Ab1759-hpr the use of promis measures in clinical studies in patients with inflammatory arthritis: a systematic review

Background Patient-reported outcome measures (PROMs) are of vital importance to evaluate the outcomes of inflammatory arthritis and its management, but limitations of conventional PROMs include a lack of precision and/or comparability across conditions. Patient Reported Outcomes Measurement Information System (PROMIS) measures [1-2] were developed since 2007 to overcome these disadvantages. They use a standardized metric (T-score), centered around the general population (score 50), enhancing their interpretability. The use of PROMIS measures in patients with inflammatory arthritis was recommended by the International Consortium for Health Outcomes Measurement (ICHOM) [3], but little is known about the extent and nature of their actual use in clinical research. Objectives We aimed to describe the use and outcomes of PROMIS measures in clinical studies involving people with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA). Methods We conducted a systematic review according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. A search of nine electronic data bases on July 29th, 2022 was conducted to identify clinical studies in patients with RA or axSpA, reporting the use of PROMIS measures and written in English, Dutch or German. Study characteristics, details of PROMIS measures and, if available, their outcomes, were extracted. Both the selection and the data extraction were performed independently by two researchers and disagreements were resolved by consensus, either or not with a third researcher. Results In total, 714 records were retrieved (272 unique references), of which 29 studies met the inclusion criteria (25 RA, 3 axSpA and one both RA and axSpA). In total, 15 different PROMIS measures were used, 13 of which were domain-specific and 2 pertained to general health (PROMIS Global Health, PROMIS-29). The five most frequently used domain specific measures were the PROMIS Pain Interference (n=17), Physical Function (n=14), Fatigue (n=13), Depression (n=12) and Anxiety (n=7) measures. The general PROMIS Global Health and PROMIS-29 were both reported in 3 studies. The PROMIS measures that were used varied considerably, with a total of 74 unique identified measures, as a result of differences in their typology into Item Banks, Computer Adaptive Tests, Short Forms, the described name or the version number. In total, 21 studies reported on 98 PROMIS results in terms of T-scores, of which 91 were worse than the general population mean (score 50), indicating impaired health status. The other 8 studies did not report actual T-scores but psychometric properties of PROMIS measures (e.g. the validity, reliability, correlations with other questionnaires, responsiveness, meaningful change). Conclusion Given the availability of PROMIS measures since 2007 and the vast amount of clinical studies in RA and axSpA, PROMIS measures seem to be relatively underused. Among the studies there was considerable variety regarding the PROMIS measures that were used as well as their versions. The reported PROMIS outcomes overall reflected the impaired health status of patients with in RA and axSpA as compared to the general population. Apart from the promotion of the use of PROMIS measures, more standardization regarding the type of measures and their versions is needed to facilitate comparisons across studies. References [1]Cella et al. J Clin Epidemiol, 2010; 63, 1179-1194. [2]Evans et al. Patient Relat Outcome Meas, 2018; 9, 345-352. [3]Oude Voshaar et al. Arthritis Care and Research, 2018; 71(12). Acknowledgements This project is financially supported by Netherlands Organization for Health Research and Development (ZonMw; 852004019/ 852004018), Ministry of Health, Welfare and Sport (VWS), the Royal Dutch Society for Physical Therapy (KNGF) and the Dutch Arthritis Society (ReumaNederland). Disclosure of Interests None Declared.