Trajectory of Mortality and Health-Related Quality of Life Morbidity Following Community-Acquired Pediatric Septic Shock.

OBJECTIVES: In-hospital pediatric sepsis mortality has decreased substantially, but long-term mortality and morbidity among children initially surviving sepsis, is unknown. Accordingly, the Life After Pediatric Sepsis Evaluation investigation was conducted to describe the trajectory of mortality and health-related quality of life morbidity for children encountering community-acquired septic shock. DESIGN: Prospective, cohort-outcome study, conducted 2013-2017. SETTING: Twelve academic PICUs in the United States. PATIENTS: Critically ill children, 1 month to 18 years, with community-acquired septic shock requiring vasoactive-inotropic support. INTERVENTIONS: Demographic, infection, illness severity, organ dysfunction, and resource utilization data were collected daily during PICU admission. Serial parent proxy-report health-related quality of life assessments were obtained at baseline, 7 days, and 1, 3, 6, and 12 months following PICU admission utilizing the Pediatric Quality of Life Inventory or Stein-Jessop Functional Status Scale. MEASUREMENTS AND MAIN RESULTS: Among 389 children enrolled, mean age was 7.4 ± 5.8 years; 46% were female; 18% were immunocompromised; and 51% demonstrated chronic comorbidities. Baseline Pediatric Overall Performance Category was normal in 38%. Median (Q1-Q3) Pediatric Risk of Mortality and Pediatric Logistic Organ Dysfunction scores at PICU admission were 11.0 (6.0-17.0) and 9.0 (6.0-11.0); durations of vasoactive-inotropic and mechanical ventilation support were 3.0 days (2.0-6.0 d) and 8.0 days (5.0-14.0 d); and durations of PICU and hospital stay were 9.4 days (5.6-15.4 d) and 15.7 days (9.2-26.0 d). At 1, 3, 6, and 12 months following PICU admission for the septic shock event, 8%, 11%, 12%, and 13% of patients had died, while 50%, 37%, 30%, and 35% of surviving patients had not regained their baseline health-related quality of life. CONCLUSIONS: This investigation provides the first longitudinal description of long-term mortality and clinically relevant, health-related quality of life morbidity among children encountering community-acquired septic shock. Although in-hospital mortality was 9%, 35% of survivors demonstrated significant, health-related quality of life deterioration from baseline that persisted at least 1 year following hospitalization for septic shock.

Assessment of Quality of Life in Young Patients with Single Ventricle after the Fontan Operation.

OBJECTIVES: To assess self-reported quality of life (QOL) in a large multicenter cohort of adolescent and young adults surviving Fontan. STUDY DESIGN: Cross-sectional. The Pediatric Quality of Life Inventory (PedsQL) was administered to 408 survivors of Fontan ages 13-25 years enrolled in the Pediatric Heart Network Fontan Follow-up Study. Subjects also completed either the Child Health Questionnaire (age <19 years) or Short Form Health Survey (age ≥ 19 years). PedsQL data were compared with matched controls without a chronic health condition. Correlations between the measures were examined. RESULTS: Mean PedsQL scores for subjects receiving Fontan were significantly lower than those for the control group for physical and psychosocial QOL (P < .001). Overall, 45% of subjects receiving Fontan had scores in the clinically significant impaired range for physical QOL with 30% in the impaired range for psychosocial QOL. For each 1 year increase in age, the physical functioning score decreased by an average of 0.76 points (P = .004) and the emotional functioning score decreased by an average of 0.64 points (P = .03). Among subjects ≥19 years of age, the physical functioning score decreased by an average of 2 points for each year increase in age (P = .02). PedsQL scale scores were significantly correlated with conceptually related Child Health Questionnaire (P < .001) and Short Form Health Survey scores (P < .001). CONCLUSIONS: Survivors of Fontan are at risk for significantly impaired QOL which may decline with advancing age. Routine assessment of QOL is essential to inform interventions to improve health outcomes. The PedsQL allowed QOL assessment from pediatrics to young adulthood. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00132782.

Health-related quality of life in pediatric patients with functional and organic gastrointestinal diseases.

OBJECTIVE: To compare health-related quality of life (HRQOL) in pediatric patients with functional gastrointestinal disorders (FGIDs) and organic gastrointestinal (GI) diseases with an age-, sex-, and race/ethnicity-matched healthy sample across GI diagnostic groups and with one another. STUDY DESIGN: The Pediatric Quality of Life Inventory 4.0 Generic Core Scales were completed in a 9-site study by 689 families. Patients had 1 of 7 physician-diagnosed GI disorders: chronic constipation, functional abdominal pain, irritable bowel syndrome, functional dyspepsia, Crohn's disease, ulcerative colitis, and gastroesophageal reflux disease. The healthy control sample included 1114 families. School days missed, days in bed and needing care, parent missed workdays, work impact, and healthcare utilization were compared as well. RESULTS: Patients with an FGID or organic GI disease demonstrated lower HRQOL than the healthy controls across all dimensions (physical, emotional, social, and school; P < .001 for all), with larger effect sizes for patients with an FGID. Patients with an FGID manifested lower HRQOL than those with an organic GI disease. Patients with an FGID or organic GI disease missed more school, spent more days in bed and needing care, had greater healthcare utilization, and had parents who missed more workdays with greater work impact (P < .001 for most), with larger effect sizes for the patients with an FGID. CONCLUSION: Patients with an FGID or organic GI disease demonstrate impaired HRQOL compared with healthy children. HRQOL can be used as a common metric to compare patient outcomes in clinical research and practice both within and across groups of patients with FGIDs and organic GI diseases.

Commentary on strengthening the assessment of factorial invariance across population subgroups: a commentary on Varni et al. (2013).

In his commentary on Varni et al.'s (Qual Life Res. doi: 10.1007/s11136-013-0370-4 , 2013) article, McIntosh (Qual Life Res. doi: 10.1007/s11136-013-0465-y , 2013) has two main arguments. First, we should have paid more attention to statistical tests (i.e., χ 2 values) instead of approximate fit indexes for our analysis, especially with the baseline model. Second, Bayesian methods are better than the frequentist methods we used in determining the model's invariance across age and gender groups. We believe that statistical tests do have a place in assessing model fit, but overemphasis on them, especially with larger sample sizes, can lead to errant decisions. Second, while we agree that Bayesian methods have the potential to contribute much to the field of assessing invariance, more development needs to be conducted before they can be widely utilized in assessing factorial invariance across groups.

PedsQL eosinophilic esophagitis module: feasibility, reliability, and validity.

OBJECTIVE: Eosinophilic esophagitis (EoE) is a chronic esophageal inflammatory condition with a paucity of information on health-related quality of life (HRQOL). The objective of the study was to report on the measurement properties of the PedsQL EoE Module. METHODS: The PedsQL EoE Module was completed in a multisite study by 196 pediatric patients with EoE and 262 parents of patients with EoE. RESULTS: The PedsQL EoE Module scales evidenced excellent feasibility (0.6%-3.1% missing), excellent group comparison reliability across total scale scores (patient α 0.93; parent proxy α 0.94), good reliability for the 7 individual scales (patient α 0.75-0.87; parent proxy α 0.81-0.92), excellent test-retest reliability (patient intraclass correlation coefficient 0.88; parent intraclass correlation coefficient 0.82), demonstrated no floor effects and low ceiling effects, and demonstrated a high percentage of scaling success for most scales. Intercorrelations with the PedsQL Generic Core Scales were in the medium (0.30) to large (0.50) range. PedsQL EoE Module scores were worse among patients with active histologic disease (≥ 5 eos/hpf) compared with those in remission (patient self-report: 63.3 vs 69.9 [P < 0.05]; parent proxy report: 65.1 vs 72.3 [P < 0.01]), and those treated with dietary restrictions compared with those with no restrictions (patient self-report: 61.6 vs 74.3 [P < 0.01]; parent proxy report: 65.5 vs 74.7 [P < 0.01]). CONCLUSIONS: The results demonstrate excellent measurement properties of the PedsQL EoE Module. Patients with active histologic disease and those treated with dietary restrictions demonstrated worse PedsQL scores. The PedsQL EoE Module may be used in the evaluation of pediatric EoE disease-specific HRQOL in clinical research and practice.

The clinical utility of health-related quality of life assessment in pediatric cardiology outpatient practice.

OBJECTIVES: Children with congenital heart disease may experience significant psychosocial morbidity related to impaired quality of life (QOL). The aim of this study was to evaluate the clinical utility of health-related QOL assessment in a pediatric cardiology outpatient clinic. DESIGN: The Pediatric Quality of Life Inventory (PedsQL) 4.0 Generic Core Scales were completed by a convenience sample of 176 patients, aged 8-18 years, being seen in a pediatric cardiology clinic. Three cardiologists enrolled in this study reviewed the completed PedsQL during the clinic visit and recorded their responses to items reported to be a problem "Often" or "Almost Always." This utilization of the instrument was compared to standardized scoring and the practicality and perceived usefulness of the practice was evaluated by physician interview. RESULTS: PedsQL responses showed 38% of patients reporting significant (Often or Almost Always) problems on at least one domain (19% Physical Functioning, 18.2% Emotional Functioning, 11.4% Social Functioning, and 22.3% School Functioning problems). Using standardized scoring, the prevalence of scores below the cutoff score for clinically significant impaired QOL in each domain ranged from 10% to 20%, with agreement between scoring methods ranging from 89% to 93%, sensitivity 68% to 86%, and specificity 89% to 97%. Cardiologists reported interventions in 30.1% of patients. They found that the PedsQL was easy to use, did not interfere with clinic operations, required minimal time (1-5 minutes), and provided information that had an important impact on their practice in some patients. CONCLUSIONS: This study demonstrates the clinical utility of health-related QOL assessment using the PedsQL in a pediatric cardiology outpatient setting. Identification of significant impairments in QOL can impact clinical decision making and may change psychosocial outcomes in children with congenital heart disease.

Content validity of the PedsQL™ 3.2 Diabetes Module in newly diagnosed patients with Type 1 diabetes mellitus ages 8-45.

OBJECTIVES: The content validity of the 28-item PedsQL™ 3.0 Diabetes Module has not been established in research on pediatric and adult patients with newly diagnosed Type 1 diabetes across a broad age range. This study aimed to document the content validity of three age-specific versions (8-12 years, 13-18 years, and 18-45 years) of the PedsQL™ Diabetes Module in a population of newly diagnosed patients with Type 1 diabetes. METHODS: The study included in-depth interviews with 31 newly diagnosed patients with Type 1 diabetes between the ages of 8 and 45 years, as well as 14 parents and/or caregivers of child and teenage patients between the ages of 8 and 18 years of age; grounded theory data collection and analysis methods; and review by clinical and measurement experts. RESULTS: Following the initial round of interviews, revisions reflecting patient feedback were made to the Child and Teen versions of the Diabetes Module, and an Adult version of the Diabetes Module was drafted. Cognitive interviews of the modified versions of the Diabetes Module were conducted with an additional sample of 11 patients. The results of these interviews support the content validity of the modified 33-item PedsQL™ 3.2 Diabetes Module for pediatric and adult patients, including interpretability, comprehensiveness, and relevance suitable for all patients with Type 1 Diabetes. CONCLUSIONS: Qualitative methods support the content validity of the modified PedsQL™ 3.2 Diabetes Module in pediatric and adult patients. It is recommended that the PedsQL™ 3.2 Diabetes Module replaces version 3.0 and is suitable for measuring patient-reported outcomes in all patients with newly diagnosed, stable, or long-standing diabetes in clinical research and practice.

The PedsQL™ Oral Health Scale: feasibility, reliability and validity of the Brazilian Portuguese version.

BACKGROUND: Oral and orofacial problems may cause a profound impact on children's oral health-related quality of life (OHRQoL) because of symptoms associated with these conditions that may influence the physical, psychological and social aspects of their daily life. The OHRQoL questionnaires found in the literature are very specific and are not able to measure the impact of oral health on general health domains. Consequently, the objective of this study was to evaluate the psychometric properties of the Portuguese version for Brazilian translation of the Pediatric Quality of Life Inventory™ (PedsQL™) Oral Health Scale in combination with the PedsQL™ 4.0 Generic Core Scales. METHODS: The PedsQL™ Oral Health Scale was forward-backward translated and cross-culturally adapted for the Brazilian Portuguese language. In order to assess the feasibility, reliability and validity of the Brazilian version of the instrument, a study was carried out in Belo Horizonte with 208 children and adolescents between 2 and 18 years-of-age and their parents. Clinical evaluation of dental caries, socioeconomic information and the Brazilian versions of the PedsQL™ Oral Health Scale, PedsQL™ 4.0 Generic Core Scales, Child Perceptions Questionnaire (CPQ11-14 and CPQ8-10) and Parental-Caregiver Perception Questionnaire (P-CPQ) were administered. Statistical analysis included feasibility (missing values), confirmatory factor analysis (CFA), internal consistency reliability, and test-retest intraclass correlation coefficients (ICC) of the PedsQL™ Oral Health Scale. RESULTS: There were no missing data for both child self-report and parent proxy-report on the Brazilian version of the PedsQL™ Oral Health Scale. The CFA showed that the five items of child self-report and parent proxy-report loaded on a single construct. The Cronbach's alpha coefficients for child/adolescent and parent oral health instruments were 0.65 and 0.59, respectively. The test-retest reliability (ICC) for child self-report and parent proxy-report were 0.90 [95% confidence interval (CI) = 0.86-0.93] and 0.86 (95%CI = 0.81-0.90), respectively. The PedsQL™ Oral Health Scale demonstrated acceptable construct validity, convergent validity and discriminant validity. CONCLUSIONS: These results supported the feasibility, reliability and validity of the Brazilian version of the PedsQL™ Oral Health Scale for child self-report for ages 5-18 years-old and parent proxy-report for ages 2-18 years-old children.

Context-specific correlates of walking behaviors to and from school: do they vary across neighborhoods and populations?

BACKGROUND: A growing number of studies have examined correlates of walking-to/from-school behaviors. However, the potential differences across neighborhoods have been understudied. To address this knowledge gap, this study compared 4 elementary school settings (low-income inner-city; mid- to low-income, urban with and without freeway in attendance area; and high-income suburban) in Austin, Texas. METHODS: Parental surveys (n = 680, response rate = 25%) were analyzed using binary logistic regressions to identify correlates of walking to/from school for each setting. Five focus groups were conducted with 15 parents and analyzed using content analysis to supplement the survey results. RESULTS: Parents' personal barrier was the only consistently significant variable across 4 settings (OR = 0.113-0.463, P < .05). Parental education showed contrasting results between the suburban setting (OR = 3.895, P < .01) and the urban setting with freeway presence (OR = 0.568, P < .05). Personal attitude and walking habit had lower explanatory power in lower-income settings than in the higher-income site. But sociodemographic, physical environment, and safety conditions had greater explanatory power in lower-income settings. Freeway barrier was significant in the inner-city setting (OR = 0.029, P < .05) and the urban setting with freeway presence (OR = 0.142, P < .05). CONCLUSIONS: Significant differences in correlates of walking-to/from-school behaviors were found across the 4 elementary school settings, suggesting the importance of context-sensitive approaches in future research and practice.

Factorial invariance of child self-report across race/ethnicity groups: a multigroup confirmatory factor analysis approach utilizing the PedsQL 4.0 Generic Core Scales.

PURPOSE: In order to compare health-related quality of life (HRQOL) research findings across race/ethnicity subpopulations, it is important to demonstrate factorial invariance, i.e., that the items have equivalent meaning across the race/ethnicity groups studied. This study examined the factorial invariance of child self-reported HRQOL across race/ethnicity groups for ages 5-18 years utilizing the 23-item PedsQL 4.0 Generic Core Scales. METHODS: Multigroup confirmatory factor analysis (CFA) was performed, specifying a five-factor model across four race/ethnicity groups (White Non-Hispanic, Hispanic, Asian/Pacific Islander, Black Non-Hispanic). Multigroup structural equation models were proposed in order to compare the factor structure across the four race/ethnicity subpopulations. The analyses were based on 5,490 children recruited from clinic, school, and community populations. RESULTS: Strict factorial invariance across the four race/ethnicity groups was demonstrated based on stability of the Comparative Fit Index (CFI) between the models, and several additional indices of practical fit including the Root Mean Squared Error of Approximation (RMSEA), the Non-Normed Fit Index (NNFI), and the Parsimony Normed Fit Index (PNFI). CONCLUSIONS: The findings support an equivalent five-factor structure across the four race/ethnicity subpopulations studied. Based on these data, it can be concluded that children across the four race/ethnicity groups studied interpreted items in a similar manner regardless of their race/ethnicity.

Barriers to care questionnaire: reliability, validity, and responsiveness to change among parents of children with asthma.

BACKGROUND: Although it is well known which groups of children are more vulnerable to poor health care access, quality, and outcomes, less is known about how and why this occurs. Barriers to care-sociobehavioral processes that interfere with successful interaction with the health care system--may be a link between vulnerability and access, experiences, and outcomes. OBJECTIVE: The aim of this study was to examine the reliability, validity, and responsiveness to change of the Barriers to Care Questionnaire (BCQ) in a sample of children with persistent asthma recruited from federally qualified health centers. METHOD: Children (N = 252; aged 2-14 years) with persistent asthma and their parents (93.7% mother, 83.3% Hispanic, 76.9% Spanish speaking; 72.6% less than a high school diploma), enrolled in a clinical trial, and completed the BCQ, questions relating to access to care, the Parent's Perceptions of Primary Care Measure, and the Pediatric Quality of Life Inventory 4.0 (PedsQL) at baseline and 3 months. RESULTS: The BCQ demonstrated internal consistency reliability. Supporting construct validity, barriers to care were worse for children without health insurance or an identified provider and who had problems with care or foregone care. Higher barriers correlated with poorer primary care and lower patient health-related quality of life. The BCQ was responsive to change, showing within- and between-subject differences for subjects with improved realized access from baseline to 3 months. CONCLUSION: The BCQ is a reliable, valid, and responsive measure of barriers to care for vulnerable children with asthma. Barriers to care were associated with poorer access, lower primary care quality, and worse health-related quality of life.

Longitudinal factorial invariance of the PedsQL 4.0 Generic Core Scales child self-report Version: one year prospective evidence from the California State Children's Health Insurance Program (SCHIP).

BACKGROUND: The measurement of health-related quality of life (HRQOL) in pediatric medicine and health services research has grown significantly over the past decade. The paradigm shift toward patient-reported outcomes (PROs) has provided the opportunity to emphasize the value and critical need for pediatric patient self-report. In order for changes in HRQOL/PRO outcomes to be meaningful over time, it is essential to demonstrate longitudinal factorial invariance. This study examined the longitudinal factor structure of the PedsQL 4.0 Generic Core Scales over a one-year period for child self-report ages 5-17 in 2,887 children from a statewide evaluation of the California State Children's Health Insurance Program (SCHIP) utilizing a structural equation modeling framework. METHODS: Specifying four- and five-factor measurement models, longitudinal structural equation modeling was used to compare factor structures over a one-year interval on the PedsQL 4.0 Generic Core Scales. RESULTS: While the four-factor conceptually-derived measurement model for the PedsQL 4.0 Generic Core Scales produced an acceptable fit, the five-factor empirically-derived measurement model from the initial field test of the PedsQL 4.0 Generic Core Scales produced a marginally superior fit in comparison to the four-factor model. For the five-factor measurement model, the best fitting model, strict factorial invariance of the PedsQL 4.0 Generic Core Scales across the two measurement occasions was supported by the stability of the comparative fit index between the unconstrained and constrained models, and several additional indices of practical fit including the root mean squared error of approximation, the non-normed fit index, and the parsimony normed fit index. CONCLUSION: The findings support an equivalent factor structure on the PedsQL 4.0 Generic Core Scales over time. Based on these data, it can be concluded that over a one-year period children in our study interpreted items on the PedsQL 4.0 Generic Core Scales in a similar manner.

Factorial invariance of child self-report across socioeconomic status groups: a multigroup confirmatory factor analysis utilizing the PedsQL 4.0 Generic Core Scales.

The measurement of health-related quality of life (HRQOL) in pediatric medicine and health services research has grown significantly over the past decade. Socioeconomic status (SES) differences in health outcomes have been extensively documented in adult and child populations. In order for HRQOL comparisons to be meaningful across different socioeconomic status (SES) groups, items on a HRQOL measure must have equivalent meaning across the SES subpopulations being compared. That is, they must demonstrate factorial invariance. This study examined factorial invariance of child self-report for ages 5-18 across SES groups in 453 children utilizing the PedsQL 4.0 Generic Core Scales. Multigroup Confirmatory Factor Analysis was performed specifying a five-factor model across two SES groups. SES groupings were assigned according to the Hollingshead Index of Social Status. Factorial invariance across socioeconomic status groups was demonstrated based on stability of the Comparative Fit Index (CFI) between the models, and several additional indices of practical fit including the Root Mean Squared Error of Approximation (RMSEA), the Non-Normed Fit Index (NNFI), and the Parsimony Normed Fit Index (PNFI). The findings support an equivalent five-factor structure of child self-report on the PedsQL across the two SES groups studied. Based on these data, it can be concluded that children across SES groups interpreted items on the PedsQL in a similar manner.

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.

Costs of recruiting couples to a clinical trial.

Multiple barriers contribute to the slow recruitment of participants to research studies, which in turn extends the time required to translate promising scientific discoveries into proven therapeutic interventions. A small but growing literature is developing on the extraordinary costs of recruiting participants to studies, and thereby demonstrating that underestimating the cost of participant recruitment can contribute to these recruitment problems. These recruitment challenges and costs are exacerbated when the participants' study eligibility is determined by relatively narrowly defined illness parameters. Recruitment challenges are further compounded when dyads (two individuals engaged in a sociologically significant relationship, such as husbands and wives, siblings or extended families) must be recruited to an illness-focused study. For these latter groups, there are no data to guide researchers in how to anticipate those participant recruitment costs. This paper describes the staff costs for a variety of strategies used to recruit participants to a randomized supportive care study for couples who were within 18 months of a prostate cancer diagnosis. Pegged to the value of the U.S. dollar for the period, the average cost of staff time was $288 per recruited and enrolled dyad, plus a promised additional $100 incentive for study retention. Within the strategies used, the staff costs per recruited dyad ranged from $152 to $1688. Accrual per strategy ranged from 0 to 107 enrolled couples. When asked for secondary sources of information about the study, many participants reported more than one source of study referral, reflective of the multifaceted recruitment strategies deployed. In spite of innovative, culturally competent, and broad based recruitment methods, attainment of a diverse sample was difficult to accomplish in this study. Having estimates of the actual cost of recruiting dyads to research studies can help investigators prepare realistic study budgets.

The impact of realized access to care on health-related quality of life: a two-year prospective cohort study of children in the California State Children's Health Insurance Program.

OBJECTIVE: To examine the effect of realized access to care (problems getting care, access to needed care) on health-related quality of life (HRQOL) in the California State Children's Health Insurance Program. STUDY DESIGN: This was a prospective cohort study (n = 4,925; 70.5% [3438] had complete data). Surveys were taken at enrollment and after 1 and 2 years in the program. Parents and children reported HRQOL (PedsQL 4.0 Generic Core Scales). Repeated-measures analysis accounted for within-person correlation and adjusted for baseline PedsQL, baseline realized access, race/ethnicity, language, chronic health condition, and having a regular physician. RESULTS: Realized access to care during the prior year was related to HRQOL for each subsequent year. Foregone care and problems getting care were associated with decrements of 3.5 (P < .001) and 4.5 (P < .001) points for parent proxy-report PedsQL and with decrements of 3.2 (P < .001) and 4.4 (P < .001) points for child self-report PedsQL. Improved realized access resulted in higher PedsQL scores, continued realized access resulted in sustained PedsQL scores, and foregone care resulted in cumulative declines in PedsQL scores. CONCLUSIONS: Realized access to care is associated with statistically significant and clinically meaningful changes in HRQOL in children enrolled in the California State Children's Health Insurance Program.

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.

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.

Measuring primary care for children of Latino farmworkers: reliability and validity of the parent's perceptions of primary care measure (P3C).

This study evaluates the feasibility, reliability, and validity of the Parent's Perceptions of Primary Care measure (P3C) in an underserved population: children of Latino farm workers. Bilingual research assistants verbally administered the P3C, as well as a measure of child health-related quality of life (HRQL: the PedsQL 4.0) and demographic questions to 297 Latino farm worker parents of young children, in San Diego and Imperial Counties. The P3C was found to be feasible, as measured by a very low percent of missing/do not know values. Internal consistency reliability for the Total Scale and most subscales was strong. The P3C's validity was demonstrated through factor analysis of the subscales, by showing that scores were lower for children without a regular physician and for children experiencing foregone health care, and by demonstrating that P3C scores were related to HRQL. The P3C can be useful to various stakeholders in measuring primary care for vulnerable populations.