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.

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.

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.

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.

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.

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.

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 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.

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.

Fear of movement: factor structure of the tampa scale of kinesiophobia in patients with fibromyalgia syndrome.

UNLABELLED: Chronic pain patients often report fears that movement will exacerbate their symptoms. The Tampa Scale of Kinesiophobia (TSK) was designed to assess fear of movement. Previous findings with the TSK showed inconsistent factor structures and varied measurement properties. The TSK was completed by a sample of 233 patients with fibromyalgia syndrome who were being evaluated for participation in a rehabilitation program. A principal components analysis initially derived a 5-factor solution. However, the factor structure accounted for less than 50% of the variance, and the internal consistency of the factors was below conventional standards (<0.70). A series of principal components analyses "forcing" different factor structures revealed that the best solution was a single factor solution that contained 4 of the original 17 TSK items, accounting for more than 50% of the variance with adequate internal consistency (alpha =0.71). Inspection of the content of these 4 items, however, suggests that this factor more likely represents catastrophic thinking, rather than fear of movement. Nevertheless, for patients with fibromyalgia syndrome, a 4-item TSK appears to retain the most acceptable factor solution while also maintaining adequate internal consistency. PERSPECTIVE: Although the TSK is one of the most commonly used measures of fear of movement, the present study using the TSK with a sample of patients with fibromyalgia syndrome suggests that the measurement properties of the TSK are problematic. Recommendations for use of the TSK are provided.

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 in type 1 and type 2 diabetes: reliability and validity of the Pediatric Quality of Life Inventory Generic Core Scales and type 1 Diabetes Module.

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 PedsQL 3.0 Type 1 Diabetes Module was designed to measure diabetes-specific HRQOL. RESEARCH DESIGN AND METHODS: The PedsQL Generic Core Scales and Diabetes Module were administered to 300 pediatric patients with type 1 or type 2 diabetes and 308 parents. RESULTS: Internal consistency reliability for the PedsQL Generic Core Total Scale score (alpha = 0.88 child, 0.89 parent-report) and most Diabetes Module scales (average alpha = 0.71 child, 0.77 parent-report) was acceptable for group comparisons. The PedsQL 4.0 distinguished between healthy children and children with diabetes. The Diabetes Module demonstrated intercorrelations with dimensions of generic and diabetes-specific HRQOL. CONCLUSIONS: The results demonstrate the reliability and validity of the PedsQL in diabetes. The PedsQL may be used as an outcome measure for diabetes clinical trials and research.

Prevalence of fear of pain and activity in patients with fibromyalgia syndrome.

UNLABELLED: Patients with fibromyalgia syndrome (FMS) report pain, fatigue, emotional distress, activity avoidance, and disability. The role of fear of pain and activity in FMS patients has received only limited attention. FMS patients (N = 233) underwent examinations by a physician, physical therapist, and psychologist and completed measures of fear of pain and activity, disability, depressive mood, impact, and pain. Patients with high levels of fear of pain and activity (38.6%) reported greater disability (t = 4.02, P < .001), depressed mood (t = -4.14, P < .001), pain severity (t = -2.71, P < .01), and lower treadmill performance (t = -2.39, P < .05) than patients with low fear. Patients classified on the Multidimensional Pain Inventory as Dysfunctional reported greater fear than Interpersonally Distressed patients and Adaptive Copers (F = 8.13, P < .001). Only 50% of Dysfunctional patients, however, met the criterion of high fear, whereas 23.4% of Adaptive Copers met this criterion. Demographic factors, perceived disability, and Multidimensional Pain Inventory subgroup significantly predicted fear of pain and activity, accounting for 21.2% of the variance. Fear of pain and activity is prevalent among FMS patients. Treatment should address patient fears, because it might reduce disability and rates of nonadherence and attrition from outcome studies. PERSPECTIVE: Fear of movement is a significant concern for chronic pain sufferers because these behaviors maintain pain and increase disability. This study examined the role of fear in FMS, including associations between fear of pain/movement, pain severity, depressed mood, physical performance, and disability in FMS subgroups.

The PedsQL Family Impact Module: preliminary reliability and validity.

BACKGROUND: The 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. METHODS: The 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. RESULTS: Internal consistency reliability was demonstrated for the PedsQL Family Impact Module Total Scale Score (alpha = 0.97), Parent HRQOL Summary Score (alpha = 0.96), Family Functioning Summary Score (alpha = 0.90), and Module Scales (average alpha = 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. CONCLUSIONS: The 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 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 State's Children's 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 pain: a prospective longitudinal analysis of pain and emotional distress.

The objective of this prospective study was to investigate the cross-sectional and longitudinal associations between pain and emotional distress in children and adolescents with cancer as measured by the Pediatric Quality of Life Inventory (PedsQL) Emotional Functioning and Pain Scales. The PedsQL 1.0 Generic Core Scales are multidimensional scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules. The PedsQL 1.0 Cancer Module was designed to measure pediatric cancer-specific health-related quality of life. The PedsQL Generic Core Scales, Emotional Functioning Scale and Cancer Module Pain Scale, were administered to 69 children and 59 adolescents and their parents at Time 1 and Time 2, which was 6 months on average after Time 1. Prospective hierarchical multiple regression analyses supported a longitudinal predictive model with Time 1 pain predicting Time 2 pain and Time 1 emotional distress predicting Time 2 emotional distress, respectively. Time 1 emotional distress did not predict Time 2 pain, and Time 1 pain did not predict Time 2 emotional distress. The results demonstrate that pediatric cancer pain and emotional distress, although associated cross-sectionally, are differentially predictive in prospective longitudinal analyses. These results suggest that both pain and emotional distress should be targeted for treatment interventions concurrently to enhance long-term health-related quality of life of the pediatric patient with cancer.

Evaluation of the built environment at a children's convalescent hospital: development of the Pediatric Quality of Life Inventory parent and staff satisfaction measures for pediatric health care facilities.

In preparation for the design, construction, and postoccupancy evaluation of a new Children's Convalescent Hospital, focus groups were conducted and measurement instruments were developed to quantify and characterize parent and staff satisfaction with the built environment of the existing pediatric health care facility, a 30-year-old, 59-bed, long-term, skilled nursing facility dedicated to the care of medically fragile children with complex chronic conditions. The measurement instruments were designed in close collaboration with parents, staff, and senior management involved with the existing and planned facility. The objectives of the study were to develop pediatric measurement instruments that measured the following: (1) parent and staff satisfaction with the built environment of the existing pediatric health care facility, (2) parent satisfaction with the health care services provided to their child, and (3) staff satisfaction with their coworker relationships. The newly developed Pediatric Quality of Life Inventory scales demonstrated internal consistency reliability (average alpha = 0.92 parent report, 0.93 staff report) and initial construct validity. As anticipated, parents and staff were not satisfied with the existing facility, providing detailed qualitative and quantitative data input to the design of the planned facility and a baseline for postoccupancy evaluation of the new facility. Consistent with the a priori hypotheses, higher parent satisfaction with the built environment structure and aesthetics was associated with higher parent satisfaction with health care services (r =.54, p <.01; r =.59, p <.01, respectively). Higher staff satisfaction with the built environment structure and aesthetics was associated with higher coworker relationship satisfaction (r =.53; p <.001; r =.51; p <.01, respectively). The implications of the findings for the architectural design and evaluation of pediatric health care facilities are discussed.

Assessing fear in patients with cervical pain: development and validation of the Pictorial Fear of Activity Scale-Cervical (PFActS-C).

The fear avoidance model (FAM) postulates that fear of pain or reinjury is a risk factor for persistent pain and disability, because it leads to the avoidance of physical activity. Research on the FAM has not yielded consistent results, which may be attributed to the model itself, but could also be a product of the way fear of movement is assessed. Studies of the FAM have measured fear using verbal scales consisting of items that are often vague and have only an indirect relationship with fear. This study reports on the development of a Pictorial Fear of Activity Scale-Cervical (PFActS-C). The instrument consists of a set of photographs depicting movements in which four factors that determine biomechanical demands on the neck are systematically varied--Direction of Movement, Arm Position, Weight Bearing, and Extremity of Movement. Patients (n=355) who had been involved in motor vehicle collisions with minimal symptoms (n=143) and moderate to severe symptoms (n=212) rated their fear of engaging in a set of activities depicted in the PFActS-C. Based on a principle components analysis, a 19 item measure was developed. Internal consistency (alpha=.98), stability over time (n=44, IntraClass Correlation=.72), and construct validity were all good to excellent. The results indicate that the PFActS-C may be a useful tool for assessing fear of movement in patients with cervical pain. Research is needed to confirm the factor structure of the PFActS-C and to assess the generalizability of the results to other samples with neck pain.