Patient involvement in the development of patient-reported outcome measures: a scoping review

Background Patient-reported outcome measures (PROMs) measure patients' perspectives on health outcomes and are increasingly used in health care. To capture the patient's perspective, it is essential that patients are involved in PROM development Objective This article reviews in what ways and to what extent patients are involved in PROM development and whether patient involvement has increased over time. Search strategy Literature was searched in PubMed, EMBASE, MEDLINE and the Cochrane Methodology Register. Inclusion criteria Studies were included if they described a new PROM development. Data extraction Basic information and information regarding patient involvement in development phases was recorded. Main results A total of 189 studies, describing the development of 193 PROMs, were included. Most PROMs were meant for chronic disease patients (n = 59) and measured quality of life (n = 28). In 25.9% of the PROM development studies, no patients were involved. Patients were mostly involved during item development (58.5%), closely followed by testing for comprehensibility (50.8%), while patient involvement in determining which outcome to measure was minimal (10.9%). Some patient involvement took place in the development of most PROMs, but in only 6.7% patients were involved in all aspects of the development. Patient involvement did not increase with time. Conclusions Although patient involvement in PROM development is essential to develop valid patient-centred PROMs, patients are not always involved. When patients are involved, their level of involvement varies considerably. These variations suggest that further attention to building and/or disseminating consensus on requirements for patient involvement in PROM development is necessary.