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Arthritis Care & Research

Wiley Online Library : Arthritis Care & Research

Published: 2018-02-01T00:00:00-05:00


Clinical characteristics and factors associated with disability and impaired quality of life in children with juvenile systemic sclerosis


Objective To investigate clinical manifestations of juvenile systemic sclerosis (jSSc), including disease characteristics and patient quality of life, through the multinational Childhood Arthritis and Rheumatology Research Alliance (CARRA) Legacy Registry. Methods Subjects with jSSc were prospectively enrolled between 2010 and 2013. Diagnosis of jSSc was determined by the enrolling pediatric rheumatologist, with disease onset required prior to age 18. Collected data included demographics, disease characteristics, medication exposure, and quality of life metrics. Results In total, 64 subjects with jSSc were enrolled a median of 3.6 years after disease onset, which occurred at a median age of 10.3 years old. The most common organ manifestations were dermatologic and vascular, followed by musculoskeletal, gastrointestinal, and pulmonary, with 38% of patients having more than four organ systems affected. Patients with jSSc had significantly more disability at enrollment than CARRA registry patients with juvenile idiopathic arthritis, dermatomyositis, or systemic lupus. While physician reported measures correlated most closely with arthritis, skin, and pulmonary manifestations, poor patient-reported measures were associated with gastrointestinal involvement. Over 50 person-years (median duration 1.4 years), there was stability of most organ manifestations with no mortalities or development of new solid organ involvement after enrollment. Conclusion In the first multicenter prospective cohort of juvenile SSc patients in North America, disease burden was large: multi-organ manifestations were common, and functional disability was greater than other childhood rheumatic diseases. Gastrointestinal involvement had the greatest impact on quality of life. This article is protected by copyright. All rights reserved.

An International, Multi-Specialty Validation Study of the IgG4-Related Disease Responder Index


Objective IgG4-related disease (IgG4-RD) can cause fibro-inflammatory lesions in nearly any organ, leading to organ dysfunction and failure. The IgG4-RD Responder Index (RI) was developed to help investigators assess the efficacy of treatment in a structured manner. We sought to validate the RI in a multi-national investigation. Methods The RI guides investigators through assessments of disease activity and damage in 25 domains, incorporating higher weights for disease manifestations that require treatment urgently or that worsen despite treatment. After a training exercise, investigators reviewed 12 written IgG4-RD vignettes (mean length: 279 words, range: 76-511 words) based upon real patients. Investigators calculated both an RI score as well as a physician global assessment (PGA) for each vignette. Three investigators used the RI on fifteen patients followed over serial visits after treatment. We assessed inter- and intra-rater reliability, precision, validity, and responsiveness. Results Twenty-six physician-investigators included representatives from 6 specialties and 9 countries. The inter-rater and intra-rater reliabilities of the RI were strong (0.88 and 0.69, respectively) and superior to those of the PGA. Correlations (construct validity) between the RI and PGA were high (Spearman's r=0.9, P<0.0001). The RI was sensitive to change (discriminant validity). Following treatment, there was significant improvement in the RI (mean change 10.5 (95% CI 5.4-12), P<0.001) which correlated with the change in the PGA. Urgent disease and damage were captured effectively. Discussion In this international, multi-specialty study, we found that the RI is a valid, and reliable disease activity assessment tool that can be used to measure response to therapy. This article is protected by copyright. All rights reserved.

Levels of cytokines and microRNAs in individuals with asymptomatic hyperuricemia and ultrasonographic findings of gout: a bench-to-bedside approach


Objective To assess potential associations among serum cytokines and microRNA (miR) levels with ultrasound (US) findings suggestive of urate deposits in chronic asymptomatic hyperuricemia and gout. Methods All participants underwent musculoskeletal US and measurements of serum IL-1β, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10, IL-12, IL-13, IFN-γ, TNF, MCP-1, and ENA-78, as well as miR-146a, miR-155, and miR-223 levels. Results Thirty individuals with asymptomatic hyperuricemia, 31 normouricemic controls, and 30 gouty patients were included. The frequency of synovitis and double contour sign using US was similar between asymptomatic hyperuricemia (67% and 27%, respectively) and gouty participants (77% and 27%), and each had a higher frequency than controls (45% and 0%). Serum IL-6 and IL-8 levels were similar between patients with asymptomatic hyperuricemia (69.7±73.4 and 18.5±25.6 pg/ml, respectively) and gout (75.8±47.6 and 24.4±31.7 pg/ml), and higher than controls (28.2±17.6 and 7.4±6.0 pg/ml). A similar distribution was observed for miR-155 levels (0.22±0.18, 0.20±0.14, and 0.08±0.04, respectively). Associations between morphostructural abnormalities suggestive of urate deposits (regardless of clinical diagnosis) and serum markers were assessed. Subjects with urate deposits had higher IL-6 (257.2 versus 47.0 pg/mL; P=0.005), IL-8 (73.2 versus 12.0 pg/mL; P=0.026), and miR-155 (0.21 versus 0.16; P=0.015) levels than those without deposition findings. Conclusion In asymptomatic individuals with chronic hyperuricemia, the presence of synovitis and double contour sign by US may represent a subclinical manifestation of monosodium urate crystals nucleation, capable of triggering inflammatory pathways (IL-6 and IL-8) and mechanisms of intercellular communication (miR-155) similar to what is observed in gout. This article is protected by copyright. All rights reserved.

High Adherence Observed to System-Level Performance Measures for Rheumatoid Arthritis in a National Early Arthritis Cohort Over 8 Years


Objective To assess adherence to three System-Level Performance Measures in a national early RA (ERA) cohort. Methods Patients enrolled in the Canadian Early Arthritis Cohort (2007-2015) who met 1987 or 2010 ACR/EULAR criteria with <1year of symptom duration and ≥1year of follow-up after enrollment were included. Performance measures assessed were: i) the percentage of RA patients seen in yearly follow-up, and number of gaps between visits of >12 or 14 months, ii) the percentage of RA patients treated with a disease-modifying drug (DMARD) and, iii) days from RA diagnosis to initiation of DMARD. Results are presented stratified by enrollment year to assess for temporal changes in performance. Results 1763 ERA patients were included (mean age: 54 years, 73% female and 82% Caucasian). At enrollment, mean(sd) disease duration was 6(3) months and DAS28 was 5.1(1.5). Over 8 years, the proportion of patients seen in annual follow-up declined from 100% to 91%. Over follow-up, 42% of patients had 0 gaps in care of >12 months, and 64% had 0 gaps >14 months. The percentage of DMARD-treated ERA patients was and remained high (95% to 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 93days). Conclusion There was evidence of high adherence to system-level performance measures in this protocolized ERA cohort. Small declines in performance were noted with increasing length of patient follow-up. Our findings are useful for performance measure benchmarking. This article is protected by copyright. All rights reserved.

Improved Gout Outcomes in Primary Care Using a Novel Disease Management Program: A Pilot Study


Objective To pilot a primary care gout management improvement intervention. Methods Two large primary care sites were selected: one underwent the intervention, the other, a control, underwent no intervention. The intervention consisted of: engagement of intervention site staff, surveys of provider performance improvement preferences, and onsite live and enduring online education. Electronic Health Record reminders were constructed. Both the intervention and control sites had 3 quality measures assessed monthly: percent of gout patients treated with urate lowering therapy, percent of treated patients monitored with serum urate, and percent of treated patients at target serum urate ≤ 6.0 mg/dl. The intervention site providers received monthly reports comparing their measures against their peers. Results By 6 months, the intervention site significantly improved all 3 gout performance measures. Percentage treated increased from 54.4 to 61.1%, OR 1.19 (95% CI 1.08, 1.31 and p-value <0.001); percentage monitored increased from 56.1 to 79.2% OR 1.52 (95% CI 1.24, 1.87 and P-value <0.001); and percentage at goal increased from 26.8 to 43.3% OR 1.43 (95% CI 1.16, 1.77 and p-value <0.001. At 6 months after intervention, gout patients at the intervention site were more likely to be monitored (79.2% vs. 53.4%, OR 3.54 (95% CI: 2.30, 5.45 and p-value < 0.001)) and at goal (43.3% vs. 28.3%; OR 1.99 (95% CI: 1.33, 2.96 and p-value <0.001) than control site patients. Numbers treated did not significantly improve over the control site. Conclusion A pilot multifaceted gout management program can significantly improve primary care gout management performance. This article is protected by copyright. All rights reserved.

Increased Burden of Psychiatric Disorders in Rheumatoid Arthritis


Objective We estimated the incidence and prevalence of depression, anxiety disorder, bipolar disorder and schizophrenia in a population-based cohort with rheumatoid arthritis (RA) as compared to an age-, sex- and geographically matched cohort without RA. Methods Using population-based administrative health data from Manitoba, Canada, we identified persons with incident RA between 1989 and 2012, and a cohort from the general population matched 5:1 on year of birth, sex and region. We applied validated algorithms for depression, anxiety disorders, bipolar disorder, and schizophrenia to determine the annual incidence of these conditions after the diagnosis of RA, and their lifetime and annual period prevalence. We compared findings between cohorts using negative binomial regression models. Results We identified 10,206 incident cases of RA and 50,960 matched individuals. After adjustment for age, sex, SES, region of residence, number of physician visits, and year, the incidence of depression was higher in the RA cohort over the study period (IRR 1.46; 95%CI: 1.35, 1.58), as was the incidence of anxiety disorder (IRR 1.24; 95%CI: 1.15, 1.34) and bipolar disorder (IRR 1.21; 95%CI: 1.00, 1.47). The incidence of schizophrenia did not differ between groups (IRR 0.96; 95%CI: 0.61, 1.50). Incidence rates of psychiatric disorders declined minimally over time. The lifetime and annual period prevalence of depression and anxiety disorder were also higher in the RA than the matched cohort over the study period. Conclusion The incidence and prevalence of depression, anxiety disorder and bipolar disorder are elevated in the RA population as compared to a matched population. This article is protected by copyright. All rights reserved.

Clinician and patients’ views about self-management support in arthritis: a cross-sectional UK survey


Objective The overall aims of the study are to (a) establish receipt and provision of self-management support for patients with inflammatory arthritis in the UK; and (b) establish if receipt of self-management support is associated with patient's knowledge, skills and confidence to self-manage. Methods Questionnaires for patients and healthcare professionals were sent to members and associates of the National Rheumatoid Arthritis Society (NRAS). Patients completed the Patient Activation Measure (PAM), and questions about receipt of self-management support. Healthcare professionals completed the Clinician Support PAM and questions about provision of self-management support. Results A total of 886 patients and 117 healthcare professionals completed the survey. Only 15% of patients had attended a structured self-management programme. Over half of patients reported having the skills, confidence and knowledge to self-manage and this was associated with receipt of self-management support that was embedded in routine care. All healthcare professionals felt that patients should be actively involved in their own care, however, 60% were unable to offer structured self-management support. Healthcare professionals reported engaging in more embedded self-management support than patients reported receiving in routine care. Conclusions Only a small proportion of patients with arthritis have attended a structured support programme. Although healthcare professionals report engaging in self-management support embedded in routine care, patients do not necessarily agree and these differences could impact on the experience of patients with arthritis. When embedded self-management support does occur this is a significant predictor of patients’ knowledge, skills and confidence to self-manage, as opposed to attendance at a structured programme. This article is protected by copyright. All rights reserved.

Understanding the factors that influence risk tolerance among minority women: A qualitative study


Objective The objective of our study was to explore the factors that influence risk tolerance among women from different racial/ethnic groups. Methods In-depth individual interviews of Non-Hispanic Black, Non-Hispanic White, and Hispanic women aged 20-45 were conducted by a trained interviewer (S.B.) using a semi-structured interview guide to elicit the factors that influence risk tolerance among minority women. The interviews were audiotaped and professionally transcribed with a final sample size of 36 determined by thematic saturation. The members of the research team used open coding to review and develop a list of codes which was modified as new codes emerged. A final list of 35 codes was applied to the transcripts and combined into broader themes. Results Participants were 30.6% Non-Hispanic Blacks, 33.3% Non-Hispanic Whites and 36.1% Hispanics, with a mean (SD) age of 34.8 (6.8) years. Several major themes explaining risk aversion among minority women emerged: discrepancies in quality of healthcare, perceived prejudice, lack of knowledge and education, medication beliefs, risk perception, and constrained resources. The latter was discussed most frequently. Conclusion While our results point out several concerns that may be addressed through medical providers implementing more effective communication strategies, they also highlight that disparities are strongly influenced by the complex ways financial and social constraints influence minority women's healthcare decisions. This article is protected by copyright. All rights reserved.

From early radiographic knee osteoarthritis to joint arthroplasty: Determinants of structural progression and symptoms


Objective Aims were to assess (1) structural progression in knees with no/mild radiographic osteoarthritis (ROA) (i.e. Kellgren-Lawrence (K-L) grades 0 to 2) that will undergo knee replacement (KR) during a 5-year period; (2) differences in structural damage on MRI between knees with no/mild ROA vs. those with severe ROA (i.e. K-L 3 and 4) at baseline; and (3) differences in pain levels between those groups. Methods All participants who underwent KR from baseline (BL) to 60 months were drawn from the Osteoarthritis Initiative. MRIs were assessed for bone marrow lesions (BMLs), Hoffa- and effusion-synovitis (i.e. hyperintensity signal changes in the fat pad and abnormal amount of capsular distension due to intraaticular joint fluid and/or synovial thickening) at BL and the time point before KR (T0). The measures of WOMAC and KOOS pain were used for pain characterization. WOMAC Activity of Daily Life (ADL) and KOOS Quality of Life (QoL) were applied to characterize functional status of the included participants. Logistic regression was used to assess the association of no/mild ROA with these MRI features and pain. Results Based on inclusion criteria 181 knees were selected. Participants were predominantly female (57.8%) with a mean age of 64.4 years. 51 (28.2%) knees had no/mild ROA at BL. Of these, 51.0% progressed to severe ROA. No/mild ROA knees showed higher odds of BMLs in the patellofemoral joint (PFJ) at BL (OR 7.92 95%CI [3.45,18.16]) and T0 (OR 9.44 95%CI [4.00, 22.28]) compared to severe ROA knees. In addition, no/mild ROA knees were associated with change from “no pain” to “pain” from BL to T0 (aOR 5.48, 95%CI [1.25, 24.00]). Conclusion Over half of the knees with no/mild ROA before KR progressed to severe ROA over 4 years of follow-up. BMLs in the PFJ were more often seen among knees that had no/mild ROA. Worsening pain status may contribute to KR in knees with no/mild ROA. This article is protected by copyright. All rights reserved.

Experience and context shape patient and clinician goals for treatment of rheumatoid arthritis: a qualitative study


Objective Patient and clinician goal alignment, central to effective patient-centered care, has been linked to improved patient experience and outcomes, but has not been explored in rheumatoid arthritis (RA). This study aimed to explore goal conceptualization among RA patients and clinicians. Methods Seven focus groups and one semi-structured interview were conducted with RA patients and clinicians recruited from four rheumatology clinics. An interview guide was developed to explore goal concordance related to RA treatment. Researchers utilized a concurrent deductive-inductive data analysis approach. Results 19 patients (mean age 55; 74% female; 32% nonwhite; 26% Spanish speakers) and 18 clinicians (44% trainees; 44% female; 28% nonwhite) participated. Across clinician and patient focus groups, two domains were identified: 1) patient knowledge of RA and 2) psychosocial dynamics (stress) in RA treatment. Within the knowledge domain, three themes emerged: 1) RA knowledge for informed choice; 2) RA knowledge to ensure adherence and medication safety; and 3) clinician assumption of patient inability to interpret information. Within the second domain of RA and stress, two themes emerged: 1) patient's illness experience informs treatment context in ways not shared by clinicians; and 2) impact of patient-clinician communication and decision making on goal concordance. Conclusion Knowledge is a shared goal, but RA patients and clinicians hold divergent attitudes towards this goal. While knowledge is integral to self-management and effective shared decision making, mismatch in attitudes may lead to suboptimal communication. Tools to support patient goal-directed RA care may promote high quality patient-centered care and result in reduced disparities. This article is protected by copyright. All rights reserved.

Minimal Disease Activity among Active Psoriatic Arthritis Patients Treated with Secukinumab: 2-year Results from the FUTURE 2 Study


Objective To evaluate minimal disease activity (MDA) among psoriatic arthritis (PsA) patients receiving secukinumab through 2 years in the FUTURE 2 study (NCT01752634). Methods Patients with active PsA were randomized to receive subcutaneous secukinumab 300, 150, or 75 mg or placebo. MDA was assessed in the overall population (anti-tumor necrosis factor [TNF]-naïve and inadequate responders [anti-TNF-IR]) and in patients stratified by prior anti-TNF exposure and by time since diagnosis at Weeks 16, 24, 52, and 104. Function, patient-reported outcomes (PROs) including health-related quality of life (QoL), and work productivity were assessed in MDA responders versus non-responders. Results Overall, 28% (27/98) and 23% (23/100) of patients achieved MDA at Week 16 with secukinumab 300 and 150 mg, respectively, versus 10% (9/94) with placebo. In the anti–TNF-naïve cohort, a higher proportion of patients achieved MDA at Week 16 with secukinumab 300 and 150 mg (34% and 32%, respectively) versus placebo (13%). The corresponding value in the anti-TNF-IR cohort was 15% and 8% with secukinumab 300 and 150 mg, respectively, versus placebo (3%). At Week 16, 27.1% (16/59) of MDA responders achieved a very low disease activity (VLDA) response, with the percentage being numerically greater with secukinumab 300 and 150 mg (30% [8/27] and 26% [6/23], respectively) versus placebo (22% [2/9]). The MDA and VLDA responses with secukinumab 300 and 150 mg were sustained through 2 years. MDA responders showed greater improvements in QoL outcomes compared to non-responders through 2 years. Conclusion A greater proportion of patients achieved MDA with secukinumab versus placebo at Week 16, with response rates sustained through 2 years. MDA was associated with improved PROs, including QoL, through 2 years. This article is protected by copyright. All rights reserved.

Mortality in Patients with Giant Cell Arteritis: A Cohort Study in UK Primary Care


Objective To examine whether giant cell arteritis (GCA) is associated with increased all-cause mortality and whether mortality differs according to age, sex, and calendar year of cohort entry. Methods Using the UK-based Clinical Practice Research Datalink we identified 9778 newly diagnosed GCA patients from 1990-2014, and up to 10 non-vasculitis patients randomly matched to each case on age, sex, practice and years of history before cohort entry. We used Cox regression to estimate adjusted hazard ratios (HRs) for mortality of GCA patients in comparison to non-vasculitis patients, then stratified by age, sex, and calendar year of cohort entry. Results Compared with non-vasculitis patients, GCA patients had increased mortality during the first year following diagnosis (adjusted HR=1.51, 95% CI 1.40-1.64), and marginally increased mortality during the period of 1-5 years after the diagnosis (adjusted HR=1.16, 95% CI 1.09-1.23), but not >5 years after the diagnosis (adjusted HR=1.06, 95% CI 1.00-1.12). GCA patients diagnosed before age 65 had the highest mortality risk during the first year following diagnosis (adjusted HR=2.32, 95% CI 1.60-3.35). The mortality risk did not differ substantially by sex or calendar year of cohort entry. Conclusion GCA patients had an increased risk of mortality during the period shortly after the GCA diagnosis, in particular during the first year, but no increased risk after 5 years post-diagnosis. The mortality risk differed by age with an even greater increased one-year mortality in those aged <65 years at diagnosis, but not by sex or calendar year of cohort entry. This article is protected by copyright. All rights reserved.

Validation of the Brief Fear of Negative Evaluation Scale-II in patients with systemic sclerosis: A Scleroderma Patient-centered Intervention Network Cohort study


Objective Fear of negative evaluation is a common concern among individuals with visible differences but has received limited attention in systemic sclerosis (SSc), which can involve substantial changes to appearance. The Brief Fear of Negative Evaluation Scale (BFNE) was specifically designed to evaluate fear of negative evaluation. There are currently three versions of the BFNE with strong demonstrated measurement properties: two eight-item versions (BFNE-S, BFNE-8) and one 12-item version (BFNE-II). The present study evaluated these versions in SSc, and identified the most appropriate version for use among SSc patients. Methods Participants were 1010 patients with SSc enrolled in the Scleroderma Patient-centered Intervention Network (SPIN) Cohort. Multiple group confirmatory factor analysis, Cronbach's alpha, and Pearson product-moment correlations were used to evaluate structural validity, internal consistency reliability, and convergent and divergent validity, respectively. Results Confirmatory factor analysis demonstrated that one-factor models fit acceptably well for the 12-item BFNE-II, the eight-item BFNE-S, and the eight-item BFNE-8. All Cronbach's alphas were excellent (BFNE-II: 0.98; BFNE-S: 0.97; BFNE-8: 0.96), and all versions had comparable associations with measures of social anxiety, body-related attitudes, depression, age, and education. Conclusion Psychometric support was found for all three versions of the BFNE, though the longer 12-item BFNE-II did not improve measurement compared to the shorter eight-item versions. Of these two, the BFNE-S has been more widely studied with strong validity data in a greater number of populations. Therefore, the BFNE-S is recommended to assess fear of negative evaluation among patients with SSc. This article is protected by copyright. All rights reserved.

Baseline Retinal Examinations among SLE Patients Newly Initiating Hydroxychloroquine in a U.S. Medicaid SLE Population, 2000-2010


Objectives Baseline retinal examination has long been recommended at hydroxychloroquine (HCQ) initiation, but it is unknown how well this guideline is followed. We investigated baseline eye examinations among U.S. Medicaid SLE patients initiating HCQ. Methods Using billing codes, we identified SLE patients aged 18-65 enrolled in Medicaid, residing in the 29 most populated U.S. states from 2000-2010. New HCQ users were identified by filling a prescription, with none in the preceding 12 months. Baseline retinal exams were identified within 30 days before to one year after this index prescription. We examined proportions of patients receiving retinal exams over the study years and compared characteristics of those who did and did not receive exams using bivariable and multivariable logistic regression models. Results Of 12,755 SLE patients newly starting HCQ, 32.5% received baseline dilated eye exams. The proportions of individuals receiving baseline eye exams did not significantly change during these years (31.0% to 34.4%, p for trend 0.12). Factors associated with increased likelihood of examinations included female sex, Asian versus White race, and receiving a higher number of laboratory tests during the preceding year. Lower proportions of Black and Native American versus White SLE patients had baseline retinal exams. Conclusion Only one third of Medicaid SLE patients newly initiating HCQ received recommended baseline retinal examinations and this proportion did not significantly increase during these years. The sociodemographic variation in this indicated care has been observed for other recommended medical care for SLE and requires both further investigation and interventions to address it. This article is protected by copyright. All rights reserved.

Measuring Disease Damage and its Severity in Childhood-Onset Systemic Lupus Erythematosus


Objectives To describe the frequency and types of disease damage occurring with childhood-onset systemic lupus erythematosus (cSLE) as measured by the 41-item Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI), and to assess the SDI's ability to reflect damage severity. Methods Information for the SDI was prospectively collected from 1,048 cSLE patients. For a subset of 559 patients physician-rated damage severity measured by visual analog scale (MD-VASdamage) was also available. Frequency of SDI-items, and the association between SDI summary-scores and MD-VASdamage were estimated. Finally, an international consensus conference, utilizing nominal group technique, considered the SDI's capture of cSLE-associated damage and its severity. Results After a mean disease duration of 3.8 years, 44.2% (463/1048) of patients already had an SDI summary-score >0 (maximum: 14). The most common SDI items scored were proteinuria, scarring alopecia, and cognitive impairment. Although there was a moderately strong association between SDI summary-scores and MD-VASdamage (rSpearman = 0.49; p<0.0001) in patients with damage (SDI summary-score >0), mixed effect analysis revealed that only four SDI items, each occurring in <2% of patients overall, were significantly associated with MD-VASdamage. There was consensus among cSLE experts that the SDI in its current form is inadequate for estimating the severity of cSLE-associated damage. Conclusion Disease damage as measured by the SDI is common in cSLE, even with relatively short disease durations. Given the shortcomings of the SDI, there is a need to develop new tools to estimate the impact of cSLE-associated damage. This article is protected by copyright. All rights reserved.

Evaluation of a Methodological Approach to Define An Inception Cohort of Rheumatoid Arthritis Patients Using Administrative Data


Background/Purpose Identifying incident rheumatoid arthritis (RA) is desirable to create inception cohorts. We evaluated an approach to identify incident RA in health plan claims data. Methods Both Medicare and commercial claims data was linked to Corrona, a U.S. RA registry. We evaluated accuracy of year of RA onset in the registry (gold standard) versus different claims algorithms, varying ICD-9 codes for RA/arthritis, duration of health plan enrollment preceding diagnosis (minimum of 1 vs. 2 years) and use of RA medications. Results were reported as positive predictive values (PPVs) of the claims-based algorithm for incident RA. Results Depending on algorithm tested and whether patients were enrolled in Medicare or the commercial health plan, the PPVs for incident RA ranged from 68%-81%. A 2 year clean period free of all RA-related diagnoses and RA medications was somewhat more optimal, although by comparison, a 1 year clean period yielded similar PPVs and retained approximately 90% more RA patients for analysis. Conclusion Claims-based algorithms can accurately identify incident RA. This article is protected by copyright. All rights reserved.

Is Rheumatoid Arthritis a Cardiovascular Risk Equivalent to Diabetes?


Background/Purpose The 2013 American College of Cardiology/American Heart Association (ACC/AHA) cholesterol treatment guidelines recommend statins for patients with diabetes aged 40-75 years due to their elevated cardiovascular disease (CVD) risk. We compared the incidence of hospitalized acute myocardial infarction (MI), stroke, and coronary revascularization according to whether patients had diabetes, rheumatoid arthritis (RA), both or neither. Methods Using 2006 to 2010 private and public health plan claims, we identified 4 mutually exclusive retrospective cohorts age>40: patients with 1) RA and diabetes; 2) RA only; 3) diabetes only; 4) neither condition. Patients with prevalent CVD were excluded. Outcomes included acute MI and stroke identified from inpatient discharge diagnosis codes, and coronary revascularization from procedure codes. Across the four cohorts, we calculated incidence rates (IRs) of the outcomes, standardized to the 2010 U.S. census age and sex distribution. Results We identified 920,772 eligible participants. The age-sex standardized IRs (per 1,000 person-years) for MI were highest among patients with RA and diabetes (IR=12.6, 95%CI 10.7-14.7), followed by patients with diabetes only (IR=10.7, 95%CI 10.3-11.0), RA only (IR=5.7,95%CI 5.2-6.3), and with neither condition (IR=4.2, 95%CI 4.1-4.3). Conclusion Findings from the present study suggest that while CVD risk in RA is elevated, it is lower in magnitude compared to the CVD risk associated with diabetes. It therefore may not be appropriate to consider RA a diabetes risk-equivalent with respect to hyperlipidemia management. This article is protected by copyright. All rights reserved.

A mixed-methods study identifying key intervention targets to improve participation in daily living activities in primary Sjögren's syndrome patients


Objective Functional ability and participation in life situations are compromised in many primary Sjögren's syndrome (PSS) patients. This study aims to identify the key barriers and priorities to participation in daily living activities, in order to develop potential future interventions. Methods Group concept mapping (GCM), a semi-quantitative, mixed-methods, approach was used to identify and structure ideas from UK PSS patients, adults living with a PSS patient (AHMs) and health care professionals (HCPs). Brainstorming generated ideas, which were summarised into a final set of statements. Participants individually arranged these statements into themes and rated each statement for importance. Multidimensional scaling and hierarchical cluster analysis were applied to sorted and rated data to produce visual representations of the ideas (concept maps), enabling identification of agreed priority areas for interventions. Results 121 patients, 43 AHMs and 67 HCPs took part. 463 ideas were distilled down to 94 statements. These statements were grouped into seven clusters; ‘Patient empowerment’, ‘Symptoms’, ‘Wellbeing’, ‘Access and coordination of healthcare’, ‘Knowledge and support’, ‘Public awareness and support’ and ‘Family and friends’. Patient empowerment and Symptoms were rated as priority conceptual themes. Important statements within priority clusters indicate patients should be taken seriously and supported to self-manage symptoms of oral and ocular dryness, fatigue, pain and poor sleep. Conclusion Our data highlighted that in addition to managing PSS symptoms; interventions aiming to improve patient empowerment, general wellbeing, access to healthcare, patient education and social support are important to facilitate improved participation in daily living activities. This article is protected by copyright. All rights reserved.

Characterization of Patients With Ankylosing Spondylitis and Non-Radiographic Axial Spondyloarthritis in the US-Based Corrona Registry


Objective To describe the characteristics of patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA) in the United States. Methods Demographics, clinical characteristics, patient-reported outcomes, and treatment characteristics of patients with AS and nr-axSpA were assessed at the time of enrollment in the Corrona Psoriatic Arthritis/Spondyloarthritis Registry. AS was defined as patients who fulfilled the 1984 modified New York criteria for AS; nr-axSpA was defined as all other patients with axSpA who did not fulfill the radiologic criterion. Results Of the 407 patients with a diagnosis of axSpA included in this study, 310 patients (76.2%) had AS, and 97 patients (23.8%) had nr-axSpA. Although patients with nr-axSpA were younger and showed a trend for shorter symptom duration, the nr-axSpA and AS groups shared a similar disease burden, as reflected by comparisons of disease activity and function, quality of life, pain, fatigue, absenteeism, and work productivity loss (all P > 0.05). The proportions of patients receiving prior (74.2% vs 64.8%) and current biologic disease-modifying antirheumatic drugs (63.9% vs 61.3%) were also similar between patients with nr-axSpA and AS, respectively (P > 0.05). Conclusion This was the first nationwide study to characterize patients with AS and nr-axSpA in the United States. Consistent with studies published outside the United States, this study showed that patients with nr-axSpA and AS shared a comparable degree of disease burden, and had similar treatment patterns in clinical practice. This article is protected by copyright. All rights reserved.

2015 American College of Rheumatology Workforce Study: Supply and Demand Projections of Adult Rheumatology Workforce (2015-2030)


Objective Describe the character and composition of the 2015 U.S. adult rheumatology workforce; evaluate workforce trends; and project supply and demand for clinical rheumatology care 2015-2030. Methods The 2015 Workforce Study of Rheumatology Specialists in the U.S. used primary and secondary data sources to estimate the baseline adult rheumatology workforce and determine demographic and geographic factors relevant to workforce modeling. Supply and demand was projected through 2030, utilizing data-driven estimations regarding the proportion and clinical full-time equivalent (FTE) of academic vs. non-academic practitioners. Results The 2015 adult workforce (physicians, NPs, and PAs) was estimated to be 6,013 providers (5,415 clinical FTE). At baseline, the estimated demand exceeded the supply of clinical FTE by 700 (12.9%). By 2030, the supply of rheumatology clinical providers is projected to fall to 4,882 providers or 4,051 clinical FTE (a 25.2% decrease in supply from 2015 baseline levels). Demand in 2030 is projected to exceed supply by 4,133 clinical FTE (102%). Conclusion The adult rheumatology workforce projections reflect a major demographic and geographic shift that will significantly impact the supply of the future workforce by 2030. These shifts include baby boomer retirements, a millennial predominance, and an increase of female and part-time providers, in parallel with an increased demand for adult rheumatology care due to the growing and aging U.S. population. Regional and innovative strategies will be necessary to manage access to care and reduce barriers to care for rheumatology patients. This article is protected by copyright. All rights reserved.

Occupational Therapy Treatment to Improve Upper Extremity Function in Individuals with Early Systemic Sclerosis: A Pilot Study


Objective To determine feasibility and preliminary effects of an occupational therapy treatment to improve upper extremity (UE) function in patients with early systemic sclerosis (SSc) who have UE contractures. Methods A one-arm pilot clinical rehabilitation trial was conducted at a university health system. Participants with SSc and ≥ 1 UE contracture (n = 21) participated in a total of 8 weekly in-person occupational therapy sessions. The therapy consisted of thermal modalities, tissue mobilization, and UE mobility. Between sessions, participants were instructed to complete UE home exercises. Feasibility was measured by percent enrollment and session attendance and duration. The primary outcome measure was the QuickDASH, secondary and exploratory outcomes included PROMIS physical function, objective UE measures, and skin thickening. Linear mixed models were performed to determine treatment effects on primary and secondary outcomes. Results Fifty percent (24/48) of potentially eligible participants were interested. Of those, 88% (21/24) enrolled; and nineteen out of 21 (91%) completed all sessions. The mean (SD) age was 47.9 years (± 16.1); 100% had diffuse SSc, and mean disease duration was 3.1 years. At 8 weeks, participants reported statistically significant improvement on QuickDASH and PROMIS physical function measures (p =.0012 and p = .004). Forty-seven and 53% percent of the sample achieved improvements that exceeded minimally important differences. Conclusion In-person treatment sessions were feasible for individuals with SSc and demonstrated statistically significant and clinically meaningful improvements on UE and physical function. Future studies need to examine effects against a control condition and examine durability of treatment effects. This article is protected by copyright. All rights reserved.

Supporting arthritis and employment across the life course: A qualitative study


Objective To examine the need, availability and use of formal and informal workplace resources, and uncover differences across the life course for adults with arthritis. Method Focus groups and interviews were conducted with young (ages 18 to 34 years, n = 7), middle-aged (ages 35 to 54 years, n = 13) and older adults (>55 years, n = 25) living with inflammatory arthritis, osteoarthritis, or other rheumatic disease diagnosis. Participants were asked about their employment experiences, formal and informal workplace resource needs, and availability and usage of workplace resources. Differences based on chronological, functional, psychosocial, organizational and lifespan dimensions of age were examined. A modified grounded theory approach was used to inductively analyze the data. Results Young, middle-aged, and older adult participants required similar workplace resources. Across all participants, scheduling modifications tended to be the most needed workplace resource. In contrast, the perceived availability and usage of formal workplace resources differed among participants. Young adult participants and those who were newer to their jobs reported that workplace resource needs were less available and utilized. Middle- and older-aged adults reported greater availability of workplace resources. Scheduling accommodations and at-work modifications were the most used workplace resources among middle- and older-aged adults, respectively. Conclusion Similar workplace resources could meet the employment needs of people with arthritis across the life course. Attention should be paid to young adults and those who are new to their job because they may perceive more barriers to accessing formal workplace resources and be susceptible to work disability. This article is protected by copyright. All rights reserved.

Skin Induration in a Patient with Aplastic Anemia


One month prior to rheumatology evaluation he was admitted to the hospital for progressive worsening of shortness of breath on exertion, epistaxis, and gingival bleeding. He had fatigue, poor appetite, and an unintentional weight loss of about 30 pounds over the preceding two years. He denied symptoms of chest pain, orthopnea, paroxysmal nocturnal dyspnea, or leg swelling. This article is protected by copyright. All rights reserved.

Do not disregard diagnostic clues of endocarditis: Reply to comment on the article by Garg et al


The presentation of endocarditis with a cutaneous vasculitis has been well reported. The concern of your team regarding the description of the rash is valid but as noted in the case that the rash was part of his past presentation which unfortunately was at a different hospital. Given the patient was transferred to our hospital with altered mental status, it was difficult to get detailed past history in regards of the distribution, symmetry and characteristics of the skin rash. This article is protected by copyright. All rights reserved.

Do not disregard diagnostic clues of endocarditis: comment on the article by Garg et al


We read with great interest the Clinicopathologic Conference by Garg et al. published recently in Arthritis Care & Research about a patient with Bartonella-related endocarditis (1). However, we regret that the ‘petechial pruritic rash’ on the lower extremities and the presence of elevated rheumatoid factor were initially neglected in a context of glomerulonephritis. Indeed the rash was poorly described. This article is protected by copyright. All rights reserved.

An Ethnographic Observational Study of the Biologic Initiation Conversation Between Rheumatologists and Biologic-naïve Rheumatoid Arthritis Patients


Objective This ethnographic market research study investigated the biologic initiation conversation between rheumatologists and biologic-naïve patients with rheumatoid arthritis to assess how therapy options, particularly mode of administration, were discussed. Methods Consenting rheumatologists (n=16) and patients (n=48) were videotaped during medical visits and interviewed by a trained ethnographer. The content, structure, and timing of conversations regarding biologic initiation were analyzed. Results The mean duration of physician-patient visits was approximately 15 minutes; biologic therapies were discussed for a mean of 5.6 minutes. Subcutaneous (SC) and intravenous (IV) therapy options were mentioned in 45 and 35 visits, respectively, out of a total of 48 visits. All patients had some familiarity with SC administration, but nearly half of patients (22/48) were unfamiliar with IV therapy going into the visit. IV administration was not defined or described by rheumatologists in 77% (27/35) of visits mentioning IV therapy. Thus, 19 of 22 patients who were initially unfamiliar with IV therapy remained unfamiliar after the visit. Disparities in physician-patient perceptions were revealed, as all rheumatologists (16/16) believed IV therapy would be less convenient than SC therapy for patients, while 46% (22/48) of patients felt this way. In post-visit interviews, some patients seemed confused and overwhelmed, particularly when presented with many treatment choices in a visit. Some patients stated they would benefit from visual aids or summary sheets of key points. Conclusion This study revealed significant educational opportunities to improve the biologic initiation conversation and indicated a disparity between patients’ and rheumatologists’ perception of IV therapy. This article is protected by copyright. All rights reserved.

Swimming Against the Current: A Qualitative Review of the Work Experiences and Adaptations made by Employees with Arthritis


Objective To describe the experiences and strategies of employees with arthritis (EwA) to maintain employment and to use this information to build a conceptual model. Methods We conducted a systematic review of qualitative studies that examined the work experiences of EwA. Published studies on arthritis and employment were searched from electronic databases (1980-2017) and bibliographical reviews of relevant studies. We used meta-ethnography to synthesize the findings. Results We reviewed 17 studies reporting on the experiences of 873 employees. We identified 11 main themes that highlight common issues experienced by EwA, and grouped these into four higher-order categories: nature of the disease (emotional issues, cognitive struggles, physical symptoms), intrapersonal issues (personal meaning of work, preserving a work identity), interpersonal issues (managing disclosure, gaining co-worker support, organizational culture issues), and work-sustainability strategies (making personal adjustments, using social support, using workplace accommodations). Using these themes, we developed the Job Sustainability Model to illustrate how disease, personal, and work-related factors interact to influence what type of coping behaviors are used and when. Initially, EwA rely on making personal adjustments, using social support, and medical intervention. However, when these coping behaviors fail to be effective, they draw upon workplace accommodations and resources. Conclusions Arthritis disrupts an employee's work life by impairing his or her capacity to be a productive worker. Our results highlight how EwA make strategic adaptations to maintain a productive work life for as long as possible. The findings of this study have implications for work-related interventions aimed at preserving employment. This article is protected by copyright. All rights reserved.

Disparities in total knee replacement: Population losses in quality-adjusted life years due to differential offer, acceptance, and complication rates for Black Americans


Objective Total knee replacement (TKR) is an effective treatment for end-stage knee osteoarthritis (OA). American racial minorities undergo fewer TKRs than Whites. We estimated quality-adjusted life years (QALYs) lost for Black knee OA patients due to differences in TKR offer, acceptance, and complication rates. Methods We used the Osteoarthritis Policy Model, a computer simulation of knee OA, to predict QALY outcomes for Black and White knee OA patients with and without TKR. We estimated per-person QALYs gained from TKR as the difference between QALYs with current TKR use and QALYs when no TKR was performed. We estimated average, per-person QALY losses in Blacks as the difference between QALYs gained with White rates of TKR and QALYs gained with Black rates of TKR. We calculated population-level QALY losses by multiplying per-person QALY losses by the number of persons with advanced knee OA. Finally, we estimated QALYs lost specifically due to lower TKR offer and acceptance and higher complications among Black knee OA patients. Results Black men and women gain 64,100 QALYs from current TKR use. With white offer and complications rates, they would gain an additional 72,000 QALYs. Because these additional gains are unrealized, we call this a loss of 72,000 QALYs. Black Americans lose 67,500 QALYs because of lower offer, 15,800 QALYs because of lower acceptance, and 2,600 QALYs because of higher complications. Conclusion Black Americans lose 72,000 QALYs due to disparities in TKR offer and complication rates. Programs to decrease disparities in TKR use are urgently needed. This article is protected by copyright. All rights reserved.

Improving Mortality in End-Stage Renal Disease due to Granulomatosis with Polyangiitis from 1995 to 2014


Introduction Granulomatosis with polyangiitis (GPA) often affects the kidneys, frequently leading to end-stage renal disease (ESRD). Cardiovascular disease (CVD) and infections are common causes of death in GPA and ESRD. Our objective was to examine temporal trends in the mortality of GPA-ESRD in a large nationwide cohort. Methods We identified ESRD due to GPA in the US Renal Data System (USRDS) between 1995 and 2014, using nephrologists’ coding for the ESRD etiology. The cohort was divided into four five-year subcohorts based on year of ESRD onset (1995-1999; 2000-2004; 2005-2009; 2010-2014) to assess trends in mortality rates and hazard ratios (HRs) for overall death and cause-specific death, adjusting for potential confounders. Results Between 1995 and 2014, there were 5,929 incident cases of GPA-ESRD. The mortality rate (per 100 patient-years) declined from 19.0 in 1995-1999 to 15.3 in 2010-2014 (P=0.01). The adjusted mortality HR of the 2010-2014 cohort was 0.77 (95% CI, 0.66-0.90), compared with the 1995-1999 cohort (P-for-trend <0.001). The corresponding cause-specific mortality HRs after accounting for competing risk were 0.61 (95% CI, 0.47-0.80) for CVD death and 0.42 (95% CI, 0.28-0.63) for infection death (both P-for-trends <0.001). Conclusion In this study of nearly all patients who developed ESRD due to GPA in the US over two decades, we found significant improvements in mortality among GPA-ESRD patients. Cause-specific death due to CVD and infections each declined significantly during the study period. These findings are encouraging and likely reflect improved management of both GPA and ESRD. This article is protected by copyright. All rights reserved.

Structured goal planning and supportive telephone followup in rheumatology care: results from a pragmatic stepped-wedge cluster-randomized trial


Objective To evaluate patient-reported health effects of an add-on structured goal planning and supportive telephone followup rehabilitation program compared with traditional rehabilitation programs in patients with rheumatic diseases. Methods In this pragmatic stepped-wedge cluster-randomized controlled trial 389 patients with rheumatic diseases recruited from six rehabilitation centres received either traditional rehabilitation or traditional rehabilitation extended with an add-on program tailored to individual needs. The add-on program comprised a self-management booklet and usage of motivational interviewing in structured individualized goal planning and four supportive followup phone-calls after discharge. Data were collected by questionnaires on admission and discharge from rehabilitation stay, and 6 months and 12 months after discharge. Primary outcome was health-related quality of life (HR-QoL) measured by the Patient Generated Index (PGI, 0-100, 0=low). Secondary outcomes included patient-reported health status, self-efficacy, pain, fatigue, global disease activity and motivation for change. The main statistical analysis was a linear repeated measures mixed model performed on the intention to treat population using all available data. Results A significant treatment effect of the add-on intervention on HR-QoL was found on discharge (mean difference = 3.32 [95% CI: 0.27, 6.37], p=0.03). No significant between-group differences were found after 6 or 12 months. Both groups showed positive changes in HR-QoL following rehabilitation which gradually declined, although the values remained at higher levels after 6 and 12 months compared with baseline values. Conclusion The add-on program enhanced the short-term effect of rehabilitation with respect to patient-specific HR-QoL, but it did not prolong the effect as intended. This article is protected by copyright. All rights reserved.

Treatment of chronic chikungunya arthritis with methotrexate: a systematic review


Objectives Chikungunya is a rapidly emerging, global viral infection that can cause chronic, debilitating arthritis that in some ways mimics rheumatoid arthritis. This study evaluated the available evidence of the efficacy and safety of methotrexate (MTX), a therapy widely used in rheumatoid arthritis, in the treatment of chronic chikungunya arthritis. Methods A systematic literature search was performed to identify all published trials that evaluated MTX as monotherapy or combination therapy in chronic chikungunya arthritis. PubMed, Scielo, Scopus and Cochrane Library databases were searched from inception to August 2017. We also searched Google Scholar, International Clinical Trials Registry Platform Search Portal and clinicaltrials . gov. Results Among 131 possibly relevant studies, six met our criteria for evaluation; four were retrospective studies, one was an uncontrolled prospective study, and one was an unblinded randomized clinical trial of combination MTX therapy. In this study, MTX in combination with hydroxychloroquine (HCQ) and sulfasalazine (HCQ) was superior to HCQ monotherapy as assessed by Disease Activity Score (DAS28ESR 3.39+/-0.87 versus 4.74+/-0.65, p <0.0001) and Health Assessment Questionnaire (HAQ 1.14+/- 0.31 versus 1.88+/- 0.47, p <0.0001). Conclusion The available studies are limited, but taken together demonstrate sufficient efficacy to justify interest in the treatment of chronic chikungunya arthritis with MTX. The trials lacked rigorous study designs and used different treatment strategies and outcome measures. This systematic review underscores the need for randomized prospective, placebo-controlled studies of MTX monotherapy in the treatment of chronic chikungunya arthritis. This article is protected by copyright. All rights reserved.

The Influence of Explanatory Images on Risk Perceptions and Treatment Preference


Objective To examine whether providing patients a series of balance scales (BS) depicting a reciprocal relationship between achieving disease control and increasing the risk of infection influences treatment preference. Methods Participants were randomized to receive a description of a medication in which risk of infection was described using one of four formats: numbers only, numbers + icon array (IA), numbers + BS, or numbers + IA + BS (i.e. combination). We compared the likelihood of starting the medication across the four formats, and whether the influence of risk formats varied by numeracy and gist risk appraisals. Results Mean (SE) likelihood was higher among participants randomized to the combination format [3.85 (0.09)] compared to those viewing the BS [3.56 (0.09), p = 0.0222] or numbers alone formats [3.51 (0.09), p = 0.0069]. Viewing an IA alone was associated with a lower likelihood of starting the medication among participants lower in numeracy and endorsing a risk avoidant non-compensatory gist risk appraisal. Conversely, viewing an IA, with or without the BS, was associated with a greater likelihood of starting the medication among those with higher numeracy and compensatory risk appraisals. Conclusion Adding explanatory images to IAs increases the likelihood to take a medication in patients with low numeracy and a non-compensatory gist risk appraisal. Explanatory images may be a feasible approach to improve willingness to try medication among subjects who are especially risk averse and believe that any risk is unacceptable.

Effects of a DASH Diet Intervention on Serum Uric Acid in African Americans with Hypertension


Objective To examine whether partially replacing one's diet with DASH-related foods in the home environment lowered uric acid (SUA). Methods We conducted an ancillary study in a randomized trial of African Americans with controlled hypertension from an urban clinic. Participants were assigned to either a control or intervention (DASH-Plus) group. The control group received a DASH brochure and a debit account of $30/week to purchase foods. DASH-Plus participants received coach-directed dietary advice, assistance with purchasing DASH-related foods ($30/week), and home food delivery via a community supermarket. SUA was measured at baseline and after 8 weeks. Results Of the original 123 randomized participants, 117 had measured SUA. Participants were 70% women and mean age 59±9.5 years with a mean SUA of 6.4±1.7 mg/dL. DASH-Plus did not reduce SUA compared with control (difference-in-difference was -0.01 mg/dL; 95% CI: -0.39, 0.38). However, there was a significant trend toward greater SUA reduction among participants with higher baseline SUA (P-trend=0.008). Baseline changes in SUA were inversely associated with changes in systolic blood pressure (P=0.002), diastolic blood pressure (P=0.001), and urine sodium excretion (P=0.05). Conclusions Overall, partial replacement of diet with DASH foods did not lower SUA compared with control. However, there was a significant trend toward greater SUA reduction among those with higher baseline SUA. Furthermore, changes in SUA were associated with known correlates, suggesting heterogeneity of effects in treatment and control arms. Future pragmatic studies of the DASH diet to lower SUA should optimize replacement strategies and enroll people with hyperuricemia or gout. This article is protected by copyright. All rights reserved.

Symmetric polyarthralgias and cutaneous papulonodules in a 56 year-old woman


A 56-year-old female with no history of arthritis presented with a two month history of a diffuse, pruritic, painful papulonodular skin eruption, diffuse myalgias, and symmetric polyarthritis of the hands, shoulders, knees, and ankles. This article is protected by copyright. All rights reserved

Validation of the Social Appearance Anxiety Scale in Patients with Systemic Sclerosis: A Scleroderma Patient-centered Intervention Network Cohort Study


Objective Systemic sclerosis (SSc) is an autoimmune disease that can cause disfiguring changes in appearance. This study examined the structural validity, internal consistency reliability, convergent validity, and measurement equivalence of the Social Appearance Anxiety Scale (SAAS) across SSc disease subtypes. Methods Patients enrolled in the Scleroderma Patient-centered Intervention Network Cohort completed the SAAS and measures of appearance-related concerns and psychological distress. Confirmatory factor analysis (CFA) was used to examine the structural validity of the SAAS. Multiple-group CFA was used to determine if SAAS scores can be compared across patients with limited and diffuse disease subtypes. Cronbach's alpha was used to examine internal consistency reliability. Correlations of SAAS scores with measures of body image dissatisfaction, fear of negative evaluation, social anxiety, and depression were used to examine convergent validity. SAAS scores were hypothesized to be positively associated with all convergent validity measures, with correlations significant and moderate to large in size. Results A total of 938 patients with SSc were included. CFA supported a one-factor structure (CFI: .92; SRMR: .04; RMSEA: .08), and multiple-group CFA indicated that the scalar invariance model best fit the data. Internal consistency reliability was good in the total sample (α = .96) and in disease subgroups. Overall, evidence of convergent validity was found with measures of body image dissatisfaction, fear of negative evaluation, social anxiety, and depression. Conclusion The SAAS can be reliably and validly used to assess fear of appearance evaluation in patients with SSc, and SAAS scores can be meaningfully compared across disease subtypes. This article is protected by copyright. All rights reserved.

Medical Care Costs Associated with Rheumatoid Arthritis in the US: A Systematic Literature Review and Meta-analysis


Background Rheumatoid arthritis (RA) is a morbid, mortal and costly condition without a cure. Treatments for RA have expanded over the last two decades and direct medical costs may differ by types of treatments. There has not been a systematic literature review since the introduction of new RA treatments, including biologic disease modifying anti-rheumatic drugs (bDMARDs). Methods We conducted a systematic literature review with meta-analysis of direct medical costs associated with RA cared for in the US since the marketing of the first bDMARD. Standard search strategies and sources were used and data were extracted independently by two reviewers. The methods and quality of included studies were assessed. Total direct medical costs as well as RA-specific costs were calculated using random effects meta-analysis. Subgroups of interest included Medicare patients and those using bDMARDs. Results We found 541 potentially relevant studies and 12 papers met the selection criteria. The quality of studies varied: 1/3 were poor, 1/3 were fair, and 1/3 were good. Total direct medical costs were estimated at $12,509 (95% CI $7,451-21,001) for all RA patients using any treatment regimen and $36,053 (95% CI $32,138-40,445) for bDMARD users. RA-specific costs were $3,723 (95% CI $2,408-5,762) for all RA patients using any treatment regimen and $20,262 (95% CI $17,480-23,487) for bDMARD users. Conclusions The total and disease-specific direct medical costs of patients with RA is substantial. Among bDMARD users, cost of RA care is over half of all direct medical costs. This article is protected by copyright. All rights reserved.

Changes in Pain Sensitization after Bariatric Surgery


Objective To evaluate changes in pain (at the knee and elsewhere) and pain sensitization in obese persons with knee pain undergoing bariatric surgery compared with similarly obese persons undergoing medical management. Methods Individuals undergoing bariatric surgery and medical management were recruited. Knee pain severity of the more painful knee (index knee) was assessed at baseline and 12 months using the WOMAC. Pressure pain threshold (PPT) was assessed at the index patella and the right wrist. Low patella PPT may reflect peripheral and/or central sensitization and low wrist PPT may reflect central sensitization Mean change in measures of pain and pain sensitization was assessed in the surgery and medical management groups separately. Results 45 individuals in the surgery group and 22 in the medical management group completed baseline and follow-up visits. The mean weight loss was 32.7 kilograms (29.0%) and 4.6 kilograms (4.1%) in the surgery and medical management groups, respectively. Knee pain decreased in the surgery group only. PPT at the patella improved by 38.5% and the PPT at the wrist improved by 30.9% (p-value=0.0007 and 0.005, respectively) in the surgery group. There was no significant change in PPT in the medical management group. Conclusions Persons who underwent bariatric surgery experienced an improvement in pain sensitization, reflected by improvements in PPT. This improvement was not only at the patella, but also at the wrist, suggesting that central sensitization improved after bariatric surgery. This article is protected by copyright. All rights reserved.

Benefits and Sustainability of a Learning Collaborative for Implementation of Treat to Target in Rheumatoid Arthritis: Results of the TRACTION Trial Phase II


Background We conducted a two-phase randomized controlled trial of a Learning Collaborative (LC) to facilitate implementation of treat to target (TTT) to manage rheumatoid arthritis (RA). We found substantial improvement in implementation of TTT in Phase I. Herein, we report on a second 9 months (Phase II) where we examined maintenance of response in Phase I and predictors of greater improvement in TTT adherence. Methods We recruited 11 rheumatology sites and randomized them to either receive the LC during Phase I or to a wait-list control group that received the LC intervention during Phase II. The outcome was change in TTT implementation score (0 to 100, 100 is best) from pre- to post-intervention. TTT implementation score is defined as a percent of components documented in visit notes. Analyses examined: 1) the extent that the Phase I intervention teams sustained improvement in TTT; and, 2) predictors of TTT improvement. Results The analysis included 636 RA patients. At baseline, mean TTT implementation score was 11% in Phase I intervention sites and 13% in Phase II sites. After the intervention, TTT implementation score improved to 57% in the Phase I intervention sites and to 58% in the Phase II sites. Intervention sites from Phase I sustained the improvement during the Phase II (52%). Predictors of greater TTT improvement included only having rheumatologist providers at the site, academic affiliation of the site, fewer providers per site, and the rheumatologist provider being a trainee. Conclusions Improvement in TTT remained relatively stable over a post-intervention period. This article is protected by copyright. All rights reserved.

Cerebrovascular Events in Systemic Lupus Erythematosus


Objective To determine the frequency, associations and outcomes of cerebrovascular events (CerVEs) in a multi-ethnic/racial, prospective, SLE disease inception cohort. Methods Patients were assessed annually for 19 neuropsychiatric (NP) events including 5 types of CerVEs: (i) Stroke; (ii) Transient ischemia; (iii) Chronic multifocal ischemia; (iv) Subarachnoid/intracranial hemorrhage; (v) Sinus thrombosis. Global disease activity (SLEDAI-2K), SLICC/ACR damage index (SDI) and SF-36 scores were collected. Time to event, linear and logistic regressions and multi-state models were used as appropriate. Results Of 1,826 SLE patients, 88.8% were female, 48.8% Caucasian, mean±SD age 35.1±13.3 years, disease duration 5.6±4.2 months and follow-up 6.6±4.1 years. CerVEs were the fourth most frequent NP event: 82/1,826 (4.5%) patients had 109 events, 103/109 (94.5%) were attributed to SLE and 44/109 (40.4%) were identified at enrollment. The predominant events were stroke [60/109 (55.0%)] and transient ischemia [28/109 (25.7%)]. CerVEs were associated with other NP events attributed to SLE (HR (95% CI): (3.16; 1.73-5.75) (p<0.001), non-SLE NP (2.60; 1.49-4.51) (p<0.001), African ancestry at US SLICC sites (2.04; 1.01-4.13) (p=0.047) and organ damage (p=0.041). Lupus anticoagulant increased the risk of first stroke and sinus thrombosis [2.23 (1.11, 4.45) p=.024] and TIA [3.01 (1.15, 7.90) p=0.025]. Physician assessment indicated resolution or improvement in the majority but patients reported sustained reduction in SF-36 summary and subscale scores following CerVEs (P<0.0001). Conclusion CerVEs, the fourth most frequent NP event in SLE, are usually attributable to lupus. In contrast to good physician reported outcomes, patients report a sustained reduction in health-related quality of life following CerVEs. This article is protected by copyright. All rights reserved.

Effectiveness of a web-based personalized rheumatoid arthritis risk tool with or without a health educator for knowledge of RA risk factors


Objective To assess knowledge of rheumatoid arthritis (RA) risk factors among unaffected first-degree relatives (FDRs) and to study whether a personalized RA education tool increases risk factor knowledge. Methods We performed a randomized controlled trial assessing RA educational interventions among 238 FDRs. The web-based Personalized Risk Estimator for RA (PRE-RA) tool displayed personalized RA risk results (genetics, autoantibodies, demographics, and behaviors) and educated about risk factors. Subjects were randomly assigned to: Comparison arm (standard RA education, n=80), PRE-RA arm (PRE-RA alone, n=78), or PRE-RA Plus arm (PRE-RA and a one-on-one session with a trained health educator, n=80). The RA Knowledge Score (RAKS, the number of 8 established RA risk factors identified as related to RA) was calculated at baseline and post-education (immediate/6 weeks/6 months/12 months). We compared RAKS and its components at each post-education point by randomization arm. Results At baseline before education, few FDRs identified behavioral RA risk factors (15.9% for dental health, 31.9% for smoking, 47.5% for overweight/obesity, and 54.2% for diet). After education, RAKS increased in all arms, higher in PRE-RA and PRE-RA Plus than Comparison at all post-education points (p<0.05). PRE-RA were more likely to identify risk factors than those that received standard education (proportion agreeing smoking is a risk factor at 6 weeks: 83.1% in PRE-RA Plus arm, 71.8% in PRE-RA, and 43.1% in Comparison arms, p<0.05 for PRE-RA vs. Comparison). Conclusion Despite being both familiar with RA and at increased risk, FDRs had low knowledge about RA risk factors. A web-based personalized RA education tool successfully increased RA risk factor knowledge. This article is protected by copyright. All rights reserved.

Geriatric Assessment of Physical and Cognitive Functioning in a Diverse Cohort of Systemic Lupus Erythematosus Patients: A Pilot Study


Objective To use multi-domain functional assessment, commonly performed in geriatric patients but novel among SLE patients, to better understand functional impairment in SLE. Methods We recruited 60 adult participants [aged 20-39 (26.7%), 40-59 (50.0%), and ≥60 (23.3%); 80.0% black; 90.0% female] from an existing cohort of SLE patients. During in-person visits (10/16-4/17), we evaluated physical performance (range 0-4; higher scores = better performance); cognitive performance (five fluid cognition domains; adjusted t-scores); and self-reported measures including physical functioning (t-scores), activities of daily living (ADLs), falls, and life-space mobility. Results Mean (±SD) balance (3.7±0.8) and gait speed (3.4±1.0) scores were high, while the mean lower body strength score was low (1.8±1.3). Cognitive performance was average (score=50) for episodic (47.7±9.2) and working (48.6±11.2) memory and low average for cognitive flexibility (43.7±14.2), processing speed (42.6±14.8), and attention/inhibitory control (38.8±8.6; >1 SD below average), compared to healthy individuals of the same age, sex, race, ethnicity, and education. Most participants reported independence in basic ADLs but many reported dependence in instrumental ADLs. Nearly half (45.0%) of participants reported falling in the prior year. Only 40.0% reported unlimited ability to travel without the help of another person. Scores generally did not differ substantially by age. Conclusion Our results suggest high prevalence of impairment across multiple domains of function in SLE patients of all ages, similar to or exceeding the prevalence seen in much older geriatric populations. Further research into the added value of geriatric assessment in routine care for SLE is warranted. This article is protected by copyright. All rights reserved.

Impact of Radiation Therapy on Scleroderma and Cancer Outcomes in Scleroderma Patients with Breast Cancer


Objectives We examined SSc patients with breast cancer to 1) identify the prevalence of radiation complications and 2) examine SSc outcomes in SSc patients who received radiation therapy (RT) as part of their cancer treatment. Methods Patients with SSc and breast cancer were identified from the Johns Hopkins and University of Pittsburgh Scleroderma Center databases. We examined whether erythema, blistering, ulceration, or thickening of the skin developed in the RT port. Changes in modified Rodnan skin score (mRSS) and forced vital capacity (FVC) 12 and 24 months post cancer diagnosis were compared between patients who did and did not receive RT. Results Forty three of 116 breast cancer patients at Johns Hopkins and 26 of 37 patients at Pittsburgh received breast RT. At Johns Hopkins, 4/30 (13.3%) with available data developed erythema, 0/30 had blistering, 1/30 (3.3%) developed ulceration, and 15/31 (48.4%) had skin thickening in the radiation port. At Pittsburgh, 7/11 (63.6%) patients with available data developed erythema, 2/11 (18.2%) had blistering, none developed ulceration, and 6/11 (54.6%) had skin thickening in the radiation port. In a limited sample, there were no significant changes in mRSS or FVC between patients who did or did not receive RT. Conclusion These data suggest that radiation injury causing local tissue fibrosis is not inevitable in SSc patients with breast cancer, occurring in ~50% of cases without evidence of lung or generalized skin disease flare. Therefore, the use of RT for breast cancer is considered an option based on the informed patient's preference. This article is protected by copyright. All rights reserved.

Rash, Fever, and Pulmonary Hypertension in a 6-Year-Old Female


A previously healthy 2-year-old Guatemalan female with an undiagnosed chronic illness characterized by fever and rash had presented with anorexia, weight loss, periorbital edema, abdominal pain and distention. A chest radiograph documented cardiomegaly. An echocardiogram demonstrated a pericardial effusion, dilated right atrium, right ventricle, and main pulmonary artery as well as diminished right ventricular systolic function and pulmonary hypertension. Right ventricular systolic pressure was estimated at 90 mmHg. Computed tomography of her chest was performed. There was no evidence of interstitial lung disease but changes included dilated pulmonary arteries consistent with the presence of pulmonary hypertension as well as acute thrombosis of the superior vena cava and left brachiocephalic vein. These findings suggested thromboembolism as the etiology of pulmonary hypertension. A ventilation / perfusion lung scan also suggested differential lung perfusion. She was placed on systemic anticoagulation transiently. The presence of antiphospholipid antibodies was documented as described below. Rheumatology consultation was requested for consideration of a possible autoimmune / inflammatory etiology. This article is protected by copyright. All rights reserved.

Multi-center Delphi Exercise Reveals Important Key Items for Classifying Systemic Lupus Erythematosus


Background The European League Against Rheumatism (EULAR) and the American College of Rheumatology (ACR) embarked on a project to re-evaluate classification criteria for systemic lupus erythematosus (SLE). The first phase of the classification project involved generation of a broad set of items potentially useful for classification of SLE and their selection for use in a subsequent forced-choice decision analysis. Methods A large international group of expert lupus clinicians was invited to participate in a 2-step process to generate, rate and select items based on their importance in diagnosing early and established SLE, respectively, via a web-based survey. Results 135 and 147 experts were invited to participate in the item generation and item reduction process, respectively. Out of 145 items generated, item reduction resulted in 40 candidate items moving forward to the next phase. Key features for classifying both early and established SLE included characteristic autoantibodies, specific renal features, and skin manifestations. A small majority (51%) stated that one organ system would be sufficient for classifying SLE, but that additional typical laboratory features (ANA, dsDNA) would be required. Notably, 85% of the expert group would positively classify SLE if renal pathology alone showed lupus nephritis. Conclusion The Delphi exercise resulted in a set of 40 candidate criteria for the classification of SLE for subsequent assessment. This study comprised the largest panel ever involved in the development of SLE classification criteria, providing a broadly representative view of the current approach to classification SLE. This article is protected by copyright. All rights reserved.

Aspirin dose in Kawasaki disease – the ongoing battle


Background Kawasaki disease (KD) is an acute childhood vasculitis that may result in coronary aneurysms. Treatment of Kawasaki disease (KD) with a single infusion of 2g/kg intravenous immunoglobulin (IVIG) is well established, but acetyl-salicylic acid (ASA) dose remains controversial. Methods We reviewed charts of patients with KD from two Canadian centres to assess the impact of ASA dose on IVIG resistance (operationally defined as administration of a second dose of IVIG). Both centres used standard IVIG dosing, but centre 1 used low-dose ASA from diagnosis (3-5 mg/kg/day) while centre 2 used initial high-dose ASA (80-100 mg/kg/day). Objectives Primary: To determine the difference in the incidence of IVIG resistance between the two centres. Secondary: To compare the duration of hospital stay and the incidence of CAA. Results There were no significant differences in baseline characteristics between the two centres. Re-treatment with a second dose of IVIG was required in 28/122 (23%) patients treated with low-dose ASA, and in 11/127 (8.7%) patients treated with high-dose ASA (p=0.003). After adjusting for confounders, low-dose ASA was associated with higher odds of IVIG resistance (OR=3.2, 95% CI 1.1, 9.1). The mean duration of hospital stay was 4.1 and 4.7 days, respectively (p= 0.37). Coronary artery aneurysms were seen in 2/117 and 6/125 patients from centre 1 and 2, respectively (p= 0.28). Conclusion Low-dose ASA was associated with 3 times higher odds of IVIG re-treatment compared to high-dose ASA, with no significant difference in duration of hospital stay or incidence of coronary artery aneurysms. This article is protected by copyright. All rights reserved.

The symptomatic course of foot osteoarthritis phenotypes: an 18-month prospective analysis of community-dwelling older adults


Objective Osteoarthritis (OA) is a heterogeneous disease with symptom progression at the foot unclear. This study investigated the symptomatic course of three pre-defined foot OA phenotypes over an 18-month period. Methods The Clinical Assessment Study of the Foot (CASF) is a community-based cohort of adults aged ≥50 years in North Staffordshire, UK. Participants who reported foot pain in a postal health survey and underwent radiographic assessment were mailed an 18-month follow-up survey. Changes in descriptive and symptomatic outcomes over 18 months were compared across the three phenotypes to determine within-phenotype changes and between-phenotype differences. Results Of 533 participants at baseline, 478 (89.7%) responded at 18 months. All three phenotypes showed small within-phenotype improvements in mean foot pain severity (scale from 0=no pain to 10=worst pain): no or minimal foot OA (18-month 4.0; mean change -1.15 [95% CI -1.46,-0.83]), isolated first metatarsophalangeal joint (MTPJ) OA (18-month 4.1; mean change -0.60 [95% CI -1.11,-0.10]) and polyarticular foot OA (18-month 5.1; mean change -0.77 [95% CI -1.42,-0.12]). The isolated first MTPJ OA phenotype had an increased likelihood of hallux valgus in the left foot (adjusted odds ratio 2.96 [95% CI 1.23,7.12]) compared to the no or minimal foot OA phenotype. Conclusion Three foot OA phenotypes showed few descriptive or symptomatic changes over 18 months. Future clinical trials should consider that people recruited with mild-to-moderate symptomatic foot OA appear likely to remain relatively stable with usual care. Longer-term follow-up using additional time-points is required to describe further the natural history of foot OA. This article is protected by copyright. All rights reserved.

Large vessel dilatation in giant cell arteritis: a different subset of disease?


Objective To compare patients with large-vessel GCA (LV-GCA) characterized by wall thickening, stenosis and/or occlusion of subclavian arteries to those with subclavian dilatation. Methods For the purposes of the present retrospective study, two different subsets of LV-GCA were identified and compared from an established cohort of patients with radiographic evidence of subclavian artery vasculitis secondary to GCA: 1.LV-GCA with wall thickening, stenosis and/or occlusion of subclavian arteries (Group 1) 2.LV-GCA with dilatation of subclavian arteries without wall thickening or stenotic changes (Group 2). Results The study included 109 patients in Group 1 and 11 in Group 2. Large vessel involvement secondary to GCA was diagnosed significantly later in patients from Group 2 compared to those from Group 1 (median 15.3 vs 0.0 months, p=0.010). Compared to patients from Group 1, those from Group 2 were more frequently male (17% vs 45%, p=0.027), ever smokers (42% vs 73%, p=0.048) and more frequently had a history of coronary artery disease (11% vs 36%, p=0.018). At LV-GCA diagnosis, 10 of the 11 patients (91%) from Group 2 had aortic dilatation compared to 13/109 patients (12%) from Group 1, (p<0.001). During the follow-up period, the prevalence of aortic aneurysm was significantly higher in patients from Group 2 compared with those from Group 1 (64% vs 7% at 5 years, p<0.001) Conclusion Two different subsets of LV-GCA were identified. Given the strong association between subclavian artery dilatation and aortic aneurysm, such patients should be evaluated and monitored carefully for aortic dilatation. This article is protected by copyright. All rights reserved.

Orthopedic Surgery among Patients with Rheumatoid Arthritis: A Population-based study to Identify Risk factors, Sex differences, and Time trends


Objective To identify risk factors for large joint (LJS) versus small joint surgery (SJS) in rheumatoid arthritis (RA) and evaluate trends in surgery rates over time. Methods A retrospective medical record review was performed of all orthopedic surgeries following first fulfillment of 1987 ACR criteria for adult-onset RA among residents of Olmsted County, Minnesota, USA in 1980-2013. Risk factors were examined using Cox models adjusted for age, sex and calendar year of RA incidence. Trends in incidence of joint surgeries were examined using Poisson regression models. Results A total of 1077 patients with RA (mean age 56 years, 69% female, 66% seropositive) were followed for a median of 10.7 years during which 112 (90 women) underwent at least one SJS and 204 (141 women) underwent at least one LJS. Risk factors included advanced age, rheumatoid factor and anti-CCP antibody positivity for both SJS and LJS, and BMI≥30 kg/m2 for LJS. Risk factors for SJS and LJS at any time during follow-up included the presence of radiographic erosions, large joint swelling, and methotrexate use. SJS rates decreased by calendar year of incidence (hazard ratio 0.53; p=0.001), with significant decline in SJS after 1995. The cumulative incidence of SJS was higher in women than men (p=0.008). Conclusion In recent years, there has been a significant decline in rates of SJS but not LJS in patients with RA. The incidence of SJS is higher among women. Traditional RA risk factors are strong predictors for SJS and LJS. Increasing age and obesity are predictive of LJS. This article is protected by copyright. All rights reserved.

“Like No One Is Listening to Me”: A Qualitative Study of Patient-Provider Discordance Between Global Assessments of Disease Activity in Rheumatoid Arthritis


Objective The objective of this study was to explore the perspectives and experiences of patients with rheumatoid arthritis (RA) whose assessments of their disease differ from those of their rheumatology care provider. Methods A total of 20 adult RA patients with patient-provider discordance at their most recent rheumatology appointment (within 4 weeks) were recruited. Discordance was defined by an absolute difference of 25 or more between patient and provider global assessments on visual analog scales (VASs) of disease activity. For descriptive purposes, participants completed the Health Assessment Questionnaire II, pain VAS, and Patient Health Questionnaire-9 depression scale. Interviews were conducted in person and individually with each patient with a semistructured interview guide. Topics ranged widely, including participants’ perspectives and experiences with living with RA, clinical disease assessments, patient-provider communication, and psychosocial or other needs. Data from the interviews were analyzed using an interpretive phenomenological approach. Results Six major themes emerged from the patient interviews describing patient-provider discordance and disease assessment: being misunderstood by others, limitations of provider assessments, discrepancy with provider findings, inadequate active listening on the part of health care providers, unmet psychosocial needs, and lack of patient empowerment. Conclusion Patients described discordance in terms of symptom assessment and understanding how RA affects everyday life. Typical clinical assessments did not capture their experience. The resulting conceptual framework should inform future interventional studies seeking to enhance concordance of patient-physician communication and to optimize satisfaction with care and health-related quality-of-life outcomes for patients with RA. This article is protected by copyright. All rights reserved.

Is ACPA-positive RA still a more severe disease than ACPA-negative RA? A longitudinal cohort study in RA-patients diagnosed from 2000 onwards


Objective Anti-citrullinated-protein antibodies (ACPA)-positive rheumatoid arthritis (RA) is considered as more severe than ACPA-negative RA, because of its association with joint destruction. Clinically relevant joint destruction is now infrequent, thanks to adequate disease suppression. According to patients, important outcomes are pain, fatigue and independence. We evaluated if ACPA-positive RA-patients diagnosed ≥2000 have more severe self-reported limitations and impairments including restrictions at work than ACPA-negative RA-patients. Methods 492 ACPA-positive, 450 ACPA-negative 2010-criteria-positive RA-patients included in the Leiden Early Arthritis Clinic cohort ≥2000 were compared for self-reported pain, fatigue, disease activity, general wellbeing (measured by numerical rating scales) and physical function (measured by the health assessment questionnaire, HAQ) and work restrictions including absenteeism at baseline and during 4-year follow-up. Linear mixed models were used. Results At disease presentation, ACPA-negative patients had more severe pain, fatigue, self-reported disease activity-scores and functional disability (p<0.05), although absolute differences were small. During follow-up ACPA-negative patients remained somewhat more fatigued (p=0.002), whereas other patient-reported impairments and limitations were similar. 38% ACPA-negative and 48% ACPA-positive patients reported absenteeism (p=0.30), with median 4 days missed in both groups in the last 3 months. Also restrictions at work among employed patients and restrictions with household work were not statistically different at baseline and during follow-up. Conclusion In current rheumatology practice, ACPA-positive RA is not more severe than ACPA-negative RA in terms of for patients relevant outcomes including physical functioning and restrictions at work. This implies that effort to further improve the disease course should be proportional to both disease subsets. This article is protected by copyright. All rights reserved.

Development and testing of a hybrid measure of muscle strength in juvenile dermatomyositis for use in routine care


Objective To develop and test a hybrid measure of muscle strength for juvenile dermatomyositis (JDM), which is based on the combination of the Manual Muscle Testing 8 (MMT8) and the Childhood Myositis Assessment Scale (CMAS), but is more comprehensive than the former and more feasible than the latter. Methods The hybrid MMT/CMAS (hMC) is composed of all 8 items of the MMT8 and 3 items of the CMAS: 1) time of head lift; 2) assessment of abdominal muscles; 3) floor rise. The score ranges from 0 to 100, with 100 indicating normal muscle strength. Validation procedures were conducted using three large multinational patient samples including a total of 810 JDM patients. Results The hMC revealed face and content validity, good construct validity, excellent test-retest reliability (intraclass correlation coefficient = 0.99) and internal consistency (Chronbach's alpha = 0.94), strong responsiveness to clinical change over time (standardized response mean = 0.8 among patients judged as improved by the caring physician), and satisfactory capacity to discriminate patients judged as being in the states of inactive disease or low, moderate, or high disease activity by the physician (p < 0.001) or patients whose parents were satisfied or not satisfied with illness course (p < 0.001). Conclusion The hMC was found to possess good measurement properties in a large population of patients with a wide range of disease activity and severity. The new tool, which is primarily intended for use in routine clinical care, should be further tested in other populations of patients evaluated prospectively. This article is protected by copyright. All rights reserved.

Factors influencing cane use for the management of knee osteoarthritis: a cross sectional survey


Objective To investigate demographic, symptom-related and cognitive determinants of cane use for knee osteoarthritis (OA) and prioritise the factors that could facilitate cane use in people with no previous cane use. Methods A survey of people aged ≥45 years with a clinical diagnosis of knee OA was conducted. The survey included two sections: i) demographic and cognitive determinants of cane use assessed via subscales of the Cane Cognitive Mediator Scale; ii) 19 statements, underpinned by the Behaviour Change Wheel theoretical framework, relating to factors that could facilitate regular cane use. Logistic regression was used to examine determinants of cane use while a priority pairwise ranking activity (1000minds) determined the rank order of the 19 statements that could facilitate cane use. Results 529 people completed Part 1 (80% females; 35% cane users) and 231 people completed Part 2. Age (OR 1.06, 95% CI 1.03, 1.09), body mass index (BMI) (OR 1.03, 95% CI 1.01, 1.06), knee pain ≥3 years (OR 2.62, 95% CI 1.63, 4.21) and numeric rating scale pain level whilst walking (OR 1.19, 95% CI 1.09, 1.30) were significant independent determinants of cane use. In people who had never used a cane, statements relating to cane use technique, fitting, knowledge of benefits and motivation were ranked highest overall. Conclusion Independent determinants of cane use include older age, higher BMI, greater pain duration and greater severity of knee pain. Strategies targeting an individual's capability and motivation to use a cane may increase cane use among people with knee OA. This article is protected by copyright. All rights reserved.

The unmet needs of Aboriginal Australians with musculoskeletal pain: A mixed method systematic review


Objective Musculoskeletal pain (MSP) conditions are the biggest cause of disability and internationally, Indigenous peoples experience a higher burden. There are conflicting reports about Aboriginal Australians and MSP. We conducted a systematic review to describe the prevalence, associated factors, impacts, care access, health care experiences, and factors associated with MSP among Aboriginal Australians. Methods A systematic search of quantitative and qualitative scientific and grey literature (PROSPERO number: CRD42016038342). Articles were appraised using the Mixed Methods Appraisal Tool. Due to study heterogeneity a narrative synthesis was conducted. Results Of 536 articles identified, 18 were included (14 quantitative, 4 qualitative), of high (n=11), medium (n=2) and low (n=5) quality. Prevalences of MSP in Aboriginal populations were similar to or slightly higher than the non-Aboriginal population (prevalence rate ratio 1.1 for back pain, 1.2-1.5 for osteoarthritis (OA), 1.0-2.0 for rheumatoid arthritis). Aboriginal people accessed primary care for knee or hip OA at around half the rate of non-Aboriginal people, and were less than half as likely to have knee or hip replacement surgery. Communication difficulties with health practitioners were the main reason why Aboriginal people with MSP choose not to access care. No articles reported interventions. Conclusions Findings provide preliminary evidence of an increased MSP burden amongst Aboriginal Australians and, particularly for OA, a mismatch between the disease burden and access to health care. To increase accessibility, health services should initially focus on improving Aboriginal patients’ experiences of care, in particular by improving patient-practitioner communication. Implications for care and research are outlined. This article is protected by copyright. All rights reserved.

Patient-Perception of Disease-Related Symptoms and Complications in Relapsing Polychondritis


Objective To assess patient-reported symptoms and burden of disease in relapsing polychondritis (RP). Methods Patients with RP completed a disease-specific online survey to identify symptoms attributed to illness. Patients were divided into subgroups based upon presence or absence of ear/nose, airway, or joint involvement. Pathway to diagnosis, treatment, and disease-related complications were assessed within each subgroup. Results Data from 304 respondents were included in this analysis. Prior to diagnosis, most patients with RP went to the emergency room (54%), saw >3 physicians (54%), and had symptoms for >5 years (64%). A concomitant diagnosis of fibromyalgia and absence of ear/nose or joint involvement was associated with diagnostic delay >1 year. Common diagnoses prior to RP diagnosis included asthma in patients with airway involvement (35% vs 22%, p=0.03) and ear infection in patients with ear/nose involvement (51% vs 6%, p<0.01). Patients with joint involvement were more likely to receive a glucocorticoid-sparing agent (85% vs 13%, p<0.01). Most patients reported a major complication including disability (25%), tracheomalacia (16%) or hearing loss (34%). Patients with airway involvement reported more tracheomalacia (20% vs 4%, p<0.01). Disability (24% vs 7%, p<0.01) and hearing loss (39% vs 11%, p<0.01) were prevalent in the joint involvement subgroup. Conclusion Patient-reported data in RP highlight a significant burden of disease. Patterns of organ involvement may lead to diagnostic delay and influence treatment decisions, ultimately impacting the development of disease-related complications. Timely diagnosis, standardization of treatment approaches, and prevention of disease-related complications are major unmet needs in RP. This article is protected by copyright. All rights reserved.

Endothelial dysfunction in early systemic lupus erythematosus patients and controls without previous cardiovascular events


Objectives To assess the prevalence and risk factors for endothelial dysfunction detected by peripheral artery tonometry in systemic lupus erythematosus patients with early disease without cardiovascular disease and risk factors. Methods All the consecutive adult lupus patients, with a disease duration less than 5 years, seen in our Hospital from December 2014 to March 2016 were considered. We excluded patients with any history of cardiovascular disease or risk factors possibly affecting peripheral artery tonometry. Enrolled patients were matched for sex, age, body mass index and blood pressure with healthy controls with the same exclusion criteria. Patients and controls performed a transthoracic Doppler echocardiogram and an evaluation of endothelial function by peripheral artery tonometry. Results Twenty patients (100% female) with a median disease duration of 14 months (1-58), a mean age of 42±15 years and a mean age at diagnosis of 40±16 years were enrolled and matched with 20 controls. Peripheral artery tonometry showed a significantly higher prevalence of endothelial dysfunction (p=0.003) and vascular stiffness (p=0.02), while echocardiography detected a significantly higher prevalence of left ventricular concentric remodelling (p=0.003), grade I diastolic dysfunction (p=0.047) and subclinical increase of filling pressures (p=0.039) in lupus patients compared to controls. Among lupus patients no features were associated with endothelial dysfunction. Conclusion A high rate of endothelial dysfunction and vascular stiffness occurs in early lupus patients without cardiovascular risk factors and disease. Larger studies are needed to confirm our results and to look for patients’ characteristics possibly associated to these abnormalities. This article is protected by copyright. All rights reserved.

News on Relapsing Polychondritis: the patients’ experience


In this issue of Arthritis Care & Research, the authors of Patient-Perception of Disease-Related Symptoms and Complications in Relapsing Polychondritis report for the first time the patient's view over the disease (1). Thanks go to them for this important step forward. The method used however, carries some limitations, as indicated very honestly by the authors. This article is protected by copyright. All rights reserved.

Children born by women with rheumatoid arthritis have increased susceptibility for selected chronic diseases – a nationwide cohort study


Objective Fetal exposure to maternal rheumatoid arthritis (RA) might impact the long-term risk of disease in the offspring. We examined a possible association between maternal RA and 15 selected groups of chronic diseases in the offspring. Methods This nationwide cohort study was based on the Danish health registries and included data on all children born alive in Denmark from January 1st 1989 to December 31st 2013. The cohort comprised 2106 children born by women with RA (exposed), and 1 378 539 children born by women without RA (unexposed). Cox proportional hazard regression models were used, taking a large range of confounders into consideration, computing the Hazard Ratios (HR) of child- and adolescence diseases. Results In children being exposed to maternal RA in utero, the HR′s of thyroid diseases was 2.19 (95% CI, 1.14 – 4.21), epilepsy 1.61 (95% CI, 1.16 – 2.25), and RA 2.89 (95% CI, 2.06 – 4.05). The HR′s for anxiety and personality disorders and chronic lung disease including asthma were in the range of 1.15 - 1.16, but these were not statistically significant. Conclusions Our results suggest that in utero exposure to maternal RA is associated with an increased risk of thyroid disease and epilepsy in childhood and adolescence, and in particular an increased risk of RA, compared to children born by mothers without RA. These important findings should encourage pediatricians and general practitioners to an increased awareness of certain chronic diseases in children being exposed to RA in utero. This article is protected by copyright. All rights reserved.

Potential effect modifiers of the association between physical activity patterns and joint symptoms in middle aged women


Objective To examine whether body mass index (BMI), menopausal status and hormone therapy (HT) use modify the association between physical activity (PA) patterns throughout middle age and incidence and prevalence of joint symptoms in later middle age in women. Methods Data were from 6661 participants (born 1946-1951) in the Australian Longitudinal Study on Women's Health. Surveys were completed every three years from 1998 to 2010 with questions on joint pain and stiffness, PA, height and weight, menopausal symptoms, and HT use. PA patterns were defined as ‘none-or-low’, ‘low-or-meeting-guidelines’, ‘fluctuating’ or ‘meeting guidelines-at-all-times’ (reference pattern). Logistic regression was used to examine the association between PA patterns and prevalent (in 2010) and cumulative incident (1998-2010) joint symptoms and effect modification by patterns of BMI, menopausal status and HT. Results The groups representing ‘fluctuating’ (odds ratio [OR]=1.34, 99% confidence interval [CI]=1.04-1.72) and ‘none-or-low’ physical activity (OR=1.60, CI =1.08-2.35) had higher odds of incident joint symptoms than those ‘meeting guidelines-at-all-times’. Stratification by BMI showed that this association was statistically significant in the obese group only. No evidence was found for effect modification by menopausal status or HT use. The findings were similar for prevalent joint symptoms. Conclusions Maintaining at least low levels of physical activity throughout middle age was associated with lower prevalence and incidence of joint symptoms in later life. This apparent protective effect of physical activity on joint symptoms was stronger in obese women than in under or normal weight women, and not related to menopause and HT status. This article is protected by copyright. All rights reserved.

High Health Care Utilization Preceding Diagnosis of Systemic Lupus Erythematosus in Youth


Objective Childhood-onset systemic lupus erythematosus (SLE) is associated with high risk for organ damage, which may be mitigated by early diagnosis and treatment. We characterized health care utilization for youth in the year preceding SLE diagnosis compared to controls. Methods Using Clinformatics™ DataMart (OptumInsight, Eden Prairie, MN) de-identified administrative data from 2000 to 2013, we identified 682 youth ages 10-24 years with new-onset SLE (≥3 International Classification of Diseases, Ninth Revision (ICD-9) codes for SLE 710.0, each >30 days apart), and 1,364 age and sex-matched healthy controls. We compared the incidence of ambulatory, emergency, and inpatient visits 12 months before SLE diagnosis, and frequency of primary diagnoses. We examined subject characteristics associated with utilization preceding SLE diagnosis. Results Youth with SLE had significantly more visits in the year preceding diagnosis than controls across ambulatory (incidence rate ratio (IRR) 2.48, p<0.001), emergency (IRR 3.42, p<0.001) and inpatient settings (IRR 3.02, p<0.001). The most frequent acute care diagnoses and median days to SLE diagnosis were: venous thromboembolism (313, interquartile range (IQR) 18-356), thrombocytopenia (278, IQR 39-354), chest pain (73, IQR 29.5-168), fever (52, IQR 17-166), and acute kidney failure (14, IQR 5-168). Having a psychiatric diagnosis prior to SLE diagnosis was strongly associated with increased utilization across all settings. Conclusion Youth with SLE have high health care utilization throughout the year preceding SLE diagnosis. Examining variable diagnostic trajectories of youth presenting for acute care preceding SLE diagnosis, and increased attention to psychiatric morbidity may help improve care for youth with new-onset SLE. This article is protected by copyright. All rights reserved.

The foot as a barrier in patients with early rheumatoid arthritis – an interview study among Swedish women and men


Objective Foot impairments are related to reduced mobility and participation restrictions in daily activities in patients with established rheumatoid arthritis (RA). The new biological medications are effective and reduce disease activity, but not disability to the same extent. Foot impairments are assumed to be related to participation restrictions also in patients with early RA, diagnosed after the introduction of biological medications. The knowledge of foot impairments needs to be more explored after the introduction of biological disease-modifying drugs (bDMARDs). The aim of this study was to explore the patients’ perspective of foot impairments related to early RA. Methods The sample included 59 patients (20-63 years) who were interviewed about participation dilemmas in daily life using the Critical Incident Technique. The interviews were audio-recorded and transcribed. Data related to foot impairments were extracted and analyzed thematically. A research partner validated the analysis. The study was approved by the Regional Ethics Committee. Results Patients with early RA described a variety of participation restrictions related to foot impairments: 1) foot hindrances in domestic life, 2) foot impairments influencing work, 3) leisure activities restricted by one's feet 4) struggling to be mobile 5) foot impairments as an early sign of rheumatic disease. Conclusion There is a need to focus on foot impairments related to early RA, and for health care professionals to understand these signs. A suggestion for future research is to conduct a longitudinal follow-up of foot impairment related to medication, disease activity and disability in patients diagnosed after the introduction of bDMARDs. This article is protected by copyright. All rights reserved.

Affect and Incident Participation Restriction in Adults With Knee Osteoarthritis


Objective Participation restriction, common among people with knee osteoarthritis (OA), may be influenced by affect. We examined the risk of incident participation restriction over 84 months conferred by positive and negative affect among people with knee OA. Methods Participants were from the Multicenter Osteoarthritis Study and had or were at high risk of knee OA. Participation restriction was measured using the Instrumental Role Limitation subscale of the Late-Life Disability Index, and affect was measured using the positive affect and depressed mood subscales of the Center for Epidemiologic Studies Depression Scale. Robust Poisson regression was used to calculate the risk of incident participation restriction over 84 months conferred by combinations of low and high positive and negative affect, adjusting for covariates. Results Of 1,810 baseline participants (mean age 62.1 years, 56% female), 470 (26%) had incident participation restriction over 84 months. Participants with low positive affect had 20% greater risk of incident participation restriction than those with high positive affect; participants with high negative affect had 50% greater risk of incident participation restriction compared to those with low negative affect. Participants with both low positive and high negative affect had 80% greater risk of incident participation restriction compared to other combinations of positive and negative affect. Conclusion Low positive and high negative affect, both alone and in combination, increase the risk of participation restriction among adults with knee OA. Efforts aimed at preventing participation restriction in this population should consider these mood states.

Trends in Hospitalizations for Serious Infections in Patients With Rheumatoid Arthritis in the US Between 1993 and 2013


Objective The epidemiology of hospitalizations with infections among patients with rheumatoid arthritis (RA) is unknown, despite an increase in RA treatments that confer a risk of infection. Methods We examined National Inpatient Sample data from 1993–2013. We identified hospitalizations among adults with RA, defined by International Classification of Diseases, Ninth Revision, Clinical Modification codes (714.xx) in any secondary diagnosis field. We evaluated 5 infections as the primary diagnosis: pneumonia, sepsis, urinary tract infection (UTI), skin and soft tissue infections (SSTIs), and opportunistic infections (OIs). The primary outcome was the proportion of hospitalizations for each infection among all hospitalizations with a secondary diagnosis of RA. Results There were 792,921 hospitalizations for infection with a secondary diagnosis of RA, with the rates increasing from 90 to 206 per 100,000 persons from 1993–2013. The proportion of hospitalizations decreased for pneumonia (from 5.4% to 4.6%), UTI (from 0.4% to 0.38%), and OIs (from 0.44% to 0.26%). The proportion of hospitalizations for SSTIs increased slightly (from 2.3% to 2.5%), while hospitalizations for sepsis more than tripled (from 1.9% to 6.4%). Conclusion Between 1993 and 2013, the proportion of hospitalizations for infections among RA patients appeared to decline for pneumonia and OIs, with a slight decrease in UTI, a slight increase in SSTIs, and a substantial increase in hospitalizations with sepsis. Our results are consistent with previous reports that the sensitivity of sepsis coding has increased over time.

Social Role Participation and Satisfaction With Life: A Study Among Patients With Ankylosing Spondylitis and Population Controls


Objective Participation in society of persons with chronic diseases receives increasing attention. However, little is known about which components of participation are most relevant to life satisfaction. This study examines the association between several aspects of social role participation and satisfaction with life (SWL) in patients with ankylosing spondylitis (AS) compared to population controls. Methods In a cross-sectional study, participants completed the Social Role Participation Questionnaire (SRPQ) and SWL scale. The SRPQ assesses several dimensions of participation (importance, satisfaction with performance, and satisfaction with time and physical difficulty) in 11 roles representing 3 domains (interpersonal relations, leisure, and work). For individuals with AS and controls, the association between role domains and SWL was examined using linear regression for each participation dimension separately, in the total and the employed population, adjusting for age, sex, education, and income. Results A total of 246 AS patients (mean ± SD age 51 ± 12 years, 62% males, mean ± SD disease duration 17 ± 12 years) and 510 controls (mean ± SD age 42 ± 15 years, 70% males) were included. AS patients were more frequently (extremely) dissatisfied with life (17.9% versus 8.6%; P < 0.05). In the total and the employed population, less physical difficulty and higher satisfaction with interpersonal relations and leisure were associated with higher SWL, and this was somewhat stronger in patients than in controls (P < 0.1). In employed controls, but not in employed patients, satisfaction with work was independently associated with SWL. Conclusion These findings highlight the importance of supporting persons with AS in ameliorating social role participation, particularly in areas like close relationships and leisure activities, which are typically ignored when treating AS.

Valuing Treatment With Infliximab for Ankylosing Spondylitis Using a Willingness-to-Pay Approach


Objective To investigate willingness to pay (WTP) for treatment with infliximab by patients with ankylosing spondylitis (AS) and explore factors associated with WTP. Methods Data from 85 patients participating in the European AS Infliximab Cohort (EASIC) open-label extension of the AS Study for the Evaluation of Recombinant Infliximab Therapy (ASSERT) were used. WTP was included at baseline in EASIC and comprised a hypothetical scenario exploring whether the patient would be willing to pay for beneficial effects of infliximab and, if so, what amount they would be willing to pay per administration. Factors associated with WTP were explored using zero-inflated negative binomial (ZINB) regressions. Results Of the 85 patients, 63 (74.1%) were willing to pay, and among these, the mean amount they were willing to pay per administration was €275 (median €100 [interquartile range €50–200]). Multivariable ZINB analysis showed that Assessment of SpondyloArthritis international Society criteria for 20% improvement (ASAS20) response was associated with a 7-fold lower likelihood to pay 0 euros (odds ratio [OR] 0.14 [95% confidence interval (95% CI) 0.03–0.71]) and a 3-fold increase in the amount willing to pay (exp(β) = 3.32 [95% CI 1.44–7.69]). In addition, the country of residence was associated with a lower likelihood to pay 0 euros (OR 0.07 [95% CI 0.02–0.36]), while increased age was associated with the amount willing to pay (exp(β) = 1.05 [95% CI 1.01–1.09]). Conclusion In a hypothetical scenario, three-quarters of patients with AS receiving long-term infliximab stated that they were willing to pay an out-of-pocket contribution for this treatment. Treatment response contributed to the willingness as well as to the amount patients were willing to pay.

Improving Adherence to Exercise: Do People With Knee Osteoarthritis and Physical Therapists Agree on the Behavioral Approaches Likely to Succeed?


Objective To describe which behavior change techniques (BCTs) to promote adherence to exercise have been experienced by people with knee osteoarthritis (OA) or used by physical therapists, and to describe patient- and physical therapist–perceived effectiveness of a range of BCTs derived from behavioral theory. Methods Two versions of a custom-designed survey were administered in Australia and New Zealand, one completed by adults with symptomatic knee OA and the second by physical therapists who had treated people with knee OA in the past 6 months. Survey questions ascertained the frequency of receiving/prescribing exercise for knee OA, BCTs received/used targeting adherence to exercise, and perceived effectiveness of 36 BCTs to improve adherence to prescribed exercise. Results A total of 230 people with knee OA and 143 physical therapists completed the survey. Education about the benefits of exercise was the most commonly received/used technique by both groups. People with knee OA rated the perceived effectiveness of all BCTs significantly lower than the physical therapists (mean difference 1.9 [95% confidence interval 1.8–2.0]). When ranked by group mean agreement score, 2 BCTs were among the top 5 for both groups: development of specific goals related to knee pain and function; and review, supervision, and correction of exercise technique at subsequent treatment sessions. Conclusion Goal-setting techniques related to outcomes were considered to be effective by both respondent groups, and testing of interventions incorporating these strategies should be a research priority.

Examination of Hydroxychloroquine Use and Hemolytic Anemia in G6PDH-Deficient Patients


Objective Some sources urge caution when prescribing hydroxychloroquine (HCQ) to patients with G6PDH deficiency, presumably due to a risk of hemolytic anemia. There are limited published data, however, to support this risk. Additionally, not all patients with G6PDH deficiency are at similar risk for hemolysis, and people with the African variant are at particularly low risk. Through a retrospective chart review, we aimed to quantify the frequency of G6PDH-deficient patients with hemolysis attributed to HCQ. Methods We identified Duke University Medical Center rheumatology patients with HCQ use and a measured G6PDH level. A retrospective chart review was performed, recording demographics, G6PDH levels, episodes of anemia, laboratory values consistent with hemolysis, and HCQ use. Results Of the 275 patients reviewed, 84% were female; 46% were African American and 48% were white. The leading diagnoses were systemic lupus erythematosus (32%), rheumatoid arthritis (29%), and inflammatory arthritis (14%). Only 4% of patients were G6PDH deficient (all African American). Two G6PDH-deficient patients had hemolysis during severe lupus flares that occurred while not taking HCQ. There were no reported episodes of hemolysis in more than 700 months of HCQ exposure among the 11 G6PDH-deficient patients. Conclusion This is the largest study to date evaluating G6PDH deficiency with concurrent use of HCQ. Of 11 patients with G6PDH deficiency, 2 had episodes of hemolysis, but these did not occur during HCQ therapy. These data do not support routine measurement of G6PDH levels or withholding HCQ therapy among African American patients with G6PDH deficiency.

Effect of Fatigue, Older Age, Higher Body Mass Index, and Female Sex on Disability in Early Rheumatoid Arthritis in the Treatment-to-Target Era


Objective To compare disease activity and disability over 2 years in early rheumatoid arthritis (RA) before and after implementation of treat-to-target therapy and identify predictors of adverse outcome. Methods The Yorkshire Early Arthritis Register (YEAR) recruited 725 patients with early RA between 2002 and 2009, treated with a step-up approach. The Inflammatory Arthritis Continuum study (IACON) recruited cases between 2010 and 2014 and treated to target. A total of 384 IACON cases met 2010 American College of Rheumatology/European League Against Rheumatism criteria. Latent growth curves of change in Disease Activity Score in 28 joints (DAS28) and the Health Assessment Questionnaire (HAQ) were compared between YEAR and IACON. Latent class growth analysis identified trajectories of change. Baseline predictors of trajectories were identified using logistic regression. Results The mean DAS28 over 2 years was lower in IACON than in YEAR. Latent trajectories of HAQ change in YEAR were high stable (21% of cohort), moderate reducing (35%), and low reducing (44%). Only moderate reducing (66%) and low reducing (34%) were seen in IACON. In both cohorts, female sex and fatigue predicted adverse HAQ trajectories (high stable and moderate reducing). Odds ratios (ORs) for moderate reducing compared to low reducing for women were 2.58 (95% confidence interval [95% CI] 1.69, 4.49) in YEAR and 5.81 (95% CI 2.44, 14.29) in IACON. ORs per centimeter fatigue visual analog score were 1.13 (95% CI 1.07, 1.20) in YEAR and 1.16 (95% CI 1.12, 1.20) in IACON. Conclusion Treat-to-target therapy gave more favorable trajectories of change in DAS28 and HAQ, but adverse HAQ trajectory was more likely in women with greater fatigue, suggesting such patients would benefit from interventions to improve function as well as reduce inflammation.

Efficacy of Mycophenolate Mofetil and Oral Cyclophosphamide on Skin Thickness: Post Hoc Analyses From Two Randomized Placebo-Controlled Trials


Objective To assess the efficacy of mycophenolate mofetil (MMF) and cyclophosphamide (CYC) on modified Rodnan skin score (MRSS) in participants enrolled in the Scleroderma Lung Study (SLS) I and II. Methods SLS I participants received daily oral CYC or matching placebo for 1 year, whereas SLS II participants received daily MMF for 2 years or daily oral CYC for 1 year followed by placebo for second year. We assessed the impact of MMF and CYC on the MRSS in SLS II over a 24-month period. We also compared the change in MRSS in patients with diffuse cutaneous systemic sclerosis (dcSSc) assigned to CYC and MMF in SLS II and SLS I versus placebo in SLS I over a 24-month period using a linear mixed model. Results In SLS II, the baseline mean ± SD MRSS was 14.0 ± 10.6 units for CYC and 15.3 ± 10.4 units for MMF; 58.5% were classified as dcSSc. CYC and MMF were associated with statistically significant improvements in MRSS from baseline over the period of 24 months in dcSSc (P < 0.05 at each time point), but there were no differences between the 2 groups. In the dcSSc subgroup, the change in MRSS from baseline to all 6-month visits was similar in SLS II groups (MMF, CYC, pooled cohort [MMF + CYC]) and in the SLS I CYC group and showed statistically significant improvements compared to SLS I placebo at 12, 18, and 24 months (P < 0.05). Conclusion In SLS II, MMF and CYC treatment resulted in improvements in MRSS in patients with dcSSc over 24 months. In addition, MMF and CYC treatment resulted in statistically significant improvements in MRSS in patients with dcSSc when compared with the SLS I placebo group.

Delays to Care in Pediatric Lupus Patients: Data From the Childhood Arthritis and Rheumatology Research Alliance Legacy Registry


Objective Prompt treatment for lupus is important to prevent morbidity. A potential barrier to early treatment of pediatric lupus is delayed presentation to a pediatric rheumatologist. To better understand factors contributing to delayed presentation among pediatric lupus patients, we examined differences in demographic and clinical characteristics of lupus patients within the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Legacy Registry with regard to time between symptom onset and presentation to a pediatric rheumatologist. Methods We analyzed data from 598 CARRA Legacy Registry participants for differences between those who presented early (within <1 month of symptom onset), between 1–3 months (typical presentation), with moderate delays (3–12 months), and with severe delays (≥1 year). Factors associated with early presentation, moderate delay, and severe delay were determined by multinomial logistic regression. Results Forty-four percent of patients presented early, while 23% had moderate delays and 9% had severe delays. Family history of lupus, absence of discoid rash, and location in a state with a higher density of pediatric rheumatologists were associated with earlier presentation. Younger age, low household income (<$25,000 per year), and a family history of lupus were associated with severe delay. Conclusion Delays to care ≥1 year exist in a notable minority of pediatric lupus patients from the CARRA Legacy Registry. In this large and diverse sample of patients, access to care and family resources played an important role in predicting time to presentation to a pediatric rheumatologist.

Relationship Between Fish Consumption and Disease Activity in Rheumatoid Arthritis


Objective To assess whether more frequent fish consumption is associated with lower rheumatoid arthritis (RA) disease activity scores among participants in an RA cohort. Methods We conducted a cross-sectional analysis using baseline data from participants in the Evaluation of Subclinical Cardiovascular Disease and Predictors of Events in Rheumatoid Arthritis cohort study. Frequency of fish consumption was assessed by a baseline food frequency questionnaire assessing usual diet in the past year. Multivariable, total energy–adjusted linear regression models provided effect estimates and 95% confidence intervals (95% CIs) for frequency of fish consumption (i.e., never to <1 time/month, 1 time/month to <1 time/week, 1 time/week, and ≥2 times/week) on baseline Disease Activity Score in 28 joints (DAS28) using the C-reactive protein (CRP) level. We also estimated the difference in DAS28-CRP associated with increasing fish consumption by 1 serving per week. Results Among 176 participants, the median DAS28-CRP score was 3.5 (interquartile range 2.9–4.3). In an adjusted linear regression model, subjects consuming fish ≥2 times/week had a significantly lower DAS28-CRP compared with subjects who ate fish never to <1 time/month (difference −0.49 [95% CI −0.97, −0.02]). For each additional serving of fish per week, DAS28-CRP was significantly reduced by 0.18 (95% CI −0.35, −0.004). Conclusion Our findings suggest that higher intake of fish may be associated with lower disease activity in RA patients.

Cluster-Randomized Trial of a Behavioral Intervention to Incorporate a Treat-to-Target Approach to Care of US Patients With Rheumatoid Arthritis


Objective To assess the feasibility and efficacy of implementing a treat-to-target approach versus usual care in a US-based cohort of rheumatoid arthritis patients. Methods In this behavioral intervention trial, rheumatology practices were cluster-randomized to provide treat-to-target care or usual care. Eligible patients with moderate/high disease activity (Clinical Disease Activity Index [CDAI] score >10) were followed for 12 months. Both treat-to-target and usual care patients were seen every 3 months. Treat-to-target providers were to have monthly visits with treatment acceleration at a minimum of every 3 months in patients with CDAI score >10; additional visits and treatment acceleration were at the discretion of usual care providers and patients. Coprimary end points were feasibility, assessed by rate of treatment acceleration conditional on CDAI score >10, and achievement of low disease activity (LDA; CDAI score ≤10) by an intent-to-treat analysis. Results A total of 14 practice sites per study arm were included (246 patients receiving treat-to-target and 286 receiving usual care). The groups had similar baseline demographic and clinical characteristics. Rates of treatment acceleration (treat-to-target 47% versus usual care 50%; odds ratio [OR] 0.92 [95% confidence interval (95% CI) 0.64, 1.34]) and achievement of LDA (treat-to-target 57% versus usual care 55%; OR 1.05 [95% CI 0.60, 1.84]) were similar between groups. Treat-to-target providers reported patient reluctance and medication lag time as common barriers to treatment acceleration. Conclusion This study is the first to examine the feasibility and efficacy of a treat-to-target approach in typical US rheumatology practice. Treat-to-target care was not associated with increased likelihood of treatment acceleration or achievement of LDA, and barriers to treatment acceleration were identified.

Effects of a Web-Based Patient Decision Aid on Biologic and Small-Molecule Agents for Rheumatoid Arthritis: Results From a Proof-of-Concept Study


Objective To assess the extent to which ANSWER-2, an interactive online patient decision aid, reduces patients’ decisional conflict and improves their medication-related knowledge and self-management capacity. Methods We used a pre–post study design. Eligible participants had a diagnosis of rheumatoid arthritis (RA), had been recommended to start using a biologic agent or small-molecule agent or to switch to a new one, and had internet access. Access to ANSWER-2 was provided immediately after enrollment. Outcome measures included 1) the Decisional Conflict Scale (DCS), 2) the Medication Education Impact Questionnaire (MeiQ), and 3) the Partners in Health Scale (PIHS). A paired t-test was used to assess differences pre- and postintervention. Results The majority of the 50 participants were women (n = 40), and the mean ± SD age of participants was 49.6 ± 12.2 years. The median disease duration was 5 years (25th, 75th percentile: 2, 10 years). The mean ± SD DCS score was 45.9 ± 25.1 preintervention and 25.1 ± 21.8 postintervention (mean change of −21.2 of 100 [95% confidence interval (95% CI) −28.1, −14.4], P < 0.001). Before using ANSWER-2, 20% of participants had a DCS score of <25, compared to 52% of participants after the intervention. Similar results were observed in the PIHS (mean ± SD 25.3 ± 14.8 preintervention and 20.4 ± 13.0 postintervention; mean change of −3.7 of 88 [95% CI −6.3, −1.0], P = 0.009). Findings from the MeiQ were mixed, with statistically significant differences found only in the self-management subscales. Conclusion Patients’ decisional conflict decreased and perceived self-management capacity improved after using ANSWER-2. Future research comparing the effectiveness of ANSWER-2 with that of educational material on biologic agents will provide further insight into its value in RA management.

Barriers and Facilitators of Mentoring for Trainees and Early Career Investigators in Rheumatology Research: Current State, Identification of Needs, and Road Map to an Inter-Institutional Adult Rheumatology Mentoring Program


Objective To determine perceived barriers and facilitators to effective mentoring for early career rheumatology investigators and to develop a framework for an inter-institutional mentoring program. Methods Focus groups or interviews with rheumatology fellows, junior faculty, and mentors were conducted, audiorecorded, and transcribed. Content analysis was performed using NVivo software. Themes were grouped into categories (e.g., mentor-mentee relationship, barriers, and facilitators of a productive relationship). Rheumatology fellows and early career investigators were also surveyed nationwide to identify specific needs to be addressed through an inter-institutional mentoring program. Results Twenty-five individuals participated in focus groups or interviews. Attributes of the ideal mentee-mentor relationship included communication, accessibility, regular meetings, shared interests, aligned goals, and mutual respect. The mentee should be proactive, efficient, engaged, committed, focused, accountable, and respectful of the mentor's time. The mentor should support/promote the mentee, shape the mentee's goals and career plan, address day-to-day questions, provide critical feedback, be available, and have team leadership skills. Barriers included difficulty with career path navigation, gaining independence, internal competition, authorship, time demands, funding, and work-life balance. Facilitators of a successful relationship included having a diverse network of mentors filling different roles, mentor-mentee relationship management, and confidence. Among 187 survey respondents, the primary uses of an inter-institutional mentoring program were career development planning and oversight, goal-setting, and networking. Conclusions In this mixed-methods study, tangible factors for optimizing the mentor-mentee relationship were identified and will inform the development of an adult rheumatology inter-institutional mentoring program.

Skeletal Muscle Fat and Its Association With Physical Function in Rheumatoid Arthritis


Objective To characterize skeletal muscle fat (SMF), intermuscular adipose tissue (IMAT), and subcutaneous adipose tissue (SAT) in individuals with rheumatoid arthritis (RA), and assess the associations between these fat depots and physical function and physical activity. Methods In a cross-sectional analysis from an RA cohort, SMF, IMAT, and SAT were measured using computed tomography imaging of the midthigh cross-sectional region. Physical function was measured using the Health Assessment Questionnaire (HAQ) and a battery of performance-based tests that included quadriceps muscle strength, gait speed, repeated chair-stands, stair ascent, and single-leg stance. Physical activity was assessed using an activity monitor. Associations between SMF, IMAT, and SAT and physical function and activity were assessed by multiple linear regression models adjusted for potential confounders such as age, sex, body mass index (BMI), muscle area, and muscle strength. Results Sixty subjects with RA (82% female, mean ± SD age 59 ± 10 years, mean ± SD BMI 31.79 ± 7.16 kg/m2) were included. In the adjusted models, lower SMF was associated with greater gait speed, single-leg stance, quadriceps strength, and physical activity, and less disability (R2Δ range 0.06–0.25; P < 0.05), whereas IMAT was not associated with physical function or physical activity and SAT was negatively associated with disability (HAQ) (R2Δ = 0.13; P < 0.05) and weakly but positively associated with muscle strength (R2Δ = 0.023; P < 0.05). Conclusion Fat infiltration within the muscle seems to independently contribute to low physical function and physical activity, contrary to IMAT or SAT accumulation. Longitudinal studies are necessary to confirm the impact of SMF on disability and health promotion in persons with RA.

Performance of Antinuclear Antibodies for Classifying Systemic Lupus Erythematosus: A Systematic Literature Review and Meta-Regression of Diagnostic Data


Objective To review the published literature on the performance of indirect immunofluorescence (IIF)–HEp-2 antinuclear antibody (ANA) testing for classification of systemic lupus erythematosus (SLE). Methods A systematic literature search was conducted in the Medline, Embase, and Cochrane databases for articles published between January 1990 and October 2015. The research question was structured according to Population, Intervention, Comparator, Outcome (PICO) format rules, and Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) recommendations were followed where appropriate. Meta-regression analysis for diagnostic tests was performed, using the ANA titer as independent variable, while sensitivity and specificity were dependent variables. Results Of 4,483 publications screened, 62 matched the eligibility criteria, and another 2 articles were identified through reference analysis. The included studies comprised 13,080 SLE patients in total, of whom 12,542 (95.9%) were reported to be IIF-ANA positive at various titers. For ANA at titers of 1:40, 1:80, 1:160, and 1:320, meta-regression gave sensitivity values of 98.4% (95% confidence interval [95% CI] 97.6–99.0%), 97.8% (95% CI 96.8–98.5%), 95.8% (95% CI 94.1–97.1%), and 86.0% (95% CI 77.0–91.9%), respectively. The corresponding specificities were 66.9% (95% CI 57.8–74.9%), 74.7% (95% CI 66.7–81.3%), 86.2% (95% CI 80.4–90.5%), and 96.6% (95% CI 93.9–98.1%), respectively. Conclusion The results of this systematic literature review and meta-regression confirm that IIF-ANAs have high sensitivity for SLE. ANAs at a titer of 1:80 have sufficiently high sensitivity to be considered as an entry criterion for SLE classification criteria, i.e., formally test other classification criteria for SLE only if ANAs of at least 1:80 have been found.

Cost-Effectiveness of Tight Control of Inflammation in Early Psoriatic Arthritis: Economic Analysis of a Multicenter Randomized Controlled Trial


Objective Treat-to-target approaches have proved to be effective in rheumatoid arthritis, but have not been studied in psoriatic arthritis (PsA). This study was undertaken to examine the cost-effectiveness of tight control (TC) of inflammation in early PsA compared to standard care. Methods Cost-effectiveness analyses were undertaken alongside a UK-based, open-label, multicenter, randomized controlled trial. Taking the perspective of the health care sector, effectiveness was measured using the 3-level EuroQol 5-domain, which allows for the calculation of quality-adjusted life-years (QALYs). Incremental cost-effectiveness ratios (ICERs) are presented, which represent the additional cost per QALY gained over a 48-week time horizon. Sensitivity analyses are presented assessing the impact of variations in the analytical approach and assumptions on the cost-effectiveness estimates. Results The mean cost and QALYs were higher in the TC group: £4,198 versus £2,000 and 0.602 versus 0.561. These values yielded an ICER of £53,948 per QALY. Bootstrapped uncertainty analysis suggests that the TC has a 0.07 probability of being cost-effective at a £20,000 threshold. Stratified analysis suggests that with certain costs being controlled, an ICER of £24,639 can be calculated for patients with a higher degree of disease severity. Conclusion A tight control strategy to treat PsA is an effective intervention in the treatment pathway; however, this study does not find tight control to be cost-effective in most analyses. Lower drug prices, targeting polyarthritis patients, or reducing the frequency of rheumatology visits may improve value for money metrics in future studies.

Effect of Biologic Therapy on Clinical and Laboratory Features of Macrophage Activation Syndrome Associated With Systemic Juvenile Idiopathic Arthritis


Objective To assess performance of the 2016 macrophage activation syndrome (MAS) classification criteria for patients with systemic juvenile idiopathic arthritis (JIA) who develop MAS while treated with biologic medications. Methods A systematic literature review was performed to identify patients with MAS while being treated with interleukin (IL)-1 and IL-6 blocking agents. Clinical and laboratory information was compared to a large previously compiled historical cohort. Results Eighteen publications were identified, and after removing duplicates, 35 patients treated with canakinumab and 49 patients with tocilizumab were available for analysis; 5 anakinra-treated patients were excluded due to limited numbers. MAS classification criteria were less likely to classify tocilizumab-treated patients as having MAS compared to the historical cohort or canakinumab-treated patients (56.7%, 78.5%, and 84%, respectively; P < 0.01). Patients who developed MAS while treated with canakinumab trended towards lower ferritin at MAS onset than the historical cohort (4,050 versus 5,353 ng/ml; P = 0.18) but had no differences in other cardinal clinical or laboratory features. In comparison, patients who developed MAS while treated with tocilizumab were less likely febrile and had notably lower ferritin levels (1,152 versus 5,353 ng/ml; P < 0.001). Other features of MAS were more pronounced in patients treated with tocilizumab, including lower platelet counts, lower fibrinogen, and higher aspartate aminotransferase levels. Mortality rates for patients with MAS treated with tocilizumab or canakinumab were not significantly different from the historical cohort. Conclusion These findings show substantial alterations in MAS features that may limit utility of defined criteria for diagnosis of systemic JIA patients treated with biologic agents.

Suppressing Inflammation in Rheumatoid Arthritis: Does Patient Global Assessment Blur the Target? A Practice-Based Call for a Paradigm Change


Objective In current management paradigms of rheumatoid arthritis (RA), patient global assessment (PGA) is crucial to decide whether a patient has attained remission (target) or needs reinforced therapy. We investigated whether the clinical and psychological determinants of PGA are appropriate to support this important role. Methods This was a cross-sectional, single-center study including consecutive ambulatory RA patients. Data collection comprised swollen 28-joint count (SJC28), tender 28-joint count (TJC28), C-reactive protein (CRP) level, PGA, pain, fatigue, function, anxiety, depression, happiness, personality traits, and comorbidities. Remission was categorized using American College of Rheumatology/European League Against Rheumatism Boolean-based criteria: remission, near-remission (only PGA >1), and nonremission. A binary definition without PGA (3v-remission) was also studied. Univariable and multivariable analyses were used to identify explanatory variables of PGA in each remission state. Results A total of 309 patients were included (remission 9.4%, near-remission 37.2%, and nonremission 53.4%). Patients in near-remission were indistinguishable from remission regarding disease activity, but described a disease impact similar to those in nonremission. In multivariable analyses, PGA in near-remission was explained (R2adjusted = 0.50) by fatigue, pain, anxiety, and function. Fatigue and pain had no relationship with disease activity measures. Conclusion In RA, a consensually acceptable level of disease activity (SJC28, TJC28, and CRP level ≤1) does not equate to low disease impact: a large proportion of these patients are considered in nonremission solely due to PGA. PGA mainly reflects fatigue, pain, function, and psychological domains, which are inadequate to define the target for immunosuppressive therapy. This consideration suggests that clinical practice should be guided by 2 separate remission targets: inflam[...]

Association Between Metabolic Syndrome and Radiographic Hand Osteoarthritis: Data From a Community-Based Longitudinal Cohort Study


Objective To explore whether metabolic syndrome and its components are associated with hand osteoarthritis (OA) using longitudinal data from the Framingham Study. Methods Our cross-sectional analyses included 1,089 persons (ages 50–75 years), of whom 785 had longitudinal radiographs obtained 7 years apart. Of these, 586 with no hand OA at baseline were included in analyses of hand OA incidence. We explored associations between metabolic syndrome and its components (central obesity, hypertension, diabetes mellitus, triglyceridemia, and low high-density lipoprotein) and radiographic hand OA (defined as ≥2 interphalangeal joints with a Kellgren/Lawrence [K/L] grade of ≥2) using logistic regression analyses with adjustment for age, sex, and body mass index. In longitudinal analyses, metabolic syndrome was used as a predictor for change in K/L sum score and incident hand OA. Results Metabolic syndrome was not associated with the presence of hand OA (odds ratio [OR] 1.11 [95% confidence interval (95% CI) 0.78–1.59]), change in K/L sum score (OR 0.83 [95% CI 0.59–1.17]), or incidence of hand OA (OR 0.91 [95% CI 0.58–1.44]). Hypertension was borderline significantly associated with the presence of hand OA (OR 1.25 [95% CI 0.90–1.74]), and a significant association was found between hypertension and change in K/L sum score (OR 1.47 [95% CI 1.08–1.99]). Consistent dose-response relationships were not demonstrated (data not shown). Furthermore, hypertension was not significantly associated with hand OA incidence (OR 1.23 [95% CI 0.82–1.83]). No significant associations were found between metabolic syndrome and erosive hand OA. Conclusion We found no association between metabolic syndrome and hand OA. The role of hypertension in hand OA pathogenesis warrants further investigation.

Tele-Health Followup Strategy for Tight Control of Disease Activity in Rheumatoid Arthritis: Results of a Randomized Controlled Trial


Objective To test the effect of patient-reported outcome (PRO)–based tele-health followup for tight control of disease activity in patients with rheumatoid arthritis (RA), and the differences between tele-health followup performed by rheumatologists or rheumatology nurses. Methods A total of 294 patients were randomized (1:1:1) to either PRO-based tele-health followup carried out by a nurse (PRO-TN) or a rheumatologist (PRO-TR), or conventional outpatient followup by physicians. The primary outcome was a change in the Disease Activity Score in 28 joints (DAS28) after week 52. Secondary outcomes were physical function, quality of life, and self-efficacy. The noninferiority margin was a DAS28 score change of 0.6. Mean differences were estimated following per protocol, intent-to-treat (ITT), and multivariate imputation analysis. Results Overall, patients had low disease activity at baseline and end followup. Demographics and baseline characteristics were similar between groups. Noninferiority was established for the DAS28. In the ITT analysis, mean differences in the DAS28 score between PRO-TR versus control were −0.10 (90% confidence interval [90% CI] −0.30, 0.13) and −0.19 (90% CI −0.41, 0.02) between PRO-TN versus control. When including 1 yearly visit to the outpatient clinic, patients in PRO-TN had mean ± SD 1.72 ± 1.03 visits/year, PRO-TR had 1.75 ± 1.03 visits/year, and controls had 4.15 ± 1.0 visits/year. This included extra visits due to inflammatory flare. Conclusion Among RA patients with low disease activity or remission, a PRO-based tele-health followup for tight control of disease activity in RA can achieve similar disease control as conventional outpatient followup. The degree of disease control did not differ between patients seen by rheumatologists or rheumatology nurses.

Physical Therapists’ Perceptions of Telephone- and Internet Video–Mediated Service Models for Exercise Management of People With Osteoarthritis


Objective To investigate physical therapists’ perceptions of, and willingness to use, telephone- and internet-mediated service models for exercise therapy for people with knee and/or hip osteoarthritis. Methods This study used an internet-based survey of Australian physical therapists, comprising 3 sections: 1 on demographic information and 2 with 16 positively framed perception statements about delivering exercise via telephone and video over the internet, for people with hip and/or knee osteoarthritis. Levels of agreement with each statement were evaluated. Logistic regression models were used to determine therapist characteristics influencing interest in delivering telerehabilitation. Results A total of 217 therapists spanning metropolitan, regional, rural, and remote Australia completed the survey. For telephone-delivered care, there was consensus agreement that it would not violate patient privacy (81% agreed/strongly agreed) and would save patient's time (76%), but there was less than majority agreement for 10 statements. There was consensus agreement that video-delivered care would save a patient's time (82%), be convenient for patients (80%), and not violate patient privacy (75%). Most agreed with all other perception statements about video-delivered care, except for liking no physical contact (14%). Low confidence using internet video technologies, and inexperience with telerehabilitation, were significantly associated with reduced interest in delivering telephone and/or video-based services. Conclusion Physical therapists agree that telerehabilitation offers time-saving and privacy advantages for people with osteoarthritis and perceive video-delivered care more favorably than telephone-delivered services. However, most do not like the lack of physical contact with either service model. These findings may inform the implementation of[...]

Issue Information


Adipose Tissue Macrophages in Rheumatoid Arthritis: Prevalence, Disease-Related Indicators, and Associations With Cardiometabolic Risk Factors


Objective Adipose tissue macrophages (ATMs) are a potent source of inflammatory cytokines, with profound effects on adipose tissue function, yet their potential role in rheumatoid arthritis (RA) pathobiology is largely unstudied. Methods Periumbilical subcutaneous adipose tissue was obtained from 36 RA patients and 22 non-RA controls frequency matched on demographics and body mass index. Samples were stained for the macrophage marker CD68, and the average proportions of ATMs, crown-like structures (periadipocyte aggregates of 3 or more ATMs), and fibrosis were compared between groups. Results The adjusted proportion of ATMs among all nucleated cells was 76% higher in RA than in non-RA samples (37.7 versus 21.3%, respectively; P < 0.001), and the adjusted average number of crown-like structures was more than 1.5-fold higher in the RA group than in controls (0.58 versus 0.23 crown-like structure/high-power field, respectively; P = 0.001). ATMs were significantly more abundant in early RA and in those with anti–cyclic citrullinated peptide seropositivity. Users of methotrexate, leflunomide, and tumor necrosis factor inhibitors had a significantly lower proportion of ATMs compared with nonusers. Crown-like structures were significantly higher in patients with rheumatoid factor seropositivity and in those with C-reactive protein levels ≥10 mg/liter, and significantly lower among those treated with statins. Linear ATMs were significantly associated with whole-body insulin resistance, but not with serum lipids. Conclusions ATMs and crown-like structures were more abundant in RA patients and were associated with systemic inflammation, autoimmunity, and whole-body insulin resistance, suggesting possible contributions to the RA disease process. Lower levels of ATMs and[...]

How Are Behavioral Theories Used in Interventions to Promote Physical Activity in Rheumatoid Arthritis? A Systematic Review


Objective To identify the use of behavioral theories in physical activity interventions in populations with rheumatoid arthritis (RA). Methods This review includes articles published in English between January 1, 1980 and November 8, 2015 in MEDLINE, Cochrane, and CINAHL, identified by a strategic literature search. Included studies were published in international peer-reviewed journals, mentioned theory, evaluated a physical activity intervention for adults with RA, and had ≥1 physical activity variable as the outcome. References and reviews were also checked. Two investigators independently selected articles and extracted data using a validated scale, the theory coding scheme. Additional extracted data included author, sample characteristics, study design, physical activity outcomes, intervention type and duration, and control group. Results A total of 245 articles were identified, 211 articles and references were screened, and 29 articles were reviewed. Of these, 18 were excluded, leaving 11 articles with 1,472 participants (75% women). Ten studies (91%) were randomized controlled trials, 8 (73%) assessed physical activity plus self-management, and 3 (27%) physical activity only. Program durations ranged from 5 weeks to 1 year. Eight studies (73%) used a single theory, 7 studies (64%) linked at least 1 intervention technique to theory, 2 studies (18%) analyzed mediating effects of theoretical constructs, and 5 studies (45%) discussed results in relation to theory. Conclusion Findings indicate that physical activity intervention studies claiming the use of behavioral theories use theory to a small extent. We suggest expanding theory use in design, evaluation, and interpretation of physical activity intervention results. Further, we [...]

Association Between Pain Sensitization and Disease Activity in Patients With Rheumatoid Arthritis: A Cross-Sectional Study


Objective Pain sensitization may contribute to pain severity in rheumatoid arthritis (RA), impacting disease activity assessment. We examined whether pain processing mechanisms were associated with disease activity among RA patients with active disease. Methods The study included 139 subjects enrolled in the Central Pain in Rheumatoid Arthritis cohort. Subjects underwent quantitative sensory testing (QST), including assessment of pressure pain thresholds (PPTs) at multiple sites, conditioned pain modulation, and temporal summation. RA disease activity was assessed using the Clinical Disease Activity Index (CDAI) and its components. We examined cross-sectional associations between QST measures and disease activity using linear regression. Results Low PPTs (high pain sensitization) at all sites were associated with high CDAI scores (P ≤ 0.03) and tender joint counts (P ≤ 0.002). Associations between PPTs and patient global assessments were also seen at most sites. High temporal summation at the forearm (also reflecting high pain sensitization) was significantly associated with high CDAI scores (P = 0.02), patient global assessment scores (P = 0.0006), evaluator global assessment scores (P = 0.01), and tender joint counts (P = 0.02). Conversely, conditioned pain modulation (a measure of descending inhibitory pain pathways) was associated only with tender joint count (P = 0.03). Conclusion High pain sensitization is associated with elevations in disease activity measures. Longitudinal studies are underway to elucidate the cause–effect relationships between pain sensitization and inflammatory disease activity in RA.

Dietary Intake of Polyunsaturated Fatty Acids and Pain in Spite of Inflammatory Control Among Methotrexate-Treated Early Rheumatoid Arthritis Patients


Objective To investigate potential associations between dietary intake of polyunsaturated fatty acids (FAs) and pain patterns in early rheumatoid arthritis (RA) patients after 3 months of methotrexate (MTX) treatment. Methods We included 591 early RA patients with MTX monotherapy from a population-based prospective case–control study, the Epidemiological Investigation of Rheumatoid Arthritis. Dietary data on polyunsaturated FAs (food frequency questionnaires) were linked with data on unacceptable pain (visual analog scale [VAS] >40 mm), noninflammatory/refractory pain (VAS >40 mm and C-reactive protein [CRP] level 40 mm and CRP level >10 mg/liter) after 3 months. Statistical analysis included logistic regression. Results After 3 months of MTX treatment, 125 patients (21.2%) had unacceptable pain, of which 92 patients had refractory pain, and 33 patients had inflammatory pain. Omega-3 FA intake was inversely associated with unacceptable pain and refractory pain (odds ratio [OR] 0.57 [95% confidence interval (95% CI) 0.35–0.95] and OR 0.47 [95% CI 0.26–0.84], respectively). The omega-6:omega-3 FA ratio, but not omega-6 FA alone, was directly associated with unacceptable pain and refractory pain (OR 1.70 [95% CI 1.03–2.82] and OR 2.33 [95% CI 1.28–4.24], respectively). Furthermore, polyunsaturated FAs were not associated with either inflammatory pain or CRP level and erythrocyte sedimentation rate at followup. Omega-3 FA supplementation was not associated with any pain patterns. Conclusion Omega-3 FA was inversely associated with, and the omega-6:omega-3 FA ratio was directly associated with, unacceptable and refractory pain, but not with inflammatory pain or systemic inflamma[...]

Development and Pilot Testing of Multimedia Patient Education Tools for Patients With Knee Osteoarthritis, Osteoporosis, and Rheumatoid Arthritis


Objective We developed and tested multimedia patient education tools (video tools) for patients with knee osteoarthritis (OA), osteoporosis (OP), and rheumatoid arthritis (RA). Methods We followed an “edutainment” model, incorporating educational patient story lines. The goals were designed to make the programs both didactic and entertaining, with navigation and graphic user interfaces as simple as possible. We created both English and Spanish language versions. Once the video tool was finalized, 60 patients, 20 per disease, were shown the tool and interviewed. Disease knowledge was our primary outcome, and decision conflict, disease management, and acceptability were secondary outcomes. Results We observed statistically significant differences in pre- to postintervention knowledge questionnaire scores (before and after viewing the video tool) (OA: P = 0.03, OP: P = 0.01, and RA: P < 0.0001). Most participants felt they gained “clarity” on disease duration, symptoms, and the time medication takes to start acting; were “encouraged to see their doctor regularly”; and were more aware about taking their medications. In terms of acceptability, most patients in all disease groups found the length and amount of information presented in the video tools to be “just right,” and the presentation to be “balanced.” In terms of comprehension, all participants provided a favorable evaluation of the video tool; all found the video easy to use, the vocabulary easy to understand, and the materials to be well organized. Conclusion Multimedia tools that incorporate videos may help patients better understand and manage their disease. Patient involvement in t[...]

Self-Acupressure for Older Adults With Symptomatic Knee Osteoarthritis: A Randomized Controlled Trial


Objective This double-blind randomized controlled trial aimed to test the efficacy of self-administered acupressure for pain and physical function improvement for older adults with knee osteoarthritis (OA). Methods Participants were community-dwelling adults with symptomatic knee OA (n = 150, mean age 73 years), randomized to 1 of 3 groups: verum acupressure, sham acupressure, or usual care. Participants in the verum and sham groups, but not those in the usual care group, were taught to self-apply acupressure once daily, 5 days/week for 8 weeks. Assessments were collected during center visits at baseline, and at 4 and 8 weeks. In addition, pain level was assessed weekly by phone using a numeric rating scale (NRS). Outcomes included the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale (primary), and subjective and objective physical function measures and the NRS and physical function measures (secondary). Linear mixed regression analysis was conducted to test between-group differences in mean changes from baseline for the outcomes at 8 weeks. Results Compared with usual care, both verum and sham acupressure participants experienced significant improvements in WOMAC pain (mean difference −1.27 units [95% confidence interval (95% CI) −1.95, −0.58] and −1.24 units [95% CI −1.92, −0.55], respectively), NRS pain (−0.74 units [95% CI −1.24, −0.24] and −0.51 units [95% CI −1.01, −0.01], respectively), and WOMAC function (−4.83 units [95% CI −6.99, −2.67] and −4.21 units [95% CI −6.37, −2.04], respectively) at 8 weeks. There were no significant differences between the v[...]

Contribution of Socioeconomic Status to Racial/Ethnic Disparities in Adverse Pregnancy Outcomes Among Women With Systemic Lupus Erythematosus


Objective We examined rates of adverse pregnancy outcomes (APO) by race/ethnicity among women with systemic lupus erythematosus (SLE), with and without antiphospholipid antibodies (aPL), and whether socioeconomic status (SES) accounted for differences. Methods Data were from the PROMISSE (Predictors of Pregnancy Outcome: Biomarkers in Antiphospholipid Antibody Syndrome and Systemic Lupus Erythematosus) study, a multicenter study that enrolled 346 patients with SLE and 62 patients with SLE and aPL (50% white, 20% African American, 17% Hispanic, 12% Asian/Pacific Islander). Measures of SES were educational attainment, median community income, and community education. Logistic regression analyses were conducted to determine odds of APO for each racial/ethnic group, controlling first for age and clinical variables, and then for SES. Results The frequency of APO in white women with SLE, with and without aPL, was 29% and 11%, respectively. For African American and Hispanic women it was approximately 2-fold greater. In African American women with SLE alone, adjustment for clinical variables attenuated the odds ratio (OR) from 2.7 (95% confidence interval [95% CI] 1.3–5.5) to 2.3 (95% CI 1.1–5.1), and after additional adjustment for SES, there were no longer significant differences in APO compared to whites. In contrast, in SLE patients with aPL, whites, African Americans, and Hispanics had markedly higher risks of APO compared to white SLE patients without aPL (OR 3.5 [95% CI 1.4–7.7], OR 12.4 [95% CI 1.9–79.8], and OR 10.4 [95% CI 2.5–42.4], respectively), which were not accounted for by clinical or S[...]

Pain and Mortality in Older Adults: The Influence of Pain Phenotype


Objective Moderate to severe chronic pain affects 1 in 5 adults. Pain may increase the risk of mortality, but the relationship is unclear. This study investigated whether mortality risk was influenced by pain phenotype, characterized by pain extent or pain impact on daily life. Methods The study population was drawn from 2 large population cohorts of adults ages ≥50 years, the English Longitudinal Study of Ageing (n = 6,324) and the North Staffordshire Osteoarthritis Project (n = 10,985). Survival analyses (Cox's proportional hazard models) estimated the risk of mortality in participants reporting any pain and then separately according to the extent of pain (total number of pain sites, widespread pain according to the American College of Rheumatology [ACR] criteria, and widespread pain according to Manchester criteria) and pain impact on daily life (pain interference and often troubled with pain). Models were cumulatively adjusted for age, sex, education, and wealth/adequacy of income. Results After adjustments, the report of any pain (mortality rate ratio [MRR] 1.06 [95% confidence interval (95% CI) 0.95–1.19]) or having widespread pain (ACR 1.07 [95% CI 0.92–1.23] or Manchester 1.16 [95% CI 0.99–1.36]) was not associated with an increased risk of mortality. Participants who were often troubled with pain (MRR 1.29 [95% CI 1.12–1.49]) and those who reported quite a bit of pain interference (MRR 1.38 [95% CI 1.20–1.59]) and extreme pain interference (MRR 1.88 [1.54–2.29]) had an increased risk of all-cause mortality. Conclusion Pain that interferes with daily life[...]

Association Between Inflammatory Back Pain Characteristics and Magnetic Resonance Imaging Findings in the Spine and Sacroiliac Joints


Objective To investigate the association between magnetic resonance imaging (MRI) findings at the sacroiliac (SI) joints and vertebral endplates and pain characteristics assumed to be indicative of axial inflammation. Methods Patients ages 18–40 years with persistent low back pain referred to an outpatient spine clinic participated, including an unknown proportion of axial spondyloarthritis patients. Data included MRI of the spine and SI joints and self-reported responses to questions covering the Calin, Berlin, Assessment of Spondyloarthritis International Society, and Bailly inflammatory back pain (IBP) definitions. Results In the 1,020 included patients, 53% were women, and the median age was 33 years. Positive associations were found between the SI joint MRI findings and pain characteristics, odds ratios ranging from 1.4 to 2.7. SI joint bone marrow edema (BME) was associated with morning stiffness >60 minutes, and SI joint erosions with the Calin, Berlin, and Bailly IBP definitions, alternating buttock pain, and good response to nonsteroidal antiinflammatory drugs. SI joint fatty marrow deposition (FMD) was associated with insidious onset, and SI joint sclerosis with pain at night. In addition, the spinal MRI changes were associated with IBP, odds ratios ranging from 1.4 to 2.0; vertebral endplate BME was associated with morning stiffness, and vertebral endplate FMD with the Calin and Bailly IBP definitions, improvement with exercise, morning stiffness >30 minutes, and pain worst in the morning. Conclusion The identified associations between [...]

Outcome Reporting in Randomized Trials for Shoulder Disorders: Literature Review to Inform the Development of a Core Outcome Set


Objective To explore the outcome domains and measurement instruments reported across randomized trials of any interventions for various shoulder disorders. Methods We searched for shoulder trials included in Cochrane reviews published up to Issue 10, 2015, or indexed in PubMed between 2006 and 2015. Trials were eligible for inclusion if they focused on any intervention for rotator cuff disease, adhesive capsulitis, shoulder instability, glenohumeral or acromioclavicular osteoarthritis, shoulder dislocation, proximal humeral or humeral head fractures, or unspecified shoulder pain. Two authors independently selected trials for inclusion and extracted information on the domains and measurement instruments reported, with consensus discussion among all authors where required. Results We included 409 trials, published between 1954 and 2015. Across the trials, we identified 319 different instruments that were classified into 32 domains. Most trials reported a measure of pain (90%), range of motion (78%), and physical function (71%). The recording of adverse events was reported in only 31% of the trials. Muscle strength was reported in 44% of the trials and imaging outcomes in 21%. Other patient-reported outcome measures, such as global assessment of treatment success, health-related quality of life, work ability, and psychological functioning, were each reported in ≤15% of the trials. Most of the domains were reported at similar frequencies across different shoulder disorders. Conclusion The domains and measurement instruments [...]

Education Preferences of People With Gout: Exploring Differences Between Indigenous and Nonindigenous Peoples from Rural and Urban Locations


Objective Gout typically responds well to medications, but adherence might be improved by education that meets individuals’ needs in a way that is inclusive of their ethnicity and rurality. The aim of this study was to compare education preferences of Māori and New Zealand European (NZEuropean) individuals with gout, and of those living in rural or urban areas. Methods People with gout managed in primary care were recruited from 2 rural regions and 1 city within Aotearoa/New Zealand. Focus groups were held with 26 Māori and 42 NZEuropean participants (44 rural, 24 urban). Participants discussed education preferences for diet, medication, and ways of communicating. The nominal group technique was employed, whereby the group compiled a list of ideas and then participants individually ranked the 3 most important ideas for each topic. Results The most frequently prioritized ideas for the 3 topics were knowing one's own food triggers, knowing side effects of medications, and communicating via a general practitioner (GP) or specialist. More Māori participants prioritized natural remedies, easy to understand information, and communicating via television. More NZEuropean participants prioritized knowing the kinds of alcohol that trigger gout, communicating via GP/specialist, and receiving written information. More urban participants prioritized knowing to stay hydrated and medication doses as important information. Conclusion Māori and NZEuropean individuals with gout report different understanding[...]

Prescribing for Children With Rheumatic Disease: Perceived Treatment Approaches Between Pediatric and Adult Rheumatologists


Objective To compare practice patterns and prescribing differences for juvenile idiopathic arthritis (JIA) between adult rheumatologists (ARs) and pediatric rheumatologists (PRs), the perceived educational needs, and factors that enhance or impede co-management. Methods Two parallel, cross-sectional surveys focusing on JIA were administered in 2009 to a random sample of 193 PRs and 500 ARs using the American College of Rheumatology membership file. Bivariate analysis was conducted for common items. Results The response rate was 62.1% for ARs (n = 306) and 72.3% for PRs (n = 138). Only 23% of responding ARs (n = 69) reported caring for children with JIA. Of these, 94% strongly agreed/agreed feeling comfortable diagnosing JIA; however, only 76% felt comfortable treating JIA. Clinical vignettes highlighted several prescribing differences. Forty-eight percent of ARs and 31% of PRs felt medications to treat JIA did not have clear dosing guidelines. Though PRs initiated disease-modifying antirheumatic drugs and biologic agents earlier, treatments were similar after 3 months. To enhance co-management, 74% of pediatric respondents endorsed shared medical records. Conclusion Nearly one-quarter of surveyed ARs care for children with JIA, with most limiting their practice to older children. There was more discomfort in treating JIA than diagnosing it, and there were significant prescribing differences. Both provider types identified the need for better dosing and treatment reso[...]

Reasons for Not Participating in Scleroderma Patient Support Groups: A Cross-Sectional Study


Objective Peer-led support groups are an important resource for many people with scleroderma (systemic sclerosis; SSc). Little is known, however, about barriers to participation. The objective of this study was to identify reasons why some people with SSc do not participate in SSc support groups. Methods A 21-item survey was used to assess reasons for nonattendance among SSc patients in Canada and the US. Exploratory factor analysis (EFA) was conducted, using the software MPlus 7, to group reasons for nonattendance into themes. Results A total of 242 people (202 women) with SSc completed the survey. EFA results indicated that a 3-factor model best described the data (χ2[150] = 302.7; P < 0.001; Comparative Fit Index = 0.91, Tucker-Lewis Index = 0.88, root mean square error of approximation = 0.07, factor intercorrelations 0.02–0.43). The 3 identified themes, reflecting reasons for not attending SSc support groups were personal reasons (9 items; e.g., already having enough support), practical reasons (7 items; e.g., no local support groups available), and beliefs about support groups (5 items; e.g., support groups are too negative). On average, respondents rated 4.9 items as important or very important reasons for nonattendance. The 2 items most commonly rated as important or very important were 1) already having enough support from family, friends, or others, and 2) not knowing of any SSc support groups offered in my area. Conclusion SSc o[...]

Natural History and Predictors of Progression to Sjögren's Syndrome Among Participants of the Sjögren's International Collaborative Clinical Alliance Registry


Objective To explore changes in the phenotypic features of Sjögren's syndrome (SS), and in SS status among participants in the Sjögren's International Collaborative Clinical Alliance (SICCA) registry over a 2–3-year interval. Methods All participants in the SICCA registry who were found to have any objective measures of salivary hypofunction, dry eye, focal lymphocytic sialadenitis in minor salivary gland biopsy, or anti-SSA/SSB antibodies were recalled over a window of 2 to 3 years after their baseline examinations to repeat all clinical examinations and specimen collections to determine whether there was any change in phenotypic features and in SS status. Results As of September 15, 2013, a total of 3,514 participants had enrolled in SICCA, and among 3,310 eligible, 771 presented for a followup visit. Among participants found to have SS using the 2012 American College of Rheumatology (ACR) classification criteria, 93% again met the criteria after 2 to 3 years, and this proportion was 89% when using the 2016 ACR/European League Against Rheumatism (EULAR) criteria. Among those who did not meet ACR or ACR/EULAR criteria at baseline, 9% and 8%, respectively, had progressed and met them at followup. Those with hypergammaglobulinemia and hypocomplementemia at study entry were, respectively, 4 and 6 times more likely to progress to SS by ACR criteria than those without these characteristics (95% confidence interval 1.5[...]

Impact of Disease Severity, Illness Beliefs, and Coping Strategies on Outcomes in Psoriatic Arthritis


Objective Little is known about how people with psoriatic arthritis (PsA) cope with and manage their condition, but data show that psychological problems are underrecognized and undertreated. The Common Sense Self-Regulatory Model (CS-SRM) suggests illness beliefs, mediated by coping, may influence health outcomes. The study aimed to investigate the roles of disease severity, illness beliefs, and coping strategies in predicting depression, anxiety, and quality of life (QoL) in people with PsA. Additionally, we aimed to assess the role of depression and anxiety in predicting QoL. Methods We conducted a cross-sectional observational study, where adults with PsA (n = 179) completed validated measures of predictor (illness beliefs, coping strategies, disease severity) and outcome variables (depression, anxiety, QoL) using an online survey distributed via social media. Results The participants were a community sample of 179 adults with PsA, ages 20 to 72 years (77.1% female). After controlling for disease severity, hierarchical multiple regression models indicated that more negative beliefs about consequences and behavioral disengagement as a coping method predicted levels of depression, and self-blame predicted anxiety. Beliefs about consequences and the presence of depression predicted quality of life scores after controlling for disease severity. Conclusion This study offers support for the[...]

Characteristics and Course of Enthesitis in a Juvenile Idiopathic Arthritis Inception Cohort


Objective To describe the prevalence, associated characteristics, and course of enthesitis in a juvenile idiopathic arthritis (JIA) inception cohort. Methods Canadian children newly diagnosed with JIA between 2005 and 2010 were categorized using International League of Associations for Rheumatology criteria at the 6-month visit and followed in the Research in Arthritis in Canadian Children Emphasizing Outcomes (ReACCh-Out) cohort for up to 5 years. The presence of entheseal tenderness on examination at 33 sites shown on a homunculus was recorded at 0, 6, 12, 18, 24, 36, 48, and 60 months after enrollment. Enthesitis was defined as entheseal tenderness at more than 1 site or on more than 1 occasion. Analyses consisted of descriptive statistics and linear mixed models for longitudinal data. Results Of 1,406 patients, 219 (16%) had enthesitis and, of those with enthesitis, 141 (64%) were classified as having enthesitis-related arthritis (ERA). Children with enthesitis were more often older (10.7 versus 7.5 years), male (57% versus 31%), and with polyarthritis (57% versus 41%) and sacroiliac involvement (30% versus 4%). Entheseal tenderness was most frequent at the calcaneal plantar fascial insertion (39%), Achilles tendon insertion (31%), and tibial tuberosity (30%). The mean number of tender entheseal sites decreased in parallel with active joint counts. There was n[...]