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.
ContributorsHoang, A. Goodman, S. M. Navarro-Millan, I. Y. Mandl, L. A. Figgie, M. P. Bostrom, M. P. Padgett, D. E. Sculco, P. K. McLawhorn, A. S. Singh, J. A.
Disease Category: Rheumatology
Disease Name: Arthritis
Age Range: Unknown
Sex: Either
Nature of Intervention: Surgery
- Clinical experts
- Consumers (patients)
- COS for clinical trials or clinical research
- Patient perspectives
- Prioritising
- Survey
We emailed a survey to all eligible patients who had undergone a primary hip or knee TJR in 2015 and had a valid email address available in the electronic health record, as well as to orthopedic surgeons at the Hospital for Special Surgery (HSS), a high-volume orthopedic center of excellence. Patients who had undergone either a bilateral hip or bilateral knee TJR in 2015 or more than one TJR (any joint) in 2015 were excluded. Patients who had undergone subsequent TJRs any time before administration of the survey in 2016 and 2017 were also excluded. To improve the response rate, after the initial administration of the survey, patients and surgeons were sent reminders every week for 3 weeks. The eligible participants were asked to rate the importance of the six core domains on their own merit, without having to prioritize them. The participants were also asked to rate the importance of two optional areas:cost and patient participation in work and social activities. These additional domains were previous candidates for core domains, but after rounds of deliberations and discussions, these two areas were regarded as noncore Unlike the core domain set, these additional domains were not meant to be reported in every TJR clinical trial. Ratings for each domain 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.