Patients and surgeons provide endorsement of core domains for total joint replacement clinical trials

Abstract Background Our objective in this study was to examine whether stakeholders further endorse the core domain set proposed by the Outcome Measures in Rheumatology Trials (OMERACT) total joint replacement (TJR) working group. Methods We emailed a survey to 3810 hip/knee arthroplasty patients and 49 arthroplasty surgeons at a high-volume arthroplasty center to rate the importance of each core domain (i.e., pain, function, patient satisfaction, revision surgery, adverse events, and death) and two additional domains (i.e., cost and participation). Ratings were on a 1–9 scale, with 1–3 indicating limited or no importance for patients, 4–6 being important but not critical, and 7–9 being critical. We calculated median (IQR) values and compared ratings by sex, age, and participant type using the Wilcoxon rank-sum test. Results The questionnaire was completed by 1295 patients (34%) and 21 surgeons (43%). Patient nonresponders were similar to responders in age (≥55 years, 85.7% vs. 88.6%), sex (female, 57.5% vs. 57.3%), and joint procedure (total hip replacement, 56.9% vs. 63.2%). Overall, all core domains and one noncore domain (i.e., participation) were confirmed as “critical” by both stakeholder groups. Cost was rated as only “important” but not “critical” by surgeons. A completed consensus for all the core domains persisted even when we stratified by sex, age, arthritis type, and the affected joint (knee vs. hip). We received suggestions for additional critical domains from 217 patients and 5 surgeons, prompting the inclusion of 2 research agenda items. Conclusions Our study confirmed a consensus rating of the OMERACT TJR core domain set as critical for patients. This broad endorsement should encourage the identification of candidate outcome instruments to further develop a TJR core measurement set that can harmonize reporting in TJR clinical trials

Toward a Core Domain Set for Glucocorticoid Impact in Inflammatory Rheumatic Diseases: The OMERACT 2018 Glucocorticoid Impact Working Group

Objective: To understand the effects of glucocorticoids (GC), which are of importance to patients. Methods: The results of 2 literature reviews, a patient survey, and a qualitative study were presented. Results: No validated instrument exists to evaluate GC effect on patients. Survey data revealed skin thinning/bruising, sleep disturbance, and weight gain as the most frequent adverse effects. The qualitative research yielded rich data covering rapid benefits and physical and emotional consequences of GC. Conclusion: It was agreed that a patient-reported outcome to measure GC effect was required and a research agenda was developed for this goal