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

2019 ◽  
Vol 46 (8) ◽  
pp. 981-989 ◽  
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.

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 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.

scholarly journals Updating the Psoriatic Arthritis (PsA) Core Domain Set: A Report from the PsA Workshop at OMERACT 2016

2017 ◽  
Vol 44 (10) ◽  
pp. 1522-1528 ◽  
Author(s):  
Ana-Maria Orbai ◽  
Maarten de Wit ◽  
Philip J. Mease ◽  
Kristina Callis Duffin ◽  
Musaab Elmamoun ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Outcome Measures ◽  
Structural Damage ◽  
Outcome Measurement ◽  
Nominal Group Technique ◽  
Well Being ◽  
Nominal Group ◽  
Core Domain ◽  
Core Domain Set

Objective.To include the patient perspective in accordance with the Outcome Measures in Rheumatology (OMERACT) Filter 2.0 in the updated Psoriatic Arthritis (PsA) Core Domain Set for randomized controlled trials (RCT) and longitudinal observational studies (LOS).Methods.At OMERACT 2016, research conducted to update the PsA Core Domain Set was presented and discussed in breakout groups. The updated PsA Core Domain Set was voted on and endorsed by OMERACT participants.Results.We conducted a systematic literature review of domains measured in PsA RCT and LOS, and identified 24 domains. We conducted 24 focus groups with 130 patients from 7 countries representing 5 continents to identify patient domains. We achieved consensus through 2 rounds of separate surveys with 50 patients and 75 physicians, and a nominal group technique meeting with 12 patients and 12 physicians. We conducted a workshop and breakout groups at OMERACT 2016 in which findings were presented and discussed. The updated PsA Core Domain Set endorsed with 90% agreement by OMERACT 2016 participants included musculoskeletal disease activity, skin disease activity, fatigue, pain, patient’s global assessment, physical function, health-related quality of life, and systemic inflammation, which were recommended for all RCT and LOS. These were important, but not required in all RCT and LOS: economic cost, emotional well-being, participation, and structural damage. Independence, sleep, stiffness, and treatment burden were on the research agenda.Conclusion.The updated PsA Core Domain Set was endorsed at OMERACT 2016. Next steps for the PsA working group include evaluation of PsA outcome measures and development of a PsA Core Outcome Measurement Set.

scholarly journals A Preliminary Core Domain Set for Clinical Trials of Shoulder Disorders: A Report from the OMERACT 2016 Shoulder Core Outcome Set Special Interest Group

2017 ◽  
Vol 44 (12) ◽  
pp. 1880-1883 ◽  
Author(s):  
Rachelle Buchbinder ◽  
Matthew J. Page ◽  
Hsiaomin Huang ◽  
Arianne P. Verhagen ◽  
Dorcas Beaton ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Interest Group ◽  
Special Interest ◽  
Inner Core ◽  
Core Outcome Set ◽  
Core Outcome ◽  
Core Domain ◽  
Outcome Set ◽  
Shoulder Disorders ◽  
Core Domain Set

Objective.The Outcome Measures in Rheumatology (OMERACT) Shoulder Core Outcome Set Special Interest Group (SIG) was established to develop a core outcome set (COS) for clinical trials of shoulder disorders.Methods.In preparation for OMERACT 2016, we systematically examined all outcome domains and measurement instruments reported in 409 randomized trials of interventions for shoulder disorders published between 1954 and 2015. Informed by these data, we conducted an international Delphi consensus study including shoulder trial experts, clinicians, and patients to identify key domains that should be included in a shoulder disorder COS. Findings were discussed at a stakeholder premeeting of OMERACT. At OMERACT 2016, we sought consensus on a preliminary core domain set and input into next steps.Results.There were 13 and 15 participants at the premeeting and the OMERACT 2016 SIG meeting, respectively (9 attended both meetings). Consensus was reached on a preliminary core domain set consisting of an inner core of 4 domains: pain, physical function/activity, global perceived effect, and adverse events including death. A middle core consisted of 3 domains: emotional well-being, sleep, and participation (recreation and work). An outer core of research required to inform the final COS was also formulated.Conclusion.Our next steps are to (1) analyze whether participation (recreation and work) should be in the inner core, (2) conduct a third Delphi round to finalize definitions and wording of domains and reach final endorsement for the domains, and (3) determine which instruments fulfill the OMERACT criteria for measuring each domain.

scholarly journals Interventions to Ameliorate the Psychosocial Effects of the COVID-19 Pandemic on Children—A Systematic Review

2021 ◽  
Vol 18 (5) ◽  
pp. 2361
Author(s):  
Katharina Boldt ◽  
Michaela Coenen ◽  
Ani Movsisyan ◽  
Stephan Voss ◽  
Eva Rehfuess ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Health Management ◽  
Psychosocial Interventions ◽  
Well Being ◽  
World Health ◽  
Research Database ◽  
Psychosocial Effects ◽  
Global Database ◽  
Study Protocols

The aim of this study was to identify interventions targeting children and their caregivers to reduce psychosocial problems in the course of the COVID-19 pandemic and comparable outbreaks. The review was performed using systematic literature searches in MEDLINE, Embase, PsycINFO and COVID-19-specific databases, including the CDC COVID-19 Research Database, the World Health Organisation (WHO) Global Database on COVID-19 Research and the Cochrane COVID-19 Study Register, ClinicalTrials.gov, the EU Clinical Trials Register and the German Clinical Trials Register (DRKS) up to 25th September 2020. The search yielded 6657 unique citations. After title/abstract and full text screening, 11 study protocols reporting on trials planned in China, the US, Canada, the UK, and Hungary during the COVID-19 pandemic were included. Four interventions targeted children ≥10 years directly, seven system-based interventions targeted the parents and caregivers of younger children and adolescents. Outcome measures encompassed mainly anxiety and depressive symptoms, different dimensions of stress or psychosocial well-being, and quality of supportive relationships. In conclusion, this systematic review revealed a paucity of studies on psychosocial interventions for children during the COVID-19 pandemic. Further research should be encouraged in light of the expected demand for child mental health management.

scholarly journals Sexual health and COVID-19: protocol for a scoping review

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Navin Kumar ◽  
Kamila Janmohamed ◽  
Kate Nyhan ◽  
Laura Forastiere ◽  
Wei-Hong Zhang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Sexual Health ◽  
Scoping Review ◽  
Current Knowledge ◽  
Grey Literature ◽  
Well Being ◽  
World Health ◽  
Original Research ◽  
Scoping Reviews

Abstract Background Global responses to the COVID-19 pandemic have exposed and exacerbated existing socioeconomic and health inequities that disproportionately affect the sexual health and well-being of many populations, including people of color, ethnic minority groups, women, and sexual and gender minority populations. Although there have been several reviews published on COVID-19 and health disparities across various populations, none has focused on sexual health. We plan to conduct a scoping review that seeks to fill several of the gaps in the current knowledge of sexual health in the COVID-19 era. Methods A scoping review focusing on sexual health and COVID-19 will be conducted. We will search (from January 2020 onwards) CINAHL, Africa-Wide Information, Web of Science Core Collection, Embase, Gender Studies Database, Gender Watch, Global Health, WHO Global Literature on Coronavirus Disease Database, WHO Global Index Medicus, PsycINFO, MEDLINE, and Sociological Abstracts. Grey literature will be identified using Disaster Lit, Google Scholar, governmental websites, and clinical trials registries (e.g., ClinicalTrial.gov, World Health Organization, International Clinical Trials Registry Platform, and International Standard Randomized Controlled Trial Number Registry). Study selection will conform to the Joanna Briggs Institute Reviewers’ Manual 2015 Methodology for JBI Scoping Reviews. Only English language, original studies will be considered for inclusion. Two reviewers will independently screen all citations, full-text articles, and abstract data. A narrative summary of findings will be conducted. Data analysis will involve quantitative (e.g., frequencies) and qualitative (e.g., content and thematic analysis) methods. Discussion Original research is urgently needed to mitigate the risks of COVID-19 on sexual health. The planned scoping review will help to address this gap. Systematic review registrations Systematic Review Registration: Open Science Framework osf/io/PRX8E

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 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.

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