AI Article Synopsis
- The ALSFRS, originally developed over 25 years ago, is used to track functional changes in ALS patients and has been adapted to create the ALSFRS-R for clinical trials, though it hasn't been fully re-validated.
- A group of clinical trialists met to discuss ways to enhance the ALSFRS-R and consider alternative measures for clinical research.
- The report emphasizes three key actions: standardizing ALSFRS-R usage worldwide, agreeing on clinical trial design and statistical analysis recommendations, and incorporating additional outcome measures.
Article Abstract
The Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) was developed more than 25 years ago as an instrument to monitor functional change over time in patients with ALS. It has since been revised and extended to meet the needs of high data quality in ALS trials (ALSFRS-R), however a full re-validation of the scale was not completed. Despite this, the scale has remained a primary outcome measure in clinical trials. We convened a group of clinical trialists to discuss and explore opportunities to improve the scale and propose alternative measures. In this meeting report, we present a call to action on the use of the ALSFRS-Revised scale in clinical trials, focusing on the need for (1) harmonization of the ALSFRS-R administration globally, (2) alignment on a set of recommendations for clinical trial design and statistical analysis plans (SAPs), and (3) use of additional outcome measures.
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| http://dx.doi.org/10.1080/21678421.2024.2320880 | DOI Listing |
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