Clinically meaningful change: evaluation of the Rasch-built Overall Amyotrophic Lateral Sclerosis Disability Scale (ROADS) and the ALSFRS-R

Figures & data

Table 1 Characteristics of the 162 participants with ALS included in analyses.

Parameter (continuous variables)	Mean (SD)
Age of onset (years)	59.75 (11.12)
Disease duration at first assessment (years)	3.16 (3.38)
Baseline ALSFRS-R score	31.54 (9.17)
Baseline normed ROADS score	83.60 (20.13)
Time between assessments (months)	6.41 (4.21)
Mean decline in ALSFRS-R per month	−0.76 (1.09)
Mean decline in normed ROADS per month	−2.03 (2.44)
Parameter (categorical variables)
Site of symptom onset
Bulbar	38 (23.46%)
Upper extremity	61 (37.65%)
Lower extremity	62 (38.27%)
Diaphragm	1 (0.06%)
Sex
Female	66 (40.74%)
Male	96 (59.26%)
Race
Asian	3 (1.85%)
Black or African American	22 (13.58%)
Pacific Islander	1 (0.62%)
White	130 (80.25%)
Other	1 (0.62%)
Unknown	5 (3.09%)
Ethnicity
Hispanic/Latino	4 (2.47%)
Non-Hispanic/Latino	148 (91.36%)
Unknown	10 (6.17%)

Table 2 Patient-reported global impression of change results.

Patient-reported global impression of change n (%)	Change in ROADS mean (SD)	Change in ALSFRS-R mean (SD)
Better/Unchanged 28 (17.28%)	−3.64 (4.56)	−0.64 (2.17)
A little worse 86 (53.09%)	−9.45 (9.77)	−3.88 (3.98)
A lot worse 48 (29.63%)	−17.56 (12.52)	−7.21 (6.08)

Data availability statement

All study data analyses are included within this manuscript. An anonymized version of the dataset used for conduct of this study will be shared upon request to a qualified investigator with institutional review and approval.