Integrating PROMIS Measures in a Treat-to-Target Approach to Standardize Patient-Centered Treatment of Rheumatoid Arthritis.

OBJECTIVE: To evaluate the effect of a patient-centered rheumatoid arthritis (RA) treat-to-target (T2T) disease management approach on patient outcomes and patient satisfaction with care. METHODS: In this longitudinal, observational pilot study, rheumatologists implemented a modified T2T approach that integrated Patient Reported Outcomes Measurement Information System (PROMIS) measures for depression, fatigue, pain interference, physical function, and social function into RA care. Study participants selected 1 PROMIS domain to target treatment and completed quarterly follow-up assessments. Participants were classified as improved if their Clinical Disease Activity Index (CDAI) changed by > 5 points. Change in PROMIS t scores was examined for the group with improved CDAI, and then compared to those with unchanged or worsened CDAI. Satisfaction with care was assessed using multiple measures, including the Functional Assessment of Chronic Illness Therapy-Treatment Satisfaction-Patient Satisfaction Scale. RESULTS: The analytical sample (n = 119, median age 57 years, 90.8% female) was split between those with CDAI > 10 (n = 63) and CDAI ≤ 10 (n = 53). At 1 year, there was improvement in CDAI by > 5 points in 66% and 13% of individuals with baseline CDAI > 10 and baseline CDAI ≤ 10, respectively. Across all participants, improvement in CDAI by > 5 points correlated with improvements in the 5 PROMIS domains. Satisfaction with RA treatment also increased. CONCLUSION: The integration of PROMIS measures into the T2T approach for RA care was associated with improvements in disease activity, and improvement in disease activity was associated with improvements in PROMIS measures.

Projected Cost Simulation in Chronic Ear Surgery: Cost in Chronic Ear Surgery.

OBJECTIVE: To examine the projected healthcare costs of intact canal wall (ICW) and canal wall down (CWD) tympanomastoidectomy surgery and associated clinic follow-up visits in the management of chronic ear disease. STUDY DESIGN: A review of literature was performed to analyze the cholesteatoma recidivism rates of ICW and CWD tympanomastoidectomy. Projected Medicare cost simulation applied to representative samples of patients undergoing otologic surgery and follow-up clinic appointments projected over 15 years with an annual 25% cholesteatoma recidivism rate. SETTING: Tertiary academic center. PATIENTS: Simulated patient population status postchronic ear surgery and representative follow-up clinic visits with or without in-office mastoid debridement procedures. INTERVENTIONS: Therapeutic and rehabilitative. MAIN OUTCOME MEASURES: Healthcare cost. RESULTS: Simulation of cost for chronic ear surgery with follow-up visits produced a higher mean cost for the ICW group compared with the CWD group at year 1 ($9112.06 versus $4954.16). However, CWD patients accumulate cost over time due to routine mastoid debridements. The accumulated costs for the CWD group surpassed the ICW group at 12.54 (CI: 12.02-13.11) years. CONCLUSIONS: Using a projected cost analysis model, intact canal wall tympanomastoidectomy incurs a larger upfront cost than the canal wall down technique. However, long-term mastoid cavity maintenance costs accumulate to surpass the intact canal wall group at 12.54 years.

Transcriptional Profiling of Synovial Macrophages Using Minimally Invasive Ultrasound-Guided Synovial Biopsies in Rheumatoid Arthritis.

OBJECTIVE: Currently, there are no reliable biomarkers for predicting therapeutic response in patients with rheumatoid arthritis (RA). The synovium may unlock critical information for determining efficacy, since a reduction in the numbers of sublining synovial macrophages remains the most reproducible biomarker. Thus, a clinically actionable method for the collection of synovial tissue, which can be analyzed using high-throughput strategies, must become a reality. This study was undertaken to assess the feasibility of utilizing synovial biopsies as a precision medicine-based approach for patients with RA. METHODS: Rheumatologists at 6 US academic sites were trained in minimally invasive ultrasound-guided synovial tissue biopsy. Biopsy specimens obtained from patients with RA and synovial tissue from patients with osteoarthritis (OA) were subjected to histologic analysis, fluorescence-activated cell sorting, and RNA sequencing (RNA-seq). An optimized protocol for digesting synovial tissue was developed to generate high-quality RNA-seq libraries from isolated macrophage populations. Associations were determined between macrophage transcriptional profiles and clinical parameters in RA patients. RESULTS: Patients with RA reported minimal adverse effects in response to synovial biopsy. Comparable RNA quality was observed from synovial tissue and isolated macrophages between patients with RA and patients with OA. Whole tissue samples from patients with RA demonstrated a high degree of transcriptional heterogeneity. In contrast, the transcriptional profile of isolated RA synovial macrophages highlighted different subpopulations of patients and identified 6 novel transcriptional modules that were associated with disease activity and therapy. CONCLUSION: Performance of synovial tissue biopsies by rheumatologists in the US is feasible and generates high-quality samples for research. Through the use of cutting-edge technologies to analyze synovial biopsy specimens in conjunction with corresponding clinical information, a precision medicine-based approach for patients with RA is attainable.

Standardizing and personalizing the treat to target (T2T) approach for rheumatoid arthritis using the Patient-Reported Outcomes Measurement Information System (PROMIS): baseline findings on patient-centered treatment priorities.

A treat to target (T2T) approach to management has become the standard of care for patients with rheumatoid arthritis (RA). While consensus T2T recommendations call for patient involvement in the treatment process, the targets commonly used to drive therapeutic decisions involve limited patient input. A pilot study was developed to explore whether the Patient-Reported Outcomes Measurement Information System (PROMIS) could add value to the T2T approach by providing a way to bring patient goals into the process. We report here the baseline data from this study. RA patients from an academic rheumatology practice were recruited to participate in this 1-year study. Patients were asked to complete PROMIS computer-assisted testing at quarterly visits during the year. At baseline, they were asked to identify the PROMIS domain (Pain Interference, Fatigue, Depression, Physical Function, and Social Function) that felt most important to their quality of life. They were then asked to select five representative items from this domain, to be followed through the year. Complete baseline data was available for 119 patients. Most selected Physical Function (39%) or Pain Interference (37%) as their highest priority PROMIS domain. Sixty percent ranked Depression as their lowest priority domain. Younger patients more frequently prioritized Social Function, while older patients more frequently prioritized Fatigue. The incorporation of PROMIS questionnaires into routine clinic visits is a feasible mechanism for incorporating patient preferences into a T2T approach to managing RA.