SPIRIT 2013 statement: defining standard protocol items for clinical trials.
An-Wen Chan,Jennifer Tetzlaff,Douglas G. Altman,Andreas Laupacis,Peter C Gøtzsche,Karmela Krleža-Jerić,Asbjørn Hróbjartsson,Howard Mann,Kay Dickersin,Jesse A. Berlin,Caroline J Doré,Wendy R. Parulekar,William S.M. Summerskill,Trish Groves,Kenneth F. Schulz,Harold C. Sox,Frank W. Rockhold,Drummond Rennie,David Moher +18 more
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TLDR
The SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013, a guideline for the minimum content of a clinical trial protocol, is presented in this paper.Abstract:
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.read more
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Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement
David Moher,Larissa Shamseer,Mike Clarke,Davina Ghersi,Alessandro Liberati,Mark Petticrew,Paul G. Shekelle,Lesley A. Stewart +7 more
TL;DR: A reporting guideline is described, the Preferred Reporting Items for Systematic reviews and Meta-Analyses for Protocols 2015 (PRISMA-P 2015), which consists of a 17-item checklist intended to facilitate the preparation and reporting of a robust protocol for the systematic review.
Ítems de referencia para publicar Protocolos de Revisiones Sistemáticas y Metaanálisis: Declaración PRISMA-P 2015 Preferred reporting items for systematic review and meta-analysis protocols (PRISMA-P) 2015 statement
David Moher,Larissa Shamseer,Michael Clarke,Davina Ghersi,Alessandro Liberati,Mark Petticrew,Lesley A. Stewart +6 more
Journal ArticleDOI
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
An-Wen Chan,Jennifer Tetzlaff,Peter C Gøtzsche,Douglas G. Altman,Howard Mann,Jesse A. Berlin,Kay Dickersin,Asbjørn Hróbjartsson,Kenneth F. Schulz,Wendy R. Parulekar,Karmela Krleza-Jeric,Andreas Laupacis,David Moher,David Moher +13 more
TL;DR: The SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations and strongly recommends that this explanatory paper be used in conjunction with the SPIRit Statement.
Journal ArticleDOI
Reporting of patient-reported outcomes in randomized trials: the CONSORT PRO extension.
Melanie Calvert,Jane M Blazeby,Douglas G. Altman,Dennis A. Revicki,David Moher,Michael Brundage +5 more
TL;DR: In this article, the authors describe the development of the CONSORT PRO extension based on the methodological framework for guideline development proposed by the Enhancing the Quality and Transparency of Health Research (EQUATOR) Network.
Journal ArticleDOI
Increasing value and reducing waste: addressing inaccessible research.
An-Wen Chan,Fujian Song,Andrew J. Vickers,Tom Jefferson,Kay Dickersin,Peter C Gøtzsche,Harlan M. Krumholz,Harlan M. Krumholz,Davina Ghersi,H. Bart van der Worp +9 more
TL;DR: Three main actions are warranted: academic institutions and funders should reward investigators who fully disseminate their research protocols, reports, and participant-level datasets, and standards for the content of protocols and full study reports should be rigorously developed and adopted for all types of health research.
References
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CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
TL;DR: The Consort 2010 Statement as discussed by the authors has been used worldwide to improve the reporting of randomised controlled trials and has been updated by Schulz et al. in 2010, based on new methodological evidence and accumulating experience.
Journal ArticleDOI
CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials.
TL;DR: The CONSORT (Consolidated Standards of Reporting Trials) statement as discussed by the authors is used worldwide to improve the reporting of randomized, controlled trials. Schulz and colleagues describe the latest version, CONSORT 2010, which updates the reporting guideline based on new methodological evidence and accumulating experience.
Journal ArticleDOI
SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials
An-Wen Chan,Jennifer Tetzlaff,Peter C Gøtzsche,Douglas G. Altman,Howard Mann,Jesse A. Berlin,Kay Dickersin,Asbjørn Hróbjartsson,Kenneth F. Schulz,Wendy R. Parulekar,Karmela Krleza-Jeric,Andreas Laupacis,David Moher,David Moher +13 more
TL;DR: The SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations and strongly recommends that this explanatory paper be used in conjunction with the SPIRit Statement.
Journal ArticleDOI
Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.
TL;DR: The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols and Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention.
Journal ArticleDOI
Systematic Review of the Empirical Evidence of Study Publication Bias and Outcome Reporting Bias
Kerry Dwan,Douglas G. Altman,Juan A. Arnaiz,Jill Bloom,An-Wen Chan,Eugenia Cronin,Evelyne Decullier,Philippa Easterbrook,Erik von Elm,Erik von Elm,Carrol Gamble,Davina Ghersi,John P. A. Ioannidis,John P. A. Ioannidis,John Simes,Paula R Williamson +15 more
TL;DR: There is strong evidence of an association between significant results and publication; studies that report positive or significant results are more likely to be published and outcomes that are statistically significant have higher odds of being fully reported.