Literature DB >> 25834208

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

Jasvinder A Singh1, Michael Dohm1, Andrew P Sprowson1, Peter D Wall1, Bethan L Richards1, Laure Gossec1, Gillian A Hawker1, Daniel L Riddle1, Rachelle Buchbinder1.   

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.

Entities:  

Keywords:  ARTHROPLASTY; CONSENSUS; DOMAINS; HARMONIZATION; OUTCOME MEASURES; TOTAL JOINT REPLACEMENT

Mesh:

Year:  2015        PMID: 25834208     DOI: 10.3899/jrheum.141201

Source DB:  PubMed          Journal:  J Rheumatol        ISSN: 0315-162X            Impact factor:   4.666


  12 in total

Review 1.  Incorporating the patient's perspective in outcomes research.

Authors:  Betty Hsiao; Liana Fraenkel
Journal:  Curr Opin Rheumatol       Date:  2017-03       Impact factor: 5.006

2.  Validation of the Hip Disability and Osteoarthritis Outcome Score and Knee Injury and Osteoarthritis Outcome Score Pain and Function Subscales for Use in Total Hip Replacement and Total Knee Replacement Clinical Trials.

Authors:  Susan M Goodman; Bella Y Mehta; Lisa A Mandl; Jackie D Szymonifka; Jackie Finik; Mark P Figgie; Iris Y Navarro-Millán; Mathias P Bostrom; Michael L Parks; Douglas E Padgett; Alexander S McLawhorn; Vinicius C Antao; Adolph J Yates; Bryan D Springer; Stephen L Lyman; Jasvinder A Singh
Journal:  J Arthroplasty       Date:  2019-12-27       Impact factor: 4.757

3.  Validation of the Mayo Hip Score: construct validity, reliability and responsiveness to change.

Authors:  Jasvinder A Singh; Cathy Schleck; W Scott Harmsen; David G Lewallen
Journal:  BMC Musculoskelet Disord       Date:  2016-01-19       Impact factor: 2.362

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

Authors:  Anh Hoang; Susan M Goodman; Iris Y Navarro-Millán; Lisa A Mandl; Mark P Figgie; Mathias P Bostrom; Douglas E Padgett; Peter K Sculco; Alexander S McLawhorn; Jasvinder A Singh
Journal:  Arthritis Res Ther       Date:  2017-12-06       Impact factor: 5.156

Review 5.  Do outcomes reported in randomised controlled trials of joint replacement surgery fulfil the OMERACT 2.0 Filter? A review of the 2008 and 2013 literature.

Authors:  Peter D H Wall; Bethan L Richards; Andrew Sprowson; Rachelle Buchbinder; Jasvinder A Singh
Journal:  Syst Rev       Date:  2017-05-30

6.  Patient Endorsement of the Outcome Measures in Rheumatology (OMERACT) Total Joint Replacement (TJR) clinical trial draft core domain set.

Authors:  Jasvinder A Singh; Michelle Dowsey; Peter F Choong
Journal:  BMC Musculoskelet Disord       Date:  2017-03-15       Impact factor: 2.362

7.  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.

Authors:  Jasvinder A Singh; Michael Dohm; Peter F Choong
Journal:  BMC Musculoskelet Disord       Date:  2017-01-26       Impact factor: 2.362

8.  Patient, physiotherapist and surgeon endorsement of the core domain set for total hip and total knee replacement in Germany: a study protocol for an OMERACT initiative.

Authors:  Robert Prill; Jasvinder A Singh; Gesine H Seeber; Sabrina Mai Nielsen; Susan Goodman; Sven Michel; Christian Kopkow; Robert Schulz; Peter Choong; Hagen Hommel
Journal:  BMJ Open       Date:  2020-06-28       Impact factor: 2.692

9.  Core outcome set for uncomplicated acute appendicitis in children and young people.

Authors:  F C Sherratt; B S R Allin; J J Kirkham; E Walker; B Young; W Wood; L Beasant; S Eaton; N J Hall
Journal:  Br J Surg       Date:  2020-03-17       Impact factor: 6.939

10.  Definitions of poor outcome after total knee arthroplasty: an inventory review.

Authors:  Malou E M Te Molder; José M H Smolders; Petra J C Heesterbeek; Cornelia H M van den Ende
Journal:  BMC Musculoskelet Disord       Date:  2020-06-13       Impact factor: 2.362

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