Abstract
ObjectivesTo 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. MethodsWe 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. ResultsOverall, 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. ConclusionsReporting 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.
Highlights
Trials of regulated interventions, such as drugs, biologics, or medical devices, must adhere to regulations of responsible authorities (e.g. European Medicines Agency, Swissmedic) [1,2,3,4]
There was an improvement in adherence of trial protocols of non-regulated intervention trials to the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) recommendations between 2012 and 2016; their reporting quality reached the level of regulated trials in 2016 but still remained suboptimal
The improvements and remaining deficiencies of trial protocols of non-regulated interventions were similar across types of intervention
Summary
Trials of regulated interventions, such as drugs, biologics, or medical devices, must adhere to regulations of responsible authorities (e.g. European Medicines Agency, Swissmedic) [1,2,3,4]. Recommendations have been developed for the design, conduct and reporting of trials with non-regulated interventions [5, 6], study reports of these trials often lack important study information, such as final sample size [7], age [8], or health status of participants [8], and adherence to the CONSORT (Consolidated Standards of Reporting Trials) Statement is generally poor [8,9,10,11,12]. The SPIRIT 2013 Statement (Standard Protocol Items: Recommendations for Interventional Trials), a checklist of a minimal set of items to be reported in a protocol, was developed to improve the reporting quality of study protocols [14]. Empirical evidence on the impact of the SPIRIT recommendations on the quality of trial protocols with non-regulated interventions is lacking
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