Using patient and care partner experiences to confirm outcomes of relevance for inclusion in a core outcome set for trials of physical rehabilitation in critical illness: A qualitative interview study

Abstract

Background: Incorporating the perspectives of patients and care partners is crucial in the development of core outcome sets. One effective approach for achieving this involvement is by seeking input to refine the outcomes for consensus. The objectives of the study were to: i) to determine patient and care partner views on outcomes that should be measured in trials of physical rehabilitation interventions across the critical illness recovery continuum; (ii) to map these views with a pre-established list of thirty outcomes for potential inclusion in a core outcome set for these trials; and (iii) to identify any new outcomes that could be considered for inclusion.

Methods: A qualitative semistructured telephone interview study was conducted with a convenience sample of post-critical illness patients and care partners, as part of core outcome set development work. Anonymised interview transcripts were analysed using a framework approach, and exemplary narrative quotes from participants were reported used to illustrate outcome reporting.

Findings: Fourteen participants were recruited (male:female ratio = 8:6, age range [minimum-maximum]: 50-80 years, 13 former patients, one spouse). Time since intensive care unit discharge ranged from less than 1 year to 10 years at the time of interview. Participants described a range of outcomes that could be measured in trials of physical rehabilitation after critical illness that mapped closely with the pre-established list. No new outcomes were introduced by participants during the interviews. Experiences described by participants commonly reflected outcomes related to physical ability and performance, functional level, activities of daily living, and emotional and mental wellbeing. Participants spoke to how the different outcomes directly impacted their day-to-day lives and highlighted their priorities centred around resumption of tasks and activities that had value to them at personal, functional, and societal level.

Conclusion: Qualitative interviews confirmed the relevance of existing outcomes for potential inclusion in a core outcome set for trials of physical rehabilitation interventions across the critical illness recovery continuum. The added significance of our findings is to provide real-world meaning to these outcomes.

Registration: COMET Initiative, ID288, https://www.comet-initiative.org/studies/details/288.

Keywords: Core outcome set; Critical illness; Experience; Interview; Outcomes; Physical rehabilitation; Qualitative; Recovery.