Abstract
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 associated
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% ± 16.02. Key methodological items including allocation
concealment and its implementations were poorly reported. There was also suboptimal
reporting 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 >100, general medical journal type, publication
date (≥2020), funding, 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 quality.
Pre-ACE and post-ACE adherence comparisons can be conducted in the future.
Keywords
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Article info
Publication history
Published online: December 16, 2022
Accepted:
December 12,
2022
Footnotes
Conflict of interests: None declared.
Author contributions: Sujata Purja, Sunuk Park, and EunYoung Kim contributed to conceptualization and design of the study. Sujata Purja, Sunuk Park, and SuA Oh contributed to data extraction. Sujata Purja and EunYoung Kim contributed to statistical analysis and interpretation of data. Sujata Purja contributed to drafting the manuscript. Sujata Purja, Sunuk Park, SuA Oh, Minji Kim, and EunYoung Kim contributed to revising the manuscript. EunYoung Kim contributed to the supervision.
Funding: This work was funded by a grant from the Korean government, South Korea (Ministry of Science and ICT, MICT; NRF-2021R1F1A1062044), and by the Basic Science Research Program through the National Research Foundation of Korea funded by the Ministry of Education, South Korea (Grant Number 2021R1A6A1A03044296). The funder had no role in the trial design, data collection, data interpretation, or report preparation.
Declaration of interests: The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this article.
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