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"Sackett, David"
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Methods of Blinding in Reports of Randomized Controlled Trials Assessing Pharmacologic Treatments: A Systematic Review
by
Estellat, Candice
,
Dechartres, Agnes
,
Ravaud, Philippe
in
Bias
,
Clinical Pharmacology
,
Clinical trials
2006
Blinding is a cornerstone of therapeutic evaluation because lack of blinding can bias treatment effect estimates. An inventory of the blinding methods would help trialists conduct high-quality clinical trials and readers appraise the quality of results of published trials. We aimed to systematically classify and describe methods to establish and maintain blinding of patients and health care providers and methods to obtain blinding of outcome assessors in randomized controlled trials of pharmacologic treatments.
We undertook a systematic review of all reports of randomized controlled trials assessing pharmacologic treatments with blinding published in 2004 in high impact-factor journals from Medline and the Cochrane Methodology Register. We used a standardized data collection form to extract data. The blinding methods were classified according to whether they primarily (1) established blinding of patients or health care providers, (2) maintained the blinding of patients or health care providers, and (3) obtained blinding of assessors of the main outcomes. We identified 819 articles, with 472 (58%) describing the method of blinding. Methods to establish blinding of patients and/or health care providers concerned mainly treatments provided in identical form, specific methods to mask some characteristics of the treatments (e.g., added flavor or opaque coverage), or use of double dummy procedures or simulation of an injection. Methods to avoid unblinding of patients and/or health care providers involved use of active placebo, centralized assessment of side effects, patients informed only in part about the potential side effects of each treatment, centralized adapted dosage, or provision of sham results of complementary investigations. The methods reported for blinding outcome assessors mainly relied on a centralized assessment of complementary investigations, clinical examination (i.e., use of video, audiotape, or photography), or adjudication of clinical events.
This review classifies blinding methods and provides a detailed description of methods that could help trialists overcome some barriers to blinding in clinical trials and readers interpret the quality of pharmacologic trials.
Journal Article
David Sackett Young Investigator Award
2020
Sarkies et al. use a highly innovative study design to demonstrate that video-based strategies for knowledge translation are more effective than written strategies for improving knowledge of health professionals about research evidence. A web interface for calculating the fragility index of meta-analyses is available at http://clinicalepidemio.fr/fragility_ma/.Mitchell N Sarkies summarizes the awarded work as follows Health service provision does not always reflect current research evidence. [...]we need to identify better approaches to enable health care professionals, managers, and policy-makers understand and use this evidence. [...]research is needed to understand whether improved knowledge from digital knowledge translation approaches can contribute toward more complex, multifaceted research implementation strategies and improve evidence uptake in health care policy and practice.
Journal Article
Need for expertise based randomised controlled trials
by
Schünemann, Holger J
,
Sackett, David L
,
Clarke, Mike
in
Angioplasty
,
Attitude of Health Personnel
,
Bias
2005
[...]trialists rarely, if ever, institute measures to ensure that the number of participating surgeons with expertise in each procedure is equal. [...]although some conventional randomised controlled trials try to reduce bias by requiring participating surgeons to perform a minimum number of both the experimental and control procedures before participating in the trial, this measure is unlikely to eliminate bias because outcomes often improve with extensive experience with a procedure. [...]they probably expect and hope that the randomised controlled trial testing the outcomes of procedure A versus procedure B will affirm their belief. [...]surgeons, who are necessarily unblinded to the procedure they perform, may subconsciously systematically bias trial findings in a conventional randomised controlled trial. [...]the likelihood of differential procedural performance, cointerventions, data collection, and outcome assessment decreases.
Journal Article
Clinician-trialist rounds: 5. Cointervention bias – how to diagnose it in their trial and prevent it in yours
A primer on preventing or overcoming cointervention bias in clinical trials is presented. Among other steps, one should think like a trialist: search for any unequal application of these clinically-relevant cointerventions to the experimental and control groups, and if present consider the impact of the resulting cointervention bias on the trial results.
Journal Article
Clinician trialist rounds: 28. When RCT participants are lost to follow-up. Part 1: Why even a few can matter
by
Devereaux, PJ
,
Sackett, David L
,
Walsh, Michael
in
Biomedical Research - standards
,
Clinical trials
,
Design of experiments
2015
Lost, in the context of a clinical trial, means that the trialist cannot ascertain whether or not that participant had the outcome of interest. If losses to follow-up are important, do RCT guidelines recommend reporting them? A quick scan of the CONSORT guidance does, indeed, show that reporting losses to follow-up is a suggested key item in reporting clinical trial results.
Journal Article
Clinician-trialist rounds: 16. Mind your explanatory and pragmatic attitudes! – part 1: what?
Pragmatic trials constitute the proof of the pudding for promising results from explanatory trials and are (or bloody well ought to be) a major focus of comparative effectiveness research.
Journal Article
Clinician-trialist rounds: 21. The presenting complaints, diagnoses and treatments of mentorships in trouble. Part 1: Dysfunctional mentorship meetings
2014
When mentee and mentor agree, at the outset, on a schedule for regular meetings, the failure to follow-through not only achieves an early diagnosis, but if corrected rescues the mentee from a prolonged period without active mentoring. Mentoring programs that require periodic recertification of mentor-ships (e.g. via 1-page reports signed by both parties) ought to prevent these failures from escaping timely detection.
Journal Article
Clinician-trialist rounds: 20. Shouldn’t ‘trialists-in-training’ rotate through RCT-clerkships?
2014
Clinical training programs routinely operate formal clerkships in which newcomers shadow senior clinicians as the latter carry out the myriad actions that sum to practical clinical expertise, often following the maxim: See one, do one, teach one. Sackett conducted an informal survey which revealed that most randomized clinical trial (RCT) training programs provide at least some of these experiences to at least some of their trainees, but that none of them were satisfied that they were doing enough.
Journal Article