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OBJECTIVE: Many patients with rheumatoid arthritis (RA) have difficulty finding clinicians to treat them because of workforce shortages. We developed an app to address this problem by improving care efficiency. The app collects patient-reported outcomes (PROs) and can be used to inform visit timing, potentially reducing the volume of low-value visits. We describe the development process, intervention design, and planned study for testing the app. METHODS: We employed user-centered design, interviewing patients and clinicians, to develop the app. To improve visit efficiency, symptom tracking logic alerts clinicians to PRO trends: worsening PROs generate alerts suggesting an earlier visit, and stable or improving PROs generate notifications that scheduled visits could be delayed. An interrupted time-series analysis with a nonrandomized control population will allow assessment of the impact of the app on visit frequency. RESULTS: Patient interviews identified several of the following needs for effective app and intervention design: the importance of a simple user interface facilitating rapid answering of PROs, the availability of condensed summary information with links to more in-depth answers to common questions regarding RA, and the need for clinicians to discuss the PRO data during visits with patients. Clinician interviews identified the following user needs: PRO data must be easy to view and use during the clinical workflow, and there should be reduced interval visits when PROs are trending worse. Some clinicians believed visits could be delayed for patients with stable PROs, whereas others raised concerns. CONCLUSION: PRO apps may improve care efficiency in rheumatology. Formal evaluation of an integrated PRO RA app is forthcoming.
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Background: Low-dose methotrexate (LD-MTX) is the most commonly used drug for systemic rheumatic diseases worldwide and is the recommended first-line agent for rheumatoid arthritis. Despite extensive clinical use for more than 30 years, few data on adverse event (AE) rates derive from randomized, placebo-controlled trials, where both causality and magnitude of risk can be inferred. Objective: To investigate AE rates, risk, and risk differences comparing LD-MTX versus placebo. Design: Prespecified secondary analyses of a double-blind, placebo-controlled, randomized trial. (ClinicalTrials.gov: NCT01594333). Setting: North America. Participants: Adults with known cardiovascular disease and diabetes or metabolic syndrome. Intervention: Random allocation to LD-MTX (≤20 mg/wk) or placebo. All participants received folic acid, 1 mg/d, 6 days per week. Measurements: Risks for specific AEs of interest, as well as for all AEs, were compared across treatment groups after blinded adjudication. Results: After an active run-in period, 6158 patients were enrolled and 4786 randomly assigned to a group; median follow-up was 23 months and median dosage 15 mg/wk. Among the randomly assigned participants, 81.2% were male, median age was 65.7 years, and median body mass index was 31.5 kg/m2. Of 2391 participants assigned to LD-MTX, 2080 (87.0%) had an AE of interest, compared with 1951 of 2395 (81.5%) assigned to placebo (hazard ratio [HR], 1.17 [95% CI, 1.10 to 1.25]). The relative hazards of gastrointestinal (HR, 1.91 [CI, 1.75 to 2.10]), pulmonary (HR, 1.52 [CI, 1.16 to 1.98]), infectious (HR, 1.15 [CI, 1.01 to 1.30]), and hematologic (HR, 1.15 [CI, 1.07 to 1.23]) AEs were elevated for LD-MTX versus placebo. With the exception of increased risk for skin cancer (HR, 2.05 [CI, 1.28 to 3.28]), the treatment groups did not differ in risk for other cancer or mucocutaneous, neuropsychiatric, or musculoskeletal AEs. Renal AEs were reduced in the LD-MTX group (HR, 0.85 [CI, 0.78 to 0.93]). Limitation: The trial was done in patients without rheumatic disease who tolerated LD-MTX during an active run-in period. Conclusion: Use of LD-MTX was associated with small to moderate elevations in risks for skin cancer and gastrointestinal, infectious, pulmonary, and hematologic AEs, whereas renal AEs were decreased. Primary Funding Source: National Institutes of Health.
