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

<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Patient‐reported outcome measures (<jats:styled-content style="fixed-case">PROM</jats:styled-content>s) 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 <jats:styled-content style="fixed-case">PROM</jats:styled-content> development</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>This article reviews in what ways and to what extent patients are involved in <jats:styled-content style="fixed-case">PROM</jats:styled-content> development and whether patient involvement has increased over time.</jats:p></jats:sec><jats:sec><jats:title>Search strategy</jats:title><jats:p>Literature was searched in <jats:styled-content style="fixed-case">P</jats:styled-content>ub<jats:styled-content style="fixed-case">M</jats:styled-content>ed, <jats:styled-content style="fixed-case">EMBASE</jats:styled-content>,<jats:styled-content style="fixed-case"> MEDLINE</jats:styled-content> and the Cochrane Methodology Register.</jats:p></jats:sec><jats:sec><jats:title>Inclusion criteria</jats:title><jats:p>Studies were included if they described a new <jats:styled-content style="fixed-case">PROM</jats:styled-content> development.</jats:p></jats:sec><jats:sec><jats:title>Data extraction</jats:title><jats:p>Basic information and information regarding patient involvement in development phases was recorded.</jats:p></jats:sec><jats:sec><jats:title>Main results</jats:title><jats:p>A total of 189 studies, describing the development of 193 <jats:styled-content style="fixed-case">PROM</jats:styled-content>s, were included. Most <jats:styled-content style="fixed-case">PROM</jats:styled-content>s were meant for chronic disease patients (<jats:italic>n</jats:italic> = 59) and measured quality of life (<jats:italic>n</jats:italic> = 28). In 25.9% of the <jats:styled-content style="fixed-case">PROM</jats:styled-content> 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 <jats:styled-content style="fixed-case">PROM</jats:styled-content>s, but in only 6.7% patients were involved in all aspects of the development. Patient involvement did not increase with time.</jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p>Although patient involvement in <jats:styled-content style="fixed-case">PROM</jats:styled-content> development is essential to develop valid patient‐centred <jats:styled-content style="fixed-case">PROM</jats:styled-content>s, 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 <jats:styled-content style="fixed-case">PROM</jats:styled-content> development is necessary.</jats:p></jats:sec>