Core Domain Set Selection According to OMERACT Filter 2.1: The OMERACT Methodology

Objective: To describe the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 methodology for core domain set selection. Methods: The “OMERACT Way for Core Domain Set selection” framework consists of 3 stages: first, generating candidate domains through literature reviews and qualitative work, then a process of consensus to obtain agreement from those involved, and finally formal voting on the OMERACT Onion. The OMERACT Onion describes the placement of domains in layers/circles: mandatory in all trials/mandatory in specific circumstances (inner circle); important but optional (middle circle); or research agenda (outer circle). Five OMERACT working groups presented their core domain sets for endorsement by the OMERACT community. Tools including a workbook and whiteboard video were created to assist the process. The methods workshop at OMERACT 2018 introduced participants to this framework. Results: The 5 OMERACT working groups achieved consensus on their proposed core domain sets. After the Methodology Workshop training exercise at OMERACT 2018, over 90% of participants voted that they were confident that they understood the process of core domain set selection. Conclusion: The methods described in this paper were successfully used by the 5 working groups voting on domains at the OMERACT 2018 meeting, demonstrating the feasibility of the process. In addition, participants at OMERACT 2018 expressed increased confidence and understanding of the core domain set selection process after the training exercise. This methodology will continue to evolve, and we will use innovative technology such as whiteboard videos as a key part of our dissemination and implementation strategy for new methods

Instrument Selection Using the OMERACT Filter 2.1: The OMERACT Methodology.

Objective: Outcome Measures in Rheumatology (OMERACT) Filter 2.1 revised the process used for core outcome measurement set selection to add rigour and transparency in decision making. This paper describes OMERACT’s methodology for instrument selection. Methods: We presented instrument selection processes, tools, and reporting templates at OMERACT 2018, introducing the concept of “3 pillars, 4 questions, 7 measurement properties, 1 answer”. Truth, Discrimination and Feasibility are the three original OMERACT pillars. Based on these, we developed four signaling questions. We introduced the Summary of Measurement Properties (SOMP) table which summarizes the seven measurement properties: Truth (domain match, construct validity), Discrimination (test-retest reliability, longitudinal construct validity (responsiveness), clinical trial discrimination, thresholds of meaning), and Feasibility. These properties address a set of standards which, when met, answer the one question: Is there enough evidence to support the use of this instrument in clinical research of the benefits and harms of treatments in the population and study setting described? The OMERACT Filter 2.1 was piloted on two instruments by the Psoriatic Arthritis Working Group Results: The methodology was reviewed in a full plenary session and facilitated breakout groups. Tools to facilitate retention of the process (i.e., “The OMERACT Way”) were provided. The two instruments were presented and the recommendation of the working group was endorsed in the first OMERACT Filter 2.1 Instrument Selection votes. Conclusion: Instrument Selection using OMERACT Filter 2.1 is feasible and is now being implemented

Navigating the path of progress: The OMERACT 2023 emerging leaders program

Objectives: The Outcome Measures in Rheumatology Clinical Trials (OMERACT) Emerging Leaders Program (ELP) aims to cultivate a cohort of skilled leaders within the OMERACT community empowering them with expertise and knowledge to help shape and steer the organization into the future. This publication highlights the significance of the ELP in driving leadership excellence, its impact on OMERACT's evolution, and the outcomes and learnings from the OMERACT 2023 ELP. Methods: Insights from the 2018 ELP report informed 2023 program improvements. Engagement was measured by attendance and WhatsApp interactions. Positive program aspects, areas for improvement and ideas for enhancing future ELPs were captured via anonymous survey and participant focus groups. Results: Engagement with the ELP was high with 9 participants, 96 % attendance at all workshops, 154 WhatsApp interactions. All program components were highly rated, with the highest being the ‘Psychological Safety’ and ‘Methodology/Process/Politics’ workshops. Future enhancements included creating further networking, connection and support activities, practical leadership and methodological skill development opportunities, and a new stream focussing on organisational advancement. Conclusions: The 2023 OMERACT ELP was well received and successfully addressed areas previously identified as requiring improvement. New educational enhancements were valued, and the importance of fostering psychological safety at all levels was highlighted. The ELP fortifies OMERACT by nurturing a diverse array of skilled leaders who embody OMERACTs core values. Continuing to refine and evolve the ELP over time will help OMERACT sustain its global influence in patient-centered outcome research

Improving Benefit-harm Assessment of Therapies from the Patient Perspective: OMERACT Premeeting Toward Consensus on Core Sets for Randomized Controlled Trials

Objective: Outcome Measures in Rheumatology (OMERACT) convened a premeeting in 2018 to bring together patients, regulators, researchers, clinicians, and consumers to build upon previous OMERACT drug safety work, with patients fully engaged throughout all phases. Methods: Day 1 included a brief introduction to the history of OMERACT and methodology, and an overview of current efforts within and outside OMERACT to identify patient-reported medication safety concerns. On Day 2, two working groups presented results; after each, breakout groups were assembled to discuss findings. Results: Five themes pertaining to drug safety measurement emerged. Conclusion: Current approaches have failed to include data from the patient’s perspective. A better understanding of how individuals with rheumatic diseases view potential benefits and harms of therapies is essential

Evolving and evaluating the OMERACT fellows program: insights and implications from OMERACT 2023 fellows

Objective: To describe the evolution of the OMERACT Fellows Program (OM FP) and to evaluate the innovative changes implemented in the 2023 program. Methods: The OM FP, the first of its kind in global rheumatology, was developed in 2000 to mentor early career researchers in methods and processes for reaching evidence-driven consensus for outcome measures in clinical studies. The OM FP has evolved through continuing iterations of face to face and online feedback. Key new features delivered in 2023 included e-learning modules, virtual introductory pre-meetings, increased networking with Patient Research Partners (PRPs), learning opportunities to give and receive personal feedback, ongoing performance feedback during the meeting from Fellow peers, PRPs, senior OMERACTers (members of the OMERACT community) and Emerging Leader mentors, involvement in pitching promotions, two-minute Lightning Talks in a plenary session and an embedded poster tour. An online survey was distributed after the meeting to evaluate the program. Results: OM FP has included 208 fellows from 16 countries across 4 continents covering 47 different aspects of rheumatology outcomes since its inception. Over 50 % have remained engaged with OMERACT work. In 2023, 18 Fellows attended and 15 (83 %) completed the post-meeting survey. A dedicated OM FP was deemed important by all respondents, and 93 % would attend the meeting in future. The PRP/Fellow Connection Carousel and Lightning Talks were rated exceptional by 93 %. Key components to improve included clarification of expectations, overall workload, the Emerging Leaders Mentoring Program, and the content and duration of daily summary sessions. Conclusion: The innovations in the 2023 OM FP were well received by the majority of participants and supports early career rheumatology researchers to develop collaborations, skills and expertise in outcome measurement. Implementation of feedback from Fellows will enhance the program for future meetings, continuing to facilitate learning and succession planning within OMERACT

The spirit of OMERACT: Q methodology analysis of conference characteristics valued by delegates

Copyright © 2015. All rights reserved. Objective. To identify the major features of OMERACT meetings as valued by frequent participants and to explore whether there are groups of participants with different opinions. Methods. Using Q methodology (a qualitative and quantitative approach to grouping people according to subjective opinion), participants (who attended more than 1 OMERACT conference) sorted 66 statements relating to the "spirit of OMERACT" according to level of agreement across a normal distribution grid. Data were examined using Q factor analysis. Results. Of 226 potential participants, 105 responded (46%). All participants highly ranked the focus on global standardization of methods, outcome measures, data-driven research, methodological discussion, and international collaboration. Four factors describing the "spirit of OMERACT" were identified: "Evidence not eminence" (n = 31) valued the data- and evidence-driven research above personality and status; "Collaboration and collegiality" (n = 19) valued the international and cross-stakeholder collaboration, interaction, and collegiality; "Equal voices, equal votes, common goals" (n = 12) valued equality in discussion and voting, with everyone striving toward the same goal; "principles and product, not process" (n = 8) valued the principles of focusing on outcome measures and the product of guiding clinical trials, but were unsure whether the process is necessary to reach this. The factors did not segregate different stakeholder groups. Conclusion. Delegates value different elements of OMERACT, and thus the "spirit of OMERACT" encompasses evidence-based research, collaboration, and equality, although a small group are unsure whether the process is necessary to achieve the end result. Q methodology may prove useful for conference organizers to identify their delegates' different needs to tailor conference content

Core domain Set selection according to OMERACT filter 2.1: The OMERACT methodology

Objective. To describe the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 methodology for core domain set selection. Methods. The “OMERACT Way for Core Domain Set selection” framework consists of 3 stages: first, generating candidate domains through literature reviews and qualitative work, then a process of consensus to obtain agreement from those involved, and finally formal voting on the OMERACT Onion. The OMERACT Onion describes the placement of domains in layers/circles: mandatory in all trials/mandatory in specific circumstances (inner circle); important but optional (middle circle); or research agenda (outer circle). Five OMERACT working groups presented their core domain sets for endorsement by the OMERACT community. Tools including a workbook and whiteboard video were created to assist the process. The methods workshop at OMERACT 2018 introduced participants to this framework. Results. The 5 OMERACT working groups achieved consensus on their proposed core domain sets. After the Methodology Workshop training exercise at OMERACT 2018, over 90% of participants voted that they were confident that they understood the process of core domain set selection. Conclusion. The methods described in this paper were successfully used by the 5 working groups voting on domains at the OMERACT 2018 meeting, demonstrating the feasibility of the process. In addition, participants at OMERACT 2018 expressed increased confidence and understanding of the core domain set selection process after the training exercise. This methodology will continue to evolve, and we will use innovative technology such as whiteboard videos as a key part of our dissemination and implementation strategy for new methods

The evolution of instrument selection for inclusion in core outcome sets at OMERACT: Filter 2.2

Introduction: OMERACT uses an evidence-based framework known as the ‘OMERACT Filter Instrument Selection Algorithm’ (OFISA) to guide decisions in the assessment of outcome measurement instruments for inclusion in a core outcome set for interventional and observational clinical trials. Methods: A group of OMERACT imaging and patient-centered outcome methodologists worked with imaging outcome groups to facilitate the selection of imaging outcome measurement instruments using the OFISA approach. The lessons learned from this work influenced the evolution to Filter 2.2 and necessitated changes to OMERACT's documentation and processes. Results: OMERACT has revised documentation and processes to incorporate the evolution of instrument selection to Filter 2.2. These revisions include creation of a template for detailed definitions of the target domain which is a necessary first step for instrument selection, modifications to the Summary of Measurement Properties (SOMP) table to account for sources of variability, and development of standardized reporting tables for each measurement property. Conclusions: OMERACT Filter 2.2 represents additional modifications of the OMERACT guide for working groups in their rigorous assessment of measurement properties of instruments of various types, including imaging outcome measurement instruments. Enhanced reporting aims to increase the transparency of the evidence base leading to judgements for the endorsement of instruments in core outcome sets