A qualitative evaluation of the revised amyotrophic lateral sclerosis functional rating scale (ALSFRS-R) by the patient community: a web-based cross-sectional survey

Abstract

Objective

The revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) is the most commonly used outcome measure in ALS studies. The aim of this study was to identify potential limitations of the ALSFRS-R from the perspective of people living with ALS and their caregivers.

Methods

A web-based survey was developed by investigators, people living with ALS, and their caregivers, and shared across social media. For each item, participants were asked, “Can you think of a situation where you might not be able to answer this item accurately or that your answer might not reflect your abilities?” Responses were divided into two categories: criticisms that could be addressed in a manual or issues with the items/responses that would require measure modification.

Results

57 participants (72% participants with ALS, 28% caregivers) responded to at least one item question, of which 71.9% expressed concern about at least one item. The most frequently identified items were speech, walking, and cutting food. Common criticisms were: language used is of a medical literacy level too high; item is situational; difficult to distinguish the difference between response choices; and the structure and/or underlying assumptions of the item makes it difficult to answer.

Conclusions

Several items of the ALSFRS-R were considered to inaccurately reflect the abilities of patients with ALS. The ALSFRS-R may need a revision to address these issues, preferably in co-development with people living with ALS and their caregivers, and/or alternate outcome measures should be considered for patients with ALS.

Keywords:

• amyotrophic lateral sclerosis
• clinical outcomes
• measurement
• qualitative study

Acknowledgements

The authors would like to thank the participants of this study. We would like to acknowledge the contributions of Mary C. Collet, MS and Phil Green, BS to the manuscript.

Declaration of interest

CJM is supported by the National Institute for Health and Care Research Sheffield Biomedical Research Center and a National Institute for Health and Care Research Professorship award. The authors report there are no other competing interests to declare.

Data availability statement

The subset of the data that support the findings of this study have been included in a Supplemental file.