Current status of clinical outcome measures in inclusion body myositis: a systematised review.

OBJECTIVES: Sporadic inclusion body myositis (IBM) is a debilitating idiopathic inflammatory myopathy (IIM) which affects hand function, ambulation, and swallowing. There is no approved pharmacological therapy for IBM, and there is a lack of suitable outcome measure to assess the effect of an intervention. The IBM scientific interest group under IMACS reviewed the previously used outcome measures in IBM clinical studies to lay the path for developing a core set of outcome measures in IBM. METHODS: In this systematised review, we have extracted all outcome measures reported in IBM clinical studies to determine what measures were being used and to assess the need for optimising outcome measures in IBM. RESULTS: We found 13 observational studies, 17 open-label clinical trials, and 15 randomised control trials (RCTs) in IBM. Six-minute walk distance, IBM-functional rating scale (IBM-FRS), quantitative muscle testing, manual muscle testing, maximal voluntary isometric contraction testing, and thigh muscle volume measured by MRI were used as primary outcome measures. Twelve different outcome measures of motor function were used in IBM clinical trials. IBM-FRS was the most used measure of functionality. Swallowing function was reported as a secondary outcome measure in only 3 RCTs. CONCLUSIONS: There are inconsistencies in using outcome measures in clinical studies in IBM. The core set measures developed by the IMACS group for other IIMs are not directly applicable to IBM. As a result, there is an unmet need for an IBM-specific core set of measures to facilitate the evaluation of new potential therapeutics for IBM.

A Pilot Study of a Sensor Enhanced Activity Management System for Promoting Home Rehabilitation Exercise Performed during the COVID-19 Pandemic: Therapist Experience, Reimbursement, and Recommendations for Implementation.

Adherence to home exercise programs (HEPs) during physical rehabilitation is usually unmonitored and is thought to be low from self-reports. This article describes exploratory implementation of a Sensor Enhanced Activity Management (SEAM) system that combines HEP management software with a movement sensor for monitoring and motivating HEP adherence. The article also presents results from attempting to gain reimbursement for home use of the system with therapist oversight using Remote Physiologic Monitoring (RPM) codes. Four therapists used the system in their regular practice during the first six months of the COVID-19 pandemic. Therapists filled out surveys, kept notes, and participated in interviews. Billing and reimbursement data were obtained from the treatment facility. Exercise data from the SEAM system were used to understand HEP adherence. Patients were active for a mean of 40% (26% SD) of prescribed days and completed a mean of 25% (25% SD) of prescribed exercises. The therapists billed 23 RPM codes (USD 2353), and payers reimbursed eight of those instances (USD 649.21). The therapists reported that remote monitoring and the use of a physical movement sensor was motivating to their patients and increased adherence. Sustained technical support for therapists will likely improve implementation of new remote monitoring and treatment systems. RPM codes may enable reimbursement for review and program management activities, but, despite COVID-19 CMS waivers, organizations may have more success if these services are billed under supervision of a physician.