SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials

被引：3916

作者：

Chan, An-Wen ^{[1
]}

Tetzlaff, Jennifer M. ^{[2
]}

Gotzsche, Peter C. ^{[3
]}

Altman, Douglas G. ^{[4
]}

Mann, Howard ^{[5
]}

Berlin, Jesse A. ^{[6
]}

Dickersin, Kay ^{[7
]}

Hrobjartsson, Asbjorn ^{[3
]}

Schulz, Kenneth F. ^{[8
]}

Parulekar, Wendy R. ^{[9
]}

Krleza-Jeric, Karmela ^{[10
]}

Laupacis, Andreas ^{[11
]}

Moher, David ^{[2
,10
]}

机构：

[1] Univ Toronto, Womens Coll Hosp, Womens Coll Res Inst, Dept Med, Toronto, ON, Canada

[2] Ottawa Hosp, Ottawa Methods Ctr, Clin Epidemiol Program, Res Inst, Ottawa, ON, Canada

[3] Rigshosp, Nord Cochrane Ctr, DK-2100 Copenhagen, Denmark

[4] Univ Oxford, Ctr Stat Med, Oxford, England

[5] Univ Utah, Sch Med, Div Med Eth & Humanities, Salt Lake City, UT USA

[6] Janssen Res & Dev, Titusville, FL USA

[7] Johns Hopkins Bloomberg Sch Publ Hlth, Ctr Clin Trials, Baltimore, MD USA

[8] Quantitat Sci, FHI 360, Res Triangle Pk, NC USA

[9] Queens Univ, NCIC Clin Trials Grp, Canc Res Inst, Kingston, ON, Canada

[10] Univ Ottawa, Dept Epidemiol & Community Med, Ottawa, ON, Canada

[11] Univ Toronto, Keenan Res Ctrsp, Li Ka Shing Knowledge Inst Med, St Michaels Hosp,Fac Med, Toronto, ON, Canada

来源：

BMJ-BRITISH MEDICAL JOURNAL | 2013年 / 346卷

基金：

加拿大健康研究院;

关键词：

RANDOMIZED CONTROLLED-TRIALS; DOUBLE DATA-ENTRY; CONFLICTS-OF-INTEREST; RESEARCH ETHICS COMMITTEE; SAMPLE-SIZE CALCULATIONS; OUTCOME REPORTING BIAS; INFORMED-CONSENT; PUBLICATION BIAS; DRUG TRIALS; EMPIRICAL-EVIDENCE;

D O I：

10.1136/bmj.e7586

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

High quality protocols facilitate proper conduct, reporting, and external review of clinical trials. However, the completeness of trial protocols is often inadequate. To help improve the content and quality of protocols, an international group of stakeholders developed the SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for International Trials). The SPIRIT Statement provides guidance in the form of a checklist of recommended items to include in a clinical trial protocol. This SPIRIT 2013 Explanation and Elaboration paper provides important information to promote full understanding of the checklist recommendations. For each checklist item, we provide a rationale and detailed description; a model example from an actual protocol; and relevant references supporting its importance. We strongly recommend that this explanatory paper be used in conjunction with the SPIRIT Statement. A website of resources is also available (www.spirit-statement.org). The SPIRIT 2013 Explanation and Elaboration paper, together with the Statement, should help with the drafting of trial protocols. Complete documentation of key trial elements can facilitate transparency and protocol review of the benefit of all stakeholders.

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页数：42

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