Towards Consensus on the Reporting of Core Outcome Domains in Total Joint Replacement Clinical Trials: The Derivation of the Preliminary Core Outcome Domain Set

Objective.Discussion and endorsement of the OMERACT total joint replacement (TJR) core domain set for total hip replacement (THR) and total knee replacement (TKR) for endstage arthritis; and next steps for selection of instruments.Methods.The OMERACT TJR working group met at the 2016 meeting at Whistler, British Columbia, Canada. We summarized the previous systematic reviews, the preliminary OMERACT TJR core domain set and results from previous surveys. We discussed preliminary core domains for TJR clinical trials, made modifications, and identified challenges with domain measurement.Results.Working group participants (n = 26) reviewed, clarified, and endorsed each of the inner and middle circle domains and added a range of motion domain to the research agenda. TJR were limited to THR and TKR but included all endstage hip and knee arthritis refractory to medical treatment. Participants overwhelmingly endorsed identification and evaluation of top instruments mapping to the core domains (100%) and use of subscales of validated multidimensional instruments to measure core domains for the TJR clinical trial core measurement set (92%).Conclusion.An OMERACT core domain set for hip/knee TJR trials has been defined and we are selecting instruments to develop the TJR clinical trial core measurement set to serve as a common foundation for harmonizing measures in TJR clinical trials.

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

Arthritis Research & Therapy ◽

10.1186/s13075-017-1476-9 ◽

2017 ◽

Vol 19 (1) ◽

Cited By ~ 11

Author(s):

Anh Hoang ◽

Susan M. Goodman ◽

Iris Y. Navarro-Millán ◽

Lisa A. Mandl ◽

Mark P. Figgie ◽

...

Keyword(s):

Clinical Trials ◽

Joint Replacement ◽

Total Joint Replacement

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Consensus on draft OMERACT core domains for clinical trials of Total Joint Replacement outcome by orthopaedic surgeons: a report from the International consensus on outcome measures in TJR trials (I-COMiTT) group

BMC Musculoskeletal Disorders ◽

10.1186/s12891-017-1409-4 ◽

2017 ◽

Vol 18 (1) ◽

Cited By ~ 8

Author(s):

Jasvinder A. Singh ◽

Michael Dohm ◽

Peter F. Choong

Keyword(s):

Clinical Trials ◽

Outcome Measures ◽

Joint Replacement ◽

Total Joint Replacement ◽

International Consensus ◽

Orthopaedic Surgeons

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

The Journal of Rheumatology ◽

10.3899/jrheum.141201 ◽

2015 ◽

Vol 42 (12) ◽

pp. 2496-2502 ◽

Cited By ~ 22

Author(s):

Jasvinder A. Singh ◽

Michael Dohm ◽

Andrew P. Sprowson ◽

Peter D. Wall ◽

Bethan L. Richards ◽

...

Keyword(s):

Clinical Trial ◽

Clinical Trials ◽

Patient Satisfaction ◽

Joint Replacement ◽

Working Group ◽

Total Joint Replacement ◽

Core Domain ◽

Trial Outcome ◽

Clinical Trial Outcome ◽

Core Domain Set

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.

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OARSI/OMERACT Criteria of Being Considered a Candidate for Total Joint Replacement in Knee/Hip Osteoarthritis as an Endpoint in Clinical Trials Evaluating Potential Disease Modifying Osteoarthritic Drugs

The Journal of Rheumatology ◽

10.3899/jrheum.090365 ◽

2009 ◽

Vol 36 (9) ◽

pp. 2097-2099 ◽

Cited By ~ 20

Author(s):

MAXIME DOUGADOS ◽

GILLIAN HAWKER ◽

STEFAN LOHMANDER ◽

AILEEN M. DAVIS ◽

PAUL DIEPPE ◽

...

Keyword(s):

Clinical Trials ◽

Joint Replacement ◽

Total Joint Replacement ◽

Task Force ◽

Joint Space Width ◽

Hip Osteoarthritis ◽

Joint Space ◽

Systematic Research ◽

Disease Modifying ◽

Space Width

Objective.A disease-modifying osteoarthritic drug (DMOAD) should interfere with the cartilage breakdown observed and improve symptoms or prevent deterioration of the patient’s clinical condition. We propose a composite index including structural and symptomatic variables of osteoarthritis (OA) as criteria for being considered a candidate for total joint replacement as an endpoint in clinical trials evaluating potential DMOAD.Methods.An OARSI/OMERACT task force conducted this study in 3 steps: (1) The 3 main domains — pain, function, structure — were revisited; (2) For each of the domains a “non-acceptable state” and a “relevant” progression for their structure were defined; and (3) a set of criteria was proposed combining the information from these 3 domains.Results.A questionnaire was elaborated for the domains “pain” and “function.” Systematic research of the literature and evaluation of different databases concluded that the domain “structure” should be evaluated by radiological joint space width in millimeters. An unacceptable radiographic progression was defined as a change in the joint space width over the measurement error. An international, cross-sectional study is proposing a definition of a “nonacceptable symptom state.”Conclusion.The objective of the ongoing OARSI/OMERACT initiative is to propose criteria for being considered a candidate for total joint replacement to be used as an endpoint in clinical trials evaluating potential DMOAD. The preliminary steps of this initiative have been completed.

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