Extension of the Composite Quality Score (CQS) as an appraisal tool for prospective, controlled clinical therapy trials–A systematic review of meta-epidemiological evidence

Abstract

AIM: To conduct a survey of current meta-epidemiological studies to identify additional trial design characteristics that may be associated with significant over- or underestimation of the treatment effect and to use such identified characteristics as a basis for the formulation of new CQS appraisal criteria. MATERIALS AND METHODS: We retrieved eligible studies from two systematic reviews on this topic (latest search May 2015) and searched the databases PubMed and Embase for further studies from June 2015 -March 2022. All data were extracted by one author and verified by another. Sufficiently homogeneous estimates from single studies were pooled using random-effects meta-analysis. Trial design characteristics associated with statistically significant estimates from single datasets (which could not be pooled) and meta-analyses were used as a basis to formulate new or amend existing CQS criteria. RESULTS: A total of 38 meta-epidemiological studies were identified. From these, seven trial design characteristics associated with statistically significant over- or underestimation of the true therapeutic effect were found. CONCLUSION: One new criterion concerning double-blinding was added to the CQS, and the original criteria for concealing the random allocation sequence and for minimum sample size were amended.

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