Tasha M. Burwinkle

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

BACKGROUND The application of health-related quality of life (HRQOL) as a pediatric population health measure may facilitate risk assessment and resource allocation, the tracking of community health, the identification of health disparities, and the determination of health outcomes from interventions and policy decisions. 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 measure of pediatric population health for children and adolescents. DESIGN Mail survey in February and March 2001 to 20 031 families with children ages 2-16 years throughout the State of California encompassing all new enrollees in the States Childrens Health Insurance Program (SCHIP) for those months and targeted language groups. METHODS The PedsQL 4.0 Generic Core Scales (Physical, Emotional, Social, School Functioning) were completed by 10 241 families through a statewide mail survey to evaluate the HRQOL of new enrollees in SCHIP. RESULTS The PedsQL 4.0 evidenced minimal missing responses, achieved excellent reliability for the Total Scale Score (alpha =.89 child;.92 parent report), and distinguished between healthy children and children with chronic health conditions. The PedsQL 4.0 was also related to indicators of health care access, days missed from school, days sick in bed or too ill to play, and days needing care. CONCLUSION The results demonstrate the feasibility, reliability, and validity of the PedsQL 4.0 as a pediatric population health outcome. Measuring pediatric HRQOL may be a way to evaluate the health outcomes of SCHIP.

The PedsQL™ in Pediatric Cancer Reliability and Validity of the Pediatric Quality of Life Inventory™ Generic Core Scales, Multidimensional Fatigue Scale, and Cancer Module

The Pediatric Quality of Life Inventory (PedsQL) is a modular instrument designed to measure health‐related quality of life (HRQOL) in children and adolescents ages 2–18 years. The PedsQL 4.0 Generic Core Scales are 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 Multidimensional Fatigue Scale was designed to measure fatigue in pediatric patients. The PedsQL 3.0 Cancer Module was designed to measure pediatric cancer specific HRQOL.

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

BackgroundThe 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.MethodsThe 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 Childrens Health Insurance Program (SCHIP) in California (n = 5,988, 69.7%).ResultsItems 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.ConclusionThe 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.

Health-Related Quality of Life

Health-Related Quality of Life (HRQOL) is the way a person describes his or her physical and mental health over time. Doctors and other health professionals use HRQOL to measure the effects of chronic illness among patients’ day-to-day lives. Adults with wellcontrolled asthma should report a good HRQOL. Unfortunately, many Mississippi adults with asthma report poor quality of life and asthma-related limitations in daily activities.

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.

BackgroundAdvances 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.MethodsThe 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.ResultsPediatric 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.ConclusionThe 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.

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.

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 PedsQLTM 4.0 (Pediatric Quality of Life InventoryTM) 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 PedsQLTM 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 PedsQLTM 4.0 evidenced minimal missing responses, achieved excellent reliability for the Total Scale Score (α = 0.89 child, 0.92, parent report), and distinguished between healthy children and children with chronic health conditions. The PedsQLTM 4.0 was related to indicators of socioeconomic status (SES) at the school and district level. The PedsQLTM 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 PedsQLTM 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.

The PedsQL™ in Pediatric Asthma: Reliability and Validity of the Pediatric Quality of Life Inventory™ Generic Core Scales and Asthma Module

The PedsQL™ is a modular instrument designed to measure health-related quality of life (HRQOL) in children and adolescents ages 2–18. The PedsQL™ 4.0 Generic Core Scales were developed to be integrated with the PedsQL™ Disease-Specific Modules. The PedsQL™ 3.0 Asthma Module was designed to measure pediatric asthma-specific HRQOL. The PedsQL™ was administered to 529 families. Internal consistency reliability was demonstrated for the PedsQL™ 4.0 Total Score (α = 0.90 child, 0.91 parent report) and Asthma Module (average α = 0.71 child, 0.86 parent report). The PedsQL™ 4.0 distinguished between healthy children and children with asthma. The validity of the PedsQL™ Asthma Module was demonstrated through intercorrelations with a previously standardized asthma disease- specific instrument. Responsiveness was demonstrated through patient change over time as a result of clinical intervention. The results demonstrate the reliability, validity, and responsiveness of the PedsQL™ required for an outcome measure in pediatric asthma clinical trials and research.

The PedsQL Family Impact Module: preliminary reliability and validity.

BackgroundThe PedsQL™ Measurement Model was designed to measure health-related quality of life (HRQOL) in children and adolescents. The PedsQL™ 4.0 Generic Core Scales were developed to be integrated with the PedsQL™ Disease-Specific Modules. The newly developed PedsQL™ Family Impact Module was designed to measure the impact of pediatric chronic health conditions on parents and the family. The PedsQL™ Family Impact Module measures parent self-reported physical, emotional, social, and cognitive functioning, communication, and worry. The Module also measures parent-reported family daily activities and family relationships.MethodsThe 36-item PedsQL™ Family Impact Module was administered to 23 families of medically fragile children with complex chronic health conditions who either resided in a long-term care convalescent hospital or resided at home with their families.ResultsInternal consistency reliability was demonstrated for the PedsQL™ Family Impact Module Total Scale Score (α = 0.97), Parent HRQOL Summary Score (α = 0.96), Family Functioning Summary Score (α = 0.90), and Module Scales (average α = 0.90, range = 0.82 – 0.97). The PedsQL™ Family Impact Module distinguished between families with children in a long-term care facility and families whose children resided at home.ConclusionsThe results demonstrate the preliminary reliability and validity of the PedsQL™ Family Impact Module in families with children with complex chronic health conditions. The PedsQL™ Family Impact Module will be further field tested to determine the measurement properties of this new instrument with other pediatric chronic health conditions.

The PedsQL: reliability and validity of the short-form generic core scales and Asthma Module.

Objective:We sought to assess the reliability and validity of the PedsQL™ 4.0 SF15, a shortened version of the 23-item PedsQL™ 4.0 Generic Core Scales, which is a pediatric health-related quality of life (HRQoL) instrument, and the PedsQL™ 3.0 SF22 Asthma Module, a short-form of the PedsQL™ 3.0 Asthma Module. Methods:The PedsQL™ 4.0 SF15 and the PedsQL™ 3.0 SF22 Asthma Module were administered by telephone to 125 adolescents (aged 12–18) and 338 parents of children with asthma (aged 2–11). Healthy (n = 451) and chronically ill (n = 422) children, matched by age, respondent status, and ethnicity to the asthma sample, provided data for selected validity tests. Results:The Total Score from the PedsQL™ 4.0 SF15 and the Asthma Symptoms scale and Treatment Problems scale from the PedsQL™ 3.0 SF22 Asthma Module were sufficiently reliable for group comparisons (alpha ≥ 0.70 across all age groups) in the asthma sample. The PedsQL™ 4.0 SF15 and the PedsQL™ 3.0 SF22 Asthma Module were able to distinguish between children of different clinical status and correlated as expected with measures of productivity and family functioning in the asthma sample. The psychometric properties of the PedsQL™ 4.0 SF15 were generally comparable to those of the original instrument. Conclusion:The Total Score of the PedsQL™ 4.0 SF15 and the Asthma Symptoms scale of the PedsQL™ 3.0 SF22 Asthma Module demonstrated the best reliability and validity and should be suitable for group-level comparisons of generic and asthma-specific HRQoL in clinical research studies of children with asthma.