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 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 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 Perceptions of Patients, Caregivers, and Healthcare Providers of Idiopathic Inflammatory Myopathies: An International OMERACT Study

2018 ◽  
Vol 46 (1) ◽  
pp. 106-111 ◽  
Author(s):  
Christopher A. Mecoli ◽  
Jin Kyun Park ◽  
Helene Alexanderson ◽  
Malin Regardt ◽  
Merrilee Needham ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Qualitative Content Analysis ◽  
Healthcare Providers ◽  
The United States ◽  
Patient Reported Outcome Measures ◽  
Patient Reported Outcome ◽  
Idiopathic Inflammatory Myopathies ◽  
Inflammatory Myopathies ◽  
Patient Reported ◽  
Initial List

Objective.Patient-reported outcome measures (PROM) that incorporate the patient perspective have not been well established in idiopathic inflammatory myopathies (IIM). As part of our goal to develop IIM-specific PROM, the Outcome Measures in Rheumatology (OMERACT) Myositis special interest group sought to determine which aspects of disease and its effects are important to patients and healthcare providers (HCP).Methods.Based on a prior qualitative content analysis of focus groups, an initial list of 24 candidate domains was constructed. We subsequently conducted an international survey to identify the importance of each of the 24 domains to be assessed in clinical research. Patients with IIM, their caregivers, and HCP treating IIM completed the survey.Results.In this survey, a total of 638 respondents completed the survey, consisting of 510 patients, 101 HCP, and 27 caregivers from 48 countries. Overall, patients were more likely to rank “fatigue,” “cognitive impact,” and “difficulty sleeping” higher compared with HCP, who ranked “joint symptoms,” “lung symptoms,” and “dysphagia” higher. Both patients and providers rated muscle symptoms as their top domain. In general, patients from different countries were in agreement on which domains were most important. One notable exception was that patients from Sweden and the Netherlands ranked lung symptoms significantly higher compared to other countries including the United States and Australia (mean weighted rankings of 2.86 and 2.04 vs 0.76 and 0.80, respectively; p < 0.0001).Conclusion.Substantial differences exist in how IIM is perceived by patients compared to HCP, with different domains prioritized. In contrast, patients’ ratings across the world were largely similar.

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 Falling Between the Cracks: Experiences of Black Dementia Caregivers Navigating U.S. Health Systems

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 977-977
Author(s):  
Karah Alexander ◽  
Sloan Oliver ◽  
Fayron Epps
Keyword(s):  
Health System ◽  
Social History ◽  
Health Systems ◽  
Healthcare Providers ◽  
Well Being ◽  
The United States ◽  
Healthcare Management ◽  
Healthcare Outcomes ◽  
Dementia Caregivers ◽  
Black Caregivers

Abstract In addition to numerous care responsibilities, family caregivers are expected to navigate health systems and engage in healthcare management tasks on behalf of their persons living with dementia (PLWD). These challenging tasks pose additional difficulties for Black dementia caregivers. Due to the centuries-old, disadvantaged social history of Black Americans, several unique stressors, vulnerabilities, and resources have emerged which inform and affect Black dementia caregivers’ experiences and well-being. Focus groups were held with Black caregivers (N = 19) from the United States (U.S.) to explore the unique experiences and perspectives of this population navigating the U.S. health system on behalf of their PLWD. Five overarching themes were developed during thematic analysis: Forced Advocacy, Poor Provider Interaction, Payor Source Dictates Care, Discrimination, and Broken Health System. Black dementia caregivers unanimously concurred that the health system that they experience in America is “broken.” Gaps in the health system can lead to people [as one caregiver passionately expressed] “falling between the cracks,” in terms of care, services, and resources needed. Caregivers agreed that class, sex, utilizing public health insurance, and being a “person of color” contribute to their difficulties navigating the health system. Caregivers perceived being dismissed by providers, forcing them to advocate for both themselves and their PLWD. Healthcare providers and researchers can utilize these findings to improve the experiences and healthcare outcomes of Black patients with dementia and their caregivers. Additionally, these findings can lead to the development of culturally tailored caregiver education programs.

Bibliometric Analysis of Integrative Medicine Studies from 2000 to 2019

2021 ◽  
pp. 1-13
Author(s):  
Bo-Young Youn ◽  
Hyun Jong Song ◽  
Keeyoung Yang ◽  
Chunhoo Cheon ◽  
Youme Ko ◽  
...  
Keyword(s):  
Patient Care ◽  
Integrative Medicine ◽  
Healthcare Providers ◽  
Well Being ◽  
The United States ◽  
Patient Centered ◽  
Medicine Research ◽  
Number Of Patients ◽  
Centered Care ◽  
Complementary And Alternative

Integrative medicine has become a vital component of patient care. It provides patient-centered care that is focused on prevention and overall well-being. As there has been a growing number of patients favoring a blend of conventional, complementary and alternative approaches, integrative medicine has exceeded beyond the evaluation of complementary therapies. However, it is noteworthy that there has been a dilemma of providing substantial evidence supporting the efficacy of some complementary and alternative therapies. This study’s goals were to analyze publication trends, most productive journals, most productive funding agencies, most productive authors, most relevant keywords, and countries in the field of integrative medicine research. Additionally, science mapping included country collaboration analysis and thematic evolution analysis. The findings from this study showed a constant rise in annual growth of publications from 2000 to 2019; the United States was dominant in various analysis categories. In conclusion, a comprehensive review of the evolution of research of integrative medicine will help healthcare providers understand an overview of the present status while encouraging more evidence-based research for the betterment of integrative patient care.

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