Assessing patient engagement approaches in the development of patient reported outcome measures

Guidelines for the development and validation of patient-reported outcome measures recommend incorporating patient input to ensure relevance and comprehension, but do not clearly define what patient input entails. As a result, meaningful patient engagement is often conflated with research participation. This study uses the adaptation and validation of the FACE-Q Craniofacial Module patient-reported outcome measure for ophthalmology patients as a case study to showcase how patients can be engaged as partners across the different phases of patient-reported outcome measure adaptation, and illustrate how their involvement influenced the adaptation process. Patient engagement strategies across five phases of the adaptation and validation of the FACE-Q Craniofacial Module (Study development, Item adaptation, Item reduction, Psychometric evaluation, and Dissemination) were retrospectively mapped to the International Association for Public Participation Spectrum. This framework outlines five levels of engagement: Inform, Consult, Involve, Collaborate, and Empower, and was used to evaluate the extent and nature of engagement. Patient partners (n = 8) with lived experience of retinoblastoma, strabismus, corneal anesthesia, and ocular prostheses were engaged across the five phases of the study. Mapping engagement activities to the International Association for Public Participation Spectrum revealed that the “Inform” and “Involve” levels of engagement were present in all five phases. The most extensive engagement, spanning all levels of the International Association for Public Participation Spectrum, occurred during the “Item Reduction” and “Dissemination” phases of the study. The current case study showcases that patient engagement can be incorporated intentionally across all phases of patient-reported outcome measure adaptation and validation. The International Association for Public Participation Spectrum provided a structured approach to map and document the nature and extent of engagement across our study. Our case study may support the planning, execution, and reporting of patient engagement strategies in future patient-reported outcome measure development and adaptation studies.