Blaisdell, B

Ferini Strambi, L

Kushida, CA

Martin, MC

Nikam, P

Ware, J

Elsevier - Publisher Connector 

320 Abstracts
to include an outpatient drug beneﬁt will decrease beneﬁciaries’
burden of multiple sclerosis. RESULTS: Few MS beneﬁciaries
(5%) reported that they did not get prescription medications that
were prescribed for them. Some beneﬁciaries (15%) reported
delaying health care due to the cost. The average out-of-pocket
cost of commonly used medications (e.g., baclofen (Baclofen®),
interferon beta-1B (Betaseron®), and ﬂuoxetine (Prozac®))
among the insured is about half the price borne by the under-
insured beneﬁciaries. For example, interferon beta-1B is $27 per
prescription among insured beneﬁciaries, and $58.50 among
under-insured beneﬁciaries. Similar results were found for other
medications that are common among MS beneﬁciaries. CON-
CLUSIONS: Our ﬁndings suggest that MS beneﬁciaries perceive
few economic barriers to necessary health care, particularly pre-
scription medications. However, we ﬁnd substantial differences
exist in the out-of-pocket price of commonly used medications
between under-insured and insured beneﬁciaries. These differ-
ences should attenuate with the expansion of Medicare to
include a drug beneﬁt decreasing the economic burden of multi-
ple sclerosis.
PNL19
DEVELOPMENT OF THE MULTIPLE SCLEROSIS TREATMENT
SATISFACTION QUESTIONNAIRE (MSTCQ)
Cramer JA1, Cuffel B2
1Yale University, West Haven, CT, USA; 2Pﬁzer, New York, NY, USA
OBJECTIVE: To develop a measure of treatment satisfaction
that assesses attributes speciﬁc to injected medications for mul-
tiple sclerosis (MS). METHODS: Item development for the MS
Treatment Satisfaction Questionnaire (MSTCQ) was initiated
with review of MS websites, literature, adverse effects, as well 
as interviews and focus groups with MS patients. Pilot testing
resulted in aggregation of items postulated to assess adverse
effects, difﬁculty of use, inconvenience, and discomforts. The
MSTCQ test instrument included nine items describing “Satis-
faction with the Injection System” and 11 items describing “Side
Effects.” The instrument was completed by 317 patients, ages
18–60 years, who had been using interferon-beta-1a subcuta-
neously for > six-months. RESULTS: The “Satisfaction with the
Injection System” subscale ﬁt a one-component solution with
internal consistency coefﬁcient with good cross-sectional relia-
bility (a = 0.70). A principal components analysis of the 11 items
assessing “Side Effects” resulted in a three-component solution:
ﬂu-like side effects (a = 0.82); injection-site reactions (a = 0.68),
and global items (a = 0.75). Test-retest reliabilities at one-week
(N = 55) were Satisfaction r = 0.68 (intraclass correlation coef-
ﬁcient); Side Effects: ﬂu-like side effects, r = 0.86; global evalu-
ation of side effects, r = 0.77; injection site side effects, r = 0.73.
Almost all correlations were statistically signiﬁcant (p < 0.001).
Correlations with demographic variables showed signiﬁcant
associations with the MSTCQ total and subscale scores. Age,
falling behind in work and home activities, and level of activ-
ity/independence exhibit the most consistent relationships to the
various MSTCQ measures. CONCLUSIONS: The initial devel-
opment and testing shows that the MSTCQ should provide
insight into the concerns of MS patients about their use of
injected medications. These data indicate that older respondents
and respondents who are relatively more active and independent
have a more favorable view of their MS treatment.
NEUROLOGICAL DISORDERS—Other
PNL20
RESTLESS LEGS SYNDROME PLACES A SUBSTANTIAL
BURDEN ON THE HEALTH-RELATED QUALITY OF LIFE OF US
AND EUROPEAN PATIENTS
Martin MC1, Nikam P2, Blaisdell B1, Kushida CA3, Ferini Strambi L4,
Ware J1
1Quality Metric Incorporated, Lincoln, RI, USA; 2GlaxoSmithKline,
Collegeville, PA, USA; 3Stanford Center of Excellence for Sleep
Disorders, Stanford, CA, USA; 4Università Vita-Salute, Milan, Italy
OBJECTIVES: Restless Legs Syndrome (RLS) is a sensorimotor
disorder resulting in a desire to move the limbs, which often leads
to severe sleep disturbances. This study aims to compare the
health-related quality of life (HRQOL) burden that RLS places
on US and European (EU) individuals. METHODS: Analyzed
cross-sectional data (with screening, RLS symptom, and SF-36
items) from EU (France, N = 75; Germany, N = 25; Italy, N =
42; Spain, N = 37; UK, N = 44) and US (N = 158) samples. SF-
36 scores of persons with RLS were compared with patient (type-
2 diabetes, depression, osteoarthritis [OA]) and US general
population norms. Regression methods were applied to estimate
sociodemographically adjusted norm values and test for signiﬁ-
cance. Comparisons to norm were conducted: 1) maintaining the
case-mix of conditions that both RLS and general population
respondents presented (“total” burden); 2) statistically adjusting
for conditions not attributed to RLS (“unique” burden). Burden
is deﬁned as a negative deviation in SF-36 scores from norm asso-
ciated with the presence of a medical condition (e.g. RLS).
RESULTS: Relative to an average adult, total burden ranged
from 0.44 to 1.07 standard deviations (SD) below general pop-
ulation norm for US, and 0.49 to 1.04 SD for EU. Relative to
an average healthy adult, the unique burden ranged from 0.63
to 1.36 SD and from 0.91 to 1.48 SD below norm for both US
and EU samples, respectively, (where 0.5 SD is viewed as meeting
standards of minimal clinically important difference). US RLS
sufferers reported the greatest burden on physical domains; EU
on mental health. For both samples, RLS burden was greater
than type-2 diabetes and OA, and similar to depression. CON-
CLUSIONS: RLS places a sizable burden on HRQOL—similar
for US and EU samples, affecting both physical and mental
health. The EU sample is more affected in mental health; the US
sample is more affected in physical health.
PNL21
FUNCTIONAL LIMITATIONS, MENTAL HEALTH,AND
RESOURCE USE ASSOCIATED WITH THE HEALTH-RELATED
QUALITY OF LIFE OF PATIENTS WITH RESTLESS 
LEGS SYNDROME
Martin MC1, Nikam P2, Blaisdell B1, Kushida CA3, Ferini Strambi L4,
Ware J1
1Quality Metric Incorporated, Lincoln, RI, USA; 2GlaxoSmithKline,
Collegeville, PA, USA; 3Stanford Center of Excellence for Sleep
Disorders, Stanford, CA, USA; 4Università Vita-Salute, Milan, Italy
OBJECTIVES: Restless legs syndrome (RLS) is a sensorimotor
disorder characterized by an irresistible urge to move the limbs,
which often results in disturbed sleep. This study aims to con-
textualize the impact of RLS on health-related quality of life
(HRQOL) in terms of functional limitations, mental health and
resource use. METHODS: Cross-sectional data from an omnibus
questionnaire (with screening and RLS symptom items) and the
SF-36 Health Survey (to assess HRQOL) from a US sample of
158 participants with RLS were analyzed. Capitalizing on prior
work that linked external criteria to patients differing in general
health self-evaluations, we assessed SF-36 physical and mental


PNL20 RESTLESS LEGS SYNDROME PLACES A SUBSTANTIAL BURDEN ON THE HEALTH-RELATED QUALITY OF LIFE OF US AND EUROPEAN PATIENTS 

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PNL20 RESTLESS LEGS SYNDROME PLACES A SUBSTANTIAL BURDEN ON THE HEALTH-RELATED QUALITY OF LIFE OF US AND EUROPEAN PATIENTS

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