Core Patient-Reported Outcomes (PROs) and PRO Measures (PROMs) for Polypharmacy Medicines Reviews: A Sequential Mixed-Methods Study

PURPOSE: Problematic polypharmacy can exaggerate “medicine burden” for the patient. Patient-reported outcomes (PROs) are key indicators of medicine burden, and PRO measures (PROMs) can help patients articulate their perceptions of medicine burden. We aimed to: (a) evaluate what PROMs currently exist that assess medicine burden, and what PROs they target, and (b) understand patients’ experiences with using multiple medicines to establish a core set of most meaningful and relevant PROs for assessment in polypharmacy medicines reviews. PATIENTS AND METHODS: We conducted a prospective, sequential mixed-methods study in two consecutive work phases. Phase 1 involved a rapid review of PROMs, informed by the published PRISMA and COSMIN initiative guidelines. We integrated all evidence in a thematic narrative synthesis. Phase 2 involved cross-sectional, one-to-one, semi-structured interviews with key stakeholders, including members of the public and healthcare professionals (HCPs). We conducted thematic content analysis to identify and classify emerging PROs. RESULTS: In Phase 1, 13 studies described the development and/or validation of 12 PROMs. The PROMs targeted 14 content domains of adult patients’ experiences with prescribed medicines. PROMs varied widely in terms of length, comprehensiveness and psychometric robustness. In Phase 2, all participants (seven members of the public; eight HCPs) agreed on the clinical relevance of PROMs, providing a rich account of justifications. We identified four core PROs: ‘Knowledge, information and communication about own medicines’; “Perceptions, views and attitudes about (own) medicines”; “Impact on daily living: Side-effects and practicalities”, and “Medicine usage: ‘as planned’, misuse, abuse, no use”. CONCLUSION: We suggest combining psychometrically robust PROMs or domains across PROMs into a bespoke PROM that addresses comprehensively and succinctly the four core PROs. We recommend a careful implementation process that must involve consultation with all relevant stakeholders, while establishing a clear purpose for collecting a PROM and realistic and ongoing collection at key time-points.