In this classic work, best-selling author Harry Frankfurt provides a compelling analysis of the question that not only lies at the heart of Descartes's Meditations, but also constitutes the central preoccupation of modern philosophy: on what basis can reason claim to provide any justification for the truth of our beliefs? Demons, Dreamers, and Madmen provides an ingenious account of Descartes's defense of reason against his own famously skeptical doubts that he might be a madman, dreaming, or, worse yet, deceived by (...) an evil demon into believing falsely.Frankfurt's masterful and imaginative reading of Descartes's seminal work not only stands the test of time; one imagines Descartes himself nodding in agreement. (shrink)

[Correction Notice: An erratum for this article was reported in Vol 109 of Psychological Review. Due to circumstances that were beyond the control of the authors, the studies reported in "Models of Ecological Rationality: The Recognition Heuristic," by Daniel G. Goldstein and Gerd Gigerenzer overlap with studies reported in "The Recognition Heuristic: How Ignorance Makes Us Smart," by the same authors and with studies reported in "Inference From Ignorance: The Recognition Heuristic". In addition, Figure 3 in the Psychological Review (...) article was originally published in the book chapter and should have carried a note saying that it was used by permission of Oxford University Press.] One view of heuristics is that they are imperfect versions of optimal statistical procedures considered too complicated for ordinary minds to carry out. In contrast, the authors consider heuristics to be adaptive strategies that evolved in tandem with fundamental psychological mechanisms. The recognition heuristic, arguably the most frugal of all heuristics, makes inferences from patterns of missing knowledge. This heuristic exploits a fundamental adaptation of many organisms: the vast, sensitive, and reliable capacity for recognition. The authors specify the conditions under which the recognition heuristic is successful and when it leads to the counter-intuitive less-is-more effect in which less knowledge is better than more for making accurate inferences. (shrink)

Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials has grown substantially (...) in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. Semi-structured interviews with key stakeholders, across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications. (shrink)

Discussions surrounding patient engagement and empowerment often use the terms “patient” and “consumer” interchangeably. But do the two terms hold the same meaning, or is a “patient” a passive actor in the health care arena and a “consumer” an informed, rational decision-maker? Has there been a shift in our usage of the two terms that aligns with the increasing commercialization of health care in the U.S. or has the patient/consumer dynamic always been a part of the buying and selling of (...) health care in the American system? Recent discussions of the issue exist in the popular press and in social media forums such as TEDMED, but few direct analyses of the ethical, legal, and policy ramifications of this possible shift in terminology are available in the academic literature. This paper analyzes our usage of the terms and any recent changes in the dynamic and discusses the ethical, legal, and policy implications of this simple terminology for the physicianpatient relationship. (shrink)

ObjectivesTo describe reporting of informed consent in pragmatic trials, justifications for waivers of consent and reporting of alternative approaches to standard written consent. To identify factors associated with (1) not reporting and (2) not obtaining consent.MethodsSurvey of primary trial reports, published 2014–2019, identified using an electronic search filter for pragmatic trials implemented in MEDLINE, and registered in ClinicalTrials.gov.ResultsAmong 1988 trials, 132 (6.6%) did not include a statement about participant consent, 1691 (85.0%) reported consent had been obtained, 139 (7.0%) reported a (...) waiver and 26 (1.3%) reported consent for one aspect (eg, data collection) but a waiver for another (eg, intervention). Of the 165 trials reporting a waiver, 76 (46.1%) provided a justification. Few (53, 2.9%) explicitly reported use of alternative approaches to consent. In multivariable logistic regression analyses, lower journal impact factor (p=0.001) and cluster randomisation (p<0.0001) were significantly associated with not reporting on consent, while trial recency, cluster randomisation, higher-income country settings, health services research and explicit labelling as pragmatic were significantly associated with not obtaining consent (all p<0.0001).DiscussionNot obtaining consent seems to be increasing and is associated with the use of cluster randomisation and pragmatic aims, but neither cluster randomisation nor pragmatism are currently accepted justifications for waivers of consent. Rather than considering either standard written informed consent or waivers of consent, researchers and research ethics committees could consider alternative consent approaches that may facilitate the conduct of pragmatic trials while preserving patient autonomy and the public’s trust in research. (shrink)

Humans and animals make inferences about the world under limited time and knowledge. In contrast, many models of rational inference treat the mind as a Laplacean Demon, equipped with unlimited time, knowledge, and computational might. Following H. Simon's notion of satisficing, the authors have proposed a family of algorithms based on a simple psychological mechanism: one-reason decision making. These fast and frugal algorithms violate fundamental tenets of classical rationality: They neither look up nor integrate all information. By computer simulation, the (...) authors held a competition between the satisficing "Take The Best" algorithm and various "rational" inference procedures. The Take The Best algorithm matched or outperformed all competitors in inferential speed and accuracy. This result is an existence proof that cognitive mechanisms capable of successful performance in the real world do not need to satisfy the classical norms of rational inference. (shrink)

Drawing on a landscape analysis of existing data-sharing initiatives, in-depth interviews with expert stakeholders, and public deliberations with community advisory panels across the U.S., we describe features of the evolving medical information commons. We identify participant-centricity and trustworthiness as the most important features of an MIC and discuss the implications for those seeking to create a sustainable, useful, and widely available collection of linked resources for research and other purposes.