PedsQL™ 4.0: Reliability and Validity of the Pediatric Quality of Life Inventory™ Version 4.

0
Generic Core Scales in Healthy and Patient Populations
Author(s): James W. Varni, Michael Seid and Paul S. Kurtin
Source: Medical Care, Vol. 39, No. 8 (Aug., 2001), pp. 800-812
Published by: Lippincott Williams & Wilkins
Stable URL: http://www.jstor.org/stable/3767969
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MEDICAL CARE
Volume39, Number8, pp 800-812
02001 LippincottWilliams& Wilkins,Inc.
4.0: Reliabilityand Validityof the PediatricQualityof
PedsQLTM
Version4.0 GenericCore Scales in Healthy
LifeInventoryTM
and PatientPopulations
SEID, PHD,* ANDPAULS. KURTIN,
JAMESW. VARNI,PHD,*t MICHAEL
BACKGROUND. The PedsQL (Pediatric Quality
of Life Inventory) (Children's Hospital and
Health Center, San Diego, California) is a
modular instrument for measuring health-
related quality of life (HRQOL) in children
and adolescents ages 2 to 18. The PedsQL 4.0
Generic Core Scales are multidimensional
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 4.0 Generic Core Scales
consist of 23 items applicable for healthy
school and community populations, as well as
pediatric populations with acute and chronic
health conditions.
METHODS. The 4 PedsQL 4.0 Generic Core
Scales (Physical, Emotional, Social, School)
were administered to 963 children and 1,629
parents (1,677 subjects accrued overall) re-
cruited from pediatric health care settings.
Item-level and scale-level measurement prop-
erties were computed.
RESULTS. Internal consistency reliability for
the Total Scale Score (a = 0.88 child, 0.90 par-
In clinical trials,1'2population health,3 clinical
improvement,4,5and among purchasers of health
care services,6 health-related quality of life
(HRQOL) has emerged as an essential health
outcome. HRQOL instruments must consist at the
*From Center for Child Health Outcomes, Children's
Hospital and Health Center, San Diego, California.
tFrom the Department of Psychiatry, University of
California, School of Medicine, San Diego, California.
This research was supported by intramural grants
from the Children's Hospital and Health Center, San
Diego.
800
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MD*
ent report), Physical Health Summary Score
(a = 0.80 child, 0.88 parent), and Psychosocial
Health Summary Score (a = 0.83 child, 0.86
parent) were acceptable for group compari-
sons. Validity was demonstrated using the
known-groups method, correlations with indi-
cators of morbidity and illness burden, and
factor analysis. The PedsQL distinguished be-
tween healthy children and pediatric patients
with acute or chronic health conditions, was
related to indicators of morbidity and illness
burden, and displayed a factor-derived solu-
tion largely consistent with the a priori
conceptually-derived scales.
CONCLUSION. The results demonstrate the re-
liability and validity of the PedsQL 4.0 Generic
Core Scales. The PedsQL 4.0 Generic Core
Scales may be applicable in clinical trials,
research, clinical practice, school health set-
tings, and community populations.
Key words: Health-related quality of life;
pediatrics; health; children; adolescents. (Med
Care 2001;39:800-812)
minimum of the physical, mental, and social
health dimensions delineated by the World Health
Organization (WHO).7
Pediatric HRQOL measurement instruments
must be sensitive to cognitive development and
Address correspondence and reprint requests to:
James W. Varni, PhD, Professor and Senior Scientist,
Center for Child Health Outcomes, Children's Hospital
and Health Center, 3020 Children's Way, San Diego, CA
92123. E-mail: jvami@chsd.org. The PedsQL is available
at http://www.pedsql.org.
Received February 8, 2000; initial review April 17,
2000; accepted March 6, 2001.
Vol.39, No. 8
include child self-report and parent proxy-
report.Imperfectconcordancehas been consis-
tently noted in adult HRQOLresearchbetween
patients'self-reports and ratings by health care
providersand significantothers.8Imperfectcon-
cordancehas been documented in the HRQOL
assessment of children with asthma,9cystic fi-
brosis,10chronicheadache," limb deficiencies,12
arthritis,13cancer,14-16as well as healthy chil-
dren.17In pediatric health assessment, agree-
ment has been found to be lower for internal-
izing problems (eg, depression, pain) than for
externalizingproblems (eg, hyperactivity,walk-
ing).1317The presence of imperfectconcordance
suggests a critical need in pediatric HRQOL
measurement for reliable and valid child self-
report instruments for the broadest age range
possible.
Although the relativemerit of generic versus
disease-specific instrumentsis a matter of em-
piricalinquiry,18there may be advantagesto an
integrated approach.19'20 Disease-specific mod-
ules may enhance measurement sensitivity for
health domains germane to a chronic health
condition (eg, fatigue in cancer), whereas a
generic instrument enables comparisonsacross
groups and bench-marking with healthy
populations.
The PedsQL (PediatricQuality of Life Inven-
tory) MeasurementModel (Children'sHospital
and Health Center,San Diego, California)inte-
grates generic core scales and disease-specific
modules into one measurement system. The
PedsQL4.0 builds on programmaticinstrument
development researchduring the past 15 years,
beginning with the measurement of pain and
functionalstatus.21,22 The PedsQL1.0,20derived
from a cancerdatabase,15,16,23 was designed as a
generic instrument to be utilized noncategori-
cally across pediatricpopulations. The PedsQL
2.0 and 3.0 included additional constructs and
items, a more sensitive scaling range, and a
broaderage range.The PedsQL4.0 has resulted
from this iterativeprocess, and was designed to
measure the core health dimensions delineated
by WHO,7including role (school) functioning.
This study presents the measurementproper-
ties of the PedsQL 4.0 Generic Core Scales,
reporting on their reliabilityand validity in a
diverse sample of healthy childrenand pediatric
patientswith acute or chronichealth conditions.
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PEDSQL4.0
Methods
Subjects and Settings
Subjects were children ages 5 to 18 years
(n = 963) and parents of childrenages 2 to 18
years (n = 1,629),with 1,677participantsaccrued
overall.For 915 childrenages 5 to 18 years,both
child-self report and parent proxy-reportwere
available.To maximizethe heterogeneityof the
sample,subjectswererecruitedfromthreetypesof
sites. Subjectswere childrenpresentingat pedia-
tricians'offices for scheduled well-child checks
(n = 98, 5.9%),childrenat one of four hospital
specialty clinics-orthopedics (n = 127, 7.6%),
cardiology (n = 156, 9.3%), rheumatology
(n = 95, 5.7%),and diabetes(n = 49, 2.9%)-and
children who had been seen as inpatients or
outpatientsat the hospitalor its outpatientcom-
munity clinics at least 3 months previously
(n = 1,141,68.0%)(11 children,0.7%had missing
data).
Two modes of administrationwere used-in
person (n = 439, 26.2%) and by telephone
(n = 1,227,73.2%).Forthe in-personmode,ques-
tionnaireswere self-administeredfor parentsand
for children ages 8 to 18 and interviewer-
administeredfor childrenages 5 to 7. The mea-
sures were administeredin two languages-En-
glish (n = 1328, 79.2%) and Spanish (n = 349,
20.8%).
Forall formscombined,the averageage of the
815 boys (48.6%)and 830 girls (49.5%;32, 1.9%
missing)was 9.3years(SD = 4.37)with a rangeof
2.0 to 18.8years.Forchildself-report,the average
age of the 643 boys (48.1%)and 664 girls (49.7%;
30, 2.2% missing) was 10.78 years (SD = 3.61)
with a range of 5.0 to 18.8. The sample was
heterogeneouswith respectto race/ethnicity, with
612 (36.5%)White non-Hispanic,667 (39.8%)
Hispanic, 117 (7.0%) Black non-Hispanic, 49
(2.9%)Asian/PacificIslander,18 (1.1%)American
Indian or AlaskanNative, 99 (5.9%)Other,and
115 (6.9%) missing. With respect to insurance
type, 31% of the sample had commercialinsur-
ance,with 56%coveredby Medicaid,2.8%Other,
0.7%self-pay,and 9.5%missing.The samplewas
also diversewith respectto socioeconomicstatus,
using mother'seducationas a proxy.In the sam-
ple, 7.1%of mothershad no more than an ele-
mentaryschool education,15.8%had some sec-
ondaryeducationbut did not graduatefromhigh
school, 14.8%were high school graduates,25.8%
801
VARNI ET AL
had some posthigh school education, 12.2% were
college graduates, 4.4% had a graduate or profes-
sional degree, with 19.8% missing data.
The sample included chronically ill children,
acutely ill children, and healthy children. The
chronically ill children were those whose parents
reported the presence of a chronic health condi-
tion (n = 683, 40.7%); acutely ill children were
those whose parents did not report the presence of
a chronic health condition, but who were assessed
at one of the specialty clinics (n = 207, 12.3%);
and healthy children were those assessed either in
physicians' offices during well-child checks or by
telephone and whose parents did not report the
presence of a chronic health condition (n = 730,
43.5%; 57 (3.4.%) missing). The response rate for
subject accrual is unknown because information
on nonparticipants was not collected.
Measures
PedsQL 4.0 (Pediatric Quality of Life
InventoryVersion 4.0)
The 23-item PedsQL 4.0 Generic Core Scales
encompass: 1) Physical Functioning (8 items), 2)
Emotional Functioning (5 items), 3) Social Func-
tioning (5 items), and 4) School Functioning (5
items), and were developed through focus groups
and cognitive interviews.20
The Generic Core Scales are comprised of par-
allel child self-report and parent proxy-report for-
mats. Child self-report includes ages 5 to 7,8 to 12,
and 13 to 18 years. Parent proxy-report includes
ages 2 to 4 (toddler), 5 to 7 (young child), 8 to 12
(child), and 13 to 18 (adolescent), and assesses
parent's perceptions of their child's HRQOL. The
items for each of the forms are essentially identi-
cal, differing in developmentally appropriate lan-
guage, or first or third person tense. The instruc-
tions ask how much of a problem each item has
been during the past 1 month. A 5-point response
scale is utilized across child self-report for ages 8
to 18 and parent proxy-report (0 = never a prob-
lem; 1 = almost never a problem; 2 = sometimes
a problem; 3 = often a problem; 4 = almost al-
ways a problem). To further increase the ease of
use for the young child self-report (ages 5-7), the
response scale is reworded and simplified to a
3-point scale (0 = not at all a problem; 2 = some-
times a problem; 4 = a lot of a problem), with each
response choice anchored to a happy to sad faces
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MEDICALCARE
scale.21'24Parent proxy-report also includes the
toddler age range (ages 2-4), which does not
include a self-report form given developmental
limitations on self-report for children younger
than 5 years of age,24'25and includes only 3 items
for the school functioning scale.
Items are reverse-scored and linearly trans-
formed to a 0 to 100 scale (0 = 100,1 = 75, 2 = 50,
3 = 25, 4 = 0), so that higher scores indicate better
HRQOL. Scale Scores are computed as the sum of
the items divided by the number of items an-
swered (this accounts for missing data). If more
than 50% of the items in the scale are missing, the
Scale Score is not computed.26For this study, more
than 99% of child and parent respondents were
included in the Scale Score analyses. The Physical
Health Summary Score (8 items) is the same as the
Physical Functioning Subscale. To create the Psy-
chosocial Health Summary Score (15 items), the
mean is computed as the sum of the items divided
by the number of items answered in the Emo-
tional, Social, and School Functioning Subscales.
PedsQL Family InformationForm
The PedsQL Family Information Form, com-
pleted by parents, contains demographic informa-
tion on the child and parents. It also asks for
information on the number of days during the past
30 days that the child needed care or missed
school because of health, the number of days the
parent missed work because of the child's health,
and the impact of the child's health on the parent's
daily work routine and ability to concentrate at
work.
Procedure
Inclusion criteria were: child ages 2 to 18 and
parent and child English- or Spanish-speaking. At
pediatricians' offices, an exclusion criterion was:
presenting complaint of acute symptomatology. At
pediatrician offices and specialty clinics, the sam-
ple was a convenience sample based on consecu-
tive patients. Subjects were identified through
clinic appointment schedules. At these sites, par-
ents of possible study participants were informed
of the study after checking in for their appoint-
ment, but before being seen by their health care
provider. Written parental informed consent and
child assent were obtained. Parents and children
Vol. 39, No. 8 PEDSQL 4.0

TABLE1. Scale Descriptives and Internal Consistency Reliability for PedsQL 4.0 Child Self-Report and
Parent Proxy-Report
InternalConsistency
ScaleDescriptives Reliability
Percentage Percentage
Numberof Floor Ceiling Total
Scale Items N Mean SD Ill/Healthy Ill/Healthy Sample Range
Self-Report Ages 5-18
Totalscore 23 960 79.62 15.26 0.0/0.0 1.9/7.2 0.88 0.85-0.90
Physicalhealth 8 959 80.19 19.30 0.0/0.0 13.1/25.8 0.80 0.77-0.85
Psychosocialhealth 15 958 79.37 15.70 0.0/0.0 5.2/12.0 0.83 0.78-0.85
Emotionalfunctioning 5 958 78.10 20.66 0.3/0.8 22.4/29.8 0.73 0.70-0.78
Socialfunctioning 5 958 84.09 18.50 0.0/0.0 33.2/47.1 0.71 0.67-0.74
Schoolfunctioning 5 933 75.87 19.71 0.3/0.5 13.0/23.1 0.68 0.59-0.75
Proxy-Report Ages 2-18
Totalscore 23 1622 80.87 16.73 0.2/0.0 4.1/10.3 0.90 0.89-0.90
Physicalhealth 8 1613 81.38 23.18 2.3/0.0 18.5/39.6 0.88 0.85-0.89
Psychosocialhealth 15 1621 80.58 16.52 0.2/0.0 5.6/13.8 0.86 0.80-0.86
Emotionalfunctioning 5 1622 77.95 20.67 1.4/0.1 19.5/29.5 0.77 0.69-0.80
Socialfunctioning 5 1615 85.38 19.17 0.5/0.0 34.4/58.1 0.75 0.68-0.78
Schoolfunctioning 5 1417 77.80 22.00 1.7/0.3 15.5/34.5 0.76 0.57-0.78
Note: PercentageFloor/Ceiling= the percentageof scoresat the extremesof the scalingrange.

completed the PedsQL separately. One parent Statistical Analysis

(80% mothers; 13% fathers; 7% other) completed
the proxy-reportversion. A research assistant (RA)
was available to answer questions regarding the
parent self-administered instruments. A RA ad-
ministered the PedsQL for the young child (ages
5-7), and was available to assist the self-
administered instrument for the child (ages 8-12)
and adolescent (ages 13-18) after the instructions
had been given and clarified.
For the telephone sample, a random sample of
children ages 2 to 18 seen as inpatients or outpa-
tients at Children's Hospital and Health Center
was generated from a list of all discharges between
April 1, 1998 and June 30, 1998. Children with a
discharge status of expired, whose payer was from
the victim/witness fund, and whose parents had
requested their phone number and address be
kept private were excluded. RAs telephoned par-
ents of children on this list, explained the study,
and obtained verbal parental informed consent
and child assent. The RA verbally administered the
PedsQL individually to the parents and their chil-
dren. If the child was not home at the time of the
initial call, the RA arranged for a call at another
time. The Institutional Review Board approved this
research protocol at Children's Hospital and
Health Center, San Diego.
Item-Level Analysis
Feasibility was determined from the percentage
of missing values for each item and the distribu-
tion of item responses. Multitrait scaling analysis
was conducted to determine the extent to which
individual items correlated with the hypothesized
scale construct rather than with other scales.27
Multitrait scaling analyses were summarized via
tests of individual item scaling success, defined as
the number of times an item correlated higher
with its hypothesized scale construct rather than
with another scale by >2 standard errors,28which
provides an approximation of scaling success. The
percentage of item scaling successes relative to the
total number of item scaling tests was calculated
for each scale.28
Scale-Level Analysis
Range of measurement was based on the per-
centage of scores at the extremes of the scaling
range, that is, the maximum possible score (ceiling
effect) and the minimum possible score (floor
effect).28

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VARNI ET AL MEDICAL
CARE

TABLE
2. One-Way ANOVA Comparing Chronically Ill, Acutely Ill, and Healthy Children:
Child Report
Scale N Mean SD df F P
Totalscore 2,913 15.05 0.001
Chronicallyill* 367 77.19 15.53
Acutelyill* 148 78.70 14.03
Healthy 401 83.00 14.79
Physicalhealth 2,912 14.16 0.001
Chronicallyill* 366 77.36 20.36
Acutelyill* 149 78.88 19.10
Healthy 400 84.41 17.26
Psychosocialhealth 2,911 11.42 0.001
Chronicallyill* 367 77.10 15.84
Acutelyill 148 78.68 14.66
Healthy 399 82.38 15.51
Emotionalfunctioning 2,911 4.84 0.001
Chronicallyill* 366 76.40 21.48
Acutelyill 148 77.33 20.04
Healthy 400 80.86 19.64
Socialfunctioning 2,911 10.16 0.001
Chronicallyill* 367 81.60 20.24
Acutelyill* 148 82.83 16.66
Healthy 399 87.42 17.18
Schoolfunctioning 2,888 6.50 0.001
Chronicallyill* 362 73.43 19.57
Acutelyill 143 75.68 18.04
Healthy 386 78.63 20.53
Note: * = different from healthy children at P <0.05.

Scale internal consistency reliability was deter-
mined by calculating Cronbach's coefficient al-
pha.29Scales with reliabilities of 0.70 or greater are
recommended for comparing patient groups,
whereas a reliability criterion of 0.90 is recom-
mended for analyzing individual patient scale
scores.30,31
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, groups differing in
known health status (healthy vs. acute or chronic
health conditions) were computed,3233 using one-
way analysis of variance (ANOVA). We hypothe-
sized that healthy children would report higher
PedsQL scores than pediatric patients with acute
and chronic health conditions. We examined po-
tential confounding between health status and
age, gender, and ethnicity. Cross-tabulations re-
vealed no relation between health status and
gender. There was a significant association be-
tween age group and health status (X26 = 16.8,
P = 0.01). Adolescents were over represented in
the chronically ill group (standardized residu-
al = 2.4) and underrepresented in the healthy
group (standardized residual = -2.1). There was a
significant association between ethnicity and ill-
ness group (X210= 67.4, P = 0.001). Whites were
over represented in the chronically ill group (stan-
dardized residual = 2.1) and underrepresented in
the healthy group (standardized residual = -3.6).
Hispanics were underrepresented in the chroni-
cally ill group (standardized residual = -2.0) and
over represented in the healthy group (standard-
ized residual = 3.8).
Given these associations, 2-Way ANOVA'swere
performed to explore interactions. No interactions
were found for self-report. Although interactions
between health status and age and ethnicity were

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Vol. 39, No. 8 PEDSQL 4.0

TABLE
3. One-Way ANOVA Comparing Chronically Ill, Acutely Ill, and Healthy Children:
Parent Report
Scale N Mean SD df F P
Total score 2, 1575 128.39 0.001
Chronically ill 662 74.22 18.40
Acutely ill 199 80.42 15.26
Healthy 717 87.61 12.33
Physical health 2, 1566 91.72 0.001
Chronically ill 653 73.28 27.02
Acutely ill 199 81.81 20.46
Healthy 717 89.32 16.35
Psychosocial health 2, 1574 98.95 0.001
Chronically ill 661 74.80 18.16
Acutely ill 199 79.56 15.51
Healthy 717 86.58 12.79
Emotional functioning 2, 1575 38.90 0.001
Chronically ill 661 73.05 23.27
Acutely ill 199 78.82 18.00
Healthy 718 82.64 17.54
Social functioning 2, 1568 72.55 0.001
Chronically ill 657 79.77 21.91
Acutely ill 198 83.58 18.29
Healthy 716 91.56 14.20
School functioning 2, 1376 73.25 0.001
Chronically ill 601 71.08 23.99
Acutely ill 167 74.74 20.95
Healthy 611 85.47 17.61
Note: For each scale, each subgroup significantly different from every other subgroup P <0.05.

found for parent proxy-report,these accounted for
approximately 1% of the variance (eta
squared = 0.008 for health status*age; eta
squared = 0.013 for health status*race). Given the
large sample size and the small eta squared, we
did not pursue these 2-Way interactions.
Construct validity was further assessed through
PedsQL correlations with indicators of morbidity
and illness burden and examination of the PedsQL
factor structure. It was hypothesized that higher
PedsQL scores would be associated with fewer
days during the past month in which the child
needed care for a physical or mental health con-
dition, fewer days missed from school for children
and work for parents, and less impact on work
routine and concentration for parents who worked
outside the home.
PedsQL factor structure was examined via
multitrait-multimethod (MTMM) analysis of the
PedsQL Subscales and factor analysis of the
PedsQL items. MTMM analysis was conducted
using MTMM.EXE software (Berkeley Heights,
New Jersey).34,35 MTMMassumes that heterotrait-
monomethod correlations (eg, correlations among
Subscales within self-report and proxy-report)
should be lower than monotrait-heteromethod
correlations (eg, concordance between self-report
and proxy-report for the same Subscale). Correla-
tions are designated as small (0.10-0.29), medium
(0.30-0.49), and large (>0.50).36 Given shared
method variance31 and that the PedsQL items
were developed to measure an integrated multidi-
mensional construct (pediatric HRQOL), it was
expected that heterotrait-monomethod correla-
tions among the Subscales would be medium to
large (r >0.40).37 Parent/child concordance for the
same Subscale was expected to demonstrate me-
dium to large effect sizes, but not so large that
child and parent reports would be redundant.
Based on previous literature,1317it was anticipated

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VARNI ET AL MEDICALCARE

4.
TABLE Pearson Correlations Between Indicators of Morbidity and Child Self-Report and Parent
Proxy-Report
Work
WorkRoutine Concentration
Scale CareNeeded SchoolMissed WorkMissed Impact Impact
Self-Report r n r n r n r n r n
Total -0.24 865 -0.22 598 NS 216 -0.23 209 -0.28 209
Physical -0.27 864 -0.21 596 -0.20 216 -0.28 209 -0.31 209
Psychosocial -0.18 863 -0.20 598 NS 216 NS 209 -0.22 209
Emotional -0.13 863 -0.13 597 NS 216 -0.16 209 -0.25 209
Social -0.13 863 -0.11 598 NS 216 NS 209 NS 209
School -0.17 841 -0.24 591 -0.21 211 NS 206 -0.19 206
Proxy-Report
Total -0.38 1522 -0.29 816 -0.30 279 -0.44 277 -0.50 277
Physical -0.38 1515 -0.26 811 -0.30 279 -0.31 277 -0.38 277
Psychosocial -0.31 1521 -0.25 816 -0.23 278 -0.43 276 -0.48 276
Emotional -0.19 1521 -0.12 817 -0.20 280 -0.40 278 -0.44 278
Social -0.27 1518 -0.13 812 -0.24 280 -0.34 278 -0.34 278
School -0.28 1324 -0.33 786 -0.23 268 -0.27 268 -0.35 268
Note: All displayedcorrelationcoefficients(r) are significantat P <0.01.

that the Physical Functioning Subscale would
demonstrate the largest concordance. Heterotrait-
heteromethod concordance was expected to be
small. Principal components analysis with oblique
rotation was performed on the 23 items to test the
PedsQL underlying dimensions.38
Statistical analyses were conducted using SPSS
for Windows.39 Response equivalence was as-
sessed across mode of administration (in-person
vs. telephone) and language (English vs. Spanish)
by examining the percent missing data, floor and
ceiling effects, and scale interal consistency
across mode of administration and language. No
differences were found across mode of adminis-
tration or language. Thurstone scaling analysis
was conducted to examine response choice equiv-
alence between the English and Spanish
forms.40'41Eight bilingual respondents were pre-

5. Multitrait-Multimethod IntercorrelationsBetween and Among PedsQL 4.0 Subscales

TABLE

Self-Report Proxy-Report
Scale Emotional Social School Physical Emotional Social School

Self-Report
PhysicalFunctioning 0.45 0.48 0.48 0.50 0.25 0.33 0.24
EmotionalFunctioning 0.42 0.47 0.19 0.36 0.26 0.25
SocialFunctioning 0.45 0.20 0.19 0.37 0.19
SchoolFunctioning 0.21 0.24 0.17 0.41
Proxy-Report
PhysicalFunctioning 0.43 0.49 0.43
EmotionalFunctioning 0.47 0.49
SocialFunctioning 0.49
=
Notes: N 871
All correlationsare significantat P <0.001.
Effectsizes are designatedas small (0.10),medium(0.30),and large(0.50).
Multitrait-monomethod correlationsare underlined;multitrait-
correlationsare in bold; monotrait-multimethod
multimethodcorrelationsare italicized.

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Vol. 39, No. 8 PEDSQL 4.0

TABLE6. PedsQL 4.0 Factor Loadings for Child Self-Report and Parent Proxy-Report*

Scale/Item Factor1 Factor2 Factor3 Factor4 Factor5

PhysicalFunctioning
Hardto walk more than one block -0.049 -0.715 0.003 0.118 0.049
0.830 -0.106 0.036 0.018 -0.015
Hardto run 0.100 -0.773 -0.060 0.049 0.118
0.836 -0.175 0.072 0.035 -0.005
Hardto do sportsor exercises 0.094 -0.779 0.009 -0.003 0.063
0.797 -0.091 0.100 0.064 0.009
Hardto lift somethingheavy 0.135 -0.456 0.058 0.161 0.045
0.746 0.032 0.102 0.039 -0.080
Hardto take bath or shower -0.063 -0.574 0.006 -0.140 -0.238
0.719 0.224 -0.107 -0.082 -0.016
Hardto do choresaroundhouse -0.039 -0.646 0.005 -0.105 -0.208
0.737 0.193 -0.019 -0.069 -0.016
Hurtor ache 0.223 -0.253 0.046 0.204 0.025
0.310 -0.148 0.326 0.291 -0.021
Low energy 0.385 -0.257 0.030 0.142 -0.025
0.274 -0.027 0.374 0.304 -0.038
EmotionalFunctioning
Feel afraidor scared 0.782 -0.034 0.114 -0.175 0.052
0.042 0.000 0.721 -0.069 0.044
Feel sad or blue 0.776 0.102 0.065 0.012 -0.015
-0.016 0.049 0.766 -0.023 0.077
Feel angry 0.657 0.007 -0.040 -0.020 -0.105
-0.044 0.090 0.664 -0.025 0.103
Troublesleeping 0.371 -0.129 0.046 0.128 -0.179
0.042 0.081 0.539 0.155 -0.013
Worryaboutwhat will happen 0.705 0.002 -0.072 0.040 0.015
-0.034 0.035 0.778 -0.049 -0.015
SocialFunctioning
Troublegettingalong w/peers 0.014 0.038 0.679 -0.077 -0.175
0.035 0.252 0.089 -0.156 0.604
Otherkids not wantingto be -0.041 0.024 0.813 -0.111 -0.054
friend
-0.036 0.022 0.062 -0.016 0.836
Teased 0.093 0.102 0.747 0.053 -0.012
-0.061 -0.096 0.098 0.078 0.810
Doing things otherpeers do 0.065 -0.308 0.417 0.183 0.169
0.484 0.024 -0.075 0.126 0.405
Hardto keep up when playwith -0.025 -0.350 0.423 0.242 0.206
others
0.547 0.149 -0.127 0.115 0.374
SchoolFunctioning
Hardto concentrate 0.119 -0.056 0.075 0.041 -0.710
0.025 0.809 0.094 0.008 0.058
(Continued)

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VARNI ET AL MEDICAL
CARE

TABLE
6. (Continued)
Scale/Item Factor1 Factor2 Factor3 Factor4 Factor5

Forgetthings 0.214 0.003 0.093 0.135 -0.522

0.031 0.734 0.129 0.077 -0.026
Troublekeepingup with -0.046 -0.119 0.144 0.204 -0.678
schoolwork
0.019 0.773 0.044 0.151 0.051
Miss school - not well -0.002 -0.002 -0.050 0.800 -0.143
-0.040 0.113 -0.044 0.901 -0.050
Miss school - doctorappointment -0.031 0.059 -0.008 0.848 -0.068
-0.026 0.071 -0.021 0.855 0.073
Eigenvalues 6.22 1.93 1.46 1.24 1.11
7.35 2.70 1.80 1.35 1.05
PercentVariance 27.02 8.37 6.35 5.40 4.82
31.94 11.72 7.82 5.86 4.54

*Reportedfor ages 5 yearsand older.

TotalVarianceExplainedfor ChildSelf-Report:52%;for ParentProxy-Report: 62%.
Bold = highestfactorloadingfor each item.
Note: In each cell, Child Self-ReportLoadingsare shown above and ParentProxy-
-Reportloadingsare shown
below in italics.

sented with two 100-cm lines anchored by the
extreme response choices ("Never" and "Almost
Always"for English, "Nunca"and "Casi Siempre"
for Spanish). Respondents were asked to make a
mark on the line to indicate where they thought
the intermediate English and Spanish response
choices fell. The Spanish intermediate response
choices fell within 5-cm of the English response
choices, indicating that the response ratings across
language were equivalent. Therefore, responses
were pooled across mode of administration and
language. Responses were also pooled across the
age ranges for both self-report and proxy-report.
Results
Data tables with item-level missing values, re-
sponse distributions, means, and SDs, item-scale
correlations, and scaling tests, are available from
the first author.
Feasibility: Missing Item Responses
To assess the feasibility of administration, the
percentage of missing values was calculated. For
self-report and proxy-report, the percentage of
missing item responses was 1.54% and 1.95%,
respectively.
Item Response Distributions
A full range for each item was demonstrated,
with item distributions tending to be skewed
toward higher HRQOL.
Item Descriptives
For all 23 items, item means for self-report
ranged from 70.8 to 92.5 with 13 of 23 items falling
within a 10-point range. Item means for proxy-
report ranged from 65.9 to 88.4, with 16 of 23
items falling within a 10-point range. Standard
deviations ranged from 25.6 to 35.3 for self-report
items and 23.3 to 35.2 for proxy-report items. For
the 15 items in the Psychosocial Health Summary
Score, item means ranged from 71.1 to 86.3 for
self-report and 65.9 to 86.8 for proxy-report. Stan-
dard deviations ranged from 25.7 to 31.6 for
self-report and 24.1 to 34.2 for proxy-report. Sim-
ple linear averaging is possible when the means
and standard deviations of items within each scale
or summary score are roughly equivalent.28

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Vol. 39, No. 8
Item-InternalConsistency
Item-scale correlations demonstrated that most
items (19/23) for self-report and all items for
proxy-report met or exceeded the 0.40 standard
for item-internal consistency corrected for item
overlap.30
Item Scaling Tests
For self-report and proxy-report,scaling success
rates ranged from 87% to 100%.
Range of Measurement
Table 1 presents the percentages of scores at the
floor and ceiling. There were no floor effects for
healthy or ill children, as no scale had more than
2.3% of respondents scoring the minimum. Ceil-
ing effects existed in some cases. These ranged
from minimal (eg, 7.2% and 10.3% of healthy
respondents, respectively, for the self- and proxy-
report Total Scale Score) to moderate (eg, 47.1% to
58.1% of healthy respondents, respectively for the
self- and proxy-report Social Functioning Sub-
scale). The ceiling effects were in the expected
direction, with healthy children and their parents
reporting more ceiling effects than children with
health conditions.
Internal Consistency Reliability
Internal consistency reliabilityalpha coefficients
are presented in Table 1. Most self-report scales
and proxy-report scales approached or exceeded
the minimum reliability standard of 0.70.
Construct Validity
One-Way ANOVA's comparing chronically ill,
acutely ill, and healthy children for all scales are
displayed in Tables 2 and 3. For self-report and
proxy-report, scales demonstrated differences
among the three groups. The hypothesis was
confirmed that healthy children would manifest
higher scores than acutely or chronically ill
children.
Table 4 shows the correlations between the
PedsQL scales and indicators of morbidity and
burden of illness. Self-report and proxy-report
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PEDSQL 4.0
demonstrate small to medium correlations with
the number of days the child needed care in the
past 30 days, and with the number of days missed
from school. Proxy-report shows medium correla-
tions with the number of days missed from work.
Self-report shows small to medium, and parent
proxy-report shows medium to large, correlations
with parent-report of the extent to which their
child's HRQOL interfered with their daily routine
and ability to concentrate at work.
The MTMM matrixis shown in Table5. Consis-
tent with hypotheses, self-report and proxy-report
heterotrait-monomethodcorrelationsare in the me-
dium to large effect size range, as are parent/child
concordance for the same Subscale (monotrait-
heteromethod). Heterotrait-heteromethod correla-
tions were small. Subscale successes were 2/24 for
monomethod and 23/24 for heteromethod. The
complete MTMMresults are availablefrom the first
author.
The results of the factor analysis for self-report
and proxy-report are shown in Table 6. An eigen-
value cutoff of 1.0 resulted in a five factor solution
for self-report and proxy-report, accounting for
52% and 62% of the variance, respectively. School
Functioning items split into two different factors,
but otherwise, the factors that emerged are con-
sistent with the a priori hypothesized factor struc-
ture, with few exceptions.
Discussion
The PedsQL 4.0 internal consistency reliabilities
generally exceeded the standard of 0.70 for group
comparisons. Across the ages, the Total Scale
Score for self-report and proxy-report approached
an alpha of 0.90, recommended for individual
patient analysis,30 making the Total Scale Score
suitable as a summary score for the primary anal-
ysis of HRQOL outcomes in clinical trials and
other group comparisons. The Physical Health and
Psychosocial Health Summary Scores are recom-
mended for secondary analyses. The School Func-
tioning Subscales for proxy-report for ages 2 to 4
and self-report for ages 5 to 7 were the only two
Subscales that did not approach or exceed 0.70.
The Emotional, Social, and School Functioning
Subscales may be utilized to examine specific
domains of functioning, with the caveat that until
further testing is conducted, these Subscales
should be used for descriptive or exploratoryanal-
yses. The means and standard deviations of the
809
VARNI ET AL
items within scales were similar, supporting the
scaling assumption of equivalent item means and
variance.
The PedsQL performed as hypothesized utiliz-
ing the known-groups method. The PedsQL dif-
ferentiated HRQOL between healthy children and
those with acute or chronic health conditions, and
was correlated with measures of morbidity and
illness burden. The MTMM analyses tested con-
vergent and discriminant validity across methods.
The heterotrait-monomethod analyses are consis-
tent with the conceptualization of the PedsQL as
measuring an integrated multidimensional con-
struct. However, further work is necessary to sup-
port the construct validity of the PedsQL scales as
measuring distinctly unique dimensions of
HRQOL. The results of the factor analysis in
general support the hypothesized factor structure
of the PedsQL. When a two-factor solution was
forced, 19 of the 23 items loaded as hypothesized
on the a priori Physical Health and Psychosocial
Health Summary Scores, for both self-report and
proxy-report. Total variance explained was 35.4%
for self-report and 45.6% for proxy-report. Be-
cause this finding may be sample-specific, further
testing with other samples will be conducted
before reconfiguring the conceptually-derived
Summary Scores.
The PedsQL Measurement Model emphasizes
the child's perceptions. The items chosen for
inclusion were derived from the measurement
properties of the self-report scales, whereas the
proxy-report scales were constructed to directly
parallel the self-report items. The imperfect
concordance observed between self- and proxy-
reports supports the need to measure the per-
spectives of child and parent in evaluating pe-
diatric HRQOL. Although self-report is
considered the standard for measuring per-
ceived HRQOL, it is the parent's perception of
their child's HRQOL that influences health care
utilization.12 This perspective may help explain
in part the pattern of higher correlations be-
tween proxy-report with the number of days
missed from school and work, care needed, and
work impact. The use of proxy-report to esti-
mate HRQOL may be necessary when the child
is either unable or unwilling to complete the
HRQOL measure. Nevertheless, proxy-reports
should be conducted with the knowledge that a
proxy rater's estimate may be insufficiently
accurate .42
810
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MEDICALCARE
The items selected for the PedsQL reflect
those that are of universal concern across age
groups. Attempts were made to keep wording,
and thus the content, as similar as possible
across parallel forms, while being sensitive to
developmental differences in cognitive ability.
This consistency facilitates the evaluation of
differences in HRQOL across and between age
groups, as well as the tracking of HRQOL
longitudinally. The PedsQL 4.0 is the only ge-
neric pediatric HRQOL measurement instru-
ment that we are aware of to span ages 2 to 18
for self-report and proxy-report while maintain-
ing item and scale construct consistency.
The present findings have several potential lim-
itations. Test-retest reliability and responsiveness
are not reported. Information on nonparticipants
was not available,which may limit generalizability.
The prevalence of Medicaid coverage may be
associated with lower HRQOL, potentially atten-
uating ceiling effects. Parents reported health con-
dition and illness burden information. Objective
measures of health condition and illness burden
will strengthen the validation process. Item-
response theory provides another analytic ap-
proach for investigation.
The PedsQL is undergoing further field-testing
nationally and interationally, including examin-
ing the usefulness of the Disease-Specific Modules
in pediatric chronic health conditions. The PedsQL
Measurement Model represents a conceptual
framework for a measurement instrument that
must be at once disease-specific and also reflective
of broader generic concerns.43,44
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