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

Lohner, Szimonetta and Gryaznov, Dmitry and von Niederhäusern, Belinda and Speich, Benjamin and Kasenda, Benjamin and Ojeda-Ruiz, Elena and Schandelmaier, Stefan and Mertz, Dominik and Odutayo, Ayodele and Tomonaga, Yuki and Amstutz, Alain and Pauli-Magnus, Christiane and Gloy, Viktoria and Bischoff, Karin and Wollmann, Katharina and Rehner, Laura and Meerpohl, Joerg J. and Nordmann, Alain and Klatte, Katharina and Ghosh, Nilabh and Heravi, Ala Taji and Wong, Jacqueline and Chow, Ngai and Hong, Patrick Jiho and McCord, Kimberly and Sricharoenchai, Sirintip and Busse, Jason W. and Agarwal, Arnav and Saccilotto, Ramon and Schwenkglenks, Matthias and Moffa, Giusi and Hemkens, Lars G. and Hopewell, Sally and von Elm, Erik and Blümle, Anette and Briel, Matthias. (2021) Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study. Journal of clinical epidemiology, 139. pp. 340-349.

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Official URL: https://edoc.unibas.ch/86991/

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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.
Faculties and Departments:03 Faculty of Medicine > Departement Public Health > Pharmazeutische Medizin ECPM > Pharmazeutische Medizin (Szucs)
UniBasel Contributors:Schwenkglenks, Matthias
Item Type:Article, refereed
Article Subtype:Research Article
Publisher:Elsevier
ISSN:1878-5921
Note:Publication type according to Uni Basel Research Database: Journal article
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Last Modified:03 Feb 2022 18:08
Deposited On:03 Feb 2022 18:08

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