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SPIRIT 2013Statement: DefiningStandard ProtocolItems for ClinicalTrials An‐Wen ChanJennifer TetzlaffDouglas G. Altman2013 год

SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials
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Аннотация: 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.
Год издания: 2013
Авторы: 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 Summerskill, Trish Groves, Kenneth F. Schulz, Harold C. Sox, Frank W. Rockhold, Drummond Rennie, David Moher
Издательство: American College of Physicians
Источник: Annals of Internal Medicine
Ключевые слова: Meta-analysis and systematic reviews, Health Systems, Economic Evaluations, Quality of Life, Statistical Methods in Clinical Trials
Другие ссылки: Annals of Internal Medicine (HTML)
Europe PMC (PubMed Central) (PDF)
Europe PMC (PubMed Central) (HTML)
PubMed Central (HTML)
DukeSpace (Duke University) (PDF)
DukeSpace (Duke University) (HTML)
PubMed (HTML)