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Aims/hypothesis: Psychological stress has long been considered a possible trigger of type 1 diabetes, although prospective studies examining the link between psychological stress or life events during pregnancy and the child's type 1 diabetes risk are rare. The objective of this study was to examine the association between life events during pregnancy and first-appearing islet autoantibodies (IA) in young children, conditioned by the child's type 1 diabetes-related genetic risk., Methods: The IA status of 7317 genetically at-risk The Environmental Determinants of Diabetes in the Young (TEDDY) participants was assessed every 3 months from 3 months to 4 years, and bi-annually thereafter. Reports of major life events during pregnancy were collected at study inception when the child was 3 months of age and placed into one of six categories. Life events during pregnancy were examined for association with first-appearing insulin (IAA) (N = 222) or GAD (GADA) (N = 209) autoantibodies in the child until 6 years of age using proportional hazard models. Relative excess risk due to interaction (RERI) by the child's HLA-DR and SNP profile was estimated., Results: Overall, 65% of mothers reported a life event during pregnancy; disease/injury (25%), serious interpersonal (28%) and job-related (25%) life events were most common. The association of life events during pregnancy differed between IAA and GADA as the first-appearing autoantibody. Serious interpersonal life events correlated with increased risk of GADA-first only in HLA-DR3 children with the BACH2-T allele (HR 2.28, p < 0.0001), an additive interaction (RERI 1.87, p = 0.0004). Job-related life events were also associated with increased risk of GADA-first among HLA-DR3/4 children (HR 1.53, p = 0.04) independent of serious interpersonal life events (HR 1.90, p = 0.002), an additive interaction (RERI 1.19, p = 0.004). Job-related life events correlated with reduced risk of IAA-first (HR 0.55, p = 0.004), particularly in children with the BTNL2-GG allele (HR 0.48; 95% CI 0.31, 0.76)., Conclusions/interpretation: Specific life events during pregnancy are differentially related to IAA vs GADA as first-appearing IA and interact with different HLA and non-HLA genetic factors, supporting the concept of different endotypes underlying type 1 diabetes. However, the mechanisms underlying these associations remain to be discovered. Life events may be markers for other yet-to-be-identified factors important to the development of first-appearing IA.

The aim of this study was to conduct a prospective analysis of the association between negative life events (NLEs) and respiratory infections in children genetically at risk for islet autoimmunity (IA) and type 1 diabetes (T1D). Long- and short-term temporal associations between NLEs and rate of respiratory infection episodes (RIEs) in 5,618 children in The Environmental Determinants of Diabetes in the Young study for at least 1 up to 4 years were analysed. All models were adjusted for demographic, day care, season of infection, and psychosocial factors associated with the rate of child RIEs between study visits. The rate of child RIEs was 26% higher in Europe (Sweden, Finland, Germany) than in the United States (rate ratio [RR] = 1.26, p < 0.001). However, the percentage of child NLEs (odds ratio [OR] = 1.18, p < 0.001) and mother NLEs (OR = 1.83, p < 0.001) was higher in the United States compared with Europe. In both continents (Europe, RR = 1.12, p < 0.001; United States, RR = 1.07, p = 0.006), high child cumulative NLEs (>1 NLE per year since study inception) was significantly associated with an increased rate of child RIEs. This large-scale prospective study confirms observations that stress may increase the susceptibility for infections in paediatric populations and suggests at least one mechanism by which stress could increase risk for IA and T1D in genetically at risk children., (© 2019 John Wiley & Sons, Ltd.)

Objective: The TEDDY Study is an international, multi-center prospective study designed to identify the environmental triggers of type 1 diabetes (T1D) in genetically at-risk children. This report investigates ethnic minority (EM) differences in patterns of enrollment and retention in the US centers., Methods: As of June 2009, 267,739 newborns had been screened at birth for high risk T1D genotypes. Data collected at the time of screening, enrollment and at the baseline visit were used. Descriptive and multiple-logistic regression analyses assessed differences between EM groups regarding exclusion, enrollment and early withdrawal., Results: Of the 10,975 eligible subjects, 6,912 (67%) were invited to participate. EM subjects were more likely to be excluded because of an inability to contact. Of those invited 3,265 (47%) enrolled by the age of 4.5 months. Adjusted analyses showed that except for those classified as other EM, the odds of enrolling were similar across groups. EM subjects had elevated early withdrawal rates. Adjusted models demonstrated that this was significantly more likely among Hispanic subjects., Conclusion: Understanding patterns associated with EM participation in research extends our ability to make more accurate inferences and permits assessment of strategies that promote inclusion of EM to better address health disparities., (Copyright © 2012 Elsevier Inc. All rights reserved.)

This paper deals with the current regulatory and legal settings of traditional plant food supplements and herbal medicinal products in the European Union (EU). Marketing of botanicals in foods and food supplements in the EU is subject to several provisions of food law, which cover aspects of safety, production, labelling and product composition, including the use of additives and maximum levels of contaminants and residues. However, due to limited harmonization at the EU level, specific national regulations adopted at a Member State level also apply and mutual recognition is the mechanism through which such products can be marketed in EU countries other than those of origin. Unlike food supplements, marketing of traditional herbal medicinal products is regulated by an ad hoc Directive (i.e. Directive 2004/24/EC) covering in detail all the relevant aspects of these products, including a facilitated registration procedure at national level. However, by distinguishing traditional herbal medicinal products from plant food supplements and establishing selective marketing modalities for these two product categories, the EU has been confronted with implementation difficulties for traditional herbal medicinal products and a lack of homogeneity in the regulatory approaches adopted in different EU Member States. In fact, currently the nature of the commercial botanical products made available to consumers as traditional medicinal products or food supplements, depends largely on the EU Member State under consideration as a consequence of how competent National Authorities and manufacturing companies interpret and apply current regulations rather than on the intrinsic properties of the botanical products and their constituents. When the EU approach is compared with approaches adopted in some non-European countries to regulate these product categories, major differences become evident.

Objective: Our objective was to identify characteristics of infants and their families who were enrolled, refused to enroll, or were excluded from The Environmental Determinants of Diabetes in the Young (TEDDY) study., Method: 16,435 infants screened at birth and identified as at increased genetic risk for type 1 diabetes (T1DM) were placed into one of three categories: enrolled, excluded, or refused to enroll. Enrollment, exclusion and refusal rates were compared across countries and between infants from the general population (GP) and infants with a first degree T1DM relative (FDR). A multivariate logistic model was used to identify factors associated with TEDDY enrollment., Results: TEDDY enrollment, exclusion, and refusal rates differed by country and by GP/FDR status but reasons for refusal to enroll were similar across countries and GP/FDR populations. Sweden had the highest enrollment rate, US had the highest exclusion rate, and Finland had the highest refusal rate. FDR infants were more likely to enroll than GP infants. Inability to re-contact the family was the most common reason for exclusion. Primary reasons for refusal to enroll included protocol factors (e.g. blood draws) or family factors (e.g., too busy). Study enrollment was associated with FDR status, European country of origin, older maternal age, a singleton birth, and having another child in TEDDY., Conclusions: Findings highlight the importance of country specific estimates for enrollment targets in longitudinal pediatric studies and suggest that enrollment estimates should be lowered when the study involves the general population, painful procedures, or makes multiple demands on families., (Copyright © 2011 Elsevier Inc. All rights reserved.)

Objective: The Environmental Determinants of Diabetes in the Young (TEDDY) study seeks to identify environmental triggers of autoimmunity and type 1 diabetes mellitus (T1DM) in children at increased human-leukocyte-antigen conferred genetic risk for this disease. The objective of this study was to identify predictors of early withdrawal from TEDDY among families with no immediate family history of T1DM., Method: Logistic multiple regression was used to discriminate 2994 (83%) families currently active in the TEDDY study for ≥1 yr from 763 (17%) families who withdrew in the first year. Data collected on the screening form at the time of the child's birth and from interview and questionnaire data obtained at the baby's first study visit (at ≤4.5 months of age) were used., Results: Significant and independent predictors of early withdrawal included country of residence, young maternal age, no father participation, and female gender of the study participant. Mothers of children who withdrew were more likely to report smoking during pregnancy, abstaining from alcohol, and reducing their work hours or not working at all during pregnancy. Mothers who withdrew were also more likely to underestimate their child's risk for T1DM and fail to respond to multiple items on the enrollment questionnaires or interview. Among mothers with accurate risk perceptions, those experiencing high anxiety about their child's risk were more likely to be early withdrawals., Conclusions: Identifying families at high risk for study withdrawal at the time of enrollment allows for targeting these families with individually tailored plans to help maintain their participation in the study., (© 2010 John Wiley & Sons A/S.)

Catholic Healthcare West, San Francisco (CHW), has developed a national Community Need Index (CNI) in partnership with Solucient, an information products company, to help health care organizations, not-for-profits, and policymakers identify and address barriers to health care access in their communities. The CNI aggregates five socioeconomic indicators long known to contribute to health disparity--income, culture/language, education, housing status, and insurance coverage--and applies them to every zip code in the United States. Each zip code is then given a score ranging from 1.0 (low need) to 5.0 (high need). Residents of communities with the highest CNI scores were shown to be twice as likely to experience preventable hospitalization for manageable conditions--such as ear infections, pneumonia or congestive heart failure--as communities with the lowest CNI scores. The CNI provides compelling evidence for addressing socioeconomic barriers when considering health policy and local health planning. The tool highlights health care disparities between geographic regions and illustrates the acute needs of several notable geographies, including inner city and rural areas.Further, it should enable health care providers, policymakers, and others to allocate resources where they are most needed, using a standardized, quantitative tool. The CNI provides CHW with an important means to strategically allocate resources where it will be most effective in maintaining a healthy community.

Study Objective: Literature reports indicate an increasing number of cases of hyponatremia in athletes participating in moderate endurance events such as standard marathons. In this study, we evaluated the incidence of hyponatremia in marathon finishers requiring medical treatment on-site and attempted to assess the contribution of fluid type ingested and nonsteroidal antiinflammatory drug (NSAID) use to the development of hyponatremia., Methods: We examined a prospective, convenience sample of runners requiring intravenous hydration at the final medical tent of a standard marathon course and a comparison group of finishers who did not require intravenous hydration. After giving informed consent, subjects had blood drawn and answered a questionnaire regarding fluid intake on the course and NSAID use before the race. Blood samples were analyzed on-site for serum sodium values as well as other hematologic parameters., Results: Fifty-one subjects requiring intravenous hydration as well as 11 subjects who did not were enrolled. Three subjects (5.6%; 95% CI, 0-11.9%; missing = 8) in the intravenous hydration group had serum sodium less than 130 mEq/L. None of the three runners suffered neurologic or pulmonary consequences and only one required overnight hospital admission for hydration. The small number of hyponatremic subjects precluded the analysis of the role of fluid type or NSAID use in the development of hyponatremia or the development of a model for prediction., Conclusion: This study found a 5.6% incidence of hyponatremia in marathon runners requiring medical treatment.

One hundred eighty-seven cases of cardiac arrest of presumed cardiac etiology were analyzed to determine factors associated with successful out-of-hospital management by paramedic teams. Field and in-hospital records were reviewed to determine the response time of the advanced life support team, the ECG rhythm on arrival, the presence of paramedics on scene at the time of the arrest, whether bystander CPR had been initiated, and the eventual outcome of the resuscitation attempt. A significant difference in survival-to-leave-hospital was seen in patients in whom ventricular fibrillation or ventricular tachycardia (VF/VT) was present on arrival (15.3%) compared to patients with asystole, idioventricular rhythms, blocks, or electromechanical dissociation (3.4%). Survival rates in patients in whom CPR was being performed by a bystander were 24% in the VF/VT group and zero in the "OTHER" rhythms group. When the advanced life support team arrived in less than four minutes, survival rates in the VF/VT group and "OTHER" rhythms group were 23.1% and 7.7%, respectively. When the field team arrived in less than four minutes and a bystander was performing CPR, the survival rates were 42.9% in the VF/VT group and 15.8% in the "OTHER." These data suggest that efforts to improve survival from out-of-hospital cardiac arrest in a community should be directed toward public education, reduction in response times of paramedic units, and lay CPR training.

HMO contracting requires a detailed knowledge of patient costs. We addressed the need for sophisticated cost accounting and patient information systems as it pertains to HMO contracting. Agencies cannot afford to overlook the global applications of such systems. The ability of an agency to make informed and competitive financial decisions in any price-based payment environment is critical. A system that can accurately identify and assist with forecasting costs will be a valuable asset for an agency as it moves toward the price-based payment environment of the future.