Core Outcome Measures in Effectiveness Trials

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

General Information

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.

Authors:
Hoang, 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.

Publication

Journal:
Arthritis Res Ther
Volume:
19
Issue:
1
Pages:
267 -
Year:
2017
DOI:
Further Study Information

Date:
January 2016 - 2017
Funding source(s):
JAS has received research grants from Takeda Pharmaceuticals and Savient Pharmaceuticals and consultant’s fees from Savient Pharmaceuticals, Takeda Pharmaceuticals, Regeneron Pharmaceuticals, Merz Pharmaceuticals, Iroko Pharmaceuticals, Bioibérica, Crealta/Horizon Pharma, Allergan, WebMD, UBM LLC, and the American College of Rheumatology (ACR). JAS serves as the principal investigator for an investigator-initiated study funded by Horizon Pharma through a grant to DINORA, Inc., a 501(c)(3) entity. JAS is a member of the executive committee of OMERACT, an organization that develops outcome measures in rheumatology and receives arm’s-length funding from 36 companies; a member of the ACR Annual Meeting Planning Committee; chair of the ACR Meet-the-Professor, Workshop and Study Group Subcommittee; and a member of the Veterans Affairs Rheumatology Field Advisory Committee. JAS is the editor and director of the University of Alabama at Birmingham Cochrane Musculoskeletal Group Satellite Center on Network Meta-analysis

Health Area

Disease Category
Rheumatology

Disease Name
Arthritis

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

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.


Stakeholders Involved

Clinical experts
Consumers (patients)

Study Type

COS for clinical trials or clinical research
Patient perspectives
Prioritising

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