Search

I analyse epistemic and non-epistemic factors involved in expert advisory practices and decision-making relating to the regulation of health claims in the US, EU, and Japan. I consider the changes that have taken place, historically, in regulatory policies in all three cases in order to confirm the hypothesis that not only epistemic, but also non-epistemic factors and values determine the methodological decisions on which expert assessments are based for the authorization of health claims. I found that the current European, US, and Japanese assessment systems are based on different kinds of what have been termed 'epistemic policies' and that these policies and other characteristics shape what might be identified as differing 'policy styles' in the regulation of health claims. [ABSTRACT FROM AUTHOR]

In this paper we analyze the Russo-Williamson Thesis (RWT) as a standard of evidence in regulatory science, in risk as well as benefit assessment. In our analysis we take account of the recent controversies that have taken place in regulation with respect to the evidentiary requirements necessary for regulatory decision making. RWT's main point is that not only probabilistic but also mechanistic evidence is necessary for being able to infer the existence of causal links. We ask in which way RWT could have an impact upon current decision making about subjecting to regulation (or, to the contrary, leaving them unregulated) certain chemical substances, food stuffs, health claims, and other typical objects of regulation. We show that the application of RWT resolves some of the problems posed by current standards of evidence. RWT makes it possible to determine with higher accuracy if a particular substance should be subjected to regulation or not, even though under certain circumstances RWT itself may turn into a source of regulatory error. The adequacy of RWT as a standard of evidence depends on the precise manner of its application to regulation (particularly the consideration of mechanistic evidence as a complementary or necessary requirement), as well as the assessment of its non-epistemic consequences. • We analyze the implications of applying the Russo-Williamson Thesis (RWT) on causality to regulatory science. • RWT requires both probabilistic and mechanistic kinds of evidence for the establishment of causal claims. • We argue that implementing RWT means a tightening of the standards of evidence for risk and benefit assessment, and might imply an increase in false negatives. • Requiring stricter standards of evidence in risk and benefit assessment consequently, at least under certain circumstances, could be detrimental to public health. [ABSTRACT FROM AUTHOR]

Abstract This paper evaluates the application of evidentiary standards originating from evidence-based medicine in nutrition advice. It shows that it is problematic to criticize nutrition recommendations for not being based on randomized controlled trials. Due to practical, ethical and methodological and reasons, it is difficult to conduct rigorous randomized controlled trials for acquiring evidence that is relevant for achieving the goals of population-level nutrition recommendations. Given the non-epistemic goals of the dietary recommendations, criteria of acceptable evidence should be adapted to the goals of the practice and the practical, ethical, and methodological constraints of the situation. Highlights • Nutrition guidelines are often criticized for the lack of evidence from RCTs. • Conducting rigorous RCTs in the nutritional context is problematic. • The standards of evidence used for evaluating nutrition advice should be flexible. [ABSTRACT FROM AUTHOR]

• Determining clinical utility requires accessing patient medical history and outcomes data. • Strategies commonly used to measure the utility include systematic reviews, clinical trials, post-market surveillance, expert opinion, and cost-effectiveness analysis. • Ultimately, measuring a diagnostic test's clinical utility requires evaluating its impact on patient outcomes, clinical decision-making, and healthcare resource utilization. • The purpose of the test should also be understood. Measuring the clinical utility of a diagnostic test involves evaluating its impact on patient outcomes, clinical decision-making, and healthcare resource utilization. Determining clinical utility requires accessing patient medical history and outcomes data. These studies involve enrolling patients undergoing diagnostic tests and tracking their clinical outcomes. Researchers can determine the test's clinical utility by comparing the outcomes of patients who receive the diagnostic test to those who do not. These outcomes include benefits and harm. The highest level of evidence to support clinical utility determinations may be obtained from clinical trials. However, clinical laboratories are often not involved in clinical trials, and laboratory specialists may not be experienced in conducting such trials. Many established laboratory tests have never had clinical utility determined. Prospective studies assessing a diagnostic test's impact on clinical outcomes may require long-term patient monitoring, which is problematic. This paper presents methods that may be used to assess clinical utility. [ABSTRACT FROM AUTHOR]

• Laboratory staff are most familiar with assessing analytical performance, but an investigation should not just have analytical validity. • The clinical utility or effectiveness of the test depends on the consequences of different test results in patients with and without a disease. • The concepts of clinical utility are not well understood and many tests have never been evaluated for clinical utility. • Tests (e.g. ESR) demonstrating poor clinical utility are still widely practised. The clinical utility of a diagnostic test refers to its usefulness in improving patient outcomes, informing clinical decision-making, and optimizing healthcare resources. A diagnostic test with high clinical utility provides accurate, reliable, and actionable information that can guide appropriate treatment decisions, monitor treatment response, and identify potential adverse events or complications. Ultimately, the clinical utility of a diagnostic test depends on how well it can improve patient outcomes by guiding appropriate treatment decisions, improving clinical outcomes, and optimizing healthcare resource utilization. Healthcare providers need to weigh the benefits and drawbacks of using a particular diagnostic test in their clinical practice to determine its clinical utility. [ABSTRACT FROM AUTHOR]

Mechanistic information is used in the field of risk assessment in order to clarify two controversial methodological issues, the selection of inference guides and the definition of standards of evidence. In this paper we present an analysis of the concept of mechanistic information in risk assessment by recurring to previous philosophical analyses of mechanistic explanation. Our conclusion is that the conceptual analysis of mechanistic explanation facilitates a better characterization of the concept of mechanistic information. However, it also shows that the use of this kind of information in risk assessment is heavily influenced by pragmatic factors, which have not been sufficiently taken into account in philosophical analysis. Mechanistic models are like hypothesis that have to be validated empirically. Due to their dependence on the standards of evidence, they are subject to the same pragmatic factors. Therefore, recurring to mechanistic information does not lead to closure of the methodological controversies in risk assessment. [ABSTRACT FROM AUTHOR]

A common strategy in bioethics is to posit a prima facie case in favour of one policy, and to then claim that the burden of proof (that this policy should be rejected) falls on those with opposing views. If the burden of proof is not met, it is claimed, then the policy in question should be accepted. This article illustrates, and critically evaluates, examples of this strategy in debates about the sale of organs by living donors, human enhancement, and the precautionary principle. We highlight general problems with this style of argument, and particular problems with its use in specific cases. We conclude that the burden ultimately falls on decision-makers (i.e. policy-makers) to choose the policy supported by the best reasons. [ABSTRACT FROM AUTHOR]

A growing research literature highlights the public health need for preventive interventions to reduce symptoms and incidence of perinatal depression among vulnerable populations. The Mothers and Babies (MB) course is a cognitive-behavioral intervention designed to teach mood regulation skills to English- and Spanish-speaking low-income women at high risk for perinatal depression. We describe the development of the MB course and evaluate the extent to which research findings support efficacy, effectiveness, and dissemination based on the Society for Prevention Research Standards Committee's standards of evidence. Our review of research and implementation activities suggests that the MB intervention demonstrates promising evidence for efficacy in reducing depressive symptoms; empirical support for prevention of major depressive episodes is still preliminary. Work is in progress to evaluate program effectiveness and prepare for broad dissemination and implementation. The MB course shows promise as an intervention for low-income women at risk for perinatal mood issues. Spanish and English intervention materials have been developed that can be delivered in different settings (hospitals, home visiting), in different dosages (6, 8, or 12 sessions), and via different modalities (group, individual). Evaluating the MB course against current standards is intended to inform other prevention intervention development research. [ABSTRACT FROM AUTHOR]

A decade ago, the Society of Prevention Research (SPR) endorsed a set of standards for evidence related to research on prevention interventions. These standards (Flay et al., Prevention Science 6:151-175, 2005) were intended in part to increase consistency in reviews of prevention research that often generated disparate lists of effective interventions due to the application of different standards for what was considered to be necessary to demonstrate effectiveness. In 2013, SPR's Board of Directors decided that the field has progressed sufficiently to warrant a review and, if necessary, publication of "the next generation" of standards of evidence. The Board convened a committee to review and update the standards. This article reports on the results of this committee's deliberations, summarizing changes made to the earlier standards and explaining the rationale for each change. The SPR Board of Directors endorses "The Standards of Evidence for Efficacy, Effectiveness, and Scale-up Research in Prevention Science: Next Generation." [ABSTRACT FROM AUTHOR]

We comment on the 2015 Society for Prevention Research standards of evidence document, summarizing major changes from the previous 2005 Standards, and point to ways in which the Standards could be further improved. We endorse important new standards, such as those on testing the causal theory and mechanisms of the intervention, improved trial reporting standards, and added attention to scale-up research and cost analyses. Despite discussion of replication in the new Standards, we are concerned about the lack of stand-alone replication standards, and the deletion of an explicit requirement for replication before an intervention is considered efficacious. Finally, we are deeply concerned about the lack of attention to the unit or level of aggregation of the intervention target. It is a major conceptual oversight. The unit targeted by an intervention (whether a cell, person, organization, community, state, nation) is a fundamental feature shaping intervention theory, research design, data collection, analyses, effect sizes, diffusion possibilities and patterns, and scale-up issues. Future Standards updates should eliminate the implicit assumption in the current text that effective preventive interventions inherently target individual persons. [ABSTRACT FROM AUTHOR]

• Registries can help services to improve child and youth psychosocial outcomes. • Improvements are needed to registry content, functionality and design. • Decision-makers need support to help them interpret and apply registry content. • Greater coordination between registries would improve consistency and usability. • More ambitious changes require support from a wide range of stakeholders. The last decade or more has seen a proliferation of online registries of evidence-based interventions designed to improve child and youth psychosocial outcomes. The purpose of these resources is typically to help decision-makers make sense of the evidence and thereby inform their decision-making about investment in interventions. Most registries are underpinned by standards of evidence, which are used to guide the rating of programs by a panel of experts. While supporters extol the influence of these initiatives in terms of making commissioners more discriminating about what they invest in, detractors contend that they stifle innovation and embody an unduly narrow view of evidence and intervention. Drawing on the literature, original analysis and first-hand experience of developing, applying and using standards of evidence and associated registries, this article reflects critically on their strengths and limitations, considering issues such as focus, functionality, content, consistency and impact. It also makes proposals for developing and extending the approach, focusing on its intrinsic conceptualization of intervention development, evaluation practice and pathways to impact. [ABSTRACT FROM AUTHOR]

The present paper focuses on evidence-based practice and policy with a specific focus on the cooperation between researchers, policy makers, and practitioners. The evidence-based practice movement has gained greatly in impact in recent years and standards for research leading to evidence-based practice have been defined. However, the slow and incomplete uptake of research findings especially in the field of education obviously has shown that the development, implementation, and dissemination of sustainable strategies requires intensive cooperation between researchers, politicians, administrators, and the media. This paper presents and discusses (1) standards of evidence; (2) the use and implementation of scientific evidence in policy and practice; (3) the development of the National Strategy for Violence Prevention in the Austrian Public School System as a successful example for establishing a sustainable cooperation between research, policy, and practice; and (4) lessons learned for the promotion of evidence-based policy and practice. [ABSTRACT FROM PUBLISHER]

We examined the effects of redefining standards of evidence for treatments targeting childhood mental health problems by expanding outcomes beyond symptom reduction to include functioning. Over 750 treatment protocols from 435 randomized controlled trials were rated based on empirical evidence. Nearly two-thirds (63.9%) demonstrated at least a minimum level of evidence for reducing symptoms; however, only 18.8% of treatments demonstrated evidence for reducing functional impairment. Of those treatments with empirical support for symptom reduction, the majority did not demonstrate empirical support for improvement in functioning because measures of functioning were not included in the studies in which these treatments were tested. However, even when measures of functioning were included, it was much more difficult for treatments to achieve improvement. Among treatments that achieved improvement in functioning, the most notable were Collaborative Problem Solving for disruptive behavior and Cognitive Behavioral Therapy plus Medication for traumatic stress because they demonstrated no support for symptom reduction but good support for improvement in functioning. Results are discussed within the context of evaluating the standards of evidence for treatments and the opportunity to move towards a multidimensional framework whose utility has the potential to exceed the sum of its parts. [ABSTRACT FROM AUTHOR]

Regulatory science, which generates knowledge relevant for regulatory decision-making, is different from standard academic science in that it is oriented mainly towards the attainment of non-epistemic (practical) aims. The role of uncertainty and the limits to the relevance of academic science are being recognized more and more explicitly in regulatory decision-making. This has led to the introduction of regulation-specific scientific methodologies in order to generate decision-relevant data. However, recent practical experience with such non-standard methodologies indicates that they, too, may be subject to important limitations. We argue that the attainment of non-epistemic values and aims (like the protection of human health and the environment) requires not only control of the quality of the data and the methodologies, but also the selection of the level of regulation deemed adequate in each specific case (including a decision about which of the two, under-regulation or over-regulation, would be more acceptable). [ABSTRACT FROM AUTHOR]

A letter to the editor is presented in response to the article "MHSPY: A children's health initiative for maintaining at-risk youth in the community," published in the 2006;33:196-203 issue of the "Journal of Behavioral Health Services & Research."