Development of a set of patient-centred outcome measures for patients with major injury: Delphi-based consensus recommendations from the International Consortium for Health Outcomes Measurement Major Injury Working Group

Background
Major injury contributes substantially to global morbidity and mortality, yet outcome measurement remains inconsistent. Development of a standardised set of patient-centred outcome measures for adults with major injuries has the potential to improve global benchmarking, quality of care and patient-centre value-based healthcare.
Methods
An international multidisciplinary working group of 28 experts and patient representatives from 11 countries (3 middle- and 8 high income) was convened. Following International Consortium for Health Outcomes Measurement methodology, a structured consensus-driven process was used, which included literature reviews, three modified Delphi rounds, and validation surveys. The target population included adult patients receiving acute care for physical injuries with an Injury Severity Score ≥9. Literature searches (Apr 16, 2005–Jun 1, 2024) in PubMed, MEDLINE, Embase.com, PsychINFO, CINAHL, and ProQuest identified relevant outcomes, measures, case-mix variables, and follow-up timepoints. Consensus on inclusion required ≥80% of members rating outcomes 7–9 on a 9-point scale. The Delphi process ran from Jul 3 to Nov 13, 2024, with patient and professional validation surveys respectively conducted between Dec 5, 2024 and Mar 28, 2025 and between Mar 5, and 28, 2025.
Findings
Seventy-two percent (n = 20) of members participated in eight calls, and 68% (n = 19) in nine surveys. The final set includes 26 outcomes (22 patient-reported, 4 clinician-reported) across four domains: patient-reported health status, functioning, psychological wellbeing and mental health, and clinical outcomes. Six patient-reported outcome measures and four injury-specific tools were endorsed. Thirty case-mix variables were identified, with measurement at baseline (as soon as possible after the injury, conditional upon the clinical stability of and safety for the patient), 6 months, and 12 months. Validation surveys with patients (n = 121) and professionals (n = 70) confirmed relevance and comprehensiveness, with >83% (n = 159) agreement on core domains. A primary subset of essential outcome measures was defined to facilitate implementation.
Interpretation
To our knowledge, this is the first international consensus-derived outcome set for major injury, supporting benchmarking of care, of outcomes of importance to patients and clinicians. We acknowledge the lack of representation from low-resource countries or regions in the working group and patient survey. Further implementation and feasibility testing are needed to ensure applicability across diverse populations, health systems and settings (e.g. military). In particular, validation in low- and middle-income settings is needed to ensure equity, feasibility and cultural relevance.