AUTHOR=Mickenautsch Steffen , Rupf Stefan , Yengopal Veerasamy 

TITLE=Application of the Composite Quality Score (CQS-2B) versus Cochrane’s Risk of Bias tool (Version 2) in systematic reviews of clinical trials – an exploratory study

JOURNAL=Frontiers in Medicine

VOLUME=11

YEAR=2024

URL=https://www.frontiersin.org/journals/medicine/articles/10.3389/fmed.2024.1307815

DOI=10.3389/fmed.2024.1307815

ISSN=2296-858X

ABSTRACT=<sec id="sec1"><title>Objectives</title><p>To explore whether systematic review conclusions generated from Cochrane’s second version of its Risk of Bias tool (RoB 2) for trial appraisal differ when the Composite Quality Score, Version 2.B (CQS-2B) is used instead and to develop a testable hypothesis based on these findings.</p></sec><sec id="sec2"><title>Methods</title><p>PubMed was searched for one single systematic review. From the review’s accepted trials, data concerning effect estimates and overall bias risk according to the RoB 2 tool were extracted. All trial reports were appraised again using the CQS-2B. Datasets were stratified according to overall bias risk (RoB 2) or corroboration (C-) level (CQS-2B). The effect estimates from trials with ‘low bias risk’ (RoB 2) and with highest C-level (CQS-2B) were pooled separately. These pooled effect estimates were statistically and all clinical conclusions qualitatively compared.</p></sec><sec id="sec3"><title>Results</title><p>The pooled effect estimates for trials with ‘low bias risk’ (RoB 2) were −0.07, 95% CI: −0.10 to −0.04 (<italic>I</italic><sup>2</sup> = 0.0%) and for the highest C-levels (CQS-2B) 0.08, 95% CI: −0.12 to −0.04 (<italic>I</italic><sup>2</sup> = 57.0%). The difference was statistically not significant (<italic>p</italic> = 0.70). Contrary to the RoB 2 tool, no clinical conclusions in line with the CQS-2B were made, because the effect estimates were judged to be erroneously overestimated, due to high risk of bias.</p></sec><sec id="sec4"><title>Conclusion</title><p>A testable hypothesis was generated suggesting that trial appraisal using the CQS-2B may provide more conservative conclusions based on similar data than with the RoB 2 tool.</p></sec>