Objective: The ALS Functional Rating Scale-Revised (ALSFRS-R) is the most frequent primary outcome measure in ALS trials. The reliable and accurate performance of this instrument is critical. The Barrow Neurological Institute Clinical Research Organization (BNI-CRO) has been performing evaluator training and certification for the ALSFRS-R since 2011. Here we evaluate the impact of evaluator training and participant practice.
Methods: Training records were reviewed for evaluators trained and certified by the BNI-CRO at least twice since 2011. We determined the impact of training intervals on ease of recertification. We also assessed whether the mode of training impacted successful vignette scoring. For self-reported participant assessment, remote training was provided by BNI CRO personnel; we determined whether there was a practice effect on reliable assessment.
Results: 117 evaluators completed at least two training sessions either via interactive in-person training, interactive remote training, or by completing a self-training module. Poorer performance on retraining was noted when the interval between pieces of training was 2 years or greater. Mode of training also impacted performance; interactive in-person and remote sessions were associated with better performance than the use of self-training modules. For participant self-assessment, week-week variability in ALSFRS-R scores declined over time as the study progressed.
Conclusions: Standard training of evaluators has an impact on the performance of the ALSFRS-R, with shorter intervals between training positively impacting performance. Interactive training sessions allowing for real-time questions also are associated with better performance. Continued training is important to maintain a high-quality ALSFRS-R assessment.
Keywords: ALS functional rating scale; clinical trials; outcome measures; outcome training; rater performance.