Perspectives of Statistician, Microbiologist, and Clinician Stakeholders on the Use of Microbiological Outcomes in Randomised Trials of Antimicrobial Stewardship Interventions
Microbiological data are used as indicators of infection, for diagnosis, and the identification
of antimicrobial resistance in trials of antimicrobial stewardship interventions. However, several
problems have been identified in a recently conducted systematic review (e.g., inconsistency in
reporting and oversimplified outcomes), which motivates the need to understand and improve the use
of these data including analysis and reporting. We engaged key stakeholders including statisticians,
clinicians from both primary and secondary care, and microbiologists. Discussions included issues
identified in the systematic review and questions about the value of using microbiological data in
clinical trials, perspectives on current microbiological outcomes reported in trials, and alternative
statistical approaches to analyse these data. Various factors (such as unclear sample collection process,
dichotomising or categorising complex microbiological data, and unclear methods of handling
missing data) were identified that contributed to the low quality of the microbiological outcomes and
the analysis of these outcomes in trials. Whilst not all of these factors would be easy to overcome,
there is room for improvement and a need to encourage researchers to understand the impact of
misusing these data. This paper discusses the experience and challenges of using microbiological
outcomes in clinical trials
