Michael Seid

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 (&agr; = 0.88 child, 0.90 parent report), Physical Health Summary Score (&agr; = 0.80 child, 0.88 parent), and Psychosocial Health Summary Score (&agr; = 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.

The PedsQL 4.0 as a pediatric population health measure: feasibility, reliability, and validity.

BACKGROUND The application of health-related quality of life (HRQOL) as a pediatric population health measure may facilitate risk assessment and resource allocation, the tracking of community health, the identification of health disparities, and the determination of health outcomes from interventions and policy decisions. OBJECTIVE To determine the feasibility, reliability, and validity of the 23-item PedsQL 4.0 (Pediatric Quality of Life Inventory) Generic Core Scales as a measure of pediatric population health for children and adolescents. DESIGN Mail survey in February and March 2001 to 20 031 families with children ages 2-16 years throughout the State of California encompassing all new enrollees in the States Childrens Health Insurance Program (SCHIP) for those months and targeted language groups. METHODS The PedsQL 4.0 Generic Core Scales (Physical, Emotional, Social, School Functioning) were completed by 10 241 families through a statewide mail survey to evaluate the HRQOL of new enrollees in SCHIP. RESULTS The PedsQL 4.0 evidenced minimal missing responses, achieved excellent reliability for the Total Scale Score (alpha =.89 child;.92 parent report), and distinguished between healthy children and children with chronic health conditions. The PedsQL 4.0 was also related to indicators of health care access, days missed from school, days sick in bed or too ill to play, and days needing care. CONCLUSION The results demonstrate the feasibility, reliability, and validity of the PedsQL 4.0 as a pediatric population health outcome. Measuring pediatric HRQOL may be a way to evaluate the health outcomes of SCHIP.

The PedsQL™ 4.0 Generic Core Scales: Sensitivity, Responsiveness, and Impact on Clinical Decision-Making

The PedsQLTM 4.0 (Pediatric Quality of Life InventoryTM) Generic Core Scales are child self-report and parent proxy-report scales developed to measure health-related quality of life (HRQOL) in children and adolescents ages 2–18. The PedsQLTM 4.0 Generic Core Scales consist of 23 items applicable for healthy school and community populations and pediatric populations with acute and chronic health conditions. The 4 PedsQLTM 4.0 Generic Core Scales (Physical, Emotional, Social, School) were administered to 209 children and 269 parents (289 subjects accrued overall) recruited from pediatric cardiology, orthopedics, and rheumatology clinics. Sensitivity, responsiveness, and the impact on clinical decision-making were determined. The PedsQLTM was differentially sensitive to increasing degrees of cardiac disease severity in the cardiology clinic setting and responsive to clinical change over time in the pediatric orthopedics clinic setting. In the pediatric rheumatology clinic setting, the PedsQLTM demonstrated an impact on clinical decision-making, resulting in subsequent increases in HRQOL.

The PedsQL 4.0 as a school population health measure: feasibility, reliability, and validity.

Background: The application of health-related quality of life (HRQOL) as a school population health measure may facilitate risk assessment and resource allocation, the tracking of student health at the school and district level, the identification of health disparities among schoolchildren, and the determination of health outcomes from interventions and policy decisions at the school, district, and county level. Objective:To determine the feasibility, reliability, and validity of the 23-item PedsQLTM 4.0 (Pediatric Quality of Life InventoryTM) Generic Core Scales as a school population health measure for children and adolescents. Design: Survey conducted in 304 classes at 18 elementary schools, 4 middle schools, and 3 high schools within a large metropolitan school district. Methods:The PedsQLTM 4.0 Generic Core Scales (Physical, Emotional, Social, School Functioning) were completed by 2437 children ages 8–18 and 4227 parents of children ages 5–18. Results:The PedsQLTM 4.0 evidenced minimal missing responses, achieved excellent reliability for the Total Scale Score (α = 0.89 child, 0.92, parent report), and distinguished between healthy children and children with chronic health conditions. The PedsQLTM 4.0 was related to indicators of socioeconomic status (SES) at the school and district level. The PedsQLTM School Functioning Scale was significantly correlated with standardized achievement scores based on the Stanford 9. Conclusion: The results demonstrate the feasibility, reliability and validity of the PedsQLTM 4.0 Generic Core Scales as a school population health measure. The implications of measuring HRQOL in schoolchildren at the school, district, and county level for identifying and ameliorating health disparities are discussed.

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

Intensive antineoplastic treatmentprotocols 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 assessmentinstrument to assess systematically pediatric cancer patients 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 studywas 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.

Coproduction of healthcare service

Efforts to ensure effective participation of patients in healthcare are called by many names—patient centredness, patient engagement, patient experience. Improvement initiatives in this domain often resemble the efforts of manufacturers to engage consumers in designing and marketing products. Services, however, are fundamentally different than products; unlike goods, services are always ‘coproduced’. Failure to recognise this unique character of a service and its implications may limit our success in partnering with patients to improve health care. We trace a partial history of the coproduction concept, present a model of healthcare service coproduction and explore its application as a design principle in three healthcare service delivery innovations. We use the principle to examine the roles, relationships and aims of this interdependent work. We explore the principles implications and challenges for health professional development, for service delivery system design and for understanding and measuring benefit in healthcare services.

The PedsQL as a pediatric patient-reported outcome: reliability and validity of the PedsQL Measurement Model in 25,000 children.

The PedsQL™ Measurement Model was designed as a modular approach to measuring pediatric health-related quality of life, and developed to integrate the relative merits of generic and disease-specific approaches. The PedsQL™ 4.0 Generic Core Scales have been translated into over 60 languages, with published data on over 25,000 children and adolescents in more than 75 peer-reviewed journals since 2001 for healthy children and numerous pediatric chronic health conditions. The PedsQL™ Disease and Condition-Specific Modules were designed to measure health-related quality-of-life dimensions specifically tailored for pediatric chronic health conditions, and include the PedsQL™ Asthma, Arthritis/Rheumatology, Cancer, Diabetes, Cardiac and Cerebral Palsy Modules, as well as the generic PedsQL™ Multidimensional Fatigue Scale, Pediatric Pain Questionnaire™, Family Impact Module and Healthcare Satisfaction Module. The PedsQL™ has demonstrated reliability, validity, sensitivity and responsiveness for child self report for ages 5–18 years and parent proxy report for ages 2–18 years. The PedsQL™ has been shown to be related to other key constructs in pediatric healthcare such as access to needed care, healthcare barriers and quality of primary care. Future advances in the PedsQL™ Measurement Model include web-based electronic administration (ePedsQL™), integration into the electronic medical record, further efficacy and effectiveness outcome trials, including PedsQL™ ResourceConnectSM and PedsQL™ TIPSSM, the development of the generic PedsQL™ Infant Scales for ages birth to 24 months and disease and condition-specific modules for other pediatric chronic health conditions.

Efficacy and Safety of Sirolimus in the Treatment of Complicated Vascular Anomalies.

BACKGROUND AND OBJECTIVES: Complicated vascular anomalies have limited therapeutic options and cause significant morbidity and mortality. This Phase II trial enrolled patients with complicated vascular anomalies to determine the efficacy and safety of treatment with sirolimus for 12 courses; each course was defined as 28 days. METHODS: Treatment consisted of a continuous dosing schedule of oral sirolimus starting at 0.8 mg/m2 per dose twice daily, with pharmacokinetic-guided target serum trough levels of 10 to 15 ng/mL. The primary outcomes were responsiveness to sirolimus by the end of course 6 (evaluated according to functional impairment score, quality of life, and radiologic assessment) and the incidence of toxicities and/or infection-related deaths. RESULTS: Sixty-one patients were enrolled; 57 patients were evaluable for efficacy at the end of course 6, and 53 were evaluable at the end of course 12. No patient had a complete response at the end of course 6 or 12 as anticipated. At the end of course 6, a total of 47 patients had a partial response, 3 patients had stable disease, and 7 patients had progressive disease. Two patients were taken off of study medicine secondary to persistent adverse effects. Grade 3 and higher toxicities attributable to sirolimus included blood/bone marrow toxicity in 27% of patients, gastrointestinal toxicity in 3%, and metabolic/laboratory toxicity in 3%. No toxicity-related deaths occurred. CONCLUSIONS: Sirolimus was efficacious and well tolerated in these study patients with complicated vascular anomalies. Clinical activity was reported in the majority of the disorders.

Transition From Pediatric to Adult Care for Youth Diagnosed With Type 1 Diabetes in Adolescence

OBJECTIVE: Youth with type 1 diabetes mellitus are at risk for poor glycemic control as they age into adulthood. The aim of this study was to describe sociodemographic and clinical correlates of poor glycemic control associated with the transfer of care from pediatric to adult diabetes providers among a cohort of youth with type 1 diabetes diagnosed in adolescence. METHODS: Analyses included 185 adolescent participants with recently diagnosed type 1 diabetes in the SEARCH for Diabetes in Youth Study with pediatric care at baseline who were age ≥18 years at follow-up. Demographic and clinical factors were measured by survey and laboratory results. Survival analysis was used to estimate the age of transition. Logistic regression analysis assessed the association of demographic and clinical factors with the transition of care and poor glycemic control at follow-up. RESULTS: Fifty-seven percent of participants had transitioned to adult diabetes care providers by the follow-up visit. The estimated median age of transition of care was 20.1 years (95% confidence interval 19.8–20.4). Older age, lower baseline glycosylated hemoglobin, and less parental education were independently associated with increased odds of transition. The odds of poor glycemic control at follow-up were 2.5 times higher for participants who transitioned to adult care compared with those who remained in pediatric care. CONCLUSIONS: Transferring from pediatric to adult care, experienced by more than half the sample, was associated with an increased risk of poor glycemic control at follow-up. These findings suggest that young adults need additional support when moving to adult care.

Electronic Health Record Identification of Nephrotoxin Exposure and Associated Acute Kidney Injury

BACKGROUND AND OBJECTIVE: Nephrotoxic medication exposure represents a common cause of acute kidney injury (nephrotoxin-AKI) in hospitalized children. Systematic serum creatinine (SCr) screening has not been routinely performed in children receiving nephrotoxins, potentially leading to underestimating nephrotoxin-AKI rates. We aimed to accurately determine nephrotoxin exposure and nephrotoxin-AKI rates to drive appropriate interventions in non–critically ill hospitalized children. METHODS: We conducted a prospective quality improvement project implementing a systematic electronic health record (EHR) screening and decision support process (trigger) at a single quaternary pediatric hospital. Patients were all noncritically ill hospitalized children receiving an intravenous aminoglycoside for ≥3 days or ≥3 nephrotoxins simultaneously (exposure). Pharmacists recommended daily SCr monitoring in exposed patients. AKI was defined by the modified pediatric Risk, Injury, Failure, Loss and End-stage Renal Disease criteria (≥25% decrease in estimated creatinine clearance). We developed 4 novel metrics: exposure rate per 1000 patient-days, AKI rate per 1000 patient-days, AKI rate (%) per high nephrotoxin admission, and AKI days per 100 exposure days (AKI intensity). RESULTS: This study included 21 807 patients accounting for 27 711 admissions. A total of 726 (3.3%) unique exposed patients accounted for 945 hospital admissions (6713 patient-days). AKI occurred in 25% of unique exposed patients and 31% of exposure admissions (1974 patient-days). Our EHR-driven SCr nephrotoxin-AKI surveillance process was associated with a 42% reduction in AKI intensity. CONCLUSIONS: Nephrotoxin-AKI rates are high in noncritically ill children; systematic screening for nephrotoxic medication exposure and AKI detection was accomplished reliably through an EHR based trigger tool.