BACKGROUND:The Outcome Measures in Rheumatology (OMERACT) group recommends pain as a core domain in clinical trials for shoulder disorders. This study evaluated the suitability of the Numerical Pain Rating Scale (NPRS) for measuring pain using the OMERACT Filter 2.2. METHODS:Following the OMERACT Handbook for instrument selection, a systematic review assessed the NPRS's construct validity, reliability, longitudinal construct validity, clinical trial discrimination, and thresholds of meaning. Articles were independently screened, appraised with the COSMIN-OMERACT Good Methods Checklist, and rated as green (good), amber (caution), red (poor), or white (no evidence). Only green and amber studies were included. Findings were summarized in a Summary of Measurement Properties table and discussed at the 2025 OMERACT Shoulder Special Interest Group workshop. RESULTS:Twelve studies, including 18 pieces of evidence met eligibility criteria. Three studies examined construct validity, two test-retest reliability, four longitudinal construct validity, six clinical trials discrimination and three thresholds of meaning. Six (33%) components of evidence had good methods and were rated green and 12 were rated amber. There was significant heterogeneity in NPRS versions and formats evaluated across studies, questioning the validity of synthesizing the data together. Therefore, 75% of respondents at the 2025 OMERACT conference agreed that synthesizing results from studies using different NPRSs was inappropriate. CONCLUSIONS:The NPRS cannot progress to the endorsement stage for the core domain of pain for shoulder conditions due to insufficient evidence for any single NPRS version. Current evidence is insufficient to support its use to measure pain in clinical trials of shoulder disorders.

Objectives The Patient Reported Outcomes Measurement Information System (PROMIS) has been recognized as a potential tool to harmonize research across diseases in the assessment of physical, mental, and social health. Previous studies have demonstrated reliability, validity and responsiveness evidence for PROMIS CAT in systemic lupus erythematosus (SLE).[1] This study extends this evidence by examining minimal important difference (MID) of PROMIS CAT domains. Methods In this longitudinal study, consecutive adult English-speaking SLE patients were invited to participate. Patients completed an assessment using PROMIS CAT’s 13 domains (physical function, mobility, pain behavior, pain interference, ability to participate in social roles, satisfaction with social roles and activities, fatigue, sleep disturbance, sleep-related impairment, applied cognition-abilities, anger, anxiety, and depression) and corresponding legacy instruments at baseline and at 3 and 6 months. The generic anchor question was asked to identify those with symptom severity change. Domain-specific anchor questions were asked at 6 months with responses graded from −7 (greatest worsening) to +7 (greatest improvement), and 0 representing no change. For domain-specific anchors, improvement was defined as >1 and worsening as < −1. Area Under the Curve (AUC) and 95% confidence intervals for each of the 13 domains were calculated and minimal important differences (MID) were derived from the above AUC analysis, also called Anchor-based approach. Results 108 patients (90.7% female) were included. MIDs for PROMIS Physical Function were calculated to be −1.84 in patients that improved and −6.17 in patients who worsened over 6 months (Figure 1). MID for Satisfaction with Social Roles and Activities was −4.40 in patients that improved over 6 months (Figure 1). AUC was considered significant (> 0.7) in PROMIS Physical Function (improved), Satisfaction with Social Roles and Activities (improved), Pain Interference (worsened), fatigue (worsened) and sleep disturbance (worsened). Figure 1: AUC and Anchor-based MID in patients reported worsening and improvement in anchor Q1 (at 6 months) Conclusion In summary, MID for PROMIS CAT in SLE cohort varied significantly among categories. Given patients did not demonstrate very significant change over 6 months as expected in the absence of intervention or change in therapy, MID is to be interpreted cautiously in this setting. Physical function and Satisfaction with Social Roles and Activities were domains in which MID could be derived. References [1.] Moazzami M. Lupus 2021;30:2102-13.

Aims To discuss and refine the preliminary definition of “independence” from the patient’s perspective in RA remission. Methods Data from a scoping review and international focus groups were presented at the OMERACT Remission in RA Patient Perspective Special Interest Group (SIG) meeting in February 2024. The SIG included 40 delegates from diverse geographic regions who discussed the findings and potential refinements of the preliminary definition of independence from the patient’s perspective in the context of RA remission. Results Drawing together findings from the scoping review and focus groups, the following preliminary definition of “independence” was presented for discussion: "Being able to do what you want, when you want, in the way you want to do it." Delegates emphasized the importance of capturing all aspects of independence, adjustments to the proposed preliminary definition were suggested, and some delegates requested more specificity before taking the preliminary definition forward for use in the next research stage. Issues were raised on whether cultural variation on concepts of independence was adequately captured in the qualitative work so far. For example, some cultures may value receiving support from others as a reaffirmation of social belonging and interdependence, rather than a contradiction of independence. This will need addressing in our future work to ensure cross-cultural differences in definitions of independence are not missed. The majority of delegates voted in favour of continuing the work toward defining targeted sub-domains, which will allow the group to develop an instrument to assess independence in RA remission from the patient’s perspective. Conclusion Consensus was reached in favour of continuing the work towards defining targeted sub-domains, which will allow the group to develop an instrument to assess independence in RA remission from the patient’s perspective. However, suggestions were made to refine and improve the current definition. The next steps include refining the definition, followed by identifying and/or developing instruments to create an outcome measure for independence in RA remission.

Background: Pain is a mandatory domain in Outcome Measures in Rheumatology (OMERACT) core outcome sets for shoulder disorder trials. We evaluated the Oxford Shoulder Score (OSS), a composite measure comprising four pain and eight function items but no separate subscales for these domains, for measuring pain using the OMERACT Filter 2.2.Methods: Following the OMERACT Handbook, we assessed domain match and feasibility, then systematically reviewed OSS measurement properties in shoulder disorders (rotator cuff disease, adhesive capsulitis, instability, osteoarthritis, dislocation, humeral head fractures and unspecified pain). MEDLINE, EMBASE and CINAHL were searched to June 2023. Reviewers independently screened, appraised methodological quality and extracted data. Measurement properties were synthesised and rated (green, amber, red or white). Results were summarised in a Summary of Measurement Properties (SOMP) table and discussed at the OMERACT 2025 workshop.Results: The OSS was rated amber for feasibility and domain match, reflecting concerns about its multidimensional nature while acknowledging interrelatedness of pain and function. Twenty-three studies were included in the systematic review: eleven examined construct validity, three test-retest reliability, ten responsiveness, five clinical trial discrimination and five thresholds of meaning. Thirty of 34 components were judged suitable to proceed (eight green; 22 amber). All studies assessed the OSS total score (pain and function); one assessed a 4-item pain subscale. For the total OSS score, construct validity and responsiveness were green and reliability, trial discrimination and thresholds of meaning were amber. Two studies reported no floor/ceiling effects, one was equivocal. At OMERACT 2025, 95% of respondents agreed multidimensional instruments should not be used to measure single domains without validated subscales.Conclusion: The OSS total score shows adequate construct validity and responsiveness, but its combined assessment of pain and function makes it unsuitable for measuring pain alone.

O045 / #659 Topic: AS05 - CNS Lupus ABSTRACT CONCURRENT SESSION 07: COGNITION IMPAIRMENT IN SLE – RECENT ADVANCEMENT AND EMERGING RESEARCH 23-05-2025 1:40 PM - 2:40 PM Cognitive impairment (CI) is a common manifestation in patients with systemic lupus erythematosus (SLE). Despite its impact on patient quality of life, treatments remain limited as its pathogenesis is poorly understood. The Automated Neuropsychological Assessment Metrics (ANAM) has superior patient acceptability and feasibility in ambulatory settings compared to the American College of Rheumatology Neuropsychological Battery (ACR-NB) [gold-standard test] and is validated in screening for CI in SLE. Data from our laboratory have revealed that serum S100A8/A9 and MMP-9 are associated with CI measured by the ACR-NB. However, the relationship between these serum analytes, ANAM subtests and CI has not been elucidated. We therefore aimed to determine if serum analytes are associated with CI measured by the ANAM. We cross-sectionally analyzed the data of 327 adults aged 18-65 who were followed longitudinally between January 2016 and October 2019 at a single SLE center. All participants fulfilled the 2019 EULAR/ACR SLE classification criteria. Cognitive function was measured using ANAM throughput scores, and serum levels of 9 analytes (IL-10, IL-6, IFN-γ, TNF-α, TWEAK, S100B, S100A8/A9, NGAL and MMP-9) were measured using ELISA. The K-means clustering algorithm was used to cluster the patient data, and the Principal Component Analysis (PCA) characterized the clusters. The silhouette coefficient(s) was calculated for 2 to 15 clusters to determine the optimal number of clusters. PCA identified 2 principal components explaining 36.2% of the variance in ANAM throughputs and serum analytes. The first component (26.7% of the variance) was correlated with ANAM throughputs, with the strongest contribution from procedural reaction time. The second component (9.44% of the variance) was correlated with serum analyte measurements, with the strongest contribution from TNF-alpha. (Figure 1) The highest silhouette value was found for 2 (s = 0.177) and 3 (s = 0.176) clusters. Only 4% of patients were classified in the 3 cluster model, so a 2 cluster model was selected. Cluster 1 had low throughput scores representing CI, and Cluster 2 had higher throughput scores representing no CI. A significant difference was observed in mean serum S100A8/A9 (SMD = 0.362), MMP-9 (SMD = 0.178) and IL-6 (SMD = 0.311) between the clusters, reflected by their correlation with the first principal component. (Figure 2) Serum levels of S100A8/A9, MMP-9 and IL-6 had a strongly negative correlation between the Go No Go and Running Memory throughputs. Figure 1: Correlation matrix for individual ANAM throughputs and serum analyte levels Figure 2: Biplot of the first 2 principal components, with 2 clusters and association with analytes Serum S100A8/A9, MMP-9, and IL-6 are associated with CI in SLE as measured by the ANAM. Patient clusters with elevated serum S100A8/A9, MMP-9, and IL-6 had strongly negative associations with throughputs representing impairment in executive function, simple attention and processing speed. Further studies are needed to uncover mechanistic relationships between these analytes and CI in SLE, and whether they may represent valuable therapeutic targets for further exploration.

BACKGROUND:Cognitive impairment (CI) is one of the most common manifestations of neuropsychiatric systemic lupus erythematosus (SLE). This study aimed to characterise the course of CI over a 1-year period in patients with SLE and its associated factors. METHODS:175 adult SLE patients from the University of Toronto Lupus Clinic were assessed at baseline, 6 months and 12 months using the American College of Rheumatology Neuropsychological Battery. CI was classified based on standardised z-scores in cognitive domains. Patients were categorised as persistent-CI (CI at all three time-points; T0, T1 and T2), never-CI (no CI at any time-point) or fluctuating-CI (CI at 1-2 assessments). Sociodemographic, clinical, laboratory and medication data were collected at each visit. Patients with persistent-CI were compared with never-CI patients. CI severity was determined based on the mean z-score of tests across all six domains. RESULTS:Over 1 year, 46% of patients experienced CI, with 17% showing persistent-CI, 29% fluctuating-CI and 54% never-CI. Persistent-CI patients exhibited more severe CI compared with fluctuating-CI. The most frequently affected cognitive domains were learning and memory, simple attention and processing speed, and visual-spatial construction. Factors associated with CI persistence over 1 year included Black race, older age at SLE diagnosis, divorced/separated status at T0 and higher disease-related damage at T0. CONCLUSION:This study highlights the variable nature of CI in SLE patients, with most exhibiting a stable course over 1 year. Factors such as sociodemographic characteristics and comorbidities may influence CI persistence.

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.

Systematic reviews of outcome measurement instruments (OMIs) are an important tool to guide the selection of OMIs for research and clinical practice. However, presenting the large amount of complex data pertaining both to the quality of each study (i.e., risk of bias) as well as the quality of the instrument (i.e., measurement properties), along with the underpinning certainty of evidence, is challenging. Here, we aim to provide guidance on optimizing data presentation in OMI systematic reviews, specifically focusing on patient-reported outcome measures (PROMs). A multidisciplinary team of experts in OMI systematic reviews, research reporting, and data visualization built on existing table templates from OMERACT and the COSMIN initiative, to align with reporting items in a recently developed reporting guideline for systematic reviews of OMIs: PRISMA-COSMIN for OMIs 2024. To enhance clarity and usability, we applied data visualization principles by reducing non-essential elements and improving interpretability through structured layouts and concise explanatory text. We present eight templates for reporting PROM systematic review results: three pertain to PROM characteristics, two to studies’ characteristics, two to the evaluation of measurement properties, and one to the summary of findings. We also provide recommendations on whether to include these templates in the review’s main manuscript or in the supplementary materials. Word versions of these templates can be downloaded from www.prisma-cosmin.ca and www.cosmin.nl . Templates complementing the PRISMA-COSMIN for OMIs 2024 reporting guidance can be used to standardize and enhance the clarity and usefulness of OMI systematic reviews focusing on PROMs. They comprise a comprehensive set of tools to effectively report OMI systematic reviews, in service of end-users who are selecting OMIs.

BACKGROUND:OMERACT (Outcome Measures in Rheumatology) is an international initiative focused on improving outcome measurement in rheumatology research, fostering collaboration among PRPs, clinicians, and researchers to develop Core Outcome Sets. The 22-item Patient Engagement In Research Scale (PEIRS-22) is a tool designed to measure the level of meaningful patient engagement and guide efforts towards improvement. AIM:1) To describe the current profile of patient engagement at OMERACT using the scores generated by the PEIRS-22 and 2) to assess the validity of the PEIRS-22 within the OMERACT group of PRPs. METHODS:We administered the PEIRS-22 to assess the level of meaningful engagement of PRPs with OMERACT. We compared the scores with self-rated participant engagement, and asked open ended questions to investigate the validity of the tool in the OMERACT PRP population. RESULTS:Overall engagement was meaningful and correlated to self-reported level of engagement. However, there were components and items that were flagged as priorities for improvement (Convenience, Benefits and Team Environment, and specifically items PR11: I participated in making decisions about the project, T2: I was an equal partner in the research project team, and SU1: I received sufficient support to contribute to the project. CONCLUSION:This study highlights the validity of the PEIRS-22 within OMERACT and reveals satisfactory levels of meaningful PRP engagement. As OMERACT continues to learn and evolve, the PEIRS-22 will be integral in developing a structured and consistent approach to patient engagement.

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.

OBJECTIVE:Cognitive impairment (CI) is common in patients with systemic lupus erythematosus (SLE). Despite its prevalence, the immune mechanisms are not well understood. We previously reported elevated serum levels of S100A8/A9 and matrix metalloproteinase 9 (MMP-9) in patients with SLE and CI. This study aims to validate those findings by examining the relationship between serum levels and CI in patients with SLE at baseline and after one year. METHODS:We assessed cognitive function in 112 patients with SLE using the adapted American College of Rheumatology-Neuropsychological Battery, defining CI as impairment in two or more domains. Serum S100A8/A9 and MMP-9 levels were measured by enzyme-linked immunosorbent assay. We compared serum levels between CI and non-CI groups, evaluated cognitive domain performance at baseline and one year, and explored associations between serum changes and cognitive status changes. RESULTS:At baseline, 48 patients (42.8%) had CI. After one year, the cognitive funtion remained stable in 55%, improved in 31.2%, and worsened in 13% of patients. Serum S100A8/A9 levels were significantly higher in CI patients at baseline (P = 0.0007, r = 0.413) and one year (P = 0.0045, r = 0.359), correlating inversely with multiple CI domains. The worsened group showed a significant increase in S100A8/A9 levels, whereas the improved group exhibited a reduction. CONCLUSION:In this large cohort of patients with well-characterized SLE, serum S100A8/A9 levels were elevated in those with CI and showed an inverse relationship with cognitive performance across multiple domains. Changes in S100A8/A9 levels corresponded with changes in cognitive status over one year. These findings warrant further investigation into the role of S100A8/A9 in CI within the context of SLE.

Cognitive impairment (CI) is a common manifestation in patients with systemic lupus erythematosus (SLE). Despite its impact on patient quality of life, treatments remain limited as its pathogenesis is poorly understood. The Automated Neuropsychological Assessment Metrics (ANAM) has superior patient acceptability and feasibility in ambulatory settings compared to the American College of Rheumatology Neuropsychological Battery (ACR-NB) [gold-standard test] and is validated in screening for CI in SLE. Data from our laboratory have revealed that serum S100A8/A9 and MMP-9 are associated with CI measured by the ACR-NB. We therefore aimed to determine if serum analytes are associated with CI measured by the ANAM. We cross-sectionally analyzed the data of 327 adults aged 18-65 who were followed longitudinally between January 2016 and October 2019 at a single SLE center. All participants fulfilled the 2019 EULAR/ACR SLE classification criteria. Cognitive function was measured using ANAM throughput scores, and serum levels of 9 analytes (IL-10, IL-6, IFN-γ, TNF-α, TWEAK, S100B, S100A8/A9, NGAL and MMP-9) were measured using ELISA. The K-means algorithm was used to cluster patient data, and the Principal Component Analysis (PCA) characterized the clusters. The silhouette coefficient was calculated for 2 to 15 clusters to determine the optimal number of clusters. PCA identified 2 principal components explaining 36.2% of the variance in ANAM throughputs and serum analytes. The first component (26.7% of the variance) was correlated with ANAM throughputs, with the strongest contribution from procedural reaction time. The second component (9.44% of the variance) was correlated with serum analyte measurements, with the strongest contribution from TNF-alpha. A 2-cluster model had the highest silhouette value and classified the most patients. Cluster 1 had low throughput scores representing CI, and Cluster 2 had higher throughput scores representing no CI. A significant difference was observed in mean serum S100A8/A9 (SMD=0.362), MMP-9 (SMD=0.178) and IL-6 (SMD=0.311) between the clusters, reflected by their correlation with the first principal component (Figure 1). Serum levels of S100A8/A9, MMP-9 and IL-6 had a strongly negative correlation between the Go No Go and Running Memory throughputs. Figure interpretation: The biplot displays the clusters projected on the first two principal components, which explains 36.2% of the variance in ANAM throughputs and serum analytes. Axis x represents the first component (explains 26.7% of the variance), which correlates with ANAM throughputs. Axis y represents the second component (explains 9.44% of the variance), which correlates with serum analyte measurements. The arrows represent the variables, and their direction indicates the relationship between the variables and the clusters. The length of the arrows indicates the strength of the relationship between the variable it represents and the cognitive dimensions. Serum S100A8/A9, MMP-9, and IL-6 are associated with CI in SLE as measured by the ANAM. Patient clusters with elevated serum S100A8/A9, MMP-9, and IL-6 had strongly negative associations with throughputs representing impairment in executive function, simple attention and processing speed. Further studies are needed to uncover mechanistic relationships between these analytes and CI in SLE, and whether they may represent valuable therapeutic targets.

OBJECTIVE:The OMERACT Composite Working Group hosted a workshop at OMERACT 2023 to explore the complexities of weighting components in the development of composite outcomes. This study presents the methodology and findings of this workshop, exploring the complexities of weighting the individual components of composite outcome measures. METHODS:The workshop featured a multifaceted program, beginning with a plenary session that introduced the concept of composite outcomes, shared a patient's journey with rheumatic disease through a narrative, illustrated a composite outcome for Osteoarthritis Flares, and outlined the five domains selected for this composite outcome. A breakout exercise engaged participants in ranking and assigning weights to these domains, followed by group discussions to reach a consensus on weights. The workshop concluded with another plenary session that discussed various weighting approaches, including discrete choice and conjoint analysis from the ANCA-Associated Vasculitis working group, and outlined future directions for research on composite outcome methods. RESULTS:The breakout exercise revealed the challenges in assigning relative importance to different domains, highlighting the variability in participant perspectives. Consensus discussions highlighted the diversity in approaches to weighting, the need for appropriate methods to determine domain weights and the impact of such weights on the interpretation of composite scores. CONCLUSION:The OMERACT 2023 workshop underscored the significance of a systematic approach to weighting components in composite outcome development. It highlighted the complexity of achieving consensus on the importance of domains and the role of incorporating the perspectives of patient research partners in this process. Future research directions include refining weighting methodologies, moving composites through the OMERACT Filter and enhancing understanding of their implications for clinical trials. The findings contribute to the ongoing discourse on optimizing composite outcome measures in rheumatology and beyond, advocating for a balanced integration of scientific rigour and patient-centeredness in their development.

Aims: Our previous work identified pain, fatigue, and independence as missing from the ACR/EULAR rheumatoid arthritis (RA) remission criteria from the patient perspective. Validated measures exist for pain and fatigue, but not for independence. As a first step towards developing such a measure, this study aimed to understand ‘Independence’ in the context of RA remission from the patient perspective.Methods: International qualitative research study comprising five focus groups of 19 participants with RA. Data were analysed using reflexive thematic analysis.Results: Five overarching themes were identified, underpinned by a construct of “stages of independence”. Independence means at least being ‘physically and functionally able’ but may go beyond this and enable ‘participation beyond function’, ‘cognitive independence’, and ‘having or taking control’. There was no agreement on whether assistance is an aid to independence or undermines ability to achieve independence (‘assistance is complicated’). The construct “Stages of independence” acknowledges that Independence may mean different things to different patients and there may be other factors beyond disease activity that hold patients in each of these stages.Conclusion: These novel data suggest a desirable definition of independence includes full active participation without the need to consider or work around disease activity, and cognitive independence from thoughts of RA. Independence in RA remission is a complex concept and next steps will be to seek patient and professional agreement on the most important issues raised in these focus groups to take forward to developing a measure for independence in the context of RA remission from the patient perspective.

Background/Aims Cognitive impairment (CI) is common in people with systemic lupus erythematosus (pwSLE). Treatment options are limited and the effects upon the brain is unclear. Differences in brain structure seen in SLE do not always associate with CI, however significant associations have been found with functional magnetic resonance imaging (fMRI). Using fMRI, this study aims to further explore potential compensatory brain mechanisms used in SLE that help with cognitive function. Methods Participants were recruited into one of two groups;pwSLE (meeting EULAR/ACR criteria) or healthy controls(HC). Demographic, clinical and psychiatric data and patient reported outcome measures were collected.Cognitive function was assessed using the ACR Neuropsychological Battery. Brain scans included two structural and two fMRI scans done during stage 1 and 2 of a cognitive task. Stage 1 of the task had an encoding, retention and working memory (WM) component. Stage 2 of the task examined long-term memory. Differences between task performances were examined using t-tests. The fMRI data was modelled using SPM12 to look for differences in blood-oxygen-level-dependent (BOLD) brain responses between the study groups during the different stages/components of the task. Results To-date 37 pwSLE and 10 HCs have been recruited. The median ages were 36 (HC) and 40 (pwSLE) years. From the pwSLE group the average disease duration was 15 years, the average SLEDAI-2K score was 5 and percentages of those on antimalarials, corticosteroids, and immunosuppressants and biologics were 66%, 32%, and 54%, respectively. There were no differences on task performance between the two groups. Greater BOLD responses were seen in the HC compared to the pwSLE group during stage 1 encoding and WM phases as well as during stage 2 (long-term memory). pwSLE had less attenuated BOLD signals during the stage 1 retention phase compared to HCs (Table 1). Conclusion We found altered brain responses to our cognitive task between pwSLE and HCs. Predominantly the HC group had greater BOLD responses in cognitive regions during the task compared to the pwSLE group. However, we did not find any difference between the two groups in regards to cognitive performance. This study is still ongoing and additional results are expected. Disclosure M. Barraclough: None. M. McCowen: None. S. McKie: None. A. Kafkas: None. B. Parker: None. J. Diaz-Martinez: None. A. Knight: None. K. Bingham: None. M. Li: None. J. Su: None. M. Kakvan: None. C. Munoz Grajales: None. M. Tartaglia: None. L. Ruttan: None. J. Wither: None. D. Bonilla: None. N. Anderson: None. D. Montaldi: None. R. Elliott: None. P. Katz: None. D. Beaton: None. R. Green: None. I. Bruce: None. Z. Touma: None.

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.

Introduction La création d'un score composite pour un instrument de mesure multidimensionnel est utile pour la prise de décision clinique. L'objectif était de comparer les qualités d'un score composite du questionnaire Flare-OA-16 caractérisant les poussées d'arthrose des membres inférieurs selon les pondérations de ses dimensions obtenues par avis d'expert versus divers modèles statistiques. Méthodes Cinq méthodes de pondération des cinq dimensions (16 items) du questionnaire Flare-OA-16 pour construire un score additif ont été comparées. Les avis d'experts ont été obtenus auprès de rhumatologues, scientifiques et patients participants au congrès international OMERACT 2023, USA. Ils ont d'abord établi un jugement individuel, puis construit des consensus par groupes. Les modèles statistiques ont été développés sur un jeu de données internationales de sujets atteints d'arthrose des membres inférieurs recrutés en France, Australie, et USA, incluant une question "avez-vous eu une poussée d'arthrose au cours des 4 dernières semaines" (1). Les méthodes de calcul du score avec différentes pondérations des dimensions, en utilisant les items recodés après analyse de Rasch (2), étaient : 1) pondération d'expert individuelle, avec le poids moyen des jugements individuels, 2) pondération consensuelle, avec le poids moyen des jugements consensuels de groupes, 3) équipondération, avec un poids égal à 1 pour chaque dimension (somme simple), 4) pondération de Rasch, avec la correspondance des items sur le trait latent, 5) pondération factorielle obtenue à partir d'une analyse factorielle confirmatoire de second ordre (items et dimensions). L'analyse a décrit la distribution de chaque score composite et leurs performances prédictives de la survenue d'une poussée par calcul de l'aire sous la courbe et son intervalle de confiance (AUC (IC95%). Résultats Un panel de 70 experts (18 patients et 52 rhumatologues et chercheurs) seuls, puis réparti en 11 groupes, a déterminé des pondérations pour chacune des cinq dimensions. Parmi les 381 sujets atteints d'arthrose des membres inférieurs, 247 déclaraient une poussée au cours des quatre dernières semaines. Les scores moyens (m (ET)) par dimension variaient de 2,4 (3,2) à 5,0 (2,9). Les pondérations des dimensions par les experts individuels et consensuelles variaient de 13,3 % à 31,2 %, et de 14,1 % à 31,8 %, respectivement. Les cinq scores composites moyens variaient de 4,3 (2,5) à 4,3 (2,6). Il y avait très peu d'effet plancher (5,8 %) et aucun effet plafond selon les cinq méthodes comparées. Les performances de chacune des méthodes pour identifier la survenue d'une poussée avec les scores composites étaient très proches, avec une AUC (IC95%) entre 0,861 (0,821-0,900) et 0,865 (0,826-0,904). A la recherche d'une cause possible de cette similarité, les corrélations (Pearson) calculées entre les dimensions variaient entre r=0,39 et 0,96. Conclusion les avis d'experts et diverses pondérations issues de modèles statistiques n'ont pas montré de différence de score moyen ni de performance pour identifier la survenue d'une poussée d'arthrose. La corrélation forte à élevée entre les dimensions du questionnaire est une explication possible de ces similarités. Un score composite du questionnaire Flare-OA-16 peut être calculé comme la somme des scores de Rasch de chaque dimension.