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Introduction Validated patient-reported outcome measures (PROMs) are crucial for assessing patients’ experiences in the healthcare system. Both clinically and theoretically, patient-centered consultations are essential in patient-care, and are often suggested as the optimal strategy in caring for patients with multimorbidity. Aim To either identify or develop and validate a patient-reported outcome measure (PROM) to assess patient-centredness in consultations for patients with multimorbidity in general practice. Methods We attempted to identify an existing PROM through a systematic literature review. If a suitable PROM was not identified, we planned to (1) construct a draft PROM based on items from existing PROMs, (2) conduct group and individual interviews among members of the target population to ensure comprehensibility, comprehensiveness and relevance, and (3) perform a psychometric validation in a broad sample of patients from primary care. Results We did not identify an eligible PROM in the literature review. The item extraction and face validity meetings resulted in a new PROM consisting of 47 items divided into five domains: biopsychosocial perspective; `patient-as-person’; sharing power and responsibility; therapeutic alliance; and coordinated care. The interviews resulted in a number of changes to the layout and phrasing as well as the deletion of items. The PROM used in the psychometric validation consisted of 28 items. Psychometric validation showed high internal consistency, overall high reliability, and moderate fit indices in the confirmatory factor analysis for all five domains. Few items demonstrated differential item functioning concerning variables such as age, sex, and education. Conclusions This study successfully developed and validated a PROM to measure patient-centredness in consultations for patients with multimorbidity. The five domains demonstrated high reliability and validity, making it a valuable tool for measuring patient-centredness of consultations in general practice. Trial registration Trial registration number (data for psychometric validation): https://clinicaltrials.gov : NCT05676541 Registration Date: 2022-12-16.

IntroductionThis study aimed to either identify or develop and validate a patient-reported outcome measure (PROM) to assess treatment burden related to general practice for patients with multimorbidity, which can be used alongside the MultiMorbidity Questionnaire part 1 (MMQ1) without overwhelming the target population with redundant items.MethodsWe conducted a systematic literature review to identify all existing PROMs measuring treatment burden. If no suitable PROM was found, our plan was to: (1) develop a draft PROM using items from existing instruments, (2) carry out group and individual interviews with patients with multimorbidity to ensure the PROM’s understandability, clarity, completeness and relevance and (3) undertake psychometric validation with a diverse sample of primary care patients with chronic conditions.ResultsWe did not identify an eligible PROM in the literature review. The draft PROM consisted of 30 items divided into six domains; Information about treatment, Challenges with medication, Medical appointments, Self-monitoring, Health behaviour and Challenges in the contact to the health system. In the psychometric validation, neither these domains nor any other theoretical constellation of items had adequate psychometric properties. Individual items had good criterion validity and sensitivity to change.ConclusionsIn this study, we developed a 30-item PROM with high content validity where various individual items showed adequate criterion validity and sensitivity to change, making these items useful as a supplemental measure to the MMQ1.Trial registration number NCT05676541 Registration Date: 16 December 2022.