scholarly journals Fibromyalgia Syndrome Module at OMERACT 9: Domain Construct

2009 ◽  
Vol 36 (10) ◽  
pp. 2318-2329 ◽  
Author(s):  
PHILIP MEASE ◽  
LESLEY M. ARNOLD ◽  
ERNEST H. CHOY ◽  
DANIEL J. CLAUW ◽  
LESLIE J. CROFFORD ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Cognitive Dysfunction ◽  
Outcome Measures ◽  
Outcome Measure ◽  
Core Domain ◽  
Patient Focus Group ◽  
Cerebrospinal Fluid Biomarkers ◽  
Core Set ◽  
Delphi Exercise ◽  
Core Domain Set

The objective of the module was to (1) establish a core domain set for fibromyalgia (FM) assessment in clinical trials and practice, (2) review outcome measure performance characteristics, (3) discuss development of a responder index for assessment of FM in clinical trials, (4) review objective markers, (5) review the domain of cognitive dysfunction, and (6) establish a research agenda for outcomes research. Presentations at the module included: (1) Results of univariate and multivariate analysis of 10 FM clinical trials of 4 drugs, mapping key domains identified in previous patient focus group: Delphi exercises and a clinician/researcher Delphi exercise, and breakout discussions to vote on possible essential domains and reliable measures; (2) Updates regarding outcome measure status; (3) Update on objective markers to measure FM disease state; and (4) Review of the issue of cognitive dysfunction (dyscognition) in FM. Consensus was reached as follows: (1) Greater than 70% of OMERACT participants agreed that pain, tenderness, fatigue, patient global, multidimensional function and sleep disturbance domains should be measured in all FM clinical trials; dyscognition and depression should be measured in some trials; and stiffness, anxiety, functional imaging, and cerebrospinal fluid biomarkers were identified as domains of research interest. (2) FM domain outcome measures have generally proven to be reliable, discriminative, and feasible. More sophisticated and comprehensive measures are in development, as is a responder index for FM. (3) Increasing numbers of objective markers are being developed for FM assessment. (4) Cognitive dysfunction assessment by self-assessed and applied outcome measures is being developed. In conclusion, a multidimensional symptom core set is proposed for evaluation of FM in clinical trials. Research on improved measures of single domains and composite measures is ongoing.

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 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.

scholarly journals Establishing an Updated Core Domain Set for Studies in Juvenile Idiopathic Arthritis: A Report from the OMERACT 2018 JIA Workshop

2019 ◽  
Vol 46 (8) ◽  
pp. 1006-1013 ◽  
Author(s):  
Esi M. Morgan ◽  
Jane E. Munro ◽  
Jennifer Horonjeff ◽  
Ben Horgan ◽  
Beverley Shea ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Outcome Measures ◽  
Healthcare Providers ◽  
Well Being ◽  
The United States ◽  
Subsequent Work ◽  
Core Domain ◽  
Core Set ◽  
Patient’S Perception ◽  
Core Domain Set

Objective.The current Juvenile Idiopathic Arthritis (JIA) Core Set used in randomized controlled trials (RCT) and longitudinal observational studies (LOS) was developed without the input of patients/parents. At the Outcome Measures in Rheumatology (OMERACT) 2016, a special interest group voted to reconsider the core set, incorporating broader input. We describe subsequent work culminating in an OMERACT 2018 plenary and consensus voting.Methods.Candidate domains were identified through literature review, qualitative surveys, and online discussion boards (ODB) held with patients with JIA and parents in Australia, Italy, and the United States. A Delphi process with parents, patients, healthcare providers, researchers, and regulators served to edit the domain list and prioritize candidate domains. After the presentation of results, OMERACT workshop participants voted, with consensus set at > 70%.Results.Participants in ODB were 53 patients with JIA (ages 15–24 yrs) and 55 parents. Three rounds of Delphi considering 27 domains were completed by 190 (response rate 85%), 201 (84%), and 182 (77%) people, respectively, from 50 countries. There was discordance noted between domains prioritized by patients/parents compared to others. OMERACT conference voting approved domains for JIA RCT and LOS with 83% endorsement. Mandatory domains are pain, joint inflammatory signs, activity limitation/physical function, patient’s perception of disease activity (overall well-being), and adverse events. Mandatory in specific circumstances: inflammation/other features relevant to specific JIA categories.Conclusion.Following the OMERACT methodology, we developed an updated JIA Core Domain Set. Next steps are to identify and systematically evaluate best outcome measures for these domains.

scholarly journals The OMERACT Core Domain Set for Outcome Measures for Clinical Trials in Polymyalgia Rheumatica

2017 ◽  
Vol 44 (10) ◽  
pp. 1515-1521 ◽  
Author(s):  
Sarah L. Mackie ◽  
Helen Twohig ◽  
Lorna M. Neill ◽  
Eileen Harrison ◽  
Beverley Shea ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Outcome Measures ◽  
Polymyalgia Rheumatica ◽  
Delphi Study ◽  
Inner Core ◽  
Core Outcome Set ◽  
Psychological Impact ◽  
Outer Core ◽  
Core Domain ◽  
Core Domain Set

Objective.To inform development of a core domain set for outcome measures for clinical trials in polymyalgia rheumatica (PMR), we conducted patient consultations, a systematic review, a Delphi study, and 2 qualitative studies.Methods.Domains identified by 70% or more of physicians and/or patients in the Delphi study were selected. The conceptual framework derived from the 2 qualitative research studies helped inform the meaning of each domain and its relationship to the others. The draft core domain set was refined by further discussion with patients and physicians who had participated in the Delphi study. At the Outcome Measures in Rheumatology (OMERACT) 2016, the domains were discussed and prioritized by 8 breakout groups. Formal voting took place at the end of the workshop and in the final plenary.Results.Ninety-three percent of voters in the final plenary agreed that the inner core of domains considered mandatory for clinical trials of PMR should consist the following: laboratory markers of systemic inflammation, pain, stiffness, and physical function. Patient’s global and fatigue were considered important but not mandatory (outer core). The research agenda included psychological impact, weakness, physical activity, participation, sleep, imaging, and health-related quality of life.Conclusion.This core domain set was considered sufficiently well-defined that the next step will be to apply the OMERACT Filter 2.0 Instrument Selection Algorithm to select candidate instruments for a subsequent “deeper dive” into the data. This will allow instruments to be mapped onto each of our core domains to derive a core outcome set for PMR.

scholarly journals Establishing a Core Domain Set to Measure Rheumatoid Arthritis Flares: Report of the OMERACT 11 RA Flare Workshop

2014 ◽  
Vol 41 (4) ◽  
pp. 799-809 ◽  
Author(s):  
Vivian P. Bykerk ◽  
Elisabeth Lie ◽  
Susan J. Bartlett ◽  
Rieke Alten ◽  
Annelies Boonen ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Trials ◽  
Focus Groups ◽  
Research Agenda ◽  
Observational Studies ◽  
Core Domain ◽  
Domain Identification ◽  
Core Set ◽  
Patient Reported ◽  
Core Domain Set

Objective.The OMERACT Rheumatoid Arthritis (RA) Flare Group (FG) is developing a data-driven, patient-inclusive, consensus-based RA flare definition for use in clinical trials, longterm observational studies, and clinical practice. At OMERACT 11, we sought endorsement of a proposed core domain set to measure RA flare.Methods.Patient and healthcare professional (HCP) qualitative studies, focus groups, and literature review, followed by patient and HCP Delphi exercises including combined Delphi consensus at Outcome Measures in Rheumatology 10 (OMERACT 10), identified potential domains to measure flare. At OMERACT 11, breakout groups discussed key domains and instruments to measure them, and proposed a research agenda. Patients were active research partners in all focus groups and domain identification activities. Processes for domain selection and patient partner involvement were case studies for OMERACT Filter 2.0 methodology.Results.A pre-meeting combined Delphi exercise for defining flare identified 9 domains as important (> 70% consensus from patients or HCP). Four new patient-reported domains beyond those included in the RA disease activity core set were proposed for inclusion (fatigue, participation, stiffness, and self-management). The RA FG developed preliminary flare questions (PFQ) to measure domains. In combined plenary voting sessions, OMERACT 11 attendees endorsed the proposed RA core set to measure flare with ≥ 78% consensus and the addition of 3 additional domains to the research agenda for OMERACT 12.Conclusion.At OMERACT 11, a core domain set to measure RA flare was ratified and endorsed by attendees. Domain validation aligning with Filter 2.0 is ongoing in new randomized controlled clinical trials and longitudinal observational studies using existing and new instruments including a set of PFQ.

scholarly journals International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials

2016 ◽  
Vol 76 (4) ◽  
pp. 673-680 ◽  
Author(s):  
Ana-Maria Orbai ◽  
Maarten de Wit ◽  
Philip Mease ◽  
Judy A Shea ◽  
Laure Gossec ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Focus Groups ◽  
Disease Activity ◽  
Physical Function ◽  
Outcome Measures ◽  
Systemic Inflammation ◽  
Skin Disease ◽  
Core Domain ◽  
Core Domain Set

ObjectiveTo identify a core set of domains (outcomes) to be measured in psoriatic arthritis (PsA) clinical trials that represent both patients' and physicians' priorities.MethodsWe conducted (1) a systematic literature review (SLR) of domains assessed in PsA; (2) international focus groups to identify domains important to people with PsA; (3) two international surveys with patients and physicians to prioritise domains; (4) an international face-to-face meeting with patients and physicians using the nominal group technique method to agree on the most important domains; and (5) presentation and votes at the Outcome Measures in Rheumatology (OMERACT) conference in May 2016. All phases were performed in collaboration with patient research partners.ResultsWe identified 39 unique domains through the SLR (24 domains) and international focus groups (34 domains). 50 patients and 75 physicians rated domain importance. During the March 2016 consensus meeting, 12 patients and 12 physicians agreed on 10 candidate domains. Then, 49 patients and 71 physicians rated these domains' importance. Five were important to >70% of both groups: musculoskeletal disease activity, skin disease activity, structural damage, pain and physical function. Fatigue and participation were important to >70% of patients. Patient global and systemic inflammation were important to >70% of physicians. The updated PsA core domain set endorsed by 90% of OMERACT 2016 participants includes musculoskeletal disease activity, skin disease activity, pain, patient global, physical function, health-related quality of life, fatigue and systemic inflammation.ConclusionsThe updated PsA core domain set incorporates patients' and physicians' priorities and evolving PsA research. Next steps include identifying outcome measures that adequately assess these domains.

scholarly journals The OMERACT Core Domain Set for Clinical Trials of Shoulder Disorders

2019 ◽  
Vol 46 (8) ◽  
pp. 969-975 ◽  
Author(s):  
Sofia Ramiro ◽  
Matthew J. Page ◽  
Samuel L. Whittle ◽  
Hsiaomin Huang ◽  
Arianne P. Verhagen ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Cognitive Dysfunction ◽  
Outcome Measurement ◽  
Well Being ◽  
Core Domain ◽  
The Core ◽  
Additional Domain ◽  
Shoulder Disorders ◽  
Core Domain Set

Objective.To reach consensus on the core domains to be included in a core domain set for clinical trials of shoulder disorders using the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 Core Domain Set process.Methods.At OMERACT 2018, the OMERACT Shoulder Working Group conducted a workshop that presented the OMERACT 2016 preliminary core domain set and its rationale based upon a systematic review of domains measured in shoulder trials and international Delphi sessions involving patients, clinicians, and researchers, as well as a new systematic review of qualitative studies on the experiences of people with shoulder disorders. After discussions in breakout groups, the OMERACT core domain set for clinical trials of shoulder disorders was presented for endorsement by OMERACT 2018 participants.Results.The qualitative review (n = 8) identified all domains included in the preliminary core set. An additional domain, cognitive dysfunction, was also identified, but confidence that this represents a core domain was very low. The core domain set that was endorsed by the OMERACT participants, with 71% agreement, includes 4 “mandatory” trial domains: pain, function, patient global — shoulder, and adverse events including death; and 4 “important but optional” domains: participation (recreation/work), sleep, emotional well-being, and condition-specific pathophysiological manifestations. Cognitive dysfunction was voted out of the core domain set.Conclusion.OMERACT 2018 delegates endorsed a core domain set for clinical trials of shoulder disorders. The next step includes identification of a core outcome measurement set that passes the OMERACT 2.1 Filter for measuring each domain.

scholarly journals Toward Development of a Fibromyalgia Responder Index and Disease Activity Score: OMERACT Module Update

2011 ◽  
Vol 38 (7) ◽  
pp. 1487-1495 ◽  
Author(s):  
PHILIP J. MEASE ◽  
DANIEL J. CLAUW ◽  
ROBIN CHRISTENSEN ◽  
LESLIE J. CROFFORD ◽  
R. MICHAEL GENDREAU ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Disease Activity ◽  
Cognitive Dysfunction ◽  
Outcome Measures ◽  
Disease Activity Score ◽  
Randomized Clinical Trials ◽  
Activity Score ◽  
Response To Treatment ◽  
Core Domain ◽  
Activity Measures

Following development of the core domain set for fibromyalgia (FM) in Outcome Measures in Rheumatology Clinical Trials (OMERACT) meetings 7 to 9, the FM working group has progressed toward the development of an FM responder index and a disease activity score based on these domains, utilizing outcome indices of these domains from archived randomized clinical trials in FM. Possible clinical domains that could be included in a responder index and disease activity score include pain, fatigue, sleep disturbance, cognitive dysfunction, mood disturbance, tenderness, stiffness, and functional impairment. Outcome measures for these domains demonstrate good to adequate psychometric properties, although measures of cognitive dysfunction need to be further developed. The approach used in the development of responder indices and disease activity scores for rheumatoid arthritis and ankylosing spondylitis represents heuristic models for our work, but FM is challenging in that there is no clear algorithm of treatment that defines disease activity based on treatment decisions, nor are there objective markers that define thresholds of severity or response to treatment. The process of developing candidate dichotomous responder definitions and continuous quantitative disease activity measures is described, along with participant discussions from OMERACT 10. Final results of this work will be published in a separate report pending completion of analyses.

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.

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