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The participation of children in medical research raises many ethical issues, in particular regarding assent. However, little is known about children's own views on participation. This study presents results from interviews with children 10–12 years old with and without experience in a large-scale longitudinal screening study. We identified five themes: (1) knowledge about research, (2) a sense of altruism, (3) shared decision-making and right to dissent, (4) notions of integrity, privacy, and access, and (5) understanding of disease risk and personal responsibilities. We conclude that the children feel positive towards medical research, and want to take an active part in decisions and have their integrity respected. However, the study also indicates that children who had participated in longitudinal screening had a limited understanding, suggesting the vital importance of providing information appropriate to their age and maturity. This information should be provided out of respect for the children as persons, but also to promote their willingness to continue participating in longitudinal studies.

[Background] The infant microbiota may play a pathogenic role in coeliac disease (CD). Antibiotic treatment in pregnancy is common and could significantly impact the infant microbiota. In this study, we aimed to investigate the association between antibiotic exposure during pregnancy and CD in offspring. ; [Methods] Prospective questionnaire data on antibiotic exposure in pregnancy were available in 8729 children participating in the All Babies in Southeast Sweden (ABIS) cohort study, and of these 46 developed CD until December 2006. Cox regression estimated hazard ratios (HRs) for CD in the offspring among mothers exposed to antibiotics during pregnancy, with adjustment for parent-reported diary data on breastfeeding, age at gluten introduction and number of infections in the child's first year of life. ; [Results] Of the 1836 children exposed to antibiotics during pregnancy, 12 (0.7%) children developed CD as compared with 34/6893 (0.5%) unexposed children (HR = 1.33; 95% CI = 0.69-2.56). Risk estimates remained unchanged after adjustment for breastfeeding, age at gluten introduction and infection load in the child's first year of life (HR = 1.28; 95% CI = 0.66-2.48). ; [Conclusions] We found no statistically significant association between antibiotic exposure during pregnancy and CD in offspring. This lack of association may either be true or the result of limited statistical power. ; This work was supported by; KM: The Swedish Society of Medicine, Karolinska Institutet; JL: Swedish Child Diabetes Foundation (Barndiabetesfonden), Research Council for Southeast Sweden, ALF (Swedish Government), Canadian Research Council, Östgöta Brandstodsbolag, Östergötland County Council, EU Research Grants. YS: grants AGL2011-25169 and Consolider Fun-C-Food CSD2007-00063 from the Spanish Ministry of Economy and Competitiveness; JFL: The Swedish Society of Medicine, the Swedish Research Council, the Örebro Society of Medicine, the Karolinska Institutet, and the Swedish Celiac Society. ; Peer Reviewed

There are an increasing number of medical research studies involving children, including many long-term birth cohort studies. Involving children raises many issues, and little is known about children's own views. This study explored children's views ( N = 5,851) on participation in a long-term screening study for type 1 diabetes. The results show that children 10 to 13 years of age have in general a positive attitude to pediatric research and emphasized trust in researchers. The children stressed the importance to receive information and to be involved in decisions. The children also reported feeling concerned about blood sampling and disease risk. Researchers involved in long-term pediatric research need to address these issues to promote involvement and decrease worry.

OBJECTIVE To evaluate if the lowest target level for glycated haemoglobin (HbA(1c)) of amp;lt; 6.5% is associated with lower risk for retinopathy and nephropathy than less tight control in children and adults with type 1 diabetes. DESIGN Population based cohort study. SETTING Swedish National Diabetes Registry, 1 January 1998 to 31 December 2017. PARTICIPANTS 10 398 children and adults with type 1 diabetes followed from diagnosis, or close thereafter, until end of 2017. MAIN OUTCOME MEASURES Relative risk (odds ratios) for retinopathy and nephropathy for different mean levels of HbA(1c). RESULTS Mean age of participants was 14.7 years (43.4% female), mean duration of diabetes was 1.3 years, and mean HbA(1c) level was 8.0% (63.4 mmol/mol). After adjustment for age, sex, duration of diabetes, blood pressure, blood lipid levels, body mass index, and smoking, the odds ratio for mean HbA(1c) amp;lt; 6.5% (amp;lt; 48 mmol/mol) compared with 6.5-6.9% (48-52 mmol/mol) for any retinopathy (simplex or worse) was 0.77 (95% confidence interval 0.56 to 1.05, P=0.10), for preproliferative diabetic retinopathy or worse was 3.29 (0.99 to 10.96, P=0.05), for proliferative diabetic retinopathy was 2.48 (0.71 to 8.62, P=0.15), for microalbuminuria or worse was 0.98 (0.60 to 1.61, P=0.95), and for macroalbuminuria was 2.47 (0.69 to 8.87, P=0.17). Compared with HbA(1c) levels 6.56.9%, HbA(1c) levels 7.0-7.4% (53-57 mmol/mol) were associated with an increased risk of any retinopathy (1.31, 1.05 to 1.64, P=0.02) and microalbuminuria (1.55, 1.03 to 2.32, P=0.03). The risk for proliferative retinopathy (5.98, 2.10 to 17.06, Pamp;lt;0.001) and macroalbuminuria (3.43, 1.14 to 10.26, P=0.03) increased at HbA(1c) levels amp;gt; 8.6% (amp;gt; 70 mmol/mol). The risk for severe hypoglycaemia was increased at mean HbA(1c) amp;lt; 6.5% compared with 6.5-6.9% (relative risk 1.34, 95% confidence interval 1.09 to 1.64, P=0.005). CONCLUSIONS Risk of retinopathy and nephropathy did not differ at HbA(1c) levels amp;lt; 6.5% but increased for severe hypoglycaemia compared with HbA(1c) levels 6.5-6.9%. The risk for severe complications mainly occurred at HbA(1c) levels amp;gt; 8.6%, but for milder complications was increased at HbA(1c) levels amp;gt; 7.0%. ; Funding Agencies|Swedish government; Novonordisk Foundation

Aims Albuminuria is strongly associated with risk of renal dysfunction, cardiovascular disease and mortality. However, clinical guidelines diverge, and evidence is sparse on what risk factor levels regarding blood pressure, blood lipids and BMI are needed to prevent albuminuria in adolescents and young adults with type 1 diabetes. Methods A total of 9347 children and adults with type 1 diabetes [mean age 15.3 years and mean diabetes duration 1.4 years at start of follow-up] from The Swedish National Diabetes Registry were followed from first registration until end of 2017. Levels for risk factors for a risk increase in nephropathy were evaluated, and the gradient of risk per 1 SD (standard deviation) was estimated to compare the impact of each risk factor. Results During the follow-up period, 8610 (92.1%) remained normoalbuminuric, 737 (7.9%) individuals developed micro- or macroalbuminuria at any time period of whom 132 (17.9% of 737) individuals developed macroalbuminuria. Blood pressure >= 140/80 mmHg was associated with increased risk of albuminuria (p = 1.0 mmol/L (p = 0.039), total cholesterol >= 5.0 mmol/L (p = 0.0003), HDL = 30 kg/m(2) (p = 0.033). HbA1c was the strongest risk factor for any albuminuria estimated by the measure gradient of risk per 1 SD, followed by diastolic blood pressure, triglycerides, systolic blood pressure, cholesterol and LDL. In patients with HbA1c > 65 mmol/mol (> 8.1%), blood pressure > 140/70 mmHg was associated with increased risk of albuminuria. Conclusions Preventing renal complications in adolescents and young adults with type 1 diabetes need avoidance at relatively high levels of blood pressure, blood lipids and BMI, whereas very tight control is not associated with further risk reduction. For patients with long-term poor glycaemic control, stricter blood pressure control is advocated. ; Funding Agencies|University of Gothenburg; Swedish government; Novo Nordisk FoundationNovo Nordisk FoundationNovocure Limited

Highly prevalent and typically beginning in childhood, asthma is a burdensome disease, yet the risk factors for this condition are not clarified. To enhance understanding, this study assessed the cohort-specific and pooled risk of maternal education on asthma in children aged 3-8 across 10 European countries. Data on 47,099 children were obtained from prospective birth cohort studies across 10 European countries. We calculated cohort-specific prevalence difference in asthma outcomes using the relative index of inequality (RII) and slope index of inequality (SII). Results from all countries were pooled using random-effects meta-analysis procedures to obtain mean RII and SII scores at the European level. Final models were adjusted for child sex, smoking during pregnancy, parity, mothers age and ethnicity. The higher the score the greater the magnitude of relative (RII, reference 1) and absolute (SII, reference 0) inequity. The pooled RII estimate for asthma risk across all cohorts was 1.46 (95% CI 1.26, 1.71) and the pooled SII estimate was 1.90 (95% CI 0.26, 3.54). Of the countries examined, France, the United Kingdom and the Netherlands had the highest prevalences of childhood asthma and the largest inequity in asthma risk. Smaller inverse associations were noted for all other countries except Italy, which presented contradictory scores, but with small effect sizes. Tests for heterogeneity yielded significant results for SII scores. Overall, offspring of mothers with a low level of education had an increased relative and absolute risk of asthma compared to offspring of high-educated mothers. ; Funding Agencies|European Unions Seventh Framework Programme as part of The Determinants to Reduce Health Inequity Via Early Childhood, Realising Fair Employment [278350]; Social Protection (DRIVERS) research programme; Ministry of Education of the Czech Republic: CETOCOEN plus project [CZ02101/00/00/15_003/0000469]; RECETOX Research Infrastructure [LM2015051]; Academy of Finland [FI-NFBC8586]; Biocenter, University of Oulu, Finland; European Commission EUROBLCS, Framework 5 Award [QLG1-CT-2000-01643]; EU [FP7 EurHEALTHAgeing-277849]; Medical Research Council, UK (PrevMetSyn/SALVE); MRC Centenary Early Career Award; Netherlands Organization for Health Research and Development (ZonMw) Grant (TOP) [40-00812-98-11010]; Juvenile Diabetes Research Foundation; Swedish Child Diabetes Foundation (Barndiabetesfonden); Research Council of South-east Sweden (FORSS); Swedish Research Council [K2005-72X-11242-11A]; ALF/County Council of Ostergotland; European Union, Spain (Instituto de Salud Carlos III) [FP7-ENV-2011-282957, HEALTH. 2010.2.4.5-1]; European Union, Spain (Ministry of Health) [FP7-ENV-2011-282957, HEALTH. 2010.2.4.5-1]; Conselleria de Sanitat of the Generalitat Valenciana; Department of Health of the Basque Government; Provincial Government of Gipuzkoa; Generalitat de Catalunya-CIRIT; US NIH Fogarty International Center; National Academy of Medical Sciences of Ukraine; Medical Research Council UK doctoral training studentship

Background A healthy start to life is a major priority in efforts to reduce health inequalities across Europe, with important implications for the health of future generations. There is limited combined evidence on inequalities in health among newborns across a range of European countries. Methods Prospective cohort data of 75 296 newborns from 12 European countries were used. Maternal education, preterm and small for gestational age births were determined at baseline along with covariate data. Regression models were estimated within each cohort and meta-analyses were conducted to compare and measure heterogeneity between cohorts. Results Mother's education was linked to an appreciable risk of preterm and small for gestational age (SGA) births across 12 European countries. The excess risk of preterm births associated with low maternal education was 1.48 (1.29 to 1.69) and 1.84 (0.99 to 2.69) in relative and absolute terms (Relative/Slope Index of Inequality, RII/SII) for all cohorts combined. Similar effects were found for SGA births, but absolute inequalities were greater, with an SII score of 3.64 (1.74 to 5.54). Inequalities at birth were strong in the Netherlands, the UK, Sweden and Spain and marginal in other countries studied. Conclusions This study highlights the value of comparative cohort analysis to better understand the relationship between maternal education and markers of fetal growth in different settings across Europe. ; All phases of this study were supported by a European Union's Seventh Framework Programme grant, 278350, as part of The Determinants to Reduce Health Inequity Via Early Childhood, Realising Fair Employment, and Social Protection (DRIVERS) research programme. The Czech ELSPAC Study was supported by the Ministry of Education of the Czech Republic (LM2011028, LO1214) and the Grant Agency of the Masaryk University (MUNI/M/1075/2013). The Northern Finland Birth Cohort (NFBC8586) received financial support from the Academy of Finland, Biocenter, University of Oulu, Finland, the European Commission (EURO-BLCS, Framework 5 award QLG1-CT-2000-01643), EU FP7 EurHEALTHAgeing -277849, the Medical Research Council, UK ( PrevMetSyn/SALVE) and the MRC Centenary Early Career Award.