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

Steffen Mickenautsch; Veerasamy Yengopal

doi:10.3389/fmed.2023.1176219

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

Front Med (Lausanne). 2023 Jun 15:10:1176219. doi: 10.3389/fmed.2023.1176219. eCollection 2023.

Authors

Steffen Mickenautsch^{1

2}, Veerasamy Yengopal³

Affiliations

¹ Review Centre for Health Science Research, Johannesburg, South Africa.
² Department of Community Dentistry, School of Oral Health Sciences, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
³ Faculty of Dentistry, University of the Western Cape, Cape Town, South Africa.

Abstract

Objectives: The objective of this study was to revise CQS-2/Criterion II concerning allocation concealment appraisal for prospective, controlled clinical therapy trials.

Methods: Meta-analyses of trials with inadequate allocation concealment were tested for in-between trial heterogeneity (I² > 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.

Result: 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.

Conclusion: Criterion II of the CQS-2 trial appraisal tool was revised. The revised appraisal tool was specified as version CQS-2B.

Keywords: Composite Quality Score; allocation concealment; clinical trial; systematic review; trial appraisal.