Outcome Measures in Rheumatology - Interventions for medication Adherence (OMERACT-Adherence) Core Domain Set for Trials of Interventions for Medication Adherence in Rheumatology: 5 Phase Study Protocol

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.

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Fibromyalgia Syndrome Module at OMERACT 9: Domain Construct

The Journal of Rheumatology ◽

10.3899/jrheum.090367 ◽

2009 ◽

Vol 36 (10) ◽

pp. 2318-2329 ◽

Cited By ~ 140

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.

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

The Journal of Rheumatology ◽

10.3899/jrheum.161109 ◽

2017 ◽

Vol 44 (10) ◽

pp. 1515-1521 ◽

Cited By ~ 16

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.

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A core outcome set for clinical trials on non-specific low back pain: study protocol for the development of a core domain set

Trials ◽

10.1186/1745-6215-15-511 ◽

2014 ◽

Vol 15 (1) ◽

Cited By ~ 31

Author(s):

Alessandro Chiarotto ◽

Caroline B Terwee ◽

Richard A Deyo ◽

Maarten Boers ◽

Chung-Wei Christine Lin ◽

...

Keyword(s):

Clinical Trials ◽

Low Back Pain ◽

Back Pain ◽

Study Protocol ◽

Core Outcome Set ◽

Core Outcome ◽

Low Back ◽

Core Domain ◽

Outcome Set ◽

Core Domain Set

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Defining Outcome Measures for Psoriasis: The IDEOM Report from the GRAPPA 2016 Annual Meeting

The Journal of Rheumatology ◽

10.3899/jrheum.170151 ◽

2017 ◽

Vol 44 (5) ◽

pp. 701-702 ◽

Cited By ~ 3

Author(s):

Kristina Callis Duffin ◽

Alice B. Gottlieb ◽

Joseph F. Merola ◽

John Latella ◽

Amit Garg ◽

...

Keyword(s):

Annual Meeting ◽

Outcome Measures ◽

Patient Reported Outcomes ◽

Nominal Group ◽

Core Domain ◽

Patient Reported ◽

Literature Reviews ◽

Working Groups ◽

Core Domain Set ◽

Future Plans

The International Dermatology Outcome Measures (IDEOM) psoriasis working group was established to develop core domains and measurements sets for psoriasis clinical trials and ultimately clinical practice. At the 2016 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis, the IDEOM psoriasis group presented an overview of its progress toward developing this psoriasis core domain set. First, it summarized the February 2016 meeting of all involved with the IDEOM, highlighting patient and payer perspectives on outcome measures. Second, the group presented an overview of the consensus process for developing the core domain set for psoriasis, including previous literature reviews, nominal group exercises, and meeting discussions. Future plans include the development of working groups to review candidate measures for at least 2 of the domains, including primary pathophysiologic manifestations and patient-reported outcomes, and Delphi surveys to gain consensus on the final psoriasis core domain set.

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

Annals of the Rheumatic Diseases ◽

10.1136/annrheumdis-2016-210242 ◽

2016 ◽

Vol 76 (4) ◽

pp. 673-680 ◽

Cited By ~ 94

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.

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

The Journal of Rheumatology ◽

10.3899/jrheum.141179 ◽

2015 ◽

Vol 43 (1) ◽

pp. 182-186 ◽

Cited By ~ 19

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.

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Identifying Possible Outcome Domains from Existing Outcome Measures to Inform an OMERACT Core Domain Set for Safety in Rheumatology Trials

The Journal of Rheumatology ◽

10.3899/jrheum.190196 ◽

2019 ◽

Vol 46 (9) ◽

pp. 1173-1178 ◽

Cited By ~ 1

Author(s):

Louise Klokker ◽

Dorthe B. Berthelsen ◽

Thasia Woodworth ◽

Kathleen M. Andersen ◽

Daniel E. Furst ◽

...

Keyword(s):

Outcome Measures ◽

Full Text ◽

Working Group ◽

Measurement Instruments ◽

Core Domain ◽

Considerable Heterogeneity ◽

Outcome Measurements ◽

Core Domain Set ◽

Patients Perspective ◽

The Ideal

Objective.The Outcome Measures in Rheumatology (OMERACT) Safety Working Group objective was to identify harm domains from existing outcome measurements in rheumatology.Methods.Systematically searching the MEDLINE database on January 24, 2017, we identified full-text articles that could be used for harm outcomes in rheumatology. Domains/items from the identified instruments were described and the content synthesized to provide a preliminary framework for harm outcomes.Results.From 435 possible references, 24 were read in full text and 9 were included: 7 measurement instruments were identified. Investigation of domains/items revealed considerable heterogeneity in the grouping and approach.Conclusion.The ideal way to assess harm aspects from the patients’ perspective has not yet been ascertained.

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Addressing Challenges in Developing a Core Domain Set in Adherence Interventions in Rheumatology: A Report from the OMERACT-Adherence Group

The Journal of Rheumatology ◽

10.3899/jrheum.181078 ◽

2019 ◽

Vol 46 (9) ◽

pp. 1202-1206

Author(s):

Ayano Kelly ◽

Susan J. Bartlett ◽

Maarten P. de Wit ◽

Dorcas E. Beaton ◽

Therese Dawson ◽

...

Keyword(s):

Medication Adherence ◽

Contextual Factors ◽

Critical Factor ◽

Drug Trials ◽

Core Domain ◽

Methodological Challenges ◽

Adherence Interventions ◽

Core Domain Set ◽

Adherence Group

Objective.The OMERACT-Adherence meeting was convened to discuss the conceptual and methodological challenges in developing a core domain set (Adherence-CDS) for trials of interventions for medication adherence in rheumatology.Methods.Forty participants from nine countries participated.Results.Four ideas emerged: for adherence trials, the Adherence-CDS could include adherence and the condition-specific CDS; many factors affect adherence and are intervention targets, contextual factors, or outcome domains; adherence is a critical factor in drug trials; and standardized adherence measures are needed.Conclusion.Despite the challenges, the meeting clarified an approach to developing an Adherence-CDS that complements existing OMERACT work and methodology.

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