Abstract
BackgroundDiverse 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.MethodsA 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.ResultsOf 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.ConclusionThis COS is recommended to be used in clinical trials aimed at improving AMS in care homes.
Highlights
Diverse outcomes reported in clinical trials of antimicrobial stewardship (AMS) interventions in care homes have hindered evidence synthesis
This study followed the Core Outcome Measures in Effectiveness Trials (COMET) and COSMIN guidelines to develop a core outcome set (COS) along with outcome measurement instrument (OMI) for use in clinical trials aimed at improving AMS in care homes
The aim of this study was to develop a COS for use in clinical trials aimed at improving AMS in care homes, this COS may be used to monitor AMS programmes implemented in care homes as part of everyday practice
Summary
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. High rates of antimicrobial prescribing, including inappropriate prescribing, have been reported in care homes [1, 2]. This issue may increase the risk of adverse drug events and antimicrobial resistance (AMR) amongst care home residents [2, 3]. The Core Outcome Measures in Effectiveness Trials (COMET) initiative has facilitated development of core outcome sets (COSs) to improve the quality and quantity of measured outcomes in research [8]. A COS is defined as a set of important outcomes which are agreed by consensus and should be measured to evaluate
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