Objective-The Environmental Determinants of Diabetes in the Young (TEDDY) study seeks to identify environmental triggers of autoimmunity and type 1 diabetes (T1DM) in children at increased HLA-conferred genetic risk for this disease. This study's objective 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 year from 763 (17%) 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. Study demands on TEDDY families are considerable and include blood draws, stool sample collections, diet records, interviews, and questionnaires. The participating infants are examined every three months until four years of age and every six months thereafter. Since TEDDY participation is both time-consuming and expensive for the families, the investigators and the funders, any loss of these valuable participants diminishes the power of the study to meet its objectivesIn this report, we describe family characteristics identified at study inception that predicted study withdrawal among general population families during the first year of the TEDDY study. This information may guide future efforts to retain families in studies like TEDDY and should prove useful in the design of future natural history epidemiological studies with pediatric populations. MethodsThe TEDDY study TEDDY is a natural history study that seeks to identify the environmental triggers of autoimmunity and T1DM onset in genetically at-risk children identified at three centers in the United States (Colorado, Washington, and Georgia/Florida) and three centers in Europe (Finland, Germany, and Sweden). Infants from the general population, as well as infants who have first degree relatives (FDR) with T1DM, are screened for genetic risk at birth using HLA genotyping. Parents with infants at increased genetic risk for T1DM are invited to participate in TEDDY. Parents are fully informed of the child's increased genetic risk and the protocol requirements of the TEDDY study, including the requirement that eligible infants must join TEDDY before the infant...

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.

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.

Aims/hypothesis Women are at higher risk of diabetesrelated cardiovascular complications than men. We tested the hypothesis that there are sex-specific differences in glucometabolic control, and in social and psychological factors. We also examined the influence of these factors on glucometabolic control. Methods We examined 257 (126 men/131 women) consecutive patients (64±9 years, means±SD) of a metropolitan diabetes outpatient service employing clinical testing and standardised psychological questionnaires. Results Mean HbA 1c (7.6±1.2%) was not different between women and men. Women patients on oral hypoglycaemic agents were better informed about diabetes (p=0.012). They employed more strategies for coping with diabetes, including religion (p=0.0001), active coping (p=0.048) and distraction (p=0.007). Women reported lower satisfaction with social support (p=0.034), but not more depression than men. Although no differences were observed in compliance, insulin-treated patients were more satisfied with their therapy (p=0.007). Variables predicting poor metabolic control were different in men (R 2 =0.737, p=0.012) and women (R 2 =0.597, p=0.019). Major predictors of high HbA 1c included depressive coping, lower sexual desire, quality of life and internal locus of control, but high external doctor-related locus of control in women and frequent emotional experiences of hyperglycaemia in men. Conclusions/interpretation Lower quality of life, internal control and socioeconomic status, and higher prevalence of negative emotions probably prevented woman patients from achieving improved glucose control despite their better knowledge of and greater efforts to cope with diabetes. We suggest that women patients would benefit from individualised diabetes care offering social support, whereas men would benefit from knowledge-based diabetes management giving them more informational and instrumental support.

The role of diet in type 1 diabetes development is poorly understood. Metabolites, which reflect dietary response, may help elucidate this role. We explored metabolomics and lipidomics differences between 352 cases of islet autoimmunity (IA) and controls in the TEDDY (The Environmental Determinants of Diabetes in the Young) study. We created dietary patterns reflecting pre-IA metabolite differences between groups and examined their association with IA. Secondary outcomes included IA cases positive for multiple autoantibodies (mAb+). The association of 853 plasma metabolites with outcomes was tested at seroconversion to IA, just prior to seroconversion, and during infancy. Key compounds in enriched metabolite sets were used to create dietary patterns reflecting metabolite composition, which were then tested for association with outcomes in the nested case-control subset and the full TEDDY cohort. Unsaturated phosphatidylcholines, sphingomyelins, phosphatidylethanolamines, glucosylceramides, and phospholipid ethers in infancy were inversely associated with mAb+ risk, while dicarboxylic acids were associated with an increased risk. An infancy dietary pattern representing higher levels of unsaturated phosphatidylcholines and phospholipid ethers, and lower sphingomyelins was protective for mAb+ in the nested case-control study only. Characterization of this high-risk infant metabolomics profile may help shape the future of early diagnosis or prevention efforts.

Aims: This study aimed to investigate burnout among physiotherapists in hospitals within four health districts in South Tyrol (the German and Italian speaking area of Italy). Method: Data were collected anonymously by envelope. The German version of the Maslach Burnout Inventory (MBI-D) ( Büssing and Perrar, 1992 ; Büssing and Glaser, 1998 ), socio-demographic, occupational data, the use of clinical supervision or support and the desire for emotional distance and closeness to clients were recorded. Questionnaires were sent to 191 physiotherapists in South Tyrol; and 132 participated in the study (return rate 69.63%). Results: In the MBI-D, which contains three scales: ‘emotional exhaustion’, ‘depersonalisation’ and ‘personal accomplishment’; the risk of burnout is reflected in high values in the emotional exhaustion and the depersonalisation scales and low values in personal accomplishment. The present study found that about 35% of the physiotherapists who responded to the questionnaire showed burnout risk in emotional exhaustion, 18% in depersonalisation and 14% in personal accomplishment. This is in agreement with many other studies conducted among health professionals. Gender differences were observed only on the depersonalisation scale, with men scoring higher than women. No differences were found regarding length of stay in the profession. Only one third of physiotherapists are offered clinical supervision or support by their employer but about 50% of physiotherapists sought psychological support. The use of supervision or support was 2.72 times more likely when available at work than not. Contrary to expectations, the impact of supervision or support did not reach significance in the burnout scales. The desire for more closeness is predicted by gender (male), higher emotional exhaustion and depersonalisation, and the desire for more distance is predicted by higher emotional exhaustion. Conclusions: More attention to mental hygiene and support in the workplace and during training would help to prevent burnout among physiotherapists, and benefit the profession, patients and organisations.

Overall, islet autoantibody testing in early childhood reduces anxiety in T1DM families. The increased anxiety associated with islet autoantibody-positive status suggests, however, that testing should be performed in centres which can provide accurate risk information and counselling if required.

OBJECTIVETo assess parent anxiety in response to genetic and islet autoantibody (IA) testing in children at increased genetic risk for type 1 diabetes followed from birth in The Environmental Determinants of Diabetes in the Young (TEDDY) study.RESEARCH DESIGN AND METHODSParent anxiety about TEDDY children’s risk was assessed with the State Anxiety Inventory (SAI). Parents completed the SAI when the child was 3, 6, and 15 months old and annually thereafter. Children were tested for IA every 3 months for 4 years and every 6 months thereafter. Parent SAI scores of 6,799 children followed with IA testing for at least 1 and up to 6 years were examined.RESULTSAt study inception, parents showed high levels of anxiety in response to their child’s increased genetic type 1 diabetes risk; mothers were more anxious than fathers, and parents with diabetes in the family were more anxious than parents with no family history. In response to repeated IA-negative (IA−) test results, parent anxiety declined to normal levels. Anxiety increased in parents faced with an IA-positive (IA+) test result. Parents faced with two or more types of IA+ test results showed particularly high levels of anxiety (all P < 0.001).CONCLUSIONSInfant genetic screening for type 1 diabetes raises parent anxiety when the child is at increased risk, but anxiety dissipates over time in cases of repeated IA− results. IA+ results heighten parent anxiety, and parents faced with two or more types of IA+ results may experience considerable anxiety for longer periods.