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SPIRIT 2013 Statement: Defining Standard Protocol Items for Clinical Trials

被引：4684
作者：
Chan, An-Wen [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Tetzlaff, Jennifer M. [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Altman, Douglas G. [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Laupacis, Andreas [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Gotzsche, Peter C. [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Krleza-Jeric, Karmela [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Hrobjartsson, Asbjorn [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Mann, Howard [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Dickersin, Kay [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Berlin, Jesse A. [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Dore, Caroline J. [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Parulekar, Wendy R. [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Summerskill, William S. M. [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Groves, Trish [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Schulz, Kenneth F. [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Sox, Harold C. [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Rockhold, Frank W. [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Rennie, Drummond [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
Moher, David [1 ,2 ,3 ,4 ,5 ,6 ,7 ,8 ,9 ,10 ,11 ,12 ,13 ,14 ,15 ,16 ]
机构：
[1] Univ Toronto, Womens Coll Res Inst, Womens Coll Hosp, St Michaels Hosp, Toronto, ON, Canada
[2] Univ Toronto, Keenan Res Ctr, Li Ka Shing Knowledge Inst, St Michaels Hosp, Toronto, ON, Canada
[3] Canadian Inst Hlth Res, Ottawa Methods Ctr, Ottawa Hosp Res Inst, Eth Off, Ottawa, ON, Canada
[4] Univ Ottawa, Ottawa, ON, Canada
[5] Univ Oxford, Ctr Stat Med, Oxford, England
[6] Rigshosp, Nord Cochrane Ctr, Copenhagen, Denmark
[7] Univ Utah, Sch Med, Salt Lake City, UT USA
[8] Johns Hopkins Bloomberg Sch Publ Hlth, Ctr Clin Trials, Baltimore, MD USA
[9] Janssen Pharmaceut Co Johnson & Johnson, Janssen Res & Dev, Titusville, NJ USA
[10] The Lancet, UK Med Res Council, Clin Trials Unit, London, England
[11] BMJ, London, England
[12] Queens Univ, NCIC Clin Trials Grp, Canc Res Inst, Kingston, ON, Canada
[13] FHI 360, Quantitat Sci, Res Triangle Pk, NC USA
[14] GlaxoSmithKline, Res Triangle Pk, NC USA
[15] Geisel Sch Med Dartmouth, Dartmouth Inst Hlth Policy & Clin Practice, Hanover, NH USA
[16] Univ Calif San Francisco, PR Lee Inst Hlth Policy Studies, San Francisco, CA USA
来源：
ANNALS OF INTERNAL MEDICINE | 2013年 / 158卷 / 03期
基金：
加拿大健康研究院;
关键词：
RANDOMIZED CONTROLLED-TRIALS; EMPIRICAL-EVIDENCE; REGISTRATION; PUBLICATIONS; QUALITY; GUIDELINE; DATABASE; ACCESS; IMPACT; BIAS;
D O I：
10.7326/0003-4819-158-3-201302050-00583
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
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.
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页码：200 / +
页数：10
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