A systematic review investigating the use of microbiology outcome measures in randomized controlled trials evaluating...

Antimicrobial stewardship interventions (ASIs) aim to reduce the emergence of antimicrobial resistance. We sought to systematically evaluate how microbiological outcomes have been handled and analysed in randomized controlled trials (RCTs) evaluating ASIs.

We searched PubMed and Embase from 2011-21. Studies were selected if they were RCTs evaluating ASIs. A narrative synthesis approach was taken, identifying whether the study reported any microbiological data (bacterial genus/species; bacterial colony counts; prevalence of bacterial, microbiologically defined infections; and antibiotic susceptibility, measured pre-randomization or post-randomization in one arm only) or outcomes (post-randomization data compared between arms). Studies with or without microbiological data/outcomes were summarized in terms of study characteristics, methods of reporting and analysis of these outcomes.

We identified 117 studies, with 34 (29.1%) collecting microbiological data and 18 (15.4%) reporting microbiological outcomes. Most studies with microbiological outcomes were conducted in secondary care (12/18, 66.7%) and targeted adult populations (14/18, 77.8%), and the intervention involved biomarker-guided rapid diagnostic testing (7/18, 38.9%). The overall quality of reporting and analysing microbiological outcomes was low and inconsistent. The selected study population in analyses and methods of handling missing data were unclear.

This review demonstrates that the quality of handling and reporting microbiological outcomes in RCTs of ASIs was low. The lack of consistency and clarity made it difficult to compare the findings across studies, limiting policy- and clinical decision-making. Therefore, there is a clear need for the development of guidance for handling microbiological outcomes in RCTs and adopting appropriate methods to evaluate these data carefully.