The ASAS-OMERACT Core Domain Set for Axial Spondyloarthritis

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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Co-producing a multi-stakeholder Core Outcome Set for distal Tibia and Ankle fractures (COSTA): a study protocol

Trials ◽

10.1186/s13063-021-05415-1 ◽

2021 ◽

Vol 22 (1) ◽

Author(s):

Nathan A. Pearson ◽

Elizabeth Tutton ◽

Alexander Joeris ◽

Stephen Gwilym ◽

Richard Grant ◽

...

Keyword(s):

Core Outcome Set ◽

Distal Tibia ◽

Ankle Fractures ◽

Core Outcome ◽

Core Domain ◽

Outcome Reporting ◽

The Core ◽

Outcome Set ◽

Multi Stakeholder ◽

Core Domain Set

Abstract Background Ankle fracture is a common injury with a strong evidence base focused on effectiveness of treatments. However, there are no reporting guidelines on distal tibia and ankle fractures. This has led to heterogeneity in outcome reporting and consequently, restricted the contribution of evidence syntheses. Over the past decade, core outcome sets have been developed to address this issue and are available for several common fractures, including those of the hip, distal radius, and open tibial fractures. This protocol describes the process to co-produce—with patient partners and other key stakeholders—a multi-stakeholder derived Core Outcome Set for distal Tibia and Ankle fractures (COSTA). The scope of COSTA will be for clinical trials. Methods The study will have five-stages which will include the following: (i) systematic reviews of existing qualitative studies and outcome reporting in randomised controlled trial studies to inform a developing list of potential outcome domains; (ii) qualitative interviews (including secondary data) and focus groups with patients and healthcare professionals to explore the impact of ankle fracture and the outcomes that really matter; (iii) generation of meaningful outcome statements with the study team, international advisory group and patient partners; (iv) a multi-round, international e-Delphi study to achieve consensus on the core domain set; and (v) an evidence-based consensus on a core measurement set will be achieved through a structured group consensus meeting, recommending best assessment approaches for each of the domains in the core domain set. Discussion Development of COSTA will provide internationally endorsed outcome assessment guidance for clinical trials for distal tibia and ankle fractures. This will enhance comparative reviews of interventions, potentially reducing reporting bias and research waste.

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LB956 Identifying a core domain set to assess psoriasis in clinical trials: Delphi survey of patients and healthcare professionals from the International Dermatology Outcome Measures Psoriasis Initiative

Journal of Investigative Dermatology ◽

10.1016/j.jid.2017.07.031 ◽

2017 ◽

Vol 137 (10) ◽

pp. B5

Author(s):

K. Duffin ◽

J. Merola ◽

J. Latella ◽

R. Christensen ◽

A. Garg ◽

...

Keyword(s):

Clinical Trials ◽

Outcome Measures ◽

Healthcare Professionals ◽

Delphi Survey ◽

Core Domain ◽

Core Domain Set

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Identifying flares in rheumatoid arthritis: reliability and construct validation of the OMERACT RA Flare Core Domain Set

RMD Open ◽

10.1136/rmdopen-2015-000225 ◽

2016 ◽

Vol 2 (1) ◽

pp. e000225 ◽

Cited By ~ 38

Author(s):

Vivian P Bykerk ◽

Clifton O Bingham ◽

Ernest H Choy ◽

Daming Lin ◽

Rieke Alten ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Construct Validation ◽

Core Domain ◽

Core Domain Set

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Feasibility and Domain Validation of Rheumatoid Arthritis (RA) Flare Core Domain Set: Report of the OMERACT 2014 RA Flare Group Plenary

The Journal of Rheumatology ◽

10.3899/jrheum.141169 ◽

2015 ◽

Vol 42 (11) ◽

pp. 2185-2189 ◽

Cited By ~ 32

Author(s):

Susan J. Bartlett ◽

Vivian P. Bykerk ◽

Roxanne Cooksey ◽

Ernest H. Choy ◽

Rieke Alten ◽

...

Keyword(s):

Rheumatoid Arthritis ◽

Disease Activity ◽

Clinical Care ◽

Joint Disease ◽

Self Management ◽

International Studies ◽

Core Domain ◽

Ongoing Work ◽

Activity Measures ◽

Core Domain Set

Objective.The Outcome Measures in Rheumatology (OMERACT) Rheumatoid Arthritis (RA) Flare Group was established to develop an approach to identify and measure RA flares. An overview of our OMERACT 2014 plenary is provided.Methods.Feasibility and validity of flare domains endorsed at OMERACT 11 (2012) were described based on initial data from 3 international studies collected using a common set of questions specific to RA flare. Mean flare frequency, severity, and duration data were presented, and domain scores were compared by flare status to examine known-groups validity. Breakout groups provided input for stiffness, self-management, contextual factors, and measurement considerations.Results.Flare data from 501 patients in an observational study indicated 39% were in flare, with mean (SD) severity of 6.0 (2.6) and 55% lasting > 14 days. Pain, physical function, fatigue, participation, and stiffness scores averaged ≥ 2 times higher (2 of 11 points) in flaring individuals. Correlations between flare domains and corresponding legacy instruments were obtained: r = 0.46 to 0.93. A combined definition (patient report of flare and 28-joint Disease Activity Score increase) was evaluated in 2 other trials, with similar results. Breakout groups debated specific measurement issues.Conclusion.These data contribute initial evidence of feasibility and content validation of the OMERACT RA Flare Core Domain Set. Our research agenda for OMERACT 2016 includes establishing duration/intensity criteria and developing criteria to identify RA flares using existing disease activity measures. Ongoing work will also address discordance between patient and physician ratings, facilitate application of flare criteria to clinical care, elucidate the role of self-management, and finalize recommendations for RA flare measurement.

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Finalizing the international core domain set for peripheral vascular malformations: the OVAMA project

British Journal of Dermatology ◽

10.1111/bjd.18043 ◽

2019 ◽

Vol 181 (5) ◽

pp. 1076-1078 ◽

Cited By ~ 3

Author(s):

M.M. Lokhorst ◽

S.E.R. Horbach ◽

C.M.A.M. Horst ◽

P.I. Spuls ◽

Keyword(s):

Vascular Malformations ◽

Peripheral Vascular ◽

Core Domain ◽

Core Domain Set

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Toward a Core Domain Set for Glucocorticoid Impact in Inflammatory Rheumatic Diseases: The OMERACT 2018 Glucocorticoid Impact Working Group

The Journal of Rheumatology ◽

10.3899/jrheum.181082 ◽

2019 ◽

Vol 46 (9) ◽

pp. 1179-1182 ◽

Cited By ~ 2

Author(s):

Jonathan T.L. Cheah ◽

Rachel J. Black ◽

Joanna C. Robson ◽

Iris Y. Navarro-Millán ◽

Sarah R. Young ◽

...

Keyword(s):

Research Agenda ◽

Patient Survey ◽

Patient Reported Outcome ◽

Inflammatory Rheumatic Diseases ◽

Core Domain ◽

Patient Reported ◽

Literature Reviews ◽

Rich Data ◽

Validated Instrument ◽

Core Domain Set

Objective.To understand the effects of glucocorticoids (GC), which are of importance to patients.Methods.The results of 2 literature reviews, a patient survey, and a qualitative study were presented.Results.No validated instrument exists to evaluate GC effect on patients. Survey data revealed skin thinning/bruising, sleep disturbance, and weight gain as the most frequent adverse effects. The qualitative research yielded rich data covering rapid benefits and physical and emotional consequences of GC.Conclusion.It was agreed that a patient-reported outcome to measure GC effect was required and a research agenda was developed for this goal.

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The OMERACT-OARSI Core Domain Set for Measurement in Clinical Trials of Hip and/or Knee Osteoarthritis

The Journal of Rheumatology ◽

10.3899/jrheum.181194 ◽

2019 ◽

Vol 46 (8) ◽

pp. 981-989 ◽

Cited By ~ 16

Author(s):

Toby O. Smith ◽

Gillian A. Hawker ◽

David J. Hunter ◽

Lyn M. March ◽

Maarten Boers ◽

...

Keyword(s):

Clinical Trials ◽

Knee Osteoarthritis ◽

Health Professionals ◽

Outcome Measurement ◽

Measurement Instrument ◽

Research Society ◽

Delphi Survey ◽

Core Domain ◽

Knee Oa ◽

Core Domain Set

Objective.To update the 1997 OMERACT-OARSI (Outcome Measures in Rheumatology-Osteoarthritis Research Society International) core domain set for clinical trials in hip and/or knee osteoarthritis (OA).Methods.An initial review of the COMET database of core outcome sets (COS) was undertaken to identify all domains reported in previous COS including individuals with hip and/or knee OA. These were presented during 5 patient and health professionals/researcher meetings in 3 continents (Europe, Australasia, North America). A 3-round international Delphi survey was then undertaken among patients, healthcare professionals, researchers, and industry representatives to gain consensus on key domains to be included in a core domain set for hip and/or knee OA. Findings were presented and discussed in small groups at OMERACT 2018, where consensus was obtained in the final plenary.Results.Four previous COS were identified. Using these, and the patient and health professionals/researcher meetings, 50 potential domains formed the Delphi survey. There were 426 individuals from 25 different countries who contributed to the Delphi exercise. OMERACT 2018 delegates (n = 129) voted on candidate domains. Six domains gained agreement as mandatory to be measured and reported in all hip and/or knee OA clinical trials: pain, physical function, quality of life, and patient’s global assessment of the target joint, in addition to the mandated core domain of adverse events including mortality. Joint structure was agreed as mandatory in specific circumstances, i.e., depending on the intervention.Conclusion.The updated core domain set for hip and/or knee OA has been agreed upon. Work will commence to determine which outcome measurement instrument should be recommended to cover each core domain.

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

The Journal of Rheumatology ◽

10.3899/jrheum.181088 ◽

2019 ◽

Vol 46 (8) ◽

pp. 1006-1013 ◽

Cited By ~ 11

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.

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