SUPPLEMENTAL MATERIAL C – Scales not critiqued/reason excluded
Visual Analogue Scale(s), VAS(s)
Porta 23 used a VAS scale with 0 indicating “normal salivation” and 100 indicating
“extremely high rate of salivation” in an open label study of botulinum toxin injections in
10 patients. No objective measures or alternative measures of sialorrhea were included
in this report and this VAS was therefore not considered for further evaluation.
Ondo et al 24 used pre- and post- treatment VASs of severity and percent change 71 in a
double-blind study of 16 patients in whom the DSFS and Drooling Rating Scale were
completed. Objective measures of salivary flow rates were also completed, but the
sample size was small.
Lagalla 17 et al used a visual analogue ratings of drooling frequency (VAS-D), and
patient embarrassment within the familial (VAS-FD) and social (VAS-SD) contexts in a
slightly larger study of 32 patients. The UPDRS drooling item and measures of dental
roll weights were included as alternative subjective and objective measures of salivary
functioning.
Conclusions: As both these studies excluded patients without troublesome drooling,
there is no data available for these VAS’s with regard to how sensitive they are to
change over time, reliability, PD severity, etc., they were not considered further for this
critique.
Unified Multiple System Atrophy Rating Scale, UMSARS
Concept Model: This scale is composed of 4 sections: I - Historical (12 items); II –
Motor exam (14 items); III – Autonomic evaluation (4 cardiovascular parameters); and
IV - Global Disability (105) and was designed as the multiple system atrophy equivalent
to the UPDRS.
The historical section includes information provided by the patient or caretaker about
speech, swallowing, handwriting, cutting food and handling utensils, dressing, hygiene,
walking, falling, orthostatic symptoms, urinary, sexual and bowel functions. The motor
exam includes facial expression, speech, ocular motor dysfunction, tremor at rest,
action tremor, increased tone, rapid alternating movements of hands, fingertapping, leg
agility, dysmetria, arising from chair, posture, body sway, and gait. In both sections, the
scoring system goes from 0 (normal) to 4 (severe). The autonomic examination section
includes blood pressure and heart rate (supine and standing up, or unable to record),
and the presence of orthostasis (yes or no). The global disability scale measures the
ADL dependence and capacity (each item has 5 answer options: l = totally independent,
without ADL difficulties; 5 = completely dependent, bedridden).
Clinimetric issues
Internal consistency - Satisfactory for the sections I and II (Cronbach’s α = 0.84 and
0.90, respectively). Sections I and II item-total correlation was satisfactory for most of
the items (rS> 0.50 for 9 items of the Section I and 11 items of the Section II). Two items
of Section I and 3 of Section II showed poor or no association with the corrected total
score.
Inter-rater reliability - The average index kappa average for the participant centers
was satisfactory (kappa > 0.70) for 8 items of the historical section. Orthostatic
hypotension was the item with worst inter-rater reliability (kappa = 0.52). Similarly, a
satisfactory agreement was found in the section II, except for oculomotor dysfunction,
hypertonia, and finger tapping items (kappa < 0.70). In the section IV, a substantial or
excellent agreement was also found (kappa = 0.75-0.94). Overall, there was an
excellent agreement (ICC= 0.88 for the Section I; ICC = 0.93 for the Section II).
Convergent validity - The section I correlated significantly with the HY, UPDRS Section II (ADL) and SE scales (rS = 0.76-0.90). The Section II correlated with the HY,
UPDRS - Section III (Motor Exam) and the International Cooperative Ataxia Rating
Scale (ICARS) (106) (rS = 0.80-0.93). The Section IV also obtained significant
correlation coefficients with HY, UPDRS – sections II and III and ICARS (rS = 0.72 0.94), as well as with the UMSARS Sections I and II. There was moderate correlation
between the sections I and II total scores and timed tests (rS = 0.42-0.57).
Well-known groups validity - The UMSARS sections I, II and IV differentiated
adequately between patients at different levels of disease severity.
UMARS Conclusion: While this scale has undergone clinimetric testing, it has
considerable overlap with the existing UPDRS and was therefore not considered further
for critique of scales for GIDS.