2090
The PedsQL™ in Pediatric Cancer
Reliability and Validity of the Pediatric Quality of Life Inventory™ Generic Core
Scales, Multidimensional Fatigue Scale, and Cancer Module
James W. Varni, Ph.D.1,2
Tasha M. Burwinkle, M.A.1
Ernest R. Katz, Ph.D.3,4
Kathy Meeske, R.N., M.N.3
Paige Dickinson, M.A., M.S.1
1
Center for Child Health Outcomes, Children’s
Hospital and Health Center, San Diego, California.
2
Department of Psychiatry, University of Califor-
nia, San Diego School of Medicine, San Diego,
California.
3
Center for Cancer and Blood Diseases, Children’s
Hospital, Los Angeles, California.
4 Score (␣ ⫽ 0.89 child, 0.92 parent report) and most Cancer Module Scales (average
Department of Pediatrics, University of Southern
California School of Medicine, Los Angeles, Cali-
fornia.
Supported by a research grant from Ortho Biotech
Products, L.P.
The PedsQL is available at http://www.pedsql.org
Address for reprints: James W. Varni, Ph.D., Center
for Child Health Outcomes, Children’s Hospital and
Health Center, 3020 Children’s Way, San Diego,
CA 92123; Fax: (858) 966-7478; E-mail:
jvarni@chsd.org
Received July 5, 2001; revision received October
30, 2001; accepted October 31, 2001.
© 2002 American Cancer Society
BACKGROUND. The Pediatric Quality of Life Inventory (PedsQL) is a modular
instrument designed to measure health-related quality of life (HRQOL) in children
and adolescents ages 2–18 years. The PedsQL 4.0 Generic Core Scales are multi-
dimensional child self-report and parent proxy-report scales developed as the
generic core measure to be integrated with the PedsQL disease specific modules.
The PedsQL Multidimensional Fatigue Scale was designed to measure fatigue in
pediatric patients. The PedsQL 3.0 Cancer Module was designed to measure
pediatric cancer specific HRQOL.
METHODS. The PedsQL Generic Core Scales, Multidimensional Fatigue Scale, and
Cancer Module were administered to 339 families (220 child self-reports; 337
parent proxy-reports).
RESULTS. Internal consistency reliability for the PedsQL Generic Core Total Scale
Score (␣ ⫽ 0.88 child, 0.93 parent report), Multidimensional Fatigue Total Scale
␣ ⫽ 0.72 child, 0.87 parent report) demonstrated reliability acceptable for group
comparisons. Validity was demonstrated using the known-groups method. The
PedsQL distinguished between healthy children and children with cancer as a
group, and among children on-treatment versus off-treatment. The validity of the
PedsQL Multidimensional Fatigue Scale was further demonstrated through hy-
pothesized intercorrelations with dimensions of generic and cancer specific
HRQOL.
CONCLUSIONS. The results demonstrate the reliability and validity of the PedsQL
Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module in pe-
diatric cancer. The PedsQL may be utilized as an outcome measure in clinical
trials, research, and clinical practice. Cancer 2002;94:2090 –106.
© 2002 American Cancer Society.
DOI 10.1002/cncr.10427
KEYWORDS: health-related quality of life, cancer, pediatrics, health status, children,
adolescents.
H ealth-related quality-of-life measurement has received ever-in-
creasing recognition as an important health outcome in clinical
trials and health services research and evaluation.1–3 Although health
status, functional status, and health-related quality of life (HRQOL)
are terms often used interchangeably, a recent meta-analysis suggests
that a more definitive distinction between these terms is warranted.4
Health status and functional status refer to the physical functioning
dimension of the broader HRQOL construct, whereas the HRQOL
construct in addition includes the psychosocial dimensions of emo-
tional, social, and role functioning, as well as related constructs. Thus,
a HRQOL instrument must be multidimensional, consisting at the

minimum of the physical, mental, and social health
dimensions delineated by the World Health Organiza-
tion.5 Although the importance of measuring HRQOL
in pediatric cancer has been advocated for several
years,6,7 the measurement of fatigue in pediatric can-
cer is a more contemporary conceptualization.8
Pediatric HRQOL measurement instruments must
be sensitive to cognitive development and integrate
both child self-report and parent proxy-report to re-
flect their potentially unique perspectives. Imperfect
concordance between self- and proxy-report, termed
cross-informant variance,9 has been consistently doc-
umented among child/adolescent, parent, teacher,
and healthcare professionals, reports in the HRQOL
assessment of healthy children10 and children with
chronic health conditions,11–14 including cancer.15
Agreement has been demonstrated to be lower for
internalizing problems (e.g., depression and pain)
than for externalizing problems (e.g., hyperactivity
and walking). Because HRQOL derives from an indi-
vidual’s perception, the demonstration of cross-infor-
mant variance indicates the need for reliable and valid
child self-report HRQOL measurement instruments
for the broadest age range possible.
The Pediatric Quality of Life Inventory (PedsQL)
builds on a programmatic measurement instrument de-
velopment effort by Varni and colleagues in pediatric
chronic health conditions, including pediatric can-
cer,15–18 during the past 15 years. The PedsQL 1.0,19
originally derived from a pediatric cancer database,15–17
was designed as a generic HRQOL instrument to be
utilized noncategorically, that is, across diverse pediatric
populations. Given that instrument development is an
iterative process, the PedsQL 2.0 and 3.0 included addi-
tional constructs and items, a more sensitive scaling
range, and a broader age range for child self-report and
parent proxy-report. The PedsQL 4.0 Generic Core Scales
have resulted from this iterative process and include
child self-report for ages 5–18 years and parent proxy-
report for ages 2–18 years.
The PedsQL 4.0 Generic Core Scales were de-
signed to measure the core physical, mental, and so-
cial health dimensions as delineated by the World
Health Organization,5 as well as role (school) func-
tioning. In the initial field trial, the PedsQL 4.0 Generic
Core Scales (physical, emotional, social, and school
functioning) were administered to 1677 families (963
child self-report; 1629 parent proxy-report), recruited
from pediatric healthcare settings.20 Internal consis-
tency reliability for the Total Scale Score (␣ ⫽ 0.88
child, 0.90 parent report), Physical Health Summary
Score (␣ ⫽ 0.80 child, 0.88 parent report), and Psycho-
social Health Summary Score (␣ ⫽ 0.83 child, 0.86
parent report) were acceptable for group compari-
The PedsQL/Varni et al. 2091
sons. The PedsQL 4.0 Generic Core Scales distin-
guished between healthy children and pediatric pa-
tients with acute or chronic health conditions and
were related to indicators of morbidity and illness
burden.20
The PedsQL Measurement Model was designed as a
modular approach to measuring pediatric HRQOL, inte-
grating the relative merits of generic and disease specific
approaches.19,21 Although disease specific modules may
enhance measurement sensitivity for health domains
germane to a particular chronic health condition, a ge-
neric HRQOL measurement instrument enables com-
parisons across pediatric populations and facilitates
benchmarking with healthy population norms.
Given that the PedsQL Measurement Model inte-
grates generic core scales and disease specific mod-
ules into one measurement system, the PedsQL 4.0
Generic Core Scales were specifically designed for ap-
plication in both healthy and patient populations. The
PedsQL 3.0 Cancer Module was designed to measure
HRQOL dimensions specifically tailored for pediatric
cancer. The PedsQL 3.0 Cancer Module, derived from
the PedsQL 1.0 Cancer Module,19 also has resulted
from an extensive iterative process, including addi-
tional constructs and items, a more sensitive scaling
range, and a broader age range for child self-report
and parent proxy-report.
The PedsQL Multidimensional Fatigue Scale is a
newly developed instrument, designed to measure
child and parent perceptions of fatigue in pediatric
patients. There are several instruments that measure
fatigue in adult cancer patients,22,23 including several
that are explicitly multidimensional fatigue mea-
sures.24 –26 In pediatric cancer, the measurement of
fatigue is exemplified by the work of Hockenberry-
Eaton, Hinds, and colleagues.8,27 In the development
of the PedsQL Multidimensional Fatigue Scale, multi-
dimensional constructs were derived from reviews of
both the adult and pediatric cancer fatigue literature
and integrated into the PedsQL Measurement Model.
The current study presents the measurement prop-
erties of the PedsQL in pediatric cancer, reporting on the
reliability and validity of the Generic Core Scales, Multi-
dimensional Fatigue Scale, and Cancer Module.
METHODS
Subjects and Settings
Oncology sample
Subjects were recruited from the Hematology/Oncol-
ogy Center at Children’s Hospital and Health Center,
San Diego, and the Center for Cancer and Blood Dis-
eases at Children’s Hospital Los Angeles. Participants
were 339 families of children ages 2–18 years. Children
ages 5–18 years completed the PedsQL child self-re-
2092 CANCER April 1, 2002 / Volume 94 / Number 7
port (n ⫽ 220), and parents of children ages 2–18 years
completed the PedsQL parent proxy-report (n ⫽ 337).
In 119 cases, a parent proxy-report was completed,
but a child self-report was not completed, and in 2
cases, a child self-report was completed, but a parent
proxy-report was not completed. Depending on the
scale, both child self-report and parent proxy-report
were available on 190 to 218 parent/child dyads.
The PedsQL was self-administered for parents and
for children ages 8 –18 years and interviewer-admin-
istered for children ages 5–7 years. Most patients and
parents (n ⫽ 180, 82%, child report; n ⫽ 276, 82%,
parent report) completed the PedsQL in the hospital
outpatient clinics. The PedsQL also was administered
when a child was an inpatient in the cancer unit (n
⫽ 15, 7%, child report; n ⫽ 23, 7%, parent report), or
while a child was admitted to the day hospital (n ⫽ 2,
1%, child report; n ⫽ 3, 1%, parent report). Some
children (n ⫽ 23, 10%) and parents (n ⫽ 35, 10%)
completed the PedsQL at home, where the parents
were given detailed written instructions about how to
complete the questionnaire as well as how to admin-
ister the questionnaire to their child. The instructions
stated that the parent should first complete the parent
proxy-report separately from their child, that they
should read the instructions and items aloud to a child
ages 5–7 years, and that children and adolescents ages
8 –18 years should independently complete the child
self-report items after reading the instructions. The
measures were administered in two languages: En-
glish (n ⫽ 174, 79%, child report; n ⫽ 223, 66%, parent
report) and Spanish (n ⫽ 46, 21%, child report; n
⫽ 114, 34%, parent report).
The oncology sample included children with
acute lymphocytic leukemia (n ⫽ 171, 50%), brain
tumor (n ⫽ 24, 7%) non-Hodgkin lymphoma (n ⫽ 20,
6%), Hodgkin lymphoma (n ⫽ 11, 3%), Wilms’ tumor
(n ⫽ 19, 6%), and other cancers (n ⫽ 94, 28%). Patients
comprised all diagnostic groups, had no comorbid
disease or major developmental disorders, and in-
cluded newly diagnosed on-treatment, recurrent dis-
ease on-treatment, in recent remission off-treatment,
or long-term off-treatment. On-treatment status was
defined as patients who were receiving medical treat-
ment to induce remission (n ⫽ 183, 54%). Off-treat-
ment status was defined as patients for whom all
therapy was completed by the time of assessment.
Off-treatment remission was defined by being disease
free accompanied by termination of cancer treatment
in the past 12 months (n ⫽ 61, 18%). Off-treatment
long-term survivor was defined by being disease free
accompanied by termination of cancer treatment for
longer than 12 months (n ⫽ 95, 28%).
For all forms combined, the average age of the 196
boys (58%) and 143 girls (42%) was 8.72 years (stan-
dard deviation [SD], 4.57) with a range of 2 to 18 years.
For child self-report, the average age of the 124 boys
(56%) and 96 girls (44%) was 10.9 years (SD, 3.83) with
a range of 5 to 18 years. Children identified as being
“off-treatment long-term survivor” were significantly
older (mean age , 10.1 years) than children on-treat-
ment (mean age , 8.2 years) and children off-treatment
for less than 12 months (mean age, 8.2; P ⬍ 0.05, based
on Tukey post hoc analysis). Comparisons among on-
cology treatment groups indicate that there was no
statistically significant difference in the ratio of males
to females. There was, however, a statistically signifi-
cant difference between the number of males and
females in the oncology sample as a whole (P ⬍ 0.001).
The sample was heterogeneous with respect to race/
ethnicity, with 98 (29%) white non-Hispanic, 175
(52%) Hispanic, 15 (4%) black non-Hispanic, 19 (6%)
Asian/Pacific Islander, 2 (1%) American Indian or
Alaskan Native, 27 (8%) other, and 3 (1%) missing.
Mean socioeconomic status (SES) for the oncology
sample was 35, based on the Hollingshead index, in-
dicating on average a low- to middle-class family
SES.28 There were no statistically significant differ-
ences in SES between on-treatment and off-treatment
groups.
Healthy sample: Generic Core Scales Acute Version
Subjects were 157 families of healthy children ages
2–18 years. Healthy children ages 5–18 years (n ⫽ 105)
and parents of healthy children ages 2–18 years (n
⫽ 157) were administered the PedsQL 4.0 Generic
Core Scales Acute Version via telephone. This sample
was accrued from a list of patients who had attended
an orthopedic clinic for broken bones or fractures 6
months before assessment with the PedsQL, and who
had been identified by the clinic nurse as having “re-
turned to health” (i.e., no current problems due to
their orthopedic injury). The average age of the 98
boys (62.4 %) and 58 girls (36.9 %; missing, 1; 0.6%)
was 11.63 years (SD, 8.59). For child self-report, the
average age of the 72 boys (68.6 %) and 33 girls (31.4
%) was 13.70 years (SD, 9.47). The sample was heter-
ogeneous with respect to race/ethnicity, with 77 (49%)
white non-Hispanic, 39 (25%) Hispanic, 6 (4%) black
non-Hispanic, 5 (3%) Asian/Pacific Islander, 14 (9%)
other, and 16 (10%) missing. Mean SES was unavail-
able for this sample. Comparisons between this
healthy sample and the oncology sample indicates
that there was no statistically significant difference in
the ratio of males to females assessed with the PedsQL
4.0 Generic Core Scales Acute Version. This healthy
sample was significantly older (mean age, 11.6 years)
than the oncology sample (mean age, 8.7 years) and

the healthy sample for the PedsQL Generic Core Scales
Standard Version (mean age, 8.9 years; P ⬍ 0.01, based
on Tukey post hoc analysis).
Healthy sample: Generic Core Scales Standard Version
Participants were 730 families of healthy children ages
2–18 years, whose scores were derived from the
PedsQL 4.0 Generic Core Scales field test.20 Healthy
children ages 5–18 years completed the PedsQL child
self-report (n ⫽ 401), and parents of healthy children
ages 2–18 years completed the PedsQL parent proxy-
report (n ⫽ 719). Healthy children were those assessed
either in their physician’s offices during well-child
checks or by telephone and whose parents did not
report the presence of a chronic health condition. The
average age of the 351 boys (48.1 %) and 378 girls (51.8
%; missing, 1) was 8.9 years (SD, 4.24; missing, 8). For
child self-report, the average age of the 182 boys (45.4
%) and 219 girls (54.6 %) was 10.9 years (SD, 3.30;
missing, 1). The sample was heterogeneous with re-
spect to race/ethnicity, with 211 (28.9 %) white non-
Hispanic, 362 (49.6 %) Hispanic, 48 (6.6 %) black non-
Hispanic, 20 (2.7 %) Asian/Pacific Islander, 4 (0.5 %)
American Indian or Alaskan Native, 47 (6.4 %) other,
and 38 (5.2 %) missing. Mean SES was unavailable for
this sample. Comparisons between this healthy sam-
ple and the oncology sample indicate that the ratio of
males to females was different in the two samples with
351 (48.1%) males and 378 (51.8%) females in the
healthy sample as compared with the oncology sam-
ple with 196 (58%) males and 143 (42%) females (chi-
square(1) ⫽ 8.66; P ⬍ 0.01). There was no statistically
significant difference in age between this healthy sam-
ple and the oncology sample.
Healthy sample: Multidimensional Fatigue Scale Acute
Version
Subjects were 102 families of healthy children ages
2–18 years. Healthy children ages 5–18 years (n ⫽ 52)
and parents of healthy children ages 2–18 years (n
⫽ 102) were administered the PedsQL Multidimen-
sional Fatigue Scale Acute Version via telephone. This
sample was accrued from a list of patients who had
attended an orthopedic clinic for broken bones or
fractures 6 months before assessment with the
PedsQL, and who had been identified by the clinic
nurse as having “returned to health” (e.g., no current
problems due to their orthopedic injury). The average
age of the 69 boys (67.7 %) and 30 girls (29.4 %;
missing, 3) was 8.88 years (SD, 10.98). For child self-
report, the average age of the 40 boys (76.9 %) and 11
girls (21.2 %; missing, 1) was 10.40 years (SD, 14.45).
The sample was heterogeneous with respect to race/
ethnicity, with 28 (27.5 %) white non-Hispanic, 47
The PedsQL/Varni et al. 2093
(46.1 %) Hispanic, 6 (5.9 %) black non-Hispanic, 2 (2.0
%) Asian/Pacific Islander, 1 (1.0 %) American Indian
or Alaskan Native, 14 (13.7 %) other, and 4 (3.9 %)
missing. Mean SES was unavailable for this sample.
Comparisons between this healthy sample and the
oncology sample indicate that the ratio of males to
females was different in the 2 samples, with 69 (67.6%)
males and 30 (29.4%) females in the healthy sample in
comparison to the oncology sample, with 196 (58%)
males and 143 (42%) females (chi-square (1) ⫽ 4.53; P
⬍ 0.05). There was no statistically significant differ-
ence in age between this healthy sample and the on-
cology sample.
Measures
The PedsQL 4.0 Generic Core Scales
The 23-item multidimensional PedsQL 4.0 Generic
Core Scales encompass 4 scales: 1) physical function-
ing (8 items), 2) emotional functioning (5 items), 3)
social functioning (5 items), and 4) school functioning
(5 items). The PedsQL 4.0 Generic Core Scales are
comprised of parallel child self-report and parent
proxy-report formats. Child self-report includes ages
5–7 years (young child), ages 8 –12 years (child), and
ages 13–18 years (adolescent). Parent proxy-report in-
cludes ages 2– 4 years (toddler), 5–7 years (young
child), 8 –12 years (child), and 13–18 years (adoles-
cent). The parent proxy-report forms are designed to
assess the parent’s perceptions of their child’s
HRQOL. The items for each of the forms are essentially
identical, differing in developmentally appropriate
language, or first or third person tense.
The instructions for the Standard Version ask how
much of a problem each item has been during the past
1 month. For the purposes of the current investiga-
tion, we utilized the PedsQL Acute Version (past 7 days
recall interval). A 5-point Likert response scale is uti-
lized across child self-report for ages 8 –18 years and
parent proxy-report (0 ⫽ never a problem; 1 ⫽ almost
never a problem; 2 ⫽ sometimes a problem; 3 ⫽ often
a problem; 4 ⫽ almost always a problem). To further
increase the ease of use for the young child self-report
(ages 5–7 years), the Likert scale is reworded and sim-
plified to a 3-point scale (0 ⫽ not at all a problem; 2
⫽ sometimes a problem; 4 ⫽ a lot of a problem), with
each response choice anchored to a happy to sad faces
scale.29, 30 Parent proxy-report also includes the tod-
dler age range (ages 2– 4 years), which does not in-
clude a self-report form given developmental limita-
tions on self-report for children younger than 5 years
of age,30, 31 and includes only 3 items for the school
functioning scale.
Items are reverse-scored and linearly transformed to
a 0 –100 scale (0 ⫽ 100, 1 ⫽ 75, 2 ⫽ 50, 3 ⫽ 25, 4 ⫽ 0), so
2094 CANCER April 1, 2002 / Volume 94 / Number 7

TABLE 1
Scale Descriptives for PedsQL 4.0 Generic Core Scales Child Self-Report and Parent Proxy-Report and Comparisons
with Healthy Children Scoresa

Healthy sample
Oncology sample (standard version) Healthy sample (acute version)
No. of
Scale items n Mean SD n Mean SD n Mean SD

Self-report
Total score 23 219 72.20 16.38 401 83.00 14.79 105 83.41 14.88
Physical health 8 219 71.79 21.80 400 84.41 17.26 105 82.60 19.52
Psychosocial health 15 219 72.62 16.41 399 82.38 15.51 105 84.03 15.55
Emotional functioning 5 219 71.83 21.44 400 80.86 19.64 105 83.12 18.61
Social functioning 5 219 76.84 20.31 399 87.42 17.18 105 86.74 18.14
School functioning 5 191 68.51 19.72 386 78.63 20.53 63 79.39 18.93
Proxy-report
Total score 23 336 69.70 19.17 717 87.61 12.33 157 84.54 15.70
Physical health 8 336 68.75 24.98 717 89.32 16.35 157 82.48 23.09
Psychosocial health 15 336 70.31 17.96 717 86.58 12.79 157 86.04 13.43
Emotional functioning 5 336 67.53 20.32 718 82.64 17.54 157 84.74 16.37
Social functioning 5 336 75.64 20.61 716 91.56 14.20 157 87.59 16.54
School functioning 5 250 66.40 23.19 611 85.47 17.61 97 86.22 17.84

SD: standard deviation.

a
The Standard Version of the PedsQL Generic Core Scales has a 1-month recall interval in the directions for both child self-report and parent proxy-report. The Acute Version of the PedsQL Generic Core Scales
has a 7-day recall interval in the directions for both child self-report and parent proxy-report. All scale scores for the Oncology Sample are significant different from the Healthy Sample (Standard Version) and the
Healthy Sample (Acute Version) for both child self-report and parent proxy-report (P ⬍ 0.001). There are no significant differences between the Healthy Sample Standard Version and the Healthy Sample Acute
Version, except for parent proxy-report Physical Health Scale Score (P ⬍ 0.001) and parent proxy-report Social Functioning (P ⬍ 0.05).

TABLE 2
Scale Descriptives for PedsQL Multidimensional Fatigue Scale: Child Self-Report and Parent Proxy-Report and Comparisons with Healthy
Children Scores

Oncology sample Healthy sample (acute version)

No. of
Scale items n Mean SD n Mean SD Difference t test

Self-report
Total fatigue 18 220 70.98 18.20 52 80.49 13.33 9.51 ⫺3.55a
General fatigue 6 220 74.99 19.59 52 85.34 14.95 10.35 ⫺3.57a
Sleep/rest fatigue 6 220 67.03 23.08 52 75.00 18.76 7.97 ⫺2.314b
Cognitive fatigue 6 220 70.92 22.35 52 81.14 17.43 10.21 ⫺3.08c
Proxy-report
Total fatigue 18 337 75.67 17.74 102 89.63 11.38 13.96 ⫺7.49a
General fatigue 6 337 73.62 20.92 102 89.30 13.33 15.68 ⫺7.14a
Sleep/rest fatigue 6 337 74.26 21.59 102 88.86 14.72 14.60 ⫺6.40a
Cognitive fatigue 6 337 79.14 21.69 102 90.72 15.15 11.58 ⫺5.03a

SD: standard deviation.

a
P ⬍ 0.001.
b
P ⬍ 0.05.
c
P ⬍ 0.01.

that higher PedsQL 4.0 scores indicate better HRQOL. unbiased and precise method to calculate a scale
Scale scores are computed as the sum of the items di- score.32 For this study, greater than 99% of child and
vided by the number of items answered (this accounts parent respondents were included in the scale score
for missing data). If greater than 50% of the items in the analyses after imputing missing values. The Physical
scale are missing, the scale score is not computed. Im- Health Summary Score (eight items) is the same as the
puting the mean of the completed items in a scale when Physical Functioning Subscale. To create the Psychoso-
50% or more items are completed is generally the most cial Health Summary Score (15 items), the mean is com-
 The PedsQL/Varni et al. 2095

TABLE 3 anxiety (3 items), 4) treatment anxiety (3 items), 5)

Scale Descriptives for PedsQL 3.0 Cancer Module (Acute Version) worry (3 items), 6) cognitive problems (5 items), 7)
Child Self-Report and Parent Proxy-Report
perceived physical appearance (3 items), and 8) com-
Scale No. of items n Mean SD munication (3 items). The format, instructions, Likert
response scale, and scoring method are identical to
Self-report the PedsQL 4.0 Generic Core Scales Acute Version,
Pain and hurt 2 219 76.20 25.21 with higher scores indicating better HRQOL (fewer
Nausea 5 220 75.81 22.68
problems or symptoms).
Procedural anxiety 3 219 68.26 30.67
Treatment anxiety 3 219 82.19 24.78 The PedsQL 3.0 Cancer Module was developed
Worry 3 217 70.08 26.97 based on our research and clinical experiences in pe-
Cognitive problems 5 218 70.46 22.00 diatric cancer, and the instrument development liter-
Perceived physical ature.33–35 Our development of the PedsQL 3.0 Cancer
appearance 3 216 70.33 23.99
Module was informed by our instrument development
Communication 3 220 74.36 24.76
Proxy-report research with the Pediatric Cancer Quality of Life In-
Pain and hurt 2 333 74.74 25.77 ventory,15–17 the PedsQL 1.0 Cancer Module,19 and
Nausea 5 333 77.78 23.78 iterations of the PedsQL pretested in pediatric cancer.
Procedural anxiety 3 333 60.26 32.86
Treatment anxiety 3 334 71.53 27.62
PedsQL Family Information Form
Worry 3 331 75.92 28.35
Cognitive problems 5 332 74.00 22.17 The PedsQL Family Information Form, completed by
Perceived physical parents, contains demographic information on the
appearance 3 333 76.21 25.00 child and parents. It contains the SES information
Communication 3 327 78.31 23.55 required to calculate the Hollingshead SES index.28
SD: standard deviation.
Procedure
Potential subjects were identified at each site through
examination of the hematology/oncology patient
puted as the sum of the item responses divided by the master list, inpatient list, and clinic appointment
number of items answered in the Emotional, Social, and schedules, as well as through discussions with the
School Functioning Subscales. clinical team. The parents of pediatric cancer patients
identified as possible study participants who were
PedsQL Multidimensional Fatigue Scale newly diagnosed on-treatment or who experienced
The 18-item PedsQL Multidimensional Fatigue Scale recurrence on-treatment and were on site regularly
Acute Version encompasses 3 subscales: 1) general were informed of the study by a graduate student
fatigue (6 items), 2) sleep/rest fatigue (6 items), and 3) research assistant. Alternatively, the parents of the
cognitive fatigue (6 items). The format, instructions, patients meeting inclusion criteria were contacted by
Likert response scale, and scoring method are identi- mail, with a follow-up telephone call, and asked to
cal to the PedsQL 4.0 Generic Core Scales Acute Ver- participate in the study after a discussion with the
sion, with higher scores indicating better HRQOL research assistant. Long-term survivors off-treatment
(fewer problems or symptoms). initially were contacted by mail or during clinic visits.
The PedsQL Multidimensional Fatigue Scale was Given the infrequency of their clinic visits at the cen-
developed based on our research and clinical experi- ters, most of the long-term survivors were contacted
ences in pediatric cancer, and the instrument devel- by mail with follow-up telephone calls. Written paren-
opment literature,33–35 which consisted of a review of tal informed consent and child assent were obtained
the extant literature on fatigue in adult and pediatric before participation in the study. Parents and children
cancer, patient and parent focus groups and individ- completed the PedsQL separately. One parent (85%
ual focus interviews, item generation, cognitive inter- mothers; 12% fathers; 3% other) completed the proxy-
viewing, pretesting, and subsequent field testing of the report version. A research assistant was available to
new measurement instrument in two pediatric cancer answer questions regarding the parent self-adminis-
centers. tered instruments. A research assistant administered
the PedsQL for the young child (ages 5–7 years) and
PedsQL 3.0 Cancer Module was available to assist the self-administered instru-
The 27-item multidimensional PedsQL 3.0 Cancer ment for the child (ages 8 –12 years) and adolescent
Module Acute Version encompasses 8 scales: 1) pain (ages 13–18 years) after the instructions had been
and hurt (2 items), 2) nausea (5 items), 3) procedural given and clarified. The PedsQL 4.0 Generic Core
2096 CANCER April 1, 2002 / Volume 94 / Number 7

TABLE 4
PedsQL 4.0 Generic Core Scales (Acute Version) Internal Consistency Reliability for Child Self-Report and Parent Proxy-Report by Age and
Summary Score/Subscale

Age group (yrs)

Scale Toddler (2–4) Young child (5–7) Child (8–12) Adolescent (13–18) Total sample

Self-report
Total score NA 0.82 0.89 0.92 0.88
Physical health NA 0.63 0.84 0.88 0.81
Psychosocial health NA 0.74 0.85 0.88 0.83
Emotional functioning NA 0.73 0.72 0.75 0.73
Social functioning NA 0.52 0.70 0.81 0.70
School functioning NA 0.39 0.73 0.75 0.66
Proxy-report
Total score 0.89 0.93 0.92 0.94 0.93
Physical health 0.84 0.89 0.90 0.90 0.89
Psychosocial health 0.80 0.89 0.87 0.92 0.89
Emotional functioning 0.74 0.78 0.80 0.88 0.80
Social functioning 0.73 0.73 0.67 0.80 0.73
School functioning 0.76 0.81 0.73 0.79 0.77

NA: not applicable.

TABLE 5
PedsQL Multidimensional Fatigue Scale Internal Consistency Reliability for Child Self-Report and Parent Proxy-Report by Age and Summary
Score/Subscale

Age group (yrs)

Scale Toddler (2–4) Young child (5–7) Child (8–12) Adolescent (13–18) Total sample

Self-report
Total fatigue NA 0.86 0.88 0.92 0.89
General fatigue NA 0.67 0.77 0.88 0.77
Sleep/rest fatigue NA 0.71 0.74 0.87 0.78
Cognitive fatigue NA 0.74 0.79 0.91 0.83
Proxy-report
Total fatigue 0.89 0.92 0.93 0.93 0.92
General fatigue 0.83 0.87 0.87 0.92 0.88
Sleep/rest fatigue 0.75 0.79 0.86 0.88 0.85
Cognitive fatigue 0.92 0.93 0.93 0.94 0.93

NA: not applicable.

Scales Acute Version, the PedsQL 3.0 Cancer Module
Acute Version, and the PedsQL Multidimensional Fa-
tigue Scale Acute Version were administered simulta-
neously, with parents completing the proxy-report
version independently and at the same time that their
child completed the self-report version. This research
protocol was approved by the Institutional Review
Boards at Children’s Hospital and Health Center, San
Diego and Children’s Hospital Los Angeles.
Statistical Analysis
Feasibility or practicality was determined from the
percentage of missing values.36 Scale internal consis-
tency reliability was determined by calculating Cron-
bach coefficient alpha.37 Scales with reliabilities of
0.70 or greater are recommended for comparing pa-
tient groups, whereas a reliability criterion of 0.90 is
recommended for analyzing individual patient scale
38, 39
scores.
Construct validity was determined utilizing the
known-groups method. The known-groups method
compares scale scores across groups known to differ
in the health construct being investigated. In this
study, PedsQL 4.0 Generic Core Scales scores in
groups differing in known health condition (healthy
children and children with cancer) were comput-
 The PedsQL/Varni et al. 2097

TABLE 6
PedsQL 3.0 Cancer Module (Acute Version) Internal Consistency Reliability for Child Self-Report and Parent Proxy-Report by Age and Subscale

Age group (yrs)

Scale Toddler (2–4) Young child (5–7) Child (8–12) Adolescent (13–18) Total sample

Self-report
Pain and hurt NA 0.60 0.81 0.70 0.70
Nausea NA 0.58 0.81 0.89 0.79
Procedural anxiety NA 0.77 0.84 0.84 0.82
Treatment anxiety NA 0.73 0.79 0.88 0.79
Worry NA 0.59 0.78 0.80 0.74
Cognitive problems NA 0.51 0.75 0.78 0.76
Perceived physical appearance NA 0.38 0.37 0.70 0.49
Communication NA 0.63 0.60 0.77 0.66
Proxy-report
Pain and hurt 0.76 0.84 0.87 0.91 0.85
Nausea 0.85 0.83 0.93 0.90 0.89
Procedural anxiety 0.92 0.93 0.92 0.91 0.93
Treatment anxiety 0.90 0.90 0.92 0.92 0.91
Worry 0.95 0.87 0.85 0.92 0.90
Cognitive problems 0.85 0.82 0.81 0.89 0.85
Perceived physical appearance 0.70 0.78 0.74 0.89 0.81
Communication 0.91 0.81 0.78 0.79 0.83

NA: not applicable.

ed,40,41 using t tests and one-way analysis of variance
(ANOVA). The data for the healthy group of children
were derived from the initial field trial of the PedsQL
4.0 Standard Version (1-month recall interval),20 and a
healthy sample that completed the Acute Version (7-
day recall period). We hypothesized that healthy chil-
dren would report higher PedsQL 4.0 scores (better
HRQOL) than pediatric patients with cancer. In addi-
tion, PedsQL Multidimensional Fatigue Scale scores in
groups differing in known health condition (healthy
children and children with cancer) were comput-
ed,40,41 using t tests and ANOVA. The data for the
healthy group of children were derived from a healthy
sample that completed the Acute Version (7-day recall
period). We hypothesized that healthy children would
report higher PedsQL scores (better HRQOL or less
fatigue) than pediatric patients with cancer. Analyses
of variance also were conducted to examine whether
there were differences in PedsQL Generic Core Scales,
Multidimensional Fatigue Scale, and Cancer Module
scores among children with cancer on-treatment, off-
treatment for 12 months or less, and off-treatment for
more than 12 months.
Construct validity was further examined through
an analysis of the intercorrelations among the PedsQL
4.0 Generic Core Total Scale Score with the PedsQL
Multidimensional Fatigue Total Scale and Subscales
scores. It was hypothesized that higher Fatigue Total
Scale and Subscale scores (fewer problems or symp-
toms) would be correlated with higher Generic Core
Total Scale Scores (better overall HRQOL), based on
the conceptualization of disease-specific symptoms as
causal indicators of HRQOL.1 Correlation effect sizes
are designated as small (0.10 – 0.29), medium (0.30 –
0.49), and large (ⱖ 0.50).42 Intercorrelations were ex-
pected to demonstrate medium to large effect sizes.1
Parent/child intercorrelations were computed to
examine cross-informant variance. Correlation effect
sizes are designated as small (0.10 – 0.29), medium
(0.30 – 0.49), and large (ⱖ 0.50).42 Parent/child concor-
dance for the Total Score, Summary Scores, and the
same Subscale were expected to demonstrate medium
to large effect sizes, but not so large that child and
parent reports would be redundant.
Statistical analyses were conducted using SPSS for
Windows.43 Response equivalence has been demon-
strated previously across language (English vs. Span-
ish) for the PedsQL by examining the percentage of
missing data, floor and ceiling effects, and scale inter-
nal consistency across language.20 Therefore, re-
sponses were pooled across languages. Responses also
were pooled across the age ranges for both self-report
and proxy-report.
RESULTS
Missing Item Responses
To assess the feasibility or practicality of administra-
tion for the PedsQL 4.0 Generic Core Scales Acute
2098 CANCER April 1, 2002 / Volume 94 / Number 7

TABLE 7
One-Way ANOVA Values Comparing Healthy Children and Children with Cancer (On- or Off-Treatment): PedsQL 4.0 Generic Core
(Acute Version) Child Report

Scale n Mean SD Difference df f P value

Total score a ⬍ c**, a, b ⬍ d*** 3320 16.78 0.001

On Txa 105 68.92 15.97
Off Tx ⱕ 12b 41 70.88 17.19
Off Tx ⬎ 12c 73 77.66 15.25
Healthyd 105 83.41 14.88
Physical health a ⬍ c, d*** 3320 13.86 0.001
On Txa 105 65.54 23.14
Off Tx ⱕ 12b 41 73.17 18.54
Off Tx ⬎ 12c 73 80.01 18.66
Healthyd 105 82.60 19.52
Psychosocial health a, b ⬍ d***, c ⬍ d* 3320 14.22 0.001
On Txa 105 71.04 15.17
Off Tx ⱕ 12b 41 69.74 19.08
Off Tx ⬎ 12c 73 76.51 16.03
Healthyd 105 84.03 15.55
Emotional functioning a ⬍ c*, a ⬍ d***, b ⬍ d** 3320 10.30 0.001
On Txa 105 68.81 21.24
Off Tx ⱕ 12b 41 69.15 22.47
Off Tx ⬎ 12c 73 77.67 20.19
Healthyd 105 83.12 18.61
Social functioning a ⬍ d**, b ⬍ d*** 3320 7.81 0.001
On Txa 105 77.19 18.29
Off Tx ⱕ 12b 41 70.98 24.98
Off Tx ⬎ 12c 73 79.64 19.78
Healthyd 105 86.74 18.14
School functioning a ⬍ d*** 3250 5.822 0.001
On Txa 92 66.22 19.60
Off Tx ⱕ 12b 37 69.32 22.30
Off Tx ⬎ 12c 62 71.41 18.12
Healthyd 63 79.39 18.93

ANOVA: analysis of variance; SD: standard deviation; On Tx, on-treatment sample; Off Tx ⱕ 12: off-treatment ⱕ 12 mos sample; Off Tx ⬎ 12: off-treatment ⬎ 12 mos/long-term survivor sample.
* P ⬍ 0.05, ** P ⬍ 0.01, *** P ⬍ 0.001 based on Tukey Honestly Significantly Different post hoc analysis.

Version, the percentage of missing values was calcu- Means and Standard Deviations
lated. For child self-report and parent proxy-report, Table 1 presents the means and standard deviations of
the percentage of missing item responses for the on- the PedsQL 4.0 Generic Core Scales for children with
cology sample was 0.4% and 0.3%, respectively, for all cancer as a group and the healthy children population
scales except the School Functioning Scale. The per- group from our previous field trial with the Standard
centage of missing items for the School Functioning Version (1-month recall interval)20 and the healthy
Scale was 15% for child self-report (ages 5–18 years) sample with the Acute Version (7-day recall interval).
and 38% for parent proxy-report (ages 2–18 years). In Table 2 contains the means and the standard devia-
almost all of these cases, all of the items on the School tions of the PedsQL Multidimensional Fatigue Scale
Functioning Scale were not completed, suggesting for children with cancer as a group and the healthy
that the patient did not attend school the previous 7 sample Acute Version. Table 3 contains the means and
days (most of the data from the Los Angeles site were standard deviations of the PedsQL 3.0 Cancer Module
collected during summer vacation). for the pediatric cancer group.
For the PedsQL Multidimensional Fatigue Scale,
the percentage of missing item responses was 0% for
child self-report, and 0% for parent proxy-report. For Internal Consistency Reliability
the PedsQL 3.0 Cancer Module, the percentage of Internal consistency reliability alpha coefficients for
missing item responses was 0.5% for child self-report the PedsQL 4.0 Generic Core Scales across all ages are
and 1.0% for parent proxy-report. presented in Table 4. The child self-report scales and
 The PedsQL/Varni et al. 2099

TABLE 8
One-Way ANOVA Values Comparing Healthy Children and Children with Cancer (On- or Off-Treatment): PedsQL 4.0 Generic Core (Acute
Version) Parent Report

Scale n Mean SD Difference df f P value

Total score a ⬍ c*, a, b, c ⬍ d*** 3489 27.42 0.001

On Txa 180 66.96 19.84
Off Tx ⱕ 12b 61 71.61 16.79
Off Tx ⬎ 12c 95 73.68 18.63
Healthyd 157 84.54 15.70
Physical health a ⬍ c**, a ⬍ d***, b ⬍ d** 3489 15.06 0.001
On Txa 180 65.03 26.21
Off Tx ⱕ 12b 61 70.03 20.68
Off Tx ⬎ 12c 95 74.96 24.01
Healthyd 157 82.48 23.09
Psychosocial health a, b, c ⬍ d*** 3489 34.24 0.001
On Txa 180 68.19 18.25
Off Tx ⱕ 12b 61 72.48 16.44
Off Tx ⬎ 12c 95 72.92 17.98
Healthyd 157 86.04 13.43
Emotional functioning a ⬍ b*, a ⬍ c***, a, b, c ⬍ d*** 3489 36.52 0.001
On Txa 180 63.26 20.70
Off Tx ⱕ 12b 61 71.86 17.09
Off Tx ⬎ 12c 95 72.84 19.85
Healthyd 157 84.74 16.37
Social functioning a, b, c ⬍ d*** 3489 13.51 0.001
On Txa 180 75.58 20.08
Off Tx ⱕ 12b 61 75.08 20.81
Off Tx ⬎ 12c 95 76.11 21.66
Healthyd 157 87.59 16.54
School functioning a, b, c ⬍ d*** 3343 20.56 0.001
On Txa 120 63.61 24.03
Off Tx ⱕ 12b 47 68.79 20.86
Off Tx ⬎ 12c 83 69.06 23.00
Healthyd 97 86.22 17.84

ANOVA: analysis of variance; SD: standard deviation; On Tx: on-treatment sample; Off Tx ⱕ 12: off-treatment ⱕ 12 mos sample; Off Tx ⬎ 12: off-treatment ⬎ 12 mos/long-term survivor sample.
* P ⬍ 0.05, ** P ⬍ 0.01, *** P ⬍ 0.001 based on Tukey Honestly Significantly Different post hoc analysis.

parent proxy-report scales approached or exceeded minimum reliability standard of 0.70.38 The child self-
the minimum reliability standard of 0.70,38 except for report results were more variable. All of the adolescent
3 young child (ages 5–7 years) self-report scales. The (ages 13–18 years) self-report scales met or exceeded
PedsQL 4.0 Generic Core Scales Total Score across the the standard of 0.70. Six of the 8 child (ages 8 –12
ages approached or exceeded the reliability criterion years) self-report scales met or exceeded the standard
of 0.90 recommended for analyzing individual patient of 0.70. Two of the young child (ages 5–7 years) self-
scale scores.38, 39 report scales met or exceeded the standard.
Table 5 contains the internal consistency reliabil-
ity coefficients for the PedsQL Multidimensional Fa- Construct Validity
tigue Scale. All child self-report and parent proxy- Table 1 demonstrates the comparisons between the
report scales approached or exceeded the minimum PedsQL 4.0 Generic Core Scales for the healthy chil-
reliability standard of 0.70.38 The PedsQL Multidimen- dren groups and children with cancer as a group. For
sional Fatigue Scale Total Score across the ages ap- every comparison, there was a statistically significant
proached or exceeded the reliability criterion of 0.90 difference between healthy children and children with
recommended for analyzing individual patient scale cancer as a group. The hypothesis was confirmed that
scores.38,39 healthy children as a group would manifest higher
Table 6 contains the internal consistency reliabil- PedsQL 4.0 Generic Core Scales scores than children
ity coefficients for the PedsQL 3.0 Cancer Module. All with cancer as a group. Tables 7 and 8 display the
of the parent proxy-report scales met or exceeded the one-way ANOVA values comparing healthy children
2100 CANCER April 1, 2002 / Volume 94 / Number 7

TABLE 9
One-Way ANOVA Values Comparing Healthy Children and Children with Cancer (On- or Off-Treatment): Child Report Multidimensional Fatigue
Scale (Acute Version)

Scale n Mean SD Difference df f P value

Total fatigue a ⬍ d***, b ⬍ d* 3268 5.992 0.001

On Txa 106 68.54 17.08
Off Tx ⱕ 12b 41 70.92 19.87
Off Tx ⬎ 12c 73 74.56 18.48
Healthyd 52 80.49 13.33
General fatigue a ⬍ c*, a ⬍ d*** 3268 7.056 0.001
On Txa 106 71.40 20.32
Off Tx ⱕ 12b 41 76.63 19.02
Off Tx ⬎ 12c 73 79.27 18.04
Healthyd 52 85.34 14.95
Sleep/rest fatigue a ⬍ c*, a ⬍ d* 3268 4.435 0.005
On Txa 106 63.43 23.01
Off Tx ⱕ 12b 41 66.12 24.24
Off Tx ⬎ 12c 73 72.78 21.64
Healthyd 52 75.00 18.76
Cognitive fatigue a ⬍ d* 3268 3.191 0.024
On Txa 106 70.79 20.94
Off Tx ⱕ 12b 41 70.02 22.46
Off Tx ⬎ 12c 73 71.63 24.48
Healthyd 52 81.14 17.43

ANOVA: analysis of variance; SD: standard deviation; On Tx: on-treatment sample; Off Tx ⱕ 12: off-treatment ⱕ 12 mos sample; Off Tx ⬎ 12: off-treatment ⬎ 12 mos/long-term survivor sample.
* P ⬍ 0.05, ** P ⬍ 0.01, *** P ⬍ 0.001 based on Tukey Honestly Significantly Different post hoc analysis.

with children with cancer on-treatment or off-treat- Multidimensional Fatigue Scale Total Score demon-
ment with the PedsQL Generic Core Scales. For child strated significant differences between the healthy
self-report, the PedsQL 4.0 Generic Core Scales Total population group and children with cancer on-treat-
Score demonstrated significant differences between ment (Table 9). For parent proxy-report, the PedsQL
the healthy population group and children with can- Multidimensional Fatigue Scale Total Score demon-
cer on-treatment (Table 7). For parent proxy-report, strated significant differences between the healthy
the PedsQL 4.0 Generic Core Scales Total Score dem- population group and children with cancer on-treat-
onstrated significant differences between the healthy ment and off-treatment (Table 10). The analyses
population group and children with cancer on-treat- among children with cancer revealed that the most
ment and off-treatment (Table 8). The analyses among consistent group differences were observed primarily
children with cancer revealed that the most consistent between children on-treatment versus off-treatment
group differences were observed primarily between greater than 12 months (Tables 9 and 10).
children with cancer on-treatment versus off-treat- For the PedsQL 3.0 Cancer Module Scales, the
ment greater than 12 months (Tables 7 and 8). analyses among children with cancer revealed that for
For the PedsQL Multidimensional Fatigue Scale, child-self report, group differences were observed on
the Total Scale Score and the Subscale scores demon- the Nausea, Treatment Anxiety, and Worry Scales be-
strated significant differences between the healthy tween children on-treatment versus off-treatment
population group and children with cancer as a group greater than 12 months (Table 11). For parent proxy-
(Table 2). For every comparison, there was a statisti- report, group differences were observed on the Pain,
cally significant difference between healthy children Nausea, Procedural Anxiety, Treatment Anxiety, and
and children with cancer as a group. The hypothesis Worry Scales between children on-treatment versus
was confirmed that healthy children as a group would off-treatment (Table 12).
manifest higher PedsQL scores (better HRQOL or less The intercorrelations between the PedsQL 4.0 Ge-
fatigue) than children with cancer as a group. Tables 9 neric Core Scales Total Score and the PedsQL Multi-
and 10 display the one-way ANOVAs comparing dimensional Fatigue Total Scale Score and Subscales
healthy children with children with cancer on-treat- are shown in Table 13. As anticipated, the correlations
ment or off-treatment with the PedsQL Multidimen- are in the medium to large effect size range, with the
sional Fatigue Scale. For child self-report, the PedsQL largest intercorrelations between the Multidimen-
 The PedsQL/Varni et al. 2101

TABLE 10
One-Way ANOVA Values Comparing Healthy Children and Children with Cancer (On- or Off-Treatment): Parent Report Multidimensional
Fatigue Scale (Acute Version)

Scale n Mean SD Difference df f P value

Total fatigue a ⬍ c*, a, b, c ⬍ d*** 3435 23.19 0.001

On Txa 181 72.79 18.24
Off Tx ⱕ 12b 61 78.94 14.93
Off Tx ⬎ 12c 95 79.06 17.65
Healthyd 102 89.63 11.38
General fatigue a ⬍ b**, a ⬍ c, d***, b, c ⬍ d** 3435 24.83 0.001
On Txa 181 69.18 22.15
Off Tx ⱕ 12b 61 78.76 16.26
Off Tx ⬎ 12c 95 78.76 19.36
Healthyd 102 89.30 13.33
Sleep/rest fatigue a ⬍ b*, a ⬍ c, d***, b ⬍ d** 3435 24.20 0.001
On Txa 181 69.11 23.08
Off Tx ⱕ 12b 61 77.32 17.24
Off Tx ⬎ 12c 95 82.11 18.34
Healthyd 102 88.86 14.72
Cognitive fatigue a, c ⬍ d***, b ⬍ d* 3435 9.32 0.001
On Txa 181 80.08 20.48
Off Tx ⱕ 12b 61 80.74 21.49
Off Tx ⬎ 12c 95 76.31 23.93
Healthyd 102 90.72 15.15

ANOVA: analysis of variance; SD: standard deviation; On Tx: on-treatment sample; Off Tx ⱕ 12: off-treatment ⱕ 12 mos sample; Off Tx ⱕ 12: off-treatment ⬎ 12 mos/long-term survivor sample.
* P ⬍ 0.05, ** P ⬍ 0.01, *** P ⬍ 0.001 based on Tukey Honestly Significantly Different post hoc analysis.

sional Fatigue Scale Total Score with the Generic Core Items on the PedsQL had minimal missing re-
Scales Total Score for both child and parent report. sponses, suggesting that children and parents are will-
The intercorrelations between the Multidimensional ing and able to provide good quality data regarding
Fatigue Scale Total Score and the Cancer Module the child’s HRQOL. The PedsQL self-report and proxy-
Scales were also in the medium to large effect size report internal consistency reliabilities generally ex-
range. ceeded the recommended minimum alpha coefficient
standard of 0.70 for group comparisons. Across the
Parent/Child Concordance ages, the PedsQL 4.0 Generic Core Scales Total Score
The parent/child concordance intercorrelations ma- for both child self-report and parent proxy-report ap-
trix is shown in Table 13. Consistent with the extant proached or exceeded an alpha of 0.90, recommended
literature, child self-report and parent proxy-report for individual patient analysis,38 making the Total
correlations are in the medium to large effect size Scale Score suitable as a summary score for the pri-
range. mary analysis of HRQOL outcome in clinical trials and
other group comparisons. The Physical Health and
DISCUSSION Psychosocial Health Summary Scores are recom-
This study presents the measurement properties for mended for secondary analyses. The Emotional, So-
the PedsQL 4.0 Generic Core Scales, PedsQL Multidi- cial, and School Functioning Subscales may be uti-
mensional Fatigue Scale, and PedsQL 3.0 Cancer Mod- lized to examine specific domains of functioning, with
ule in pediatric cancer. The analyses support the reli- the caveat that until further testing is conducted, the
ability and validity of the PedsQL as a child self-report Social and School Functioning Subscales should be
and parent proxy-report HRQOL measurement instru- used only for descriptive or exploratory analyses for
ment for pediatric cancer. The PedsQL is the only young children ages 5–7 years.
empirically validated generic and cancer specific The PedsQL Multidimensional Fatigue Scale Total
HRQOL measurement instrument that we are aware of and Subscale internal consistency reliabilities demon-
to span this broad age range for child self-report and strated the recommended minimum alpha coefficient
parent proxy-report while maintaining item and scale standard of 0.70 for group comparisons for child self-
construct consistency. report ages 5–18 years and parent proxy-report ages
2102 CANCER April 1, 2002 / Volume 94 / Number 7

TABLE 11
One-Way ANOVA Values Comparing Children On- or Off-Treatment: Child Report Cancer Module (Acute Version)

Scale n Mean SD Difference df f P value

Pain and hurt 2216 0.53 0.592

On Txa 105 76.31 24.57
Off Tx ⱕ 12b 41 72.87 29.03
Off Tx ⬎ 12c 73 77.91 23.98
Nausea a ⬍ c*** 2217 9.65 0.001
On Txa 106 69.76 25.03
Off Tx ⱕ 12b 41 76.26 18.91
Off Tx ⬎ 12c 73 84.35 18.03
Procedural anxiety 2216 2.13 0.121
On Txa 106 64.54 30.84
Off Tx ⱕ 12b 40 67.50 29.34
Off Tx ⬎ 12c 73 74.09 30.64
Treatment anxiety a ⬍ c* 2216 4.15 0.017
On Txa 106 77.28 26.06
Off Tx ⱕ 12b 40 86.88 22.16
Off Tx ⬎ 12c 73 86.76 23.11
Worry a ⬍ c* 2214 3.46 0.033
On Txa 103 66.22 28.14
Off Tx ⱕ 12b 41 67.99 32.44
Off Tx ⬎ 12c 73 76.71 20.18
Cognitive problems 2215 0.17 0.847
On Txa 104 71.24 20.23
Off Tx ⱕ 12b 41 68.94 24.43
Off Tx ⬎ 12c 73 70.21 23.22
Perceived physical
appearance 2213 0.41 0.666
On Txa 102 70.51 23.97
Off Tx ⱕ 12b 41 67.48 25.67
Off Tx ⬎ 12c 73 71.69 23.23
Communication 2217 0.83 0.438
On Txa 106 72.17 25.04
Off Tx ⱕ 12b 41 75.61 25.71
Off Tx ⬎ 12c 73 76.83 23.86

ANOVA: analysis of variance; SD: standard deviation; On Tx: on-treatment sample; Off Tx ⱕ 12: off-treatment ⱕ 12 mos sample; Off Tx ⬎ 12: off-treatment ⬎ 12 mos/long-term survivor sample.
* P ⬍ 0.05, ** P ⬍ 0.01, *** P ⬍ 0.001 based on Tukey Honestly Significantly Different post hoc analysis.

2–18 years. Across the ages, the PedsQL Multidimen- dural Anxiety and Treatment Anxiety Scales met the
sional Fatigue Scale Total Score for both child self- 0.70 standard for group comparisons. The Perceived
report and parent proxy-report approached or ex- Appearance and the Communication Scales did not
ceeded an alpha of 0.90, recommended for individual meet the 0.70 standard for child self-report ages 8 –12
patient analysis,38 making the PedsQL Multidimen- years. Until further testing is conducted, the child
sional Fatigue Scale Total Score suitable as a summary self-report scales that did not achieve the standard of
score for the primary analysis of HRQOL fatigue out- 0.70 should be used only for descriptive or exploratory
come in clinical trials and other group comparisons. analyses. For parent proxy-report, reliability for all
The General Fatigue, Sleep/Rest Fatigue, and Cogni- Cancer Module Scales met or exceeded the 0.70 stan-
tive Fatigue Subscales may be utilized to examine dard and for most Scales were in the 0.80 to 0.90 range.
specific dimensions of fatigue, and are recommended The PedsQL 4.0 Generic Core Scales performed as
for secondary analyses. hypothesized utilizing the known-groups method. The
The PedsQL 3.0 Cancer Module Scales internal PedsQL 4.0 differentiated HRQOL in healthy children
consistency reliabilities generally exceeded the recom- as a group in comparison to children with cancer as a
mended minimum alpha coefficient standard of 0.70 group. The PedsQL Multidimensional Fatigue Scale
for group comparisons for child self-report ages 8 –18 differentiated fatigue in healthy children as a group in
years and parent proxy-report ages 2–18 years. For comparison to children with cancer as a group. The
young child self-report ages 5–7 years, only the Proce- intercorrelations among the PedsQL Multidimen-
 The PedsQL/Varni et al. 2103

TABLE 12
One-Way ANOVA Values Comparing Children On- or Off-Treatment: Parent Report Cancer Module (Acute Version)

Scale n Mean SD Difference df f P value

Pain and hurt a ⬍ c** 2330 5.71 0.004

On Txa 177 70.34 26.30
Off Tx ⱕ 12b 61 78.89 24.10
Off Tx ⬎ 12c 95 80.26 24.50
Nausea a ⬍ b, c*** 2330 20.18 0.001
On Txa 179 70.58 24.60
Off Tx ⱕ 12b 60 84.17 20.60
Off Tx ⬎ 12c 94 87.41 19.26
Procedural anxiety a ⬍ b*, a ⬍ c** 2330 6.07 0.003
On Txa 178 54.49 31.74
Off Tx ⱕ 12b 60 67.08 32.85
Off Tx ⬎ 12c 95 66.75 33.19
Treatment anxiety a ⬍ b** 2331 5.32 0.005
On Txa 179 67.37 29.71
Off Tx ⱕ 12b 60 79.86 22.36
Off Tx ⬎ 12c 95 74.12 25.16
Worry a ⬍ b*, a ⬍ c** 2328 6.41 0.002
On Txa 175 70.74 31.67
Off Tx ⱕ 12b 61 81.97 24.02
Off Tx ⬎ 12c 95 81.58 22.17
Cognitive problems 2329 1.83 0.162
On Txa 176 74.96 22.24
Off Tx ⱕ 12b 61 76.71 20.76
Off Tx ⬎ 12c 95 70.47 22.72
Perceived physical
appearance 2330 0.11 0.896
On Txa 178 75.73 25.95
Off Tx ⱕ 12b 61 77.46 23.98
Off Tx ⬎ 12c 94 76.33 24.02
Communication 2324 0.90 0.407
On Txa 173 77.99 22.28
Off Tx ⱕ 12b 60 81.81 23.04
Off Tx ⬎ 12c 94 76.68 26.06

ANOVA: analysis of variance; SD: standard deviation; On Tx: on-treatment sample; Off Tx ⱕ 12: off-treatment ⱕ 12 mos sample; Off Tx ⬎ 12: off-treatment ⬎ 12 mos/long-term survivor sample.
* P ⬍ 0.05, ** P ⬍ 0.01, *** P ⬍ 0.001 based on Tukey Honestly Significantly Different post hoc analysis.

sional Fatigue Total Scale Score and Subscales with self-report items. The cross-informant variance ob-
the PedsQL 4.0 Generic Core Scales and PedsQL 3.0 served in the parent/child intercorrelations matrix
Cancer Module Scales are consistent with the con- supports the need to measure the perspectives of child
ceptualization of disease-specific symptoms as and parent informants in evaluating HRQOL in pedi-
causal indicators of HRQOL1 and with the adult atric cancer. Although patient self-report is considered
cancer literature, which has demonstrated associa- the standard for measuring perceived HRQOL, it is the
tions between fatigue with health status, emotional parent’s perception of their child’s HRQOL that may
functioning (depression, anxiety), pain, cognitive func- influence healthcare utilization.14 Furthermore, the
tioning, and role functioning.25,26 Differences also have use of parent proxy-report to estimate child HRQOL
been demonstrated between healthy adults and adults may be necessary when the child is either unable or
with cancer.25 unwilling to complete the HRQOL measure, or as
The development and testing of the PedsQL Mea- proxy information when young child self-report scale
surement Model emphasize the child’s perceptions of reliabilities do not achieve the 0.70 standard. Never-
HRQOL. The items chosen for inclusion initially were theless, proxy-reports should be conducted with the
derived from the measurement properties of the child knowledge that proxy ratings of patient HRQOL may
self-report scales, whereas the parent proxy-report not be sufficiently accurate.44
scales were constructed to directly parallel the child The current findings have several potential limi-
2104 CANCER April 1, 2002 / Volume 94 / Number 7

TABLE 13
Pearson Correlation Coefficients between PedsQL Scales: Patient Self-Report above the Diagonal, Parent Proxy-Report below the Diagonal,
Patient/Parent Correlations on the Diagonala

Tot Ph Psy Em Soc Sch TF GF SF CF P N PA TA W CP A C

Total core (Tot) 0.561 0.850 0.914 0.788 0.745 0.679 0.728 0.672 0.577 0.593 0.512 0.494 0.338 0.422 0.455 0.571 0.456 0.445
Physical health (Ph) 0.915 0.568 0.567 0.532 0.475 0.369 0.559 0.554 0.485 0.379 0.405 0.449 0.268 0.374 0.390 0.420 0.351 0.383
Psychosocial health
(Psy) 0.944 0.732 0.487 0.831 0.805 0.770 0.709 0.626 0.530 0.636 0.491 0.433 0.320 0.373 0.417 0.572 0.451 0.399
Emotional
functioning (Em) 0.794 0.613 0.843 0.543 0.494 0.458 0.540 0.488 0.463 0.412 0.443 0.468 0.262 0.371 0.439 0.387 0.389 0.397
Social functioning
(Soc) 0.829 0.647 0.876 0.592 0.395 0.445 0.532 0.456 0.377 0.509 0.364 0.250 0.297 0.253 0.328 0.461 0.390 0.275
School functioning
(Sch) 0.793 0.603 0.839 0.536 0.620 0.362 0.674 0.579 0.474 0.668 0.373 0.325 0.188 0.238 0.223 0.586 0.295 0.292
Total fatigue (TF) 0.794 0.718 0.754 0.634 0.628 0.680 0.401 0.904 0.847 0.740 0.630 0.592 0.285 0.438 0.449 0.615 0.423 0.438
General fatigue (GF) 0.782 0.728 0.725 0.655 0.584 0.622 0.835 0.381 0.584 0.562 0.639 0.619 0.315 0.463 0.455 0.460 0.377 0.379
Sleep/rest fatigue
(SF) 0.720 0.683 0.660 0.591 0.524 0.588 0.849 0.767 0.404 0.530 0.558 0.632 0.208 0.353 0.438 0.368 0.397 0.293
Cognitive fatigue
(CF) 0.478 0.381 0.496 0.337 0.456 0.499 0.835 0.491 0.343 0.303 0.379 0.227 0.189 0.278 0.229 0.689 0.275 0.417
Pain (P) 0.627 0.574 0.591 0.545 0.511 0.465 0.499 0.448 0.430 0.382 0.416 0.400 0.174 0.251 0.345 0.376 0.181 0.216
Nausea (N) 0.599 0.568 0.550 0.581 0.413 0.384 0.470 0.509 0.381 0.308 0.557 0.422 0.246 0.395 0.473 0.252 0.224 0.364
Procedural anxiety
(PA) 0.305 0.238 0.323 0.382 0.245 0.220 0.297 0.273 0.240 0.236 0.308 0.316 0.499 0.606 0.336 0.321 0.277 0.275
Treatment anxiety
(TA) 0.448 0.375 0.457 0.506 0.350 0.311 0.346 0.312 0.269 0.291 0.399 0.426 0.627 0.436 0.437 0.301 0.244 0.301
Worry (W) 0.469 0.365 0.500 0.495 0.383 0.403 0.282 0.294 0.236 0.189 0.388 0.536 0.292 0.478 0.363 0.263 0.319 0.303
Cognitive problems
(CP) 0.507 0.407 0.527 0.377 0.482 0.478 0.637 0.472 0.455 0.672 0.355 0.258 0.237 0.350 0.351 0.340 0.396 0.443
Appearance (A) 0.450 0.318 0.502 0.449 0.472 0.332 0.362 0.288 0.300 0.322 0.366 0.356 0.189 0.326 0.478 0.318 0.370 0.359
Communication (C) 0.369 0.276 0.405 0.369 0.372 0.280 0.438 0.422 0.276 0.415 0.276 0.199 0.216 0.369 0.290 0.375 0.395 0.300

a
Correlations among Generic Core Total Score with the Multidimensional Fatigue Scale and the Cancer Module Scales are set in boldface. Correlations between Patient and Parent Report are underlined. All
correlations are significant at the P ⬍ 0.01 level (2-tailed). Effect sizes are designated as small (0.10), medium (0.30), and large (0.50).

tations. Information on nonparticipants was not avail-
able, which may limit the generalizability of the find-
ings. Test–retest reliability was not conducted;
however, test–retest reliability may be less useful than
internal consistency reliability in HRQOL instrument
development given that short-term fluctuations are
highly likely in a health condition in which external
factors, such as disease and treatment variables, are
expected to influence functioning. The method for
testing construct validity utilized the known groups
approach. Additional methods for testing construct
validity include correlating the instrument with other
standardized measures of functioning. Because three
PedsQL instruments were tested in this investigation,
issues of respondent burden were a consideration,
precluding the inclusion of other standardized mea-
sures. Group analysis (including oncology and healthy
samples) indicated that significantly more males than
females were assessed. Furthermore, the healthy sam-
ple assessed with the PedsQL 4.0 Generic Core Scales
Acute Version was significantly older than the oncol-
ogy sample and the other healthy samples. Neverthe-
less, instrument validation is an iterative process and
consistent with this paradigm, the PedsQL instru-
ments currently are being further field-tested nation-
ally and internationally in pediatric cancer and with
larger populations of healthy children.
The PedsQL Measurement Model represents a
conceptual framework for a measurement instrument
that must be at once disease specific and also reflec-
tive of broader generic concerns.45, 46 Although it is
likely that children and adolescents will have different
concerns related to HRQOL, the items selected for the
PedsQL Generic Core Scales, Cancer Module, and
Multidimensional Fatigue Scales reflect those items
that are of universal concern across age groups. At-
tempts were made to keep wording, and thus the
content, of items as similar as possible across parallel
forms, while being sensitive to developmental differ-
ences in cognitive ability. This consistency facilitates
the evaluation of differences in HRQOL across and
between age groups, between healthy children and

children with chronic health conditions, and for track-
ing of HRQOL longitudinally.
The results of the current study demonstrate the
reliability and validity of the PedsQL Generic Core
Scales, Multidimensional Fatigue Scale and Cancer
Module in pediatric cancer. These PedsQL measure-
ment instruments may be utilized as outcome mea-
sures in pediatric cancer clinical trials, research, and
clinical practice for HRQOL outcome assessment.
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