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Randomized trials and observational studies: the current philosophical controversy
University of Oxford.ORCID iD: 0000-0003-0280-7206
Philosophy and History, KTH, School of Architecture and the Built Environment (ABE), Philosophy and History of Technology, Philosophy. University of Oxford, UK.ORCID iD: 0000-0001-9730-2133
2016 (English)In: Handbook of the Philosophy of Medicine / [ed] Schramme, Thomas and Steven Edwards, Springer, 2016, p. 873-886Chapter in book (Refereed)
Abstract [en]

The supposed superiority of randomized over non-randomized studies is used to justify claims about therapeutic effectiveness of medical interventions and also inclusion criteria for many systematic reviews of therapeutic interventions. However, the view that randomized trials provide better evidence has been challenged by philosophers of science. In addition, empirical evidence for average differences between randomized trials and observational studies (which we would expect if one method were superior) has proven difficult to find. This chapter reviews the controversy surrounding the relative merits of randomized trials and observational studies. It is concluded that while (well-conducted) observational can often provide the same level of evidential support as randomized trials, merits of (well-conducted) randomized trials warrant claims about their superiority, especially where results from the two methods are contradictory.

Place, publisher, year, edition, pages
Springer, 2016. p. 873-886
National Category
Philosophy Health Care Service and Management, Health Policy and Services and Health Economy Medical Ethics
Research subject
Philosophy
Identifiers
URN: urn:nbn:se:kth:diva-161234Scopus ID: 2-s2.0-85042842139ISBN: 978-94-017-8687-4 (print)OAI: oai:DiVA.org:kth-161234DiVA, id: diva2:794285
Note

QC 20150311

Available from: 2015-03-11 Created: 2015-03-11 Last updated: 2018-03-15Bibliographically approved
In thesis
1. Philosophical controversies in the evaluation of medical treatments: With a focus on the evidential roles of randomization and mechanisms in Evidence-Based Medicine
Open this publication in new window or tab >>Philosophical controversies in the evaluation of medical treatments: With a focus on the evidential roles of randomization and mechanisms in Evidence-Based Medicine
2015 (English)Doctoral thesis, comprehensive summary (Other academic)
Abstract [en]

This thesis examines philosophical controversies surrounding the evaluation of medical treatments, with a focus on the evidential roles of randomised trials and mechanisms in Evidence-Based Medicine. Current 'best practice' usually involves excluding non-randomised trial evidence from systematic reviews in cases where randomised trials are available for inclusion in the reviews. The first paper challenges this practice and evaluates whether adding of evidence from non-randomised trials might improve the quality and precision of some systematic reviews. The second paper compares the alleged methodological benefits of randomised trials over observational studies for investigating treatment benefits. It suggests that claims about the superiority of well-conducted randomised controlled trials over well-conducted observational studies are justified, especially when results from the two methods are contradictory. The third paper argues that postulating the unpredictability paradox in systematic reviews when no detectable empirical differences can be found requires further justification. The fourth paper examines the problem of absence causation in the context of explaining causal mechanisms and argues that a recent solution (Barros 2013) is incomplete and requires further justification. Solving the problem by describing absences as causes of 'mechanism failure' fails to take into account the effects of absences that lead to vacillating levels of mechanism functionality (i.e. differences in effectiveness or efficiency). The fifth paper criticises literature that has emphasised functioning versus 'broken' or 'non-functioning' mechanisms emphasising that many diseases result from increased or decreased mechanism function, rather than complete loss of function. Mechanistic explanations must account for differences in the effectiveness of performed functions, yet current philosophical mechanistic explanations do not achieve this. The last paper argues that the standard of evidence embodied in the ICE theory of technological function (i.e. testimonial evidence and evidence of mechanisms) is too permissive for evaluating whether the proposed functions of medical technologies have been adequately assessed and correctly ascribed. It argues that high-quality evidence from clinical studies is necessary to justify functional ascriptions to health care technologies.

Place, publisher, year, edition, pages
Stockholm: KTH Royal Institute of Technology, 2015. p. 20
Series
Theses in philosophy from the Royal Institute of Technology, ISSN 1650-8831
Keyword
Evidence, randomized controlled trials, observational studies, systematic reviews, meta-analysis, methodology, process assessment, outcome assessment, medical care, randomization, evidence-based medicine, selection bias, philosophy of medicine, philosophy of science, mechanisms, quality of evidence, animal studies, treatment effect, causation by absence, medical technology
National Category
Health Care Service and Management, Health Policy and Services and Health Economy Philosophy Public Health, Global Health, Social Medicine and Epidemiology
Research subject
Philosophy
Identifiers
urn:nbn:se:kth:diva-161489 (URN)978-91-7595-489-9 (ISBN)
Public defence
2015-03-27, Kollegiesalen, Brinellvägen 8, KTH, Stockholm, 13:00 (English)
Opponent
Supervisors
Note

QC 20150312

Available from: 2015-03-12 Created: 2015-03-11 Last updated: 2015-03-12Bibliographically approved

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Howick, JeremyMebius, Alexander

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