Reporting quality was suboptimal in a systematic review of randomized controlled trials with adaptive designs

Objective: The study was conducted to evaluate the reporting quality of randomized controlled trials (RCTs) that use an adaptive design (AD) based on the 2020 AD Consolidated Standards for Reporting Trials 2010 extension (ACE) guidelines and identify factors asso-ciated with better reporting quality.Study Design and Setting: PubMed, Embase, Cochrane, Web of Science, and Google Scholar were searched until November 1, 2022. Multivariable linear regression analysis was performed to investigate potential predictors.Results: In total, 109 RCTs were included in our study. The mean compliance rate for the ACE checklist items was 69.75% 6 16.02. Key methodological items including allocation concealment and its implementations were poorly reported. There was also suboptimal re-porting of checklist items related to the conduct of interim analyzes. Multivariable regression analysis showed better reporting quality with trial registration, nonindustry affiliation (first author), a sample size of O100, general medical journal type, publication date (>= 2020), fund-ing, and disclosure of the number of interim analyzes. Conclusion: Our study showed that RCTs with AD had suboptimal reporting of 2020 ACE checklist items, particularly AD-specific items. Following the development of ACE guidelines, stricter adherence to the ACE guideline is necessary to improve their reporting qual-ity. Pre-ACE and post-ACE adherence comparisons can be conducted in the future.(c) 2022 Elsevier Inc. All rights reserved.

Automated summary

The objective of this study was to evaluate the reporting quality of randomized controlled trials (RCTs) using adaptive design (AD) based on the 2020 AD Consolidated Standards for Reporting Trials 2010 extension (ACE) guidelines. A total of 109 RCTs were included in the study, and the mean compliance rate for the ACE checklist items was found to be 69.75% ± 16.02. Key methodological items, such as allocation concealment, were poorly reported, and there was suboptimal reporting of checklist items related to interim analyzes. The study concluded that stricter adherence to the ACE guidelines is necessary to improve the reporting quality of RCTs with AD.