Epilepsia. W(Suppl. 4):S28-S33.
1993
Raven Press, Ltd., New York
0 International League Against Epilepsy
A New Quality-of-Life Inventory for
Epilepsy Patients: Interim Results
Kenneth R. Perrine
Comprehensive Epilepsy Center, Depurtment qf Neurology, New York University School of Medicine
and Hospitul.li,r Joint Diseuses, New York, New York, U.S.A.
Summary: The process for developing and evaluating a
comprehensive, self-report measure of quality of life in epi-
lepsy (QOLIE) is described, and interim results for 64 patients
are reported. A test battery of 98 quality-of-life items was
constructed with use of the RAND 36-Item Health Survey
as a generic core and adding other quality-of-life items, the
latter derived from a literature review and expert opinion on
areas of importance to people with mild to moderate epilepsy.
Seventeen scales tapping unique quality-of-life dimensions
were identified from this QOLIE test battery. The battery
was administered to 64 adults with mild to moderate epilepsy
and their proxies (relative or close friend) on two separate
visits 2-3 weeks apart. Patients also completed a neuropsy-
chological test battery on the first visit. Interim analysis of
Epilepsy continues to be a common and important
health problem. There are an estimated 1.5 million
persons with epilepsy controlled by medication and
800,000 more with refractory or intractable seizures,
while 125,000 new cases of epilepsy are reported each
year (NIH, 1990).These figures indicate that 1% of this
nation’s population has epilepsy. The disorder is similar
to other chronic illnesses in that medical management
usually provides control but not a cure. Patients with
epilepsy usually are prescribed antiepileptic drugs
(AEDs) for seizure control. Many AEDs are accom-
panied by side effects in varying degrees of severity.
Epilepsy and the drugs used in its management can
significantly affect a person’s life. Until recently, the
vast majority of research on epilepsy has been directed
toward medical management, surgery, or selected areas
such as personality or cognitive functioning.
Address correspondenceand reprint requests to Dr. K. R. Pemne
at Department of Neurology, NYU School of Medicine and Hospital
for Joint Diseases, 301 E. 17th Street, New York, NY 10003, U.S.A.
S28
these data demonstrated that 16 of 17 scales on the QOLIE
test battery are sufficiently reliable for group comparison:
Cronbach’s alpha for the 16 scales ranged from 0.73 to 0.88;
test-retest reliability ranged from 0.56 to 0.88. Preliminary
evaluation of validity confirmed hypothesized correlations
between selected QOLIE scales and Profile of Mood State
scales. Correlations between patient and proxy scores ranged
from 0.29 to 0.69 (all statistically significant at p < 0.005).
A more detailed, final analysis of data for over 300 patients
currently enrolled in the study will be published later. Key
Words: Medical history taking-Medical informatics-
Medical informatics application-Quality of life-Epilepsy-
Seizures-Clinical trials-Anticonvulsants.
An interest in broader quality-of-life factors beyond
simple cure or control rates began with cancer research
in the 1940s (Karnofsky and Burchenal, 1949).Within
the past 10 years, research and clinical care in chronic
diseases has expanded to include an emphasis on many
quality-of-life issues. This newer focus is on the pa-
tient’s perception and experience of disease and its
overall impact.
The World Health Organization (WHO) defined
health as “a state of complete physical, mental, and
social well-being and not merely the absence of disease
or infirmity” (WHO, 1948).Domains of health-related
quality of life include physical functions (strength, am-
bulation, endurance, systemic functions, and pain);
psychological factors, including mood disorders (anx-
iety and depression), self-perception, stigma, and cop-
ing mechanisms (self-efficacy and locus of control); so-
cial factors (family interactions, friendships, romantic
relationships, social supports, and community in-
volvement); daily activity (employment, household
management, recreation, and transportation); and
economic factors (unemployment and health care).
 A NEW INVENTORY
Numerous models for assessing quality of life in
chronic disease states have been proposed (Spilker,
1990), and a variety of measures have been developed
(Guadagnoli and Mor, 1990; McDowell and Newell,
1987; Shumaker et al., 1990).There are disease-specific
inventories for a broad range of chronic illnesses, as
well as more general quality-of-life inventories such as
the Sickness Impact Profile (Bergner et al., 1981), the
General Health Questionnaire (Godberg, 1979), and
the Nottingham Health Profile (Hunt et al., 1980).
Although psychosocial adjustment issues have been
studied in the epilepsy population (Antonak and Liv-
neh, 1992), most reports focus on psychopathology
(Pemne, 1991) or cognitive dysfunction (Perrine et al.,
1992). There are some studies of epilepsy patients on
discrete quality-of-life domains such as self-efficacy
(Dilorio et al., 1992), and some reports of domains
using a combination of discrete scales (Hermann and
Whitman, 1989). Until recently, however, very little
attention has been paid to the comprehensive assess-
ment of health-related quality of life (Chaplin et al.,
1990; Collings, 1990; Jacoby, 1992).
Part of the difficulty in conducting research on qual-
ity of life in epilepsy is the paucity of standardized
instruments for assessing a broad range of relevant do-
mains. Dodrill et al. ( 1980) developed the Washington
Psychosocial Seizure Inventory (WPSI) to quantify se-
lected areas of psychological and social problems in
patients with epilepsy. The WPSI includes scales of
family background, emotional adjustment, interper-
sonal adjustment, vocational adjustment, financial
status, adjustment to seizures, medicine and medical
management, and overall psychosocial functioning.
Although the WPSI represented a step forward in self-
reporting and quantitative assessment of these areas at
the time of its development, it does not satisfy many
criteria for health-related quality-of-life assessment that
have been generated by health services and social sci-
ence researchers over the last decade (Antonak and
Livneh, 1992). Vickrey et al. ( 1992)developed the Epi-
lepsy Surgery Inventory (ES1)-55. The ESI-55 has the
RAND 36-Item Health Survey-the product of re-
search conducted during the Health Insurance Exper-
iment and the Medical Outcomes Study (Stewart et al.,
1992)-as its generic core, and includes an epilepsy-
specific supplement. The instrument was validated in
a large sample, and demonstrated very good reliability
as well as discriminant and convergent validity in this
population of epilepsy surgery patients.
To date, however, there is no comprehensive, single
quality-of-life measure for persons with low to mod-
erate seizure frequency or severity, the largest popu-
lation of epilepsy patients. The need to develop a
S29
health-related quality-of-lifeinventory for such patients
led to formation of the Quality of Life in Epilepsy
(QOLIE) Development Group. The current article de-
scribes the preliminary development of an inventory
and presents interim data on its reliability and validity
from an ongoing study. The final analysis in a larger
population of more than 300 patients will be made
available in a future report by the Development Group.
METHODS
Subjects
Subjects were recruited from 15 sites across the con-
tinental United States. Most of the sites were compre-
hensive epilepsy centers, although several were hospital
and medical school neurology clinics. Subjects were
required to meet the following criteria: age, 17-70
years; 10th grade education and an ability to read En-
glish; seizure types consisting of complex partial sei-
zures, simple partial seizures, generalized tonic-clonic
seizures, absence seizures, or myoclonic seizures; no
other medical or psychiatric illness; no medication
(other than AEDs) with central nervous system effects;
no neuropsychological testing within the last 6 months;
and no craniotomy in the last 12 months. Eligible sub-
jects had seizure frequencies falling into the low or
moderate range (Table 1). Only subjects who had a
relative, friend, or significant other available to com-
plete the proxy questionnaire were included in the
study.
The interim analysis is based on data collected from
64 patients and proxies who had completed the study
as of November 1992. The final analyses will include
data from more than 300 patients.
Measures
QOLIE test battery
The QOLIE test battery consists of 98 unique self-
report items. Most items were scored using a Likert
scale format. Several items used a yes/no format; there
was a single visual analogue item. The inventory was
developed by using the RAND 36-Item Health Survey
as a generic core (Stewart et al., 1992; Ware and Sher-
TABLE 1. Criteria for low and moderate seizure
frequency by type of seizure
Number of seizures
per year
Seizure type LOW Moderate
520 21-100
Simple partial
Complex partial 54 5-12
Generalized tonic-clonic I 1 2-4
Absence I20 21-100
Myoclonic I20 21-100
Epilepsia. Vol. 34, Suppl. 4, 1993
S30 K. R. PERRINE

bourne, 1992). The RAND 36-Item Health Survey in-
cludes the following scales: general health perceptions,
physical function, role limitations due to physical
problems, role limitations due to emotional problems,
social function, energy and fatigue, emotional well-
being, and pain. There is a single item on change in
health.
A supplemental battery of items designed to assess
health-related quality of life in patients with low to
moderate seizure frequency was added by our group
of researchers based on a literature review and expert
opinion. To tap into domains that are important to
people with epilepsy, we added items in the areas of
seizure-specific health perceptions, seizure worry, at-
tention and concentration, memory, language, working
and driving limitations, medication effects, overall
quality of life, social support, and social isolation. Items
were adapted or derived from several sources (Nelson
et al., 1987; Hadorn and Hays, 1991; Vickrey et al.,
1992) or were created de novo. Hypothesized scales in
the resultant test battery and examples of items are
shown in Table 2.
There were identical inventories for patient and
proxy. However, the items were rephrased for the
proxy, who was instructed to answer them in the way
he or she believed best described the patient's situation.
Neuropsychological meastires
A brief battery of neuropsychological tests sensitive
to cognitive problems caused by epilepsy and AEDs
was administered to patients following completion of
the QOLIE questionnaire. Three memory measures
were included to address the frequent complaint of
memory problems by patients with epilepsy (Pemne
et al., 1992). A measure of immediate and delayed ver-
bal semantic memory was assessed by the Logical
Memory subtest of the Wechsler Memory Scale-
Revised (Wechsler, 1987). Verbal learning and recall
were assessed by the Rey Auditory Verbal Learning
Test, which comprises five trials of a 15-word list, a
15-word distractor list, immediate and delayed recall
of the original 15-word list, and delayed recognition of
the 15-word list (Rey, 1964). Nonverbal memory was
assessed by immediate and delayed reproductions of
the Rey-Ostemeth Complex Figure Test (Ostemeth,
1944). Verbal fluency was assessed by the Controlled
Oral Word Association Test and visual confrontation
naming by the Visual Naming subtest of the Multilin-
gual Aphasia Examination (Benton and Hamsher,
1983). Cognitive processing speed and resistance to
competing response sets were assessed by the Stroop
Color Word Test (Golden, 1978), fine motor dexterity
and speed by the Grooved Pegboard Test (Lezak, 1983),
and visuo-motor learning and speed by the Symbol
Digit Modalities Test (Smith, 1968). Finally, a self-'
report of mood was assessed by the Profile of Mood
States (POMS) (McNair et al., 1992).
All tests were scored with use of established proce-
dures outlined in standardized manuals or references.
Because the Rey-Ostemeth Complex Figure Test is dif-
ficult to score and can produce unreliable results, all
figures were scored by one neuropsychologist who was
not part of the QOLIE investigation team. Interrater
reliability was determined with scoring of randomly

TABLE 2. Qualit.v-qJL& in Epilepsy (QOLIE) test battery scules and sample items
Test battery scales Sample item
Health perception In general, would you say your health is excellent, very good, good. fair, poor?"
Seizure wony Do you worry about hurting yourself during a seizure?
Physical function Does your health limit you in doing vigorous activities such as running, lifting heavy objects, participating
in strenuous sports?
Role limitations-physical Do you accomplish less than you would like to because of physical problems?
Role limitations-emotional Do you do your work or other activities less carefully because of emotional problems?
Pain How much bodily pain have you had in the past 4 weeks?
Overall quality of life Overall, how would you rate your quality of life (best to worst on a scale of lo)?
Emotional well-being How much of the time in the past 4 weeks have you felt downhearted and blue?
Energy/fatigue How often have you felt worn out?
Attention/concentration How often do you feel you react slowly to things that are said or done?
Memory How often do you have trouble remembering names of people?
Language How often do you have trouble finding the right word?
Working/driving limitations How much are you bothered by driving limitations?
Medication effects How much are you bothered by physical effects of antiepileptic medication?
Social function How much of the time during the past 4 weeks has your health limited your social activities (such as
visiting with friends or close relatives)?
Social support Please rate the support your family and/or friends give each other.
Social isolation How much of the time during the past 4 weeks did you feel left out?

There was also a single item on change in health from the RAND 36-item survey.
Items were derived from several sources or were created de novo. Sources were Medical Outcomes Study (Stewart et al., 1992; Hadorn and
Hays, 1991); the ESI-55 (Vickrey et al., 1992), and the COOP charts (Nelson et al., 1990).

Epilepsiu, Vol. 34. Siippl. 4. I993

 A NEW INVENTORY
selected figures by a senior neuropsychologist (the au-
thor) who was a QOLIE Development group member.
The neuropsychological tests were administered in the
following order: (a) Logical Memory-immediate; (b)
Rey Complex Figure Test-copy; (c) Rey Complex
Figure Test-immediate recall; (d) Rey Auditory Ver-
bal Learning Test (through trial 6); (e) Grooved Peg-
board Test; (f) Controlled Oral Word Association Test;
(g) Stroop Test; (h) Profile of Mood States; (i) Logical
Memory-delayed recall; (j)Rey Complex Figure
Test-delayed recall; (k)Rey Auditory Verbal Learning
Test-delayed recall and delayed recognition; (I) Visual
Naming Test; and (m) Symbol Digit Modalities Test.
This order was occasionally altered to meet the time
constraints of the delayed recall for the three memory
tests, all of which occurred at fixed intervals.
Data collection
Potential subjects were identified by chart reviews
or examination of admission notes by the principal
investigator or designated research coordinator at each
site and recruited by one of the study personnel. All
subjects gave informed consent for participation. One
of the study personnel (typically a nurse) recorded de-
mographic information for the patient and proxy and
medical information for the patient on prepared forms.
For the patient, the information included age, gender,
marital status, education, occupation, seizure history
(age at onset, seizure frequency by type in the past 12
months, date of the most recent seizure), current AEDs
and total daily dosage, health care utilization, and cur-
rent comorbid medical conditions. For the proxy, this
information included gender and age, education, oc-
cupation, and relationship to and frequency of contact
with the patient.
Patients were rated by a neurologist or nurse on
standardized scales of neurotoxicity and systemic tox-
icity (Cramer et al., 1983). The neurotoxicity scale in-
cluded assessment of diplopia, nystagmus, dysarthria,
abnormal gait, impaired rapid alternating movements,
tremor, sedation, disrupted affect and mood, impaired
cognitive function, AED-related dizziness or light-
headedness, and AED-related headaches. The systemic
toxicity scale assessed gastrointestinal problems, im-
potence, weight gain, changes in hair quantity or tex-
ture, and other AED-related systemic effects.
After all information was recorded, both the patient
and proxy completed the QOLIE questionnaires. The
patients then received the series of neuropsychological
tests described above. Both the patient and proxy again
completed the QOLIE questionnaire 2-3 weeks later,
either by mail or by returning to the testing site. In-
dividual study folders for each patient/proxy pair were
sent to a central site for review and data entry.
S31
Analysis plan
Initially, a total of 17 hypothesized scales were iden-
tified in the QOLIE test battery. Eight of these were
drawn from the RAND Health Survey generic core;
nine more were derived by grouping supplemental
items into clusters based on content (Table 2). A single
item on change in health from the RAND Health Sur-
vey was also in the test battery.
Scores on all of these scales were linearly transformed
to scales of 0- 100 points, the higher values representing
better functioning. Descriptive statistics, including
mean, standard deviation, minimum, maximum, and
percentage scoring at the ceiling, were calculated for
each scale.
Two methods were used in assessing reliability. In-
ternal consistency reliability coefficients (Cronbach,
1951) were calculated for each scale. To evaluate item
convergence within each scale, item-scale correlations
were also generated. Correlations between patients’
scale scores on the first and second visits were calculated
for determining test-retest reliability of each scale.
Correlations were also calculated between the patient
and proxy forms as a measure of construct validity.
The correlations between POMS scales and QOLIE
test battery scales were also determined, as were cor-
relations between neuropsychological measures and
QOLIE test battery scales.
RESULTS
Subject characteristics
The 64 subjects (27 men and 37 women) in this pilot
analysis ranged in age from 18 to 66 years (mean k
SD, 35.2 f 11.6 years). Duration of epilepsy ranged
from 1 to 50 years (mean f SD, 17.9 f 12.5 years).
Descriptive statistics
Mean patient scores (first visit) on the 17 QOLIE
test battery scales ranged from 57 (seizure worry) to
87 (physical function). Minimum scale scores ranged
from 0 to 25. Some patients scored the maximum (100)
on all scales except health perceptions; however, on
only one scale (role limitations due to emotional prob-
lems) did more than one-half of the patients score the
maximum.
Reliability
Cronbach’s alpha ranged from 0.73 to 0.88 for 16
of the 17 multi-item scales (alpha = 0.68 for medication
effects). Evaluation of item-scale correlations revealed
low correlation between one item each in the seizure
worry and social support scales and between other items
in each scale. Based on this limited item analysis, these
two items were excluded from the remainder of the
interim data analyses.
Epilepsia. Vol. 34, Suppl. 4, I993
S32 K . R. PERRINE
Correlations between patients’ scores on the first and
second visits ranged from 0.56 to 0.88 for all scales
except medication effects (alpha = 0.37). Based on the
very low test-retest reliability for the medication effects
scale, it also was excluded from the remainder of the
interim data analyses.
Validity
Correlations between patient and proxy scores at the
first visit ranged from 0.29 (physical function) to 0.69
(pain); all were statistically significant ( p < 0.005).
Correlations between the QOLIE emotional well-
being scale and the POMS tension, depression, and
anger scales ranged from -0.62 to -0.79 (all statisti-
cally significant at p < 0.000 1). Other correlations were
as follows: between the QOLIE energy/fatigue scale and
the POMS vigor and fatigue scales, 0.61 and -0.65,
respectively ( p < 0.0001); and between the POMS
confusion scale and the QOLIE attention/concentra-
tion, memory, and language scales, -0.6 1, -0.5 1, and
-0.52, respectively.(all p < 0.0001).
Significant correlations were also found between the
QOLIE language scale and selected neuropsychological
measures. The QOLIE language scale correlated sig-
nificantly with the Controlled Oral Word Association
word fluency test (r = 0.39, p < 0.002) and with the
Visual Naming test (r = 0.31, p < 0.01). The language
scale also correlated significantly with the word, color,
and color-word trials of the Stroop test (r = 0.40,0.39,
0.27; p < 0.001, 0.001, and 0.03, respectively). Neu-
ropsychological tests not dependent on language func-
tion did not significantly correlate with the QOLIE
language scale.
DISCUSSION
The need for a comprehensive, self-report quality-
of-life measure for patients with varying degrees of epi-
lepsy was identified. A process for developing and eval-
uating such a measure was defined, and data collection
was begun. The measure used consisted of a generic
core supplemented with additional items tapping into
dimensions of quality of life important to people with
epilepsy. These included self-perceived cognitive func-
tion (attention, memory, and language), work and
driving limitations, seizure worry, and social health-
all of particular importance to these patients.
To evaluate the potential reliability and validity of
the resulting quality-of-life items in patients with epi-
lepsy, an interim data analysis was performed based
on the first 64 patients enrolled in this study. This in-
terim analysis revealed no “ceiling” or “floor” effects,
i.e., scale scores did not tend to cluster at the scoring
maximum or minimum. The exception was the scale
for role limitations due to emotional problems. Thus,
Epilepsia. Vol. 34, Suppl. 4. 1993
all but one scale in the QOLIE test battery appear to
have the potential for sensitivity to changes in quality
of life over time. With respect to reliability, 16 of 17
QOLIE test battery scales appear to be sufficiently re-
liable for group comparisons, based on internal con-
sistency reliability coefficients that exceed 0.70 (Nun-
nally, 1978). In general, test-retest reliability was also
satisfactory for all but one scale on medication effects,
although a few test-retest correlations were lower than
internal consistency reliability coefficients. There is also
preliminary evidence for construct validity, with sig-
nificant correlations between QOLIE test battery scale
scores and proxy scores, POMS scores, and selected
neuropsychological test battery scores. All of these
findings will be re-evaluated in the expanded data
analysis that will be performed with data from the
complete study cohort.
Although item convergence within scales was eval-
uated in this interim analysis, a more detailed scale
development procedure using multitrait scaling to
evaluate item discrimination across scales will be per-
formed in the final analysis (Hays and Hayashi, 1990).
(The multitrait scaling procedure could not be per-
formed on this interim data set because of insufficient
sample size.) This item analysis may lead to consoli-
dation of some of the hypothesized scales presented
here, or to deletion or change in placement of some
items, or both. Therefore, these results, while prom-
ising, must be viewed as preliminary.
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