow guidelines based on evidence. But when presented with patient vignettes in which a physician made a guideline-based recommendation against a cancer-screening test, less than 10% believed that this recommendation alone, without further dialogue and/or the patient's own research, was sufficient to make such a decision. CONCLUSIONS: Given these demonstrated low levels of knowledge and mistrust regarding guidelines, coupled with a strong preference for shared decision making, better consumer education and decision supports for evidence-based guidelines for clinical preventive services are greatly needed.

The Use of Economic Evidence to Inform Drug Pricing Decisions in Jordan.

BACKGROUND: Drug pricing is an example of a priority setting in a developing country with official requirements for the use of cost-effectiveness (CE) evidence. OBJECTIVE: To describe the role of economic evidence in drug pricing decisions in Jordan. METHODS: A prospective review of all applications submitted between November 2013 and May 2015 to the Jordan Food and Drug Association's drug pricing committee was carried out. All applications that involved requests for CE evidence were reviewed. Details on the type of study, the extent, and whether the evidence submitted was part of the formal deliberations were extracted and summarized. RESULTS: The committee reviewed a total of 1608 drug pricing applications over the period of the study. CE evidence was requested in only 11 applications. The submitted evidence was of limited use to the committee due to concerns about quality, relevance of studies, and lack of pharmacoeconomic expertise. There were also no clear rules describing how CE would inform pricing decisions. CONCLUSIONS: Limited local data and health economic experience were the main barriers to the use of economic evidence in drug pricing decisions in Jordan. In addition, there are no official rules describing the elements and process by which the CE evidence would inform drug pricing decisions. This study summarized accumulated observations for the current use of economic evaluations and evidence-based decision making in Jordan. Recommendations have been proposed to applicants and key decision makers to enhance the role of economic evidence in influencing health policies and evidence-based decision making across priority settings.

Asbestos: Socio-legal and Scientific Controversies and Unsound Science in the Context of the Worldwide Asbestos Tragedy - Lessons to be Learned.

Eight to fifteen per cent of lung cancer cases and nearly all mesothelioma cases are caused by asbestos. Problems in compensation issues ensue from strict legal requirements for eligibility and regulations of the statutory accident insurance institution pertaining to eligibility for occupational disease benefits. The latter include the unscientific requirement for set numbers of asbestos bodies or fibers to be found in lung tissue in order to "prove" disease causation if lung specimen are available. Although the validity of such evidence has been discredited by independent scientists, it is still used as evidence by an influential US pathology department. Frequently, epidemiological evidence regarding causal relationships and exposure histories is also often being ignored by insurance-affiliated medical experts.Similar misleading arguments are currently being used in newly industrialized countries where white asbestos - which is carcinogenic and fibrogenic like other asbestos types - is efficiently promoted as being less harmful. As a result, asbestos use is increasing in some of these countries. Behind the worldwide asbestos tragedy, a well-designed strategy orchestrated by certain transnational or multinational industrial interest groups can be perceived.Beyond the asbestos tragedy their covert plan is motivated by economic interests and discounts the ensuing damage to health and the impact of the diseases they create on public health systems.

Breast cancer screening in the era of density notification legislation: summary of 2014 Massachusetts experience and suggestion of an evidence-based management algorithm by multi-disciplinary expert panel.

Stemming from breast density notification legislation in Massachusetts effective 2015, we sought to develop a collaborative evidence-based approach to density notification that could be used by practitioners across the state. Our goal was to develop an evidence-based consensus management algorithm to help patients and health care providers follow best practices to implement a coordinated, evidence-based, cost-effective, sustainable practice and to standardize care in recommendations for supplemental screening. We formed the Massachusetts Breast Risk Education and Assessment Task Force (MA-BREAST) a multi-institutional, multi-disciplinary panel of expert radiologists, surgeons, primary care physicians, and oncologists to develop a collaborative approach to density notification legislation. Using evidence-based data from the Institute for Clinical and Economic Review, the Cochrane review, National Comprehensive Cancer Network guidelines, American Cancer Society recommendations, and American College of Radiology appropriateness criteria, the group collaboratively developed an evidence-based best-practices algorithm. The expert consensus algorithm uses breast density as one element in the risk stratification to determine the need for supplemental screening. Women with dense breasts and otherwise low risk (<15% lifetime risk), do not routinely require supplemental screening per the expert consensus. Women of high risk (>20% lifetime) should consider supplemental screening MRI in addition to routine mammography regardless of breast density. We report the development of the multi-disciplinary collaborative approach to density notification. We propose a risk stratification algorithm to assess personal level of risk to determine the need for supplemental screening for an individual woman.