A meta-research study of randomized controlled trials found infrequent and delayed availability of protocols

被引：14

作者：

Schoenenberger, Christof Manuel ^{[1
,2
]}

Griessbach, Alexandra ^{[1
,2
]}

Heravi, Ala Taji ^{[1
,2
]}

Gryaznov, Dmitry ^{[1
,2
]}

Gloy, Viktoria L. ^{[1
,2
]}

Lohner, Szimonetta ^{[3
,4
]}

Klatte, Katharina ^{[1
,2
]}

Ghosh, Nilabh ^{[1
,2
]}

Lee, Hopin ^{[5
]}

Mansouri, Anita ^{[5
]}

Marian, Ioana R. ^{[5
]}

Saccilotto, Ramon ^{[2
,6
]}

Nury, Edris ^{[7
,8
]}

Busse, Jason W. ^{[9
,10
]}

von Niederhausern, Belinda ^{[11
]}

Mertz, Dominik ^{[12
]}

Bluemle, Anette ^{[13
,14
]}

Odutayo, Ayodele ^{[5
,10
]}

Hopewell, Sally ^{[5
]}

Speich, Benjamin ^{[1
,2
,5
]}

Briel, Matthias ^{[1
,2
,9
]}

机构：

[1] Univ Basel, Meta Res Ctr, Dept Clin Res, Spitalstr 12, CH-4056 Basel, Switzerland

[2] Univ Hosp Basel, Spitalstr 12, CH-4056 Basel, Switzerland

[3] Univ Pecs, Clin Ctr, Med Sch, Cochrane Hungary, Pecs, Hungary

[4] Univ Pecs, Med Sch, Dept Publ Hlth Med, Pecs, Hungary

[5] Univ Oxford, Ctr Stat Med, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Oxford Clin Trials Res Unit, Oxford, England

[6] Univ Basel, Dept Clin Res, Clin Trial Unit, Basel, Switzerland

[7] Univ Freiburg, Cochrane Germany Fdn, Fac Med & Med Ctr, Inst Evidence Med, Freiburg, Germany

[8] Med Ctr Hamburg Eppendorf UKE, Dept Gen Practice & Primary Care, Hamburg, Germany

[9] McMaster Univ, Dept Hlth Res Methods Evidence & Impact, Hamilton, ON, Canada

[10] McMaster Univ, Dept Anesthesia, Hamilton, ON, Canada

[11] Roche Pharma AG, Grenzach Wyhlen, Germany

[12] McMaster Univ, Dept Med, Hamilton, ON, Canada

[13] Univ Freiburg, Fac Med, Clin Trials Unit, Freiburg, Germany

[14] Univ Freiburg, Med Ctr, Freiburg, Germany

来源：

JOURNAL OF CLINICAL EPIDEMIOLOGY | 2022年 / 149卷

基金：

瑞士国家科学基金会;

关键词：

Randomized controlled trials; Trial protocols; Trial registration; Protocol publication; Meta-research; Transparency;

D O I：

10.1016/j.jclinepi.2022.05.014

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

Objectives: Availability of randomized controlled trial (RCT) protocols is essential for the interpretation of trial results and research transparency. Study Design and Setting: In this study, we determined the availability of RCT protocols approved in Switzerland, Canada, Germany, and the United Kingdom in 2012. For these RCTs, we searched PubMed, Google Scholar, Scopus, and trial registries for publicly available protocols and corresponding full-text publications of results. We determined the proportion of RCTs with (1) publicly available protocols, (2) publications citing the protocol, and (3) registries providing a link to the protocol. A multivariable logistic regression model explored factors associated with protocol availability. Results: Three hundred twenty-six RCTs were included, of which 118 (36.2%) made their protocol publicly available; 56 (47.6% 56 of 118) provided as a peer-reviewed publication and 48 (40.7%, 48 of 118) provided as supplementary material. A total of 90.9% (100 of 110) of the protocols were cited in the main publication, and 55.9% (66 of 118) were linked in the clinical trial registry. Larger sample size ( > 500; odds ratio [OR] = 5.90, 95% confidence interval [CI], 2.75-13.31) and investigator sponsorship (OR = 1.99, 95% CI, 1.11-3.59) were associated with increased protocol availability. Most protocols were made available shortly before the publication of the main results. Conclusion: RCT protocols should be made available at an early stage of the trial. (C) 2022 The Author(s). Published by Elsevier Inc.

引用

页码：45 / 52

页数：8

共 34 条

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