Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study

被引：10

作者：

Lohner, Szimonetta ^{[1
,2
]}

Gryaznov, Dmitry ^{[3
,4
]}

von Niederhausern, Belinda ^{[4
,5
,6
]}

Speich, Benjamin ^{[3
,4
,7
]}

Kasenda, Benjamin ^{[3
,4
,8
,9
]}

Ojeda-Ruiz, Elena ^{[3
,4
,10
]}

Schandelmaier, Stefan ^{[3
,4
,11
]}

Mertz, Dominik ^{[11
]}

Odutayo, Ayodele ^{[7
,12
]}

Tomonaga, Yuki ^{[13
]}

Amstutz, Alain ^{[3
,4
,14
,15
]}

Pauli-Magnus, Christiane ^{[4
,5
]}

Gloy, Viktoria ^{[3
,4
]}

Bischoff, Karin ^{[16
,17
]}

Wollmann, Katharina ^{[16
,17
]}

Rehner, Laura ^{[16
,18
]}

Meerpohl, Joerg J. ^{[16
,17
]}

Nordmann, Alain ^{[3
,4
]}

Klatte, Katharina ^{[4
,5
]}

Ghosh, Nilabh ^{[19
,20
]}

Heravi, Ala Taji ^{[3
,4
]}

Wong, Jacqueline ^{[11
]}

Chow, Ngai ^{[11
]}

Hong, Patrick Jiho ^{[11
,21
]}

McCord, Kimberly ^{[3
,4
]}

Sricharoenchai, Sirintip ^{[3
,4
]}

Busse, Jason W. ^{[11
,22
]}

Agarwal, Arnav ^{[11
,23
]}

Saccilotto, Ramon ^{[3
,4
]}

Schwenkglenks, Matthias ^{[13
,24
]}

Moffa, Giusi ^{[3
,4
,25
]}

Hemkens, Lars G. ^{[3
,4
,26
,27
,28
]}

Hopewell, Sally ^{[7
]}

von Elm, Erik

Bluemle, Anette ^{[29
]}

Briel, Matthias ^{[3
,4
,11
]}

机构：

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

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

[3] Univ Hosp Basel, Basel Inst Clin Epidemiol & Biostat, Dept Clin Res, Basel, Switzerland

[4] Univ Basel, Basel, Switzerland

[5] Univ Hosp Basel, Clin Trial Unit, Dept Clin Res, Basel, Switzerland

[6] Roche Pharma AG, Grenzach Wyhlen, Germany

[7] Univ Oxford, Nuffield Dept Orthopaed Rheumatol & Musculoskelet, Ctr Stat Med, Oxford, England

[8] Univ Hosp Basel, Dept Med Oncol, Basel, Switzerland

[9] iOMEDICO AG, Res & Dev, Freiburg, Germany

[10] Infanta Elena Univ Hosp, Prevent Med Dept, Madrid, Spain

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

[12] St Michaels Hosp, Li Ka Shing Knowledge Inst, Appl Hlth Res Ctr, Toronto, ON, Canada

[13] Univ Zurich, Epidemiol Biostat & Prevent Inst, Zurich, Switzerland

[14] Univ Basel, Swiss Trop & Publ Hlth Inst, Basel, Switzerland

[15] Univ Hosp Basel, Dept Infect Dis & Hosp Epidemiol, Basel, Switzerland

[16] Univ Freiburg, Fac Med, Med Ctr, Inst Evidence Med, Freiburg, Germany

[17] Cochrane Germany Fdn, Cochrane Germany, Freiburg, Germany

[18] Univ Med Grafswald, Inst Community Med, Dept Epidemiol & Community Hlth, Greifswald, Germany

[19] Univ Basel, Univ Hosp Basel, Dept Neurosurg, Basel, Switzerland

[20] Univ Basel, Univ Hosp Basel, Dept Biomed, Basel, Switzerland

[21] Univ Toronto, Dept Anesthesiol & Pain Med, Toronto, ON, Canada

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

[23] Univ Toronto, Dept Med, Toronto, ON, Canada

[24] Univ Basel, Inst Pharmaceut Med ECPM, Basel, Switzerland

[25] Univ Basel, Dept Math & Comp Sci, Basel, Switzerland

[26] Stanford Univ, Metares Innovat Ctr Stanford METRICS, Stanford, CA 94305 USA

[27] Berlin Inst Hlth, Metares Innovat Ctr Berlin METRIC B, Berlin, Germany

[28] Univ Lausanne, Cochrane Switzerland, Ctr Primary Care & Publ Hlth Unisante, Lausanne, Switzerland

[29] Univ Freiburg, Fac Med, Med Ctr, Clin Trials Unit, Freiburg, Germany

来源：

JOURNAL OF CLINICAL EPIDEMIOLOGY | 2021年 / 139卷

基金：

瑞士国家科学基金会;

关键词：

Clinical trial protocol; Randomized controlled trials; Dietary interventions; Surgical procedures; Behavioural and lifestyle interventions; Reporting guidelines; RANDOMIZED CONTROLLED-TRIALS; REGISTRATION; SURGERY;

D O I：

10.1016/j.jclinepi.2021.05.011

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: To investigate the adherence of randomised controlled trial (RCT) protocols evaluating non-regulated interventions (including dietary interventions, surgical procedures, behavioural and lifestyle interventions, and exercise programmes) in comparison with regulated interventions to the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) 2013 Statement. Methods: We conducted a repeated cross-sectional investigation in a random sample of RCT protocols approved in 2012 (n = 257) or 2016 (n = 292) by research ethics committees in Switzerland, Germany, or Canada. We investigated the proportion of accurately reported SPIRIT checklist items in protocols of trials with non-regulated as compared to regulated interventions. Results: Overall, 131 (24%) of trial protocols tested non-regulated interventions. In 2012, the median proportion of SPIRIT items reported in these protocols (59%, interquartile range [IQR], 53%-69%) was lower than in protocols with regulated interventions (median, 74%, IQR, 66%-80%). In 2016, the reporting quality of protocols with non-regulated interventions (median, 75%, IQR, 62%-83%) improved to the level of regulated intervention protocols, which had not changed on average. Conclusions: Reporting of RCT protocols evaluating non-regulated interventions improved between 2012 and 2016, although remained suboptimal. SPIRIT recommendations need to be further endorsed by researchers, ethics committees, fund- ing agencies, and journals to optimize reporting of RCT protocols. (C) 2021 The Author(s). Published by Elsevier Inc.

引用

页码：340 / 349

页数：10

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