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 (2021) Reporting quality of trial protocols improved for non-regulated interventions but not regulated interventions: A repeated cross-sectional study. JOURNAL OF CLINICAL EPIDEMIOLOGY. pp. 1-10. ISSN 0895-4356 (print); 1878-5921 (online) (In Press)

Preview

Text Lohner_J Clin Epidemiol_2021.pdf - Published Version Available under License Creative Commons Attribution. Download (438kB) | Preview

Abstract

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, funding agencies, and journals to optimize reporting of RCT protocols.

Actions (login required)

Edit Item