A FeAsibility items Checklist for assessing implementation characTeristics of patient-reported Outcome measures in Research, Regulation and Routine clinical care (FACTOR3): Development and evaluation

Study objective: Patient-reported outcome measures (PROMs) provide valuable data to inform regulatory decision making, health technology assessment and routine clinical care. We aimed to develop a feasibility item checklist for PROMs and their selection, beyond their psychometric properties (FACTOR3). Methods: We followed a five-stage method to select parameters for PROM evaluation. 1) A scoping literature review identified candidate items for consideration; 2) round 1 modified Delphi was used to select items for inclusion or exclusion, conducted by the design group (n = 14); 3) feedback on the checklist was provided by representatives from the European Medicines Agency and National Institute for Health and Care Excellence; 4) round 2 modified Delphi was used to finalise item selection, conducted by the clinical domains group (n = 21) and 5) evaluation of the feasibility item checklist using a selection of PROMS (EQ5D-5L, HeartQOL, the Oxford Hip Score, The EORTC Core Questionnaire QLQ-C30, Re-QOL-10 and NEI-VFQ-25) (Fig. 1). Results: The scoping review identified 13 items relating to the intrinsic feasibility of using PROMs which were considered in the modified Delphi. The final FACTOR3 checklist included eight unique candidate items: price; licensing, comprehensibility, duration, coverage, translations, electronic device compatibility; and minimal important difference. Of the six PROMS evaluated, the intraclass correlation coefficient was 0.81, suggesting good reliability. Conclusions: FACTOR3 is a feasibility item checklist to assess the implementation characteristics of PROMs in research, regulation and routine clinical care. It may be used in conjunction with existing psychometric evaluation and user guides for PROMS to facilitate their use in health care.