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.

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.

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.

BackgroundCurrently we are in the golden age of therapy for patients with rheumatoid arthritis (RA). However, currently there exists no available assay to predict the response to a particular therapy for an individual patient. Today, rheumatologists do not have information at han for therapeutic decisions. It is clear that the target organ in RA patients, i.e. the synovium, has the potential to unlock the secret for determining therapeutic response. Ideally, a sufficient synovial sample would be obtained from each patient to perform histology, sorting of individual cell populations and transcriptional analyses.ObjectivesOur goal is to establish a minimally invasive ultrasound guided synovial biopsy program in the United States to obtain synovial tissue for determining therapeutic response.MethodsRheumatologists from six Universities in the United States were trained in ultrasound guided minimally invasive synovial tissue biopsy procedures. Only patients with a grey scale synovitis score of 2 or greater were selected. A disposable semi-automatic-guillotine type biopsy needle (Quick-Core) was utilized for all patients and 25/26 patients had the biopsy performed on the wrist. Histology was performed on whole tissue. RNA was extracted from whole tissue and from FACS sorted macrophages in order for RNA sequencing (RNA-seq) analysis to be performed.ResultsOur group has already performed over 26 minimally invasive ultrasound guided synovial tissue biopsies on RA patients with active disease. We had minimal adverse effects and patients tolerated the procedure very well. At least 6–12 needle biopsies of synovial tissue were obtained via biopsy per patient. A minimum of 4 needle biopsies were placed in formalin and synovial lining was confirmed via histologic analyses. The remaining pieces were used to prepare libraries for RNA-seq. We observed comparable RNA integrity numbers, a measure of RNA quality, between the whole synovial tissue from RA (biopsy obtained) and OA (surgically-obtained) patients. OA patients segregated together transcriptionally, while RA patients are more heterogeneous as demonstrated via RNAseq analysis. We also optimized a protocol for digestion of synovial tissue biopsies for isolation of macrophages. We identified genes differentially associated with macrophage activity in RA versus OA synovial macrophages that were not evident in the whole tissue transcriptional profile.ConclusionsUltrasound guided synovial tissue biopsies are feasible in the United States. Based on our recent success using minimally invasive ultrasound guided synovial biopsies, we believe that this procedure coupled with cutting-edge technologies will provide the critical information to rheumatologists to establish precision based medicine as a reality for RA patients.Disclosure of InterestNone declared

BackgroundThe Patient Reported Outcomes Measurement Information System (PROMIS) is an NIH initiative to develop patient-reported outcome measures for use across chronic conditions. PROMIS instruments assess outcomes relevant in Rheumatoid Arthritis (RA) including pain interference, physical function social function, fatigue, and depression. We aimed to learn whether the use of PROMIS instruments could inform the treat-to-target (T2T) approach to RA management, and to understand whether patient reports of disease impact correlate with objective clinical measures.ObjectivesFor this study, patients are treated for 1 year using a T2T approach. Using PROMIS item banks, we developed patient-centered targets in five domains: pain, fatigue, depression, physical function, and social function. We report on the baseline status of the full sample of patients enrolled in the study (n=119) stratified by disease activity (remission or low disease activity, CDAI ≤10 vs. moderate or high disease activity, CDAI >10). We also report on patient satisfaction with the individualized T2T approach, in addition to clinician feedback on the feasibility and usefulness of this approach.MethodsPatients with RA diagnosed by 2010 ACR/EULAR criteria were recruited from our academic clinical practice. At baseline data collection, standard RA assessments included joint counts, RAPID3, and CDAI scores. The research assessment battery included clinical questionnaires, PROMIS CAT's (computer adaptive tests), prioritization of PROMIS domains, and selection of five items that patients felt were most important within their most highly prioritized domain.ResultsThe baseline sample consists of 119 RA patients with a median age of 57 years (range: 21–77). The sample was 91% female, 71% White, and 12% Hispanic. Approximately 54% (n=57) exhibited moderate or high disease activity (CDAI m=13.4; SD=11.0). When selecting prioritization areas for treatment targets, 39% of patients selected physical function, followed by 37% of participants selecting pain, 16% fatigue, 5% depression, and 3% social function. Those with high active disease were more likely to select pain (44% vs. 22%). Compared to the U.S. general population reference values for PROMIS (m=50; SD=10), patients reported worse fatigue (m=56.4), pain interference (m=57.6), and physical function (m=42.3). Baseline scores on depression and social functioning were closer to average in the general U.S. population. Patient feedback about the study has been positive. An overwhelming majority of patients reported that they would be “somewhat” (33%) to “very likely” (56%) to participate in similar treatment programs. Response from health care providers has been positive as well, with limited reports of negative impacts of data collection on clinic flow.ConclusionsMost patients selected physical function, pain, and fatigue as the most important domains for their personal treatment goal setting. Consistent with these selections, patients' health ratings in these domains were worse compared to the general populat...

ObjectiveTo evaluate the impact of a patient-centered rheumatoid arthritis (RA) treat to target (T2T) disease management approach on patient outcomes and patient satisfaction with care.MethodsIn this longitudinal, observational pilot study, rheumatologists implemented a modified T2T approach that integrated PROMIS measures for depression, fatigue, pain interference, physical function, and social function into RA care. Study participants selected one 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, compared to those with unchanged or worsened CDAI. Satisfaction with care was assessed using multiple measures, including the FACIT Treatment Satisfaction – Patient Satisfaction Scale.ResultsThe analytic 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 five PROMIS domains. Satisfaction with RA treatment also increased.ConclusionThe 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.