The explanatory/pragmatic-trial distinction enjoys a burgeoning philosophical and medical literature and a significant contingent of support among philosophers and healthcare stakeholders as an important way to assess the design and results of randomized controlled trials. A major motivation has been the need to provide relevant, generalizable data to drive healthcare decisions. While talk of pragmatic and explanatory trials could be seen as convenient shorthand, the distinction can also be seen as harboring deeper issues related to inferential strategies used to evaluate (...) causal claims regarding medical treatments. A comprehensive, critical analysis of the distinction and underlying epistemological framework upon which the distinction is based, particularly with respect to treatment effectiveness, has yet to be forthcoming. I provide this, analyzing the distinction’s relationship to generalizability and cognate distinctions between ideal conditions and real-world practice, internal and external validity, and efficacy and effectiveness. I also analyze recent philosophical work that relies on the explanatory/pragmatic-trial distinction and that advocates for more pragmatic trials. I conclude that as an organizing principle for trial-design decisions and trial evaluation, the explanatory/pragmatic-trial distinction is conceptually problematic and not as useful as its proponents seem to think. Since some pragmatic-trial features can be inimical to establishing treatment effectiveness, pragmatic-trial features should not be conflated with pragmatic trials’ avowed goals. If the distinction is to be useful, it and some associated concepts, including generalizability, should be reformulated, lest they continue to underlie a medical epistemology that could contribute to methodologically flawed and potentially unethical advice for the design and interpretation of trials. (shrink)

In this article we explore the role evidence ought to play in complementary and alternative medicine. First, we consider the claim that evidence in the form of randomized controlled trials cannot be obtained for CAMs. Second, we consider various claims to the effect that there are ways of obtaining evidence that do not make use of RCTs. We argue that there is no good reason why CAM should be exempted from the general requirement that treatments undergo evaluation by RCT. Third, (...) we consider two implications for health care policy. First, many activities in conventional medicine have never been rigorously evaluated and are widely in use nonetheless. We argue that this fails to provide a reason for exempting CAM from a demand for evidence. Second, CAM use may be compared to a choice of lifestyle, and this has a significant impact on which requirements of evidence can reasonably be imposed. (shrink)

The use of complementary and alternative medicine is increasing in the Western world. However, there is no clear evidence of effect of alternative therapies. Moreover, there is no consensus between practitioners and researchers as to the right way of assessing the efficacy of alternative therapies. To investigate practitioners’ perspective on evidence and ways of assessing efficacy twelve in-depth interviews were conducted in Denmark with acupuncturists, including physicians practising acupuncture, acupuncturists with a health-related background, and acupuncturists without a health-related background. Two (...) themes predominated the study, first, the interviewees’ general reflections on how it is possible to establish knowledge about an effect of acupuncture; and second the interviewees’ reflections on the use of randomized controlled trials in acupuncture, including obstacles and alternatives to conducting randomized controlled trials. Further, two conceptions of what constitutes evidence were identified: a biomedical conception and an experience-based conception. Most interviewees were sceptical about the use of randomized controlled trials in acupuncture. Two reasons, especially, were given for this scepticism. First, practical and instrumental reasons concerning the specific elements of the randomized controlled trial or relating to limited resources; and second, value-based reasons are concerning the nature of acupuncture. However, the interviewees were really opposed only to a certain kind of randomized controlled trial, the so-called explanatory trial. They would actually welcome a pragmatic trial. The study gives valuable insight into an under explored field and provide a platform for further investigation, and a better informed discussion of the subject. (shrink)

In Science as Social Knowledge in 1990 and The Fate of Knowledge in 2002, Helen Longino develops an epistemological theory known as Critical Contextual Empiricism (CCE). Knowledge production, she argues, is an active, value-laden practice, evidence is context dependent and relies on background assumptions, and science is a social inquiry that, under certain conditions, produces social knowledge with contextual objectivity. While Longino’s work has been generally well-received, there have been a number of criticisms of CCE raised in the philosophical literature (...) in recent years. In this paper I outline the key elements of Longino’s theory and propose modifications to the four norms offered by the account. The version of CCE I defend, which draws on lessons learned by medical researchers in recent years, gives principles of epistemic diversity a central role and also provides greater specification of three of the four norms. Further, it offers additional resources for defending CCE against Alvin Goldman’s suggestion that there is a need for a “healthy dogmatism” in science, as well as a concern about “manufactured uncertainty” arising out of recent work by David Michaels. Finally, the modified version proposed here is also well positioned to respond (negatively) to a suggestion from Kristen Intemann that CCE needs to be adapted to incorporate a central insight from feminist standpoint theory. In light of the variety of social pressures influencing contemporary scientific research, and the role of science in shaping public policy, I argue that a rigorous social epistemology such as CCE is indispensable for understanding and assessing contemporary scientific practice. (shrink)

Hierarchies of evidence are an important and influential tool for appraising evidence in medicine. In recent years, hierarchies have been formally adopted by organizations including the Cochrane Collaboration [1], NICE [2,3], the WHO [4], the US Preventive Services Task Force [5], and the Australian NHMRC [6,7]. The development of such hierarchies has been regarded as a central part of Evidence-Based Medicine, a movement within healthcare which prioritises the use of epidemiological evidence such as that provided by Randomised Controlled Trials. Philosophical (...) work on the methodology of medicine has so far mostly focused on claims about the superiority of RCTs, and hence has largely neglected the questions of what hierarchies are, what assumptions they require, and how they affect clinical practice. This thesis shows that there is great variation in the hierarchies defended and in the interpretations they are, and can be, given. The interpretative assumptions made in using hierarchies are crucial to the content and defensibility of the underlying philosophical commitments concerning evidence and medical practice. Once this variation is been identified, it becomes clear that the little philosophical work that has been done so far affects only some hierarchies, under some interpretations. Modest interpretations offered by La Caze [11], conditional hierarchies like GRADE [12-14], and heuristic approaches such as that defended by Howick et al. [15,16] all survive previous philosophical criticism. This thesis extends previous criticisms by arguing that modest interpretations are so weak as to be unhelpful for clinical practice; that GRADE and similar conditional models omit clinically relevant information, such as information about variation in treatments’ effects and the causes of different responses to therapy; and that heuristic approaches lack the necessary empirical support. The conclusion is that hierarchies in general embed untenable philosophical assumptions: principally that information about average treatment effects backed by high-quality evidence can justify strong recommendations, and that the impact of evidence from individual studies can and should be appraised in isolation. Hierarchies are a poor basis for the application of evidence in clinical practice. The Evidence-Based Medicine movement should move beyond them and explore alternative tools for appraising the overall evidence for therapeutic claims. (shrink)