AUTHOR=Mickenautsch Steffen , Yengopal Veerasamy 

TITLE=Allocation concealment appraisal of clinical therapy trials using the extended Composite Quality Score (CQS-2)—An empirically based update

JOURNAL=Frontiers in Medicine

VOLUME=10

YEAR=2023

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1176219

DOI=10.3389/fmed.2023.1176219

ISSN=2296-858X

ABSTRACT=<sec><title>Objectives</title><p>The objective of this study was to revise CQS-2/Criterion II concerning allocation concealment appraisal for prospective, controlled clinical therapy trials.</p></sec><sec><title>Methods</title><p>Meta-analyses of trials with inadequate allocation concealment were tested for in-between trial heterogeneity (<italic>I</italic><sup>2</sup> &gt; 0) due to imbalances in baseline variables. Meta-analyses with positive test results were used as a basis to deduce criteria for adequate allocation concealment. The CQS-2/Criterion II was reformulated in line with the findings.</p></sec><sec><title>Result</title><p>One suitable meta-analysis was identified. Two forest plots with data from five and four trials with inadequate/unclear allocation concealment were selected for testing. In addition, a total of five trials with adequate allocation concealment were identified. The meta-analysis test results were positive, and keywords for the judgment of adequate allocation concealment were extracted verbatim from the text of the meta-analysis. The extracted keywords indicated “central allocation” as the main criterion for adequate allocation concealment. Criterion II of the CQS-2 was revised accordingly.</p></sec><sec><title>Conclusion</title><p>Criterion II of the CQS-2 trial appraisal tool was revised. The revised appraisal tool was specified as version CQS-2B.</p></sec>