Towards use of Patient-informed Relevant Outcomes (PRO) in trials of bloodstream infections: a mixed-methods study protocol (BALANCE+PRO)

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INTRODUCTION: Bloodstream infections (BSIs) are a major cause of morbidity and mortality worldwide. Although recent clinical trials have increasingly adopted patient-centred outcome measures, patient-informed selection of outcome measures remains limited in infectious disease research. Greater deliberate engagement and partnership with patients and families are required to ensure that outcomes reflect priorities that are meaningful to those with lived experience. Our study aims to incorporate patient-informed perspectives into outcome selection for BSI clinical trials. METHODS AND ANALYSIS: We will undertake an exploratory sequential mixed methods study nested with the currently running international BALANCE+ trial of Gram-negative BSI (NCT06537609). All study materials will be co-developed and piloted with patient partners. Phase I will consist of virtual focus groups with past patient and family member participants of the BALANCE+ trial from intensive care and ward settings (total of 24-40 participants), using purposive sampling to maximise variation across demographic characteristics. Data will be audio-recorded and transcribed verbatim and analysed thematically using dual independent coding and consensus methods. Phase II will encompass development and administration of a survey (total ~100 respondents) to rank and prioritise outcomes identified in phase I, with responses descriptively summarised and integrated with qualitative findings. In phase III, virtual meetings with relevant parties including patients/families and investigators/study team members in the infectious disease field will be held to generate consensus-based recommendations and inform implementations with BALANCE+ and future trials. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the University of Calgary for all study activities and participating BALANCE+ sites to enable recruitment. Study findings will be disseminated through peer-reviewed publications, community engagement, conference presentations and integration into ongoing and future trials.

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