Content validity of psoriatic arthritis composite indices: anchoring with the patient perspective and the core domain set

Rheumatology ◽  
2019 ◽  
Vol 59 (1) ◽  
pp. 1-4 ◽  
Author(s):  
Ana-Maria Orbai
Keyword(s):  
Psoriatic Arthritis ◽  
Content Validity ◽  
Patient Perspective ◽  
Core Domain ◽  
The Core ◽  
Composite Indices ◽  
Core Domain Set

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

Trials ◽  
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.

scholarly journals Report of the GRAPPA-OMERACT Psoriatic Arthritis Working Group from the GRAPPA 2015 Annual Meeting

2016 ◽  
Vol 43 (5) ◽  
pp. 965-969 ◽  
Author(s):  
Ana-Maria Orbai ◽  
Philip J. Mease ◽  
Maarten de Wit ◽  
Umut Kalyoncu ◽  
Willemina Campbell ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Working Group ◽  
Outcome Measurement ◽  
Measurement Instrument ◽  
Evidence Based ◽  
Measurement Instruments ◽  
Core Domain ◽  
Literature Reviews ◽  
Core Domain Set ◽  
Selection Of

The GRAPPA-OMERACT psoriatic arthritis (PsA) working group is in the process of updating the PsA core domain set to improve and standardize the measurement of PsA outcomes. Work streams comprise literature reviews of domains and outcome measurement instruments, an international qualitative research project with PsA patients to generate domains important to patients, outcome measurement instrument assessment, conduct of domain consensus panels with patients and physicians, and evidence-based selection of instruments. Patient research partners are involved in each of the projects. The working group will present findings and seek endorsement for the new PsA core domain set, outcome measurement set, and research agenda at the OMERACT meeting in May 2016.

scholarly journals Review of the Psoriatic Arthritis Working Group at OMERACT 12: A Report from the GRAPPA 2014 Annual Meeting

2015 ◽  
Vol 42 (6) ◽  
pp. 1048-1051 ◽  
Author(s):  
William Tillett ◽  
Lihi Eder ◽  
Niti Goel ◽  
Maarten de Wit ◽  
Alexis Ogdie ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Annual Meeting ◽  
Outcome Measures ◽  
Working Group ◽  
Patient Perspective ◽  
Patient Involvement ◽  
Group Discussions ◽  
The Core ◽  
Breakout Group ◽  
Core Set

At the 2014 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), the psoriatic arthritis (PsA) working group of OMERACT (Outcome Measures in Rheumatology) presented a review of the progress made at the OMERACT 12 meeting, held in 2014. Members of the PsA OMERACT working group presented work from the Patient Involvement in Outcome Measures for PsA initiative to improve the incorporation of patient research partners in PsA outcomes research, the results of discussions within the OMERACT breakout groups, and finally the voting results. The OMERACT 12 participants had endorsed the need to update the PsA core set according to the Filter 2.0 framework. The breakout group discussions identified potential opportunities for revising the core set, including consolidating existing redundancy within the core set, improving incorporation of the patient perspective, and including disease effects such as fatigue as a core criterion. GRAPPA members of the OMERACT working group now have a program of research to update the core set with the goal of seeking endorsement at OMERACT 13, to be held in 2016.

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 OMERACT Development of a Core Domain Set of Outcomes for Shared Decision-making Interventions

2019 ◽  
Vol 46 (10) ◽  
pp. 1409-1414 ◽  
Author(s):  
Karine Toupin-April ◽  
Jennifer L. Barton ◽  
Liana Fraenkel ◽  
Alexa Meara ◽  
Linda C. Li ◽  
...  
Keyword(s):  
Decision Making ◽  
Shared Decision Making ◽  
White Paper ◽  
Consensus Building ◽  
Shared Decision ◽  
Core Domain ◽  
The Core ◽  
Outcome Domain ◽  
Process Domains ◽  
Core Domain Set

Objective.The Outcome Measures in Rheumatology (OMERACT) Shared Decision Making (SDM) Working Group aims to determine the core outcome domain set for measuring the effectiveness of SDM interventions in rheumatology trials.Methods.A white paper was developed to clarify the draft core domain set. It was then used to prepare for interviews to investigate reasons for lack of consensus on it and to suggest further improvements.Results.OMERACT scientists/clinicians (n = 13) and patients (n = 10) suggested limiting the core domain set to outcome domains, removing process domains, and clarifying remaining domains.Conclusion.A revised core domain set will undergo further consensus-building.

scholarly journals Systematic literature review of domains assessed in psoriatic arthritis to inform the update of the psoriatic arthritis core domain set

RMD Open ◽  
2016 ◽  
Vol 2 (1) ◽  
pp. e000217 ◽  
Author(s):  
Umut Kalyoncu ◽  
Alexis Ogdie ◽  
Willemina Campbell ◽  
Clifton O Bingham ◽  
Maarten de Wit ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Literature Review ◽  
Systematic Literature Review ◽  
Core Domain ◽  
Core Domain Set

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 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.

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