Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module for youth with Type 2 diabetes: reliability and validity.

AIM: To test the measurement properties of the revised and updated Pediatric Quality of Life Inventory (PedsQL) 3.2 Diabetes Module originally developed in Type 1 diabetes in youth with Type 2 diabetes. METHODS: The PedsQL 3.2 Diabetes Module and PedsQL Generic Core Scales were administered in a field test study to 100 young people aged 9-25 years with Type 2 diabetes. Factor analysis was conducted to determine the factor structure of the items. RESULTS: The 15-item Diabetes Symptoms Summary Score and 12-item Type 2-specific Diabetes Management Summary Score were empirically derived through factor analysis. The Diabetes Symptoms and Type 2-specific Diabetes Management Summary Scores showed acceptable to excellent reliability across the age groups tested (α = 0.85-0.94). The Diabetes Symptoms and Type 2-specific Diabetes Management Summary Scores evidenced construct validity through large effect size correlations with the Generic Core Scales Total Scale Score (r = 0.67 and 0.57, respectively). HbA1c was correlated with the Diabetes Symptoms and Type 2-specific Diabetes Management Summary Scores (r = -0.13 and -0.22). Minimal clinically important difference (MCID) scores were 5.91 and 7.39 for the Diabetes Symptoms and Type 2-specific Diabetes Management Summary Scores. CONCLUSIONS: The PedsQL 3.2 Diabetes Module Diabetes Symptoms Summary Score and Type 2-specific Diabetes Management Summary Score exhibited satisfactory measurement properties for use as youth self-reported diabetes symptoms and diabetes management outcomes for clinical research and clinical practice for young people with Type 2 diabetes.

Prospective, comparative effectiveness trial of cow's milk elimination and swallowed fluticasone for pediatric eosinophilic esophagitis.

Eosinophilic esophagitis (EoE) is a chronic, immune-mediated disease in which food antigens play a key role. Current therapeutic options are limited to long-term steroid medication and dietary elimination of multiple foods, each of which is challenging. Our objective was to compare single food elimination of cow's milk to swallowed fluticasone in pediatric EoE patients. This is a prospective, comparative effectiveness trial of newly diagnosed EoE patients (ages 2-18 years) treated with swallowed fluticasone (n = 24) or elimination of cow's milk (n = 20). The dual outcome measures of repeat esophageal biopsy (6-8 weeks) and change in Pediatric Quality of Life Inventor (PedsQL) EoE Module and Symptoms Scales were used to assess response to treatment. After 6-8 weeks of treatment, peak esophageal eosinophil counts decreased to below the threshold of 15 eosinophils/high-power field in 64% of patients treated with cow's milk elimination and 80% of patients treated with swallowed fluticasone (P = 0.4). Mean PedsQL EoE Module total scores (69 vs. 82; P < 0.005) and Total Symptoms scores (58 vs. 75; P = 0.001) showed significant improvement with cow's milk elimination. Among children treated with swallowed fluticasone, mean PedsQL EoE Module total scores (64 vs. 75; P < 0.05) and Total Symptoms scores (58 vs. 69; P < 0.01) were also significantly improved after 6-8 weeks of therapy. Removal of cow's milk from the diet is an effective single food elimination treatment for pediatric patients with EoE as assessed by statistically significant histologic and symptomatic improvement. Cow's milk elimination may be more desirable for EoE patients who do not want to take chronic, long-term steroid medications.

Health-related quality of life in pediatric patients after allogeneic SCT: development of the PedsQL Stem Cell Transplant module and results of a pilot study.

With increased survival after pediatric allogeneic hematopoietic SCT health-related quality of life (HRQL) has emerged as an essential health outcome. The impact of transplant and chronic GVHD (cGVHD)-associated morbidity remains a major obstacle. In 2005, the National Institutes of Health (NIH) Consensus Conference on Criteria for Clinical Trials in cGVHD recommended HRQL tools as an independent measure of the impact of disease burden. The NIH recommendations did not provide a cGVHD-specific tool for HRQOL measures in children. This report focuses on the development of an SCT-specific instrument to assess HRQL in children and adolescents. For the assessment of generic HRQL we chose the PedsQL (Pediatric Quality of Life Inventory) Generic Cores Scales, which have been used in a large number of healthy, acutely ill and chronically ill children and adolescents. To capture SCT- and, specifically, cGVHD-related problems, we developed the PedsQL Stem Cell Transplant module by reviewing the literature, taking over some items/scales of other PedsQL modules, interviewing patients, parents and members of the health-care team, and applying the PedsQL measurement methods. The final PedsQL Stem Cell Transplant module consists of the HRQL domains: pain and hurt, fatigue/sleeping problems/weakness, nausea, worry/anxiety about disease/treatment, nutritional problems, neurocognitive problems, communication about disease/treatment, loneliness, physical functioning and additional somatic complaints (pruritus, skin inflammation, oral problems, eyes or breathing) including patients' and parents' assessment. It was tested in 35 pediatric patients, who were referred to our SCT Outpatient Clinic about 100 days post SCT. Both the generic PedsQL and the SCT-specific scales showed high internal consistency, with Cronbach alpha levels of ⩾0.70 in almost all scales. Most problems were detected within the HRQL domains of physical functioning and pain. The summary scores of the generic PedsQL and the PedsQL Stem Cell Transplant module showed high correlations (r=0.89 in patients' and r=0.81 in parents' assessments). Moreover, both tools discriminated between patients with and without cGVHD. The PedsQL Stem Cell Transplant module is practical for use and suitable across a broad age range (2-18 years) both in patients with and without cGVHD. However, it is still a pilot instrument and needs further development and testing in a larger patient population.

Quality of life in paediatric eosinophilic oesophagitis: what is important to patients?

BACKGROUND AND AIMS: Current research outcomes in paediatric eosinophilic oesophagitis (EoE) are directed towards histological improvement with no attention to health-related quality of life (HRQOL). The primary objective of this study was to identify key patient-reported and parent proxy outcome elements of EoE disease-specific HRQOL. METHODS: The research team comprised clinical allergists and gastroenterologists with expertise in paediatric EoE as well as two PhD psychologists with extensive experience in qualitative research. Focused interview techniques were adapted from the Pediatric Quality of Life Inventory 4.0™ methodology and the consolidated criteria for reporting qualitative research. A semi-structured interview guide of open-ended questions was developed, and extensive review of audio-taped transcripts was performed. RESULTS: A total of 42 focus interviews were conducted. Child self-reports were obtained for patients in the 5-7, 8-12 and 13-18 years of age groups, and parent proxy reports were obtained in the 2-4, 5-7, 8-12 and 13-18 years of age groups. We discovered that patients and parents often had different concerns, illustrating unique aspects of EoE-specific HRQOL that were not captured in generic HRQOL instruments. Specific themes that emerged from these interviews included, but are not limited to: feelings of being different than family and peers, diet and medication adherence, difficulties with eating food and worry about symptoms and illness. CONCLUSION: Paediatric EoE patient and parent proxy interviews revealed many EoE-specific aspects of HRQOL that are not captured in generic HRQOL instruments. Outcome measures that reflect patient- and parent proxy-reported HRQOL are a critical need in paediatric EoE.

Pediatric health-related quality of life: Feasibility, reliability and validity of the PedsQL transplant module.

The measurement properties of the newly developed Pediatric Quality of Life Inventory (PedsQL) 3.0 Transplant Module in pediatric solid organ transplant recipients were evaluated. Participants included pediatric recipients of liver, kidney, heart and small bowel transplantation who were cared for at seven medical centers across the United States and their parents. Three hundred and thirty-eight parents of children ages 2-18 and 274 children ages 5-18 completed both the PedsQL 4.0 Generic Core Scales and the Transplant Module. Findings suggest that child self-report and parent proxy-report scales on the Transplant Module demonstrated excellent reliability (total scale score for child self-report alpha= 0.93; total scale score for parent proxy-report alpha= 0.94). Transplant-specific symptoms or problems were significantly correlated with lower generic HRQOL, supporting construct validity. Children with solid organ transplants and their parents reported statistically significant lower generic HRQOL than healthy children. Parent and child reports showed moderate to good agreement across the scales. In conclusion, the PedsQL Transplant Module demonstrated excellent initial feasibility, reliability and construct validity in pediatric patients with solid organ transplants.

Health-related quality of life of school-age children with familial Mediterranean fever.

OBJECTIVES: To describe and compare the parent proxy-reported and child self-reported physical and psychosocial HRQOL of school age children who have FMF with healthy peers. METHODS: The Pediatric Quality of Life Inventory 4.0 (Peds QL 4.0) Generic Core Scales was used to measure HR-QOL. Fifty-one patients and 81 healthy peers were enrolled in the study. Patients were grouped according to their ages as : 1) Children (8-12 years) and 2) Adolescents (13-18 years). An accompanying parent completed the parent proxy-report of the Peds QL 4.0. RESULTS: Peds QL scores of children (8-12 years) with FMF were significantly lower than healthy peers for physical and psychosocial functioning for both child self-report and parent proxy-report. The parent proxy-report and child self-reported Peds QL scores of adolescent patients (13-18 years) with FMF were lower than the healthy group for physical, emotional and school functioning; however no significant difference was detected regarding the social functioning. Adolescents with FMF had significantly higher social scores when compared to the younger age group (8-12 years) with FMF, 92.6 +/- 8.5 and 82.2 +/- 17.6, respectively (p=0.028). The scores of physical, emotional and school functioning were similar in both groups (p=0.73, p=0.93, and p=0.028). Correlations among child self-report subscales and proxy-report subscales were all significant and varied from moderate to high. CONCLUSION: This study suggested that assessment of HRQOL has potential clinical implications for the healthcare needs of children and adolescents with FMF. Given the degree of reported impairment in their health-related quality of life, individualized counseling and interventions are needed.

The Italian version of the PedsQL in children with rheumatic diseases.

OBJECTIVE: The aim of the study was to test the reliability and validity of the Italian translation of the PedsQL 4.0 Generic Core Scales and the PedsQL 3.0 Rheumatologic Module in a sample of rheumatologic children in Italy. METHODS: The PedsQL 4.0 and the PedsQL 3.0 were administered to rheumatic and healthy children. 102 children 5-18 years old and 132 parents of children 2-18 years old were tested. Additionally, the Child Health Questionnaire - Parent Form 50 - was administered to the rheumatologic sample. RESULTS: Internal consistency reliability for group comparisons reached the recommended coefficient alpha of 0.70 for PedsQL 4.0 and PedsQL 3.0. The inter-correlation between these last ones was highly significant. The correlation between the PedsQL 4.0 and the CHQ was statistically significant. CONCLUSION: The Italian version of the PedsQL 4.0 and PedsQL 3.0 Rheumatology Module demonstrate acceptable reliability and validity for both patient self-report and parent proxy-report.

Religious coping and problem-solving by couples faced with prostate cancer.

Religion can be an important resource for people struggling with chronic illness. Problem-solving skills have also been shown to be helpful. This study examined whether turning to religion as a coping resource would be associated with better problem-solving in couples trying to manage challenges associated with prostate cancer. The sample was 101 patients with prostate cancer and their wives. Wives completed the Social Problem-Solving Inventory--Revised at baseline (T1) and 10 weeks later (T2). Patients and their wives also completed a measure that included items on religious coping. These items were used to classify couples into four groups based on whether one or both members engaged in religious coping: (1) husband only, (2) wife only, (3) both husband and wife, and (4) neither husband nor wife. From T1 to T2, wives who used religious coping along with their husbands (group 3) showed a significantly greater reduction in dysfunctional problem-solving (specifically, on impulsive/careless problem-solving) in comparison with wives who used religious coping while their husbands did not (group 2). Findings suggest that when couples share in turning to religion as a source of coping, this may be associated with improved problem-solving, but sole engagement in religious coping by wives may be associated with worse problem-solving.

Validation of the German version of the Pediatric Quality of Life Inventory (PedsQL) in childhood cancer patients off treatment and children with epilepsy.

The Pediatric Quality of Life Inventory (PedsQL) is a relatively new instrument developed in the US to assess health-related quality of life (HRQL) in healthy and ill children and adolescents. It is quick and easy to use, suitable for assessment by children and parents and based on a modular approach with a generic measure addressing all general domains of HRQL and disease-specific modules. We report here the results of translating the original US generic core instrument and the cancer module into German and testing the German PedsQL in samples of paediatric patients who have been treated for cancer or epilepsy. Like in studies with the original instrument, score distributions tended to be skewed toward higher HRQL, but a full response range was demonstrated for each item. The German PedsQL is reliable in terms of internal consistency with the majority of scales exceeding a Cronbach's alpha of 0.70. Clinical validity was confirmed by differences between the cancer and epilepsy groups in the expected direction and by the ability of the PedsQL to discriminate between subjects with different degrees of medical and psychosocial sequelae. Comparing our findings to US results, the German PedsQL seems to be equivalent to the original version. Future methodologic research should evaluate construct validity, sensitivity and responsiveness, and test the usefulness of the instrument in other clinical populations and healthy children.

Measuring quality of life in children referred for psychiatric problems: psychometric properties of the PedsQL 4.0 generic core scales.

OBJECTIVE: The aim of this study was to assess the psychometric properties of the Dutch translation of the Pediatric Quality of Life Inventory (PedsQL 4.0) generic core scales and assess its usefulness in measuring quality of life (QoL) in a child psychiatric population. METHODS: Reliability and validity of the PedsQL were assessed in 310 referred children (ages 6-18 years) and a comparison group consisting of 74 non-referred children (ages 7-18 years), and the parents in both groups. RESULTS: Confirmatory factor analysis resulted in a four-factor solution. Internal consistency reliability for the PedsQL Total Scale Score (alpha = 0.84 child self-report, alpha = 0.87 parent proxy-report), Psychosocial Health Score (alpha = 0.70 child self-report, alpha = 0.81 parent proxy-report), and most subscale scores were acceptable for group comparisons. Correlations between scores of fathers and mothers were large. Criterion-related validity was demonstrated by significantly lower PedsQL scores for referred vs. non-referred children. Significant correlations between PedsQL scales and measures of psychopathology showed convergent validity. Small correlations between PedsQL scales and intelligence of the child evidenced discriminant validity. CONCLUSION: The PedsQL seems a valid instrument in measuring QoL in children referred for psychiatric problems.

The relationship between health-related quality of life, pain and coping strategies in juvenile idiopathic arthritis.

OBJECTIVES: To investigate the relationship between health-related quality of life (HRQL), experience of pain and pain coping strategies in children with juvenile idiopathic arthritis (JIA). To compare reports describing these variables obtained from children and their parents. METHODS: Participants were 59 children aged 8 to 18 yr with JIA and their parents. Parents and children completed the PedsQL generic core scales and arthritis module, the visual analogue scale of the Varni-Thompson Pediatric Pain Questionnaire, and the Waldron/Varni Pediatric Pain Coping Inventory. Parents rated children's functional disability using the Childhood Health Assessment Questionnaire. RESULTS: Parents reported significantly lower scores (indicating worse HRQL) than children on five of the eight PedsQL scales rating children's HRQL. Parents and children reported a significant negative relationship between pain levels and the PedsQL scores assessing children's physical, emotional and social functioning. They also reported a significant negative relationship between scores on several pain coping scales and scores on the PedsQL scales. However, the pattern of these relationships varied for reports from parents and children. CONCLUSIONS: Pain intensity and pain coping strategies have a significant and independent relationship with several domains that comprise the HRQL of children with JIA. However, parents and children have differing perceptions of the nature of these relationships. The differences emphasize the importance of clinicians obtaining information about children's HRQL, pain levels and pain coping strategies from both parents and children.

Parents' Perceptions of Primary Care: measuring parents' experiences of pediatric primary care quality.

OBJECTIVE: A measure of pediatric primary care quality that is brief, practical, reliable, and valid would be useful to patients and pediatricians, policymakers, and health system leaders. Parents have a unique perspective from which to report their experiences with their child's primary care, and these reports may be valid indicators of pediatric primary care quality. The research objective was to develop a brief parent report of their children's primary care, the Parent's Perceptions of Primary Care measure (P3C), and to test its reliability and validity as a measure of pediatric primary care quality. STUDY DESIGN: The P3C was based on the elements of primary care as defined by the Institute of Medicine. Pretesting of domain content and item clarity was accomplished via focus interviews. The P3C was developed in English and translated to Spanish, Vietnamese, and Tagalog. The 23-item P3C yields a total score, as well as subscale scores for continuity, access, contextual knowledge, communication, comprehensiveness, and coordination. The P3C was administered to 3371 parents of children in kindergarten through sixth grades in a large, urban school district. PRINCIPAL FINDINGS: The percentage of missing values for the overall sample was 1.88%, indicating acceptable feasibility. Range of measurement, assessed via floor and ceiling effects, was moderate to good. Cronbach's coefficient alpha, an indicator of scale internal consistency reliability, was 0.95 for the P3C total scale. Factor analysis supported the subscale structure, and P3C scores were higher for children with health insurance, whose parents completed the survey in English, and who had a regular physician. P3C scores were positively related to parent reports of the child's health-related quality of life. CONCLUSIONS: The P3C is a practical, reliable, and valid measure of parents' reports of pediatric primary care quality. This brief measure could be used alone, or in conjunction with other measures, to enhance outcomes and evaluate the impact of systems changes on the delivery of the main elements of primary care.

PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations.

BACKGROUND: The PedsQL (Pediatric Quality of Life Inventory) (Children's Hospital and Health Center, San Diego, California) is a modular instrument for measuring health-related quality of life (HRQOL) in children and adolescents ages 2 to 18. The PedsQL 4.0 Generic Core Scales are multidimensional child self-report and parent proxy-report scales developed as the generic core measure to be integrated with the PedsQL Disease-Specific Modules. The PedsQL 4.0 Generic Core Scales consist of 23 items applicable for healthy school and community populations, as well as pediatric populations with acute and chronic health conditions. METHODS: The 4 PedsQL 4.0 Generic Core Scales (Physical, Emotional, Social, School) were administered to 963 children and 1,629 parents (1,677 subjects accrued overall) recruited from pediatric health care settings. Item-level and scale-level measurement properties were computed. RESULTS: Internal consistency reliability for the Total Scale Score (alpha = 0.88 child, 0.90 parent report), Physical Health Summary Score (alpha = 0.80 child, 0.88 parent), and Psychosocial Health Summary Score (alpha = 0.83 child, 0.86 parent) were acceptable for group comparisons. Validity was demonstrated using the known-groups method, correlations with indicators of morbidity and illness burden, and factor analysis. The PedsQL distinguished between healthy children and pediatric patients with acute or chronic health conditions, was related to indicators of morbidity and illness burden, and displayed a factor-derived solution largely consistent with the a priori conceptually-derived scales. CONCLUSION: The results demonstrate the reliability and validity of the PedsQL 4.0 Generic Core Scales. The PedsQL 4.0 Generic Core Scales may be applicable in clinical trials, research, clinical practice, school health settings, and community populations.

Measuring quality of care for vulnerable children: challenges and conceptualization of a pediatric outcome measure of quality.

This article addresses conceptual and practical issues in the assessment of pediatric health care quality, outlines a conceptual model for measuring quality, and describes ongoing research to validate an outcome measure of health care quality for vulnerable children. Pediatric quality measurement is distinct from that for adults due to development, dependence, differential epidemiology, demographic factors, and differences between the child and adult health services systems. A noncategorical approach to quality measurement, rather than one based on illness status or specific condition, is necessary to adequately measure quality for the majority of children, both healthy and ill. One promising noncategorical measure of pediatric health care quality is health outcome, specifically health-related quality of life (HRQOL). The Pediatric Quality of Life Inventory (PedsQL), a brief, practical, reliable, valid, generic pediatric HRQOL measure, is a suitable candidate measure. Ongoing research to validate the PedsQL as an outcome measure of health care quality is described.

The Pediatric Cancer Quality of Life Inventory-32 (PCQL-32). II. Feasibility and range of measurement.

The Pediatric Cancer Quality of Life Inventory-32 (PCQL-32) has been developed to be a standardized assessment instrument to assess systematically pediatric cancer patient's health-related quality of life (HRQOL) outcomes. Multidimensional serial measurement of pediatric cancer patients' HRQOL in Phase III randomized controlled clinical trials is increasingly being recognized as an essential component in evaluating the comprehensive health outcomes of modern antineoplastic treatment protocols. The 32-item PCQL-32 short form was empirically derived from the PCQL long form (84-87 items), which was administered to 291 pediatric cancer patients and their parents during various stages of treatment. The feasibility (percentage of missing values per item) and range of measurement [percentage of minimum (floor effect) and maximum (ceiling effect) possible scores] was calculated for the five PCQL-32 scales and the total scale score. Feasibility for the PCQL-32 was very good, with less than .01% missing values. Range of measurement was full, with no ceiling effects (higher symptoms/problems) and low to moderate floor effects (lower symptoms/problems). The PCQL-32 demonstrated very good feasibility and range of measurement. In its short form, the PCQL-32 is practical for Phase III clinical trials. Future studies will test the utility of the PCQL-32 as a brief serial measure for monitoring the HRQOL outcomes for children and adolescents with cancer.

Toddlers with limb deficiency: conceptual basis and initial application of a functional status outcome measure.

OBJECTIVE: To describe the conceptual foundation, development, and initial psychometric analyses of a new outcome measure of functional status in toddlers with limb deficiency. DESIGN: Parents of children with limb deficiency completed self-report measures during a routine medical clinic visit. SETTING: Outpatient orthopedic pediatric clinic. PARTICIPANTS: Twenty parents (mothers) of children (ages 1 to 4 years) with acquired or congenital limb deficiency. MAIN OUTCOME MEASURE: The newly developed Child Amputee Prosthetics Project-Functional Status Inventory for Toddlers (CAPP-FSIT). RESULTS: Estimates of internal consistency reliability of the measure are high, suggesting conceptual congruence among the items. Initial validity studies confirm the CAPP-FSIT differentiates between toddlers with upper limb deficiency and lower limb deficiency in terms of functional activity and prosthesis use. The new measure does not appear to be contaminated by gender or socioeconomic status. CONCLUSION: The CAPP-FSIT is a promising measure for assessing functional abilities in toddlers with limb deficiency.

The PedsQL: measurement model for the pediatric quality of life inventory.

BACKGROUND: Pediatric patients' self-report of health-related quality of life (HRQOL) has emerged as an important patient-based health outcome. A practical, validated generic measure of HRQOL facilitates assessing risk, tracking health status, and measuring treatment outcomes in pediatric populations. METHODS: The PedsQL is a brief, standardized, generic assessment instrument that systematically assesses patients' and parents' perceptions of HRQOL in pediatric patients with chronic health conditions using pediatric cancer as an exemplary model. The PedsQL is based on a modular approach to measuring HRQOL and consists of a 15-item core measure of global HRQOL and eight supplemental modules assessing specific symptom or treatment domains. The PedsQL was empirically derived from data collected from 291 pediatric cancer patients and their parents at various stages of treatment. RESULTS: Both reliability and validity were determined. Cronbach's alpha coefficients for the core measure (alpha = .83 for patient and alpha = .86 for parent) were acceptable for group comparisons. Alphas for the patient self-report modules generally ranged from .70 to .89. Discriminant or clinical validity, using the known-groups approach, was demonstrated for patients on- versus off-treatments. The 11 scales showed small-to-medium positive intercorrelations, supporting the multidimensional measurement model. Further construct validity was demonstrated via a multimethod-multitrait matrix using standardized psychosocial questionnaires. CONCLUSION: The results support the PedsQL as a reliable and valid measure of HRQOL. The PedsQL core and modular design makes it flexible enough to be used in a variety of research and clinical applications for pediatric chronic health conditions.

The Pediatric Cancer Quality of Life Inventory: a modular approach to measuring health-related quality of life in children with cancer.

Measurement of pediatric cancer patients' health-related quality of life (HRQL) in phase III randomized, controlled clinical trials is being recognized increasingly as an essential component in evaluating the comprehensive health outcomes of modern anti-neoplastic treatment protocols. Use of a brief core measure of HRQL plus disease-specific symptom modules is a way to assess specific HRQL outcomes with a minimum of subject burden. Demonstrating a measure's feasibility, reliability and validity also represents children's ability to provide reliable and valid responses to HRQL questions. The Pediatric Cancer Quality of Life Inventory (PCQL) Modular Approach consists of a 15-item core measure of HRQL and 2 specific symptom modules: pain and nausea. To validate a patient-report form and a parent-report form, the PCQL was administered to 291 pediatric cancer patients and to their parents. Feasibility and range of measurement, as well as patient-parent concordance, were assessed. Internal consistency reliability was assessed via Cronbach's alpha. Validity was determined by the known-groups approach and by correlating PCQL scores with days missed from school. Patients had minimal missing data, and the range of measurement for the items was good. Patient-parent concordance was large but not perfect. For both patient and parent forms, internal consistency reliability of the PCQL core scale (0.83 and 0. 86, respectively) was strong. The internal consistency reliabilities of the 2 symptom modules for both patient and parent forms were in the acceptable range for group comparisons. Regarding clinical validity, the core scale and the 2 symptom modules distinguished between patients on and off treatment for both patient and parent reports. Further, both patient and parent reports correlated with days of missed school in the past 6 and 12 months. The PCQL Modular Approach has demonstrated acceptable internal consistency reliability and clinical validity for both patient-report and parent-report forms. By implication, children are capable of providing reliable and valid responses to these HRQL questions.

The Pediatric Cancer Quality of Life Inventory (PCQL). I. Instrument development, descriptive statistics, and cross-informant variance.

Intensive antineoplastic treatment protocols have been developed and implemented in controlled clinical trials with the goal of improving the survival of pediatric cancer patients. Multidimensional health outcome evaluation of this cohort of pediatric cancer patients being treated with these modern regimens is essential in order to enhance health-related quality of life. The Pediatric Cancer Quality of Life Inventory (PCQL) was developed to be a standardized assessment instrument to assess systematically pediatric cancer patient's health-related quality of life outcomes. The PCQL was administered to 291 pediatric cancer patients and their parents at various stages of treatment. The aim of the present study was to present the development, descriptive statistics, and cross-informant variance for the PCQL items. Large variability in symptoms and health-related problems were found as expected given the wide heterogeneity in the patient population sampled. Patient/parent concordance on individual items averaged in the medium effect size range. The findings underscore the importance of measuring both patient report and parent report of patient symptoms and problems in pediatric cancer health-related quality of life assessment.