Embracing unity at OMERACT: Valuing equity, promoting diversity, fostering inclusivity.

OBJECTIVE: To increase awareness and understanding of the principles of Equity, Diversity, and Inclusivity (EDI) within Outcome Measures in Rheumatology's (OMERACT) members. For this, we aimed to obtain ideas on how to promote and foster these principles within the organization and determine the diversity of the current membership in order to focus future efforts. METHODS: We held a plenary workshop session at OMERACT 2023 with roundtable discussions on barriers and solutions to increased diversity within OMERACT. We conducted an anonymous, web-based survey of members to record characteristics including population group, gender identity, education level, age, and ability. RESULTS: The workshop generated ideas to increase diversity of participants across the themes of building relationships [12 topics], materials and methods [5 topics], and conference-specific [6 topics]. Four hundred and seven people responded to the survey (25 % response rate). The majority of respondents were White (75 %), female (61 %), university-educated (94 %), Christian (42 %), spoke English at home (60 %), aged 35 to 55 years (50 %), and did not report a disability (64 %). CONCLUSION: OMERACT is committed to improving its diversity. Next steps include strategic recruitment of members to the EDI working group, drafting an EDI mission statement centering equity and inclusivity in the organization, and developing guidance for the OMERACT Handbook to help all working groups create actionable plans for promoting EDI principles.

Strategies to promote implementation of core outcomes for medication adherence trials in rheumatology: A report from the OMERACT-Adherence Group.

OBJECTIVES: To identify barriers, facilitators, and strategies for future implementation of the OMERACT-Adherence Core Outcome Set (COS) in medication adherence trials for rheumatic conditions. METHODS: Preliminary Delphi survey findings were discussed at OMERACT 2023, utilising the Consolidated Framework for Implementation Research 2 to identify implementation barriers, facilitators, and solutions. RESULTS: Implementation strategies included simplifying the COS definitions, making it adaptabile for clinical practice and drug trials, adherence trial training workshops, and collaborating with key stakeholders such as payers and other COS developers. CONCLUSION: Ongoing collaboration with individuals and organisations within and beyond rheumatology ensures broader applicability of OMERACT-Adherence COS.

Consensus on the definitions and descriptions of the domains of the OMERACT Core Outcome Set for shared decision making interventions in rheumatology trials.

OBJECTIVE: To gain consensus on the definitions and descriptions of the domains of the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials evaluating shared decision making (SDM) interventions. METHODS: Following the OMERACT Handbook methods, our Working Group (WG), comprised of 90 members, including 17 patient research partners (PRPs) and 73 clinicians and researchers, had six virtual meetings in addition to email exchanges to develop draft definitions and descriptions. The WG then conducted an international survey of its members to gain consensus on the definitions and descriptions. Finally, the WG members had virtual meetings and e-mail exchanges to review survey results and finalize names, definitions and descriptions of the domains. RESULTS: WG members contributed to developing the definitions. Fifty-two members representing four continents and 13 countries completed the survey, including 15 PRPs, 33 clinicians and 37 researchers. PRPs and clinicians/researchers agreed with all definitions and descriptions with agreements ranging from 87% to 100%. Respondents suggested wording changes to the names, definitions and descriptions to better reflect the domains. Discussions led to further simplification and clarification to address common questions/concerns about the domains. CONCLUSION: Our WG reached consensus on the definitions and descriptions of the domains of the core domain set for rheumatology trials of SDM interventions. This step is crucial to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set. CLINICAL SIGNIFICANCE: The current study provides consensus-based definitions and descriptions for the domains of the OMERACT core domain set for shared decision making interventions from patients/caregivers, clinicians and researchers. This is a crucial step to understand each domain and provides the foundation to identify instruments to measure each domain for inclusion in the Core Outcome Measurement Set for trials of SDM interventions.

OMERACT Core outcome measurement set for shared decision making in rheumatic and musculoskeletal conditions: a scoping review to identify candidate instruments.

OBJECTIVES: Shared decision making (SDM) is a central tenet in rheumatic and musculoskeletal care. The lack of standardization regarding SDM instruments and outcomes in clinical trials threatens the comparative effectiveness of interventions. The Outcome Measures in Rheumatology (OMERACT) SDM Working Group is developing a Core Outcome Set for trials of SDM interventions in rheumatology and musculoskeletal health. The working group reached consensus on a Core Outcome Domain Set in 2020. The next step is to develop a Core Outcome Measurement Set through the OMERACT Filter 2.2. METHODS: We conducted a scoping review (PRISMA-ScR) to identify candidate instruments for the OMERACT Filter 2.2 We systematically reviewed five databases (Ovid MEDLINE®, Embase, Cochrane Library, CINAHL and Web of Science). An information specialist designed search strategies to identify all measurement instruments used in SDM studies in adults or children living with rheumatic or musculoskeletal diseases or their important others. Paired reviewers independently screened titles, abstracts, and full text articles. We extracted characteristics of all candidate instruments (e.g., measured construct, measurement properties). We classified candidate instruments and summarized evidence gaps with an adapted version of the Summary of Measurement Properties (SOMP) table. RESULTS: We found 14,464 citations, read 239 full text articles, and included 99 eligible studies. We identified 220 potential candidate instruments. The five most used measurement instruments were the Decisional Conflict Scale (traditional and low literacy versions) (n=38), the Hip/Knee-Decision Quality Instrument (n=20), the Decision Regret Scale (n=9), the Preparation for Decision Making Scale (n=8), and the CollaboRATE (n=8). Only 44 candidate instruments (20%) had any measurement properties reported by the included studies. Of these instruments, only 57% matched with at least one of the 7-criteria adapted SOMP table. CONCLUSION: We identified 220 candidate instruments used in the SDM literature amongst people with rheumatic and musculoskeletal diseases. Our classification of instruments showed evidence gaps and inconsistent reporting of measurement properties. The next steps for the OMERACT SDM Working Group are to match candidate instruments with Core Domains, assess feasibility and review validation studies of measurement instruments in rheumatic diseases or other conditions. Development and validation of new instruments may be required for some Core Domains.

Endorsement of the OMERACT core domain set for shared decision making interventions in rheumatology trials: Results from a multi-stepped consensus-building approach.

OBJECTIVE: To gain consensus on the Outcome Measures in Rheumatology (OMERACT) core domain set for rheumatology trials of shared decision making (SDM) interventions. METHODS: The process followed the OMERACT Filter 2.1 methodology, and used consensus-building methods, with patients involved since the inception. After developing the draft core domain set in previous research, we conducted five steps: (i) improving the draft core domain set; (ii) developing and disseminating white-board videos to promote its understanding; (iii) conducting an electronic survey to gather feedback on the draft core domain set; (iv) finalizing the core domain set and developing summaries, a plenary session video and discussion boards to promote its understanding; and (v) conducting virtual workshops with voting to endorse the core domain set. RESULTS: A total of 167 participants from 28 countries answered the survey (62% were patients/caregivers). Most participants rated domains as relevant (81%-95%) and clear (82%-93%). A total of 149 participants (n = 48 patients/caregivers, 101 clinicians/researchers) participated in virtual workshops and voted on the proposed core domain set which received endorsement by 95%. Endorsed domains are: 1- Knowledge of options, their potential benefits and harms; 2- Chosen option aligned with each patient's values and preferences; 3- Confidence in the chosen option; 4- Satisfaction with the decision-making process; 5- Adherence to the chosen option and 6- Potential negative consequences of the SDM intervention. CONCLUSION: We achieved consensus among an international group of stakeholders on the OMERACT core domain set for rheumatology trials of SDM interventions. Future research will develop the Core Outcome Measurement Set. CLINICAL SIGNIFICANCE: Prior to this study, there had been no consensus on the OMERACT core domain set for SDM interventions. The current study shows that the OMERACT core domain set achieved a high level of endorsement by key stakeholders, including patients/caregivers, clinicians and researchers.

Health Care Utilization for Musculoskeletal Issues During the Prediagnosis Period in Psoriatic Arthritis: A Population-Based Study.

OBJECTIVE: Information about the prediagnosis period in psoriatic arthritis (PsA) is limited. The present study was undertaken to compare health care utilization related to musculoskeletal issues during a 5-year period prior to the diagnosis of PsA versus that of subjects with no prior inflammatory arthritis within a primary care setting. METHODS: We conducted a population-based, matched cohort study using electronic medical records and administrative data in Ontario, Canada. Age- and sex-matched cohorts of PsA patients and comparators from the same family physicians were assembled. Comparators were not allowed to have prior spondyloarthritis, ankylosing spondylitis, or rheumatoid arthritis billing code diagnoses. The study outcomes included health care utilization and costs related to nonspecific musculoskeletal issues during a 5-year period prior to the index date. RESULTS: We studied 462 PsA patients and 2,310 matched comparators. The odds ratio (OR) related to visiting a primary care physician for nonspecific musculoskeletal issues in patients with PsA was 2.14 (95% confidence interval 1.73-2.64) in the year immediately preceding the index date and was similarly elevated up to 5 years prior. The OR related to using other musculoskeletal-related health care services, including musculoskeletal specialists visits, joint injections, joint imaging, and emergency department visits, was higher in PsA as early as 5 years preceding the index date. Total and musculoskeletal-related health care costs prior to the index date were higher for patients with PsA versus comparators. CONCLUSION: A prodromal PsA phase characterized by nonspecific musculoskeletal symptoms may exist. Further study is needed to determine if this represents a window for earlier diagnosis of PsA.

Trends in mortality and cause-specific mortality among patients with psoriasis and psoriatic arthritis in Ontario, Canada.

BACKGROUND: There is limited information about mortality rates among patients with psoriasis and psoriatic arthritis (PsA) in North America and their change over the past 2 decades. OBJECTIVE: To compare all-cause and cause-specific mortality rates in patients with psoriasis to the general population in Ontario, Canada, from 1996 to 2016. METHODS: We conducted a population-based, retrospective cohort study of adult residents using administrative health data. All-cause and cause-specific standardized mortality rates, standardized mortality ratios, and excess mortality rates were calculated. RESULTS: 176,858 (2,524 deaths) patients with psoriasis and 15,430 (221 deaths) patients with PsA were identified in 2016. Patients with psoriasis and PsA had standardized excess mortality rates of 1.44 and 2.43 per 1000 population, respectively. Standardized mortality rates decreased by approximately 30% over the study period in both disease groups but remained significantly elevated compared to the general population. The leading causes of death in psoriasis and PsA patients were cancer, circulatory disease, and respiratory conditions. LIMITATIONS: We were unable to classify patients according to disease severity. CONCLUSIONS: Despite improvements in psoriasis treatment, the relative excess mortality, which may be related to risk factors for psoriatic disease, remained unchanged, with an average of approximately 1 to 2 extra deaths per 1,000 patients in 2016.

Identifying and Characterizing Psoriasis and Psoriatic Arthritis Patients in Ontario Administrative Data: A Population-based Study From 1991 to 2015.

OBJECTIVES: We assessed the accuracy of case definition algorithms for psoriasis and psoriatic arthritis (PsA) in health administrative data and used primary care electronic medical records (EMR) to describe disease and treatment characteristics of these patients. METHODS: We randomly sampled 30,424 adult Ontario residents from the Electronic Medical Record Primary Care database and identified 2215 patients with any possible psoriatic disease-related terms in their EMR. The relevant patient records were chart abstracted to confirm diagnoses of psoriasis or PsA. This validation set was then linked to health administrative data to assess the performance of different algorithms for physician billing diagnosis codes, hospitalization diagnosis codes, and medications for psoriatic disease. We report the performance of selected case definition algorithms and describe the disease characteristics of the validation set. RESULTS: Our reference standard identified 1028 patients with psoriasis and 77 patients with PsA, for an overall prevalence of 3.4% for psoriasis and 0.3% for PsA. Most patients with PsA (66%) had a rheumatology-confirmed diagnosis, while only 30% of the patients with psoriasis had dermatology-confirmed diagnosis. The use of systemic medications was much more common with PsA than with psoriasis. All algorithms had excellent specificity (97-100%). The sensitivity and positive predictive value were moderate and varied between different algorithms (34-72%). CONCLUSION: The accuracy of case definition algorithms for psoriasis and PsA varies widely. However, selected algorithms produced population prevalence estimates that were within the expected ranges, suggesting that they may be useful for future research purposes.

OMERACT Development of a Core Domain Set of Outcomes for Shared Decision-making Interventions.

OBJECTIVE: The Outcome Measures in Rheumatology (OMERACT) Shared Decision Making (SDM) Working Group aims to determine the core outcome domain set for measuring the effectiveness of SDM interventions in rheumatology trials. METHODS: A white paper was developed to clarify the draft core domain set. It was then used to prepare for interviews to investigate reasons for lack of consensus on it and to suggest further improvements. RESULTS: OMERACT scientists/clinicians (n = 13) and patients (n = 10) suggested limiting the core domain set to outcome domains, removing process domains, and clarifying remaining domains. CONCLUSION: A revised core domain set will undergo further consensus-building.

Trends in the Prevalence and Incidence of Psoriasis and Psoriatic Arthritis in Ontario, Canada: A Population-Based Study.

OBJECTIVE: To estimate the prevalence and incidence of psoriasis and psoriatic arthritis (PsA) over time in Ontario, Canada. METHODS: We performed a population-based study of Ontario health administrative data, using validated case definitions for psoriasis and PsA. We computed the crude and age- and sex-standardized cumulative prevalence and incidence of psoriasis from 2000 to 2015. RESULTS: Among the 10,774,802 individuals ages ≥20 years residing in Ontario in 2015, we identified 273,238 patients with psoriasis and 18,655 patients with PsA, equating to cumulative prevalence estimates of 2.54% and 0.17%, respectively. Correcting the prevalence estimates for imperfect sensitivity and specificity resulted in similar estimates. The male:female ratio was approximately 1.0 for both conditions. For psoriasis, the age- and sex-standardized cumulative prevalence increased from 1.74% in 2000 to 2.32% in 2015. For PsA, the age- and sex-standardized cumulative prevalence increased from 0.09% in 2008 to 0.15% in 2015. Between 2008 and 2015, annual incidence rates for psoriasis decreased, whereas those for PsA remained relatively stable. CONCLUSION: The prevalence and incidence of psoriasis and PsA in Ontario are similar to those observed in Europe and the US. The steady increase in the prevalence of psoriasis and PsA over the past decade may be due to a combination of population aging, population growth, and increasing life expectancy.

The Patient Research Partner Network Matures: A Report from the GRAPPA 2017 Annual Meeting.

The Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) has reached the third of 5 stages of organizational maturity regarding incorporating patient research partners (PRP) into psoriatic arthritis (PsA) and psoriasis research and educational efforts. Herein, we report the involvement of PRP at the GRAPPA 2017 annual meeting and plans for future PRP engagement.

Outcome Measures in Rheumatology - Interventions for medication Adherence (OMERACT-Adherence) Core Domain Set for Trials of Interventions for Medication Adherence in Rheumatology: 5 Phase Study Protocol.

BACKGROUND: Over the last 20 years, there have been marked improvements in the availability of effective medications for rheumatic conditions such as gout, osteoporosis and rheumatoid arthritis (RA), which have led to a reduction in disease flares and the risk of re-fracture in osteoporosis, and the slowing of disease progression in RA. However, medication adherence remains suboptimal, as treatment regimens can be complex and difficult to continue long term. Many trials have been conducted to improve adherence to medication. Core domains, which are the outcomes of most relevance to patients and clinicians, are a pivotal component of any trial. These core domains should be measured consistently, so that all relevant trials can be combined in systematic reviews and meta-analyses to reach conclusions that are more valid. Failure to do this severely limits the potential for trial-based evidence to inform decisions on how to support medication adherence. The Outcome Measures in Rheumatology (OMERACT) - Interventions for Medication Adherence study by the OMERACT-Adherence Group aims to develop a core domain set for interventions that aim to support medication adherence in rheumatology. METHODS/DESIGN: This OMERACT-Adherence study has five phases: (1) a systematic review to identify outcome domains that have been reported in interventions focused on supporting medication adherence in rheumatology; (2) semi-structured stakeholder interviews with patients and caregivers to determine their views on the core domains; (3) focus groups using the nominal group technique with patients and caregivers to identify and rank domains that are relevant to them, including the reasons for their choices; (4) an international three-round modified Delphi survey involving patients with diverse rheumatic conditions, caregivers, health professionals, researchers and other stakeholders to develop a preliminary core domain set; and (5) a stakeholder workshop with OMERACT members to review, vote on and reach a consensus on the core domain set for interventions to support medication adherence in rheumatology. DISCUSSION: Establishing a core domain set to be reported in all intervention studies undertaken to support patients with medication adherence will enhance the relevance and the impact of these results and improve the lives of people with rheumatic conditions.

The effects of cultural background on patient-perceived impact of psoriatic arthritis - a qualitative study conducted in Brazil and France.

BACKGROUND: In psoriatic arthritis (PsA) almost all qualitative studies have been performed in European populations. This work aimed to evaluate the impact of PsA in Brazilian and French subjects, as well as to explore cultural differences in the experience of disease and to recognize domains important for patients living with PsA outside Europe. METHODS: A qualitative study was conducted in two university hospitals in Brazil and France; outpatients fulfilling Classification Criteria for PsA participated in individual interviews regarding the impact of PsA; interviews were conducted in the local language. The sample size was defined by saturation; interviews were recorded and transcribed and content analysis was performed. RESULTS: Fifteen patients were interviewed in Brazil and 13 in France. Mean disease duration was 16.5 ± 12.5 years (range: 8 months to 47 years) and 14.4 ± 8.4 years (range 12 months to 29 years) for Brazilian and French subjects, respectively. A broad impact was perceived: 67 codes emerged from the interviews and were grouped in 41 categories. Although 2/3 of categories were common to both nationalities, some important health domains from the perspective of PsA patients from a non-European background were brought to light including sexual dysfunction, emotional impact of psoriasis and impact of prejudice on social and professional life. CONCLUSIONS: This study highlights the importance of assessing the impact of PsA on a national level, emphasizing the common cross-cultural aspects but also revealing domains of interest for patients with PsA living outside Europe which merit further study.

Group for Research and Assessment of Psoriasis and Psoriatic Arthritis/Outcome Measures in Rheumatology Consensus-Based Recommendations and Research Agenda for Use of Composite Measures and Treatment Targets in Psoriatic Arthritis.

OBJECTIVE: A meeting was convened by the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) and Outcome Measures in Rheumatology (OMERACT) to further the development of consensus among physicians and patients regarding composite disease activity measures and targets in psoriatic arthritis (PsA). METHODS: Prior to the meeting, physicians and patients completed surveys on outcome measures. A consensus meeting of 26 rheumatologists, dermatologists, and patient research partners reviewed evidence on composite measures and potential treatment targets plus results of the surveys. The meeting consisted of plenary presentations, breakout sessions, and group discussions. International experts including members of GRAPPA and OMERACT were invited to the meeting, including the developers of all of the measures discussed. After discussions, participants voted on proposals for use, and consensus was established in a second survey. RESULTS: Survey results from 128 health care professionals and 139 patients were analyzed alongside a systematic literature review summarizing evidence. A weighted vote was cast for composite measures. For randomized controlled trials, the most popular measures were the PsA disease activity score (40 votes) and the GRAPPA composite index (28 votes). For clinical practice, the most popular measures were an average of scores on 3 visual analog scales (45 votes) and the disease activity in PsA score (26 votes). After discussion, there was no consensus on a composite measure. The group agreed that several composite measures could be used and that future studies should allow further validation and comparison. The group unanimously agreed that remission should be the ideal target, with minimal disease activity (MDA)/low disease activity as a feasible alternative. The target should include assessment of musculoskeletal disease, skin disease, and health-related quality of life. The group recommended a treatment target of very low disease activity (VLDA) or MDA. CONCLUSION: Consensus was not reached on a continuous measure of disease activity. In the interim, the group recommended several composites. Consensus was reached on a treatment target of VLDA/MDA. An extensive research agenda was composed and recommends that data on all PsA clinical domains be collected in ongoing studies.

Toward the Development of a Core Set of Outcome Domains to Assess Shared Decision-making Interventions in Rheumatology: Results from an OMERACT Delphi Survey and Consensus Meeting.

OBJECTIVE: The aim of this Outcome Measures in Rheumatology (OMERACT) Working Group was to determine the core set of outcome domains and subdomains for measuring the effectiveness of shared decision-making (SDM) interventions in rheumatology clinical trials. METHODS: Following the OMERACT Filter 2.0, and based on a previous literature review of SDM outcome domains and a nominal group process at OMERACT 2014, (1) an online Delphi survey was conducted to gather feedback on the draft core set and refine its domains and subdomains, and (2) a workshop was held at the OMERACT 2016 meeting to gain consensus on the draft core set. RESULTS: A total of 170 participants completed Round 1 of the Delphi survey, and 116 completed Round 2. Respondents came from 29 countries, with 49% being patients/caregivers. Results showed that 14 out of the 17 subdomains within the 7 domains exceeded the 70% criterion (endorsement ranged from 83% to 100% of respondents). At OMERACT 2016, only 8% of the 96 attendees were patients/caregivers. Despite initial votes of support in breakout groups, there was insufficient comfort about the conceptualization of these 7 domains and 17 subdomains for these to be endorsed at OMERACT 2016 (endorsement ranged from 17% to 68% of participants). CONCLUSION: Differences between the Delphi survey and consensus meeting may be explained by the manner in which the outcomes were presented, variations in participant characteristics, and the context of voting. Further efforts are needed to address the limited understanding of SDM and its outcomes among OMERACT participants.

Proceedings of the GRAPPA 2016 Retreat.

In advance of its 2016 annual meeting, members of the steering committee of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) convened for a strategic planning meeting. The purpose of this advance meeting was to review the work of GRAPPA since its inception in 2003, ascertain and review the current priorities of the group, and devise a strategy for proceeding. The key accomplishments of GRAPPA to date, priorities and objectives for the next 5 years, and goals and opportunities for the GRAPPA committees were discussed. GRAPPA has a responsibility and commitment to patients, its members, and partners to innovate, inspire, and improve knowledge and the ability to care for people with psoriasis and psoriatic arthritis.

Defining Outcome Measures for Psoriatic Arthritis: A Report from the GRAPPA-OMERACT Working Group.

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.

Tackling Patient Centricity: A Report from the GRAPPA 2016 Annual Meeting.

In line with the global trend to have disease-related organizations be more patient-centric in their approach, the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) has made substantial progress incorporating patient research partners (PRP) into psoriatic arthritis and psoriasis research. Herein we summarize the involvement of PRP at the GRAPPA 2016 annual meeting. Plans for future PRP engagement were also discussed.

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

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.

Health Equity Considerations for Developing and Reporting Patient-reported Outcomes in Clinical Trials: A Report from the OMERACT Equity Special Interest Group.

OBJECTIVE: Despite advances integrating patient-centered outcomes into rheumatologic studies, concerns remain regarding their representativeness across diverse patient groups and how this affects equity. The Outcome Measures in Rheumatology (OMERACT) Equity Working Group aims to determine whether and how to address equity issues within the core outcome sets of domains and instruments. METHODS: We surveyed current and previous OMERACT meeting attendees and members of the Campbell and Cochrane Equity Group regarding whether to address equity issues within the OMERACT Filter 2.0 Core Outcome Sets and how to assess the appropriateness of domains, instruments, and measurement properties among diverse patients. At OMERACT 2016, results of the survey and a narrative review of differential psychosocial effects of rheumatoid arthritis (i.e., on men) were presented to stimulate discussion and develop a research agenda. RESULTS: We proposed 6 moments for which an equity lens could be added to the development, selection, or testing of patient-reported outcome measures (PROM): (1) recruitment, (2) domain selection, (3) feasibility in diverse settings, (4) instrument validity, (5) thresholds of meaning, and (6) consideration of statistical power of subgroup analyses for outcome reporting. CONCLUSION: There is a need to (1) conduct a systematic review to assess how equity and population characteristics have been considered in PROM development and whether these differences influence the ranking of importance of outcome domains or a patient's response to questionnaire items, and (2) conduct the same survey described above with patients representing groups experiencing health inequities.