PedsQLTM Generic Core Scales Research Articles

PedsQL™ Spinal Cord Injury Module: Reliability and Validity.

The objective was to report on the initial measurement properties of the Pediatric Quality of Life Inventory™ (PedsQL™) Spinal Cord Injury (SCI) Module in youth with SCI from the youth and parent perspectives. PedsQL™ SCI Module and PedsQL™ 4.0 Generic Core Scales SF15 were completed in a multisite national study by 166 youth ages 8 to 25 years and 128 parents of youth ages 5 to 23 years. Data from the PedsQL™ Generic Core Scales were compared with an age- and sex-matched healthy control sample. Factor analysis was conducted to determine the factor structure of the items. In addition to a Total Scale Score, nine unidimensional scales were derived measuring daily activities, mobility, bladder function, bowel function, pressure injury, pain interference, social participation, worry bladder bowel, and worry social. The PedsQL™ SCI Module evidenced excellent reliability for Total Scale Scores (youth self-report, α = 0.93; parent proxy-report, α = 0.93) and acceptable reliability for the nine individual scales (youth self-report, α = 0.71-0.83; parent proxy-report, α = 0.67-0.87). Intercorrelations with the Generic Core Scales supported construct validity with medium to large effect sizes (most ps < .001). Factor analysis supported the unidimensionality of the nine individual scales. PedsQL™ Generic Core Scales comparisons to healthy controls demonstrated significantly impaired generic health-related quality of life in youth with SCI with large effect sizes. The PedsQL™ SCI Module Scales demonstrated acceptable measurement properties and may be utilized as standardized scales to assess SCI-specific concerns and problems in clinical research and practice in youth with SCI.

Mapping PedsQL™ Generic Core Scales to EQ-5D-3L utility scores in transfusion-dependent thalassemia patients.

To develop a mapping algorithm for generating EQ-5D-3L utility scores from the PedsQL Generic Core Scales (PedsQL GCS) in patients with transfusion-dependent thalassemia (TDT). The algorithm was developed using data from 345 TDT patients. Spearman's rank correlation was used to evaluate the conceptual overlap between the instruments. Model specifications were chosen using a stepwise regression. Both direct and response mapping methods were attempted. Six mapping estimation methods ordinary least squares (OLS), a log-transformed response using OLS, generalized linear model (GLM), two-part model (TPM), Tobit and multinomial logistic regression (MLOGIT) were tested to determine the root mean squared error (RMSE) and mean absolute error (MAE). Other criterion used were accuracy of the predicted utility score, proportions of absolute differences that was less than 0.03 and intraclass correlation coefficient. An in-sample, leave-one-out cross validation was conducted to test the generalizability of each model. The best performing model was specified with three out of the four PedsQL GCS scales-the physical, emotional and social functioning score. The best performing estimation method for direct mapping was a GLM with a RMSE of 0.1273 and MAE of 0.1016, while the best estimation method for response mapping was the MLOGIT with a RMSE of 0.1597 and MAE of 0.0826. The mapping algorithm developed using the GLM would facilitate the calculation of utility scores to inform economic evaluations for TDT patients when EQ-5D data is not available. However, caution should be exercised when using this algorithm in patients who have poor quality of life.

A survey of the young person's experience of Graves' disease and its management.

A suboptimal quality of life (QoL) has been reported in patients with Graves' disease treated in adult life, but long-term QoL in those treated in childhood and adolescence is unclear. We wanted to understand how Graves' disease and its management impact on the physical, psychological and social well-being of young people and their longer-term QoL. Two questionnaires were used to assess QoL and patient experience of Graves' disease; PedsQL™ Generic Core Scales and a Graves' disease questionnaire devised for this project. The anonymized questionnaires were sent to young people (<30years) diagnosed with Graves' disease in childhood and adolescence and managed at a tertiary paediatric endocrine unit in the North of England. Respondent QoL scores were compared with a healthy UK cohort. Questionnaires were sent to 51 young people, and 26 responded (51%). Graves' patients reported a lower total QoL score compared with the healthy cohort (p=.003). This was particularly apparent in the psychosocial domain (p=.0016). No patient regretted having definitive treatment (surgery/radioiodine), and all said they would recommend it to others. Half of those who had received definitive treatment still did not feel recovered. There was no difference in the long-term QoL in those who did/did not receive definitive treatment (p=.40). This study highlights short- and long-term impacts on the QoL and general well-being of young people with Graves' disease. There were no regrets regarding the choice of definitive treatment. This information will help inform the counselling of patients and their families.

Environment, lifestyle behavior and health-related quality of life in childhood and adolescent cancer survivors of extracranial malignancies

BackgroundChildhood cancer is a chronic disease with high survival rates. Childhood cancer survivors (CCS) can still face health effects later in their lives. Health-related quality of life (HRQoL) and the factors that modify it allow CCS and their families to improve care in the long-term follow-up. This study aims to: (1) examine the differences in HRQoL between CCS of extracranial malignancies and a comparison group, and (2) explore the clinical, environmental and lifestyles factors implicated in the HRQoL of CCS. MethodsIn this cross-sectional study with a case vs. non-case comparison, the HRQoL of 117 CCS between 8 and 18 years old was compared with healthy non-cases paired by sex and age. The Pediatric Environmental History (PEHis) was applied to obtain information on sociodemographic, clinical, environmental and lifestyle factors. The PedsQL™ Generic Core Scales questionnaire was used to evaluate HRQoL. ResultsIn the multivariate analysis among the CCS, the following variables were significantly associated with HRQoL: Poor outdoor air quality (Total, Psychosocial, Emotional, Social and School domains); household income (Total, Psychosocial and School domains); and the presence of late effects (Total, Physical, Psychosocial, and Social domains); regular contact with nature (Physical domain); and the daily hours of screen-time (Emotional domain). CCS present HRQoL results superior to the non-cases group in the physical domain (86.10 vs. 80.34; p=0.001), finding no differences in the other domains evaluated. ConclusionsAn environmental and community health approach, such as PEHis, in CCS long-term programs promoting the creation of healthier environments and lifestyles contributes to improving their HRQoL and secondarily other chronic diseases.

Improving the Care for Pediatric Transplant Patients through Integration of Patient-Reported Outcome Measures into Clinical Practice

Subjective evaluation of medical care and treatment from the patient's perspective is increasingly important. Patient-reported outcome measures (PROMs) are "any report of the patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else" and can comprise information about symptoms, functional status, and quality of life. PROMs have the ability to engage patients meaningfully, give them a voice in their healthcare, and capture their experiences and attitudes. This study explores the perspectives of pediatric solid organ transplant patients, caregivers and healthcare providers on implementing PROMs into clinical practice. Semi-structured interviews were conducted at five Canadian pediatric transplant centres. Maximum variation sampling was used to provide concurring and confirming data, and ensure saturation. An iterative coding process was applied with constant comparative data analysis to identify themes. A total of 20 patients, 22 caregivers and 20 healthcare providers participated. Nearly all participants (n = 59, 95%) were supportive of implementing PROMs with the primary goals to 1) enhance patient-provider communication - "Opens conversations"; "[Patients] state what they're feeling", and 2) increase patient engagement - "Like you're part of the team". Participants discussed the potential impact of PROMs as the provision of preventative - "You'll be proactive", and holistic care - "You cannot separate medical from other aspects. [Patients] are struggling from a mental health perspective". Participants identified selected PROMs, the PedsQLTM Generic Core Scales - "Covers aspects I wouldn't usually include in my assessment" and the PedsQLTM Transplant Module - "More related to transplant patients". Recommendations included 1) PROM data collection for patients eight years of age and older, 2) remote administration and completion of electronic PROMs, prior to clinical appointments, and 3) visual data representation. Findings highlight support for the implementation of PROMs into pediatric solid organ transplantation. Future research is needed to develop implementation strategies to effectively integrate PROMs into clinical workflow and assess the impact on patient health outcomes.

PedsQL™ Cognitive Functioning Scale in youth with epilepsy: Reliability and validity

ObjectiveThe objective of the study was to report on the internal consistency reliability and discriminant, concurrent and construct validity of the Pediatric Quality of Life Inventory™ (PedsQL™) Cognitive Functioning Scale as a brief generic cognitive functioning measure in youth with epilepsy. MethodsThe 6-item PedsQL™ Cognitive Functioning Scale and 23-item PedsQL™ 4.0 Generic Core Scales were completed by 221 pediatric patients ages 5–18 years with epilepsy and 336 parents of patients ages 2–18 years in a national field test study for the PedsQL™ Epilepsy Module. Parents also completed the 86-item Behavior Rating Inventory of Executive Function (BRIEF), a widely validated measure of executive functioning. ResultsThe PedsQL™ Cognitive Functioning Scale evidenced excellent reliability (patient self-report α = 0.88; parent proxy-report α = 0.96), distinguished between youth with epilepsy and an age, gender, and race/ethnicity-matched healthy sample supporting discriminant validity with large effect sizes (~20–30 point score differences, P < 0.001), and demonstrated concurrent and construct validity, respectively, through large effect size intercorrelations with the BRIEF (Behavioral Regulation Index, Metacognition Index, Global Executive Composite Summary Scores rs = 0.43–0.67, P < 0.001) and the PedsQL™ Generic Core Scales (Total Scale Scores rs = 0.67–0.74, P < 0.001). Minimal clinically important difference (MCID) scores ranged from 5.92 to 8.80. ConclusionsThe PedsQL™ Cognitive Functioning Scale demonstrated excellent internal consistency reliability, discriminant, concurrent, and construct validity in youth with epilepsy and may be suitable as a brief generic patient-reported outcome (PRO) measure for clinical research, clinical trials, and routine clinical practice in pediatric epilepsy.

Patient-reported outcome measures within pediatric solid organ transplantation: A systematic review.

Subjective evaluation of medical care and disease outcomes from patients' perspectives has become increasingly important. Patient-reported outcome measures (PROMs) play a prominent role in engaging patients, capturing their experiences and improving patient care. This systematic review sought to identify PROMs that are used in the field of pediatric solid organ transplantation, with the aim to inform the implementation of PROMs into clinical practice for this population. A systematic review of English language, peer-reviewed articles was performed on key health science databases to identify publications using PROMs in pediatric solid organ transplantation. The search yielded 3670 articles, with a final data set of 62 articles that included 47 different PROMs. The three most frequently used PROMs included the following: (a) PedsQL™ Generic Core Scales (n=25); (b) Children's Depression Inventory (n=6); and (c) Child Health Questionnaire (n=6). Of the 47 PROMs, 42 were generic and five were disease-specific; only six PROMS had a documented psychometric evaluation within a pediatric solid organ transplant population. This review outlines the attributes of the instruments (eg, domains captured), as well as the psychometric properties of those evaluated. PROMs are increasingly used in the field of pediatric transplantation; however, there are limited details in the current literature about their conceptual underpinnings and psychometric properties. This review highlights the need for additional psychometric evaluation of identified measures to establish the necessary foundation to inform the implementation of PROMs into clinical care for pediatric solid organ transplant patients.

Pain, skin sensations symptoms, and cognitive functioning predictors of health-related quality of life in pediatric patients with Neurofibromatosis Type 1.

The aim was to investigate pain, skin sensations symptoms and patient self-reported, and parent proxy-reported cognitive functioning as predictors of generic health-related quality of life (HRQOL) in pediatric patients with Neurofibromatosis Type 1 (NF1) from the perspectives of patients and parents. The Pain, Skin Itch Bother, Skin Sensations, and Cognitive Functioning Scales from the PedsQL™ Neurofibromatosis Type 1 Module and the PedsQL™ Generic Core Scales were completed in a multi-site national study by 323 patients and 335 parents. Patients were 5-25years of age. Pain and skin symptoms and cognitive functioning were tested for bivariate and multivariate linear associations with generic HRQOL. Pain, skin itch bother, skin sensations, and cognitive functioning were associated with decreased HRQOL in bivariate analyses (Ps < 0.001). In predictive analytics models, utilizing hierarchical multiple regression analyses controlling for demographic covariates, pain, skin itch bother, skin sensations, and cognitive functioning as a group accounted for 61 percent of the variance in patient-reported generic HRQOL (P < 0.001), reflecting a large effect size. For parent proxy-report, the predictor variables as a group accounted for 53% of the variance in generic HRQOL. Pain, skin symptoms, and patient self-reported and parent proxy-reported cognitive functioning are key predictors of generic HRQOL in pediatric patients with NF1. Delineating NF1-specific symptoms and cognitive functioning as high-priority predictors from the patient and parents perspective enhances a family-centered approach in clinical research, clinical trials, and clinical practice intended to improve the global generic HRQOL of pediatric patients with NF1.

Changes in quality of life in individuals with narcolepsy type 1 after the H1N1-influenza epidemic and vaccination campaign in Norway: a two-year prospective cohort study

ObjectiveCross-sectional studies show a lower health-related quality of life (HRQoL) in individuals with narcolepsy. We aimed to describe changes in HRQoL after two years of multidisciplinary follow-up in a cohort of mainly post-H1N1 vaccination narcolepsy type-1 (NT1) patients in Norway. MethodsProspective-cohort study. Narcolepsy diagnosis was based on the International Classification of Sleep Disorders (third edition). Psychiatric comorbidity was assessed using the Achenbach System of Empirically Based Assessment (ASEBA). HRQoL was evaluated with the Pediatric Quality of Life Inventory (PedsQL™ Generic Core Scales 4.0) at baseline and follow-up. Mean follow-up time was 20.7 (2.7) months. ResultsThirty one patients (18 females) with NT1, mean age 14.6 (SD = 4.8) years answered questionnaires at baseline and follow-up. On a group level, the PedsQL Total Health Summary score significantly improved by a mean of 5.9 (95%CI = 0.4, 11.9), p = 0.038; this was mainly driven by improvements in the Physical Health Summary score by 9.8 (3.0, 16.5) points, p = 0.006 and the School Functioning Scale score by 7.5 (1.0, 13.9) points p = 0.025. The Total ASEBA score was correlated with PedsQL Total Health Summary score at baseline, but not with changes in HRQoL. Sodium oxybate (Xyrem®) treatment at follow up was positively associated with changes in PedsQL Total Health Summary score, after adjusting for age and gender, p = 0.027. ConclusionHRQoL in NT1 patients improved after two years of follow-up. The use of sodium oxybate (Xyrem®) at follow-up was associated with increases in HRQoL. Psychiatric comorbidity was correlated with HRQoL at baseline but did not predict changes in HRQoL at follow-up.

A.01 The relationship between fatigue and health-related quality of life in a clinical trial population of Duchenne muscular dystrophy patients

Background: Fatigue was recently reported to be the largest contributor to poor health-related quality of life (HRQOL) in paediatric Duchenne muscular dystrophy (DMD). Additional studies are necessary to confirm the generalizability of this finding. Our objective was to explore the longitudinal relationship between fatigue and HRQOL in an additional cohort of DMD patients. Methods: We performed a secondary analysis of data from a clinical trial (NCT00592553), which enrolled patients with nonsense mutation DMD, aged 5–20 years, from 37 sites in 11 countries (N=174). Fatigue and HRQOL were assessed using the PedsQLTM Multidimensional Fatigue Scale and Generic Core Scales, respectively, by patient- and parent-report at baseline and over 48 weeks. Results: Patients reported greater fatigue than healthy controls from published data. There was no significant difference between patient- and parent-reported fatigue. Fatigue was significantly correlated with worse HRQOL at baseline, by patient-report (r=0.70, P&lt;0.001) and parent-report (r=0.70, P&lt;0.001); and at 48 weeks, by patient-report (r=0.79, P&lt;0.001) and parent-report (r=0.74, P&lt;0.001). Change in fatigue was significantly correlated with change in HRQOL over 48 weeks, by patient-report (r=0.64, P&lt;0.001) and parent-report (r=0.67, P&lt;0.001). Conclusions: Fatigue is a major contributor to HRQOL in DMD. The strong association between fatigue and HRQOL corroborates previous studies, and suggests that reducing fatigue may improve HRQOL.

Can in-the-moment diary methods measure health-related quality of life in Duchenne muscular dystrophy?

To investigate whether in-the-moment diary reports of daily experience, taken collectively, are a valid representation of health-related quality of life (HRQL). A total of 35 boys with Duchenne muscular dystrophy (DMD) were recruited through four neuromuscular care providers across Australia. Participants completed the PedsQL™ Generic Core scales and one week of experience-sampling diary reporting on a personal digital assistant. Rasch analysis was undertaken on the diary data to derive a single valid measure score. The resulting measure score for each participant was correlated with the summary score from the PedsQL™ Generic Core scales to examine whether daily experience was representative of HRQL. The daily diary method showed good metric properties, with adequate goodness of fit for data from items and participants suggesting unidimensionality of the construct: quality of everyday experience. The correlation of the daily diary measure score with overall PedsQL™ summary score showed moderate agreement (r=.60, p=0.001). The benefits of measuring daily quality of life include detailed descriptions of day-to-day experiences of children without the need for retrospective recall. Diary methods on an electronic platform or software application for personal devices may be a useful tool to understand HRQL as the repeated measures data provide a detailed experience directly from the child and the platform makes data completion highly motivating.

Health-related quality of life and functional changes in DMD: A 12-month longitudinal cohort study

In Duchenne muscular dystrophy (DMD) little has been reported on the association between clinical outcome measures and patient health-related quality of life (HRQOL) tools. Our study evaluated the relationship between 12 month changes on the Generic Core Scales (GCS), the Multidimensional Fatigue Scale and the Neuromuscular Module of the PedsQLTM with several outcome measures (6 minute walk test, North Star Ambulatory Assessment and timed items) in ambulatory DMD. Ninety-eight ambulatory DMD in a multicentric setting were included in the study. At baseline, the PedsQLTM inventories correlated with almost all the functional measures On the Child Self-Report there was a significant decrease between baseline and 12 months on the PedsQLTM GCS and its first domain, in parallel with the decrement in the functional outcome measures. Correlation between the 12 month changes on the PedsQLTM inventories and functional measures were almost all negligible. Similar results were obtained on the Parent Proxy-Report.In conclusion, PedsQLTM correlates with the level of impairment at baseline, but this does not hold true when 12 month changes are considered. Further studies comparing different tools are needed to better elucidate the complexity of the relationship between HRQOL and functional performances.

PedsQL™ multidimensional fatigue scale in sickle cell disease: Feasibility, reliability, and validity

Sickle cell disease (SCD) is an inherited blood disorder characterized by a chronic hemolytic anemia that can contribute to fatigue and global cognitive impairment in patients. The study objective was to report on the feasibility, reliability, and validity of the PedsQL™ Multidimensional Fatigue Scale in SCD for pediatric patient self-report ages 5-18 years and parent proxy-report for ages 2-18 years. This was a cross-sectional multi-site study whereby 240 pediatric patients with SCD and 303 parents completed the 18-item PedsQL™ Multidimensional Fatigue Scale. Participants also completed the PedsQL™ 4.0 Generic Core Scales. The PedsQL™ Multidimensional Fatigue Scale evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.90; parent proxy-report α = 0.95), and acceptable reliability for the three individual scales (patient self-report α = 0.77-0.84; parent proxy-report α = 0.90-0.97). Intercorrelations of the PedsQL™ Multidimensional Fatigue Scale with the PedsQL™ Generic Core Scales were predominantly in the large (≥0.50) range, supporting construct validity. PedsQL™ Multidimensional Fatigue Scale Scores were significantly worse with large effects sizes (≥0.80) for patients with SCD than for a comparison sample of healthy children, supporting known-groups discriminant validity. Confirmatory factor analysis demonstrated an acceptable to excellent model fit in SCD. The PedsQL™ Multidimensional Fatigue Scale demonstrated acceptable to excellent measurement properties in SCD. The results demonstrate the relative severity of fatigue symptoms in pediatric patients with SCD, indicating the potential clinical utility of multidimensional assessment of fatigue in patients with SCD in clinical research and practice.

Quality of life in pediatric patients with unremitting constipation pre and post Malone Antegrade Continence Enema (MACE) procedure

ObjectiveThe primary aim of this study was to determine if there is a change in the quality of life in pediatric patients with unremitting functional constipation and/or encopresis after undergoing a MACE procedure. MethodsPatients, ages 5 to 18years with unremitting constipation and a normal evaluation, including anorectal manometry and colonic manometry, who opted to undergo a MACE procedure were contacted to participate in the study. Patients with congenital anorectal malformations as well as spinal cord disorders were excluded from the study. The patient's parent/guardian completed the PedsQLTM Generic Core Scales QOL survey prior to the operation, 6months, and 12months after the procedure. ResultsA total of 15 consecutive patients meeting protocol criteria were recruited within a period of 20months. The mean age at the MACE procedure was 9.8years (range 7.0–11.1). 5 patients were female. The mean QOL score pre-MACE was 64.1. At 6months post-MACE the mean overall QOL score was 90.2, and it was 92.0 at 12months. All 15 patients at the 6month follow up had significant improvement in their QOL (p=1.9×10−7) and all subcategories of QOL were significantly improved as well. ConclusionsA MACE procedure is of benefit to otherwise normal pediatric patients who have unremitting functional constipation with failure of medical treatment. Our patients had a significant improvement in all QOL categories and overall QOL.

PedsQL™ sickle cell disease module: Feasibility, reliability, and validity

Sickle cell disease (SCD) is an inherited chronic disease that is characterized by complications such as recurrent painful vaso-occlusive events that require frequent hospitalizations and contribute to early mortality. The objective of the study was to report on the initial measurement properties of the new PedsQL™ SCD Module for pediatric patient self-report ages 5-18 years and parent proxy-report for ages 2-18 years. The 43-item PedsQL™ SCD Module was completed in a multisite study by 243 pediatric patients with SCD and 313 parents. Participants also completed the PedsQL™ 4.0 Generic Core Scales and PedsQL™ Multidimensional Fatigue Scale. The PedsQL™ SCD Module Scales evidenced excellent feasibility, excellent reliability for the Total Scale Scores (patient self-report α = 0.95; parent proxy-report α = 0.97), and good reliability for the nine individual scales (patient self-report α = 0.69-0.90; parent proxy-report α = 0.83-0.97). Intercorrelations with the PedsQL™ Generic Core Scales and PedsQL™ Multidimensional Fatigue Scales were medium (0.30) to large (0.50) range, supporting construct validity. PedsQL™ SCD Module Scale Scores were generally worse for patients with severe versus mild disease. Confirmatory factor analysis demonstrated an acceptable to excellent model fit. The PedsQL™ SCD Module demonstrated acceptable measurement properties. The PedsQL™ SCD Module may be utilized in the evaluation of SCD-specific health-related quality of life in clinical research and practice. In conjunction with the PedsQL™ Generic Core Scales and the PedsQL™ Multidimensional Fatigue Scale, the PedsQL™ SCD Module will facilitate the understanding of the health and well-being of children with SCD.

Reliability and validity of the PedsQL™ Generic Core Scales 4.0 for Chinese children with epilepsy

This investigation examines the reliability and validity of the Chinese version of the PedsQL 4.0 Generic Core Scales for prognostic measures of pediatric epilepsy. The study comprised 163 parents whose children, between the ages of 2 and 18years, were diagnosed with epilepsy. The parents were given a questionnaire to be completed on behalf of the child. Reliability was assessed by Cronbach's alpha analysis. Validity was assessed by the exploratory factor analysis and intercorrelation analysis between the four subscales as well as Student's t-test. The internal consistency reliability for Total Scale Score was 0.94 by Cronbach's alpha test. Four major factors were extracted by factor analysis. The scores from all sub-scales derived from healthy children were significantly higher than children with epilepsy (P<0.001). The reliability and validity of the parent proxy-report scales from the Chinese version of the PedsQL™ 4.0 Generic Core Scales effectively matched the original version and could be used to evaluate the health-related quality of life of children with epilepsy.

Feasibility, reliability, and validity of the pediatric quality of life inventory™ generic core scales, cancer module, and multidimensional fatigue scale in long‐term adult survivors of pediatric cancer

Most health-related quality of life assessments are designed for either children or adults and have not been evaluated for adolescent and young adult survivors of pediatric cancer. The objective of this study was to examine the feasibility, reliability, and validity of the Pediatric Quality of Life Inventory (PedsQL ™ Generic Core Scales, Cancer Module, and Multidimensional Fatigue Scale in adult survivors of pediatric cancer. Adult survivors (n = 64; Mean age 35 year old; >2 years after treatment) completed the PedsQL™ Generic Core Scales, Cancer Module, and Multidimensional Fatigue Scale. Feasibility was examined with floor and ceiling effects; and internal consistency was determined by Cronbach's coefficient alpha calculations. Inter-factor correlations were also assessed. Significant ceiling effects were observed for the scales of social function, nausea, procedural anxiety, treatment anxiety, and communication. Internal consistency for all subscales was within the recommended ranges (α ≥ 0.70). Moderate to strong correlations between most Cancer Module and Generic Core Scales (r = 0.25 to r = 0.76) and between the Multidimensional Fatigue Scale and Generic Core Scales (r = 0.37 to r = 0.73). The PedsQL™ Generic Core Scales, Cancer Module, and Multidimensional Fatigue Scale appear to be feasible for an older population of pediatric cancer survivors; however, some of the Cancer Module Scales (nausea, procedural/treatment anxiety, and communication) were deemed not relevant for long-term survivors. More information is needed to determine whether the issues addressed by these modules are meaningful to long-term adult survivors of pediatric cancers.

Health related quality of life of Iranian children with type 1 diabetes: reliability and validity of the Persian version of the PedsQL™ Generic Core Scales and Diabetes Module

BackgroundThe 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.MethodsParticipants 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.ResultsCronbach'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.ConclusionsWhile 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 in Pediatric Patients With Unremitting Constipation Pre and Post Malone Antegrade Continence Enema (MACE) Procedure

Objective: The primary aim of this study was to determine if there is a change in the quality of life in pediatric patients with unremitting functional constipation and/or encopresis after undergoing a MACE procedure. Methods: Patients, ages 5 to 18 years with unremitting constipation and a normal evaluation, including anorectal manometry and colonic manometry, who opted to undergo a MACE procedure were contacted to participate in the study. Patients with congenital anorectal malformations as well as spinal cord disorders were excluded from the study. The patient's parent/guardian completed the PedsQL TM Generic Core Scales QOL survey prior to the operation, 6 months, and 12 months after

Development of the Japanese version of the Pediatric Quality of Life Inventory™ Brain Tumor Module

BackgroundThe Pediatric Quality of Life Inventory™ (PedsQL™) is a widely-used modular instrument for measuring health-related quality of life in children aged 2 to 18 years. The PedsQL™ Brain Tumor Module is comprised of six scales: Cognitive Problems, Pain and Hurt, Movement and Balance, Procedural Anxiety, Nausea, and Worry. In the present study, we developed the Japanese version of the PedsQL™ Brain Tumor Module and investigated its feasibility, reliability, and validity among Japanese children and their parents.MethodsTranslation equivalence and content validity were verified using the standard back-translation method and cognitive debriefing tests. Participants were recruited from 6 hospitals in Japan and the Children's Cancer Association of Japan, and questionnaires were completed by 137 children with brain tumors and 166 parents. Feasibility of the questionnaire was determined based on the amount of time required to complete the form and the percentage of missing values. Internal consistency was assessed using Cronbach's coefficient alpha. Test-retest reliability was assessed by retesting 22 children and 27 parents. Factorial validity was verified by exploratory factor analyses. Known-groups validity was described with regard to whole brain irradiation, developmental impairment, infratentorial tumors, paresis, and concurrent chemotherapy. Convergent and discriminant validity were determined using Generic Core Scales and State-Trait Anxiety Inventory for children.ResultsInternal consistency was relatively high for all scales (Cronbach's coefficient alpha > 0.70) except the Pain and Hurt scale for the child-report, and sufficient test-retest reliability was demonstrated for all scales (intraclass correlation coefficient = 0.45-0.95). Factorial validity was supported through exploratory factor analysis (factor-item correlation = 0.33-0.96 for children, 0.55-1.00 for parents). Evaluation of known-groups validity confirmed that the Cognitive Problems scale was sensitive for developmental impairment, the Movement and Balance scale for infratentorial tumors or paresis, and the Nausea scale for a patient currently undergoing chemotherapy. Convergent and discriminant validity with the PedsQL™ Generic Core Scales and State-Trait Anxiety Inventory for children were acceptable.ConclusionsThe Japanese version of the PedsQL™ Brain Tumor Module is suitable for assessing health-related quality of life in children with brain tumors in clinical trials and research studies.