Development of a core outcome set for clinical trials aimed at improving antimicrobial stewardship in care homes

Abstract

Background: Diverse outcomes reported in clinical trials of antimicrobial stewardship (AMS) interventions in care homes have hindered evidence synthesis. Our main objective was to develop a core outcome set (COS) for use in trials aimed at improving AMS in care homes. Methods: A refined inventory of outcomes for AMS interventions in care homes, compiled from a previous study, was rated in a three-round international Delphi survey with 82 participants, using a nine-point Likert scale (from 1, unimportant, to 9, critical). This was followed by an online consensus exercise with 12 participants from Northern Ireland to finalise the COS content. Subsequently, a suitable outcome measurement instrument (OMI) was selected for each outcome in the COS by: identifying existing OMIs through a literature search and experts’ suggestions, assessing the quality of OMIs, and selecting one OMI for each core outcome via a two-round international Delphi survey with 59 participants. Results: Of 14 outcomes initially presented, consensus was reached for inclusion of five outcomes in the COS after the three-round Delphi survey and the online consensus exercise, comprising the total number of antimicrobial courses prescribed, appropriateness of antimicrobial prescribing, days of therapy per 1000 resident-days, rate of antimicrobial resistance, and mortality related to infection. Of 17 potential OMIs identified, three were selected for the two-round Delphi exercise after the quality assessment. Consensus was reached for selection of two OMIs for the COS. Conclusion: This COS is recommended to be used in clinical trials aimed at improving AMS in care homes.