| Literature DB >> 27440100 |
An-Wen Chan1, Jennifer M Tetzlaff2, Douglas G Altman3, Andreas Laupacis4, Peter C Gøtzsche5, Karmela Krle A-Jerić6, Asbjørn Hrobjartsson5, Howard Mann7, Kay Dickersin8, Jesse A Berlin9, Caroline J Dore10, Wendy R Parulekar11, William S M Summerskill12, Trish Groves13, Kenneth F Schulz14, Harold C Sox15, Frank W Rockhold14, Drummond Rennie16, David Moher17.
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.Entities:
Mesh：
Year: 2015 PMID： 27440100 PMCID： PMC5114122
Source DB: PubMed Journal: Rev Panam Salud Publica ISSN： 1020-4989