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We appreciate the interest in our manuscript concerning the Health Assessment Questionnaire disability index (HAQ) in an early rheumatoid arthritis incident cohort (the CATCH cohort) which predicted all-cause mortality (1). We will clarify queries raised in letters to the editor (2-4).

Summary Background Pain is an important and detrimental feature of systemic sclerosis but is often overlooked or deprioritised in research and clinical care. Raynaud's phenomenon, arthritis, and cutaneous ulcers are among the commonly reported disease manifestations of systemic sclerosis that could be associated with pain. We aimed to assess levels of pain intensity and interference and to evaluate disease factors associated with pain intensity and interference. Methods In this multicentre cross-sectional study, participants from the Scleroderma Patient-centered Intervention Network cohort who completed pain intensity and interference measures (Patient Reported Outcomes Information System-29 profile, version 2·0) as part of baseline assessments were included. Patients were recruited from 46 centres in Australia, Canada, France, Mexico, Spain, the UK, and the USA between April 15, 2014, and Jan 7, 2020. Eligible patients included those aged 18 years or older who met the criteria for systemic sclerosis devised by the American College of Rheumatology and the European League Against Rheumatism. Associations of pain intensity and pain interference with systemic sclerosis-related variables and overlap syndromes, controlling for sociodemographic variables, were assessed with multiple linear regression. Continuous independent variables were standardised. Findings Among 2157 participants with systemic sclerosis (268 [12%] males and 1889 [88%] females), 1870 (87%) reported mild, moderate, or severe pain (defined as ≥1 on a 0 to 10 scale), and 815 (38%) reported moderate or severe pain (defined as ≥5). Moreover, 757 (35%) participants reported moderate or severe pain interference. Greater pain intensity was independently associated with female sex (0·58 points [95% CI 0·26–0·90]), non-White race or ethnicity (0·50 points [0·21–0·79]), fewer years in formal education (0·30 points per SD [0·19–0·41]), country (reference: USA; Canada: 0·29 points [0·01–0·57] and UK: 0·58 points [0·21–0·95]), greater body-mass index (0·35 points per SD [0·24–0·45]); joint contractures (0·67 points [0·39–0·94]), digital ulcers (0·33 points [0·10–0·55]), gastrointestinal involvement (0·66 points [0·33–0·98]), skin involvement (measured using modified Rodnan skin score; 0·22 points per SD [0·10–0·35]), rheumatoid arthritis (0·96 points [0·50–1·43]), and Sjogren's syndrome (0·42 points [0·01–0·83]). Pain interference results were similar. Interpretation Pain is common among people with systemic sclerosis. Controlling for sociodemographic variables, greater pain was associated with multiple systemic sclerosis-related manifestations, including joint contractures, digital ulcers, gastrointestinal involvement, skin involvement, and the presence of overlap syndromes. Health-care providers should work with patients to address pain, including identifying and addressing systemic sclerosis manifestations associated with their pain, and supporting behavioural approaches to minimise impact on function and quality of life. Funding Canadian Institutes of Health Research, Arthritis Society, The Lady Davis Institute for Medical Research of the Jewish General Hospital, Jewish General Hospital Foundation, McGill University, Scleroderma Society of Ontario, Scleroderma Canada, Sclerodermie Quebec, Scleroderma Manitoba, Scleroderma Atlantic, Scleroderma Association of BC, Scleroderma SASK, Scleroderma Australia, Scleroderma New South Wales, Scleroderma Victoria, and Scleroderma Queensland.

The PACIC assesses key components of the Chronic Care Model. The purpose of this study is to examine the dimensionality and psychometric properties of the PACIC. A convenience sample of 221 adults in Canada who self-identified as living with one or more physical and/or mental chronic diseases was invited to participate via an online survey link. Rasch analysis was performed, including item and person misfit, reliability, response format, targeting, unidimensionality of subscales, and differential item functioning (DIF). Also, Confirmatory Factor Analysis (CFA) was conducted and model fit of alternative factor structures proposed for the PACIC in the literature and those suggested by the Rasch analysis were explored. The patient activation, delivery system, and problem-solving subscales fit the Rasch model expectations; no modifications were required. The goal setting item 10 had a disordered threshold and was recoded. Four of the five follow-up subscale items had a disordered threshold and were recoded. All subscales were unidimensional and no local dependency was detected. DIF was only detected for some items in the follow-up subscale. The CFA revealed that none of the published factor structures fit the data; the fit statistics were appropriate when item 10 was removed and the follow-up subscale was removed. Improving chronic disease care relies upon having validated measures to evaluate the extent to which care goals are met. With some modifications, four of the five PACIC subscales were found to be psychometrically robust.

Background The use of Patient-Reported Outcome Measures (PROMs) in routine clinical care can help ensure symptoms are identified, acknowledged and addressed. In 2007, the provincial cancer agency, Cancer Care Ontario, began to implement routine symptom screening with the Edmonton Symptom Assessment System (ESAS) for ambulatory cancer patients. Having had a decade of experience with ESAS, the program developed a strategic interest in implementing new and/or additional measures. This article describes the development of a streamlined PROM selection and implementation evaluation process with core considerations. Methods Development of the PROM selection and implementation evaluation process involved analysis of quantitative and qualitative data as well as consensus building through a multi-stakeholder workshop. Core PROM selection considerations were developed through a literature scan, review and refinement by a panel of methodological experts and patient advisors, and testing via a test case. Core PROM implementation evaluation considerations were developed through analysis of PROM evaluation frameworks, and review and refinement by a committee of provincial implementation leads. Results Core PROM selection considerations were identified under three overarching themes: symptom coverage, usability and psychometric properties. The symptom coverage category assesses each PROM to determine how well the PROM items address the most prevalent and burdensome symptoms in the target patient population. The usability category aims to assess each measure on characteristics key to successful implementation in the clinical setting. The psychometric properties category assesses each PROM to ensure the data collected is credible, meaningful and interpretable. A scoring system was developed to rate PROM performance by assigning a grade of “weak”, “average” or “good” for each category. The process results in a summary matrix which illustrates the overall assessment of each PROM. Implementation evaluation considerations were identified under three overarching concepts: acceptability, outcomes, and sustainability. A consensus building exercise resulted in the further identification of patient, provider, and clinic specific indicators for each consideration. Conclusion To address the need for a systematic, evidence-based approach to selection, implementation and evaluation of PROMs in the clinical setting, Cancer Care Ontario defined a process with embedded core considerations to facilitate decision-making and encourage standardization.

Rheumatoid arthritis (RA) is chronic, painful, disabling condition resulting in significant impairments in physical, emotional, and social health. Our objective was to use different methods and perspectives to evaluate the responsiveness of Patient-Reported Outcomes Measurement Information System (PROMIS) short forms (SFs) and to identify minimal and meaningful score changes.Adults with RA who were enrolled in a multisite prospective observational cohort completed PROMIS physical function, pain interference, fatigue, and participation in social roles/activities SFs, the PROMIS 29-item form (PROMIS-29), and pain and patient global assessment, and rated change in specific symptoms and RA (a little versus lot better or worse) at the second visit. Physicians recorded joint counts, physician global assessment, and change in RA at visit 2. We compared mean score differences for minimal and meaningful improvement/worsening using patient and physician change ratings and distribution-based methods, and we visually inspected empirical cumulative distribution function curves by change categories.The 348 adults were mostly female (81%) with longstanding RA. Using patient ratings, generally 1-3-point differences were observed for minimal change and 3-7 points for meaningful change. Larger differences were observed with patient versus physician ratings and for symptom-specific versus RA change. Mean differences were similar among SF versions. Prespecified hypotheses about change in PROMIS physical function, pain interference, fatigue, and participation and legacy scales were supported.PROMIS SFs and the PROMIS-29 profiles are responsive to change and generally distinguish between minimal and meaningful improvement and worsening in key RA domains. These data add to a growing body of evidence demonstrating the robust psychometric properties of PROMIS and supporting its use in RA care, research, and decision-making.

Introduction No studies have examined factors associated with fear in any group of people vulnerable during COVID-19 due to pre-existing medical conditions. Objective To investigate factors associated with fear of consequences of COVID-19 among people living with a pre-existing medical condition, the autoimmune disease systemic sclerosis (SSc; scleroderma), including country. Methods Pre-COVID-19 data from the Scleroderma Patient-centered Intervention Network (SPIN) Cohort were linked to COVID-19 data collected in April 2020. Multivariable linear regression was used to assess factors associated with continuous scores of the 10-item COVID-19 Fears Questionnaire for Chronic Medical Conditions, controlling for pre-COVID-19 anxiety symptoms. Results Compared to France (N = 156), COVID-19 Fear scores among participants from the United Kingdom (N = 50) were 0.12 SD (95% CI 0.03 to 0.21) higher; scores for Canada (N = 97) and the United States (N = 128) were higher, but not statistically significant. Greater interference of breathing problems was associated with higher fears due to COVID-19 (Standardized regression coefficient = 0.12, 95% CI 0.01 to 0.23). Participants with higher financial resources adequacy scores had lower COVID-19 Fear scores (Standardized coefficient = −0.18, 95% CI −0.28 to −0.09). Conclusions Fears due to COVID-19 were associated with clinical and functional vulnerabilities in this chronically ill population. This suggests that interventions may benefit from addressing specific clinical issues that apply to specific populations. Financial resources, health policies and political influences may also be important. The needs of people living with chronic illness during a pandemic may differ depending on the social and political context in which they live., Highlights • People with chronic diseases may experience high levels of fear due to COVID-19. • We examined factors associated with fears due to COVID-19 in an at-risk population. • We used the validated COVID-19 Fears Questionnaire for Chronic Medical Conditions. • Fears due to COVID-19 among people with SSc differed substantially by country. • Interference of breathing problems and financial adequacy were related to fears.

BackgroundNo studies have reported comparisons of mental health symptoms prior to and during COVID-19 in vulnerable populations. Objectives were to compare anxiety and depression symptoms among people with a pre-existing medical condition, the autoimmune disease systemic sclerosis (SSc; scleroderma), including continuous change scores, proportion with change ≥ 1 minimal clinically important difference (MCID), and factors associated with changes, including country.MethodsPre-COVID-19 Scleroderma Patient-centered Intervention Network Cohort data were linked to COVID-19 data collected April 9 to April 27, 2020. Anxiety symptoms were assessed with the PROMIS Anxiety 4a v1.0 scale (MCID = 4 points) and depression symptoms with the Patient Health Questionnaire-8 (MCID = 3 points). Multiple linear and logistic regression were used to assess factors associated with continuous change and change ≥ 1 MCID.FindingsAmong 435 participants (Canada = 98; France = 159; United Kingdom = 50; United States = 128), mean anxiety symptoms increased 4.9 points (95% confidence interval [CI] 4.0 to 5.7). Depression symptom change was negligible (0.3 points; 95% CI −0.7 to 0.2). Compared to France, adjusted scores from the United States and United Kingdom were 3.8 points (95% CI 1.7 to 5.9) and 2.9 points higher (95% CI 0.0 to 5.7); scores for Canada were not significantly different. Odds of increasing by ≥ 1 MCID were twice as high for the United Kingdom (2.0, 95% CI 1.0 to 4.2) and United States (1.9, 95% CI 1.1 to 3.2). Participants who used mental health services pre-COVID had adjusted increases 3.7 points (95% CI 1.7 to 5.7) less than other participants.InterpretationAnxiety symptoms, but not depression symptoms, increased dramatically during COVID-19 among people with a pre-existing medical condition. Increase was larger in the United Kingdom and United States than in Canada and France but substantially less for people with pre-COVID-19 mental health treatment.RESEARCH IN CONTEXTEvidence before this studyWe referred to a living systematic review that is evaluating mental health changes from pre-COVID-19 to COVID-19 by searching 7 databases, including 2 Chinese language databases, plus preprint servers, with daily updates (https://www.depressd.ca/covid-19-mental-health). As of June 13, 2020, only 5 studies had compared mental health symptoms prior to and during COVID-19. In 4 studies of university students, there were small increases in depression or general mental health symptoms but minimal or no increases in anxiety symptoms. A general population study from the United Kingdom reported a small increase in general mental health symptoms but did not differentiate between types of symptoms. No studies have reported changes from pre-COVID-19 among people vulnerable due to pre-existing medical conditions. No studies have compared mental health changes between countries, despite major differences in pandemic responses.Added value of this studyWe evaluated changes in anxiety and depression symptoms among 435 participants with the autoimmune condition systemic sclerosis and compared results from Canada, France, the United Kingdom, and the United States. To our knowledge, this is the first study to compare mental health symptoms prior to and during COVID-19 in any vulnerable population. These are the first data to document the substantial degree to which anxiety symptoms have increased and the minimal changes in depression symptoms among vulnerable individuals. It is also the first study to examine the association of symptom changes with country of residence and to identify that people receiving pre-COVID-19 mental health services may be more resilient and experience less substantial symptom increases than others.Implications of all the available evidenceAlthough this was an observational study, it provided evidence that vulnerable people with a pre-existing medical condition have experienced substantially increased anxiety symptoms and that these increases appear to be associated with where people live and, possibly, different experiences of the COVID-19 pandemic across countries. By comparing with evidence from university samples, which found that depression symptoms were more prominent, these data underline the need for accessible interventions tailored to specific needs of different populations. They also suggest that mental health treatments may help people to develop skills or create resilience, which may reduce vulnerability to major stressors such as COVID-19.

Patient-reported outcomes (pros) are essential to capture the patient&rsquo, s perspective and to influence care. Although pros and pro measures are known to have many important benefits, they are not consistently being used and there is there no Canadian pros oversight. The Position Statement presented here is the first step toward supporting the implementation of pros in the Canadian health care setting. The Canadian pros National Steering Committee drafted position statements, which were submitted for stakeholder feedback before, during, and after the first National Canadian Patient Reported Outcomes (canpros) scientific conference, 14&ndash, 15 November 2019 in Calgary, Alberta. In addition to the stakeholder feedback cycle, a patient advocate group submitted a section to capture the patient voice. The canpros Position Statement is an outcome of the 2019 canpros scientific conference, with an oncology focus. The Position Statement is categorized into 6 sections covering 4 theme areas: Patient and Families, Health Policy, Clinical Implementation, and Research. The patient voice perfectly mirrors the recommendations that the experts reached by consensus and provides an overriding impetus for the use of pros in health care. Although our vision of pros transforming the health care system to be more patient-centred is still aspirational, the Position Statement presented here takes a first step toward providing recommendations in key areas to align Canadian efforts. The Position Statement is directed toward a health policy audience, future iterations will target other audiences, including researchers, clinicians, and patients. Our intent is that future versions will broaden the focus to include chronic diseases beyond cancer.

Background Systemic sclerosis (SSc), or scleroderma, is a rare disease that often results in significant disruptions to activities of daily living and can negatively affect physical and psychological well-being. Because there is no known cure, SSc treatment focuses on reducing symptoms and disability and improving health-related quality of life (HRQoL). Self-management programs are known to increase self-efficacy for disease management in many chronic diseases. The Scleroderma Patient-centered Intervention Network (SPIN) developed a Web-based self-management program (SPIN self-management; SPIN-SELF) to increase self-efficacy for disease management and to improve HRQoL for patients with SSc. Objective The proposed study aims to assess the feasibility of conducting a full-scale randomized controlled trial (RCT) of the SPIN-SELF program by evaluating the trial implementation processes, required resources and management, scientific aspects, and participant acceptability and usage of the SPIN-SELF program. Methods The SPIN-SELF feasibility trial will be conducted via the SPIN Cohort. The SPIN Cohort was developed as a framework for embedded pragmatic trials using the cohort multiple RCT design. In total, 40 English-speaking SPIN Cohort participants with low disease management self-efficacy (Self-Efficacy for Managing Chronic Disease Scale score ≤7), who have indicated interest in using a Web-based self-management program, will be randomized with a 3:2 ratio into the SPIN-SELF program or usual care for 3 months. Feasibility outcomes include trial implementation processes, required resources and management, scientific aspects, and patient acceptability and usage of the SPIN-SELF program. Results Enrollment of the 40 participants occurred between July 5, 2019, and July 27, 2019. By November 25, 2019, data collection of trial outcomes was completed. Data analysis is underway, and results are expected to be published in 2020. Conclusions The SPIN-SELF program is a self-help tool that may improve disease-management self-efficacy and improve HRQoL in patients with SSc. The SPIN-SELF feasibility trial will ensure that trial methodology is robust, feasible, and consistent with trial participant expectations. The results will guide adjustments that need to be implemented before undertaking a full-scale RCT of the SPIN-SELF program. International Registered Report Identifier (IRRID) DERR1-10.2196/16799

People with systemic sclerosis (scleroderma) face difficulties being physically active. This study identified physical activity barriers and facilitators experienced by people with scleroderma.We conducted nominal group technique sessions with scleroderma patients who shared physical activity barriers, barrier-specific facilitators, and general facilitators. Participants rated importance of barriers and likelihood of using facilitators from 0 to 10, and indicated whether they had tried facilitators. Barriers and facilitators across sessions were merged to eliminate overlap; edited by investigators, patient advisors, and clinicians; and categorized using qualitative content analysis.We conducted 9 sessions (Scleroderma patients reported many barriers related to health and medical aspects of scleroderma and several barriers in other categories. They reported facilitators to remain physically active despite the barriers.Implications for RehabilitationPeople with scleroderma experience difficulty being physically active due to the diverse and often severe manifestations of the disease, including involvement of the skin, musculoskeletal system, and internal organs.In addition to regular care of scleroderma-related symptoms, patients overcome many exercise challenges by selecting physical activities that are comfortable for them, adjusting the intensity and duration of activities, adapting activities, and using adapted equipment or other materials to reduce discomfort.Rehabilitation professionals should help people with scleroderma to tailor activity options to their capacity and needs when providing care and advice to promote physical activity.

Objective Contagious disease outbreaks and related restrictions can lead to negative psychological outcomes, particularly in vulnerable populations at risk due to pre-existing medical conditions. No randomised controlled trials (RCTs) have tested interventions to reduce mental health consequences of contagious disease outbreaks. The primary objective of the Scleroderma Patient-centered Intervention Network COVID-19 Home-isolation Activities Together (SPIN-CHAT) Trial is to evaluate the effect of a videoconference-based program on symptoms of anxiety. Secondary objectives include evaluating effects on symptoms of depression, stress, loneliness, boredom, physical activity, and social interaction. Methods The SPIN-CHAT Trial is a pragmatic RCT that will be conducted using the SPIN-COVID-19 Cohort, a sub-cohort of the SPIN Cohort. Eligible participants will be SPIN-COVID-19 Cohort participants without a positive COVID-19 test, with at least mild anxiety (PROMIS Anxiety 4a v1.0 T-score ≥ 55), not working from home, and not receiving current counselling or psychotherapy. We will randomly assign 162 participants to intervention groups of 7 to 10 participants each or waitlist control. We will use a partially nested RCT design to reflect dependence between individuals in training groups but not in the waitlist control. The SPIN-CHAT Program includes activity engagement, education on strategies to support mental health, and mutual participant support. Intervention participants will receive the 4-week (3 sessions per week) SPIN-CHAT Program via videoconference. The primary outcome is PROMIS Anxiety 4a score immediately post-intervention. Ethics and dissemination The SPIN-CHAT Trial will test whether a brief videoconference-based intervention will improve mental health outcomes among at-risk individuals during contagious disease outbreak., Highlights • No RCTs have tested mental health interventions in contagious disease outbreaks. • People with scleroderma face fear and isolation during COVID-19. • SPIN-CHAT is designed to improve mental health in SSc patients during COVID-19. • SPIN-CHAT provides 12 group sessions over 4 weeks. • The SPIN-CHAT trial will randomize 162 participants to intervention or waitlist.

The Patient-Reported Outcomes Measurement Information System (PROMIS) aims to address the lack of generalizable and universal measure of patient-reported outcomes to assess health-related quality of life. It has not been validated for patients with chronic kidney disease. We aim to validate the PROMIS-57 and PROMIS-29 questionnaires among kidney transplant recipients.A cross-sectional sample of stable kidney transplant recipients was recruited. Each participant completed PROMIS-57, a 57-question instrument covering seven domains-physical function, anxiety, depression, fatigue, pain, sleep disturbance, and social functioning-alongside validated legacy questionnaires [Patient Health Questionnaire (PHQ9), General Anxiety Disorder (GAD7), Edmonton Symptom Assessment Scale revised (ESASr), and Kidney Disease Quality of Life (KDQoL-36)]. PROMIS-29, a 29-question instrument, is nested within PROMIS-57 and measures the same domains. Structural validity of PROMIS was assessed with confirmatory factor analysis, reported using the Comparative Fit Index (CFI). Construct validity was assessed with known-groups comparisons. Internal consistency was evaluated with Cronbach's α and convergent validity was assessed with Spearman's Rho. Test-retest reliability was assessed through the intraclass correlation coefficient (ICC).Mean (± SD) age of the 177 participants was 50 (± 17), 57% were male and 55% Caucasian. Internal consistency of each domain was high (Cronbach's α 0.88). Confirmatory factor analysis showed good structural validity for most domains (CFI 0.95, RMSEA 0.05). Test-retest reliability indicated good agreement (ICC 0.6). Known-groups comparisons by clinical and socio-demographic differences were found as hypothesized.Our results provide evidence that PROMIS-57 and PROMIS-29 are highly reliable and valid instruments among kidney transplant recipients. We propose it as a valuable tool to assess important domains of the illness experience.

Overweight/obesity is a common, reversible risk factor for obstructive sleep apnea severity (OSA). The purpose of this guideline is to provide evidence-based recommendations for the management of overweight/obesity in patients with OSA.The Grading of Recommendations, Assessment, Development and Evaluation approach was used to evaluate the literature. Clinical recommendations were formulated by a panel of pulmonary, sleep medicine, weight management, and behavioral science specialists.Behavioral, pharmacological, and surgical treatments promote weight loss and can reduce OSA severity, reverse common comorbidities, and improve quality of life, although published studies have methodological limitations. After considering the quality of evidence, feasibility, and acceptability of these interventions, the panel made a strong recommendation that patients with OSA who are overweight or obese be treated with comprehensive lifestyle intervention consisting of 1) a reduced-calorie diet, 2) exercise or increased physical activity, and 3) behavioral guidance. Conditional recommendations were made regarding reduced-calorie diet and exercise/increased physical activity as separate management tools. Pharmacological therapy and bariatric surgery are appropriate for selected patients who require further assistance with weight loss.Weight-loss interventions, especially comprehensive lifestyle interventions, are associated with improvements in OSA severity, cardiometabolic comorbidities, and quality of life. The American Thoracic Society recommends that clinicians regularly assess weight and incorporate weight management strategies that are tailored to individual patient preferences into the routine treatment of adult patients with OSA who are overweight or obese.

Patient-centered outcomes research (PCOR) represents a paradigm shift in research methods aimed to create the body of evidence that supports clinical practice and informs health care decisions. PCOR integrates patients and other key stakeholders including family members, policy makers, clinicians, and patient advocates and advocacy groups as research partners throughout all stages of the research process. The importance of PCOR has received increased recognition, yet there is little evidence available to help guide researchers interested in the design and conduct of PCOR. In May 2014, we convened a workshop to identify key issues related to designing, conducting, and disseminating findings from PCOR studies. Workshop participants included a diverse group of patients, patient advocates, clinicians (physicians, nurses, psychologists, and advanced practice providers), researchers, administrators, and funders within and beyond the pulmonary, critical care, and sleep medicine communities. Participants identified important issues and considerations to address when undertaking PCOR. In this report, we summarize the results of this workshop to inform members of the pulmonary, sleep, and critical care community interested in participating in PCOR. Key findings include the following: 1) requirements for research to be considered PCOR; 2) the potential significant impact of PCOR on patients, clinicians, and researchers; 3) guiding principles and practical strategies to form successful patient-centered research partnerships, conduct PCOR, and disseminate study results to a broad audience of stakeholders; 4) benefits and challenges of PCOR for researchers; and 5) resources available within the American Thoracic Society to help with the conduct of PCOR.

Objective.Nonadherence to medications is common in rheumatic conditions and associated with increased morbidity. Heterogeneous outcome reporting by researchers compromises the synthesis of evidence of interventions targeting adherence. We aimed to assess the scope of outcomes in interventional studies of medication adherence.Methods.We searched electronic databases to February 2019 for published randomized controlled trials and observational studies of interventions with the primary outcome of medication adherence including adults with any rheumatic condition, written in English. We extracted and analyzed all outcome domains and adherence measures with prespecified extraction and analysis protocols.Results.Overall, 53 studies reported 71 outcome domains classified into adherence (1 domain), health outcomes (38 domains), and adherence-related factors (e.g., medication knowledge; 32 domains). We subdivided adherence into 3 phases: initiation (n = 13 studies, 25%), implementation (n = 32, 60%), persistence (n = 27, 51%), and phase unclear (n = 20, 38%). Thirty-seven different instruments reported adherence in 115 unique ways (this includes different adherence definitions and calculations, metric, and method of aggregation). Forty-one studies (77%) reported health outcomes. The most frequently reported were medication adverse events (n = 24, 45%), disease activity (n = 11, 21%), bone turnover markers/physical function/quality of life (each n = 10, 19%). Thirty-three studies (62%) reported adherence-related factors. The most frequently reported were medication beliefs (n = 8, 15%), illness perception/medication satisfaction/satisfaction with medication information (each n = 5, 9%), condition knowledge/medication knowledge/trust in doctor (each n = 3, 6%).Conclusion.The outcome domains and adherence measures in interventional studies targeting adherence are heterogeneous. Consensus on relevant outcomes will improve the comparison of different strategies to support medication adherence in rheumatology.

OBJECTIVE Obesity is implicated in rheumatoid arthritis (RA) development, severity, outcomes, and treatment response. We estimated the independent effects of overweight and obesity on ability to achieve sustained remission (sREM) in the 3 years following RA diagnosis. METHODS Data were from the Canadian Early Arthritis Cohort, a multicenter observational trial of early RA patients treated by rheumatologists using guideline-based care. sREM was defined as Disease Activity Score in 28 joints (DAS28)

To assess adherence to 3 system-level performance measures in a national early rheumatoid arthritis (RA) cohort.Patients enrolled in the Canadian Early Arthritis Cohort (2007-2015) who met 1987 or 2010 American College of Rheumatology/European League Against Rheumatism criteria with1 year of symptom duration and ≥1 year of followup after enrollment were included. Performance measures assessed were the percentage of RA patients seen in yearly followup, and the number of gaps between visits of12 or14 months, the percentage of RA patients treated with a disease-modifying antirheumatic drug (DMARD), and days from RA diagnosis to initiation of a DMARD. Results are shown stratified by enrollment year to assess for temporal changes in performance.A total of 1,763 early RA patients were included (mean age 54 years, 73% female, and 82% white). At enrollment, mean ± SD disease duration was 6 ± 3 months, and Disease Activity Score in 28 joints was 5.1 ± 1.5. Over 8 years, the proportion of patients seen in annual followup declined from 100% to 91%. Over followup, 42% of patients had 0 gaps in care of12 months, and 64% had 0 gaps14 months. The percentage of DMARD-treated early RA patients was and remained high (95-87%), and the percentage receiving DMARDs within 14 days of diagnosis was 75%. Median time-to-DMARD therapy was 1 day, indicating DMARDs were initiated at diagnosis (90th percentile 93 days).There was evidence of high adherence to system-level performance measures in this early RA cohort following a protocol. Small declines in performance were noted with increasing length of patient followup. Our findings are useful for performance measure benchmarking.

Background:The RA-FQ is a patient-reported measure of current disease activity in RA that can be used to identify disease flares. The RA-FQ queries pain, physical function, fatigue, stiffness, and participation and yields a score from 0-50. We previously reported on reliability, validity, and responsiveness.Objectives:To identify changes in RA-FQ that represent minimal and meaningful improvement or worsening from the perspective of people with RA, treating rheumatologists, and in relation to disease activity indices. We hypothesized thatMethods:Data were from adults with early RA (sx Results:The 808 adults were mostly white (84%) women (71%) with a mean (SD) age of 55 (15) and moderate-high CDAI level (85%) at enrollment. Most (79%) reported their RA had changed; 59% were better and 20% worse. Patients who were a lot worse had a mean increase of 8.9 points whereas those who rated themselves as a lot better had a -6.0 decrease on the RA-FQ (Figure 1). Minimal worsening and improvement were associated with 4.7 and -1.8 change in RA-FQ scores, respectively, while patients who rated their RA unchanged had stable RA-FQ scores (Table 1).Similar changes were evident in CDAI, SDAI, and DAS indices (Table 1). Larger differences were observed with patient vs. physician global scores and tender vs. swollen joints. Across measures, the change associated with worsening was greater than for improvement. Results supported all prespecified hypotheses ab.Table 1.Spearman’s correlation coefficients of PsAQoL with the other parameters for construct validityDomainA Lot Better(N=346; 43%)A Little Better(N=132; 16%)The Same(N=174; 21%)A Little Worse(N=94; 12%)A Lot Worse(N=62; 8%)Δ95% CISDΔ95% CISDΔ95% CISDΔ95% CISDΔ95% CISDRA-FQ Total (0-50)-6.0(-7.1, -4.9)10.3-1.8(-3.2, -0.3)8.4-0.1(-1.3, 1.1)8.14.7(2.9, 6.6)9.18.9(5.1, 12.7)15.0 Pain-1.2(-1.4, -0.9)2.4-0.4(-0.8, 0.0)2.30.0(-0.2, 0.3)1.81.3(0.8, 1.7)2.22.0(1.2, 2.9)3.3 Physical Function-1.3(-1.6, -1.1)2.4-0.3(-0.6, 0.1)2.10.0(-0.3, 0.3)2.10.9(0.4, 1.4)2.41.8(0.8, 2.7)3.7 Fatigue-1.1(-1.4, -0.8)2.6-0.4(-0.7, 0.0)1.90.0(-0.3, 0.3)2.10.7(0.3, 1.1)2.11.3(0.5, 2.1)3.2 Stiffness-1.1(-1.4, -0.9)2.4-0.4(-0.7, 0.0)2.0-0.1(-0.4, 0.2)2.01.1(0.6, 1.5)2.21.8(1.0, 2.7)3.3 Participation-1.2(-1.5, -1.0)2.5-0.1(-0.5, 0.3)2.1-0.1(-0.4, 0.2)2.20.8(0.4, 1.3)2.22.0(1.1, 2.8)3.4Disease ActivityCDAI*-5.3(-6.3, -4.3)9.1-3.3(-5.4, -1.3)11.5-0.8(-2.0, 0.5)8.11.7(-0.1, 3.5)8.86.8(3.7, 9.8)12.0SDAI-5.6(-6.8, -4.4)9.2-3.5(-6.1, -0.9)12.2-1.9(-3.6, -0.2)8.91.5(-0.7, 3.7)9.24.7(1.0, 8.4)12.2DAS28-CRP-0.7(-0.8, -0.6)1.01-0.5(-0.7, -0.2)1.2-0.2(-0.4, 0.0)1.00.3(0.1, 0.5)1.00.5(0.2, 0.9)1.2Patient Global (0-10)-1.3(-1.5, -1.0)2.7-0.5(-0.9, -0.1)2.1-0.1(-0.4, 0.2)2.11.3(0.8, 1.8)2.42.9(2.1, 3.6)3.1MD Global (0-10)-1.2(-1.4, -1.0)1.9-0.7(-1.1, -0.3)-0.1-0.1(-0.4, 0.2)1.90.1(-0.3, 0.5)2.80.7(0.0, 1.5)2.8Swollen Joints (28)-1.4(-1.7, 1.0)3.2-1.0(-1.8, -0.2)4.6-0.4(-0.9, 0.0)3.00.0(-0.7, 0.7)3.41.3(0.2, 2.5)4.6Tender Joints (28)-1.5(-1.9, -1.1)3.9-1.3(-2.2, -0.3)5.50.0(-0.7, 0.6)4.30.3(-0.7, 1.2)4.52.2(0.8, 3.5)5.4Conclusion:In this large cohort of adults with ERA, the RA-FQ was responsive to change and generally distinguish between minimal and meaningful improvement and worsening. These data add to a growing evidence demonstrating robust psychometric properties of the RA-FQ and offer initial guidance about the amount of change associated with improvement or worsening, supporting its use in RA care, research and decision-making.Acknowledgements:The CATCH study was designed and implemented by the investigators and financially supported through unrestricted research grants from: Amgen and Pfizer Canada - Founding sponsors since January 2007; AbbVie Corporation and Hoffmann-LaRoche since 2011; Medexus Inc. since 2013;, Merck Canada since 2017, Sandoz Canada, Biopharmaceuticals since 2019,Gilead Sciences Canada since 2020 and Fresenius Kabi Canada Ltd. since 2021. Previously funded by Janssen Biotech from 2011-2016, UCB Canada and Bristol-Myers Squibb Canada from 2011-2018, Sanofi Genzyme from 2016-2017, and Eli Lilly Canada from 2016-2020.Disclosure of Interests:None declared

Objective To determine if inhaled and intranasal ciclesonide are superior to placebo at decreasing respiratory symptoms in adult outpatients with covid-19. Design Randomised, double blind, placebo controlled trial. Setting Three Canadian provinces (Quebec, Ontario, and British Columbia). Participants 203 adults aged 18 years and older with polymerase chain reaction confirmed covid-19, presenting with fever, cough, or dyspnoea. Intervention Participants were randomised to receive either inhaled ciclesonide (600 μg twice daily) and intranasal ciclesonide (200 μg daily) or metered dose inhaler and nasal saline placebos for 14 days. Main outcome measures The primary outcome was symptom resolution at day 7. Analyses were conducted on the modified intention-to-treat population (participants who took at least one dose of study drug and completed one follow-up survey) and adjusted for stratified randomisation by sex. Results The modified intention-to-treat population included 203 participants: 105 were randomly assigned to ciclesonide (excluding two dropouts and one loss to follow-up) and 98 to placebo (excluding three dropouts and six losses to follow-up). The median age was 35 years (interquartile range 27-47 years) and 54% were women. The proportion of participants with resolution of symptoms by day 7 did not differ significantly between the intervention group (42/105, 40%) and control group (34/98, 35%); absolute adjusted risk difference 5.5% (95% confidence interval −7.8% to 18.8%). Results might be limited to the population studied, which mainly included younger adults without comorbidities. The trial was stopped early, therefore could have been underpowered. Conclusion Compared with placebo, the combination of inhaled and intranasal ciclesonide did not show a statistically significant increase in resolution of symptoms among healthier young adults with covid-19 presenting with prominent respiratory symptoms. As evidence is insufficient to determine the benefit of inhaled and intranasal corticosteroids in the treatment of covid-19, further research is needed. Trial registration ClinicalTrials.gov NCT04435795 .

Background Obtaining the patient's view about the outcome of care is an essential component of patient-centered care. Many patient-reported outcome (PRO) instruments for different purposes have been developed since the 1960s. Measurement validation is fundamental in the development, evaluation, and use of PRO instruments. Objectives This paper provides a review of modern perspectives of measurement validation in relation to the followings three questions as applied to PROs: (1) What evidence is needed to warrant comparisons between groups and individuals? (2) What evidence is needed to warrant comparisons over time? and (3) What are the value implications, including personal and societal consequences, of using PRO scores? Discussion Measurement validation is an ongoing process that involves the accumulation of evidence regarding the justification of inferences, actions, and decisions based on measurement scores. These include inferences pertaining to comparisons between groups and comparisons over time as well as consideration of value implications of using PRO scores. Personal and societal consequences must be examined as part of a comprehensive approach to measurement validation. The answers to these three questions are fundamental to the the validity of different types of inferences, actions, and decisions made on PRO scores in health research, health care administration, and clinical practice.

Background Patient-centered health care, where we design and deliver care to address the needs and preferences of patients, represents an important paradigm shift. Patient-reported outcomes (PROs) are critical to capture the patient voice, understand how illness and treatments affect people, and establish how well services and treatments address what matters most to patients. Objective Originally developed for use in research, PROs are now used to monitor individuals and populations, manage care, evaluate services and providers, and inform policy. However, moving PROs beyond research settings incurs considerable methodological, organizational, technological, and ethical considerations. National collaborative networks of researchers, clinicians, patients, and other stakeholders can address these challenges by coordinating development, creating standards for use, sharing costs and delivery platforms, and improving widespread uptake of core sets of measures to better inform health care decisions and improve outcomes. Discussion We introduce eight papers from researchers, clinicians, patients, and decision makers who participated in deliberations around creating a national network to accelerate the application and harmonized use of PROs in Canada. They offer a snap shot of the strategies that pioneers and innovative thinkers are using to integrate the patient voice into comprehensive care, research, and health policy planning of chronic diseases.

Background Given that the goal of health care systems is to improve and maintain the health of the populations they serve, the indicators of performance must include outcomes that are meaningful to patients. The growth of health technologies provides an unprecedented opportunity to integrate the patient voice into clinical care by linking electronic health records (EHRs) to patient-reported outcome (PRO) data collection. However, PRO data must be relevant, meaningful, and actionable for those who will have to invest the time and effort to collect it. Objective In this study, we highlight opportunities to integrate PRO data collection into EHRs. We consider how stakeholder perspectives should influence the selection of PROs and ways to enhance engagement in and commitment to PRO implementation. We propose a research and policy agenda to address unanswered questions and facilitate the widespread adoption of PRO data collection into EHRs. Discussion Building a learning health care system that gathers PRO data in ways that can inform individual patient care, quality improvement, and comparative effectiveness research has the potential to accelerate the application of new evidence and knowledge to patient care.

Contains fulltext : 197998.pdf (Publisher’s version ) (Closed access) Purpose: Systemic sclerosis or scleroderma is a chronic, rare connective tissue disease with negative physical and psychological implications. Coping strategies used by scleroderma patients have not been studied in-depth. The objective of the present study was to gain a greater understanding of the coping strategies employed by people living with scleroderma. Method: Three semi-structured focus group discussions were conducted with a total of 22 people with scleroderma. Interviews were recorded, transcribed, and analyzed using content analysis. Coping strategies discussed were analyzed through Lazarus and Folkman's theoretical model of coping, including: (1) problem-focused, (2) emotion-focused, and (3) meaning-focused coping. Results: Participants reported using a combination of problem-focused (e.g., professional help; seeking disease-related information), emotion-focused (e.g., social support; adaptive distraction techniques), and meaning-focused coping strategies (e.g., benefit finding; goal reappraisal) to help them to cope with and manage their disease. However, many patients reported having difficulty in accessing support services. Conclusions: Scleroderma patients use similar coping strategies as patients with more common diseases, but they may not have access to the same level of support services. Accessible interventions, including self-management programs, aimed at improving problem- and emotion-focused coping are needed. Further, increased access to support groups may provide patients with opportunities to obtain social support and enhance coping. 10 p.

Background:Several composite RA disease activity indices are commonly used in clinical practice and research. Different disease activity indices however can be inconsistent in classifying remission (REM).Objectives:1) Compare remission prevalence across 4 common RA indices; 2) compare changes in remission across indices; and, 3) Identify predictors of persistent active disease across all indices, in real-world early RA patients over 1 year follow up.Methods:Data were from patients with early RA (symptoms < 1 year) enrolled in the Canadian Early Arthritis Cohort (CATCH) between 2007 and 2018. Participants had active disease at enrolment, were treated with csDMARDs and completed standardized clinical assessments every 3-months. Remission status was assessed using 4 indices: 1) DAS28< 2.6 OR DAS28CRP < 2.5, 2) CDAI ≤ 2.8, 3) SDAI≤ 3.3, and 4) ACR/EULAR Boolean remission – SJC28, TJC28, CRP, PGA all ≦1. T-tests/ chi-squared tests were used to compare differences in remission prevalence by 1 year, and changes in remission before and after a QI program. Logistic regression was used to identify predictors of persistent active disease on all 4 indices.Results:1202 adults were eligible for this analysis. At enrolment, 877 (73%) were women, mean (sd) age was 55 (14), average disease activity was high (DAS28 5.1 (1.4); CDAI 27 (14); SDAI 29 (15)). Prevalence of remission by 12-months follow up was 14-21% higher when estimated with the DAS28 compared with CDAI, SDAI and Boolean criteria, and 378 (31%) did not achieve remission according to any of the 4 indices (Fig 1). Improvement in remission after a QI program however was similar across all 4 indices(~+15-17%). In adjusted logistic regression, Persistent active disease across all measures was most strongly associated with positive serostatus and smoking in men, and with obesity and more tender joints in women. Pain and lower education were predictors in BOTH men and women (Table 2)Table 1.Multivariable Logistic Regression Predicting Persistent Active Disease by 12-months across ALL RA indicesConclusion:In the absence of a single “best measure” that also takes in to account the patient’s perspective, we estimate unmet needs for achieving remission in the first year of follow up in 1 in 3 ERA patients who did not achieve remission by ANY of the 4 indices.References:[1] Kuriya B, Sun Y, Boire G, Haraoui B, etal. Remission in Early Rheumatoid Arthritis – A Comparison of New ACR/EULAR Remission Criteria to Established Criteria.J Rheumatol2012;39:1155-1158.Disclosure of Interests:Orit Schieir: None declared, Susan J. Bartlett Consultant of: Pfizer, UCB, Lilly, Novartis, Merck, Janssen, Abbvie, Speakers bureau: Pfizer, UCB, Lilly, Novartis, Merck, Janssen, Abbvie, Marie-France Valois: None declared, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, Gilles Boire Grant/research support from: Merck Canada (Registry of biologices, Improvement of comorbidity surveillance)Amgen Canada (CATCH, clinical nurse)Abbvie (CATCH, clinical nurse)Pfizer (CATCH, Registry of biologics, Clinical nurse)Hoffman-LaRoche (CATCH)UCB Canada (CATCH, Clinical nurse)BMS (CATCH, Clinical nurse, Observational Study Protocol IM101664. SEROPOSITIVITY IN A LARGE CANADIAN OBSERVATIONAL COHORT)Janssen (CATCH)Celgene (Clinical nurse)Eli Lilly (Registry of biologics, Clinical nurse), Consultant of: Eli Lilly, Janssen, Novartis, Pfizer, Speakers bureau: Merck, BMS, Pfizer, Glen Hazlewood: None declared, Carol Hitchon Grant/research support from: UCB Canada; Pfizer Canada, Edward Keystone Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, Consultant of: AbbVie, Amgen, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Celltrion,Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, LillyPharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, UCB., Speakers bureau: Amgen, AbbVie, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Merck, Pfizer Pharmaceuticals, Sanofi Genzyme, UCB, Janet Pope Grant/research support from: AbbVie, Bristol-Myers Squibb, Eli Lilly & Company, Merck, Roche, Seattle Genetics, UCB, Consultant of: AbbVie, Actelion, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eicos Sciences, Eli Lilly & Company, Emerald, Gilead Sciences, Inc., Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Speakers bureau: UCB, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Tin: None declared, Vivian Bykerk: None declared

Background:RA patients with inadequate DMARD response may be treated with a TNF inhibitor (TNFi), non-TNFi or janus kinase inhibitor (JAKi) [1].Objectives:Compare characteristics of real-world early RA (ERA) patients starting TNFi, non-TNFi, and JAKi post DMARD failure.Methods:Data were analyzed from early RA patients (symptoms < 1 year) enrolled in CATCH who started TNFi, non-TNFi or JAKi as first line advanced therapy from 2014 to 2019. Descriptive statistics, t-tests and chi-square tests summarized and compared secular trends and patient characteristics initiating each class of therapy. Multinomial logistic regression analyses were done.Results:246 participants started advanced therapy during the study period; (75%) female, mean(SD) age 50(14) years. First line prescriptions for JAKi increased and TNFi decreased (Fig. 1). Those receiving JAKi had longer disease duration, fewer tender joints, and lower DAS28, CDAI, ESR, MD global (all p Table 1.Characteristics prior to starting advanced therapyVariableTotal Sample(N = 246)JAKi(N = 61)TNFi(N = 153)Non-TNFi(N = 32)p-value£Disease duration (months) mean (SD)39 (34.1)50.8 (39.3)32.5 (29.1)48 (38.6)0.0006DAS28 (ESR - CRP if ESR was missing) mean (SD)4.2 (1.4)3.6 (1.4)4.3 (1.4)4.8 (1.5)0.0012CDAI mean (SD)21.5 (14.8)16.5 (13.7)22.9 (14.8)24.8 (14.9)0.0089Tender joint count (0-28), median (IQR)§4 (7)2 (6)5 (8)6 (9)0.0224ESR median (IQR)§13 (20)12 (13)13 (20)28.0 (23.5)0.0448MD Global (0-10) mean (SD)4.2 (2.7)3.2 (2.7)4.4 (2.6)4.8 (2.8)0.0030§IQR: 75 – 25 percentile£p-value: ANOVA for continuous variable, chi-square for categoricalTable 2.Multinomial regression for initiating advanced DMARD therapyDisease stage & Clinical Disease ActivityAdvanced DMARDAdjusted for Age, sex, education, comorbidityFullyAdjustedφNon-TNF vs TNFJAK vsTNFNon-TNF vs TNFJAK vsTNFAge1.01 (0.98, 1.05)1.01 (0.99, 1.04)1.01 (0.97, 1.05)1.02 (0.99, 1.05)Women vs Men1.98 (0.71, 5.58)1.33 (0.63, 2.80)2.35 (0.76, 7.27)1.72 (0.73, 4.02)Education(< HS vs ≥ HS)2.92 (1.28, 6.63)1.49 (0.78, 2.86)2.83 (1.12, 7.15)2.08 (0.97, 4.47)RDCI baseline1.35 (1.01, 1.81)1.21 (0.95, 1.53)1.30 (0.95, 1.78)1.23 (0.94, 1.60)Private Insurance(No vs Yes)NINI1.26 (0.47, 3.40)0.99 (0.44, 2.25)RF PositiveNINI1.47 (0.56, 3.85)1.84 (0.82, 4.12)CDAININI1.01 (0.98, 1.04)0.97 (0.94, 1.00)RegionQuebec vs Ontario (ON)NINI0.59 (0.20, 1.72)0.44 (0.20, 0.94)West vs ONNINI1.32 (0.29, 5.98)0.11 (0.01, 0.99)φAdjusted for; baseline age, sex, education, RDCI; province; RF positive in first year; private insurance; CDAI at visit prior to initiationConclusion:Patient and physician related factors (location of practice) determined which advanced therapeutic was prescribed. JAKi use is increasing in ERA.Reference:[1]Smolen JS, Landewé RBM, Bijlsma JWJ, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Annals of the Rheumatic Diseases Published Online First: 22 January 2020Disclosure of Interests:Madina Weiler: None declared, Orit Schieir: None declared, Marie-France Valois: None declared, Susan J. Bartlett Consultant of: Pfizer, UCB, Lilly, Novartis, Merck, Janssen, Abbvie, Speakers bureau: Pfizer, UCB, Lilly, Novartis, Merck, Janssen, Abbvie, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, Gilles Boire Grant/research support from: Merck Canada (Registry of biologices, Improvement of comorbidity surveillance)Amgen Canada (CATCH, clinical nurse)Abbvie (CATCH, clinical nurse)Pfizer (CATCH, Registry of biologics, Clinical nurse)Hoffman-LaRoche (CATCH)UCB Canada (CATCH, Clinical nurse)BMS (CATCH, Clinical nurse, Observational Study Protocol IM101664. SEROPOSITIVITY IN A LARGE CANADIAN OBSERVATIONAL COHORT)Janssen (CATCH)Celgene (Clinical nurse)Eli Lilly (Registry of biologics, Clinical nurse), Consultant of: Eli Lilly, Janssen, Novartis, Pfizer, Speakers bureau: Merck, BMS, Pfizer, Glen Hazlewood: None declared, Carol Hitchon Grant/research support from: UCB Canada; Pfizer Canada, Edward Keystone Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, Consultant of: AbbVie, Amgen, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Celltrion,Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, LillyPharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, UCB., Speakers bureau: Amgen, AbbVie, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Merck, Pfizer Pharmaceuticals, Sanofi Genzyme, UCB, Diane Tin: None declared, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Vivian Bykerk: None declared, Janet Pope Grant/research support from: AbbVie, Bristol-Myers Squibb, Eli Lilly & Company, Merck, Roche, Seattle Genetics, UCB, Consultant of: AbbVie, Actelion, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eicos Sciences, Eli Lilly & Company, Emerald, Gilead Sciences, Inc., Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Speakers bureau: UCB

Background:Early diagnosis and rapid initiation of DMARDs following a treat-to-target approach have made remission a realizable goal for many with RA. Yet, some patients are unable to sustain remission over time.Objectives:To describe longitudinal patterns of remission and identify predictors of sustained vs transient remission in real-world early RA patients.Methods:Data were from the Canadian Early Arthritis Cohort (CATCH), a prospective study of early RA patients (symptoms < 1 year) treated in rheumatology clinics across Canada from 2007- 2019. The sample was limited to patients with active disease at enrolment who later reached remission (SDAIResults:The study included 1,419 (46%) CATCH participants that reached remission. At enrolment, most (70%) were female, mean(sd) SDAI was high (27(15)) and 92% were treated with csDMARDs. Only 47% remained in sustained remission by 12-months and, only 40% by 24 months (Pattern 1) (Figure). Among patients with transient remission patterns, transitions to LDA only (Pattern 2) were more common than to MDA/HDA over FU (Pattern 3) (Fig 1). Older age, female sex, smoking, higher comorbidity index and positive serology, were significantly associated with transient remission patterns (Table). There were also borderline significant associations between transient remission patterns and longer time to remission, lack of early MTX treatment and reducing treatment after remission (Table).Table .Adjusted Multinomial Regression Results of Predictors of Transient Remission Patterns over 24-Month Follow UpPattern 2 vs, Pattern 1OR (95% CI)Pattern 3 vs. Pattern 1OR (95% CI)Age1.01 (1.00, 1.02)1.01 (0.99, 1.02)Women vs Men1.78 (1.33, 2.39)1.63 (1.09, 2.44)Current smoker1.57 (1.09, 2.28)1.53 (0.95, 2.47)RDCI at baseline1.11 (0.99, 1.25)1.30 (1.13, 1.50)Seropositive1.38 (1.03, 1.85)1.21 (0.81, 1.80)MTX first 3 months1.18 (0.85, 1.63)0.76 (0.51, 1.12)Time to remission (months)1.01 (1.00, 1.01)1.01 (1.00, 1.02)Treatment reduction after REM vs. No Change1.33 (0.96, 1.86)1.01 (0.99, 1.02) Pattern 1: Sustained REM Pattern 2: Transient REM: Transitions to LDA only Pattern 3: Transient REM: Transitions to MDA/HDA RDCI: Rheumatic Disease Comorbidity Index (range 0-9) Treatment reduction: Change from biologic or JAK to csDMARD(s) OR reduction in number of csDMARDs OR change from MTX +/- csDMARDs to non-MTX csDMARDFigure.Distribution of Disease Activity States over 12-24 After First Achieving SDAI REMConclusion:Results of this large longitudinal analysis of real-world data suggests that < 50% of patients that reach remission sustain remission for 12-24months. Closer monitoring of patients with prognostic indicators for transient remission and additional research focusing on why remission is lost may help improve the rates of sustained remission.References:[1]Ajeganova S, Huizinga T. Sustained remission in rheumatoid arthritis: latest evidence and clinical considerations. Ther Adv Musculoskelet Dis. 2017;9(10):249-62.Disclosure of Interests:Orit Schieir: None declared, Glen Hazlewood: None declared, Susan J. Bartlett Consultant of: Pfizer, UCB, Lilly, Novartis, Merck, Janssen, Abbvie, Speakers bureau: Pfizer, UCB, Lilly, Novartis, Merck, Janssen, Abbvie, Marie-France Valois: None declared, Louis Bessette Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi, UCB Pharma, Speakers bureau: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Merck, Novartis, Pfizer, Sanofi, Gilles Boire Grant/research support from: Merck Canada (Registry of biologices, Improvement of comorbidity surveillance)Amgen Canada (CATCH, clinical nurse)Abbvie (CATCH, clinical nurse)Pfizer (CATCH, Registry of biologics, Clinical nurse)Hoffman-LaRoche (CATCH)UCB Canada (CATCH, Clinical nurse)BMS (CATCH, Clinical nurse, Observational Study Protocol IM101664. SEROPOSITIVITY IN A LARGE CANADIAN OBSERVATIONAL COHORT)Janssen (CATCH)Celgene (Clinical nurse)Eli Lilly (Registry of biologics, Clinical nurse), Consultant of: Eli Lilly, Janssen, Novartis, Pfizer, Speakers bureau: Merck, BMS, Pfizer, Carol Hitchon Grant/research support from: UCB Canada; Pfizer Canada, Edward Keystone Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, Consultant of: AbbVie, Amgen, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Celltrion, Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, UCB., Speakers bureau: Amgen, AbbVie, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Merck, Pfizer Pharmaceuticals, Sanofi Genzyme, UCB, Janet Pope Grant/research support from: AbbVie, Bristol-Myers Squibb, Eli Lilly & Company, Merck, Roche, Seattle Genetics, UCB, Consultant of: AbbVie, Actelion, Amgen, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Eicos Sciences, Eli Lilly & Company, Emerald, Gilead Sciences, Inc., Janssen, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi, UCB, Speakers bureau: UCB, Carter Thorne Consultant of: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Tin: None declared, Vivian Bykerk: None declared

BACKGROUND Ensuring care is patient-centered can be particularly challenging in spinal cord injury (SCI). Due to the sudden onset and variable severity, people with SCI often experience a wide range of limitations and secondary complications that evolve over time. Patient-Reported Outcomes (PROs) offer a primary way of monitoring secondary complications, tracking changes in functioning over time, and identifying clinical issues that are salient to the person with SCI. Despite the potential for using PROs in clinical practice, there exist barriers, which impede the implementation of PROs in clinical settings. PRO data must be perceived to be relevant, meaningful and actionable to those who will have to invest the time and effort to collect it. Hypothesis: We hypothesize that collection of SCI-PROs at regular intervals will be feasible and acceptable, will increase patient engagement, satisfaction, communication, and shared decision-making between patients and providers, facilitate goal setting and problem-solving, and increase the focus on patient-valued outcomes. We also hypothesize that this type of clinical encounter will not only provide skill enhancement for clinicians but also increase positive psychological functioning, social participation and engagement, and overall quality of life of persons with SCI. OBJECTIVE 1) Develop a participatory stakeholder-driven process to identify a minimal battery of essential SCI PROs and clinician ratings (SCI-CORE) that will be collected regularly via online electronic data capture with real-time scoring and reporting (EDCR), and 2) to assess acceptability, and feasibility and fidelity of integrating SCI-CORE EDCR into routine care in rehabilitation settings, and 3) evaluate the impact of using longitudinal SCI-CORE assessments on patient and clinicians perceptions. METHODS Phase 1 will use a participatory approach with our stakeholders (n=200) to identify a harmonized core set of PROs for use in SCI rehabilitation. Phase 2 will develop the PRO prototype battery and platform including a customized interface. In Phase 3, we will implement and evaluate the SCI-PRO intervention in a user’s needs assessment allowing us to evaluate facilitators and barriers to implementation and sustainability. Evaluation: Data will be collected through standardized questionnaires, focus groups, individual interviews, local administrative data, and patient chart reviews and web analytics from the e-PRO system and we will evaluate the tool’s reach, acceptability, feasibility and fidelity of implementation and measure the perceptions of care and change in health-related quality of life RESULTS Results of this demonstration study will potentially have an impact that is relevant to make health care more patient-centered, increase shared decision-making, promote self-management, and facilitate clinical research across the SCI network CONCLUSIONS If hypothesized outcomes are observed, data will be used as preliminary data for a full scale RCT evaluating the effectiveness of this approach across settings in the US and Canada. CLINICALTRIAL

Objective.The Outcome Measures in Rheumatology (OMERACT) Safety Working Group is identifying core safety domains that matter most to patients with rheumatic disease.Methods.International focus groups were held with 39 patients with inflammatory arthritis to identify disease-modifying antirheumatic drug (DMARD) experiences and concerns. Themes were identified by pragmatic thematic coding and discussed in small groups by meeting attendees.Results.Patients view DMARD side effects as a continuum and consider the cumulative effect on day-to-day function. Disease and drug experiences, personal factors, and life circumstances influence tolerance of side effects and treatment persistence.Conclusion.Patients weigh overall adverse effects and benefits over time in relation to experiences and life circumstances.

PurposeTo identify physical activity barriers and facilitators experienced by people with systemic sclerosis (SSc; scleroderma).Materials and MethodsWe conducted nominal group technique sessions with SSc patients who shared barriers to physical activities, barrier-specific facilitators, and general facilitators. Participants rated importance of barriers and likelihood of using facilitators from 0-10, and indicated whether they had tried facilitators. Barriers and facilitators across sessions were subsequently merged to eliminate overlap; edited based on feedback from investigators, patient advisors, and clinicians; and categorized.ResultsWe conducted nine sessions (n=41 total participants) and initially generated 181 barriers, 457 barrier-specific facilitators, and 20 general facilitators. The number of consolidated barriers (barrier-specific facilitators in parentheses) for each category were: 14 (61) for health and medical; 4 (23) for social and personal; 1 (3) for time, work, and lifestyle; and 1 (4) for environmental. There were 12 consolidated general facilitators. The consolidated items with ≥ 1/3 of participants’ ratings ≥ 8 were: 15 barriers, 69 barrier-specific facilitators, and 9 general facilitators.ConclusionsPeople with SSc reported many barriers related to health and medical aspects of SSc and several barriers in other categories. They reported facilitators to remain physically active despite the barriers.Implications for RehabilitationPeople with scleroderma experience difficulty being physically active due to the diverse and often severe manifestations of the disease, including involvement of the skin, musculoskeletal system, and internal organs.In addition to regular care of scleroderma-related symptoms, patients overcome many exercise challenges by selecting physical activities that are comfortable for them, adjusting the intensity and duration of activities, adapting activities, and using adapted equipment or other materials to reduce discomfort.Rehabilitation professionals should help people with scleroderma to tailor activity options to their capacity and needs when providing care and advice to promote physical activity.

Background The frequency and characteristics of patients with Palindromic Rheumatism (PR) (transient acute attacks of articular inflammation) prior to early rheumatoid arthritis (ERA) are unknown. Objectives To compare ERA patients who did versus did not report a history of transient episodes of joint inflammation preceding RA diagnosis. Methods Study participants were patients with ERA or suspected RA (symptoms Results 154 ERA patients were included; 66% were female and mean (sd) age was 54 (15) years. 54% had previous joint pain and swelling prior to their current episode; 42% endorsed prior episodic joint pain and swelling, approximately half of whom (20% of total, N=31) reported transient joint symptoms for over six months. Patients reporting previous palindromic symptoms were more often female, seropositive, had more comorbidities, and lower swollen joints and baseline CDAI (p Conclusion Half of ERA patients self-reported transient episodes of inflammatory arthritis prior to being diagnosed with RA. They are more likely female, seropositive, with higher income and lower disease activity. Acknowledgement The CATCH study was designed and implemented by the investigators and financially supported through unrestricted research grants from: Amgen and Pfizer Canada - Founding sponsors since January 2007; AbbVie Corporation since 2011; Medexus Inc. since 2013; Eli Lilly Canada since 2016 and Merck Canada since 2017. Previously funded by Hoffmann-LaRoche and Janssen Biotech from 2011-2016,UCB Canada and Bristol-Myers Squibb Canada from 2011-2018, and Sanofi Genzyme from 2016-2017. Disclosure of Interests Leah Ellingwood: None declared, Orit Schieir: None declared, Marie-France Valois: None declared, Susan J. Bartlett Consultant for: Pfizer, UCB, Lilly, Novartis, Merck, Jansen, Abbvie, Louis Bessette Grant/research support from: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Consultant for: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Speakers bureau: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Carol Hitchon: None declared, Gilles Boire Grant/research support from: Investigator-initiated studies: Amgen, Abbvie, BMS, Eli Lilly, Merck, Novartis, Pfizer, Consultant for: Advisory boards: Amgen, BMS, Celgene, Eli Lilly, Pfizer, Speakers bureau: Merck, BMS, Pfizer, Glen Hazlewood: None declared, Edward Keystone Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, Consultant for: AbbVie, Amgen, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Celltrion, Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, UCB., Speakers bureau: Amgen, AbbVie, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Merck, Pfizer Pharmaceuticals, Sanofi Genzyme, UCB, Diane Tin: None declared, Carter Thorne Grant/research support from: Investigator-initiated studies: Amgen, Pfizer. RCTs: Abbvie, Celgene, CaREBiodam, Novartis, Pfizer, Consultant for: Advisory board: Abbvie, Amgen, Celgene, Lilly, Medexus/Medac, Merck, Novartis, Pfizer, Sanofi. Consultant: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Vivian Bykerk Grant/research support from: Mallinckrodt, BMS, Crescendo Biosciences, Sanofi/Regeneron., Consultant for: Amgen, Pfizer, UCB, Scipher, Sanofi/Genzyme/Regeneron, Janet Pope Consultant for: Eli Lilly and Company

Background Rheumatoid arthritis (RA) treatment emphasizes aggressive titration of disease-modifying antirheumatic drugs (DMARDs) with the goal of achieving disease remission. This often includes the use of multiple DMARDs in combination, which can have a significant impact on patients’ lives and add costs to the healthcare system. Objectives To describe the patterns of sustained remission and subsequent treatment reduction in usual clinical practice for patients with early RA. Methods Patients (age >18) enrolled in the Canadian early ArThritis CoHort (CATCH) between January 2007 to March 2017 were analyzed. CATCH is a prospective, observational study of patients with early inflammatory arthritis (symptoms 2.6) and those treated with at least one DMARD or biologic agent within the first three months of study enrolment. We defined sustained remission as achieving a DAS28 Results Eight hundred and thirty-seven (40%) of the 2,097 eligible patients achieved sustained remission during the study period. Of these, 60% did so within the first 18 months and 92% within the first four years (Figure 1). The mean (SD) baseline DAS28 was 5.1 (1.3), and HAQ-DI was 1.0 (0.7). At the time of remission, 80% were prescribed methotrexate (55% subcutaneously), 71% were prescribed combination therapy with other conventional synthetic DMARDs, and 13% were prescribed a biologic agent. In the year after attaining sustained remission, 327 (39%) patients reduced treatment in the following pattern (patients may have had more than one change): 250 patients (30%) reduced or stopped methotrexate, 196 patients (23%) reduced or stopped non-methotrexate DMARDs, and 34 patients (4%) reduced or stopped biologic agents. Of those that reduced or stopped a biologic, only one was due to side effects. For the 250 patients who reduced or stopped methotrexate, 25 were for a side effect. Conclusion Achieving sustained remission occurred in 40% of early RA patients in usual clinical practice. Treatment reductions following sustained remission occurred in over a third of patients over the next 12 months, and consisted mainly of adjustment in non-biologic DMARDs. Disclosure of Interests Maria Powell: None declared, Vivian Bykerk Grant/research support from: Mallinckrodt, BMS, Crescendo Biosciences, Sanofi/Regeneron., Consultant for: Amgen, Pfizer, UCB, Scipher, Sanofi/Genzyme/Regeneron, Orit Schieir: None declared, Janet Pope Consultant for: Eli Lilly and Company, Susan J. Bartlett Consultant for: Pfizer, UCB, Lilly, Novartis, Merck, Jansen, Abbvie, Louis Bessette Grant/research support from: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Consultant for: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Speakers bureau: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Gilles Boire Grant/research support from: Investigator-initiated studies: Amgen, Abbvie, BMS, Eli Lilly, Merck, Novartis, Pfizer, Consultant for: Advisory boards: Amgen, BMS, Celgene, Eli Lilly, Pfizer, Speakers bureau: Merck, BMS, Pfizer, CArol Hitchon Grant/research support from: Pfizer, UCB (unrelated studies), Edward Keystone Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, Consultant for: AbbVie, Amgen, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Celltrion, Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, UCB., Speakers bureau: Amgen, AbbVie, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Merck, Pfizer Pharmaceuticals, Sanofi Genzyme, UCB, Carter Thorne Grant/research support from: Investigator-initiated studies: Amgen, Pfizer. RCTs: Abbvie, Celgene, CaREBiodam, Novartis, Pfizer, Consultant for: Advisory board: Abbvie, Amgen, Celgene, Lilly, Medexus/Medac, Merck, Novartis, Pfizer, Sanofi. Consultant: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Tin: None declared, Marie-France Valois: None declared, Glen Hazlewood : None declared

Background Fatigue is common in early RA(ERA) and though some patients experience improvement in fatigue when disease is well controlled, others experience persistent fatigue associated with work disability, poor QOL, and depression. Objectives To compare patterns and predictors of improved vs. persistent fatigue in the first year of ERA. Methods Data were from ERA patients (symptoms Results The 1002 pts were mostly white (81%), female (71%), with a mean (SD) age of 54 (15); 32% were obese. 70% had high fatigue at baseline; these patients were more obese, had OA/backpain, poor sleep, depression, major stress, and higher disease activity (Table 1). Among those with initial high fatigue, 30% had persistent fatigue at 12 months and was associated with obesity, comorbidities, FM, longer symptom duration, and slightly lower baseline fatigue. Predictors of improved fatigue in multivariable models were BMI Conclusion Fatigue is common in ERA and associated with active disease, worse pain and disability, obesity, depression, major stressors, poor sleep and OA/backpain. In high fatigue pts, those who are not obese, have higher pain, and take ≥20 mg MTX are more likely to improve over the first year. Optimizing weight, sleep, physical and emotional health and MTX use may improve persistent fatigue beyond control of RA inflammation. Disclosure of Interests Susan J. Bartlett Consultant for: Pfizer, UCB, Lilly, Novartis, Merck, Jansen, Abbvie, Orit Schieir: None declared, Marie-France Valois: None declared, CArol Hitchon Grant/research support from: Pfizer, UCB (unrelated studies), Louis Bessette Grant/research support from: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Consultant for: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Speakers bureau: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Glen Hazlewood: None declared, Carter Thorne Grant/research support from: Investigator-initiated studies: Amgen, Pfizer. RCTs: Abbvie, Celgene, CaREBiodam, Novartis, Pfizer, Consultant for: Advisory board: Abbvie, Amgen, Celgene, Lilly, Medexus/Medac, Merck, Novartis, Pfizer, Sanofi. Consultant: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Janet Pope Consultant for: Eli Lilly and Company, Gilles Boire Grant/research support from: Investigator-initiated studies: Amgen, Abbvie, BMS, Eli Lilly, Merck, Novartis, Pfizer, Consultant for: Advisory boards: Amgen, BMS, Celgene, Eli Lilly, Pfizer, Speakers bureau: Merck, BMS, Pfizer, Diane Tin: None declared, Edward Keystone Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, Consultant for: AbbVie, Amgen, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Celltrion, Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, UCB., Speakers bureau: Amgen, AbbVie, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Merck, Pfizer Pharmaceuticals, Sanofi Genzyme, UCB, Vivian Bykerk Grant/research support from: Mallinckrodt, BMS, Crescendo Biosciences, Sanofi/Regeneron., Consultant for: Amgen, Pfizer, UCB, Scipher, Sanofi/Genzyme/Regeneron

Background: RA patients may cancel scheduled visits with their rheumatologist. In clinical practice, a validated patient-reported disease activity measure that tracks well with traditional clinical indices could address an important gap by providing real-time information on RA disease activity when a visit to the rheumatologist is not possible. Objectives: To assess concordance between the 5-item patient-reported Rheumatoid Arthritis Flare Questionnaire (RA-FQ) (1,2) and the Clinical Disease Activity Index (CDAI) in patients with early RA (ERA) treated in rheumatology clinics in 2 countries with different health systems. Methods: Data were analyzed from patients enrolled in the Canadian early ArThritis CoHort (CATCH) between Nov 2011 and March 2017 and in the Consortium of early ArThritis Cohorts- USA (CATCH-US) from Dec 2014 to Dec 2018. Both observational studies had a similar design; enrolled patients diagnosed with EIA ( Results: The study included 818 Canadian and 75 American early RA patients. Age, male sex, and disease activity was higher in the Canadian cohort, while post-secondary education was higher in the US cohort (Table1). RA-FQ and CDAI scores tracked closely with one another over time in both cohorts (Canada ICC: 0.76; US ICC: 0.80) Conclusion: There was high concordance between the RA-FQ and CDAI measures over the 1st year of follow up in 2 early RA samples recruited in 2 countries. The RA-FQ may help patients and clinicians track patient disease activity between clinic visits. References: [1] Bykerk VP et al. RMD Open, 2016 [2] Bartlett SJ et al. J Rheumatol. 2017 Acknowledgement: CATCH: Amgen & pfizer-founding sponsors 2007+; abbvie 2011+; medexus 2013+; eli lilly 2016+, merck canada 2017+, hoffmann-laroche & janssen biotect 2011-2016, ucb & bms 2011-2018, sanofi-genzyme 2016-2017. catch-us: bms, ucb, genentech; cedar hill foundation Disclosure of Interests: Vivian Bykerk Grant/research support from: Mallinckrodt, BMS, Crescendo Biosciences, Sanofi/Regeneron., Consultant for: Amgen, Pfizer, UCB, Scipher, Sanofi/Genzyme/Regeneron, Orit Schieir: None declared, Marie-France Valois: None declared, Glen Hazlewood : None declared, Gilles Boire Grant/research support from: Investigator-initiated studies: Amgen, Abbvie, BMS, Eli Lilly, Merck, Novartis, Pfizer, Consultant for: Advisory boards: Amgen, BMS, Celgene, Eli Lilly, Pfizer, Speakers bureau: Merck, BMS, Pfizer, CArol Hitchon Grant/research support from: Pfizer, UCB (unrelated studies), Louis Bessette Grant/research support from: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Consultant for: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Speakers bureau: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Carter Thorne Grant/research support from: Investigator-initiated studies: Amgen, Pfizer. RCTs: Abbvie, Celgene, CaREBiodam, Novartis, Pfizer, Consultant for: Advisory board: Abbvie, Amgen, Celgene, Lilly, Medexus/Medac, Merck, Novartis, Pfizer, Sanofi. Consultant: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Edward Keystone Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, Consultant for: AbbVie, Amgen, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Celltrion, Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, UCB., Speakers bureau: Amgen, AbbVie, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Merck, Pfizer Pharmaceuticals, Sanofi Genzyme, UCB, Diane Tin: None declared, Caroline Benson: None declared, Janet Pope Consultant for: Eli Lilly and Company, Clifton Bingham Grant/research support from: BMS, Consultant for: AbbVie, BMS, Eli Lilly, Genentech/Roche, Janssen, Pfizer, Sanofi/Regeneron, Susan J. Bartlett Consultant for: Pfizer, UCB, Lilly, Novartis, Merck, Jansen, Abbvie

Background: While treat-to-target strategies can dramatically reduce RA inflammation, persistent fatigue is present in up to half of RA patients, and is an important unmet need. Proposed underlying causes include RA disease, cognitive/emotional/behavioral (CEB), and personal (health) factors. Objectives: To identify risk factors for persistent fatigue at 12-months in men and women with ERA on immunomodulatory therapies. Methods: Data were from patients enrolled in the Canadian Early Arthritis Cohort (CATCH) between 01-2007 and 03-2017 who met 1987 or 2010 ACR/EULAR RA criteria, had active disease treated with DMARDS, and had complete data on DAS28, BMI, and fatigue severity (0-10) over 12-months. Persistent fatigue, was defined as fatigue >4 at baseline with Results: Patients were mostly white (81%), female (71%), with a mean (SD) age of 54 (15), symptom duration of 6 (3) months, and BMI of 28.0 (6.1); 32% were obese (BMI≥30). Women were generally younger, better educated, seropositive, and had greater disability, fatigue, depressive symptoms, and major stress in the past year (p In multivariable regression that included all Table 1 variables, predictors of persistent fatigue in women were obesity (OR 1.7; 95% CI 1.1, 2.6), initial steroid use (OR 1.7; 95% CI 1.1, 2.7), seronegativity (OR 0.6; 95% CI 0.4, 1.0) and poor sleep (OR 1.1; 95% CI 1.0, 1.2). Obesity was the only significant predictor in men and was assoicated with a 2.4 times higher odds (95% CI 1.1, 5.1) of persistent fatigue at 1 yr. Other sociodemographic, RA characteristic, CEB and personal/health factors were not associated with persistent fatigue in either sex in multivariable models. Conclusion: Obesity is common in ERA and a major determinant of persistent fatigue in women and men. In obese RA patients on guideline-based treatment, lifestyle interventions targeting weight loss may play an important role in reducing persistent fatigue that does not improve with RA treatment. Disclosure of Interests: Susan J. Bartlett Consultant for: Pfizer, UCB, Lilly, Novartis, Merck, Jansen, Abbvie, Orit Schieir: None declared, Marie-France Valois: None declared, Janet Pope Consultant for: Eli Lilly and Company, Louis Bessette Grant/research support from: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Consultant for: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Speakers bureau: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, CArol Hitchon Grant/research support from: Pfizer, UCB (unrelated studies), Carter Thorne Grant/research support from: Investigator-initiated studies: Amgen, Pfizer. RCTs: Abbvie, Celgene, CaREBiodam, Novartis, Pfizer, Consultant for: Advisory board: Abbvie, Amgen, Celgene, Lilly, Medexus/Medac, Merck, Novartis, Pfizer, Sanofi. Consultant: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Tin: None declared, Glen Hazlewood: None declared, Gilles Boire Grant/research support from: Investigator-initiated studies: Amgen, Abbvie, BMS, Eli Lilly, Merck, Novartis, Pfizer, Consultant for: Advisory boards: Amgen, BMS, Celgene, Eli Lilly, Pfizer, Speakers bureau: Merck, BMS, Pfizer, Edward Keystone Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, Consultant for: AbbVie, Amgen, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Celltrion, Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, UCB., Speakers bureau: Amgen, AbbVie, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Merck, Pfizer Pharmaceuticals, Sanofi Genzyme, UCB, Vivian Bykerk Grant/research support from: Mallinckrodt, BMS, Crescendo Biosciences, Sanofi/Regeneron., Consultant for: Amgen, Pfizer, UCB, Scipher, Sanofi/Genzyme/Regeneron

Background Up to 80% of rheumatoid arthritis patients report clinically relevant fatigue.1 Fatigue is complex multi-factorial process that can result in adverse affects on patients’ physical and emotional well-being.2 Objectives To examine the relationship between disease activity and fatigue over time in early rheumatoid arthritis (ERA). Methods Data were from patients with ERA (symptoms ≤ 12 months) enrolled in the Canadian Early Arthritis Cohort (CATCH). CATCH participants completed repeat clinical assessments, laboratory investigations and self-reported questionnaires including rating their fatigue over the past week using a 10 point numerical rating scale (NRS). Fatigue severity was classified as low (≤2); moderate (>2 but Results Of the 1864 patients included, 1640 (88%) met criteria for RA, 1342 (72%) were women and most had moderate-high baseline disease with a mean (SD) DAS28 of 4.9 (1.5). Fatigue was common with 19% reporting moderate and 59% severe fatigue at baseline. Fatigue was positively and strongly correlated with pain and patient global ratings (r 0.56-0.67, p DAS28: disease activity score in 28 joints; REM: remission; LDA: low disease activity; MDA: moderate disease activity; HDA: high disease activity. Conclusion Fatigue is common in ERA and is most strongly correlated with pain and disease activity. Early treatment response within 3-months was associated with short and long-term improvements in fatigue over time. Further longitudinal research examining the time-varing effects of both clinical and psychosocial factors on fatigue is needed. References [1] Pollard, LC., Choy, HE., Gonzalez, J., Khoshaba, B., and Scott, DL. Fatigue in rheumatoid arthritis reflects pain, not disease activity. Rheumatology. 2006;45:885-889. [2] Nikolaus, S., Bode, C., Taal, E., and Van De Laar, MA. Fatigue and Factors Relating to Fatigue in Rheumatoid Arthritis: A systematic Review. American College of Rheumatology. 2013;65:1128-1146. Acknowledgement On behalf of Canadian Early Arthritis Cohort (CATCH) Investigators Disclosure of Interests Melissa Holdren: None declared, Orit Schieir: None declared, Susan J. Bartlett Consultant for: Pfizer, UCB, Lilly, Novartis, Merck, Jansen, Abbvie, Louis Bessette Grant/research support from: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Consultant for: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Speakers bureau: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Gilles Boire Grant/research support from: Investigator-initiated studies: Amgen, Abbvie, BMS, Eli Lilly, Merck, Novartis, Pfizer, Consultant for: Advisory boards: Amgen, BMS, Celgene, Eli Lilly, Pfizer, Speakers bureau: Merck, BMS, Pfizer, Glen Hazlewood : None declared, CArol Hitchon Grant/research support from: Pfizer, UCB (unrelated studies), Edward Keystone Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, Consultant for: AbbVie, Amgen, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Celltrion, Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, UCB., Speakers bureau: Amgen, AbbVie, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Merck, Pfizer Pharmaceuticals, Sanofi Genzyme, UCB, Diane Tin: None declared, Carter Thorne Grant/research support from: Investigator-initiated studies: Amgen, Pfizer. RCTs: Abbvie, Celgene, CaREBiodam, Novartis, Pfizer, Consultant for: Advisory board: Abbvie, Amgen, Celgene, Lilly, Medexus/Medac, Merck, Novartis, Pfizer, Sanofi. Consultant: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Vivian Bykerk Grant/research support from: Mallinckrodt, BMS, Crescendo Biosciences, Sanofi/Regeneron., Consultant for: Amgen, Pfizer, UCB, Scipher, Sanofi/Genzyme/Regeneron, Janet Pope Consultant for: Eli Lilly and Company

Background Prevalence studies of metabolic syndrome (MetS) in early rheumatoid arthritis (ERA) are sparse and estimates are variable. Differences by sex and menopausal status have not been formally assessed. Objectives We estimated prevalence and factors associated with MetS in ERA patients treated in routine practice settings. Variations by sex, and by menopausal status were also examined. Methods Cross-sectional data were analyzed from patients meeting 1987 or 2010 ACR/EULAR RA criteria enrolled in the Canadian Early Arthritis Cohort (CATCH) from January 2007-March 2017. CATCH is a prospective multicenter observational study of patients diagnosed and treated for early inflammatory arthritis (symptoms Results The sample included 1543 participants; 71% were female and mean(SD) age was 54 (15) years. 476 (31%) of the total sample met criteria for MetS. Participants with MetS were older, more frequently past smokers and reported more comorbid conditions, including cardiovascular disease (CVD) (p Conclusion Approximately 1 in 3 ERA patients met crietria for MetS. Though men had a higher prevalence of MetS and individual MetS components, post-menopausal women had a similar MetS profile as men, and should equally be considered high risk for CVD development. Characteristics and associations with MetS differed in men and women suggesting sex-specific variations are important considerations for comorbidity screening and surveillance of CVD outcomes in ERA. Reference [1] Alberti KG, Zimmet PZ. Definition, diagnosis and classification of diabetes mellitus and its complications. Part 1: diagnosis and classification of diabetes mellitus provisional report of a WHO consultation. Diabet Med. 1998;15(7):539-53. Acknowledgement Sponsors: Amgen & Pfizer-Founding sponsors 2007+; AbbVie 2011+; Medexus 2013+;EliLilly2016+, Merck Canada 2017+, Hoffmann-LaRoche & Janssen Biotect 2011-2016, UCB & BMS 2011-2018, Sanofi-Genzyme 2016-2017. Disclosure of Interests Bindee Kuriya Consultant for: Advisory Board Member: Abbvie, Sanofi Genzyme, Eli Lilly, Pfizer Canada, Roche, Orit Schieir: None declared, Marie-France Valois: None declared, Janet Pope Consultant for: Eli Lilly and Company, Gilles Boire Grant/research support from: Investigator-initiated studies: Amgen, Abbvie, BMS, Eli Lilly, Merck, Novartis, Pfizer, Consultant for: Advisory boards: Amgen, BMS, Celgene, Eli Lilly, Pfizer, Speakers bureau: Merck, BMS, Pfizer, Louis Bessette Grant/research support from: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Consultant for: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Speakers bureau: Amgen, BMS, Janssen, Roche, UCB, AbbVie, Pfizer, Merck, Celgene, Sanofi, Lilly, Novartis, Glen Hazlewood : None declared, Carter Thorne Grant/research support from: Investigator-initiated studies: Amgen, Pfizer. RCTs: Abbvie, Celgene, CaREBiodam, Novartis, Pfizer, Consultant for: Advisory board: Abbvie, Amgen, Celgene, Lilly, Medexus/Medac, Merck, Novartis, Pfizer, Sanofi. Consultant: Abbvie, Centocor, Janssen, Lilly, Medexus/Medac, Pfizer, Speakers bureau: Medexus/Medac, Diane Tin: None declared, CArol Hitchon Grant/research support from: Pfizer, UCB (unrelated studies), Susan J. Bartlett Consultant for: Pfizer, UCB, Lilly, Novartis, Merck, Jansen, Abbvie, Edward Keystone Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, F. Hoffmann-La Roche Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Pfizer Pharmaceuticals, Sanofi-Aventis, Consultant for: AbbVie, Amgen, AstraZeneca Pharma, Biotest, Bristol-Myers Squibb Company, Celltrion, Crescendo Bioscience, F. Hoffmann-La Roche Inc, Genentech Inc, Gilead, Janssen Inc, Lilly Pharmaceuticals, Merck, Pfizer Pharmaceuticals, Sandoz, UCB., Speakers bureau: Amgen, AbbVie, Bristol-Myers Squibb Canada, F. Hoffmann-La Roche Inc., Janssen Inc., Merck, Pfizer Pharmaceuticals, Sanofi Genzyme, UCB, Vivian Bykerk Grant/research support from: Mallinckrodt, BMS, Crescendo Biosciences, Sanofi/Regeneron., Consultant for: Amgen, Pfizer, UCB, Scipher, Sanofi/Genzyme/Regeneron, Lillian Barra: None declared

Yoga is a popular activity which may be well suited for some individuals with certain rheumatic disorders. Regular yoga practice can increase muscle strength and endurance, proprioception and balance, with emphasis on movement through a full range of motion to increase flexibility and mobility. Additional beneficial elements of yoga include breathing, relaxation, body awareness and meditation, which can reduce stress and anxiety and promote a sense of calmness, general well-being and improved quality of life. Yoga also encourages a meditative focus, increased body awareness and mindfulness; some evidence suggests yoga may help decrease inflammatory mediators including C-reactive protein and interleukin-6. Yoga is best learned under the supervision of qualified teachers who are well informed about the potential musculoskeletal needs of each individual. Here, we briefly review the literature on yoga in healthy, musculoskeletal, and rheumatic disease populations and offer recommendations for discussing ways to begin yoga with patients.

Objective—To evaluate the impact of Integral-based hatha yoga in sedentary people with arthritis.Methods—75 sedentary adults aged 18+ with rheumatoid arthritis (RA) or knee osteoarthritis (OA) were randomly assigned to 8 weeks of yoga (2 60 min classes and 1 home practice/wk) or waitlist. Poses were modified for individual needs. The primary endpoint was physical health (SF36 Physical Component Summary [PCS]) adjusted for baseline; exploratory adjusted outcomes included fitness, mood, stress, self-efficacy, SF36 health-related quality of life (HRQL) and RA disease activity. In everyone completing yoga, we explored long-term effects at 9 months.Results—Participants were mostly female (96%), white (55%), and college-educated (51%), with a mean (SD) age of 52 (12). Average disease duration was 9 (9) yrs. and 49% had RA. At 8 weeks, yoga was associated with significantly higher PCS (6.5; 95% CI: 2.0,10.7), walking capacity (125 m; 95% CI:15,235), positive affect (5.2; 95% CI:1.4,8.9) and lower CES-D (−3.0; 95% CI: −4.8,−1.3). Significant (p

Background Fatigue is prevalent and impactful in rheumatoid arthritis (RA). There is no standardized measure for its assessment nor data concerning the performance of PROMIS-Fatigue short forms (SFs) in people with RA. We evaluated the construct validity of 4-, 7-, and 8-item PROMIS-Fatigue SFs in RA patients across the range of disease activity. Methods Adult RA patients were recruited from an online patient community and an observational cohort from three academic medical centers. Measures included PROMIS-Fatigue SFs, other PROMIS measures, and other patient reported outcomes including RAND-36 Vitality, Fatigue NRS, and patient global assessment of disease activity. Other measures from the observational cohort included 28-joint swollen and tender joints, physician global assessment, and the composite RA clinical disease activity index (CDAI). Results Two-hundred online participants and 348 participants from the observational cohort were included. PROMIS Fatigue SF scores spanned the measurement continuum and correlated highly with each other (r’s ≥ 0.91) and other fatigue measures (r’s ≥ 0.85). PROMIS-Fatigue SF scores were highly and inversely associated with Physical Function and Participation (r’s − 0.77 to − 0.78), and moderately-highly and positively correlated with pain, sleep disturbance, anxiety, and depression (r’s 0.60 to 0.75). PROMIS-Fatigue SF scores showed dose-response relationships across fatigue severity descriptors and CDAI categories. Conclusions These results provide robust evidence supporting the construct validity of the 4, 7, and 8-item PROMIS-Fatigue SFs. They capture fatigue across the spectrum of RA disease activity in diverse groups of individuals and should be considered for use as patient-centered assessments of disease control and treatment efficacy.

ObjectiveEarly rheumatoid arthritis (RA) treatment requires timely recognition. This large, multicentre study compared patient-reported vs physician-reported onset of early RA.MethodsPatients from the Canadian Early ArThritis CoHort with early/suspected RA (persistent synovitis ResultsIn 2683 patients, the median patient symptom duration (IQR) was 178 days (163) and physician-reported duration was 166 (138). 1940 (72%) patients had similar patient-reported and physician-reported onset (ConclusionOver one-fourth of patients reported differences of >1 month in symptom onset from their rheumatologist. Patients with longer symptom durations had less improvement at 1 year, which may be reflective of comorbid musculoskeletal conditions.

Objective.To improve measurement of stiffness in rheumatic disease.Methods.Data presented included (1) 2 qualitative projects, (2) the rheumatoid arthritis (RA) stiffness patient-reported outcome measure (RAST), and (3) 3 items assessing stiffness severity, duration, and interference.Results.Stiffness is multidimensional and includes aspects of stiffness experience such as duration, severity, and effect. Stiffness items showed construct validity in RA. Further efforts are required to develop an instrument that will be taken through the Outcome Measures in Rheumatology (OMERACT) Filter 2.1 for instrument selection.Conclusion.The research agenda for the group includes domain content voting for individual diseases, and development of stiffness item banks and disease-specific short forms.

Objectives Among Canadian adults with chronic disease: 1) to identify groups that differ in self-management task frequency and self-efficacy; 2) to compare group characteristics and preferences for self-management support. Methods Using data from an online survey, cluster analysis was used to identify groups that differed in self-management task frequency and self-efficacy. Multivariable regression was used to explore relationships with patient characteristics and preferences. Results Cluster analysis (n = 247) revealed three groups:Vulnerable Self-Managers (n = 55), with the highest task frequency and lowest self-efficacy; Confident Self-Managers (n = 73), with the lowest task frequency and highest self-efficacy; and Moderate Needs Self-Managers (n = 119), with intermediate task frequency and self-efficacy. Vulnerable Self-Managers, when compared with the Confident group, were more often: on illness-related employment disability or unemployed; less well educated; diagnosed with emotional problems or hypertension, and had greater multimorbidity. They participated less often in self-management programs, and differed in support preferences. Conclusions Knowing the characteristics of vulnerable self-managers can help in targeting those in greater need for self-management support that matches their preferences. Practice Implications Different approaches are needed to support self-management in the vulnerable population.

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

Contains fulltext : 175251.pdf (Publisher’s version ) (Closed access) Objective. The Patient-Reported Outcomes Measurement Information System (PROMIS)-29 assesses seven health-related quality of life domains plus pain intensity. The objective was to examine PROMIS-29v2 validity and explore clinical associations in patients with SSc. Methods. English-speaking SSc patients in the Scleroderma Patient-centered Intervention Network Cohort from 26 sites in Canada, the USA and the UK completed the PROMIS-29v2 between July 2014 and November 2015. Enrolling physicians provided medical data. To examine convergent validity, hypotheses on the direction and magnitude of correlations with legacy measures were tested. For clinical associations, t-tests were conducted for dichotomous variables and PROMIS-29v2 domain scores. Effect sizes (ESs) were labelled as small (0.75). Results. There were 696 patients (87% female), mean (s.d.) disease duration 11.6 (8.7) years, 57% with limited cutaneous subtype. Validity indices were consistent with seven of nine hypotheses (|r| =0.51-0.87, P < 0.001), with minor divergence for two hypotheses. Gastrointestinal involvement was associated with significantly worse outcomes for all eight PROMIS-29v2 domains (moderate or moderate to large ES in six of eight). Presence of joint contractures was associated with significant decrements in seven domains (small or small to moderate ESs). Skin thickening, diffuse cutaneous subtype and presence of overlap syndromes were significantly associated (small or small to moderate ESs) with five or six domains. Conclusion. This study further establishes the validity of the PROMIS-29v2 in SSc and underlines the importance of gastrointestinal symptoms and joint contractures in reduced health-related quality of life. 10 p.

Objective.Developing international consensus on outcome measures for clinical trials is challenging. The following paper will review consensus building in Outcome Measures in Rheumatology (OMERACT), with a focus on the Delphi.Methods.Based on the literature and feedback from delegates at OMERACT 2018, a set of recommendations is provided in the form of the OMERACT Delphi Consensus Checklist.Results.The OMERACT delegates generally supported the use of the checklist as a guide. The checklist provides guidance for clearly outlining the multiple aspects of the Delphi process.Conclusion.OMERACT is deeply committed to consensus building and these recommendations should be considered a work in progress.

Background:Different tools are commonly used to assess fatigue in RA including single items (visual analogue (VAS), numeric rating (NRS), and Likert scales), SF-36 Vitality, and PROMIS. Evidence is needed to identify scores that reflect meaningful change to patients to interpret fatigue results in trials and for clinical care.Objectives:To use symptom-specific and RA change anchors to estimate meaningful and detectable change scores from the patient perspective across several fatigue measures.Methods:Stable RA patients (ACR/EULAR 2010 criteria) were recruited from 3 academic clinical practices across the Southern, Mid-Atlantic, and Northeastern United States. Scales were administered at 2 consecutive visits to capture PROs including fatigue. We also asked a fatigue-specific change question (How would you rate your fatigue since the last visit?). Response options were a lot better, a little better, the same, a little worse, and a lot worse. An RA disease activity change question followed a similar format. We compared mean change between visits across fatigue and RA change categories for the Fatigue NRS, Fatigue 5-point Likert (none to very severe), SF36 Vitality, and PROMIS Fatigue 4a, 7a, and 8a.Results:The sample included 282 patients with stable RA who completed questionnaires 4.6 (SD 2.4) months apart. Patients were mostly white (78%) women (82%) with RA duration of 13 (11) years. At V1, most were in CDAI LDA (57%) or MDA (30%) with 5% in REM and 8% in HDA states. Using the Fatigue change anchor, 6% were a lot better, with mean change ranging from |1-11|points across scales (Table 1); among 13% a little better, smaller changes |0.4 to 5|were reported. Across all measures score changes for meaningful and minimal improvement were numerically larger for improvement than worsening.Fatigue Change CategoriesLot Better 6%Little Better 13%Same 49%Little Worse 22%Lot Worse 10%NMeanSDNMeanSDNMeanSDNMeanSDNMeanSDFatigue 11 point NRS19-2.22.437-0.72.3137-0.51.9610.41.9261.32.1Fatigue 5-point Likert19-0.81.236-0.41.21370.00.9600.20.9270.61.2SF36 Vitality (0-100)1911.216.1364.913.71370.310.659-3.215.326-11.416.6PROMIS Fatigue 7a19-5.98.537-2.67.51380.06.462-0.36.5274.38.3PROMIS Fatigue 8a19-6.110.237-2.77.1138-0.37.1621.36.9275.611.0PROMIS Fatigue 4a19-6.89.937-3.38.2138-0.47.4601.27.2275.211.5Using the RA change categories, more people rated their RA as at least a little better compared with fatigue (28% vs. 19%, respectively) at the second visit (Table 2). Similar patterns were evident across RA change categories, though score changes associated with improvement and worsening were about half those observed using fatigue change anchors.RA Disease Activity Change CategoriesLot Better13%Little Better15%Same42%Little Worse21%Lot Worse9%NMeanSDNMeanSDNMeanSDNMeanSDNMeanSDFatigue 11 point NRS36-0.82.343-0.62.7117-0.21.958-0.21.9260.72.2Fatigue 5-point Likert35-0.31.242-0.31.11180.11.0580.10.8260.31.3SF36 Vitality (0-100)356.417.4433.813.0117-0.612.957-3.711.325-6.017.0PROMIS Fatigue 7a37-1.69.543-1.57.4118-0.37.0590.55.6261.37.5PROMIS Fatigue 8a37-2.19.543-1.79.01180.17.6590.74.8263.011.4PROMIS Fatigue 4a36-2.79.643-2.39.01180.18.1590.45.6252.612.0Conclusion:The score change associated with meaningful improvement and worsening between visits on commonly used fatigue scales was much larger with fatigue vs. RA change categories. More people rated their RA improved as compared with fatigue at the 2nd visit. Symptom-specific anchors are likely to offer more relevant change scores associated with meaningful improvement and worsening than RA change anchors. These estimates offer new information about meaningful and detectable improvement and worsening on common measures for trialists, researchers, and clinicians monitoring fatigue in people with RA.Acknowledgements:The primary research data included within this report were acquired through funding in part from a PCORI Methods Award (SC14-1402-10818). This work was also supported by the NIH through the Rheumatic Diseases Resource-based Core Center (P30-AR053503 Core D, and P30-AR070254, Core B), the Camille Julia Morgan Arthritis Research and Education Fund, and the Rheumatoid Arthritis Discovery Fund.Disclosure of Interests:None declared

Background:RA is an inflammatory disease that results in pain and loss of function, especially in the hands and wrists. Brief self-assessment tools that can reliably and precisely quantify hand/wrist function are needed to assess inflammatory activity when a physical exam is not feasible and to capture day-to-day experience of living with RA. Neuro-QoL is part of the PROMIS family of self-report measures created using a patient-centred approach and IRT methodology. The Neuro-Qol Upper Extremity Function (UEF) scale measures ability across fine motor and ADLs involving digital, manual and reach-related function and self-care. Little is known about its performance in RA.Objectives:To evaluate the validity and responsiveness of the 8-item Neuro-QoL UEF in RA. We hypothesized scores would be strongly (r>.70) associated with MHAQ, MD-HAQ, and PROMIS PF, moderately (r=.4 to .7) to symptoms, disease activity, and QoL indicators, and be responsive to change in disease activity and PF.Methods:Data were from the 0 and 6-month visits of adults with early RA (sx Results:The 262 participants were mostly white (83%) women (71%) with a mean (SD) age of 55 (13). Summary statistics at 6-months are shown in Table 1. Neuro-QOL UEF was moderately-strongly correlated with MHAQ, MDHAQ, PROMIS-PF (|r|=.63-.75) and moderately correlated with pain and stiffness, (|r|=.59, -.64), and CDAI, SDAI, PT&MD Global, TJ & SJ (|r|=.39-.58). Neuro-QOL UEF was moderately correlated with PROMIS QoL domains Pain, Fatigue, Anxiety, Depression, Sleep & Participation (|r|=.39-.60).Table 1.Summary statistics of physical function and RA disease activity indices at 6 months.MeanSDMdn25%75%(Min, Max)Physical FunctionNeuro-Qol UEF46.59.753.837.553.8(21.8, 53.8)MHAQ (0-3)0.290.430.130.000.38(0.00, 2.25)MD-HAQ (0-10)1.391.640.700.002.00(0.00, 8.00)PROMIS-PF46.48.546.239.556.0(23.3, 56.0)RA Disease ActivityCDAI9.39.96.03.013.0(0.0, 56.0)SDAI10.710.96.83.115.2(0.0, 57.0)Patient Global3.02.5315(0, 10)MD Global1.82.2103(0, 9)Swollen Joints (28)2.13.7002(0, 20)Tender Joints (28)2.43.9103(0, 24)Neuro-QOL scores decreased in a dose-response manner across worsening CDAI DA states reflecting increasing impairment (Table 2). Persons with HDA reported the highest disability, scoring nearly 0.5 SD lower on the Neuro-QoL UEF than PROMIS PF. Change from baseline to 6 months in Neuro-QoL UEF was moderately correlated with changes in PROMIS PF, MHAQ, PT Global, and CDAI (|r|=.44-.65). The mean change and range from 0-6 months in Neuro-QoL was significantly larger than in PROMIS (8.9 [95% CI 7.5, 10.4] vs. 5.4 [95% CI 4.4, 6.4])(see Figure).Table 2.Mean scores (95% CI) at 6 months by CDAI level.REMLDAMDAHADNeuroQol UEF52.8 (51.8, 53.7)48.1 (46.6, 49.7)42.0 (39.4, 44.6)33.8 (30.5, 37.1)MHAQ (0-3)0.05 (0.02, 0.09)0.19 (0.14, 0.24)0.45 (0.34, 0.57)0.90 (0.63, 1.17)MD-HAQ (0-10)0.31 (0.17, 0.46)1.11 (0.90, 1.32)2.15 (1.71, 2.59)3.56 (2.56, 4.56)PROMIS-PF52.8 (51.4, 54.2)46.8 (45.3, 48.2)42.3 (40.4, 44.2)38.0 (34.4, 41.6)Conclusion:Clinicians, researchers, and patients benefit from practical self-report tools that reliably and precisely monitor hand function in RA. Results offer initial evidence of validity and responsiveness and support use of Neuro-QoL UEF to self-assess inflammatory activity in the hands and day-to-day experiences of living with RA.Acknowledgements:The CATCH study was designed and implemented by the investigators and financially supported through unrestricted research grants from: Amgen and Pfizer Canada - Founding sponsors since January 2007; AbbVie Corporation and Hoffmann-LaRoche since 2011; Medexus Inc. since 2013;, Merck Canada since 2017, Sandoz Canada, Biopharmaceuticals since 2019,Gilead Sciences Canada since 2020 and Fresenius Kabi Canada Ltd. since 2021. Previously funded by Janssen Biotech from 2011-2016, UCB Canada and Bristol-Myers Squibb Canada from 2011-2018, Sanofi Genzyme from 2016-2017, and Eli Lilly Canada from 2016-2020.Disclosure of Interests:None declared

Objective: To develop and validate a short form of the Cochin Hand Function Scale (CHFS), which measures hand disability, for use in systemic sclerosis, using objective criteria and reproducible techniques. Methods: Responses on the 18-item CHFS were obtained from English-speaking patients enrolled in the Scleroderma Patient-Centered Intervention Network Cohort. CHFS unidimensionality was verified using confirmatory factor analysis, and an item response theory model was fit to CHFS items. Optimal test assembly (OTA) methods identified a maximally precise short form for each possible form length between 1 and 17 items. The final short form selected was the form with the least number of items that maintained statistically equivalent convergent validity, compared to the full-length CHFS, with the Health Assessment Questionnaire (HAQ) disability index (DI) and the physical function domain of the 29-item Patient-Reported Outcomes Measurement Information System (PROMIS-29). Results: There were 601 patients included. A 6-item short form of the CHFS (CHFS-6) was selected. The CHFS-6 had a Cronbach's alpha of 0.93. Correlations of the CHFS-6 summed score with HAQ DI (r = 0.79) and PROMIS-29 physical function (r = -0.54) were statistically equivalent to the CHFS (r = 0.81 and r = -0.56). The correlation with the full CHFS was high (r = 0.98). Conclusion: The OTA procedure generated a valid short form of the CHFS with minimal loss of information compared to the full-length form. The OTA method used was based on objective, prespecified criteria, but should be further studied for viability as a general procedure for shortening patient-reported outcome measures in health research.