Quality of life in children with heart disease as perceived by children and parents.

OBJECTIVES: The aims of this study were to evaluate and compare the parent-reported and self-reported quality of life of children who have cardiovascular disease with the healthy pediatric population across age groups and to determine the relationship between perceived quality of life and severity of cardiovascular disease. METHODS: The Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales and Cardiac Module were administered to 475 families including 347 children with cardiovascular disease during a pediatric cardiology outpatient visit. The PedsQL scores reported by children with cardiovascular disease and their parents were compared with pediatric population norms. The relationship between Pediatric Quality of Life Inventory scores and patient characteristics was examined. RESULTS: By self-report, mean PedsQL scores for children with cardiovascular disease were significantly lower than healthy child norms for physical and psychosocial functioning. Psychosocial quality of life scores were classified as significantly impaired as reported by 21% of children > or = 8 years of age. Even among children with less severe cardiovascular disease, 19.2% reported significantly impaired psychosocial quality of life. By parental report, overall PedsQL scores were not significantly different from healthy children except in the teenage group, and both the 8- to 12-year-old and teenage groups had lower mean psychosocial quality of life scores than healthy peers. Parent-reported mean PedsQL scores for both physical and psychosocial quality of life were significantly lower in children with more severe cardiovascular disease. Children with more severe cardiovascular disease reported lower mean scores for physical functioning, but smaller differences in psychosocial quality of life scores were observed related to disease severity. CONCLUSIONS: Overall, children with cardiovascular disease perceived lower quality of life than healthy children across all age groups. As perceived by parents, overall quality of life was not significantly different in young children with cardiovascular disease, but children with more severe cardiovascular disease have worse physical and psychosocial quality of life. One in 5 children with cardiovascular disease perceives impaired psychosocial functioning, including children with mild disease severity.

The ePedsQL in type 1 and type 2 diabetes: feasibility, reliability, and validity of the Pediatric Quality of Life Inventory Internet administration.

OBJECTIVE: The Pediatric Quality of Life Inventory (PedsQL) is a modular instrument designed to measure health-related quality of life (HRQOL) in children and adolescents aged 2-18 years. The PedsQL 4.0 Generic Core Scales are child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL disease-specific modules. The electronic version of the PedsQL 4.0 (ePedsQL) was designed for Internet administration. RESEARCH DESIGN AND METHODS: Utilizing a randomized crossover design, the PedsQL scales were administered to 92 pediatric patients with type 1 or type 2 diabetes and 93 parents in electronic and paper formats. RESULTS: Missing values (0.76% child report, 0.37% parent report), internal consistency reliability (total scale score alpha = 0.90 child report, 0.92 parent report), and mean scores (total scale score M = 78.41 child report, 76.19 parent report) were equivalent between the electronic and paper-and-pencil modes of administration. The ePedsQL distinguished between healthy children and children with diabetes. CONCLUSIONS: The ePedsQL Internet mode of administration demonstrated equivalent measurement properties to the well-established PedsQL paper-and-pencil mode of administration.

Item response theory detected differential item functioning between healthy and ill children in quality-of-life measures.

OBJECTIVE: To demonstrate the value of item response theory (IRT) and differential item functioning (DIF) methods in examining a health-related quality-of-life measure in children and adolescents. STUDY DESIGN AND SETTING: This illustration uses data from 5,429 children using the four subscales of the PedsQL 4.0 Generic Core Scales. The IRT model-based likelihood ratio test was used to detect and evaluate DIF between healthy children and children with a chronic condition. RESULTS: DIF was detected for a majority of items but canceled out at the total test score level due to opposing directions of DIF. Post hoc analysis indicated that this pattern of results may be due to multidimensionality. We discuss issues in detecting and handling DIF. CONCLUSION: This article describes how to perform DIF analyses in validating a questionnaire to ensure that scores have equivalent meaning across subgroups. It offers insight into ways information gained through the analysis can be used to evaluate an existing scale.

Measuring health-related quality of life in children with ESRD: performance of the generic and ESRD-specific instrument of the Pediatric Quality of Life Inventory (PedsQL).

BACKGROUND: Minimal data exist to describe health-related quality of life in children with end-stage renal disease (ESRD). STUDY DESIGN: Cross-sectional study. SETTING & PARTICIPANTS: 193 children aged 5 to 18 years with ESRD and 190 parents of children aged 2 to 18 years with ESRD at 4 pediatric nephrology centers across the United States. OUTCOMES & MEASUREMENTS: Generic and disease-specific health-related quality of life. The Pediatric Quality of Life Inventory version 4.0 (PedsQL 4.0) Generic Core Scales encompass: (1) Physical Functioning (8 items), (2) Emotional Functioning (5 items), (3) Social Functioning (5 items), and (4) School Functioning (5 items). The PedsQL 3.0 ESRD Module encompasses: (1) General Fatigue (4 items), (2) About My Kidney Disease (5 items), (3) Treatment Problems (4 items), (4) Family and Peer Interaction (3 items), (5) Worry (10 items), (6) Perceived Physical Appearance (3 items), and (7) Communication (5 items). RESULTS: Internal consistency reliability for the PedsQL 4.0 Generic Core Scales and the PedsQL 3.0 ESRD Module was acceptable for both parent-proxy report and child self-report, with the exception of 1 parent-proxy report and 3 child self-report scales on the ESRD Module. The PedsQL Generic Core Scales differentiated between healthy children and children with ESRD, supporting discriminant validity. Intercorrelations between the PedsQL Generic Core Scales and the ESRD Module were in the medium to large range, supporting construct validity. A confirmatory factor analysis further supported construct validity of the ESRD Module. LIMITATIONS: Test-retest reliability was not conducted, limited generalizability may exist given the age distribution of the children included, and imperfect agreement between child and parent-proxy reports. CONCLUSIONS: Results support the feasibility, reliability, and validity of the PedsQL 4.0 Generic Core Scales in children with ESRD and provide initial support for the PedsQL 3.0 ESRD Module, although additional validation testing is warranted.

Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL 4.0 Generic Core Scales.

BACKGROUND: Advances in biomedical science and technology have resulted in dramatic improvements in the healthcare of pediatric chronic conditions. With enhanced survival, health-related quality of life (HRQOL) issues have become more salient. The objectives of this study were to compare generic HRQOL across ten chronic disease clusters and 33 disease categories/severities from the perspectives of patients and parents. Comparisons were also benchmarked with healthy children data. METHODS: The analyses were based on over 2,500 pediatric patients from 10 physician-diagnosed disease clusters and 33 disease categories/severities and over 9,500 healthy children utilizing the PedsQL 4.0 Generic Core Scales. Patients were recruited from general pediatric clinics, subspecialty clinics, and hospitals. RESULTS: Pediatric patients with diabetes, gastrointestinal conditions, cardiac conditions, asthma, obesity, end stage renal disease, psychiatric disorders, cancer, rheumatologic conditions, and cerebral palsy self-reported progressively more impaired overall HRQOL than healthy children, respectively, with medium to large effect sizes. Patients with cerebral palsy self-reported the most impaired HRQOL, while patients with diabetes self-reported the best HRQOL. Parent proxy-reports generally paralleled patient self-report, with several notable differences. CONCLUSION: The results demonstrate differential effects of pediatric chronic conditions on patient HRQOL across diseases clusters, categories, and severities utilizing the PedsQL 4.0 Generic Core Scales from the perspectives of pediatric patients and parents. The data contained within this study represents a larger and more diverse population of pediatric patients with chronic conditions than previously reported in the extant literature. The findings contribute important information on the differential effects of pediatric chronic conditions on generic HRQOL from the perspectives of children and parents utilizing the PedsQL 4.0 Generic Core Scales. These findings with the PedsQL have clinical implications for the healthcare services provided for children with chronic health conditions. Given the degree of reported impairment based on PedsQL scores across different pediatric chronic conditions, the need for more efficacious targeted treatments for those pediatric patients with more severely impaired HRQOL is clearly and urgently indicated.

Practical issues in the application of item response theory: a demonstration using items from the pediatric quality of life inventory (PedsQL) 4.0 generic core scales.

BACKGROUND: Item response theory (IRT) is increasingly being applied to health-related quality of life instrument development and refinement. This article discusses results obtained using categorical confirmatory factor analysis (CCFA) to check IRT model assumptions and the application of IRT in item analysis and scale evaluation. OBJECTIVES: To demonstrate the value of CCFA and IRT in examining a health-related quality of life measure in children and adolescents. METHODS: This illustration uses data from 10,241 children and their parents on items from the 4 subscales of the PedsQL 4.0 Generic Core Scales. CCFA was applied to confirm domain dimensionality and identify possible locally dependent items. IRT was used to assess the strength of the relationship between the items and the constructs of interest and the information available across the latent construct. RESULTS: CCFA showed generally strong support for 1-factor models for each domain; however, several items exhibited evidence of local dependence. IRT revealed that the items generally exhibit favorable characteristics and are related to the same construct within a given domain. We discuss the lessons that can be learned by comparing alternate forms of the same scale, and we assess the potential impact of local dependence on the item parameter estimates. CONCLUSIONS: This article describes CCFA methods for checking IRT model assumptions and provides suggestions for using these methods in practice. It offers insight into ways information gained through IRT can be applied to evaluate items and aid in scale construction.

Literature review: health-related quality of life measurement in pediatric oncology: hearing the voices of the children.

OBJECTIVES: The objective of this literature review is to provide an overview of the evidence for pediatric patient self-report in pediatric oncology. Methods A review of the general literature on pediatric health-related quality of life (HRQOL) measurement as background, with pediatric patient self-report data from the Journal of Pediatric Psychology during the past 5 years in pediatric oncology summarized. Utilizing the PedsQL available at (http://www.pedsql.org), data are presented to illustrate child and parent reports in pediatric oncology. Results Data demonstrate that children as young as 5 years of age can reliably and validly self-report their HRQOL when an age-appropriate instrument is utilized. Conclusions The evidence supports including pediatric patients' perspectives in clinical trials. Parent proxy-report is recommended when pediatric patients are too young, too cognitively impaired, too ill or fatigued to complete a HRQOL instrument, but not as a substitute for child self-report when the child is willing and able to provide their perspective.

The PedsQL as a patient-reported outcome in children and adolescents with fibromyalgia: an analysis of OMERACT domains.

BACKGROUND: Fibromyalgia is a chronic health condition characterized by widespread musculoskeletal pain, multiple tender points on physical examination, generalized muscular aching, stiffness, fatigue, nonrestorative sleep pattern, cognitive dysfunction, and mood disturbance. Recently, the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT) Fibromyalgia Syndrome Workshop ranked and prioritized the domains that should be consistently measured in fibromyalgia clinical trials, specifically, pain, generic health-related quality of life, fatigue, sleep quality, and physical function. The focus of these deliberations was exclusively on adult patients, and to our knowledge, these domains have not been previously tested within a multidimensional framework in children and adolescents with fibromyalgia. METHODS: An analysis to determine the feasibility, reliability, and validity of the PedsQL 4.0 (Pediatric Quality of Life Inventory) Generic Core Scales, PedsQL Multidimensional Fatigue Scale, and PedsQL Rheumatology Module Pain and Hurt Scale as patient-reported outcome (PRO) measures for pediatric patients with fibromyalgia. The PedsQL Scales were completed by 59 families in a pediatric rheumatology clinic in a large children's hospital. RESULTS: The PedsQL evidenced minimal missing responses (0.53% patient self-report, 0.70% parent proxy-report), achieved excellent reliability for the Generic Core Scales Total Scale Score (alpha = 0.88 patient self-report, 0.87 parent proxy-report), the Multidimensional Fatigue Scale Total Scale Score (alpha = 0.94 patient self-report, 0.94 parent proxy-report), and acceptable reliability for the 4-item Rheumatology Module Pain and Hurt Scale (alpha = 0.68 patient self-report, 0.75 parent proxy-report). The PedsQL Generic Core Scales and Multidimensional Fatigue Scale significantly distinguished between pediatric patients with fibromyalgia and healthy children. Pediatric patients with fibromyalgia self-reported severely impaired physical and psychosocial functioning, significantly lower on most dimensions when compared to pediatric cancer patients receiving cancer treatment, and significantly lower on all dimensions than pediatric patients with other rheumatologic diseases. Patients with fibromyalgia self-reported significantly greater pain and fatigue than pediatric patients with other rheumatologic conditions, and generally more fatigue than pediatric patients receiving treatment for cancer. CONCLUSION: The results demonstrate the excellent measurement properties of the PedsQL Scales in fibromyalgia. These PedsQL Scales measure constructs consistent with the recommended OMERACT Fibromyalgia Syndrome Workshop domains. The findings highlight the severely impaired HRQOL of pediatric patients with fibromyalgia. Regular monitoring of pediatric patients with fibromyalgia will help identify children and adolescents at risk for severely impaired HRQOL. These PedsQL Scales are appropriate outcome measures for clinical trials and health services research for pediatric patients with fibromyalgia.

How young can children reliably and validly self-report their health-related quality of life?: an analysis of 8,591 children across age subgroups with the PedsQL 4.0 Generic Core Scales.

BACKGROUND: The last decade has evidenced a dramatic increase in the development and utilization of pediatric health-related quality of life (HRQOL) measures in an effort to improve pediatric patient health and well-being and determine the value of healthcare services. The emerging paradigm shift toward patient-reported outcomes (PROs) in clinical trials has provided the opportunity to further emphasize the value and essential need for pediatric patient self-reported outcomes measurement. Data from the PedsQL DatabaseSM were utilized to test the hypothesis that children as young as 5 years of age can reliably and validly report their HRQOL. METHODS: The sample analyzed represented child self-report age data on 8,591 children ages 5 to 16 years from the PedsQL 4.0 Generic Core Scales DatabaseSM. Participants were recruited from general pediatric clinics, subspecialty clinics, and hospitals in which children were being seen for well-child checks, mild acute illness, or chronic illness care (n = 2,603, 30.3%), and from a State Children's Health Insurance Program (SCHIP) in California (n = 5,988, 69.7%). RESULTS: Items on the PedsQL 4.0 Generic Core Scales had minimal missing responses for children as young as 5 years old, supporting feasibility. The majority of the child self-report scales across the age subgroups, including for children as young as 5 years, exceeded the minimum internal consistency reliability standard of 0.70 required for group comparisons, while the Total Scale Scores across the age subgroups approached or exceeded the reliability criterion of 0.90 recommended for analyzing individual patient scale scores. Construct validity was demonstrated utilizing the known groups approach. For each PedsQL scale and summary score, across age subgroups, including children as young as 5 years, healthy children demonstrated a statistically significant difference in HRQOL (better HRQOL) than children with a known chronic health condition, with most effect sizes in the medium to large effect size range. CONCLUSION: The results demonstrate that children as young as the 5 year old age subgroup can reliably and validly self-report their HRQOL when given the opportunity to do so with an age-appropriate instrument. These analyses are consistent with recent FDA guidelines which require instrument development and validation testing for children and adolescents within fairly narrow age groupings and which determine the lower age limit at which children can provide reliable and valid responses across age categories.

Parent proxy-report of their children's health-related quality of life: an analysis of 13,878 parents' reliability and validity across age subgroups using the PedsQL 4.0 Generic Core Scales.

BACKGROUND: Health-related quality of life (HRQOL) measurement has emerged as an important health outcome in clinical trials, clinical practice improvement strategies, and healthcare services research and evaluation. While pediatric patient self-report should be considered the standard for measuring perceived HRQOL, there are circumstances when children are too young, too cognitively impaired, too ill or fatigued to complete a HRQOL instrument, and reliable and valid parent proxy-report instruments are needed in such cases. Further, it is typically parents' perceptions of their children's HRQOL that influences healthcare utilization. Data from the PedsQL DatabaseSM were utilized to test the reliability and validity of parent proxy-report at the individual age subgroup level for ages 2-16 years as recommended by recent FDA guidelines. METHODS: The sample analyzed represents parent proxy-report age data on 13,878 children ages 2 to 16 years from the PedsQL 4.0 Generic Core Scales DatabaseSM. Parents were recruited from general pediatric clinics, subspecialty clinics, and hospitals in which their children were being seen for well-child checks, mild acute illness, or chronic illness care (n = 3,718, 26.8%), and from a State Children's Health Insurance Program (SCHIP) in California (n = 10,160, 73.2%). RESULTS: The percentage of missing item responses for the parent proxy-report sample as a whole was 2.1%, supporting feasibility. The majority of the parent proxy-report scales across the age subgroups exceeded the minimum internal consistency reliability standard of 0.70 required for group comparisons, while the Total Scale Scores across the age subgroups approached or exceeded the reliability criterion of 0.90 recommended for analyzing individual patient scale scores. Construct validity was demonstrated utilizing the known groups approach. For each PedsQL scale and summary score, across age subgroups, healthy children demonstrated a statistically significant difference in HRQOL (better HRQOL) than children with a known chronic health condition, with most effect sizes in the medium to large effect size range. CONCLUSION: The results demonstrate the feasibility, reliability, and validity of parent proxy-report at the individual age subgroup for ages 2-16 years. These analyses are consistent with recent FDA guidelines which require instrument development and validation testing for children and adolescents within fairly narrow age groupings and which determine the lower age limit at which reliable and valid responses across age categories are achievable. Even as pediatric patient self-report is advocated, there remains a fundamental role for parent proxy-report in pediatric clinical trials and health services research.

Pain, fatigue, and school functioning in children with cerebral palsy: a path-analytic model.

OBJECTIVE: This study tests a model of how pain and fatigue, independently or in combination, relate to school functioning in pediatric cerebral palsy (CP). METHODS: One hundred eighty-nine parents of children with CP completed the Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales and the PedsQL 3.0 Cerebral Palsy Module. Seventy-three children with CP completed the PedsQL. Path-analytic and mediational techniques were utilized to test the a priori model. RESULTS: Data from both parent proxy-report and child self-report were found to have acceptable model fit. Results supported the existence of an indirect relationship between diagnostic subtypes and school functioning that was partially mediated by both pain and fatigue. CONCLUSIONS: Pain and fatigue represent potentially modifiable targets for interventions designed to improve school functioning in children with CP.

The PedsQL Brain Tumor Module: initial reliability and validity.

BACKGROUND: Brain tumors (BT) are second only to acute lymphoblastic leukemia as the most prevalent form of pediatric cancer, with BT 5-year survival rates approaching 70%. With increased survival, quality of life has emerged as an essential health outcome. This investigation examines the internal consistency reliability and construct validity of the Pediatric Quality of Life Inventory (PedsQL) Brain Tumor Module. METHODS: The PedsQL 4.0 Generic Core Scales, PedsQL Multidimensional Fatigue Scale, and PedsQL Brain Tumor Module were administered to 99 families. The average age of the 56 boys and 43 girls was 9.76 years (range=2-18 years). The sample included children with tumors located in the posterior fossa/brainstem (N=62, 62.6%), supratentorial (N=15, 15.2%), and midline (N=22, 22.2%). Children were on treatment (N=46, 46.5%), off treatment<12 months (N=19, 19.2%), or off treatment>12 months/long-term survivor (N=34, 34.3%). Treatment included radiation (N=61, 61.6%), surgery (N=83, 83.8%), chemotherapy (N=87, 87.9%), and bone marrow transplant (N=5, 5.1%). RESULTS: Internal consistency reliability was demonstrated for the 24-item PedsQL Brain Tumor Module (average alpha=0.78-0.92, parent proxy-report, n=99; average alpha=0.76-0.87, child self-report, n=51). Construct validity for the PedsQL Brain Tumor Module was supported through an analysis of the intercorrelations with the Generic Core Scales and Fatigue Scale. CONCLUSIONS: The findings provide support for the measurement properties of the PedsQL Brain Tumor Module.

Health-related quality of life in pediatric patients with irritable bowel syndrome: a comparative analysis.

The primary aim of the study was to investigate the generic health-related quality of life (HRQOL) of pediatric patients meeting Rome II criteria for irritable bowel syndrome (IBS) in comparison to healthy children. The secondary aim was to compare pediatric patients with IBS to pediatric patients with Rome II criteria diagnosed functional abdominal pain (FAP) and patients with diagnosed organic gastrointestinal (GI) disorders. The study also investigated the associations between GI symptoms with generic HRQOL and evaluated group differences in school days missed and days sick in bed and needing care. HRQOL was measured with the PedsQLtrade mark 4.0 Generic Core Scales (Physical, Emotional, Social, and School Functioning). The PedsQLtrade mark was administered in outpatient pediatric gastroenterology clinics in California, Texas, and New Jersey. A total of 287 families (280 child self-report, 286 parent proxy-report) with children diagnosed with IBS (n = 123), FAP (n = 82), or organic GI disorders (n = 82) participated. Pediatric patients with IBS demonstrated significantly lower Physical, Emotional, Social, and School Functioning in comparison to healthy children, and comparable HRQOL to patients with FAP and organic GI diagnoses. GI symptoms were significantly associated with generic HRQOL. Patients with IBS demonstrated a significantly greater number of days missed from school, days sick in bed/too ill to play, and days needing someone to care for them than healthy children, but significantly fewer days than patients with FAP and organic GI disorders. Pediatric patients with IBS demonstrated impaired HRQOL in dimensions measuring Physical, Emotional, Social, and School Functioning. These findings suggest the need for targeted interventions to address these dimensions of impaired HRQOL.

The PedsQL Present Functioning Visual Analogue Scales: preliminary reliability and validity.

BACKGROUND: The PedsQL Present Functioning Visual Analogue Scales (PedsQL VAS) were designed as an ecological momentary assessment (EMA) instrument to rapidly measure present or at-the-moment functioning in children and adolescents. The PedsQL VAS assess child self-report and parent-proxy report of anxiety, sadness, anger, worry, fatigue, and pain utilizing six developmentally appropriate visual analogue scales based on the well-established Varni/Thompson Pediatric Pain Questionnaire (PPQ) Pain Intensity VAS format. METHODS: The six-item PedsQL VAS was administered to 70 pediatric patients ages 5-17 and their parents upon admittance to the hospital environment (Time 1: T1) and again two hours later (Time 2: T2). It was hypothesized that the PedsQL VAS Emotional Distress Summary Score (anxiety, sadness, anger, worry) and the fatigue VAS would demonstrate moderate to large effect size correlations with the PPQ Pain Intensity VAS, and that patient" parent concordance would increase over time. RESULTS: Test-retest reliability was demonstrated from T1 to T2 in the large effect size range. Internal consistency reliability was demonstrated for the PedsQL VAS Total Symptom Score (patient self-report: T1 alpha = .72, T2 alpha = .80; parent proxy-report: T1 alpha = .80, T2 alpha = .84) and Emotional Distress Summary Score (patient self-report: T1 alpha = .74, T2 alpha = .73; parent proxy-report: T1 alpha = .76, T2 alpha = .81). As hypothesized, the Emotional Distress Summary Score and Fatigue VAS were significantly correlated with the PPQ Pain VAS in the medium to large effect size range, and patient and parent concordance increased from T1 to T2. CONCLUSION: The results demonstrate preliminary test-retest and internal consistency reliability and construct validity of the PedsQL Present Functioning VAS instrument for both pediatric patient self-report and parent proxy-report. Further field testing is required to extend these initial findings to other ecologically relevant pediatric environments.

The PedsQL in pediatric cerebral palsy: reliability, validity, and sensitivity of the Generic Core Scales and Cerebral Palsy Module.

This investigation determined the measurement properties of the Pediatric Quality of Life Inventory (PedsQL) 3.0 Cerebral Palsy (CP) Module. PedsQL 4.0 Generic Core Scales and 3.0 CP Module were administered to 245 families. Mean age of the 134 males and 107 females was 8 years 1 month (SD 4y 4mo; range 2-18y). The sample included children with hemiplegia (n=55), diplegia (n=84), and quadriplegia (n=85). Twenty eight children had a Gross Motor Function Classification System classification at Level I, 40 at Level II, 86 at Level III, 43 at Level IV, and 37 at Level V. Reliability was demonstrated for the PedsQL 4.0 (alpha=0.86 child, 0.89 parent) and CP Module (alpha=0.79 child, 0.91 parent). The PedsQL 4.0 distinguished between healthy children and children with CP. Construct validity of the CP Module was supported. Sensitivity of the PedsQL was demonstrated among children with different diagnostic categories and gross motor function.

The PedsQL as a patient-reported outcome in children and adolescents with Attention-Deficit/Hyperactivity Disorder: a population-based study.

BACKGROUND: Attention-Deficit/Hyperactivity Disorder (ADHD) is the most common chronic mental health condition in children and adolescents. The application of health-related quality of life (HRQOL) as a pediatric population health measure may facilitate risk assessment and resource allocation, the identification of health disparities, and the determination of health outcomes from interventions and policy decisions for children and adolescents with ADHD at the local community, state, and national health level. METHODS: An analysis from an existing statewide database to determine the feasibility, reliability, and validity of the 23-item PedsQL 4.0 (Pediatric Quality of Life Inventory) Generic Core Scales as a patient-reported outcome (PRO) measure of pediatric population health for children and adolescents with ADHD. The PedsQL 4.0 Generic Core Scales (Physical, Emotional, Social, School Functioning) were completed by families through a statewide mail survey to evaluate the HRQOL of new enrollees in the State of California State's Children's Health Insurance Program (SCHIP). Seventy-two children ages 5-16 self-reported their HRQOL. RESULTS: The PedsQL 4.0 evidenced minimal missing responses, achieved excellent reliability for the Total Scale Score (alpha = 0.92 child self-report, 0.92 parent proxy-report), and distinguished between healthy children and children with ADHD. Children with ADHD self-reported severely impaired psychosocial functioning, comparable to children with newly-diagnosed cancer and children with cerebral palsy. CONCLUSION: The results suggest that population health monitoring may identify children with ADHD at risk for adverse HRQOL. The implications of measuring pediatric HRQOL for evaluating the population health outcomes of children with ADHD internationally are discussed.

The PedsQL 4.0 as a school population health measure: feasibility, reliability, and validity.

BACKGROUND: The application of health-related quality of life (HRQOL) as a school population health measure may facilitate risk assessment and resource allocation, the tracking of student health at the school and district level, the identification of health disparities among schoolchildren, and the determination of health outcomes from interventions and policy decisions at the school, district, and county level. OBJECTIVE: To determine the feasibility, reliability, and validity of the 23-item PedsQL 4.0 (Pediatric Quality of Life Inventory) Generic Core Scales as a school population health measure for children and adolescents. DESIGN: Survey conducted in 304 classes at 18 elementary schools, 4 middle schools, and 3 high schools within a large metropolitan school district. METHODS: The PedsQL 4.0 Generic Core Scales (Physical, Emotional, Social, School Functioning) were completed by 2437 children ages 8-18 and 4227 parents of children ages 5-18. RESULTS: The PedsQL 4.0 evidenced minimal missing responses, achieved excellent reliability for the Total Scale Score (alpha = 0.89 child, 0.92, parent report), and distinguished between healthy children and children with chronic health conditions. The PedsQL 4.0 was related to indicators of socioeconomic status (SES) at the school and district level. The PedsQL School Functioning Scale was significantly correlated with standardized achievement scores based on the Stanford 9. CONCLUSION: The results demonstrate the feasibility, reliability and validity of the PedsQL 4.0 Generic Core Scales as a school population health measure. The implications of measuring HRQOL in schoolchildren at the school, district, and county level for identifying and ameliorating health disparities are discussed.

Health-related quality of life of children and adolescents with cerebral palsy: hearing the voices of the children.

The aim of the study was to determine whether pediatric patients with cerebral palsy (CP; 24.3% hemiplegic, 30.4% diplegic, 38.5% quadriplegic) can self-report their health-related quality of life (HRQOL) with the Pediatric Quality of Life Inventory Version 4.0 (PedsQL 4.0) Generic Core Scales. The PedsQL was administered to 148 families (84 males, 64 females; mean 10y, SD 3y 9mo, range 5 to 18y) recruited from a children's hospital clinic and state medical therapy clinics. Sixty-nine children (47%) were able to self-report. Children with CP self-reported a significantly lower HRQOL (mean 65.9) than healthy children (mean 83.8). Children with CP self-reported a similar HRQOL to pediatric cancer patients receiving treatment (mean 68.9). Children diagnosed with quadriplegia (mean 49.4) self-reported more impaired HRQOL than children with diplegia (mean 69.1) and hemiplegia (mean 72.4). Parent-child concordance was lowest for emotional functioning. Providers and parents should obtain the children's HRQOL perceptions whenever possible.

Profile of daily life in children with brain tumors: an assessment of health-related quality of life.

PURPOSE: The survival of children with CNS tumors approaches 70%, yet health-related quality of life (HRQOL) has not been investigated rigorously in this population. We aimed to show that universal assessment of HRQOL could be obtained easily by using the PedsQL 4.0 and to provide a composite profile of their daily lives. PATIENTS AND METHODS: The PedsQL was administered to all patients seen in the neuro-oncology clinic at Lucile Packard Children's Hospital (Palo Alto, CA) from December 2001, to September 2002. Patients were compared with healthy controls by using two-sided t tests to evaluate statistically significant differences. RESULTS: One hundred thirty-four patients (73 male; mean age +/- standard deviation, 11.8 +/- 5.4 years; 55 had low-grade glioma, 32 had medulloblastoma/primitive neuroectodermal tumor/embryonal tumor, 17 had malignant astrocytoma, nine had germ-cell tumor, and 21 had other types of tumors) were assessed, each in less than 20 minutes. Scores on both child and parent-proxy reports for the total HRQOL, psychosocial, physical, emotional, social, and school-functioning scales were all significantly lower than controls (P < .01). Patients with low-grade glioma were reported to have the highest total HRQOL. Children receiving radiation therapy (XRT) but no chemotherapy had significantly lower total, psychosocial, emotional, and social functioning than those receiving other treatments, including XRT plus chemotherapy. CONCLUSION: The PedsQL can be used to assess HRQOL rapidly and easily in children with CNS tumors, who have significantly worse HRQOL than healthy children. Children receiving XRT fare worse overall; chemotherapy added to XRT does not seem to worsen HRQOL. Assessment of HRQOL should be included as an outcome in future clinical trials.

Health-related quality of life measurement in pediatric clinical practice: an appraisal and precept for future research and application.

Health-related quality of life (HRQOL) measurement has emerged as an important health outcome in clinical trials, clinical practice improvement strategies, and healthcare services research and evaluation. HRQOL measures are also increasingly proposed for use in clinical practice settings to inform treatment decisions. In settings where HRQOL measures have been utilized with adults, physicians report such measures as useful, some physicians alter their treatment based on patient reports on such instruments, and patients themselves generally feel the instruments to be helpful. However, there is a dearth of studies evaluating the clinical utility of HRQOL measurement in pediatric clinical practice. This paper provides an updated review of the literature and proposes a precept governing the application of pediatric HRQOL measurement in pediatric clinical practice. Utilizing HRQOL measurement in pediatric healthcare settings can facilitate patient-physician communication, improve patient/parent satisfaction, identify hidden morbidities, and assist in clinical decision-making. Demonstrating the utility of pediatric HRQOL measurement in identifying children with the greatest needs, while simultaneously demonstrating the cost advantages of providing timely, targeted interventions to address those needs, may ultimately provide the driving force for incorporating HRQOL measurement in pediatric clinical practice.