INTRODUCTION:People with IA may suffer from pain of differing aetiologies and subtypes including nociceptive joint pain, neuropathic pain of carpal tunnel syndrome or nociplastic pain from concomitant fibromyalgia. Lack of precise measurement tools to identify nociplastic pain influences as a contextual factor potentially all outcomes in collected clinical trials as residual pain might impact various measurements in IA. The OMERACT 2025 pain SIG discussed, developing a scoping review from protocol, to identify an instrument to measure nociplastic pain in IA and a contextualised domain definition for nociplastic pain in IA. Stakeholder opinions were sought regarding pain in IA and the importance of identifying an instrument to measure nociplastic pain in IA. METHODS:A total of twenty-four participants attending the OMERACT 2025 pain SIG session included a mix of patients, clinicians, researchers, methodologists, and industry representatives. Patient research partner (PRP), MC spoke about the impact of pain including different pain subtypes in IA. She recapped the results of OMERACT 2023 poll where participants, including PRPs, agreed that assessing different pain subtypes in IA was important to improve targeted treatments for pain. SK - a pain specialist- presented evidence supporting the presence and impact of nociplastic pain in different IA's including rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondylarthritis (AxSpA). Details of the scoping review protocol developed by the OMERACT Pain Working Group identifying candidate instruments for nociplastic pain assessment in IA was presented. Participants opinions were polled regarding their perspectives of the nociplastic pain definition and measurement. RESULTS:Polling showed clear agreement on advancing efforts to identify or develop an outcome measure for nociplastic pain. Most participants (86 %, 19/24) endorsed beginning with a systematic review of the existing literature to identify an appropriate validated instrument. Following a pain neuroscience education session five of the six (83 %) patient research partners (PRP) agreed they would be able to report the different pain types experienced in IA. Only one participant (1/24) agreed that the current IASP nociplastic pain definition is directly applicable to IA. Most participants (96 %) either disagreed or were uncertain, and over half (14/24) felt the definition likely requires contextualisation for IA. DISCUSSION:There was broad agreement that, in a substantial proportion of patients with inflammatory arthritis, nociplastic pain persists despite optimal treatment, is challenging to manage in routine clinical practice, and is associated with substantial patient suffering. The OMERACT meeting underscored the need for a standardized measure of nociplastic pain in inflammatory arthritis to refine eligibility criteria and support the development of stratified approaches in future clinical trials.

Objectives To assess the construct validity of a modified single-item measure of bother due to side effects (the GP5 item) from the Functional Assessment of Chronic Illness Therapy (FACIT) system by comparing it to current symptomatic side effects from the Patient-Reported Outcomes of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) reported by patients with rheumatoid arthritis (RA). Methods Through a cross-sectional, web-based survey we collected information on the frequency of symptomatic side effects and bother from side effects related to RA medications. We applied multiple correspondence analysis (MCA) to reduce 80 symptomatic side effects into key dimensions (≥5% of the total variance each). We then examined associations among key dimensions, individual items, the sum of current side effects, and the single-item bother measure using Spearman rho. Results A total of 560 patients participated in the online survey. Our scree plot showed a clear elbow point after the first dimension, indicating that keeping just one dimension captured the most meaningful information. This overall side effect burden score appeared to reflect a broad concept influenced by a variety of symptomatic side effects, each having only a negligible to weak impact. Conclusions Our results may indicate that individuals have diverse experiences of side effects, allowing the global index to capture these variations, even when they differ across patients. Thus, a single-item burden measure to side effects can potentially serve as a useful summary indicator, shedding light on the impact of symptomatic side effects experienced by RA patients.

Randomized trials are used to evaluate health care interventions because they minimize confounding and selection bias through randomization. Harms reporting in trials remain suboptimal, despite established guidelines. To improve transparency and clinical relevance, trialists should share information about harms-whether assessed systematically or nonsystematically. Nonsystematically assessed adverse events warrant greater attention, as they are often underreported or inconsistently documented. Trialists should specify what was measured, when, and by whom. For each study arm, tables or data should be available that include all harms observed. For dichotomous outcomes, tables or data should include the number of people who experienced each harm in each group: the number of participants at risk of harms (ie, randomized individuals); the number of deaths; participants with one or more adverse events; withdrawals (discontinuations) due to harms; and the total number of events, if appropriate. Thresholds should not be used to limit the sharing of information about harms. Zero events should be included for harms systematically assessed. For combined adverse events, such as the proportion of participants with one or more serious adverse events, researchers should report or share data for all component events (eg, deaths, major cardiovascular events, cancers, infections, and psychiatric events). Better harms reporting could improve evidence synthesis, enhance interpretability, and support informed clinical decision-making as well as patient safety.

OBJECTIVES:There is growing interest in collecting outcome information directly from patients in clinical trials. This study evaluates what patients with rheumatic and musculoskeletal diseases (RMDs) consider important to know about symptomatic side effects they may experience from a new prescription drug. METHODS:Patients with inflammatory arthritis, who had one or more prescribed drugs for their disease for at least 12 months, participated in focus groups and individual interviews. Discussions were analysed using reflexive thematic analysis. RESULTS:We conducted seven focus groups with 34 participants across three continents. We found four overarching and two underpinning themes. The 'impact on life' was connected to participants' 'daily life', 'family life', 'work life' and 'social life'. In 'psychological and physical aspects' participants described 'limitation to physical function', 'emotional dysregulation' and 'an overall mental state'. Extra tests, hospital visits and payment for medication were considered a 'time, energy and financial burden' of side effects. Participants explained important measurement issues to be 'severity', 'frequency' and 'duration'. Underpinning these issues, participants evaluated the 'benefit-harm balance' which includes 'the cumulative burden' of having several side effects and the persistence of side effects over time. CONCLUSIONS:In treatment for RMDs, there seems to be an urgent need for feasible measures of patient-reported bother (impact on life and cumulative burden) from side effects and the benefit-harm balance. These findings contribute new evidence in support of a target domain-an outcome that represents the patient voice evaluating the symptomatic treatment-related side effects for people with RMDs enrolled in clinical trials.

BACKGROUND:Literature reviews of measurement properties of an outcome measurement instrument are fast becoming the evidence base for making decisions about the suitability of the instrument for a given application. In our case at OMERACT it is the fitness of an instrument for inclusion in a Core Outcome Set. Transparency in the processes and decision making at each step are important to allow consumers of the literature review to have a clear understanding of the decision-making process. We used an iterative process between methodologists and users to develop a summary of measurement properties table (SOMP) as a knowledge translation tool to communicate what was done, what was found, and what recommendations can be made from it. This, in turn, would provide a readily accessible, summary of findings for those who may need this information to make informed decisions about the adequacy of evidence concerning a measurement instrument. METHODS:Working with key collaborators and end users, including patients, clinical trialists, clinicians, and methodologists across several disease areas, the information that is needed to be included in a SOMP was determined, and initial designs laid out. Users provided feedback and revisions, which were integrated while ensuring the core elements were also being communicated. RESULTS:Several features emerged for inclusion in the SOMP: the background context for the review, all the evidence that went into the review, what was done in the review process, and the decision made based on the review. The SOMP was designed to capture this in a single document. Working group feedback helped to improve overall understandability. CONCLUSIONS:The SOMP was designed to capture the body of evidence available on the measurement properties for a given instrument, and the processes used to come to a decision about its fit with the intended application. In our case whether it was of good enough quality for use in a Core Outcome Set to represent the domain of interest. The SOMP's iterative development within a multidisciplinary consensus-based organization has helped us develop a tool useful in transparent communication about methods and decision-making made in a given review.

ABSTRACT IntroductionNociplastic pain is an important mechanistic pain descriptor that plays a significant role in influencing reported pain intensity and complicating outcome assessment in inflammatory arthropathies (IA). This pain is not driven by inflamed joints but is instead driven by the functional reorganisation of the central nervous system. Although several defining criteria for nociplastic pain have been proposed in literature there is paucity of validated and agreed comprehensive instrument to identify or measure this pain.Pain of IA differs from that seen in archetypical nociplastic condition -primary fibromyalgia due to the encompassing elements of nociceptive joint inflammation and additional pain of secondary fibromyalgia in a cross section of patients. However, the exact chronology for transition of nociceptive to mixed pain state in these patients is yet unknown. Therefore, identifying a validated instrument to measure this potential confounder in rheumatological studies will improve interpretation of study results in rheumatology and future pain management in Rheumatic Musculoskeletal Diseases (RMD’s). MethodsA scoping review protocol will be developed and all instruments assessing nociplastic pain will be systematically reviewed. Individual items in each instrument with potential to identify nociplastic pain in patients with RMDs using the OMERACT Filter 2.2 methodology will also be collated. Relevant associated central symptoms including mood, fatigue, sleep, and cognition will be noted. ConclusionFollowing development of an agreed protocol the scoping review will be developed. Preliminary report of the scoping review will provide basis for an initial feedback from OMERACT 2025 participants including patient partners. This work contributes towards ongoing research in this space. Keywords: OMERACT, nociplastic pain, inflammatory arthritis, contextual factorsHIGHLIGHTS•Nociplastic pain is a newly defined term to describe persistent pain that is mechanistically neither nociceptive nor neuropathic and is often described as secondary fibromyalgia or non inflammatory pain in IA’s.•Nociplastic pain is a potential confounder in rheumatological research and therefore developing agreed validated measurement tools is paramount. •A scoping review will be undertaken following development of this protocol to identify currently used instruments and items within instruments. The domains from the identified instruments and items which map on to the defined parameters of nociplastic pain will be described.

ObjectiveTo 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.MethodsWe 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.ResultsThe 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%).ConclusionOMERACT 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.

Objectives To achieve consensus on domains of active disease for inclusion in a novel outcome measure for SLE randomised controlled trials (RCTs), the Treatment Response Measure for SLE (TRM-SLE).Methods Domains nominated by TRM-SLE Taskforce members were rated in a two-stage modified Delphi study. Each stage comprised two online survey rounds separated by a structured discussion meeting. In Stage 1, expert lupus clinicians and patient representatives rated domain 'importance' (impact on symptoms, function or survival). In Stage 2, clinicians rated 'important' domains on three characteristics relevant to RCT utility: 'appropriateness' for evaluating change in disease activity, 'representation' in patients with active SLE and 'measurability' in an RCT context. Consensus for domain inclusion was prespecified as all four characteristics achieving a rating >= 7 on a 1-9 scale by >= 70% of participants.Results Domain nominations from 36/59 (61%) TRM-SLE Taskforce members yielded 34 potential domains which were rated in the modified Delphi study. At least one Delphi round was completed by 87 clinicians and 13 patient representatives. In Stage 1, 14 domains met consensus on 'importance' in both clinician and patient groups, and 11 domains met consensus among patients only. After Stage 2, eight of these domains also reached consensus on 'appropriateness', 'representation' and 'measurability': alopecia, arthritis, haemolytic anaemia, nephritis, mucosal ulcers, rash, serositis and thrombocytopenia.Conclusions Considering patient and clinician perspectives, we reached consensus to include eight disease activity domains for future development into the novel TRM-SLE clinical trial outcome measure, aiming to improve trial interpretability and success.

ObjectiveTo develop a set of detailed definitions for foundational domains commonly used in OMERACT (Outcome Measures in Rheumatology) core domain sets.MethodsWe identified candidate domain definitions from prior OMERACT publications and websites and publications of major organizations involved in outcomes research for six domains commonly used in OMERACT Core Domain Sets: pain intensity, pain interference, physical function, fatigue, patient global assessment, and health-related quality of life. We conducted a two-round survey of OMERACT working groups, patient research partners, and then the OMERACT Technical Advisory Group to establish their preferred domain definitions. Results were presented at the OMERACT 2023 Methodology Workshop, where participants discussed their relevant lived experience and identified potential sources of variability giving the needed detail in our domain definitions.ResultsOne-hundred four people responded to both rounds of the survey, and a preferred definition was established for each of the domains except for patient global assessment for which no agreement was reached. Seventy-five participants at the OMERACT 2023 Methodology Workshop provided lived experience examples, which were used to contextualise domain definition reports for each of the five domains.ConclusionUsing a consensus-based approach, we have created a detailed definition for five of the foundational domains in OMERACT core domain sets; patient global assessment requires further research. These definitions, although not mandatory for working groups to use, may facilitate the initial domain-match assessment step of instrument selection, and reduce the time and resources required by future OMERACT groups when developing core outcome sets.

Purpose (the aim of the study): Global prevalence of knee osteoarthritis (KOA) was estimated at 365 million in 2019. Recommended treatment includes topical and oral NSAIDs, and intra-articular (IA) corticosteroids. However, available IA corticosteroids have limited duration of effect and risk of side effects. EP-104IAR is a long-acting fluticasone propionate (FP) IA injection being developed for OA symptoms. EP-104IAR employs a novel controlled-release technology to optimize the pharmacokinetics of FP, maximizing IA residence time while limiting systemic exposure, providing a greater duration of efficacy with fewer systemic and local side effects.

BACKGROUND:Since the development of the OMERACT Systemic Lupus Erythematosus (SLE) Core Outcome Set (COS) in 1998, many new SLE domains have been identified and measures developed, creating a need to update the SLE COS. To revisit the 1998 SLE COS and research agenda domains, and generate new candidate domains, we conducted this study of patients with SLE and collaborators. OBJECTIVE:(1) To evaluate existing candidate SLE domains for inclusion in the SLE COS. (2) To generate additional candidate SLE domains for COS consideration. (3) To engage SLE collaborators, including patients, in developing the updated SLE COS. METHODS:The OMERACT SLE Working Group's steering committee developed a survey to assess the importance of candidate SLE domains and generate additional domains for consideration towards the SLE COS. Patients with SLE followed at the University of Toronto Lupus Clinic (patient group) and members of the OMERACT SLE Working Group (collaborator group) were invited to complete the survey between August 2022 and February 2023. RESULTS:A total of 175 patients were invited and 100 completed the survey. Of 178 collaborators invited, 145 completed the survey. Patients tended to prioritize life-impact domains while collaborators prioritized clinical domains. Both patients and collaborators recommended additional domains to those included in the 1998 SLE COS and research agenda. CONCLUSION:The domain inclusion and importance results demonstrate that patients and collaborators prioritize different domains, so capturing the perspectives of both groups is essential to ensure a holistic assessment of SLE. The results of the study identify domains that already have a high level of agreement for potential inclusion in the SLE COS, domains that require further explanation, and novel domains that warrant consideration.

Objective: The global impact of osteoarthritis is growing. Currently no disease modifying osteoarthritis drugs/therapies exist, increasing the need for preventative strategies. Knee injuries have a high prevalence, distinct onset, and strong independent association with post-traumatic osteoarthritis (PTOA). Numerous groups are embarking upon research that will culminate in clinical trials to assess the effect of interventions to prevent knee PTOA despite challenges and lack of consensus about trial design in this population. Our objectives were to improve awareness of knee PTOA prevention trial design and discuss state-of-the art methods to address the unique opportunities and challenges of these studies. Design: An international interdisciplinary group developed a workshop, hosted at the 2023 Osteoarthritis Research Society International Congress. Here we summarize the workshop content and outputs, with the goal of moving the field of PTOA prevention trial design forward. Results: Workshop highlights included discussions about target population (considering risk, homogeneity, and possibility of modifying osteoarthritis outcome); target treatment (considering delivery, timing, feasibility and effectiveness); comparators (usual care, placebo), and primary symptomatic outcomes considering surrogates and the importance of knee function and symptoms other than pain to this population. Conclusions: Opportunities to test multimodal PTOA prevention interventions across preclinical models and clinical trials exist. As improving symptomatic outcomes aligns with patient and regulator priorities, co-primary symptomatic (single or aggregate/multidimensional outcome considering function and symptoms beyond pain) and structural/physiological outcomes may be appropriate for these trials. To ensure PTOA prevention trials are relevant and acceptable to all stakeholders, future research should address critical knowledge gaps and challenges.

Abstract Pragmatic, randomized, controlled trials hold the potential to directly inform clinical decision making and health policy regarding the treatment of people experiencing pain. Pragmatic trials are designed to replicate or are embedded within routine clinical care and are increasingly valued to bridge the gap between trial research and clinical practice, especially in multidimensional conditions, such as pain and in nonpharmacological intervention research. To maximize the potential of pragmatic trials in pain research, the careful consideration of each methodological decision is required. Trials aligned with routine practice pose several challenges, such as determining and enrolling appropriate study participants, deciding on the appropriate level of flexibility in treatment delivery, integrating information on concomitant treatments and adherence, and choosing comparator conditions and outcome measures. Ensuring data quality in real-world clinical settings is another challenging goal. Furthermore, current trials in the field would benefit from analysis methods that allow for a differentiated understanding of effects across patient subgroups and improved reporting of methods and context, which is required to assess the generalizability of findings. At the same time, a range of novel methodological approaches provide opportunities for enhanced efficiency and relevance of pragmatic trials to stakeholders and clinical decision making. In this study, best-practice considerations for these and other concerns in pragmatic trials of pain treatments are offered and a number of promising solutions discussed. The basis of these recommendations was an Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) meeting organized by the Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks.

Objective: This manuscript highlights the importance of enhancing the uptake of Core Outcome Sets (COS) by building partnerships with Collaborators and addressing their needs in COS development. Methods and setting: This session was structured as a simulation, resembling a format akin to a classic television game show. The moderator posed a series of questions to eight different Collaborator groups who briefly described the importance of COS within their areas of interest. Previous studies examining the uptake of individual core outcomes revealed disparities in uptake rates. The Identified barriers to the uptake of COS include the lack of recommendations for validated instruments for each domain, insufficient involvement of patients and key Collaborator groups in COS development, and a lack of awareness regarding the existence of COS. Conclusions: This analysis underscores the need for COS development approaches that prioritize the inclusion of patients and diverse Collaborator groups at every stage. While current studies on COS uptake are limited, future research should explore the broader implementation of COS across diverse disease categories and delve into the factors that hinder or facilitate their uptake such as, the importance of COS developers extending their work to recommending domains with well validated instruments. Embracing patient leadership and multifaceted engagement is essential for advancing the relevance and impact of COS in clinical research.

BACKGROUND:The Outcome Measures in Rheumatology (OMERACT) Systemic Lupus Erythematosus (SLE) Working Group held a Special Interest Group (SIG) at the OMERACT 2023 conference in Colorado Springs where SLE collaborators reviewed domain sub-themes generated through qualitative research and literature review. OBJECTIVE:The objective of the SIG and the subsequent meetings of the SLE Working Group was to begin the winnowing and binning of candidate domain sub-themes into a preliminary list of candidate domains that will proceed to the consensus Delphi exercise for the SLE COS. METHODS:Four breakout groups at the SLE SIG in Colorado Springs winnowed and binned 132 domain sub-themes into candidate domains, which was continued with a series of virtual meetings by an advisory group of SLE patient research partners (PRPs), members of the OMERACT SLE Working Group Steering Committee, and other collaborators. RESULTS:The 132 domain sub-themes were reduced to a preliminary list of 20 candidate domains based on their clinical and research relevance for clinical trials and research studies. CONCLUSION:A meaningful and substantial winnowing and binning of candidate domains for the SLE COS was achieved resulting in a preliminary list of 20 candidate domains.