Abstract
Clinical outcome assessments of function or strength, assessed by physical therapists, are commonly used as primary endpoints in clinical trials, natural history studies and within clinics for individuals with neuromuscular disorders. These evaluations not only inform the efficacy of investigational agents in clinical trials, but also importantly track disease trajectory to prospectively advise need for equipment, home and work modifications, and other assistive devices. The COVID-19 pandemic had a global impact on the safety and feasibility of in-person visits and assessments, necessitating rapid development of mitigation strategies to ensure ongoing collection of key clinical trial endpoints and access to expert clinical care despite travel restrictions. Physical therapists who are expert in neuromuscular disorders working across clinics, countries, and clinical trials developed initial guidelines and methods for the suitability and feasibility of performing remote evaluations. A number of Sponsors introduced amendments to their study protocols to enable remote evaluations, supported by live video streaming of the assessment to their local clinical evaluators. Similarly, application of these techniques to clinical telemedicine enabled objective evaluations for use in payer discussions, equipment procurement, and general access to expert physical therapy services. Here we report on our methodology for adapting current practices to remote testing and considerations for remote evaluations.
Highlights
The COVID-19 pandemic presented unprecedented challenges to the delivery of clinical care and the conduct of clinical outcome assessments (COA) for individuals with neuromuscular disorders (NMD)
In the midst of the pandemic, replacement of in person visits with video consultations and utilizing telemedicine was considered to be the most appropriate option for end point collection of clinical trial primary and secondary COA normally performed by Physical therapists (PTs)
In conjunction with Sponsors, expert PTs reviewed study protocols and schedule of events to determine the suitability and feasibility of all study COA that were normally collected by PTs in the clinic or trained Clinical Evaluators (CEs) for clinical trials, for remote evaluation, where the PT administered instructions via video call
Summary
The COVID-19 pandemic presented unprecedented challenges to the delivery of clinical care and the conduct of clinical outcome assessments (COA) for individuals with neuromuscular disorders (NMD). Due to the frequent comorbidities seen in NMD, it was considered a significant risk for many patients to leave their homes and attend hospital clinics during the height of the pandemic and subsequent waves. This was further exacerbated by heavily restricted travel within and between. Prior to the COVID-19 pandemic, remote testing and telehealth assessment were not routinely part of standard clinical practice and less often part of clinical trials in NMD. In the midst of the pandemic, replacement of in person visits with video consultations and utilizing telemedicine was considered to be the most appropriate option for end point collection of clinical trial primary and secondary COA normally performed by Physical therapists (PTs)
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