Health-related quality of life (HRQOL) has been recognized as an important health outcome measurement for pediatric patients. One of the most promising instruments in measuring pediatric HRQOL emerged in recent years is the Pediatric Quality of Life Inventory (PedsQL™). The PedsQL™ 3.0 Asthma Module, one of the PedsQL™disease-specific scales, was designed to measure HRQOL dimensions specifically tailored for pediatric asthma. The present study is aimed to evaluate the psychometric properties of the Chinese version of the PedsQL™ 3.0 Asthma Module.
The PedsQL™ 3.0 Asthma Module was translated into Chinese following the PedsQL™ Measurement Model Translation Methodology. The Chinese version scale was administered to 204 children with asthma and 337 parents of children with asthma from four Triple A hospitals. The psychometric properties were then evaluated.
The percentage of missing value for each item of the scale ranged from 0.00% to 8.31%. All child self-report subscales and parent proxy-report subscales approached or exceeded the minimum reliability standard of 0.70 for alpha coefficient, except 3 subscales of Young Child (aged 5-7) self-report (alphas ranging from 0.59 to 0.68). Test-retest reliability was satisfactory with intraclass correlation coefficients (ICCs) which exceeded the recommended standard of 0.80 in all subscales. Correlation coefficients between items and their hypothesized subscales were higher than those with other subscales. The PedsQL™ 3.0 Asthma Module distinguished between outpatients and inpatients. Patients with mild asthma reported higher scores than those with moderate/severe asthma in majority of subscales. The intercorrelations among the PedsQL™ 3.0 Asthma Module subscales and the PedsQL™ 4.0 Generic Core Scales were in medium to large effect size. The child self-report scores were consistent with the parent proxy-report scores.
The Chinese version of the PedsQL™ 3.0 Asthma Module has acceptable psychometric properties, except the internal consistency reliability for Young Child (aged 5-7) self-report. Further studies should be focused on testing responsiveness of the Chinese version scale in longitudinal studies, evaluating the reliability and validity of the scale for the patients with severe asthma or teens independently, and assessing HRQOL of children with asthma in other areas.
Asthma; Children; Health-related quality of life; Reliability; Validity; PedsQL
Previous pediatric studies have observed a cross-informant variance in patient self-reported health-related quality of life (HRQoL) versus parent proxy-reported HRQoL. This study assessed in older children and adolescents with a variety of chronic pain conditions: 1) the consistency and agreement between pediatric patients’ self-report and their parents’ proxy-report of their child’s HRQoL; 2) whether this patient-parent agreement is dependent on additional demographic and clinical factors; and 3) the relationship between pediatric patient HRQoL and parental reported HRQoL.
The 99 enrolled patients (mean age 13.2 years, 71% female, 81% Caucasian) and an accompanying parent completed the PedsQLTM 4.0 and 36-Item Short-Form Health Survey Version 2 (SF-36v2) at the time of their initial appointment in a pediatric chronic pain medicine clinic. Patients’ and parents’ total, physical, and psychosocial HRQoL scores were analyzed via an intra-class correlation coefficient, Spearman’s correlation coefficient, Wilcoxon signed rank test, and Bland-Altman plot. A multivariable linear regression model was used to evaluate the association between clinical and demographic variables and the difference in patient and proxy scores for the Total Scale Score on the PedsQL™.
With the exception of the psychosocial health domain, there were no statistically significant differences between pediatric patients’ self-report and their parents’ proxy-report of their child’s HRQoL. However, clinically significant patient-parent variation in pediatric HRQoL was observed. Differences in patient-parent proxy PedsQL™ Total Scale Score Scores were not significantly associated with patient age, gender, race, intensity and duration of patient’s pain, household income, parental marital status, and the parent’s own HRQoL on the SF-36v2. No significant relationship existed among patients’ self-reported HRQoL (PedsQL™), parental proxy-reports of the child’s HRQoL, and parents’ own self-reported HRQoL on the SF-36v2.
We observed clinically significant variation between pediatric chronic pain patients’ self-reports and their parents’ proxy-reports of their child’s HRQoL. While whenever possible the pediatric chronic pain patient’s own perspective should be directly solicited, equal attention and merit should be given to the parent’s proxy-report of HRQoL. To do otherwise will obviate the opportunity to use any discordance as the basis for a therapeutic discussion about the contributing dynamic with in parent-child dyad.
Health-related quality of life; Chronic pain; Pediatric; Children; Adolescents; Proxy-report; Child-parent agreement
To compare 2 health-related quality of life (HRQOL) instruments: the condition-specific intermittent exotropia questionnaire (IXTQ) and the generic Pediatric Quality of Life Inventory (PedsQL) questionnaire in children with intermittent exotropia.
Fifty-one children with intermittent exotropia (median, 7; range, 5–16 years) were recruited from outpatient clinics with one of their parents. All children completed age-appropriate Child IXTQ (12 items) and Child PedsQL (23 items). Parents completed parallel Proxy IXTQ and Proxy PedsQL questionnaires (parent assessment of child’s HRQOL). Possible scores ranged from 0 to 100 (worst to best HRQOL). Normal thresholds were defined using the 5th percentile in a control group of 47 normal non-strabismic children. Proportions scoring below normal on each questionnaire were compared. Median scores in intermittent exotropia and control groups were also compared.
More scores were subnormal using Proxy IXTQ than Proxy PedsQL (55% vs 18%, p = 0.0004). Using Child questionnaires, similar proportions scored below normal (IXTQ 8% vs PedsQL 14%, p = 0.3). Median scores were lower for intermittent exotropia children compared to controls using Child IXTQ (83 vs 92; p = 0.04), Proxy IXTQ (81 vs 98; p < 0.0001), and Proxy PedsQL (p = 0.04), but not using Child PedsQL (p = 0.3).
The Proxy IXTQ detects reduced HRQOL related to intermittent exotropia more often than the Proxy PedsQL. There were few subnormal scores on Child IXTQ and Child PedsQL. Children with intermittent exotropia scored, on average, lower than controls using the IXTQ, but most individual scores fell within the normal range. The IXTQ may prove useful for clinical assessment of intermittent exotropia.
To investigate whether spectacle wear in children affects responses on the Intermittent Exotropia Questionnaire (IXTQ) or the Pediatric Quality of Life Inventory (PedsQL).
We recruited 49 children, median age 8 years (range, 5–13), presenting with visual acuity 20/40 or better and an otherwise normal eye examination (no strabismus), who either had no refractive error (n = 29) or had refractive error corrected with spectacles (n = 20). The IXTQ and PedsQL were completed, each comprising a child report (Child IXTQ, Child PedsQL) and a parent proxy report (Proxy IXTQ, Proxy PedsQL). In addition, the IXTQ contains a parent self-report (Parent IXTQ). Each questionnaire is scored from 0 (worst health-related quality of life [HRQOL]) to 100 (best HRQOL). Median scores were compared using Wilcoxon rank-sum tests.
Child IXTQ and Proxy IXTQ scores were similar between groups; nevertheless, Parent IXTQ scores were lower for spectacle wearers (90.4 vs 97.1, p = 0.01). Parent IXTQ questions that scored lower in the spectacle group were related to parental worry about permanent damage to their child’s eyes, longterm eyesight, surgery, self-consciousness, and teasing. The PedsQL composite scores and all subscale scores were similar between spectacle wearers and nonspectacle wearers, both for Child PedsQL and Proxy PedsQL.
Parental HRQOL, measured using the Parent IXTQ, was lower for children wearing spectacles than for children who did not wear spectacles. There was no difference between spectacle and no-spectacle groups using either Child IXTQ, Proxy IXTQ, Child PedsQL, or Proxy PedsQL.
The Pediatric Quality of Life Inventory (PedsQL) is widely used instrument to measure pediatric health-related quality of life (HRQOL) for children aged 2 to 18 years. The purpose of the current study was to investigate the feasibility, reliability and validity of the Chinese mandarin version of the PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module in a group of Chinese children with cancer.
The PedsQL 4.0 Genetic Core Scales and the PedsQL 3.0 Cancer Module were administered to children with cancer (aged 5-18 years) and parents of such children (aged 2-18 years). For comparison, a survey on a demographically group-matched sample of the general population with children (aged 5-18) and parents of children (aged 2-18 years) was conducted with the PedsQL 4.0 Genetic Core Scales.
The minimal mean percentage of missing item responses (except the School Functioning scale) supported the feasibility of the PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module for Chinese children with cancer. Most of the scales showed satisfactory reliability with Cronbach's α of exceeding 0.70, and all scales demonstrated sufficient test-retest reliability. Assessing the clinical validity of the questionnaires, statistically significant difference was found between healthy children and children with cancer, and between children on-treatment versus off-treatment ≥12 months. Positive significant correlations were observed between the scores of the PedsQL 4.0 Generic Core Scale and the PedsQL 3.0 Cancer Module. Exploratory factor analysis demonstrated sufficient factorial validity. Moderate to good agreement was found between child self- and parent proxy-reports.
The findings support the feasibility, reliability and validity of the Chinese Mandarin version of PedsQL 4.0 Generic Core Scales and 3.0 Cancer Module in children with cancer living in mainland China.
Pediatric Quality of Life Inventory (PedsQL) is a measure to assess health-related quality of life (HRQoL) in children and adolescents. It is formed by 23 items adapted to children age and includes a parent proxy report version. With four multidimensional subscales and three summary scores, it measures health as defined by WHO. The concepts measured by this instrument are ‘physical functioning’ (8 items), ‘emotional functioning’ (5 items), ‘social functioning’ (5 items) and ‘school functioning’ (5 items). It also measures a ‘total scale score’ (23 items), a ‘physical health summary score’ (8 items) and a ‘psychosocial health summary score’ (15 items). The aim of this paper is to present the main results of the cultural adaptation and validation of the PedsQL into European Portuguese.
The Portuguese version was the result of a forward-backward translation process, with a cognitive debriefing analysis, guaranteeing face validity and semantic equivalence. Children aged 5–7 and 8–12 were randomly selected and were asked to fill a socio-demographic data survey and the Portuguese versions of PedsQL and KINDL, another HRQoL measure for children and adolescents. They were divided into three groups, healthy children, children with type I diabetes and children with spina bifida.
The reliability was tested for reproducibility (ICC) and internal consistency (Cronbach’s alpha). The construct validity (known-groups discriminant validity) was supported by differences between self-reports from healthy children and children with chronic conditions, and from children with chronic diseases and their parents. The criterion validity was tested after the correlations of the scores obtained by both children and adolescents HRQoL assessment instruments.
A total of 179 children and 97 parents were recruited. PedsQL demonstrated good levels of reproducibility (r > 0.95 in all versions) and acceptable levels of internal consistency with Cronbach’s alpha at 0.70 on most scales. Concordance values between children’s and parents’ perceptions ranged between 0.36 and 0.78 and the correlations with KINDL questionnaire were excellent, supporting concurrent validity.
The Portuguese version of the PedsQL demonstrated acceptable psychometric properties for future research and clinical practice for children aged 5–12.
PedsQL; Children; Chronic illness; Health-related quality of life; Pediatrics
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.
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.
Internal consistency reliability was demonstrated for the PedsQL™ Family Impact Module Total Scale Score (α = 0.97), Parent HRQOL Summary Score (α = 0.96), Family Functioning Summary Score (α = 0.90), and Module Scales (average α = 0.90, range = 0.82 – 0.97). The PedsQL™ Family Impact Module distinguished between families with children in a long-term care facility and families whose children resided at home.
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.
health-related quality of life; family; pediatrics; children; PedsQL™
The aim of the study was to investigate the psychometric properties of the Hungarian version of the Pediatric Quality of Life Inventory™ (PedsQL™) Generic Core Scales and Cardiac Module.
The PedsQL™ 4.0 Generic Core Scales and the PedsQL™ 3.0 Cardiac Module was administered to 254 caregivers of children (aged 2-18 years) and to 195 children (aged 5-18 years) at a pediatric cardiology outpatient unit. A postal survey on a demographically group-matched sample of the general population with 525 caregivers of children (aged 2-18 years) and 373 children (aged 5-18 years) was conducted with the PedsQL™ 4.0 Generic Core Scale. Responses were described, compared over subgroups of subjects, and were used to assess practical utility, distributional coverage, construct validity, internal consistency, and inter-reporter agreement of the instrument.
The moderate scale-level mean percentage of missing item responses (range 1.8-2.3%) supported the feasibility of the Generic Core Scales for general Hungarian children. Minimal to moderate ceiling effects and no floor effects were found on the Generic Core Scales. We observed stronger ceiling than floor effects in the Cardiac Module. Most of the scales showed satisfactory reliability with Cronbach's α estimates exceeding 0.70. Generally, moderate to good agreement was found between self- and parent proxy-reports in the patient and in the comparison group (intraclass correlation coefficient range 0.52-0.77), but remarkably low agreement in the perceived physical appearance subscale in the age group 5-7 years (0.18) and for the treatment II scale (problems on taking heart medicine) scale of the Cardiac Module in children aged 8-12 years (0.39). Assessing the construct validity of the questionnaires, statistically significant difference was found between the patient group and the comparison group only in the Physical Functioning Scale scores (p = 0.003) of the child self-report component, and in Physical (p = 0.022), Emotional, (p = 0.017), Psychosocial Summary (p = 0.019) scores and in the total HRQoL (health-related quality of life) scale score (p = 0.034) for parent proxy-report.
The findings generally support the feasibility, reliability and validity of the Hungarian translation of the PedsQL™ 4.0 Generic Core Scales and the PedsQL™ 3.0 Cardiac Module in Hungarian children with heart disease.
Schistosomiasis remains a global public health challenge, with 93% of the ∼237 million infections occurring in sub-Saharan Africa. Though rarely fatal, its recurring nature makes it a lifetime disorder with significant chronic health burdens. Much of its negative health impact is due to non-specific conditions such as anemia, undernutrition, pain, exercise intolerance, poor school performance, and decreased work capacity. This makes it difficult to estimate the disease burden specific to schistosomiasis using the standard DALY metric.
In our study, we used Pediatric Quality of Life Inventory (PedsQL), a modular instrument available for ages 2–18 years, to assess health-related quality of life (HrQoL) among children living in a Schistosoma haematobium-endemic area in coastal Kenya. The PedsQL questionnaires were administered by interview to children aged 5–18 years (and their parents) in five villages spread across three districts. HrQoL (total score) was significantly lower in villages with high prevalence of S. haematobium (−4.0%, p<0.001) and among the lower socioeconomic quartiles (−2.0%, p<0.05). A greater effect was seen in the psychosocial scales as compared to the physical function scale. In moderate prevalence villages, detection of any parasite eggs in the urine was associated with a significant 2.1% (p<0.05) reduction in total score. The PedsQL reliabilities were generally high (Cronbach alphas ≥0.70), floor effects were acceptable, and identification of children from low socioeconomic standing was valid.
We conclude that exposure to urogenital schistosomiasis is associated with a 2–4% reduction in HrQoL. Further research is warranted to determine the reproducibility and responsiveness properties of QoL testing in relation to schistosomiasis. We anticipate that a case definition based on more sensitive parasitological diagnosis among younger children will better define the immediate and long-term HrQoL impact of Schistosoma infection.
Because urogenital schistosomiasis is a multi-decadal chronic disease that begins in early childhood, and because it is a disease that may affect nearly everyone in endemic communities, its impact on personal health-related quality of life (HrQoL) has been difficult to gauge accurately. In order to provide a more precise estimate of schistosomiasis' impact on overall health status, we used a standardized questionnaire, the PedsQL SF15 Inventory, to interview children, aged 5–18 years, and their parents, to quantify their reported physical, social, emotional, and scholastic performance status. Scores were significantly lower in villages having high Schistosoma prevalence, as compared those having moderate prevalence. In adjusting for age, sex, socioeconomic standing, undernutrition, anemia, and hookworm parasites, we found that relative poverty, stunting, wasting, and S. haematobium infection were significant correlates of HrQoL scores, with differential effects in high- and moderate-prevalence communities. The greatest differences were noted in the psychosocial domains of performance. We conclude that exposure to urogenital schistosomiasis has an overall detrimental effect on HrQoL at a level of 2–4% impairment. New implementation of better diagnostics for children is expected to refine our estimates of this association, as will follow-up studies of HrQoL following effective individual and community deworming.
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.
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.
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 (α = 0.88 patient self-report, 0.87 parent proxy-report), the Multidimensional Fatigue Scale Total Scale Score (α = 0.94 patient self-report, 0.94 parent proxy-report), and acceptable reliability for the 4-item Rheumatology Module Pain and Hurt Scale (α = 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.
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.
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.
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%).
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.
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 Pediatric Quality of Life Inventory™ (PedsQL™) is a child self-report and parent proxy-report instrument designed to assess health-related quality of life (HRQOL) in healthy and ill children and adolescents. It has been translated into over 70 international languages and proposed as a valid and reliable pediatric HRQOL measure. This study aimed to assess the psychometric properties of the Korean translation of the PedsQL™ 4.0 Generic Core Scales.
Following the guidelines for linguistic validation, the original US English scales were translated into Korean and cognitive interviews were administered. The field testing responses of 1425 school children and adolescents and 1431 parents to the Korean version of PedsQL™ 4.0 Generic Core Scales were analyzed utilizing confirmatory factor analysis and the Rasch model.
Consistent with studies using the US English instrument and other translation studies, score distributions were skewed toward higher HRQOL in a predominantly healthy population. Confirmatory factor analysis supported a four-factor and a second order-factor model. The analysis using the Rasch model showed that person reliabilities are low, item reliabilities are high, and the majority of items fit the model's expectation. The Rasch rating scale diagnostics showed that PedsQL™ 4.0 Generic Core Scales in general have the optimal number of response categories, but category 4 (almost always a problem) is somewhat problematic for the healthy school sample. The agreements between child self-report and parent proxy-report were moderate.
The results demonstrate the feasibility, validity, item reliability, item fit, and agreement between child self-report and parent proxy-report of the Korean version of PedsQL™ 4.0 Generic Core Scales for school population health research in Korea. However, the utilization of the Korean version of the PedsQL™ 4.0 Generic Core Scales for healthy school populations needs to consider low person reliability, ceiling effects and cultural differences, and further validation studies on Korean clinical samples are required.
To assess health-related quality of life (HRQOL) in children and adolescents with sickle cell disease (SCD).
Design, Setting, and Participants
The PedsQL™ 4.0 Generic Scales, a multidimensional self-report instrument that has been shown to be valid and reliable for use in children and adolescents with chronic illness, consists of 23 items that assess physical, emotional, social, and school functioning. Questionnaires were administered to 124 children and adolescents (aged 8-18 years, child self-report) with SCD (100 sickle cell anemia [SS], 24 sickle beta zero thalassemia [Sβ0thal]) and their parents (parent-proxy report). Summary scores for children’s and parents’ ratings of overall HRQOL and psychosocial health and subscale scores for physical, emotional, social, and school functioning were compared to published data for healthy children. Both summary and subscale scores for children with SCD were also compared to those of their parents.
Children with SCD and their parents rated overall HRQOL and all sub-domains of HRQOL lower than ratings of healthy children and their parents (p < .001). Children with SCD rated their own HRQOL significantly better than their parents for overall HRQOL and all sub-domains (p <.001) except emotional functioning (p = .06).
Children with SCD and their parents perceived overall HRQOL and all HRQOL sub-domains to be lower than scores reported in healthy children. Therefore, successful therapeutic efforts to improve HRQOL could represent important advances in the health of children with SCD.
Quality of Life; Health Related Quality of Life; Sickle Cell Disease; Chronic Illness; Children and Adolescents
The aim of this study was to measure health related quality of life (HRQOL) in Iranian children with type 1 diabetes and to test the psychometric properties of the Persian version of the PedsQL™ 4.0 Generic Core Scales and the PedsQL™ 3.0 Diabetes Module.
Participants were 94 children and adolescents diagnosed with type 1 diabetes for at least 3 months in Shiraz, southern Iran. Convergent, discriminant, and construct validity of the PedsQL™ 4.0 Generic Core Scales and the PedsQL™ 3.0 Diabetes Module were assessed. Moreover, internal consistency was checked by Cronbach's alpha coefficient.
Cronbach's α for the PedsQL™ 4.0 Generic Core Scales and the PedsQL™ 3.0 Diabetes Module was greater than 0.80 both in the child self-report and parent proxy-report. Both generic and disease-specific versions of the PedsQL showed excellent convergent and acceptable discriminant validity except for 'diabetes symptoms' subscale in the child self-report of the disease-specific module. Moreover, Iranian children with diabetes, as compared with other countries, had lower HRQOL scores.
While this study showed that the Persian version of the PedsQL™ 4.0 Generic Core Scales has good psychometric properties in children with type 1 diabetes, the PedsQL™ 3.0 Diabetes Module needs some modifications to be used as a disease-specific quality of life (QOL) measure. Also, more support should be provided for the care of Iranian children with diabetes.
quality of life; diabetes; validation studies; Iran
Thalassemia is a common disorder worldwide with a predominant incidence in Mediterranean countries, North Africa, the Middle East, India, Central Asia, and Southeast Asia. Whilst substantial progress has been made towards the improvement of Health related quality of life (HRQoL) in western countries, scarce evidence-based data exists on HRQol of thalassemia children and adolescents living in developing countries.
We studied 60 thalassemia children from Middle Eastern countries with a median age of 10 years (range 5 to 17 years). HRQoL was assessed with the Pediatric Quality of Life Inventory (PedsQL) 4.0. The Questionnaire was completed at baseline by all patients and their parents. The agreement between child-self and parent-proxy HRQoL reports and the relationship between HRQoL profiles and socio-demographic and clinical factors were investigated.
The scores of parents were generally lower than those of their children for Emotional Functioning (mean 75 vs 85; p = 0.002), Psychosocial Health Summary (mean 70.3 vs 79.1; p = 0.015) and the Total Summary Score (mean 74.3 vs 77.7 p = 0.047). HRQoL was not associated with ferritin levels, hepatomegaly or frequency of transfusions or iron chelation therapy. Multivariate analysis showed that a delayed start of iron chelation had a negative impact on total PedsQL scores of both children (p = 0.046) and their parents (p = 0.007).
The PedsQL 4.0 is a useful tool for the measurement of HRQoL in pediatric thalassemia patients. This study shows that delayed start of iron chelation has a negative impact on children’s HRQoL.
Quality of life; Thalassemia; PEDsQL 4.0
Knowledge about psychometric properties of the Pediatric Quality of Life Inventory (PedsQL) in the Netherlands is limited and Dutch reference data are lacking. Aim of the current study is to collect Dutch reference data of the PedsQL and subsequently assess reliability, socio-demographic within-group differences and construct validity.
In this study the PedsQL was administered to Dutch children aged 5 to 18 years. A socio-demographic questionnaire was completed as well. The sample consisted of three age groups: 5-7 years (parent proxy report), 8-12 years and 13-18 years (child self report). Analysis was performed with SPSS 16.0.2. A reliability analysis was done using Cronbach's alpha coefficient. Socio-demographic within-group differences were assessed by means of an ANOVA with post hoc Bonferroni correction and t-tests. Subsequently, construct validity was determined by t-tests and effect sizes.
For 496 children PedsQL reference data were collected. PedsQL total scores were 84.18 (group 5-7), 82.11 (group 8-12) and 82.24 (group 13-18). Internal consistency coefficients ranged from .53 to .85. Socio-demographic within-group differences demonstrated that, in group 8-12, children of parents born in the Netherlands had significantly lower scores on several PedsQL subscales, compared to children of parents born in another country. With respect to construct validity, healthy children of group 5-7 and 13-18 scored significantly higher than children with a chronic health condition on all subscales, except for emotional functioning. In group 5-7, the PedsQL total score for healthy children was 85.31, whereas the same age group with a chronic health condition scored 78.80. Effect sizes in this group varied from 0.58 to 0.88. With respect to group 13-18, healthy children obtained a PedsQL total score of 83.14 and children suffering from a chronic health condition 77.09. Effect sizes in this group varied from 0.45 to 0.67. No significant differences were found in group 8-12 regarding health.
The Dutch version of the PedsQL has adequate psychometric properties and can be used as a health related quality of life instrument in paediatric research in the Netherlands.
A pediatric chronic health condition not only influences a child's life, but also has impacts on parent health-related quality of life (HRQOL) and family functioning. To provide care and social support to these families, a psychometrically well-developed instrument for measuring these impacts is of great importance. The present study is aimed to evaluate the psychometric properties of the Chinese version of the PedsQL™ Family Impact Module.
The cross-cultural adaptation of the PedsQL™ Family Impact Module was performed following the PedsQL™ Measurement Model Translation Methodology. The Chinese version of the PedsQL™ Family Impact Module was administered to 136 parents of children with asthma and 264 parents of children with heart disease from four Triple A hospitals. The psychometric properties such as feasibility, internal consistency reliability, item-subscale correlations and construct validity were evaluated.
The percentage of missing item responses was less than 0.1% for both asthma and heart disease sample groups. The Chinese version of the PedsQL™ Family Impact Module showed ceiling effects but had acceptable reliability (Cronbach's Alpha Coefficients were higher than 0.7 in all the subscales except "Daily Activities" in the asthma sample group). There were higher correlation coefficients between items and their hypothesized subscales than those with other subscales. The asthma sample group reported higher parent HRQOL and family functioning than the heart disease sample group. In the heart disease sample group, parents of outpatients reported higher parent HRQOL and family functioning than parents of inpatients. Confirmatory factor analysis showed that the instrument had marginally acceptable construct validity with some Goodness-of-Fit indices not reaching the standard indicating acceptable model fit.
The Chinese version of the PedsQL™ Family Impact Module has adequate psychometric properties and could be used to assess the impacts of pediatric asthma or pediatric heart disease on parent HRQOL and family functioning in China. This instrument should be field tested on parents of children with other chronic medical conditions in other areas. Construct validity tested by confirmatory factor analysis and test-retest reliability should be further assessed.
To assess the health-related quality of life (HRQOL) of parents of children with intermittent exotropia using the newly developed condition-specific Parent Intermittent Exotropia Questionnaire (Parent IXTQ) and the generic PedsQL Family Impact Module (PedsQL FIM) and to compare the performance of both instruments.
One parent was recruited for each of 59 children with intermittent exotropia (age range, 3 to 16; median, 7 years) and for each of 29 visually normal children (age range, 5 to 13; median, 8 years). The parent completed the Parent IXTQ and the PedsQL FIM. For each questionnaire, we compared median HRQOL scores between the intermittent exotropia group and visually normal group. We also calculated normal thresholds, which were defined as the 5th percentile score in the cohort of parents of visually normal children. The proportion of subnormal scores between questionnaires in parents of children with intermittent exotropia was compared.
The Parent IXTQ score was worse in the intermittent exotropia group than in the visually normal group (70.6 vs 94.1, p < 0.0001), whereas the PedsQL FIM scores were similar (97.9 vs 95.8, p = 0.8). More parents scored below normal using the Parent IXTQ than using the PedsQL FIM (31% vs 12%; p = 0.008, McNemar's test).
The Parent IXTQ detects subnormal HRQOL in parents of children with intermittent exotropia more often than the PedsQL FIM. It is possible that parental worry may influence management decisions in children with intermittent exotropia and therefore parental HRQOL is worthy of further study.
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.
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.
The PedsQL™ 4.0 evidenced minimal missing responses, achieved excellent reliability for the Total Scale Score (α = 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.
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.
Juvenile Idiopathic Arthritis (JIA) affects children and adolescents with both short-term and long-term disability. These children also report lower health-related quality of life (HRQOL) compared to their healthy peers. However, there seems to be some discrepancies between self- and parent-reports, and gender differences need to be further studied. This study aims to describe HRQOL in girls and boys with JIA, and to explore gender differences in self-reports compared to parent-reports of HRQOL in children with JIA.
Fifty-three children and adolescents with JIA (70% girls and 30% boys) with a median age of 14 years (8–18 years), and their parents, participated in this cross-sectional study in Sweden. Data was systematically collected prior to ordinary visits at a Pediatric outpatient clinic, during a period of 16 months (2009–2010). Disability was assessed with the Childhood Health Assessment Questionnaire (CHAQ), and disease activity by physicians’ assessments and Erythrocyte Sedimentation Rate (ESR). The Pediatric Quality of Life Inventory 4.0 Generic Core Scales (PedsQL) was used to assess self- and parent-reports of HRQOL in the child.
In this sample of children with generally low disease activity and mild to moderate disability, more than half of the children experienced suboptimal HRQOL, equally in girls and boys. Significant differences between self- and parent-reports of child HRQOL were most evident among girls, with lower parent-reports regarding the girl’s physical- and psychosocial health as well as in the total HRQOL score. Except for the social functioning subscale, where parents’ reports were higher compared to their sons, there were no significant differences between boys- and parent-reports.
More than half of the girls and boys experienced suboptimal HRQOL in this sample, with no gender differences. However, there were differences between self- and parent-reports of child HRQOL, with most significant differences found among the girls. Thus, differences between self- and parent-reports of child HRQOL must be taken into account in clinical settings, especially among girls with JIA.
Adolescent; Child; Gender; Parents; Pediatrics; Questionnaire
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.
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%).
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.
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.
Pediatric health-related quality of life (HRQOL) has emerged as an important health outcome in clinical trials and healthcare research, for which HRQOL assessment instruments have played an important role. However, these instruments are not available in all countries or all languages. The Pediatric Quality of Life Inventory™ (PedsQL™) Family Impact Module is a multidimensional instrument developed to assess the impact of chronic medical conditions on the HRQOL of parents and family functioning. The objective of the present study was to evaluate the psychometric properties of the PedsQL™ Family Impact Module cross-culturally adapted for use in Brazil.
The PedsQL™ Family Impact Module was administered to 95 parents/guardians of children with cancer in active therapy from 2 to 18 years of age of both genders. Subjects were recruited by means of convenience samples from the Pediatric Hematology/Oncology Centers at two public hospitals. The 'in-patient' sample was defined as individuals who were hospitalized for the administration of chemotherapy. The 'out-patient' sample was defined as individuals who were receiving chemotherapy and were not hospitalized.
Test-retest reliability exhibited correlation values ranging from 0.81 to 0.96 for all subscales. Internal consistency reliability was demonstrated for the PedsQL™ Family Impact Module: Total Scale Score (α = 0.89), Parent Health-Related Quality of Life Summary Score (α = 0.83) and Family Summary Score (α = 0.73). The Total Impact Score for the in-patient and out-patient samples was 67.60 and 56.43, respectively (p < 0.01). The construct validity demonstrated that the PedsQL™ Family Impact Module proved capable of distinguishing between families whose children/adolescents were hospitalized and families of children/adolescents who are being taken care of at home.
The Brazilian version of the PedsQL™ Family Impact Module was considered reliable and valid for assessing the impact of a chronic pediatric health condition on the HRQOL of parents and family functioning. The instrument should be field tested on other chronic pediatric illnesses.
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.
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.
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.
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.
Oral health; PedsQL; Quality of life; Validation; Child; Adolescent
The aim of this study was to explore the main influencing factors of the health related quality of life (HRQL) of children living in HIV/AIDS-affected families in rural areas in Yunnan, China. The HRQL of 116 children aged 8 to 17 from HIV/AIDS-affected families and of 109 children from unaffected families was evaluated by the Chinese Version of PedsQL TM 4.0. Some potential influencing factors were investigated, such as demographic characteristics, the families’ social and economic status, foster models, children’s self-esteem etc. The HRQL of the children’s caregivers may also have been among the influencing factors, as measured by the SF-36. Multiple regression analysis was used to explore the influence of independent variables on children’s HRQL. Results showed that lower scores of children’s self-esteem and caregivers’ SF 36 reduced the majority of the PedsQL domains. Results showed children from HIV/AIDS-affected families reported lower scores of HRQL than those from unaffected families, especially in the psychosocial functioning, emotional functioning and school functioning domains. Children living with grandparents reported higher PedsQL scores in psychosocial health, social functioning and school functioning. Disclosure of parental HIV/AIDS status reduced children’s PedsQL scores in emotional functioning and social functioning. Caregivers spending more hours accompanying the children appeared to increase the PedsQL scores in psychosocial health and school functioning. The findings indicate the child’s self-esteem, the caregiver’s perceived quality of life, the child’s foster pattern, the average hours of company provided by the caregiver, and whether the child was informed of the parent’s HIV/AIDS status are important factors influencing HRQL. Interventions aiming at these factors should be developed to improve the QL of children affected by HIV/AIDS.
Child; Quality of life; PedsQL; HIV/AIDS; Influencing factors
To compare the health related quality of life (HRQOL) of children with chronic kidney disease (CKD) to healthy children; to evaluate the association between CKD severity and HRQOL; to identity demographic, socioeconomic and health-status variables associated with impairment in HRQOL in children with mild to moderate CKD.
Patients and Methods
This is a cross-sectional assessment of HRQOL in children aged 2-16 with mild to moderate CKD using the Varni PedsQL™. Overall HRQOL and PedsQL domain means for parents and youth were compared to previously published norms using independent sample t-tests. Study participants were categorized according to kidney disease stage (measured by iohexol based glomerular filtration rate, iGFR) and group differences in HRQOL were evaluated using ANOVA and Cuzick trend tests. The association between hypothesized predictors of HRQOL and PedsQL scores was evaluated with linear and logistic regression analyses.
The study sample was comprised of 402 participants (Mean age =11 yrs, 60% male, 70% Caucasian, 40% anemic, median iGFR=42.5 ml/min/1.73m2, median CKD duration= 7 yrs). Youth with CKD had significantly lower physical, school, emotional and social domain scores than healthy youth (p<.001). IGFR was not associated with HRQOL. Longer disease duration and older age was associated with higher PedsQL scores in the domains of physical, emotional and social functioning (p<.05). Older age was associated with lower school functioning domain scores (p<.05). Maternal education ≥16 years was associated with higher PedsQL scores in the domains of physical, school, and social functioning (p<.05). Short stature was associated with lower scores in the physical functioning domain (p<.05).
Children with mild to moderate CKD, in comparison to healthy children, report poorer overall HRQOL as well as poorer physical, school, emotional and social functioning. Early intervention to improve linear growth and to address school functioning difficulties is recommended.
HRQOL; kidney disease; QOL; short-stature