Browsing by Author "Dickersin, Kay"

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    Caveat emptor: the combined effects of multiplicity and selective reporting.
    (Trials, 2018-09-17) Li, Tianjing; Mayo-Wilson, Evan; Fusco, Nicole; Hong, Hwanhee; Dickersin, Kay
    Clinical trials and systematic reviews of clinical trials inform healthcare decisions. There is growing concern, however, about results from clinical trials that cannot be reproduced. Reasons for nonreproducibility include that outcomes are defined in multiple ways, results can be obtained using multiple methods of analysis, and trial findings are reported in multiple sources ("multiplicity"). Multiplicity combined with selective reporting can influence dissemination of trial findings and decision-making. In particular, users of evidence might be misled by exposure to selected sources and overly optimistic representations of intervention effects. In this commentary, drawing from our experience in the Multiple Data Sources in Systematic Reviews (MUDS) study and evidence from previous research, we offer practical recommendations to enhance the reproducibility of clinical trials and systematic reviews.
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    Correction to: Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol for a systematic review.
    (Alzheimer's research & therapy, 2018-02-16) Mayo-Wilson, Evan; Hutfless, Susan; Li, Tianjing; Gresham, Gillian; Fusco, Nicole; Ehmsen, Jeffrey; Heyward, James; Vedula, Swaroop; Lock, Diana; Haythornthwaite, Jennifer; Payne, Jennifer L; Cowley, Theresa; Tolbert, Elizabeth; Rosman, Lori; Twose, Claire; Stuart, Elizabeth A; Hong, Hwanhee; Doshi, Peter; Suarez-Cuervo, Catalina; Singh, Sonal; Dickersin, Kay
    CORRECTION:The correct title of the article [1] should be "Integrating multiple data sources (MUDS) for meta-analysis to improve patient-centered outcomes research: a protocol". The article is a protocol for a methodological study, not a systematic review.
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    SPIRIT 2013 statement: defining standard protocol items for clinical trials.
    (Ann Intern Med, 2013-02-05) Chan, An-Wen; Tetzlaff, Jennifer M; Altman, Douglas G; Laupacis, Andreas; Gøtzsche, Peter C; Krleža-Jerić, Karmela; Hróbjartsson, Asbjørn; Mann, Howard; Dickersin, Kay; Berlin, Jesse A; Doré, Caroline J; Parulekar, Wendy R; Summerskill, William SM; Groves, Trish; Schulz, Kenneth F; Sox, Harold C; Rockhold, Frank W; Rennie, Drummond; Moher, David
    The protocol of a clinical trial serves as the foundation for study planning, conduct, reporting, and appraisal. However, trial protocols and existing protocol guidelines vary greatly in content and quality. This article describes the systematic development and scope of SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol.The 33-item SPIRIT checklist applies to protocols for all clinical trials and focuses on content rather than format. The checklist recommends a full description of what is planned; it does not prescribe how to design or conduct a trial. By providing guidance for key content, the SPIRIT recommendations aim to facilitate the drafting of high-quality protocols. Adherence to SPIRIT would also enhance the transparency and completeness of trial protocols for the benefit of investigators, trial participants, patients, sponsors, funders, research ethics committees or institutional review boards, peer reviewers, journals, trial registries, policymakers, regulators, and other key stakeholders.