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

Bianca Wiering,Dolf De Boer,Diana Delnoij

doi:10.1111/hex.12442

Abstract

BackgroundPatient‐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 developmentObjectiveThis article reviews in what ways and to what extent patients are involved in PROM development and whether patient involvement has increased over time.Search strategyLiterature was searched in PubMed, EMBASE, MEDLINE and the Cochrane Methodology Register.Inclusion criteriaStudies were included if they described a new PROM development.Data extractionBasic information and information regarding patient involvement in development phases was recorded.Main resultsA 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.ConclusionsAlthough 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.

Highlights

Patient-reported outcome measures (PROMs) assess health outcomes from the patients’ perspective.[1,2] PROMs were originally developed for the use in clinical research as a way to measure treatment effectiveness
Conclusions patient involvement in PROM development is essential to develop valid patient-centred PROMs, patients are not always 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
PROMs are increasingly used in clinical practice to monitor and to improve the care for individual patients and in health policy and management, for example in the English National Health Service (NHS), to measure the performance of health-care providers[2,3] or by the American Centres for Medicare and Medicaid Services (CMS) to award incentive payments for eligible professionals.[4]

Summary

Introduction

Patient-reported outcome measures (PROMs) assess health outcomes from the patients’ perspective.[1,2] PROMs were originally developed for the use in clinical research as a way to measure treatment effectiveness. To truly capture the patient’s perspective, it is essential that patients are involved in PROM development,[5,6,7,8,9] as only patients can determine which health outcomes are relevant for them[9,10,11] and whether the questionnaire captures these outcomes in a comprehensible and understandable manner.[12,13,14,15] Besides, if a questionnaire fails to represent the patients’ perspective, it may result in patients failing to complete the questionnaire and a negative impact on the validity.[16] Only a few studies investigated patient involvement in the development of PROMs, and only for a small number of PROMs, or for a specific disease.[7,17] there are concerns that there are many PROMs in use where no patients were involved during the development process. To capture the patient’s perspective, it is essential that patients are involved in PROM development

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