Epilepsin, 37(6):577-582, 1996
Lippincott-Raven Publishers, Philadelphia
0 International League Against Epilepsy
A Brief Questionnaire to Screen for Quality of Life in
Epilepsy The QOLIE-10
Joyce A. Cramer, *Kenneth Perrine, “Orrin Devinsky, and ‘fKimford Meador
Health Services Research, Department of Veterans Affairs Medical Center, West Haven, and Department of
Neurology, Yale University School of Medicine, New Haven, Connecticut; “Department of Neurology New York
University, and Comprehensive Epilepsy Program, Hospital for Joint Diseases, New York, New York; and
?Department of Neurology, Medical College of Georgia, Augusta, Georgia, U.S.A.
Summary: Purpose: To evaluate a brief questionnaire to
screen aspects of health-related quality of life for persons
with epilepsy.
Methods: A study of 304 adults with epilepsy was under-
taken at 25 seizure clinics in the United States. It was
used for derivation of a brief screening tool from a longer
instrument (QOLIE-89).
Results: The 10-item questionnaire (QOLIE-10) covers
general and epilepsy-specific domains, grouped into three
factors: Epilepsy Effects (memory, physical effects, and
mental effects of medication), Mental Health (energy, de-
Measuring the outcome of treatment of epilepsy
traditionally has been in the realm of the health care
provider, who assesses results of treatment by using
seizure frequency and severity, adverse effects, and
antiepileptic drug (AED)-level parameters (1,2). Pa-
tient perceptions of outcome often include additional
parameters that encompass the effects of epilepsy
on daily activities and functions (3). This expanded
scope of impact was defined by the World Health
Organization (WHO) as health-related quality of life:
“a state of complete physical, mental, and social
well-being and not merely the absence of disease or
infirmity” (4). The WHO Classification of Impair-
ment, Disability, and Handicap also provides insight
into these issues by defining impairment as the con-
cern of clinicians, whereas patients tend to focus on
their handicaps (5).
Epilepsy is an example of a medical diagnosis that
is retained even when signs and symptoms (i.e.,
seizures) are well controlled and all laboratory tests
are normal. Jacoby (6) described epilepsy as “both
a medical diagnosis and a social label.” The possibil-
Received May 5, 1995; revision accepted March 1, 1996.
Address correspondence and reprint requests to J. A. Cramer
at Health Services Research (116A), VA Medical Center, 950
Campbell Ave., West Haven, CT 06516, U.S.A.
577
pression, overall quality of life), and Role Functioning
(seizure worry, work, driving, social limits). Scale scores
were significantly different among seizure groups (p =
0.003).
Conclusions: The QOLIE-10 can be completed by a
patient in several minutes and reviewed rapidly by the
physician. This screening tool could provide potentially
useful information for initial assessment or follow-up of
problem areas that are not commonly evaluated during
routine clinical visits with patients with epilepsy. Key
Words: Quality of life-Epilepsy.
ity of recurrent seizures is a silent but ever-present
component of daily life for most patients who carry
the diagnosis of epilepsy. Issues of compliance with
medication, restrictions on drinking alcohol, re-
quirements for special driver’s license approval, and
reporting of epilepsy on job and insurance applica-
tions often are life-long concerns. Although a
lengthy interview would be needed to examine these
topics completely with each patient, understanding
of health-related quality-of-life issues €or an individ-
ual can be approached by using a questionnaire com-
pleted by the patient.
A variety of instruments are available for evaluat-
ing health-related quality of life in a general popula-
tion. One of the most widely used questionnaires is
the RAND 36-Item Health Survey (SF-36) (7,8). The
Dartmouth COOP charts (9) are pictorial representa-
tions of how a patient might feel about each of seven
general health-related quality-of-life issues. Surveys
of patients and physicians have confirmed the useful-
ness of these screening questions in improving com-
munication and raising issues between patients and
providers (10). To improve the specificity of infor-
mation, generic questionnaires need to be tailored
for special populations (e.g., persons with epilepsy)
with supplementary items pertinent to problems typ-
ically reported by that population (1 1-13). The
578 J . A . CRAMER ET AL.

TABLE 1. The QOLIE-I0 questionnairea

How much of the time during All of the Most of the Some of the A little of None of the
the past 4 weeks ... time time time the time time
1. Have you had a lot of 1 2 3 4 5
energy?
None of A little of Some of Most of All of the
the time the time the time the time time
2. Have you felt down- 1 2 3 4 5
hearted and blue?
A great
Not at all A little Somewhat A lot deal
3. Has your epilepsy or 1 2 3 4 5
antiepileptic medication
caused trouble with
driving?
During the past 4 weeks, how
much have you been bothered Not at all Extremely
by ... bothersome A little Somewhat A lot bothered
4. Memory difficulties? 1 2 3 4 5
5 . Work limitations? 1 2 3 4 5
6. Social limitations? 1 2 3 4 5
7. Physical effects of 1 2 3 4 5
antiepileptic medication?
8. Mental effects of 1 2 3 4 5
antiepileptic medication?
Not at all Moderately Extremely
fearful Mildly fearful fearful Very fearful fearful
9. How fearful are you of 1 2 3 4 5
having a seizure during the
next month?
Very well; Good and Very bad;
could hardly bad parts could hardly
be better Pretty good about equal Pretty bad be worse
10. How has the quality of 1 2 3 4 5
your life been during the
past 4 weeks? That is,
how have things been
going for
“With permission from Professional Postgraduate Services. Permission to use the QOLIE-10 may be obtained from Professional
Postgraduate Services, 400 Plaza Drive, Secaucus, NJ 07094, U.S.A.
*Item 10 uses a chart figure (ref. 9).

QOLIE-89 instrument was developed to assess qual-
ity of life in a general population with epilepsy (14).
This report describes the development of a brief,
10-item questionnaire (QOLIE- 10) for screening
quality-of-life issues for patients with epilepsy, in
clinical practice.
METHODS
Instrument development
The QOLIE-89, containing 89 items within 17 scales,
was developed from the initial pool of 99 items by
using the method described by Devinsky et al. (14).
The choice of a 4-week retrospective review was
based on the RAND SF-36 (7,8) as a convenient
frame of reference for recall. Once the QOLIE-89
was derived, the QOLIE-10 (Table 1). was devel-
oped. An expert panel identified seven domains that
were considered important for patients with epi-
lepsy, all of which were represented by separate
QOLIE-89 scales. Items from the QOLIE-89 were
selected for inclusion in the QOLIE-10 by the expert
panel by examination of item-to-scale correlations
for each of the seven relevant domains, choosing
items with high item-scale correlations that also had
consistent or appropriate wording and sentence
structure. One item each was selected from five of
the seven QOLIE-89 scales (Seizure Worry, Emo-
tional Worry, Energy/Fatigue, Cognition, and Over-
all QOL). Two items were selected from the Medica-
tion Effects scale to sample physical and mental
effects of medications, and three items were selected
from the Social Function scale to provide individual
questions for driving, social, and work limitations.
Thus the final QOLIE-10 had 10 items drawn from

Epilepsia, Vol. 37, No. 6 , 1996

 QOLIE-10
seven QOLIE-89 scales on a combined empiric and
rational basis.
Instrument evaluation
The entire 99-item QOLIE test instrument was
administerd initially and repeated 2-3 weeks later.
The VA Systemic and Neuro Toxicity Scales (15)
were used to assess signs that were objectively eval-
uated by a clinician (e.g., tremor, gait disorder) and
symptoms that were reported by patients (e.g., gas-
trointestinal distress, tiredness). A neuropsycho-
logic test battery was administered after completion
of the first QOLIE questionnaire. The test battery
included measures of problems (e.g., attention,
memoryAanguage, cognitive speed, motor speed)
typically related to epilepsy and the use of AEDs
(16). The Profile of Mood States (POMS) (17) was
used to assess tension, depression, anger, vigor, fa-
tigue, and confusion. The questionnaire, systemic
and neurotoxicity ratings, and neuropsychologic tes-
ting were completed by the patient at the initial visit,
and the questionnaire alone was repeated at the sec-
ond visit.
Subjects
The study sample consisted of 304 adult (mean
age, 36 years; range, 17 to 60 years), English-speak-
ing patients with epilepsy (43% men) recruited from
25 epilepsy clinics in the United States to participate
in the evaluation of the instrument. Eligibility crite-
ria defined the sample as persons who were function-
ing at a relatively normal level, who could read and
comprehend the questions. The QOLIE instruments
were not intended for use by intellectually impaired
patients. Mean age of epilepsy onset was 17 k 12
years. Ninety-three percent of patients had a high
school equivalency diploma or higher education.
Other than having epilepsy and taking AEDs, pa-
tients had no significant medical or psychiatric ill-
ness, used no medication that could affect the central
nervous system, and had not undergone a craniot-
omy in the past year. Patients with either generalized
or partial epilepsy were grouped into controlled
(n = 21), low (n = 116), moderate (n = 136), and
high (n = 31) seizure-frequency groups based on
seizures in the past year (14).
Analyses
Varimax rotation was used for factor analysis of
the 10 items. Variables with loadings of 20.4 were
included in subscales. Reliability was assessed for
test-retest data by using Pearson correlation coeffi-
cients. Construct validity was assessed by the rela-
tion between individual items compared with the
source subscales and other external measures (e.g.,
5 79
demographic characteristics, seizure-frequency
group, toxicity scores, neuropsychologic test
scores) hypothesized a priori to be related to the
item. Discriminant validity was assessed by univari-
ate F tests of scales and items with seizure groups.
RESULTS
Table 2 shows the item correlations between
QOLIE-10 items and QOLIE-89 parent scales
(range, 0.54-0.73). Factor analyses yielded three
factors that we have labeled (a) epilepsy effects, (b)
mental health, and (c) role function, based on the
content of items loading on each factor (Table 3).
Scales were derived for each of these factors by
summing the raw scores for each item that loaded
at >0.40 on each factor. The three resultant QOLIE-
10 scales correlated well (all at p < 0.0001) with
their QOLIE-89 counterparts: QOLIE-10 Epilepsy
Effects with QOLIE-89 Medication Effects (r =
0.88); QOLIE-10 Mental Health with QOLIE-89 En-
ergy (r = 0.78), Mental Effects ( r = 0.80), and Over-
all QOL (r = 0.81); and QOLIE-10 Role Function
with QOLIE-89 Social Function (r = 0.92).
Reliability
Test-retest data (Table 3) showed significant
Pearson correlations for individual items (range,
r = 0.48-0.81; all p < 0.001) and scales (range, r =
0.55-0.77; all p < 0.0001).
Validity
We hypothesized that QOLIE-10 items and sub-
scales would correlate with external criterion vari-
ables such as neurotoxicity and systemic toxicity.
Analyses included data from 202 to 261 patients for
whom toxicity scales were completed. Systemic tox-
icity and neurotoxicity scores correlated best with
Epilepsy Effects ( r = -0.24 and r = -0.30, respec-
tively) and Mental Health (Y = -0.20 and r = -0.34,
respectively) QOLIE-10 subscales, in which a nega-
tive correlation represents higher levels of toxicity
and poorer quality-of-life status. Role Function cor-
related better with neurotoxicity (Y = -0.25; p <
0.0001) than with systemic toxicity (r = -0.14; p =
0.016; all other p < 0.001). Systemic toxicity corre-
lated best with the physical effects item (r = -0.23;
p = 0.0001) but not at all with driving and seizure
worry. Neurotoxicity had a modest correlation with
all items (range r = -0.22 to -0.33; all p < 0.0001)
except driving and seizure worry.
Discriminant validity
Comparisons were made among seizure groups to
assess differences in scales and individual items.
Epilepsia, Vol. 37, No. 6 , 1996
580 J . A . CRAMER ET A L .

TABLE 2. Correlation of each QOLIE-10 item with the source summary scale in QOLIE-89
Item in Correlation of QOLIE-I0 item
QOLIE- 10 Source Scale in QOLIE-89 with Source Scale“
Seizure worry Seizure Worry 0.64
Overall QOL Overall QOL 0.66
Depression Emotional Worry 0.67
Energy EnergyiFatigue 0.72
Memory Cognition 0.64
Physical effect Medication Effectb 0.67
Mental effect Medication Effect 0.73
Driving Social Function‘ 0.68
Social Social Function 0.54
Work Social Function 0.57
~~

“n = 304 patients with epilepsy.

b T ~QOLIE-I0
o items were selected from the Medication Effects scale to provide separate questions for physical and mental effects.
‘Three QOLIE-10 items were selected from the Social Function scale to provide separate questions for driving, social, and work
limitations.

Scales differed significantly among seizure groups
by multivariate testing ( d f = 9.674; F = 2.78; p <
0.003). Patients with low seizure frequency had bet-
ter Role Function scores than did patients with mod-
erate (p < 0.0001) or high seizure frequency (p <
0.01), suggesting increased impact of work, driving,
social, and seizure-worry issues for patients with
more frequent seizures.
DISCUSSION
The QOLIE- 10 is a simple screening questionnaire
that can be completed easily and quickly by patients.
The 10 items fall into three distinct topics as (a)
medication effects, (b) mental health, and (c) role
functioning and seizure worry, all of which pertain
to aspects of daily living for persons with epilepsy.
The reliability and validity of responses are reflected
in test-retest data and high correlations with the
POMS Mood Scale. Correlations with systemic tox-
icity and neurotoxicity, as well as with seizure-fre-
quency group, also demonstrate the validity of the
scale. These data suggest the usefulness of the
QOLIE-10 as a screening tool in clinical practice.
The discriminant validity of the QOLIE-I0 was dem-
onstrated by findings of differences among seizure
groups for role-function items (driving, work, and
social issues). The correlation of QOLIE-10 items
with toxicity ratings and neuropsychologic test
scores suggests that patients’ perceptions approxi-
mately reflect standard clinical test results.
Evaluation of every patient’s state of health
should encompass the domains listed for the World
Health Organization’s definition of quality of life:
physical health, psychological health, level of inde-
pendence, social relations, and environment/eco-
nomic resources (18). Routine clinical care for pa-
tients with can be expanded by using a questionnaire
that allows patients to express their concerns about a
variety of issues affected by the diagnosis, including
seizure frequency, fear of seizures, medication ef-
fects, and impact on multiple domains of daily life.

TABLE 3. Reliability and reproducibility of QOLIE-I0

Test-retest
Cronbach’s Percentage Pearson Item-scale
alpha variance corelationO correlation
Epilepsy effects scale [eigenvalue, 1.181 0.51 19.5 0.63
Physical effect 0.48 0.83
Mental effect 0.61 0.91
Memory 0.72 0.72
Mental Health Scale [eigenvalue, 1.341 0.48 20.4 0.55
Overall QOL 0.65 0.80
Depression 0.58 0.80
Energy 0.64 0.80
Role Function scale [eigenvalue, 3.721 0.50 22.7 0.77
Driving 0.81 0.69
Social 0.62 0.78
Work 0.71 0.79
Seizure worry 0.62 0.59
“All p < 0.0001.

Epilepsia, Vol. 37, N o . 6,1996

 QOLIE-10
Traditionally, clinicians deferred to the formal neu-
ropsychologic tests or other assessments and dis-
counted patient complaints because they did not
match external indicators of those symptoms. Two
scales developed in the United Kingdom, The Im-
pact of Epilepsy Scale (19) and the Social Effects
Scale (20), also are brief patient questionnaires that
provide useful information about individual issues.
Jacoby et al. (21) included the Impact of Epilepsy
Scale in a community-based study, finding that peo-
ple with frequent seizures were more likely to report
an impact of epilepsy on their daily lives than were
a seizure-free group.
The QOLIE-I0 provides individual patients with
an opportunity to denote epilepsy-related problems
and express their concerns to health-care providers.
Unlike diagnostic or laboratory tests that report
whether a patient’s results are within the “normal”
range, quality-of-life instruments indicate how an
individual functions in the real world (e.g., work and
social opportunities, transportation, independent
living, worry about seizures) (22).
The clinical usefulness of a brief screening instru-
ment was demonstrated by using simple pictorial
charts in the Dartmouth COOP, a primary care re-
search network, to elicit patient opinion about func-
tional capacity. The charts were practical, useful,
and acceptable in a busy clinical setting, providing
new information to physicians about 25% of patients
(10). Specific patient responses flagged the attention
of busy physicians, assuring referral for expert eval-
uation (e.g., vocational rehabilitation, psychiatric
evaluation) and led to changes in patient treatment
(9). Screening data have several clinical applications
for quality of life: (a) alert physician and clinic staff
to common patient concerns, (b) inform patients of
problems common for this disorder, and (c) facilitate
interaction between and decision making by patient
and physician (23). The 10 simple questions in the
QOLIE-10 may serve as a screen for problems.
Short-form measures can correlate well with
longer instruments (24). These data demonstrate
good correlation between QOLIE- 10 items and their
source scales in the QOLIE-89. Because of their
brevity and convenience, short-form measures allow
health-care providers to assess a variety of issues
without spending extra time and resources required
for administration and scoring of longer instruments
and without requiring an extended interview to re-
view all topics at every visit. Because use of the
QOLIE- 10 will provide information about patient
concerns, it might be possible for the physician or
clinic to obtain reimbursement for quality-of-life as-
sessment as a brief, office-based psychological test
(ICD Code 90830-52).
581
The brevity of this screening tool has the potential
of saving physician time without sacrificing the qual-
ity of information collected or interfering with the
physician-patient relationship. Patients can com-
plete the questionnaire while waiting to be seen,
complete it at home and bring it to the next visit,
or return it by mail for later use. Sequential adminis-
trations of the instrument might document changes
over time. For example, although many patients
complain about poor memory, a new report of dimin-
ished ability to concentrate or ability to cope with
changes at work may represent a new problem re-
quiring further neurologic assessment. Asking the
patient to complete the QOLIE-10 before seeing the
physician brings fresh information to the clinical in-
terview in a uniform style that could enhance the
patient’s ability to focus on issues pertinent to epi-
lepsy while economizing on the amount of time the
physician needs to cover the range of health-related
quality-of-life topics. Future studies will evaluate
how the QOLIE-10 could be used to screen new
patients, evaluate long-term patients for new prob-
lems, assess patients before changes in treatment,
or open new topics for discussion with long-term
patients. Although it is not a research tool, the QO-
LIE-10 could provide a value-added aspect to the
clinical evaluation.
Acknowledgment: Development of the QOLIE-10 was
supported by an unrestricted educational grant from Wal-
lace Laboratories,administered by Professional Postgrad-
uate Services,a division of Physicians World Communica-
tions. Permission for use of the QOLIE-10 will be granted
automatically and at no cost by Professional Postgraduate
Services, Secaucus, NJ 07094, U.S.A..
Some statistical analyses were conducted at RAND,
Santa Monica, CA, with assistance from Karen Spritzer.
Barbara Vickrey, M.D., M.P.H., and Bruce Hermann,
Ph.D., provided assistance.
REFERENCES
1. Cramer JA. A clinimetric approach to assessing quality of
life in epilepsy. Epilepsia 1993;34(suppl 4):S8-13.
2. Cramer JA. Quality of life for people with epilepsy. In: Devin-
sky 0, ed. Neurologic clinics: epilepsy II: special issues.
New York: WB Saunders, 1994;12:1-13.
3. Baker GA, Smith DF, Dewey M, Jacoby A, Chadwick DW.
The initial development of a health-related quality of life
model as an outcome measure for epilepsy. Epilepsy Res
1993;16:65-81.
4. World Health Organization. World Health Organization: the
first 10 years of the World Health Organization. Geneva,
Switzerland: World Health Organization. 1958.
5. Schipper H , Clinch J , Powell ?. Definitions and conceptual
issues. In: Spilker B, ed. Quality of life assessments in clinical
trials. New York: Raven Press, 199O:ll-24.
6. Jacoby A. Epilepsy and the quality of everyday life: findings
from a study of people with well-controlled epilepsy. SOCSci
Med 1992;34:657-66.
Epilepsia, Vol. 37, No, 6 , 1996
582 J . A . CRAMER ET AL.
7. Stewart AL, Greenfield S , Hays RD, et al. Functional
status and well-being of patients with chronic conditions:
results from the Medical Outcomes Study. JAMA
1989;262:907- 13.
8. Ware JE, Sherbourne CD. A 36-item short form health survey
(SF-36). I. Conceptual framework and item selection. Med
Care 1992;30:473-83.
9. Nelson EC, Wasson J, Kirk J, et al. Assessment of function
in routine clinical practice: description of the COOP chart
method and preliminary findings. J Chronic Dis 1987;40:
55s-63s.
10. Nelson EC, Landgraf JM, Hays RD, Wasson JH, Kirk JW.
The functional status of patients: how can it be measured in
physicians’ offices? Med Care 1990;28:1111-26.
11. Vickrey BG, Hays RD, Graber J, Rausch R, Engel J, Brook
RH. A health-related quality of life instrument for patients
evaluated for epilepsy surgery. Med Care 1992;30:299-319.
12. Smith DF, Baker GA, Dewey M, Jacoby A, Chadwick DW.
Seizure frequency, patient perceived seizure severity and the
psychosocial consequences of intractable epilepsy. Epilepsy
Res 1991;9:231-41.
13. Wagner AK, Bungay KM, Bromfield EB, Ehrenberg BL.
Health-related quality of life of adult persons with epilepsy as
compared with health-related quality of life of well persons.
Epilepsia 1993;34(suppl 6):5.
14. Devinsky 0, Vickrey BG, Cramer JA, et al. Development
of the Quality Of Life In Epilepsy Inventory. Epilepsia
1995;36:1089-104.
15. Cramer JA, Smith DB, Mattson RH, Delgado-Escueta AV,
Collins JF, and the VA Epilepsy Cooperative Study Group.
Epilepsia, Vol. 37, No. 6, 1996
A method of quantification for the evaluation of antiepileptic
drug therapy. Neurology 1983;33(suppl 1):26-37.
16. Perrine K, Hermann BP, Meador KJ, et al. The relationship
of neuropsychological functioning to quality of life in epi-
lepsy. Arch Neurol 1995;52:997-1003.
17. McNair D, Lorr M, Droppleman L. POMS: profile of mood
states. San Diego, CA: EITS/Educational and Industrial Tes-
ting Service, 1992.
18. Orley J. Development of the World Health Organization
Quality of Life Instrument. In: Dodson WE, Trimble MR,
eds. Quality of life f o r epilepsy patients. New York: Raven
Press, 1995:99-108.
19. Jacoby A, Baker GA, Smith DF, Dewey M, Chadwick DW.
Measuring the impact of epilepsy; the development of a novel
scale. Epilepsy Res 1994;16:83-8.
20. Chaplin JE, Yepez R, Shorvon S, Floyd M. A quantitative
approach to measuring the social effect of epilepsy. Neuroe-
pidemiology 1990;9:151-8.
21. Jacoby A, Baker GA, Steen N, Potts P, Chadwick DW. The
clinical course of epilepsy and its psychosocial correlates:
findings from a UK community study. Epilepsia 1996;37:
148-61.
22. MacKeigan LD, Pathak DS. Overview of health-related qual-
ity of life measures. Am J H o s p Pharm 1992;49:2236-45.
23. Meyerowitz BE. Quality of life in breast cancer patients: the
contribution of data to the care of patients. Eur J Cancer
1993; 2 9 4 ( ~ ~ p I):
p l S59-S62.
24. Hays RD, Larson C, Nelson EC, Batalden PB. Hospital
quality trends: a short-form based measure. Med Care 1991;
29:66 1-8.