Core Outcome Measures in Effectiveness Trials

Outcome Domains and Measures in Total Joint Replacement Clinical Trials: Can We Harmonize Them? An OMERACT Collaborative Initiative

General Information

Abstract:
OBJECTIVE: To develop a plan for harmonizing outcomes for people undergoing total joint replacement (TJR), to achieve consensus regarding TJR outcome research. METHODS: The TJR working group met during the 2014 Outcome Measures in Rheumatology (OMERACT) 12 meeting in Budapest, Hungary. Multiple conference calls preceded the face-to-face meeting. Brief presentations were made during a 1.5-h meeting, which included an overview of published systematic reviews of TJR trials and the results of a recent systematic review of TJR clinical trial outcome domains and measures. This was followed by discussion of potential core set areas/domains for TJR clinical trials (as per OMERACT Filter 2.0) as well as the challenges associated with the measurement of these domains. RESULTS: Working group participants discussed which TJR clinical trial outcome domains/areas map to the inner versus outer core for core domain set. Several challenges were identified with TJR outcomes including how to best measure function after TJR, elucidating the source of the pre- and post-TJR joint pain being measured, joint-specific versus generic quality of life instruments and the importance of patient satisfaction and revision surgery as outcomes. A preliminary core domain set for TJR clinical trials was proposed and included pain, function, patient satisfaction, revision, adverse events, and death. This core domain set will be further vetted with a broader audience. CONCLUSION: An international effort with active collaboration with the orthopedic community to standardize key outcome domains and measures is under way with the TJR working group. This effort will be further developed with new collaborations.

Authors:
Singh, J. A. Dohm, M. Sprowson, A. P. Wall, P. D. Richards, B. L. Gossec, L. Hawker, G. A. Riddle, D. L. Buchbinder, R.

Publication

Journal:
J Rheumatol
Volume:
42
Issue:
12
Pages:
2496 - 2502
Year:
2015
DOI:
Further Study Information

Date:
Not stated
Funding source(s):
JAS is supported by grants from the US Agency for Health Quality and Research Center for Education and Research on Therapeutics, National Institute of Arthritis, Musculoskeletal and Skin Diseases P50, National Institute of Aging U01, National Cancer Institute, the resources and the use of facilities at the Veterans Affair (VA) Medical Center at Birmingham, Alabama, and research contract CE-1304-6631 from the Patient Centered Outcomes Research. JAS has received research grants from Takeda and Savient and consultant fees from Savient, Takeda, Regeneron, and Allergan. JAS is a member of the American College of Rheumatology’s Guidelines Subcommittee of the Quality of Care Committee; the VA Rheumatology Field Advisory Committee; and the executive of OMERACT, an organization that develops outcome measures in rheumatology and receives arms-length funding from 36 companies.

Health Area

Disease Category
Rheumatology

Disease Name
Arthritis

Target Population

Age Range
-

Sex
Either


Nature / type of Intervention
Surgery

Method(s)

Literature review
Semi structured discussion
Teleconferences

The TJR working group met during the 2014 Outcome Measures in Rheumatology
(OMERACT) 12 meeting in Budapest, Hungary. Multiple conference calls preceded the face-to-face meeting. Brief presentations were made during a 1.5-h meeting, which included an overview of published systematic reviews of TJR trials and the results of a recent systematic review of TJR clinical trial outcome domains and measures. This was followed by discussion of potential core set areas/domains for TJR clinical trials (as per OMERACT Filter 2.0) as well as the challenges associated with the measurement of these domains.


Stakeholders Involved

Clinical experts
Methodologists
Patient/ support group representatives

Study Type

COS for clinical trials or clinical research

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