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

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

SUBMITTER: Mickenautsch S 

PROVIDER: S-EPMC10308079 | biostudies-literature | 2023

REPOSITORIES: biostudies-literature