Perspectives of statistician, microbiologist, and clinician stakeholders on the use of microbiological outcomes in randomised trials of antimicrobial stewardship interventions

Lau, Tin, Gillespie, David ORCID: https://orcid.org/0000-0002-6934-2928, Hood, Kerenza ORCID: https://orcid.org/0000-0002-5268-8631, Daniel, Rhian ORCID: https://orcid.org/0000-0001-5649-9320, Hughes, Kathryn ORCID: https://orcid.org/0000-0002-8099-066X, Stuart, Beth, Hayward, Gail, Szakmany, Tamas ORCID: https://orcid.org/0000-0003-3632-8844 and Gillespie, David ORCID: https://orcid.org/0000-0002-6934-2928 2023. Perspectives of statistician, microbiologist, and clinician stakeholders on the use of microbiological outcomes in randomised trials of antimicrobial stewardship interventions. Antibiotics , 885. 10.3390/antibiotics12050885

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Abstract

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.

Item Type:	Article
Date Type:	Published Online
Status:	Published
Schools:	Medicine
Date of First Compliant Deposit:	19 May 2023
Date of Acceptance:	6 May 2023
Last Modified:	26 May 2023 05:46
URI:	https://orca.cardiff.ac.uk/id/eprint/159680

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