Results for 'RCTs'

27 found
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  1. An unattractive hypothesis – RCTs' descent to non-science.Clifford Miller - 2011 - International Journal of Person Centered Medicine 1 (4):841-842.
    Eyal Shahar’s essay review [1] of James Penston’s remarkable book [2] seems more inspired playful academic provocation than review or essay, expressing dramatic views of impossible validity. The account given of modern biostatistical causation reveals the slide from science into the intellectual confusion and non-science RCTs have created: “…. the purpose of medical research is to estimate the magnitude of the effect of a causal contrast, for example the probability ratio of a binary outcome …” But Shahar’s world is (...)
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  2. The ethics of public policy RCTs: The principle of policy equipoise.Douglas MacKay - 2017 - Bioethics 32 (1):59-67.
    In this article, I ask whether a principle analogous to the principle of clinical equipoise should govern the design and conduct of RCTs evaluating the effectiveness of policy interventions. I answer this question affirmatively, and introduce and defend the principle of policy equipoise. According to this principle, all arms of a policy RCT must be, at minimum, in a state of equipoise with the best proven policy that is also morally and practically attainable and sustainable. For all arms of (...)
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  3. Is meta-analysis the platinum standard of evidence?Jacob Stegenga - 2011 - Studies in History and Philosophy of Science Part C: Studies in History and Philosophy of Biological and Biomedical Sciences 42 (4):497-507.
    An astonishing volume and diversity of evidence is available for many hypotheses in the biomedical and social sciences. Some of this evidence—usually from randomized controlled trials (RCTs)—is amalgamated by meta-analysis. Despite the ongoing debate regarding whether or not RCTs are the ‘gold-standard’ of evidence, it is usually meta-analysis which is considered the best source of evidence: meta-analysis is thought by many to be the platinum standard of evidence. However, I argue that meta-analysis falls far short of that standard. (...)
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  4. Herding QATs: Quality Assessment Tools for Evidence in Medicine.Jacob Stegenga - 2015 - In Huneman, Silberstein & Lambert (eds.), Herding QATs: Quality Assessment Tools for Evidence in Medicine. pp. 193-211.
    Medical scientists employ ‘quality assessment tools’ (QATs) to measure the quality of evidence from clinical studies, especially randomized controlled trials (RCTs). These tools are designed to take into account various methodological details of clinical studies, including randomization, blinding, and other features of studies deemed relevant to minimizing bias and error. There are now dozens available. The various QATs on offer differ widely from each other, and second-order empirical studies show that QATs have low inter-rater reliability and low inter-tool reliability. (...)
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  5. Government Policy Experiments and the Ethics of Randomization.Douglas MacKay - 2020 - Philosophy and Public Affairs 48 (4):319-352.
    Governments are increasingly using randomized controlled trials (RCTs) to evaluate policy interventions. RCTs are often understood to provide the highest quality evidence regarding the causal efficacy of an intervention. While randomization plays an essential epistemic role in the context of policy RCTs however, it also plays an important distributive role. By randomly assigning participants to either the intervention or control arm of an RCT, people are subject to different policies and so, often, to different types and levels (...)
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  6. Randomized Controlled Trials and the Flow of Information: Comment on Cartwright.Sherrilyn Roush - 2009 - Philosophical Studies 143 (1):137-145.
    The transferability problem—whether the results of an experiment will transfer to a treatment population—affects not only Randomized Controlled Trials but any type of study. The problem for any given type of study can also, potentially, be addressed to some degree through many different types of study. The transferability problem for a given RCT can be investigated further through another RCT, but the variables to use in the further experiment must be discovered. This suggests we could do better on the epistemological (...)
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  7. Randomized Controlled Trials for Diagnostic Imaging: Conceptual and Pratical Problems.Elisabetta Lalumera & Stefano Fanti - 2019 - Topoi 38 (2):395-400.
    We raise a problem of applicability of RCTs to validate nuclear diagnostic imaging tests. In spite of the wide application of PET and other similar techniques that use radiopharmaceuticals for diagnostic purposes, RCT-based evidence on their validity is sparse. We claim that this is due to a general conceptual problem that we call Prevalence of Treatment, which arises in connection with designing RCTs for testing any diagnostic procedure in the present context of medical research, and is particularly apparent (...)
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  8. What is the standard of care in experimental development economics?Marcos Picchio - 2024 - Politics, Philosophy and Economics 23 (2):205-226.
    A central feature of experimental development economics is the use of randomized controlled trials (RCTs) to evaluate the effectiveness of prospective socioeconomic interventions. The use of RCTs in development economics raises a host of ethical issues which are just beginning to be explored. In this article, I address one ethical issue in particular: the routine use of the status quo as a control when designing and conducting a development RCT. Drawing on the literature on the principle of standard (...)
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  9. Rhetoric and argumentation: how clinical practice guidelines think.Jonathan Fuller - 2013 - Journal of Evaluation in Clinical Practice 19 (3):433-441.
    Introduction: Clinical practice guidelines (CPGs) are an important source of justification for clinical decisions in modern evidence-based practice. Yet, we have given little attention to how they argue their evidence. In particular, how do CPGs argue for treatment with long-term medications that are increasingly prescribed to older patients? Approach and rationale: I selected six disease-specific guidelines recommending treatment with five of the medication classes most commonly prescribed for seniors in Ontario, Canada. I considered the stated aims of these CPGs and (...)
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  10. Bayesian versus frequentist clinical trials.David Teira - 2011 - In Fred Gifford (ed.), Philosophy of Medicine. Boston: Elsevier. pp. 255-297.
    I will open the first part of this paper by trying to elucidate the frequentist foundations of RCTs. I will then present a number of methodological objections against the viability of these inferential principles in the conduct of actual clinical trials. In the following section, I will explore the main ethical issues in frequentist trials, namely those related to randomisation and the use of stopping rules. In the final section of the first part, I will analyse why RCTs (...)
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  11. An Argument for Fewer Clinical Trials.Kirstin Borgerson - 2016 - Hastings Center Report 46 (6):25-35.
    The volume of clinical research is increasing exponentially—far beyond our ability to process and absorb the results. Given this situation, it may be beneficial to consider reducing the flow at its source. In what follows, I will motivate and critically evaluate the following proposal: researchers should conduct fewer clinical trials. More specifically, I c onsider whether researchers should be permitted to conduct only clinical research of very high quality and, in turn, whether research ethics committees should prohibit all other, lower-quality (...)
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  12. Rules versus Standards: What Are the Costs of Epistemic Norms in Drug Regulation?David Teira & Mattia Andreoletti - 2019 - Science, Technology, and Human Values 44 (6):1093-1115.
    Over the last decade, philosophers of science have extensively criticized the epistemic superiority of randomized controlled trials for testing safety and effectiveness of new drugs, defending instead various forms of evidential pluralism. We argue that scientific methods in regulatory decision-making cannot be assessed in epistemic terms only: there are costs involved. Drawing on the legal distinction between rules and standards, we show that drug regulation based on evidential pluralism has much higher costs than our current RCT-based system. We analyze these (...)
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  13. Standard of Care, Institutional Obligations, and Distributive Justice.Douglas MacKay - 2015 - Bioethics 29 (4):352-359.
    The problem of standard of care in clinical research concerns the level of treatment that investigators must provide to subjects in clinical trials. Commentators often formulate answers to this problem by appealing to two distinct types of obligations: professional obligations and natural duties. In this article, I investigate whether investigators also possess institutional obligations that are directly relevant to the problem of standard of care, that is, those obligations a person has because she occupies a particular institutional role. I examine (...)
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  14.  48
    Policy Equipoise and Interventional Superiority.Douglas MacKay - forthcoming - Journal of Development Effectiveness.
    According to the norm of policy equipoise, it is permissible to randomly assign participants to two or more interventions in a public policy randomized controlled trial (RCT) when there is meaningful uncertainty among the relevant expert community regarding which intervention is superior. While this norm is gaining traction in the research ethics literature, the idea of interventional superiority remains unclear. Is one intervention superior to another if it is reasonably expected to realize one outcome of interest more effectively, even though (...)
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  15. Public Policy Experiments without Equipoise: When is Randomization Fair?Douglas MacKay & Emma Cohn - 2023 - Ethics and Human Research 45 (1):15-28.
    Government agencies and nonprofit organizations have increasingly turned to randomized controlled trials (RCTs) to evaluate public policy interventions. Random assignment is widely understood to be fair when there is equipoise; however, some scholars and practitioners argue that random assignment is also permissible when an intervention is reasonably expected to be superior to other trial arms. For example, some argue that random assignment to such an intervention is fair when the intervention is scarce, for it is sometimes fair to use (...)
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  16. Averaged versus individualized: pragmatic N-of-1 design as a method to investigate individual treatment response.Davide Serpico & Mariusz Maziarz - 2023 - European Journal for Philosophy of Science 13 (4):1-28.
    Heterogeneous treatment effects represent a major issue for medicine as they undermine reliable inference and clinical decision-making. To overcome the issue, the current vision of precision and personalized medicine acknowledges the need to control individual variability in response to treatment. In this paper, we argue that gene-treatment-environment interactions (G × T × E) undermine inferences about individual treatment effects from the results of both genomics-based methodologies—such as genome-wide association studies (GWAS) and genome-wide interaction studies (GWIS)—and randomized controlled trials (RCTs). (...)
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  17. Evidencia y Explicación en Economía.Ignacio Andrés Torres-Ulloa - 2021 - Culturas Cientificas 2 (1):107-136.
    En economía, la investigación se divide en dos grandes metodologías: los modelos teórico-matemáticos y los estudios empíricos. Estudiando modelos teóricos y métodos empíricos ) se da cuenta de las limitaciones de ambos métodos. Se concluye que ninguno de estos puede generar explicaciones de cómo en realidad suceden las cosas, sino que solo de cómo posiblemente suceden. La razón es que ambos necesitan un enlace interpretativo que permita extrapolar desde su propio sistema hacia un sistema objetivo. Los modelos tienen dominio general (...)
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  18. Disagreement about Evidence-based Policy.Nick Cowen & Nancy Cartwright - forthcoming - In Maria Baghramian, J. Adam Carter & Rach Cosker-Rowland (eds.), Routledge Handbook of Philosophy of Disagreement. Routledge.
    Evidence based-policy (EBP) is a popular research paradigm in the applied social sciences and within government agencies. Informally, EBP represents an explicit commitment to applying scientific methods to public affairs, in contrast to ideologically-driven or merely intuitive “common-sense” approaches to public policy. More specifically, the EBP paradigm places great weight on the results of experimental research designs, especially randomised controlled trials (RCTs), and systematic literature reviews that place evidential weight on experimental results. One hope is that such research designs (...)
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  19. Van Gordon, W., Shonin, E., Dunn, T., Garcia-Campayo, J., & Griffiths, M. D. (2017). Meditation Awareness Training for the treatment of fibromyalgia: A randomised controlled trial. British Journal of Health Psychology, 22, 186-206.William Van Gordon, Edo Shonin, Thomas Dunn, Javier Garcia-Campayo & Mark Griffiths - 2017 - British Journal of Health Psychology 22:186-206.
    Objectives. The purpose of this study was to conduct the first randomized controlled trial (RCT) to evaluate the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating fibromyalgia syndrome (FMS). Compared to first generation mindfulness-based interventions, SG-MBIs are more acknowledging of the spiritual aspect of mindfulness. Design. A RCT employing intent-to-treat analysis. Methods. Adults with FMS received an 8-week SG-MBI known as meditation awareness training (MAT; n = 74) or an active control intervention known as cognitive behaviour theory for groups (...)
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  20. Hypochondria and Self-Recalibration.Sherrilyn Roush - manuscript
    Health anxiety is, among other things, a response to a universal epistemological problem about whether changes in one’s body indicate serious illness, a problem that grows more challenging to the individual with age and with every advance in medical science, detection, and treatment. There is growing evidence that dysfunctional metacognitive beliefs – beliefs about thinking – are the driving factor, with dysfunctional substantive beliefs about the probability of illness a side‐effect, and that Metacognitive Therapy (MCT) is more effective than Cognitive (...)
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  21. Can Economics can be a separate Science?Lukas Beck - 2017 - Rerum Causae 9 (2):17-36.
    Mill (1872, 1874) is an early proponent of the thesis that economics has a special domain in which it can operate relatively independently of findings from other sciences. Contra Mill, I argue that this so-called separateness-thesis is best defendedunder an externalist interpretation of Rational Choice Theory (RCT). Mill’s defence is consistent with an internalist interpretation of RCT. Internalism holds that RCT depicts psychological mechanisms operating in economic agents. I argue that such a defence fails to establish separateness, because it makes (...)
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  22. Interpersonal comparisons of well-being, the evaluative attitudes, and type correspondence between mind and brain.JP Sevilla - manuscript
    Interpersonal comparisons of well-being (ICWs) confront the longstanding unsolved epistemic problem of other minds (EPOM): the problem of how to achieve objective knowledge of people's subjective mental states. The intractability of the EPOM may lead to the hope that Rational Choice Theory (RCT) can show that information about how people would choose over goods and gambles is sufficient--and information about subjective mental states therefore unnecessary--for interpersonal comparisons of levels and changes in well-being, thereby bypassing the EPOM. I argue that this (...)
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  23. Introducing Regime Cluster Theory: Framing Regional Diffusion Dynamics of Democratization and Autocracy Promotion.Jeroen Van den Bosch - 2020 - International Journal of Political Theory 4 (1):74-106.
    Recently the role of ideology and hegemony has received increased attention to explain varying dynamics of diffusion and autocratic cooperation. As a result, patterns of interaction in clusters from regions without hegemony or ideology have been overlooked because their autocracy-toautocracy transitions are no threat to the global status of democracy, even when active regime promotion is very common. This article will apply insights from economic cluster theory to political regimes and introduce a typology to differentiate among clusters. Regime Cluster Theory (...)
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  24. Intraoperative Liposomal Bupivacaine Does Not Reduce Opioid Use vs. Ropivacaine: A Systematic Review.Boris Yang, Violet Victoria, Radhika Rastogi & Zequan Yang - 2022 - Journal of Surgery 7 (1570).
    Introduction: Liposomal bupivacaine (LB) is a long-acting analgesic that, due to its liposomal formulation, purportedly extends its analgesic effect up to 72 hours. However, the clinical efficacy of LB appears mixed. This systematic review seeks to evaluate the effectiveness of liposomal bupivacaine in improving postoperative outcomes compared to ropivacaine (ROPI), another commonly used long-acting analgesic. -/- Materials and Methods: Prospective and randomized controlled trials (RCTs) evaluating the efficacy of LB compared to ROPI were selected for review. Primary outcomes included (...)
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  25. The Real World Failure of Evidence-Based Medicine.Donald W. Miller & Clifford Miller - 2011 - International Journal of Person Centered Medicine 1 (2):295-300.
    As a way to make medical decisions, Evidence-Based Medicine (EBM) has failed. EBM's failure arises from not being founded on real-world decision-making. EBM aspires to a scientific standard for the best way to treat a disease and determine its cause, but it fails to recognise that the scientific method is inapplicable to medical and other real-world decision-making. EBM also wrongly assumes that evidence can be marshaled and applied according to an hierarchy that is determined in an argument by authority to (...)
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  26. Down with the Hierarchies.Jacob Stegenga - 2014 - Topoi 33 (2):313-322.
    Evidence hierarchies are widely used to assess evidence in systematic reviews of medical studies. I give several arguments against the use of evidence hierarchies. The problems with evidence hierarchies are numerous, and include methodological shortcomings, philosophical problems, and formal constraints. I argue that medical science should not employ evidence hierarchies, including even the latest and most-sophisticated of such hierarchies.
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  27. Evidence-Based Policy.Donal Khosrowi - 2022 - In Conrad Heilmann & Julian Reiss (eds.), Routledge Handbook of Philosophy of Economics. Routledge. pp. 370-381.
    Public policymakers and institutional decision-makers routinely face questions about whether interventions “work”: does universal basic income improve people’s welfare and stimulate entrepreneurial activity? Do gated alleyways reduce burglaries or merely shift the crime burden to neighbouring communities? What is the most cost-effective way to improve students’ reading abilities? These are empirical questions that seem best answered by looking at the world, rather than trusting speculations about what will be effective. Evidence-based policy (EBP) is a movement that concretizes this intuition. It (...)
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