How to Choose Core Outcome Measurement Sets for Clinical Trials: OMERACT 11 Approves Filter 2.0

2014 ◽  
Vol 41 (5) ◽  
pp. 1025-1030 ◽  
Author(s):  
Maarten Boers ◽  
John R. Kirwan ◽  
Laure Gossec ◽  
Philip G. Conaghan ◽  
Maria-Antonietta D’Agostino ◽  
...  
Keyword(s):  
Conceptual Framework ◽  
Outcome Measures ◽  
Outcome Measurement ◽  
Measurement Instrument ◽  
Health Condition ◽  
Core Outcome ◽  
Core Domain ◽  
Face To Face ◽  
Life Impact ◽  
Core Sets

Objective.The Outcome Measures in Rheumatology (OMERACT) initiative works to develop core sets of outcome measures for trials and observational studies in rheumatology. At the OMERACT 11 meeting, substantial time was devoted to discussing a conceptual framework and a proposal for a more explicit working process to develop what we now propose to term core outcome measurement sets, collectively termed “OMERACT Filter 2.0.”Methods.Preconference work included a literature review, and discussion of preliminary proposals through face-to-face discussions and Internet-based surveys with people within and outside rheumatology. At the conference, 5 interactive sessions comprising plenary and small-group discussions reflected on the proposals from the viewpoint of previous and ongoing OMERACT work. These considerations were brought together in a final OMERACT presentation seeking consensus agreement for the Filter 2.0 framework.Results.After debate, clarification, and agreed alterations, the final proposal suggested all core sets should contain at least 1 measurement instrument from 3 Core Areas: Death, Life Impact, and Pathophysiological Manifestations, and preferably 1 from the area Resource Use. The process of core set development for a health condition starts by selecting core domains within the areas (“core domain set”). This requires literature searches, involvement (especially of patients), and at least 1 consensus process. Next, developers select at least 1 applicable measurement instrument for each core domain. Applicability refers to the original OMERACT Filter and means that the instrument must be truthful (face, content, and construct validity), discriminative (between situations of interest) and feasible (understandable and with acceptable time and monetary costs). Depending on the quality of the instruments, participants formulate either a preliminary or a final “core outcome measurement set.” At final vote, 96% of participants agreed “The proposed overall framework for Filter 2.0 is a suitable basis on which to elaborate a Filter 2.0 Handbook.”Conclusion.Within OMERACT, Filter 2.0 has made established working processes more explicit and includes a broadly endorsed conceptual framework for core outcome measurement set development.

scholarly journals OMERACT Filter 2.1: Elaboration of the Conceptual Framework for Outcome Measurement in Health Intervention Studies

2019 ◽  
Vol 46 (8) ◽  
pp. 1021-1027 ◽  
Author(s):  
Maarten Boers ◽  
Dorcas E. Beaton ◽  
Beverley J. Shea ◽  
Lara J. Maxwell ◽  
Susan J. Bartlett ◽  
...  
Keyword(s):  
Conceptual Framework ◽  
Outcome Measures ◽  
Intervention Studies ◽  
Outcome Measurement ◽  
Core Outcome Set ◽  
Health Intervention ◽  
Health Conditions ◽  
Core Outcome ◽  
Outcome Set ◽  
Core Set

Objective.The Outcome Measures in Rheumatology (OMERACT) Filter 2.0 framework was developed in 2014 to aid core outcome set development by describing the full universe of “measurable aspects of health conditions” from which core domains can be selected. This paper provides elaborations and updated concepts (OMERACT Filter 2.1).Methods.At OMERACT 2018, we discussed challenges in the framework application caused by unclear or ambiguous wording and terms and incompletely developed concepts.Results.The updated OMERACT Filter 2.1 framework makes benefits and harms explicit, clarifies concepts, and improves naming of various terms.Conclusion.We expect that the Filter 2.1 framework will improve the process of core set development.

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.

Toward a Generalized Framework of Core Measurement Areas in Clinical Trials: A Position Paper for OMERACT 11

2014 ◽  
Vol 41 (5) ◽  
pp. 978-985 ◽  
Author(s):  
Maarten Boers ◽  
Leanne Idzerda ◽  
John R. Kirwan ◽  
Dorcas Beaton ◽  
Reuben Escorpizo ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Conceptual Framework ◽  
Outcome Measures ◽  
Outcome Measurement ◽  
Group Processes ◽  
Health Condition ◽  
Measurement Instruments ◽  
International Consensus ◽  
Surrogate Outcome ◽  
Key Concepts

Objective.The Outcome Measures in Rheumatology (OMERACT) international consensus initiative has successfully developed core sets of outcome measures for trials of many rheumatologic conditions, but its expanding scope called for clarification and updating of its underlying conceptual framework and working process. To develop a core set of what we propose to call outcome measurement instruments, consensus must be reached both on what to measure and how to measure. This article deals with the first part: a framework necessary to ensure comprehensiveness of the domains chosen for measurement. We formulated a conceptual framework of core measurement areas in clinical trials, for discussion at the OMERACT 11 conference.Methods.We formulated a framework and definitions of key concepts adapted from the literature, and followed an iterative consensus process (small group processes and an Internet-based survey) of those involved including patients, health professionals, and methodologists within and outside rheumatology.Results.The draft framework comprises 4 core “areas”: death, life impact (all aspects of how a patient feels or functions), resource use (monetary and other costs of the health condition and interventions), and pathophysiologic manifestations (disease-specific clinical and psychological signs, biomarkers, and potential surrogate outcome measures necessary to assess specific effects). The survey responses (262 of 2293, response rate 11%) indicated broad agreement with the draft framework and the proposed definitions of key concepts, including understandability and feasibility. A total of 283 comments were processed.Conclusion.In an iterative process, we have developed a generic framework for outcome measurement and working definitions of key concepts ready for discussion at the OMERACT 11 conference.

Can We Decide Which Outcomes Should Be Measured in Every Clinical Trial? A Scoping Review of the Existing Conceptual Frameworks and Processes to Develop Core Outcome Sets

2014 ◽  
Vol 41 (5) ◽  
pp. 986-993 ◽  
Author(s):  
Leanne Idzerda ◽  
Tamara Rader ◽  
Peter Tugwell ◽  
Maarten Boers
Keyword(s):  
Conceptual Framework ◽  
Outcome Measures ◽  
Scoping Review ◽  
Cochrane Library ◽  
Core Outcome ◽  
Conceptual Frameworks ◽  
Core Outcome Sets ◽  
Core Set ◽  
Core Sets ◽  
Google Search

Objective.The usefulness of randomized control trials to advance clinical care depends upon the outcomes reported, but disagreement on the choice of outcome measures has resulted in inconsistency and the potential for reporting bias. One solution to this problem is the development of a core outcome set: a minimum set of outcome measures deemed critical for clinical decision making. Within rheumatology the Outcome Measures in Rheumatology (OMERACT) initiative has pioneered the development of core outcome sets since 1992. As the number of diseases addressed by OMERACT has increased and its experience in formulating core sets has grown, clarification and update of the conceptual framework and formulation of a more explicit process of area/domain core set development has become necessary. As part of the update process of the OMERACT Filter criteria to version 2, a literature review was undertaken to compare and contrast the OMERACT conceptual framework with others within and outside rheumatology.Methods.A scoping search was undertaken to examine the extent, range, and nature of conceptual frameworks for core set outcome selection in health. We searched the following resources: Cochrane Library Methods Group Register; Medline; Embase; PsycInfo; Environmental Studies and Policy Collection; and ABI/INFORM Global. We also conducted a targeted Google search.Results.Five conceptual frameworks were identified: the WHO tripartite definition of health; the 5 Ds (discomfort, disability, drug toxicity, dollar cost, and death); the International Classification of Functioning (ICF); PROMIS (Patient-Reported Outcomes Measurement System); and the Outcomes Hierarchy. Of these, only the 5 Ds and ICF frameworks have been systematically applied in core set development. Outside the area of rheumatology, several core sets were identified; these had been developed through a limited range of consensus-based methods with varying degrees of methodological rigor. None applied a framework to ensure content validity of the end product.Conclusion.This scoping review reinforced the need for clear methods and standards for core set development. Based on these findings, OMERACT will make its own conceptual framework and working process more explicit. Proposals for how to achieve this were discussed at the OMERACT 11 conference.

Achieving Consensus in the Measurement of Psychological Adjustment to Cleft Lip and/or Palate at Age 8+ Years

2020 ◽  
Vol 57 (6) ◽  
pp. 746-752 ◽  
Author(s):  
Nicola Marie Stock ◽  
Vanessa Hammond ◽  
Daniela Hearst ◽  
Tina Owen ◽  
Zoe Edwards ◽  
...  
Keyword(s):  
Conceptual Framework ◽  
Psychological Adjustment ◽  
Outcome Measures ◽  
Clinical Utility ◽  
Cleft Lip ◽  
Outcome Measurement ◽  
Collaborative Process ◽  
The United Kingdom ◽  
Core Outcome Measures ◽  
Current Article

Background: Consensus regarding optimal outcome measurement has been identified as one of the most important, yet most challenging developments for the future of cleft lip and/or palate (CL/P) services. In 2011, a process began to adopt a shared conceptual framework and to identify a set of core outcome measures for the comprehensive assessment of psychological adjustment. Objectives: The aim of the current article is to outline the collaborative process used to achieve consensus in the academic and clinical measurement of psychological adjustment to CL/P from the age of 8 years onward. Results: A conceptual framework and corresponding parent- and self-reported outcome measures for use at ages 8, 10, 12, 15, 18, 20, and 25 years have been agreed upon by clinicians, researchers, and patient and parent representatives. All measures have been evaluated according to their psychometric properties, clinical utility, ability to produce meaningful longitudinal data, and a range of pragmatic considerations. Conclusions: Although the collaborative process has been challenging and has required ongoing dedication from multiple stakeholders, consistency in data collection over time will allow for key research questions in CL/P to be addressed, both in the United Kingdom (UK) and internationally. The process has also demonstrated the clinical utility of the measures and the potential for the gradual integration of the measures into clinical practice. UK progress has sparked global interest, and the adaptation of the framework and its corresponding measures for worldwide use is now a prominent focus.

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 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 Outcomes Measured in Polymyalgia Rheumatica and Measurement Properties of Instruments Considered for the OMERACT Core Outcome Set: A Systematic Review

2020 ◽  
pp. jrheum.200248 ◽  
Author(s):  
Helen Twohig ◽  
Claire Owen ◽  
Sara Muller ◽  
Christian D. Mallen ◽  
Caroline Mitchell ◽  
...  
Keyword(s):  
Physical Function ◽  
Outcome Measures ◽  
Polymyalgia Rheumatica ◽  
Outcome Measurement ◽  
Core Outcome Set ◽  
Full Range ◽  
Measurement Properties ◽  
Core Outcome ◽  
Health Measurement ◽  
Outcome Set

Objective To systematically identify the outcome measures and instruments used in clinical studies of polymyalgia rheumatica (PMR) and to evaluate evidence about their measurement properties. Methods Searches based on the MeSH term “polymyalgia rheumatica” were carried out in 5 databases. Two researchers were involved in screening, data extraction, and risk of bias assessment. Once outcomes and instruments used were identified and categorized, key instruments were selected for further review through a consensus process. Studies on measurement properties of these instruments were appraised against the COSMIN-OMERACT (COnsensus-based Standards for the selection of health Measurement Instruments–Outcome Measures in Rheumatology) checklist to determine the extent of evidence supporting their use in PMR. Results Forty-six studies were included. In decreasing order of frequency, the most common outcomes (and instruments) used were markers of systemic inflammation [erythrocyte sedimentation rate (ESR), C-reactive protein (CRP)], pain [visual analog scale (VAS)], stiffness (duration in minutes), and physical function (elevation of upper limbs). Instruments selected for further evaluation were ESR, CRP, pain VAS, morning stiffness duration, and the Health Assessment Questionnaire. Five studies evaluated measurement properties of these instruments, but none met all of the COSMIN-OMERACT checklist criteria. Conclusion Measurement of outcomes in studies of PMR lacks consistency. The critical patient-centered domain of physical function is poorly assessed. None of the candidate instruments considered for inclusion in the core outcome set had high-quality evidence, derived from populations with PMR, on their full range of measurement properties. Further studies are needed to determine whether these instruments are suitable for inclusion in a core outcome measurement set for PMR.

scholarly journals AB0373 PSYCHOMETRIC PROPERTIES OF OUTCOME MEASUREMENT INSTRUMENTS FOR LARGE VESSEL VASCULITIS: A SYSTEMATIC LITERATURE REVIEW

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1213.1-1213
Author(s):  
G. Boleto ◽  
A. Berti ◽  
P. A. Merkel ◽  
S. Aydin ◽  
H. Direskeneli ◽  
...  
Keyword(s):  
Disease Activity ◽  
Psychometric Properties ◽  
Outcome Measures ◽  
Outcome Measurement ◽  
Large Vessel Vasculitis ◽  
Large Vessel ◽  
Measurement Instruments ◽  
Core Domain ◽  
Patient Reported ◽  
Disease Damage

Background:Giant cell arteritis (GCA) and Takayasu arteritis (TAK) are two forms of chronic progressive large-vessel vasculitis (LVV) of unknown etiology. In 2016, the OMERACT Vasculitis Working Group proposed the development of a Core Domain Set of outcome measures for LVV including organ and arterial function, fatigue, pain, biomarkers, and death (1). Understanding the psychometric properties of outcome measurement instruments is essential when selecting among instruments to use in research; a summary of such properties for measures of LVV has not been developed.Objectives:To systematically review and summarize the psychometric properties of outcome measurement instruments used to measure the domains of the OMERACT core domain set for LVV.Methods:A comprehensive search of several databases (Medline, EMBASE, Cochrane, among others) from inception to July 14, 2020 was conducted. Articles were included if they covered psychometric properties of instruments used in LVV. Following the COSMIN and OMERACT frameworks, different psychometric properties (validity, inter- and intra-observer reliability, sensitivity to change, and feasibility) of outcome measurement instruments used in LVV (GCA and TAK) were assessed. Risk of bias was assessed according to the COSMIN checklist.Results:Among the 3534 articles identified, 15 studies focusing on the development or validation of psychometric properties on LVV met the predefined criteria. Two were development studies and 13 were validation studies. These studies provided information on 13 instruments: 5 instruments specific to TAK, 2 specific to systemic vasculitides, and 6 general, non-disease-specific instruments. No instruments specific to GCA were identified.Of the main psychometric properties assessed in the included studies, 40% had a low, 47% had moderate, and 13% had high risk of bias. Construct validity was the property most frequently assessed (in 93% of the tools) (Figure 1).In TAK, the Indian Takayasu Clinical Activity Score 2010 (ITAS2010) showed good consistency (r=0.97), reliability (intra-observer, ICC=0.60; inter-observer, ICC=0.92) and validity (correlation with Physician Global Assessment (PGA) (r=0.73)) for disease activity. Regarding disease damage, the Disease Extent Index-Takayasu (DEI-Tak) showed good validity (correlation with NIH score 94%, k=0.85). Non-specific vasculitis instruments such as the Vasculitis Damage Index (VDI) and the Birmingham Vasculitis Activity Score (BVAS) showed moderate validity in the assessment of disease damage in GCA (cumulative glucocorticoid dose and disease duration, r=0.30 and r=0.29) and TAK (cumulative glucocorticoid dose and disease duration, r=0.29 and r=0.25) in the former and disease activity in GCA in the later (PGA, r=0.50).Six non-vasculitis-specific patient-reported outcomes (PROs) instruments were identified, all showing low to moderate validity in GCA/TAK.Conclusion:The psychometric properties of 13 outcome measures to study LVV covering the OMERACT domains of disease activity, damage, and patient-reported outcomes were assessed. ITAS2010, DEI-Tak, VDI, and BVAS were the instruments with better psychometric properties for disease activity and/or damage. Disease activity and/or damage instruments specific for GCA, and validated PROs for both GCA and TAK are needed.References:[1]Sreih GA, Alibaz-Oner F, Kermani TA, Aydin SZ, Cronholm PF, Davis T, et al. Development of a Core Set of Outcome Measures for Large-vessel Vasculitis: Report from OMERACT 2016 | The Journal of Rheumatology [Internet]. [cité 26 avr 2020]. Disponible sur: http://www.jrheum.org/content/44/12/1933.longDisclosure of Interests:None declared

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