New indicator for discordance between patient-reported and traditional disease activity outcomes in patients with early rheumatoid arthritis.

OBJECTIVE: To unravel disease impact in early RA by separately quantifying patient-reported (PRF), clinical (CF) and laboratory (LF) factors. We propose a new indicator, the discordance score (DS), for early identification and prediction of patient's unmet needs and of future achievement of sustained remission (SR) and RA-related quality of life (QoL). METHODS: Factor-scores obtained by factor analysis in the CareRA trial, allowed to compute DS, reflecting the difference between PRF and the mean of CF and LF. Improvement from baseline to week 104 (%) and area-under-the-curve (AUC) across time points per factor-score were calculated and compared between patients achieving/not achieving sustained (week 16-104) remission (DAS28CRP < 2.6) with ANOVA. Logistic and linear regressions were used to predict SR based on previous factor and discordance scores, and QoL at year 1 and 2 based on DS at week 16. RESULTS: PRF, CF and LF scores improved rapidly within 8 weeks. PRF improved 57%, CF 90% and LF 27%, in those achieving SR, compared with 32% (PRF: P = 0.13), 77% (CF: P < 0.001) and 9% (LF: P = 0.36) in patients not achieving SR. Patients achieving SR had an AUC of 15.7, 3.4 and 4.8 for PRF, CF and LF, respectively, compared with 33.2, 10.1 and 7.2 in participants not achieving SR (P < 0.001 for all). Early discordance was associated with later factor scores, QoL and self-efficacy. CONCLUSIONS: All factor scores improved rapidly, especially in patients achieving sustained remission. Patient-reported burden improved less. Discordance scores could help predicting the need for additional non-pharmacological interventions to achieve sustained remission and decrease disease impact.

Development, usability and acceptability of an integrated eHealth system for spondyloarthritis in the Netherlands (SpA-Net).

Objective: To develop and test the usability and acceptability of a disease-specific integrated electronic health (eHealth) system for spondyloarthritis (SpA) in the Netherlands ('SpA-Net'). Methods: SpA-Net was developed in four phases. First, content and design were discussed with experts on SpA and patients. Second, the database, electronic medical record (EMR) and quality management system were developed. Third, multiple rounds of testing were performed. Fourth, the eHealth system was implemented in practice and feasibility was tested among patients through semistructured focus interviews (n=16 patients) and among care providers through feedback meetings (n=11 rheumatologists/fellows and 5 nurses). Results: After completion of the first three steps of development in 2015, SpA-Net was implemented in 2016. All patients included have a clinical diagnosis of SpA. Information on domains relevant to clinical record-keeping is prospectively collected at routine outpatient consultations and readily available to care providers, presented in a clear dashboard. Patients complete online questionnaires prior to outpatient visits. In February 2019, 1069 patients were enrolled (mean [SD] age 54.9 [14.1] years, 52.4% men). Patients interviewed (n=16) considered SpA-Net an accessible system that was beneficial to disease insight and patient-physician communication, and had additional value to current care. Care providers appreciated the additional information for (preparing) consultations. Barriers were the initial time required to adopt the EMR and the quantity of data entry. Conclusion: SpA-Net enables monitoring of patients with SpA and real-life data collection, and could help improve knowledge and optimise communication between patients and care providers. Both considered SpA-Net a valuable addition to current care. Trial registration number: NTR6740.

Rheumatologists' Views and Experiences in Managing Rheumatoid Arthritis in Elderly Patients: A Qualitative Study.

OBJECTIVE: In this qualitative study we analyzed the (1) influence of age, comorbidity, and frailty on management goals in elderly patients with RA; (2) experiences of rheumatologists regarding the use of the Disease Activity Score at 28 joints (DAS28) to monitor disease activity; and (3) differences in management strategies in elderly patients with RA compared to their younger counterparts. METHODS: Rheumatologists were purposively sampled for a semistructured interview. Two readers independently read and coded the interview transcripts. Important concepts were taxonomically categorized and combined in overarching themes by using NVivo 11 software. RESULTS: Seventeen rheumatologists (mean age 44.8 yrs, SD 7.7 yrs; 29% male) from 9 medical centers were interviewed. Preserving an acceptable level of functioning was the most important management goal in patients ≥ 80 years and in patients with high levels of comorbidity and frailty. The DAS28 score less frequently steered the management strategy, because rheumatologists commented that comorbidity and an age-related erythrocyte sedimentation rate elevation might distort the DAS28 score. Instead, management of elderly patients highly depended on comorbidity, frailty, and their subsequent effects such as cognitive and physical decline, dependency, and polypharmacy. Presence of 1 or more of these factors frequently resulted in a less future-oriented management approach with less emphasis on the maximal prevention of joint erosions. CONCLUSION: The treat-to-target model is not automatically adopted in the elderly patient population. Future evidence-based RA management recommendations for elderly patients with RA are needed and should account for factors such as comorbidity and frailty.

Including health equity considerations in development of instruments for rheumatology research: an introduction to a novel OMERACT paradigm.

The Outcome Measures in Rheumatology (OMERACT) Equity Special Interest Group (SIG) was established in 2008 to create a preliminary core set of outcome measures for clinical trials that can assess equity gaps in healthcare and the effectiveness of interventions to close or narrow gaps between advantaged and disadvantaged populations with musculoskeletal (MSK) conditions. At the OMERACT 11 meeting in 2012, the Equity SIG workshop focused on health assessment scales and their applicability for disadvantaged patients with MSK conditions. The intent was to determine whether the items and domains in 2 common questionnaires, the Health Assessment Questionnaire and the Medical Outcome Study Short Form-36 Survey, are appropriate for the activities and life experiences of certain disadvantaged populations, and whether completion of any of the scales would present a challenge to disadvantaged persons. To generate discussion, we considered the reading level of items in these questionnaires and whether they would be accessible to people with different levels of literacy. The group concluded that the choice of measurement instrument may contribute to "outcome measure-generated inequalities" because disadvantaged groups might have difficulty understanding some of the questions. The future work of the Equity SIG will explore the appropriateness of different measurement scales as they relate to inequities in arthritis as well as the risk of exacerbating disadvantages for patients with low literacy.

Inequities in access to biologic and synthetic DMARDs across 46 European countries.

OBJECTIVES: We investigated access to biologic and synthetic disease modifying drugs (bDMARDs and sDMARDs) in patients with rheumatoid arthritis (RA) across Europe. METHODS: A cross-sectional study at national level was performed in 49 European countries. A questionnaire was sent to one expert, addressing the number of approved and reimbursed bDMARDs and sDMARDs, prices and co-payments, as well as acceptability of bDMARDs (barriers). Data on socio-economic welfare (gross domestic product per capita (GDP), health expenditure, income) were retrieved from web-based sources. Data on health status of RA patients were retrieved from an observational study. Dimensions of access (availability, affordability and acceptability) were correlated with the country's welfare and RA health status. RESULTS: In total, 46 countries (94%) participated. Six countries did not reimburse any of the five sDMARDs surveyed, and in ten countries no bDMARDs were reimbursed. While the price of annual treatment with an average sDMARD was never higher than GPD, the price of one year treatment with a bDMARD exceeded GPD in 26 countries. Perceived barriers for access to bDMARDs were mainly found among financial and administrative restrictions. All dimensions of access were positively correlated with the country's economic welfare (coefficients 0.69 to 0.86 for overall access scores). CONCLUSIONS: Patients with RA in lower income European countries have less access to bDMARDs and sDMARDs, with particularly striking unaffordability of bDMARDs in some of these countries. When accepting that sDMARDs and bDMARDs are equally needed across countries to treat RA, our data point to inequities in access to pharmacological treatment for RA in Europe.

Catastrophic health expenses and impoverishment of households of patients with rheumatoid arthritis.

BACKGROUND: The cost of certain diseases may lead to catastrophic expenses and impoverishment of households without full financial support by the state and other organizations. OBJECTIVE: To determine the socioeconomic impact of the rheumatoid arthritis (RA) cost in the context of catastrophic expenses and impoverishment. PATIENTS AND METHODS: This is a cohort-nested cross-sectional multicenter study on the cost of RA in Mexican households with partial, full, or private health care coverage. Catastrophic expenses referred to health expenses totaling >30% of the total household income. Impoverishment defined those households that could not afford the Mexican basic food basket (BFB). RESULTS: We included 262 patients with a mean monthly household income (US dollars) of $376 (0­18,890.63). In all, 50.8%, 35.5%, and 13.7% of the patients had partial, full, or private health care coverage, respectively. RA annual cost was $ 5534.8 per patient (65% direct cost, 35% indirect). RA cost caused catastrophic expenses in 46.9% of households, which in the logistic regression analysis were significantly associated with the type of health care coverage (OR 2.7, 95%CI 1.6­4.7) and disease duration (OR 1.024, 95%CI 1.002­1.046). Impoverishment occurred in 66.8% of households and was associated with catastrophic expenses (OR 3.6, 95%CI 1.04­14.1), high health assessment questionnaire scores (OR 4.84 95%CI 1.01­23.3), and low socioeconomic level (OR 4.66, 95%CI 1.37­15.87). CONCLUSION: The cost of RA in Mexican households, particularly those lacking full health coverage leads to catastrophic expenses and impoverishment. These findings could be the same in countries with fragmented health care systems.

Cost effectiveness of combined spa-exercise therapy in ankylosing spondylitis: a randomized controlled trial.

OBJECTIVE: To evaluate the cost effectiveness and cost utility of a 3-week course of combined spa therapy and exercise therapy in addition to standard treatment consisting of antiinflammatory drugs and weekly group physical therapy in ankylosing spondylitis (AS) patients. METHODS: A total of 120 Dutch outpatients with AS were randomly allocated into 3 groups of 40 patients each. Group 1 was treated in a spa resort in Bad Hofgastein, Austria; group 2 in a spa resort in Arcen, The Netherlands. The control group stayed at home and continued their usual activities and standard treatment during the intervention weeks. After the intervention, all patients followed weekly group physical therapy. The total study period was 40 weeks. Effectiveness of the intervention was assessed by functional ability using the Bath Ankylosing Spondylitis Function Index (BASFI). Utilities were measured with the EuroQoL (EQ-5D(utility)). A time-integrated summary score defined the clinical effects (BASFI-area under the curve [AUC]) and utilities (EQ-5D(utility)-AUC) over time. Both direct (health care and non-health care) and indirect costs were included. Resource utilization and absence from work were registered weekly by the patients in a diary. All costs were calculated from a societal perspective. RESULTS: A total of 111 patients completed the diary. The between-group difference for the BASFI-AUC was 1.0 (95% confidence interval [95% CI] 0.4-1.6; P = 0.001) for group 1 versus controls, and 0.6 (95% CI 0.1-1.1; P = 0.020) for group 2 versus controls. The between-group difference for EQ-5D(utility)-AUC was 0.17 (95% CI 0.09-0.25; P < 0.001) for group 1 versus controls, and 0.08 (95% CI 0.00-0.15; P = 0.04) for group 2 versus controls. The mean total costs per patient (including costs for spa therapy) in Euros (euro;) during the study period were euro;3,023 for group 1, euro;3,240 for group 2, and euro;1,754 for the control group. The incremental cost-effectiveness ratio per unit effect gained in functional ability (0-10 scale) was euro;1,269 (95% CI 497-3,316) for group 1, and euro;2,477 (95% CI 601-12,098) for group 2. The costs per quality-adjusted life year gained were euro;7,465 (95% CI 3,294-14,686) for group 1, and euro;18,575 (95% CI 3,678-114,257) for group 2. CONCLUSION: Combined spa-exercise therapy besides standard treatment with drugs and weekly group physical therapy is more effective and shows favorable cost-effectiveness and cost-utility ratios compared with standard treatment alone in patients with AS.