Remote-Use Applications of the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised Clinical Outcome Assessment Tool: A Scoping Review.

OBJECTIVES: In 2021, the US Congress passed the Accelerating Access to Critical Therapies for Amyotrophic Lateral Sclerosis Act. The law encourages development of "tools, methods, and processes" to improve clinical trial efficiency for neurodegenerative diseases. The Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) is an outcome measure administered during in-person clinic visits and used to support investigational studies for persons living with amyotrophic lateral sclerosis. Availability of a standardized, remote-use version of the ALSFRS-R may promote more inclusive, decentralized clinical trials. A scoping literature review was conducted to identify existing remote-use ALSFRS-R tools, synthesize feasibility and comparability of administration modes, and summarize barriers and facilitators to inform development of a standardized remote-use ALSFRS-R tool. METHODS: Included studies reported comparisons between remote and in-person, clinician-reported, ALSFRS-R administration and were published in English (2002-2022). References were identified by searching peer-reviewed and gray literature. Twelve studies met the inclusion criteria and were analyzed to compare findings within and across modes of administration. RESULTS: Remote modes of ALSFRS-R administration were categorized into 4 nonmutually exclusive categories: telephone (n = 6), videoconferencing (n = 3), computer or online platforms (n = 3), mobile applications and wearables (n = 2), and 1 unspecified telemedicine modality (n = 1). Studies comparing in-person to telephone or videoconferencing administration reported high ALSFRS-R rating correlations and nonsignificant between-mode differences. CONCLUSIONS: There is insufficient information in the ALSFRS-R literature to support remote clinician administration for collecting high quality data. Future research should engage persons living with amyotrophic lateral sclerosis, care partners, and providers to develop a standardized remote-use ALSFRS-R version.

Concurrent Validity Evidence for Pressure-Sensing Walkways Measuring Spatiotemporal Features of Gait: A Systematic Review and Meta-Analysis.

Technologies that capture and analyze movement patterns for diagnostic or therapeutic purposes are a major locus of innovation in the United States. Several studies have evaluated their measurement properties in different conditions with variable findings. To date, the authors are not aware of any systematic review of studies conducted to assess the concurrent validity of pressure-sensing walkway technologies. The results of such an analysis could establish the body of evidence needed to confidently use these systems as reference or gold-standard systems when validating novel tools or measures. A comprehensive search of electronic databases including MEDLINE, Embase, and Cumulative Index to Nursing and Allied Health Literature (CINAHL) was performed. The initial search yielded 7670 papers. After removing duplicates and applying study inclusion/exclusion criteria, 11 papers were included in the systematic review with 10 included in a meta-analysis. There were 25 spatial and temporal gait parameters extracted from the included studies. The results showed there was not a significant bias for nearly all spatiotemporal gait parameters when the walkway system was compared to the reference systems. The findings from this analysis should provide confidence in using the walkway systems as reference systems in future studies to support the evaluation and validation of novel technologies deriving gait parameters.