Gender differences in trajectories of health-related quality of life from childhood to adolescence in a 7-year follow-up study in a urban socially disadvantaged sample from Argentina.

PURPOSE: The transition from childhood to adolescence is a period of developmental changes, with social influences. Few previous studies have analyzed changes in health-related quality of life (HRQoL) during childhood and adolescence based on longitudinal studies in high-income countries. This study aimed to describe the evolution of HRQoL scores by gender in a school sample over a 7-year period in Argentina. METHODS: Prospective cohort of children attending fourth grade in public schools. HRQoL was measured using the KIDSCREEN-52 questionnaire. Trajectories of HRQoL were estimated for girls and boys through multilevel models, adjusted by socioeconomic status (SES). RESULTS: The study began in 2014 with a sample of 494 school children, reaching an 85.6% response rate in 2016, 31.4% in 2018, and 41.9% in 2021. Most of the predicted scores are negatively associated with linear age or/and quadratic age, suggesting a decrease in scores over the 7-year follow-up. Interactions between gender and age denote an increase in the differences in scores between girls and boys over time in favor of the latter. For the Index, Physical Well-being, Psychological Well-being, Autonomy, Parent relations, Social support and peers and Financial resources, individuals with medium or high SES have significantly higher scores than those with low SES. CONCLUSIONS: HRQoL scores decrease during the transition period from childhood to adolescence, with girls showing the greatest decrease. There were also socioeconomic inequalities in the evolution of HRQoL in a context characterized by social segregation and economic crisis, possibly aggravated by the COVID-19 pandemic.

Austerity policy and child health in European countries: a systematic literature review.

BACKGROUND: To analyse the impact of austerity measures taken by European governments as a response to the 2008 economic and financial crisis on social determinants on child health (SDCH), and child health outcomes (CHO). METHODS: A systematic literature review was carried out in Medline (Ovid), Embase, Web of Science, PsycInfo, and Sociological abstracts in the last 5 years from European countries. Studies aimed at analysing the Great Recession, governments' responses to the crisis, and its impact on SDCH were included. A narrative synthesis of the results was carried out. The risk of bias was assessed using the STROBE and EPICURE tools. RESULTS: Fourteen studies were included, most of them with a low to intermediate risk of bias (average score 72.1%). Government responses to the crisis varied, although there was general agreement that Greece, Spain, Ireland and the United Kingdom applied higher levels of austerity. High austerity periods, compared to pre-austerity periods were associated with increased material deprivation, child poverty rates, and low birth weight. Increasing child poverty subsequent to austerity measures was associated with deterioration of child health. High austerity was also related to poorer access and quality of services provided to disabled children. An annual reduction of 1% on public health expenditure was associated to 0.5% reduction on Measles-Mumps-Rubella vaccination coverage in Italy. CONCLUSIONS: Countries that applied high level of austerity showed worse trends on SDCH and CHO, demonstrating the importance that economic policy may have for equity in child health and development. European governments must act urgently and reverse these austerity policy measures that are detrimental to family benefits and child protection.

The Incidence of Obesity, Assessed as Adiposity, Is Reduced After 1 Year in Primary Schoolchildren by the POIBA Intervention.

BACKGROUND: Childhood obesity is becoming a serious problem, and prevention programs are needed. OBJECTIVE: The purpose of this study was to evaluate, after 1 y, the effectiveness of a multicomponent, school-based obesity intervention program. METHODS: This intervention, conducted in Barcelona, Spain, was a quasi-experimental obesity primary prevention intervention targeting schoolchildren aged 9-10 y. Participants were assigned to an intervention group (IG) (1464 students) or to a comparison group (CG) (1609 students). The intervention consisted of a 9-session classroom program, 6 weekly sessions of physical education and out-of-school physical activity, and a workshop for families. It lasted from October 2011 to May 2012. Data obtained at baseline (spring 2011) and follow-up (spring 2012) included information on nutrition and physical activity, through 2 self-reported questionnaires, and measurement of weight, height, triceps skinfold thickness, and waist circumference. The cumulative incidence rate (CIR) of obesity was calculated from triceps skinfold measures. A multilevel logistic regression model was fitted to determine the association between the intervention and the CIR of obesity. The effect size of the program was estimated with Cohen's criteria. RESULTS: The overall prevalence of obesity at baseline was 12.7%. At the 12-mo follow-up, the incidence of obesity was 7.8% in the IG compared with 11.4% in the CG (P < 0.005), representing 31% fewer new cases of obesity in the IG. The Cohen's d effect size of the program was 0.33. In the multilevel analysis, there was a protective effect of the intervention on the CIR of obesity at 12 mo (OR: 0.7; 95% CI: 0.5, 0.9) (P = 0.009). CONCLUSIONS: The first Prevención de la Obesidad Infantil en Barcelona (Childhood Obesity Prevention in Barcelona) (POIBA) intervention, targeting children aged 9-10 y, reduced the incidence of obesity as measured by adiposity. The intervention could prevent 1 in 3 new cases of childhood obesity in this age range.

Austerity Policies and Mortality Rates in European Countries, 2011-2015.

OBJECTIVES: To assess time trends in mortality rates in European countries for the period 2011 to 2015 by level of austerity measures imposed by governments in response to the economic and financial crisis. METHODS: We analyzed standardized mortality rates (SMRs) for 2011 through 2015 in 15 European countries based on Eurostat data ( http://ec.europa.eu/eurostat/data/database ). We used the Cyclically Adjusted Primary Balance (CAPB) in terciles as an independent variable to represent the level of austerity adopted in each country. We conducted a longitudinal analysis of panel data using generalized estimating equation models of SMR. We included interaction terms to assess the influence of time period and level of austerity. RESULTS: SMRs generally declined in the study period, except in the last year of the study. In 2015, compared with countries in the low-austerity group, countries with intermediate austerity had excess mortality of 40.2 per 100 000 per year and those with high austerity had excess mortality of 31.22 per 100 000 per year. CONCLUSIONS: The results suggest a negative effect on mortality in those countries that apply a higher level of austerity.

Measurement Properties of the Online EuroQol-5D-Youth Instrument in Children and Adolescents With Type 1 Diabetes Mellitus: Questionnaire Study.

BACKGROUND: The lack of continuity between health-related quality of life (HRQoL) instruments designed for children and adults hinders change analysis with a life course approach. To resolve this gap, EuroQol (EQ) developed the EQ-5D-Youth (EQ-5D-Y), derived from the EQ-5D for adults. Few studies have assessed the metric properties of EQ-5D-Y in children with specific chronic conditions, and none have done so for children with type I diabetes mellitus (T1DM). OBJECTIVE: This study aimed to evaluate the acceptability, validity, reliability, and responsiveness of the EQ-5D-Y in children and adolescents with T1DM, when administered online. METHODS: Participants with T1DM were consecutively recruited from July to December 2014, from a list of potential candidates aged 8-19 years, who attended outpatient pediatric endocrinology units. Before every quarterly routine visit, participants received an email/telephone reminder to complete the online version of two generic HRQoL questionnaires: EQ-5D-Y and KIDSCREEN-27. The EQ-5D-Y measures five dimensions, from which an equally weighted summary score was constructed (range: 0-100). Completion rate and distribution statistics were calculated. Construct validity was evaluated through known group comparisons based on general health, acute diabetic decompensations, mental health, family function, and a multitrait, multimethod matrix between EQ-5D-Y and KIDSCREEN by using Spearman correlations. Construct validity hypotheses were stated a priori. Reliability was assessed with the intraclass correlation coefficient and responsiveness by testing changes over time and calculating the effect size. Reliability and responsiveness were tested among the stable and improved subsamples defined by a KIDSCREEN-10 index change of <4.5 points or ≥4.5 points, respectively, from the first to the fourth visit. RESULTS: Of the 136 participants, 119 (87.5%) responded to the EQ-5D-Y at the last visit. The dimensions that showed higher percentages of participants with problems were "having pain/discomfort" (34.6%) and "worried/sad/unhappy" (28.7%). The mean (SD) of the EQ-5D-Y summary score was 8.5 (10.9), with ceiling and floor effects of 50.7% and 0%, respectively. Statistically significant HRQoL differences between groups defined by their general health (excellent/very good and good/regular/bad) and mental health (Strengths and Difficulties Questionnaire score ≤15 and >16, respectively) were found in three EQ-5D-Y dimensions ("doing usual activities," "having pain/discomfort," and "feeling worried/sad/unhappy"), summary score (effect size for general health and mental health groups=0.7 and 1.5, respectively), and KIDSCREEN-10 index (effect size for general health and mental health groups=0.6 and 0.9, respectively). Significant differences in the EQ-5D-Y dimensions were also found according to acute diabetic decompensations in "looking after myself" (P=.005) and according to family function in "having pain/discomfort" (P=.03). Results of the multitrait, multimethod matrix confirmed three of the four relationships hypothesized as substantial (0.21, 0.58, 0.50, and 0.46). The EQ-5D-Y summary score presented an intraclass correlation coefficient of 0.83. Statistically significant change between visits was observed in the improved subsample, with an effect size of 0.7 (P<.001). CONCLUSIONS: These results support the use of the EQ-5D-Y administered online as an acceptable, valid, reliable, and responsive instrument for evaluating HRQoL in children and adolescents with T1DM.

Head-to-head comparison between the EQ-5D-5L and the EQ-5D-3L in general population health surveys.

BACKGROUND: The EQ-5D has been frequently used in national health surveys. This study is a head-to-head comparison to assess how expanding the number of levels from three (EQ-5D-3L) to five in the new EQ-5D-5L version has improved its distribution, discriminatory power, and validity in the general population. METHODS: A representative sample (N = 7554) from the Catalan Health Interview Survey 2011-2012, aged ≥18, answered both EQ-5D versions, and we evaluated the response redistribution and inconsistencies between them. To assess validity of this redistribution, we calculated the mean of the Visual Analogue Scale (VAS), which measures perceived health. The discriminatory power was examined with Shannon Indices, calculated for each dimension separately. Spanish preference value sets were applied to obtain utility indices, examining their distribution with statistics of central tendency and dispersion. We estimated the proportion of individuals reporting the best health state in EQ-5D-5L and EQ-5D-3L within groups of specific chronic conditions and their VAS mean. RESULTS: A very small reduction in the percentage of individuals with the best health state was observed, from 61.8% in EQ-5D-3L to 60.8% in EQ-5D-5L. In contrast, a large proportion of individuals reporting extreme problems in the 3 L version moved to severe problems (level 4) in the 5 L version, particularly for pain/discomfort (75.5%) and anxiety/depression (66.4%). The average proportion of inconsistencies was 0.9%. The pattern of the perceived health VAS mean confirmed the hypothesis established a priori, supporting the validity of the observed redistribution. Shannon index showed that absolute informativity was higher in the 5 L version for all dimensions. The means (SD) of the Spanish EQ-5D-3L and EQ-5D-5L indices were 0.87 (0.25) and 0.89 (0.22). The proportion of individuals with the best health state within each specific chronic condition was very similar, regardless of the EQ-5D version (≤ 30% in half of the 28 chronic conditions). CONCLUSION: Although the proportion of individuals with the best possible health state is still very high, our findings support that the increase of levels provided by the EQ-5D-5L contributed to the validity and discriminatory power of this new version to measure health in general population, as in the national health surveys.

Validity of the EQ-5D-5L and reference norms for the Spanish population.

BACKGROUND AND OBJECTIVE: The EuroQol 5 dimensions 5 levels (EQ-5D-5L) is the new version of EQ-5D, developed to improve its discriminatory capacity. This study aims to evaluate the construct validity of the Spanish version and provide index and dimension population-based reference norms for the new EQ-5D-5L. METHODS: Data were obtained from the 2011/2012 Spanish National Health Survey, with a representative sample (n = 20,587) of non-institutionalized Spanish adults (≥ 18 years). The EQ-5D-5L index was calculated by using the Spanish value set. Construct validity was evaluated by comparing known groups with estimators obtained through regression models, adjusted by age and gender. Sampling weights were applied to restore the representativeness of the sample and to calculate the norms stratified by gender and age groups. We calculated the percentages and standard errors of dimensions, and the deciles, percentiles 5 and 95, means, and 95% confidence intervals of the health index. RESULTS: All the hypotheses established a priori for known groups were confirmed (P < 0.001). The EQ-5D-5L index indicated worse health in groups with lower education level (from 0.94 to 0.87), higher number of chronic conditions (0.96-0.79), probable psychiatric disorder (0.94 vs 0.80), strong limitations (0.96-0.46), higher number of days of restriction (0.93-0.64) or confinement to bed (0.92-0.49), and hospitalized in the previous 12 months (0.92 vs 0.81). CONCLUSIONS: The EQ-5D-5L is a valid instrument to measure perceived health in the Spanish-speaking population. The representative population-based norms provided here will help improve the interpretation of results obtained with the new EQ-5D-5L.

Impact of monitoring health-related quality of life in clinical practice in children with type 1 diabetes mellitus.

PURPOSE: To test whether the systematic monitoring of health-related quality of life (HRQOL) in clinical practice in Spanish pediatric patients with T1DM helps improve their daily life in a multicenter longitudinal study. METHODS: One hundred thirty-six patients participated, recruited from five centers in Barcelona, Spain (72 girls, mean age 13.4 years). Complete data were collected for 119 patients (85%). Pediatricians were randomly assigned to the HRQOL intervention (n = 70), or control group (n = 49). The intervention group discussed the results of HRQOL face to face with the physician, quarterly over a year. The control group received care as usual. HRQOL was assessed using KIDSCREEN-27 collected online. Standardized mean differences (effect size, ES) and generalized estimating equation (GEE) were computed to compare group differences between baseline and follow-up, taking into account sociodemographic and clinical variables. RESULTS: Statistically significant higher scores were seen in the intervention group at follow-up for the dimensions of Psychological well-being (ES = 0.56), School environment (ES = 0.56), and the KIDSCREEN-10 index (ES = 0.63). No differences were found in the control group. GEE analysis showed an improvement in HRQOL at follow-up with statistically significant association of the intervention on Psychological well-being (B = 4.32; p 0.03 for the interaction of group by follow-up) and School environment (B = 4.64; p 0.02 for the same interaction term). CONCLUSIONS: Routine assessment and face-to-face patient-physician discussion of HRQOL results improved HRQOL scores after a year of follow-up, especially in Psychological well-being and school environment. The results support the routinary use of HRQOL assessment in clinical practice.

Health-related quality of life (HRQOL) and its associated factors in children with Type 1 Diabetes Mellitus (T1DM).

BACKGROUND: The objective of the study was to describe the baseline health-related quality of life (HRQOL) in a cohort of children and adolescents with type 1 diabetes mellitus (T1DM), and analyze its associated clinical and sociodemographic factors, assessing HRQOL through internet. METHODS: This was a descriptive study of 136 patients with T1DM from 5 hospitals in Catalonia, Spain (72 girls, mean age 13.4 years (range 8-19). Inclusion criteria were more than 6 months from diagnosis, more than 8 years old and without cognitive problems. Sociodemographic (age, sex, family level of education, type of family and origin) and clinical variables (type of insulin therapy, duration of disease, adherence to treatment, body mass index and HbA1c) were collected. HRQOL was assessed using the EuroQol-5D (EQ-5D-Y) and KIDSCREEN, collected via web. Mental health status was assessed using the Strengths and Difficulties Questionnaire. Multiple linear regression models were adjusted. RESULTS: Physical-well-being mean scores were lower (worse) than the European average (<50) and especially in girls, older children (>11 years old), those from single-parent families, and those with low adherence. Older children and patients with poor metabolic control (HbA1c >7,5% [58 mmol/mol]) showed worse scores in the KIDSCREEN-10 index. Similar results were observed with the EQ-5D-Y. Multivariate models showed that age, single-parent families, adherence and mental health were the most influential factors. CONCLUSIONS: Diabetic patients report similar HRQOL than the population of the same age with slightly worse physical well-being. The study shows some factors to be taken into account to improve HRQOL, and also the feasibility of using web to collect information in clinical practice.

Understanding the impact of the economic crisis on child health: the case of Spain.

INTRODUCTION: The objectives of the study were to explore the effect of the economic crisis on child health using Spain as a case study, and to document and assess the policies implemented in response to the crisis in this context. METHODS: Serial cross-sectional data from Eurostat, the Spanish Health Interview Survey, and the database of childhood hospitalisation were analysed to explore impacts on child health, and key determinants of child health. A content analysis of National data sources/government legislation, and Spanish literature was used to describe policies implemented following the crisis. RESULTS: Unemployment rates in the general population (8.7% in 2005 and 25.6% in 2013), and children living in unemployed families (5.6% and 13.8%) increased in the study period. The percentage of children living under the poverty line, and income inequalities increased 15-20% from 2005 to 2012. Severe material deprivation rate has worsened in families with Primary Education, while the number of families attending Non-Governmental Organisations has increased. An impact on children's health at the general population level has not currently been detected; however an impact on general health, mental health and use of healthcare services was found in vulnerable groups. Investment in social protection and public policy for children showed a reduction as part of austerity measures taken by the Spanish governments. CONCLUSIONS: Despite the impact on social determinants, a short-term impact on child health has been detected only in specific vulnerable groups. The findings suggest the need to urgently protect vulnerable groups of children from the impact of austerity.

Development of the web-based Spanish and Catalan versions of the Euroqol 5D-Y (EQ-5D-Y) and comparison of results with the paper version.

BACKGROUND: The objectives of the study were to develop web-based Spanish and Catalan versions of the EQ-5D-Y, and to compare scores and psychometric properties with the paper version. METHODS: Web-based and paper versions of EQ-5D-Y were included in a cross-sectional study in Palafolls (Barcelona), Spain and administered to students (n = 923) aged 8 to 18 years from 2 primary and 1 secondary school and their parents. All students completed both the web-based and paper versions during school time with an interval of at least 2 h between administrations. The order of administration was randomized. Participants completed EQ-5D-Y, a measure of mental health status (the Strengths and Difficulties Questionnaire), and sociodemographic variables using a self-administered questionnaire. Parents questionnaire included parental level of education and presence of chronic conditions in children. Missing values, and floor and ceiling effects were compared between versions. Mean score differences were computed for the visual analogue scale (VAS). Percentage of agreement, kappa index (k) and intraclass correlation coefficient (ICC) were computed to analyze the level of agreement between web-based and paper versions on EQ-5D-Y dimensions and VAS. Known groups validity was analyzed and compared between the two formats. RESULTS: Participation rate was 77 % (n = 715). Both formats of EQ-5D-Y showed low percentages of missing values (n = 2, and 4 to 9 for web and paper versions respectively), and a high ceiling effect by dimension (range from 79 % to 96 %). Percent agreement for EQ-5D-Y dimensions on the web and paper versions was acceptable (range 89 % to 97 %), and k ranged from 0.55 (0.48-0.61, usual activities dimension) to 0.75 (0.68-0.82, mobility dimension). Mean score difference on the VAS was 0.07, and the ICC for VAS scores on the two formats was 0.84 (0.82-0.86). Both formats showed acceptable ability to discriminate according to self-perceived health, reporting chronic conditions, and mental health status. CONCLUSIONS: The digital EQ-5D-Y showed almost identical VAS scores and acceptable levels of agreement on dimensions. Both formats demonstrated acceptable levels of construct validity. Availability of the Spanish and Catalan web-version will facilitate its use in HRQOL assessment and in economic evaluation.

Assessing health-related quality of life in patients with heart failure: a systematic, standardized comparison of available measures.

To systematically evaluate available health-related quality of life (HRQL) instruments for use in patients with heart failure (HF). Seven HF-specific HRQL questionnaires and associated studies of their metric properties were identified by systematic review: the Chronic Heart Failure Assessment Tool, the Cardiac Health Profile congestive heart failure, the Chronic Heart Failure Questionnaire (CHFQ), the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Left Ventricular Disease Questionnaire (LVDQ), the Minnesota Living with Heart Failure Questionnaire (MLHFQ), and the Quality of Life in Severe Heart Failure Questionnaire. Each instrument was assessed by four experts using a standardized tool for evaluating patient-reported outcomes (EMPRO; scores from 0 to 100). Four questionnaires were given adequate scores (median >50) for the attribute "conceptual model." The LVDQ had the highest rated median for "reliability" (72.8). The CHFQ, the KCCQ, and the MLHFQ all got reasonable scores for "validity" (from 54.4 to 76.4). The reviewers rated the KCCQ the highest in terms of "sensitivity to change" (median 94.4). Only the CHFQ (50.0) and the KCCQ (72.2) received adequate scores for the "interpretability" attribute. The most highly rated instruments based on the overall EMPRO score were the KCCQ (64.4) and the MLHFQ (60.7), followed by the CHFQ (59.2). Based on the first systematic and reliable expert-based evaluation of available HF-specific HRQL questionnaires, the evidence seems to support the choice of the KCCQ, the MLHFQ, and the CHFQ over the others, which require further research on metric properties.

Assessing quality of life in patients with prostate cancer: a systematic and standardized comparison of available instruments.

PURPOSE: The objective was to obtain a standardized evaluation of available prostate cancer-specific quality of life instruments used in patients with early-stage disease. METHODS: We carried out systematic literature reviews in the PubMed database to identify manuscripts which contained information regarding either the development process or metric properties of prostate cancer-specific quality of life instruments. Each instrument was evaluated by two experts, independently, using the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. An overall and seven attribute-specific EMPRO scores were calculated (range 0-100, worst to best): measurement model, reliability, validity, responsiveness, interpretability, burden and alternative forms. RESULTS: Eight instruments and 57 manuscripts (2-15 per instrument) were identified. The Expanded Prostate Cancer Index Composite (EPIC) was the best rated (overall EMPRO score 83.1 points). Good results were also obtained by University of California Los Angeles-Prostate Cancer Index (UCLA-PCI), Patient-Oriented Prostate Utility Scale (PORPUS) and Prostate Cancer Quality of Life Instrument (PC-QoL) with 77.3, 70.5 and 64.8 points, respectively. These four instruments passed with distinction the validity and responsiveness evaluation. Insufficient reliability results were observed for UCLA-PCI and PORPUS. CONCLUSIONS: Current evidence supports the choice of EPIC, PORPUS or PC-QoL. Attribute-specific EMPRO results facilitate selecting the adequate instrument for every purpose. For longitudinal studies or clinical trials, where responsiveness is the priority, EPIC or PC-QoL should be considered. We recommend the PORPUS for economic evaluations because it allows cost-utility analysis, and EPIC short versions to minimize administration burden.

Reference values of the Strengths and Difficulties Questionnaire (SDQ) version for parents in the Spanish population, 2006.

INTRODUCTION: The Strengths and Difficulties Questionnaire (SDQ) is one of the most frequently used screening test for children and adolescents mental health (MH). In 2006, the Spanish National Health Survey included the child's MH section through the SDQ version for parents. OBJECTIVE: To obtain reference values of the SDQparents Spanish version for the 4-15 year-old population living in Spain during 2006-2007. METHODOLOGY: From the Spanish National Health Survey-2006, measurements of central tendency, dispersion and percentiles scores were calculated for the "Total Difficulties Score" (TDS-SDQ) Index and for the five dimensions of the questionnaire. RESULTS: A sample made up of 6266 children, ages 4 to 15 years, having national representativeness was obtained. Regarding the TDS-SDQ Index, scores were higher (worse MH) in boys than in girls (9.66 vs 9.04) and were higher in the younger age group in the total sample (9.90, 9.49 and 8.73) and also in boys. Girls scored higher than boys on the emotional symptoms and prosocial dimensions, and the scores were higher in older age group for the total sample. Regarding behavior problems, the younger age group scored higher in the total sample (2.19, 1.87 and 1.76) and by sex. Boys scored higher than girls on hyperactivity (4.51 vs. 3.92) and scores were lower in older ages in total sample (4.71, 4.19 and 3.82) and by sex. Peer problems dimension has no statistically significant differences by sex or age. CONCLUSIONS: The population values shown are informative and extend the knowledge and interpretation of the SDQ results.

Impact of a multi-level intervention to prevent secondhand smoke exposure in schoolchildren: a randomized cluster community trial.

OBJECTIVE: To assess the effectiveness of a multi-level (individual, family, and school) school-based intervention to prevent the exposure to secondhand smoke (SHS) in a population of schoolchildren (12-14 years old). METHOD: This was a community trial with cluster randomization of schools to an intervention and comparison group (ClinicalTrials.Gov identifier NCT01881607). The intervention targeted schoolchildren in Terrassa (Catalonia, Spain). We assessed SHS exposure in different settings and tobacco consumption by means of a questionnaire before and one year after the intervention. RESULTS: We analyzed data from 1734 students with both baseline and follow-up data. The crude analysis showed that SHS exposure among students in the intervention group significantly decreased at school (-14.0%), at home (-19.9%), and on transportation (-21.8%). In the comparison group, SHS exposure significantly decreased only at home (-16.9%). After adjustment for potential confounders, the good accomplishment of the activities showed a possible trend towards a non-significant reduction in exposure at home, transportation, and leisure time. CONCLUSION: While this school-based multi-level intervention had no overall effect in SHS exposure, the improvement of the activities focused on preventing SHS would be needed in order to achieve a significant decrease in the proportion of children exposed to SHS.

Pediatric patient-reported outcome instruments for research to support medical product labeling: report of the ISPOR PRO good research practices for the assessment of children and adolescents task force.

BACKGROUND: Patient-reported outcome (PRO) instruments for children and adolescents are often included in clinical trials with the intention of collecting data to support claims in a medical product label. OBJECTIVE: The purpose of the current task force report is to recommend good practices for pediatric PRO research that is conducted to inform regulatory decision making and support claims made in medical product labeling. The recommendations are based on the consensus of an interdisciplinary group of researchers who were assembled for a task force associated with the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). In those areas in which supporting evidence is limited or in which general principles may not apply to every situation, this task force report identifies factors to consider when making decisions about the design and use of pediatric PRO instruments, while highlighting issues that require further research. GOOD RESEARCH PRACTICES: Five good research practices are discussed: 1) Consider developmental differences and determine age-based criteria for PRO administration: Four age groups are discussed on the basis of previous research (<5 years old, 5-7 years, 8-11 years, and 12-18 years). These age groups are recommended as a starting point when making decisions, but they will not fit all PRO instruments or the developmental stage of every child. Specific age ranges should be determined individually for each population and PRO instrument. 2) Establish content validity of pediatric PRO instruments: This section discusses the advantages of using children as content experts, as well as strategies for concept elicitation and cognitive interviews with children. 3) Determine whether an informant-reported outcome instrument is necessary: The distinction between two types of informant-reported measures (proxy vs. observational) is discussed, and recommendations are provided. 4) Ensure that the instrument is designed and formatted appropriately for the target age group. Factors to consider include health-related vocabulary, reading level, response scales, recall period, length of instrument, pictorial representations, formatting details, administration approaches, and electronic data collection (ePRO). 5) Consider cross-cultural issues. CONCLUSIONS: Additional research is needed to provide methodological guidance for future studies, especially for studies involving young children and parents' observational reports. As PRO data are increasingly used to support pediatric labeling claims, there will be more information regarding the standards by which these instruments will be judged. The use of PRO instruments in clinical trials and regulatory submissions will help ensure that children's experience of disease and treatment are accurately represented and considered in regulatory decisions.

Parent-child agreement on health-related quality of life (HRQOL): a longitudinal study.

BACKGROUND: Few studies have evaluated changes on parent-child agreement in HRQOL over time. The objectives of the study were to assess parent-child agreement on child's HRQOL in a 3-year longitudinal study, and to identify factors associated with possible disagreement. METHODS: A sample of Spanish children/adolescents aged 8-18 years and their parents both completed the KIDSCREEN-27 questionnaire. Data on age, gender, family socioeconomic status (SES), and mental health (Strengths and Difficulties Questionnaire, SDQ) was also collected at baseline (2003), and again after 3 years (2006). Changes in family composition were collected at follow-up. Agreement was assessed through intraclass correlation coefficient (ICC), and Bland and Altman plots. Generalizing Estimating Equation (GEE) models were built to analyze factors associated with parent-child disagreement. RESULTS: A total of 418 parent-child pairs were analyzed. At baseline the level of agreement on HRQOL was low to moderate and it was related to the level of HRQOL reported. Physical well-being at baseline showed the highest level of parent-child agreement (ICC=0.59; 0.53-0.65) while less "observable" dimensions presented lower levels of agreement, (i.e. Psychological well-being: ICC= 0.46; 0.38-0.53). Agreement parent-child was lower at follow-up. Some interactions were found between rater and child's age; with increasing age, child scored lower than parents on Parents relationships and Autonomy (Beta [B] -0.47; -0.71 / -0.23) and the KIDSCREEN-10 (-0.49; -0.73 /-0.25). CONCLUSIONS: Parent-child agreement on child's HRQOL is moderate to low and tends to diminish with children age. Measuring HRQOL of children/adolescents mainly in healthy population samples might require direct self-assessments.

Environmental risk and protective factors of adolescents' and youths' mental health: differences between parents' appraisal and self-reports.

PURPOSE: We investigated the effect of parents' mental health, life events, and home life (among other factors) on adolescents'/youths' mental health, whether such an effect varies when several variables are assessed jointly, and also whether the informant source of the mental health problem modifies the estimations. METHODS: We studied a representative sample of 454 Spanish adolescents/youths studied longitudinally (2 assessments, 3 years apart). We considered factors associated with adolescents'/youths' mental health (conduct, emotional, and hyperactivity scores [SDQ]): risk factors (parents' mental health and life events) and mediators (social and financial support). Structural equation modeling was applied. We constructed two models: (a) with parents' SDQ responses and (b) with self-reported SDQ responses (in a subsample of N = 260). RESULTS: Model fit was adequate for parents' appraisal. Parents' mental health (p < 0.05) and undesirable life events (p < 0.05) were the most important risk factors. The same model showed poorer fit when self-reported measures were used. Home life exerted a stronger protective effect on adolescents'/youths' mental health when reported by adolescents/youths. The negative effect of parents' mental health was significantly protected by home life in emotional [-0.14 (0.07)] and hyperactivity scores [-0.2 (0.08)]. CONCLUSIONS: Even in the presence of other factors, parents' mental health has an important effect on adolescents'/youths' mental health. Good levels of home life are protective, especially when adolescents'/youths' mental health is self-reported.

Living in two homes-a Swedish national survey of wellbeing in 12 and 15 year olds with joint physical custody.

BACKGROUND: The practice of joint physical custody, where children spend equal time in each parent's home after they separate, is increasing in many countries. It is particularly common in Sweden, where this custody arrangement applies to 30 per cent of children with separated parents. The aim of this study was to examine children's health-related quality of life after parental separation, by comparing children living with both parents in nuclear families to those living in joint physical custody and other forms of domestic arrangements. METHODS: Data from a national Swedish classroom study of 164,580 children aged 12 and 15-years-old were analysed by two-level linear regression modelling. Z-scores were used to equalise scales for ten dimensions of wellbeing from the KIDSCREEN-52 and the KIDSCREEN-10 Index and analysed for children in joint physical custody in comparison with children living in nuclear families and mostly or only with one parent. RESULTS: Living in a nuclear family was positively associated with almost all aspects of wellbeing in comparison to children with separated parents. Children in joint physical custody experienced more positive outcomes, in terms of subjective wellbeing, family life and peer relations, than children living mostly or only with one parent. For the 12-year-olds, beta coefficients for moods and emotions ranged from -0.20 to -0.33 and peer relations from -0.11 to -0.20 for children in joint physical custody and living mostly or only with one parent. The corresponding estimates for the 15-year-olds varied from -0.08 to -0.28 and from -0.03 to -0.13 on these subscales. The 15-year-olds in joint physical custody were more likely than the 12-year-olds to report similar wellbeing levels on most outcomes to the children in nuclear families. CONCLUSIONS: Children who spent equal time living with both parents after a separation reported better wellbeing than children in predominantly single parent care. This was particularly true for the 15-year-olds, while the reported wellbeing of 12-years-olds was less satisfactory. There is a need for further studies that can account for the pre and post separation context of individual families and the wellbeing of younger age groups in joint physical custody.

Migrant density and well-being--a national school survey of 15-year-olds in Sweden.

BACKGROUND: The aim of this study was to investigate the impact of migrant density in school on the well-being of pupils with a migrant origin in first as well as second generation. METHODS: Cross-sectional analysis of data from a national classroom survey of 15-year-old Swedish schoolchildren. The study population included 76 229 pupils (86.5% participation) with complete data set from 1352 schools. Six dimensions of well-being from the KIDSCREEN were analysed in two-level linear regression models to assess the influence of migrant origin at individual level and percentage of students with a migrant origin at school level, as well as interaction terms between them. Z-scores were used to equalize scales. RESULTS: A high density (>50%) of pupils with a migrant origin in first or second generation was associated with positive well-being on all six scales for foreign-born pupils originating in Africa or Asia compared with schools with low (<10%) migrant density. The effect sizes were 0.56 for boys and 0.29 for girls on the comprehensive KIDSCREEN 10-index (P<0.001) and 0.61 and 0.34, respectively, for psychological well-being (P<0.001). Of the boys and girls born in Africa or Asia, 31.6% and 34.6%, respectively, reported being bullied during the past week in schools with low (<10%) migrant density. CONCLUSIONS: Pupils born in Africa or Asia are at high risk for being bullied and having impaired well-being in schools with few other migrant children. School interventions to improve peer relations and prevent bullying are needed to promote well-being in non-European migrant children.