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Objective. Outcome Measures in Rheumatology (OMERACT) Filter 2.1 revised the process used for core outcome measurement set selection to add rigor 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 3 original OMERACT pillars. Based on these, we developed 4 signaling questions. We introduced the Summary of Measurement Properties table that summarizes the 7 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 2 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 2 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.

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.

Objective. To describe the Outcome Measures in Rheumatology (OMERACT) stepwise approach to select and develop an imaging instrument with musculoskeletal ultrasound (US) as an example. Methods. The OMERACT US Working Group (WG) developed a 4-step process to select instruments based on imaging. Step 1 applies the OMERACT Framework Instrument Selection Algorithm (OFISA) to existing US outcome measurement instruments for a specific indication. This step requires a literature review focused on the truth, discrimination, and feasibility aspects of the instrument for the target pathology. When the evidence is completely unsatisfactory, Step 2 is a consensus process to define the US characteristics of the target pathology including one or more so-called “elementary lesions”. Step 3 applies the agreed definitions to the image, evaluates their reliability, develops a severity grading of the lesion(s) at a given anatomical site, and evaluates the effect of the acquisition technique on feasibility and lesion(s) detection. Step 4 applies and assesses the definition(s) and scoring system(s) in cross-sectional studies and multicenter trials. The imaging instrument is now ready to pass a final OFISA check. Results. With this process in place, the US WG now has 18 subgroups developing US instruments in 10 different diseases. Half of them have passed Step 3, and the groups for enthesitis (spondyloarthritis, psoriatic arthritis), synovitis, and tenosynovitis (rheumatoid arthritis) have finished Step 4. Conclusion. The US WG approach to select and develop outcome measurement instruments based on imaging has been repeatedly and successfully applied in US, but is generic for imaging and fits with OMERACT Filter 2.1.

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.

Objective. While there has been substantial progress in the development of core outcomes sets, the degree to which these are used by researchers is variable. We convened a special workshop on knowledge translation at the Outcome Measures in Rheumatology (OMERACT) 2016 with 2 main goals. The first focused on the development of a formal knowledge translation framework and the second on promoting uptake of recommended core outcome domain and instrument sets. Methods.We invited all 189 OMERACT 2016 attendees to the workshop; 86 attended, representing patient research partners (n = 15), healthcare providers/clinician researchers (n = 52), industry (n = 4), regulatory agencies (n = 4), and OMERACT fellows (n = 11). Participants were given an introduction to knowledge translation and were asked to propose and discuss recommendations for the OMERACT community to (1) strengthen stakeholder involvement in the core outcome instrument set development process, and (2) promote uptake of core outcome sets with a specific focus on the potential role of post-regulatory decision makers. Results.We developed the novel "OMERACT integrated knowledge translation" framework, which formalizes OMERACT's knowledge translation strategies. We produced strategies to improve stakeholder engagement throughout the process of core outcome set development and created a list of creative and innovative ways to promote the uptake of OMERACT's core outcome sets. Conclusion. The guidance provided in this paper is preliminary and is based on the views of the participants. Future work will engage OMERACT groups, "post-regulatory decision makers," and a broad range of different stakeholders to identify and evaluate the most useful methods and processes, and to revise guidance accordingly.