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

2015 ◽  
Vol 42 (12) ◽  
pp. 2496-2502 ◽  
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.

Achieving Consensus on Total Joint Replacement Trial Outcome Reporting Using the OMERACT Filter: Endorsement of the Final Core Domain Set for Total Hip and Total Knee Replacement Trials for Endstage Arthritis

2017 ◽  
Vol 44 (11) ◽  
pp. 1723-1726 ◽  
Author(s):  
Jasvinder A. Singh ◽  
Michelle M. Dowsey ◽  
Michael Dohm ◽  
Susan M. Goodman ◽  
Amye L. Leong ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Total Knee Replacement ◽  
Knee Replacement ◽  
Joint Replacement ◽  
Working Group ◽  
Total Joint Replacement ◽  
Core Domain ◽  
Total Knee ◽  
Core 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.

scholarly journals Need for Outcome Scenario Analysis of Clinical Trials in Diabetes

2016 ◽  
Vol 11 (2) ◽  
pp. 327-334 ◽  
Author(s):  
Rosa Garcia-Verdugo ◽  
Michael Erbach ◽  
Oliver Schnell
Keyword(s):  
Clinical Trial ◽  
Decision Making ◽  
Clinical Trials ◽  
Theoretical Model ◽  
Scenario Analysis ◽  
Cardiovascular Safety ◽  
Time Cost ◽  
Phase 3 ◽  
Trial Outcome ◽  
Clinical Trial Outcome

Since the FDA requirement for cardiovascular safety of all new antihyperglycemic drugs to enter the market, the number and extent of phase 3 clinical trials has markedly increased. Unexpected trial results imply an enormous economic, personal and time cost and has deleterious effects over R&D. To prevent unforeseen developments in clinical trials, we recommend performing a comprehensive prospective outcome scenario analysis before launching the trial. In this commentary, we discuss the most important factors to take in consideration for prediction of clinical trial outcome scenarios and propose a theoretical model for decision making.

scholarly journals Guidelines for the conduct of clinical trials for spinal cord injury (SCI) as developed by the ICCP panel: clinical trial outcome measures

Spinal Cord ◽  
2006 ◽  
Vol 45 (3) ◽  
pp. 206-221 ◽  
Author(s):  
J D Steeves ◽  
D Lammertse ◽  
A Curt ◽  
J W Fawcett ◽  
M H Tuszynski ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Spinal Cord ◽  
Spinal Cord Injury ◽  
Clinical Trials ◽  
Outcome Measures ◽  
Trial Outcome ◽  
Clinical Trial Outcome ◽  
Cord Injury

scholarly journals Development of a Provisional Core Domain Set for Polymyalgia Rheumatica: Report from the OMERACT 12 Polymyalgia Rheumatica Working Group

2015 ◽  
Vol 43 (1) ◽  
pp. 182-186 ◽  
Author(s):  
Toby Helliwell ◽  
Elisabeth Brouwer ◽  
Colin T. Pease ◽  
Rodney Hughes ◽  
Catherine L. Hill ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Literature Review ◽  
Outcome Measures ◽  
Polymyalgia Rheumatica ◽  
Working Group ◽  
Face Validity ◽  
Measurement Instruments ◽  
Core Domain ◽  
Core Set ◽  
Core Domain Set

Objective.The Outcome Measures in Rheumatology (OMERACT) polymyalgia rheumatica (PMR) working group aims to develop a core set of outcome measures to be used in clinical trials for PMR. Previous reports from OMERACT 11 included a qualitative study of the patient experience and a preliminary literature review.Methods.A 3-round Delphi survey of clinicians and patients with PMR was undertaken to identify a candidate core domain set for PMR research. Additionally, a literature review of outcome measures and their respective measurement instruments was undertaken. Meetings of patient research partners and clinicians were convened to review face validity of the provisional core domain set, which was subsequently presented and discussed at the OMERACT 12 congress.Results.Of the 60 clinicians taking part in round 1, 55 took part in round 2 and 51 in round 3. Of the 55 patients who took part in round 1, 46 and 35 took part in subsequent rounds. In total, 91% of participants in round 3 deemed the resulting draft core domain set reasonable. The literature review identified 28 studies for full review. Measurement instruments for each proposed domain were identified. Clinicians are highly aware of glucocorticoid-related adverse effects, but there is relatively little evidence about their true prevalence and severity, especially in PMR.Conclusion.A provisional core domain set, presented for clinical trials in PMR, comprises acute phase markers, physical function, death, glucocorticoid-related adverse events, and development of giant cell arteritis. Measurement instruments are suggested that may cover each domain, but these require formal validation for clinical trials in PMR.

scholarly journals 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

BMJ Open ◽  
2020 ◽  
Vol 10 (6) ◽  
pp. e035207
Author(s):  
Robert Prill ◽  
Jasvinder A Singh ◽  
Gesine H Seeber ◽  
Sabrina Mai Nielsen ◽  
Susan Goodman ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Total Joint Replacement ◽  
Core Domain ◽  
Orthopaedic Surgeons ◽  
The Core ◽  
Ethical Approval ◽  
Registration Number ◽  
The Usa ◽  
Clinical Trials Registry ◽  
Core Domain Set

IntroductionThere is a lack of harmonising measures for clinical trials on total joint replacement (TJR) that would allow for results from TJR studies to be compared or pooled. The Outcome Measures in Rheumatology (OMERACT) TJR core domain set is already endorsed among patients and physicians in the USA and Australia. Physiotherapists use different types of measurements compared to orthopaedic surgeons while both make substantial contributions to research in the field of TJR. To achieve consensus on core measurements sets, patients, physiotherapists and orthopaedic surgeons need to achieve consensus on the core domains for TJR trials.Methods and analysisFor this multistage study, first, the OMERACT TJR core domain set survey will be translated to German and validated according to WHO guidelines. Next, the TJR core domain set will be considered for endorsement in different German stakeholder groups including patients, physiotherapists and orthopaedic surgeons.Ethics and disseminationEthical approval for this protocol was given by the ethics committee of the Brandenburg University of Technology Cottbus—Senftenberg (BTU—CS, EK 2019—2). This article is based on the protocol version 2.5 from 6 May 2020. Anonymous data will be presented only. We will publish the results in peer-reviewed publications and at international conferences.Trial registration numberGerman Clinical Trials Registry (DRKS00016015).

scholarly journals Defining Outcome Measures for Psoriatic Arthritis: A Report from the GRAPPA-OMERACT Working Group

2017 ◽  
Vol 44 (5) ◽  
pp. 697-700 ◽  
Author(s):  
Alexis Ogdie ◽  
Maarten de Wit ◽  
Kristina Callis Duffin ◽  
Willemina Campbell ◽  
Jeffrey Chau ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Outcome Measures ◽  
Working Group ◽  
Development Process ◽  
Outcome Measurement ◽  
Core Outcome ◽  
Core Domain ◽  
Core Set ◽  
Core Domain Set

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA)-Outcome Measures in Rheumatology (OMERACT) Psoriatic Arthritis (PsA) Core Set working group recently published the updated 2016 psoriatic arthritis (PsA) core domain set, a set of disease features that should be measured in all clinical trials. At the GRAPPA annual meeting in July 2016, the PsA working group presented the updated PsA core domain set endorsed by 90% of participants at OMERACT in May 2016 and drafted a roadmap for the development of the PsA core outcome measurement set. In this manuscript, we review the development process of the PsA core domain set and the ongoing and proposed work streams for development of a PsA core measurement set.

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