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

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State: Public
Version: Final published version
License: CC BY 4.0
Serval ID
serval:BIB_ED7EF381F727
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study.
Journal
Journal of clinical epidemiology
Author(s)
Lohner S., Gryaznov D., von Niederhäusern B., Speich B., Kasenda B., Ojeda-Ruiz E., Schandelmaier S., Mertz D., Odutayo A., Tomonaga Y., Amstutz A., Pauli-Magnus C., Gloy V., Bischoff K., Wollmann K., Rehner L., Meerpohl J.J., Nordmann A., Klatte K., Ghosh N., Heravi A.T., Wong J., Chow N., Hong P.J., McCord K., Sricharoenchai S., Busse J.W., Agarwal A., Saccilotto R., Schwenkglenks M., Moffa G., Hemkens L.G., Hopewell S., von Elm E., Blümle A., Briel M.
ISSN
1878-5921 (Electronic)
ISSN-L
0895-4356
Publication state
Published
Issued date
11/2021
Peer-reviewed
Oui
Volume
139
Pages
340-349
Language
english
Notes
Publication types: Comparative Study ; Journal Article ; Research Support, Non-U.S. Gov't
Publication Status: ppublish
Abstract
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.
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.
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.
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, funding agencies, and journals to optimize reporting of RCT protocols.
Keywords
Canada, Clinical Trial Protocols as Topic, Cross-Sectional Studies, Data Accuracy, Ethics Committees, Research, Geography, Germany, Guideline Adherence/statistics & numerical data, Guidelines as Topic, Humans, Randomized Controlled Trials as Topic/standards, Randomized Controlled Trials as Topic/statistics & numerical data, Research Design/standards, Research Design/statistics & numerical data, Switzerland, Behavioural and lifestyle interventions, Clinical trial protocol, Dietary interventions, Randomized controlled trials, Reporting guidelines, Surgical procedures
Pubmed
Web of science
Open Access
Yes
Create date
31/05/2021 8:42
Last modification date
06/02/2024 8:31
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