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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 BACKGROUND. The Pediatric Quality of Life Inventory (PedsQL) is a modular
Tasha M. Burwinkle, M.A.1 instrument designed to measure health-related quality of life (HRQOL) in children
Ernest R. Katz, Ph.D.3,4 and adolescents ages 2–18 years. The PedsQL 4.0 Generic Core Scales are multi-
Kathy Meeske, R.N., M.N.3 dimensional child self-report and parent proxy-report scales developed as the
Paige Dickinson, M.A., M.S.1 generic core measure to be integrated with the PedsQL disease specific modules.
The PedsQL Multidimensional Fatigue Scale was designed to measure fatigue in
1
Center for Child Health Outcomes, Children’s pediatric patients. The PedsQL 3.0 Cancer Module was designed to measure
Hospital and Health Center, San Diego, California. pediatric cancer specific HRQOL.
2
Department of Psychiatry, University of Califor- METHODS. The PedsQL Generic Core Scales, Multidimensional Fatigue Scale, and
nia, San Diego School of Medicine, San Diego, Cancer Module were administered to 339 families (220 child self-reports; 337
California. parent proxy-reports).
3
Center for Cancer and Blood Diseases, Children’s RESULTS. Internal consistency reliability for the PedsQL Generic Core Total Scale
Hospital, Los Angeles, California. Score (␣ ⫽ 0.88 child, 0.93 parent report), Multidimensional Fatigue Total Scale
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- ␣ ⫽ 0.72 child, 0.87 parent report) demonstrated reliability acceptable for group
fornia. 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.

Supported by a research grant from Ortho Biotech


Products, L.P. 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
The PedsQL is available at http://www.pedsql.org
status, functional status, and health-related quality of life (HRQOL)
Address for reprints: James W. Varni, Ph.D., Center are terms often used interchangeably, a recent meta-analysis suggests
for Child Health Outcomes, Children’s Hospital and that a more definitive distinction between these terms is warranted.4
Health Center, 3020 Children’s Way, San Diego, Health status and functional status refer to the physical functioning
CA 92123; Fax: (858) 966-7478; E-mail:
dimension of the broader HRQOL construct, whereas the HRQOL
jvarni@chsd.org
construct in addition includes the psychosocial dimensions of emo-
Received July 5, 2001; revision received October tional, social, and role functioning, as well as related constructs. Thus,
30, 2001; accepted October 31, 2001. a HRQOL instrument must be multidimensional, consisting at the

© 2002 American Cancer Society


The PedsQL/Varni et al. 2091

minimum of the physical, mental, and social health sons. The PedsQL 4.0 Generic Core Scales distin-
dimensions delineated by the World Health Organiza- guished between healthy children and pediatric pa-
tion.5 Although the importance of measuring HRQOL tients with acute or chronic health conditions and
in pediatric cancer has been advocated for several were related to indicators of morbidity and illness
years,6,7 the measurement of fatigue in pediatric can- burden.20
cer is a more contemporary conceptualization.8 The PedsQL Measurement Model was designed as a
Pediatric HRQOL measurement instruments must modular approach to measuring pediatric HRQOL, inte-
be sensitive to cognitive development and integrate grating the relative merits of generic and disease specific
both child self-report and parent proxy-report to re- approaches.19,21 Although disease specific modules may
flect their potentially unique perspectives. Imperfect enhance measurement sensitivity for health domains
concordance between self- and proxy-report, termed germane to a particular chronic health condition, a ge-
cross-informant variance,9 has been consistently doc- neric HRQOL measurement instrument enables com-
umented among child/adolescent, parent, teacher, parisons across pediatric populations and facilitates
and healthcare professionals, reports in the HRQOL benchmarking with healthy population norms.
assessment of healthy children10 and children with Given that the PedsQL Measurement Model inte-
chronic health conditions,11–14 including cancer.15 grates generic core scales and disease specific mod-
Agreement has been demonstrated to be lower for ules into one measurement system, the PedsQL 4.0
internalizing problems (e.g., depression and pain) Generic Core Scales were specifically designed for ap-
than for externalizing problems (e.g., hyperactivity plication in both healthy and patient populations. The
and walking). Because HRQOL derives from an indi- PedsQL 3.0 Cancer Module was designed to measure
vidual’s perception, the demonstration of cross-infor- HRQOL dimensions specifically tailored for pediatric
mant variance indicates the need for reliable and valid cancer. The PedsQL 3.0 Cancer Module, derived from
child self-report HRQOL measurement instruments the PedsQL 1.0 Cancer Module,19 also has resulted
for the broadest age range possible. from an extensive iterative process, including addi-
The Pediatric Quality of Life Inventory (PedsQL) tional constructs and items, a more sensitive scaling
builds on a programmatic measurement instrument de- range, and a broader age range for child self-report
velopment effort by Varni and colleagues in pediatric and parent proxy-report.
chronic health conditions, including pediatric can- The PedsQL Multidimensional Fatigue Scale is a
cer,15–18 during the past 15 years. The PedsQL 1.0,19 newly developed instrument, designed to measure
originally derived from a pediatric cancer database,15–17 child and parent perceptions of fatigue in pediatric
was designed as a generic HRQOL instrument to be patients. There are several instruments that measure
utilized noncategorically, that is, across diverse pediatric fatigue in adult cancer patients,22,23 including several
populations. Given that instrument development is an that are explicitly multidimensional fatigue mea-
iterative process, the PedsQL 2.0 and 3.0 included addi- sures.24 –26 In pediatric cancer, the measurement of
tional constructs and items, a more sensitive scaling fatigue is exemplified by the work of Hockenberry-
range, and a broader age range for child self-report and Eaton, Hinds, and colleagues.8,27 In the development
parent proxy-report. The PedsQL 4.0 Generic Core Scales of the PedsQL Multidimensional Fatigue Scale, multi-
have resulted from this iterative process and include dimensional constructs were derived from reviews of
child self-report for ages 5–18 years and parent proxy- both the adult and pediatric cancer fatigue literature
report for ages 2–18 years. and integrated into the PedsQL Measurement Model.
The PedsQL 4.0 Generic Core Scales were de- The current study presents the measurement prop-
signed to measure the core physical, mental, and so- erties of the PedsQL in pediatric cancer, reporting on the
cial health dimensions as delineated by the World reliability and validity of the Generic Core Scales, Multi-
Health Organization,5 as well as role (school) func- dimensional Fatigue Scale, and Cancer Module.
tioning. In the initial field trial, the PedsQL 4.0 Generic
Core Scales (physical, emotional, social, and school METHODS
functioning) were administered to 1677 families (963 Subjects and Settings
child self-report; 1629 parent proxy-report), recruited Oncology sample
from pediatric healthcare settings.20 Internal consis- Subjects were recruited from the Hematology/Oncol-
tency reliability for the Total Scale Score (␣ ⫽ 0.88 ogy Center at Children’s Hospital and Health Center,
child, 0.90 parent report), Physical Health Summary San Diego, and the Center for Cancer and Blood Dis-
Score (␣ ⫽ 0.80 child, 0.88 parent report), and Psycho- eases at Children’s Hospital Los Angeles. Participants
social Health Summary Score (␣ ⫽ 0.83 child, 0.86 were 339 families of children ages 2–18 years. Children
parent report) were acceptable for group compari- 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 boys (58%) and 143 girls (42%) was 8.72 years (stan-
completed the PedsQL parent proxy-report (n ⫽ 337). dard deviation [SD], 4.57) with a range of 2 to 18 years.
In 119 cases, a parent proxy-report was completed, For child self-report, the average age of the 124 boys
but a child self-report was not completed, and in 2 (56%) and 96 girls (44%) was 10.9 years (SD, 3.83) with
cases, a child self-report was completed, but a parent a range of 5 to 18 years. Children identified as being
proxy-report was not completed. Depending on the “off-treatment long-term survivor” were significantly
scale, both child self-report and parent proxy-report older (mean age , 10.1 years) than children on-treat-
were available on 190 to 218 parent/child dyads. ment (mean age , 8.2 years) and children off-treatment
The PedsQL was self-administered for parents and for less than 12 months (mean age, 8.2; P ⬍ 0.05, based
for children ages 8 –18 years and interviewer-admin- on Tukey post hoc analysis). Comparisons among on-
istered for children ages 5–7 years. Most patients and cology treatment groups indicate that there was no
parents (n ⫽ 180, 82%, child report; n ⫽ 276, 82%, statistically significant difference in the ratio of males
parent report) completed the PedsQL in the hospital to females. There was, however, a statistically signifi-
outpatient clinics. The PedsQL also was administered cant difference between the number of males and
when a child was an inpatient in the cancer unit (n females in the oncology sample as a whole (P ⬍ 0.001).
⫽ 15, 7%, child report; n ⫽ 23, 7%, parent report), or The sample was heterogeneous with respect to race/
while a child was admitted to the day hospital (n ⫽ 2, ethnicity, with 98 (29%) white non-Hispanic, 175
1%, child report; n ⫽ 3, 1%, parent report). Some (52%) Hispanic, 15 (4%) black non-Hispanic, 19 (6%)
children (n ⫽ 23, 10%) and parents (n ⫽ 35, 10%) Asian/Pacific Islander, 2 (1%) American Indian or
completed the PedsQL at home, where the parents Alaskan Native, 27 (8%) other, and 3 (1%) missing.
were given detailed written instructions about how to Mean socioeconomic status (SES) for the oncology
complete the questionnaire as well as how to admin- sample was 35, based on the Hollingshead index, in-
ister the questionnaire to their child. The instructions dicating on average a low- to middle-class family
stated that the parent should first complete the parent SES.28 There were no statistically significant differ-
proxy-report separately from their child, that they ences in SES between on-treatment and off-treatment
should read the instructions and items aloud to a child groups.
ages 5–7 years, and that children and adolescents ages
8 –18 years should independently complete the child Healthy sample: Generic Core Scales Acute Version
self-report items after reading the instructions. The Subjects were 157 families of healthy children ages
measures were administered in two languages: En- 2–18 years. Healthy children ages 5–18 years (n ⫽ 105)
glish (n ⫽ 174, 79%, child report; n ⫽ 223, 66%, parent and parents of healthy children ages 2–18 years (n
report) and Spanish (n ⫽ 46, 21%, child report; n ⫽ 157) were administered the PedsQL 4.0 Generic
⫽ 114, 34%, parent report). Core Scales Acute Version via telephone. This sample
The oncology sample included children with was accrued from a list of patients who had attended
acute lymphocytic leukemia (n ⫽ 171, 50%), brain an orthopedic clinic for broken bones or fractures 6
tumor (n ⫽ 24, 7%) non-Hodgkin lymphoma (n ⫽ 20, months before assessment with the PedsQL, and who
6%), Hodgkin lymphoma (n ⫽ 11, 3%), Wilms’ tumor had been identified by the clinic nurse as having “re-
(n ⫽ 19, 6%), and other cancers (n ⫽ 94, 28%). Patients turned to health” (i.e., no current problems due to
comprised all diagnostic groups, had no comorbid their orthopedic injury). The average age of the 98
disease or major developmental disorders, and in- boys (62.4 %) and 58 girls (36.9 %; missing, 1; 0.6%)
cluded newly diagnosed on-treatment, recurrent dis- was 11.63 years (SD, 8.59). For child self-report, the
ease on-treatment, in recent remission off-treatment, average age of the 72 boys (68.6 %) and 33 girls (31.4
or long-term off-treatment. On-treatment status was %) was 13.70 years (SD, 9.47). The sample was heter-
defined as patients who were receiving medical treat- ogeneous with respect to race/ethnicity, with 77 (49%)
ment to induce remission (n ⫽ 183, 54%). Off-treat- white non-Hispanic, 39 (25%) Hispanic, 6 (4%) black
ment status was defined as patients for whom all non-Hispanic, 5 (3%) Asian/Pacific Islander, 14 (9%)
therapy was completed by the time of assessment. other, and 16 (10%) missing. Mean SES was unavail-
Off-treatment remission was defined by being disease able for this sample. Comparisons between this
free accompanied by termination of cancer treatment healthy sample and the oncology sample indicates
in the past 12 months (n ⫽ 61, 18%). Off-treatment that there was no statistically significant difference in
long-term survivor was defined by being disease free the ratio of males to females assessed with the PedsQL
accompanied by termination of cancer treatment for 4.0 Generic Core Scales Acute Version. This healthy
longer than 12 months (n ⫽ 95, 28%). sample was significantly older (mean age, 11.6 years)
For all forms combined, the average age of the 196 than the oncology sample (mean age, 8.7 years) and
The PedsQL/Varni et al. 2093

the healthy sample for the PedsQL Generic Core Scales (46.1 %) Hispanic, 6 (5.9 %) black non-Hispanic, 2 (2.0
Standard Version (mean age, 8.9 years; P ⬍ 0.01, based %) Asian/Pacific Islander, 1 (1.0 %) American Indian
on Tukey post hoc analysis). or Alaskan Native, 14 (13.7 %) other, and 4 (3.9 %)
missing. Mean SES was unavailable for this sample.
Healthy sample: Generic Core Scales Standard Version Comparisons between this healthy sample and the
Participants were 730 families of healthy children ages oncology sample indicate that the ratio of males to
2–18 years, whose scores were derived from the females was different in the 2 samples, with 69 (67.6%)
PedsQL 4.0 Generic Core Scales field test.20 Healthy males and 30 (29.4%) females in the healthy sample in
children ages 5–18 years completed the PedsQL child comparison to the oncology sample, with 196 (58%)
self-report (n ⫽ 401), and parents of healthy children males and 143 (42%) females (chi-square (1) ⫽ 4.53; P
ages 2–18 years completed the PedsQL parent proxy- ⬍ 0.05). There was no statistically significant differ-
report (n ⫽ 719). Healthy children were those assessed ence in age between this healthy sample and the on-
either in their physician’s offices during well-child cology sample.
checks or by telephone and whose parents did not
report the presence of a chronic health condition. The Measures
average age of the 351 boys (48.1 %) and 378 girls (51.8 The PedsQL 4.0 Generic Core Scales
%; missing, 1) was 8.9 years (SD, 4.24; missing, 8). For The 23-item multidimensional PedsQL 4.0 Generic
child self-report, the average age of the 182 boys (45.4 Core Scales encompass 4 scales: 1) physical function-
%) and 219 girls (54.6 %) was 10.9 years (SD, 3.30; ing (8 items), 2) emotional functioning (5 items), 3)
missing, 1). The sample was heterogeneous with re- social functioning (5 items), and 4) school functioning
spect to race/ethnicity, with 211 (28.9 %) white non- (5 items). The PedsQL 4.0 Generic Core Scales are
Hispanic, 362 (49.6 %) Hispanic, 48 (6.6 %) black non- comprised of parallel child self-report and parent
Hispanic, 20 (2.7 %) Asian/Pacific Islander, 4 (0.5 %) proxy-report formats. Child self-report includes ages
American Indian or Alaskan Native, 47 (6.4 %) other, 5–7 years (young child), ages 8 –12 years (child), and
and 38 (5.2 %) missing. Mean SES was unavailable for ages 13–18 years (adolescent). Parent proxy-report in-
this sample. Comparisons between this healthy sam- cludes ages 2– 4 years (toddler), 5–7 years (young
ple and the oncology sample indicate that the ratio of child), 8 –12 years (child), and 13–18 years (adoles-
males to females was different in the two samples with cent). The parent proxy-report forms are designed to
351 (48.1%) males and 378 (51.8%) females in the assess the parent’s perceptions of their child’s
healthy sample as compared with the oncology sam- HRQOL. The items for each of the forms are essentially
ple with 196 (58%) males and 143 (42%) females (chi- identical, differing in developmentally appropriate
square(1) ⫽ 8.66; P ⬍ 0.01). There was no statistically language, or first or third person tense.
significant difference in age between this healthy sam- The instructions for the Standard Version ask how
ple and the oncology sample. much of a problem each item has been during the past
1 month. For the purposes of the current investiga-
Healthy sample: Multidimensional Fatigue Scale Acute tion, we utilized the PedsQL Acute Version (past 7 days
Version recall interval). A 5-point Likert response scale is uti-
Subjects were 102 families of healthy children ages lized across child self-report for ages 8 –18 years and
2–18 years. Healthy children ages 5–18 years (n ⫽ 52) parent proxy-report (0 ⫽ never a problem; 1 ⫽ almost
and parents of healthy children ages 2–18 years (n never a problem; 2 ⫽ sometimes a problem; 3 ⫽ often
⫽ 102) were administered the PedsQL Multidimen- a problem; 4 ⫽ almost always a problem). To further
sional Fatigue Scale Acute Version via telephone. This increase the ease of use for the young child self-report
sample was accrued from a list of patients who had (ages 5–7 years), the Likert scale is reworded and sim-
attended an orthopedic clinic for broken bones or plified to a 3-point scale (0 ⫽ not at all a problem; 2
fractures 6 months before assessment with the ⫽ sometimes a problem; 4 ⫽ a lot of a problem), with
PedsQL, and who had been identified by the clinic each response choice anchored to a happy to sad faces
nurse as having “returned to health” (e.g., no current scale.29, 30 Parent proxy-report also includes the tod-
problems due to their orthopedic injury). The average dler age range (ages 2– 4 years), which does not in-
age of the 69 boys (67.7 %) and 30 girls (29.4 %; clude a self-report form given developmental limita-
missing, 3) was 8.88 years (SD, 10.98). For child self- tions on self-report for children younger than 5 years
report, the average age of the 40 boys (76.9 %) and 11 of age,30, 31 and includes only 3 items for the school
girls (21.2 %; missing, 1) was 10.40 years (SD, 14.45). functioning scale.
The sample was heterogeneous with respect to race/ Items are reverse-scored and linearly transformed to
ethnicity, with 28 (27.5 %) white non-Hispanic, 47 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 tency reliability was determined by calculating Cron-
Acute Version, and the PedsQL Multidimensional Fa- bach coefficient alpha.37 Scales with reliabilities of
tigue Scale Acute Version were administered simulta- 0.70 or greater are recommended for comparing pa-
neously, with parents completing the proxy-report tient groups, whereas a reliability criterion of 0.90 is
version independently and at the same time that their recommended for analyzing individual patient scale
38, 39
child completed the self-report version. This research scores.
protocol was approved by the Institutional Review Construct validity was determined utilizing the
Boards at Children’s Hospital and Health Center, San known-groups method. The known-groups method
Diego and Children’s Hospital Los Angeles. compares scale scores across groups known to differ
in the health construct being investigated. In this
Statistical Analysis study, PedsQL 4.0 Generic Core Scales scores in
Feasibility or practicality was determined from the groups differing in known health condition (healthy
percentage of missing values.36 Scale internal consis- 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 toms) would be correlated with higher Generic Core
(ANOVA). The data for the healthy group of children Total Scale Scores (better overall HRQOL), based on
were derived from the initial field trial of the PedsQL the conceptualization of disease-specific symptoms as
4.0 Standard Version (1-month recall interval),20 and a causal indicators of HRQOL.1 Correlation effect sizes
healthy sample that completed the Acute Version (7- are designated as small (0.10 – 0.29), medium (0.30 –
day recall period). We hypothesized that healthy chil- 0.49), and large (ⱖ 0.50).42 Intercorrelations were ex-
dren would report higher PedsQL 4.0 scores (better pected to demonstrate medium to large effect sizes.1
HRQOL) than pediatric patients with cancer. In addi- Parent/child intercorrelations were computed to
tion, PedsQL Multidimensional Fatigue Scale scores in examine cross-informant variance. Correlation effect
groups differing in known health condition (healthy sizes are designated as small (0.10 – 0.29), medium
children and children with cancer) were comput- (0.30 – 0.49), and large (ⱖ 0.50).42 Parent/child concor-
ed,40,41 using t tests and ANOVA. The data for the dance for the Total Score, Summary Scores, and the
healthy group of children were derived from a healthy same Subscale were expected to demonstrate medium
sample that completed the Acute Version (7-day recall to large effect sizes, but not so large that child and
period). We hypothesized that healthy children would parent reports would be redundant.
report higher PedsQL scores (better HRQOL or less Statistical analyses were conducted using SPSS for
fatigue) than pediatric patients with cancer. Analyses Windows.43 Response equivalence has been demon-
of variance also were conducted to examine whether strated previously across language (English vs. Span-
there were differences in PedsQL Generic Core Scales, ish) for the PedsQL by examining the percentage of
Multidimensional Fatigue Scale, and Cancer Module missing data, floor and ceiling effects, and scale inter-
scores among children with cancer on-treatment, off- nal consistency across language.20 Therefore, re-
treatment for 12 months or less, and off-treatment for sponses were pooled across languages. Responses also
more than 12 months. were pooled across the age ranges for both self-report
Construct validity was further examined through and proxy-report.
an analysis of the intercorrelations among the PedsQL
4.0 Generic Core Total Scale Score with the PedsQL RESULTS
Multidimensional Fatigue Total Scale and Subscales Missing Item Responses
scores. It was hypothesized that higher Fatigue Total To assess the feasibility or practicality of administra-
Scale and Subscale scores (fewer problems or symp- 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- ogy sample and the other healthy samples. Neverthe-
able, which may limit the generalizability of the find- less, instrument validation is an iterative process and
ings. Test–retest reliability was not conducted; consistent with this paradigm, the PedsQL instru-
however, test–retest reliability may be less useful than ments currently are being further field-tested nation-
internal consistency reliability in HRQOL instrument ally and internationally in pediatric cancer and with
development given that short-term fluctuations are larger populations of healthy children.
highly likely in a health condition in which external The PedsQL Measurement Model represents a
factors, such as disease and treatment variables, are conceptual framework for a measurement instrument
expected to influence functioning. The method for that must be at once disease specific and also reflec-
testing construct validity utilized the known groups tive of broader generic concerns.45, 46 Although it is
approach. Additional methods for testing construct likely that children and adolescents will have different
validity include correlating the instrument with other concerns related to HRQOL, the items selected for the
standardized measures of functioning. Because three PedsQL Generic Core Scales, Cancer Module, and
PedsQL instruments were tested in this investigation, Multidimensional Fatigue Scales reflect those items
issues of respondent burden were a consideration, that are of universal concern across age groups. At-
precluding the inclusion of other standardized mea- tempts were made to keep wording, and thus the
sures. Group analysis (including oncology and healthy content, of items as similar as possible across parallel
samples) indicated that significantly more males than forms, while being sensitive to developmental differ-
females were assessed. Furthermore, the healthy sam- ences in cognitive ability. This consistency facilitates
ple assessed with the PedsQL 4.0 Generic Core Scales the evaluation of differences in HRQOL across and
Acute Version was significantly older than the oncol- between age groups, between healthy children and
The PedsQL/Varni et al. 2105

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