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1.	Rewers, Marian, et al. (author) The Environmental Determinants of Diabetes in the Young (TEDDY) Study 2008 In: Annals of the New York Academy of Sciences. - : Wiley. - 0077-8923 .- 1749-6632. ; 1150, s. 1-13 Journal article (peer-reviewed)abstract The etiology of type 1 diabetes (T1D) remains unknown, but a growing body of evidence points to infectious agents and/or components of early childhood diet. The National Institutes of Health has established the TEDDY Study consortium of six clinical centers in the United States and Europe and a data coordinating center to identify environmental factors predisposing to, or protective against, islet autoimmunity and T1D. From 2004-2009, TEDDY will screen more than 360,000 newborns from both the general population and families already affected by T1D to identify an estimated 17,804 children with high-risk HLA-DR,DQ genotypes. Of those, 7,801 (788 first-degree relatives and 7,013 newborns with no family history of T1D) will be enrolled in prospective follow-up beginning before the age of 4.5 months. As of May 2008, TEDDY has screened more than 250,000 newborns and enrolled nearly 5,000 infants--approximately 70% of the final cohort. Participants are seen every 3 months up to 4 years of age, with subsequent visits every 6 months until the subject is 15 years of age. Blood samples are collected at each visit for detection of candidate infectious agents and nutritional biomarkers; monthly stool samples are collected for infectious agents. These samples are saved in a central repository. Primary endpoints include (1) appearance of one or more islet autoantibodies (to insulin, GAD65 or IA-2) confirmed at two consecutive visits; (2) development of T1D. By age 15, an estimated 800 children will develop islet autoimmunity and 400 will progress to T1D; 67 and 27 children have already reached these endpoints.
2.	TEDDY study group, The, et al. (author) The environmental determinants of diabetes in the young (TEDDY) study: Study design 2007 In: Pediatric Diabetes. - : Hindawi Limited. - 1399-543X .- 1399-5448. ; 8:5, s. 286-298 Journal article (peer-reviewed)abstract The primary objective of this multicenter, multinational, epidemiological study is the identification of infectious agents, dietary factors, or other environmental exposures that are associated with increased risk of autoimmunity and type 1 diabetes mellitus (T1DM). Factors affecting specific phenotypic manifestations such as early age of onset or rate of progression or with protection from the development of T1DM will also be identified. The Environmental Determinants of Diabetes in the Young (TEDDY) is an observational cohort study in which newborns who are younger than 4 months and have high-risk human leukocyte antigen alleles in the general population or are first-degree relatives (FDRs) of patients affected with T1DM will be enrolled. Six clinical centers in the USA and Europe will screen 361 588 newborns, of which it is anticipated that 17 804 will be eligible for enrollment with just over 7800 followed. Recruitment will occur over 5 yr, with children being followed to the age of 15 yr. Identification of such factors will lead to a better understanding of disease pathogenesis and result in new strategies to prevent, delay, or reverse T1DM.
3.	Haghighi, Mona, et al. (author) A Comparison of Rule-based Analysis with Regression Methods in Understanding the Risk Factors for Study Withdrawal in a Pediatric Study 2016 In: Scientific Reports. - : Springer Science and Business Media LLC. - 2045-2322. ; 6 Journal article (peer-reviewed)abstract Regression models are extensively used in many epidemiological studies to understand the linkage between specific outcomes of interest and their risk factors. However, regression models in general examine the average effects of the risk factors and ignore subgroups with different risk profiles. As a result, interventions are often geared towards the average member of the population, without consideration of the special health needs of different subgroups within the population. This paper demonstrates the value of using rule-based analysis methods that can identify subgroups with heterogeneous risk profiles in a population without imposing assumptions on the subgroups or method. The rules define the risk pattern of subsets of individuals by not only considering the interactions between the risk factors but also their ranges. We compared the rule-based analysis results with the results from a logistic regression model in The Environmental Determinants of Diabetes in the Young (TEDDY) study. Both methods detected a similar suite of risk factors, but the rule-based analysis was superior at detecting multiple interactions between the risk factors that characterize the subgroups. A further investigation of the particular characteristics of each subgroup may detect the special health needs of the subgroup and lead to tailored interventions.
4.	Jensen, Richard A., et al. (author) Multiple factors affect the loss of measurable C-peptide over 6 years in newly diagnosed 15- to 35-year-old diabetic subjects 2007 In: Journal of diabetes and its complications. - : Elsevier BV. - 1056-8727 .- 1873-460X. ; 21:4, s. 205-213 Journal article (peer-reviewed)abstract Objective: The aim of this study is to identify risk factors for the loss of measurable plasma C-peptide in newly diagnosed 15- to 35-year-old diabetic subjects. Methods: This Swedish study included 778 subjects. C-peptide levels were obtained each year for 6 years after diagnosis. Loss of measurable C-peptide was defined as a level at or below the lower detection limit of the local assay (0.13 nmol/l). In addition to C-peptide, other baseline covariates included gender, age, body mass index, HLA genotype, and autoantibody levels. Results: Compared with autoantibody-negative subjects, autoantibody-positive subjects had lower median baseline C-peptide (0.27 vs. 0.50, P<001), their levels declined over the study period, and the risk of losing measurable C-peptide was significantly higher when more than one autoantibody was present [odds ratio (OR), 4.0; 95% confidence interval (CI), 2.13-7.54]. Among autoantibody-positive individuals, the presence of GAD65Ab (OR, 1.8; 95% Cl, 1.24-2.51) and islet cell antibodies (OR, 1.6; 95% CI, 1.19-2.18) conferred a higher risk for loss of measurable C-peptide as did female gender (OR, 1.6; 95% CI, 1.17-2.11) and time after diagnosis (OR, 1.5 for each additional year postdiagnosis; 95% CI, 1.41-1.57). Higher baseline C-peptide levels were protective (OR, 0.5 for each additional log nanomoles per liter; 95% CI, 0.36-0.58). Conclusions: This study identified autoantibody status, gender, and baseline C-peptide levels as factors that will be useful for predicting the disease course of 15- to 35-year-old diabetic individuals.
5.	Jensen, R., et al. (author) Islet cell autoantibody levels after the diagnosis of young adult diabetic patients 2007 In: Diabetic Medicine. - : Wiley. - 0742-3071 .- 1464-5491. ; 24:11, s. 1221-1228 Journal article (peer-reviewed)abstract Aims The aim was to determine the course of islet cell antibodies [glutamate decarboxylase (GADA), tyrosine phosphatase-like islet antigen 2 (IA-2A) and islet cell (ICA)] after the diagnosis of the diabetic patient. Methods The Diabetes Incidence Study in Sweden (DISS) attempted to prospectively enrol all newly diagnosed diabetic patients aged 15–34 years during 1992 and 1993. C-peptide and autoantibody levels were determined from venous blood samples at diagnosis and again at yearly intervals for 6 years. Results After the first year, the odds of remaining GADA positive decreased by 9% per year [odds ratio (OR) = 0.91, 95% confidence interval (CI) = 0.85–0.96] while the mean GADA index remained unchanged ( = 0.8, P = 0.37). There was no change in the percentage of subjects testing IA-2A positive after the first year ( = 0.1, P = 0.75). However, the mean index decreased 0.04 per year (95% CI: 0.03–0.05)—a 7.9% decline (95% CI: 5.4–10.4%). The odds of a subject testing positive for ICA decreased by 24% per year (OR = 0.76, 95% CI = 0.70–0.82). The mean ICA levels decreased 0.75 per year (95% CI: 0.66–0.84)—a 16.4% decline (95% CI: 14.1–18.6%). The rate of change in titres for all three autoantibodies was independent of gender, human leucocyte antigen genotype and C-peptide status. Conclusions GADA levels remained high while ICA levels declined. In contrast to a previous study, we found that the proportion of IA-2A subjects remaining positive did not decrease after the first year, while the average index decreased slightly.
6.	Larsson, Helena, et al. (author) Diabetes-associated HLA genotypes affect birthweight in the general population. 2005 In: Diabetologia. - : Springer Science and Business Media LLC. - 1432-0428 .- 0012-186X. ; 48:Jul 1, s. 1484-1491 Journal article (peer-reviewed)abstract Aims/hypothesisThe aim of our study was to test the hypothesis that HLA genotypes conferring risk of diabetes, cord blood autoantibodies, or both are associated with increased birthweight. Methods: HLA genotypes were determined in dried blood spots of cord blood from a total of 16,709 children born to healthy mothers in the Diabetes Prediction in Skane (DiPiS) study, a population-based observational clinical investigation of newborn children. Children born to mothers with diabetes or gestational diabetes were excluded. Autoantibodies to glutamic acid decarboxylase (GAD65Ab) and insulinoma-associated protein 2 were determined in standard radioligand binding assays. Birthweight was adjusted for gestational age and divided into quartiles. The upper quartile was defined as high relative birthweight (HrBW) and the lower quartile as low relative birthweight (LrBW). Results: Genotypes conferring risk of type 1 diabetes were strongly associated with relative birthweight (rBW) (p=0.01). The high-risk HLA-DQ2/8, DQ8/0604 and DQ8/X genotypes were associated with HrBW (odds ratio [OR] [95% CI]=1.20 [1.08-1.33], p=0.0006). The HLA-DQB10603 allele, which is negatively associated with type 1 diabetes, was also associated with HrBW (p=0.025), confirming a previous report on DQB10603-linked HLA-DR13. GAD65Ab were negatively associated with HrBW (OR [95% CI]=0.72 [0.56-0.93], p=0.01). Regression analysis showed that the HLA-associated increase in rBW was independent of confounding factors. Conclusions/Interpreation: HLA genotypes may be associated with intrauterine growth independent of type 1 diabetes risk. The epidemiological observation that high birthweight is a risk factor for type 1 diabetes could possibly result from a moderating effect on intrauterine growth of HLA genotypes conferring a high risk of diabetes.
7.	Larsson, Helena, et al. (author) Relationship between increased relative birthweight and infections during pregnancy in children with a high-risk diabetes HLA genotype. 2007 In: Diabetologia. - : Springer Science and Business Media LLC. - 1432-0428 .- 0012-186X. ; 50:6, s. 1161-1169 Journal article (peer-reviewed)abstract Aims/hypothesis Children with high-risk type 1 diabetes HLA genotype have increased risk of high relative birthweight (HrBW), while cord blood islet autoantibodies decrease the risk. As gestational infections may affect offspring type 1 diabetes risk, the aims were to test whether: (1) children of mothers reporting gestational infections have increased HrBW; (2) gestational infections explain islet autoantibody reduction of HrBW; and (3) gestational infections affect the association between HLA and HrBW. Subjects and methods HLA genotypes and autoantibodies to glutamic acid decarboxylase, insulinoma-associated protein 2 and insulin were determined in cord blood of children born to non-diabetic mothers in the Diabetes Prediction in Skane (DiPiS) study. Mothers reported gestational infections when the child was 2 months old. Results Fever or gastroenteritis during pregnancy was reported by 2,848/19,756 mothers (14%); 339 in more than one trimester. Children whose mothers reported infections had increased risk of HrBW (p=0.0003), particularly in the absence of cord blood islet autoantibodies (interaction between HrBW, islet autoantibodies and infections, p=0.0005). The effect on HrBW by high-risk HLA-DQ2/8 was aggravated by infections in more than one trimester (odds ratio [OR]=5.24; p=0.003) (interaction; p=0.022). When infections were reported, cord blood islet autoantibodies decreased HrBW (OR=0.34; p=0.0002). Conclusions/intrepretation This study revealed that: (1) gestational fever, gastroenteritis, or both, increased the risk of HrBW; (2) cord blood islet autoantibodies decreased the risk of HrBW only in combination with infections; and (3) infections aggravated the association between HLA-DQ2/8 and HrBW. These data suggest an interaction between HLA, gestational infections, islet autoantibodies and fetal growth.
8.	Larsson, K, et al. (author) Genetic and perinatal factors as risk for childhood type 1 diabetes 2004 In: Diabetes/Metabolism Research & Reviews. - : Wiley. - 1520-7552. ; 20:6, s. 429-437 Research review (peer-reviewed)abstract The mechanisms by which gestational infections, blood incompatibility, birth weight, mother's age and other prenatal or neonatal events increase the risk for type 1 diabetes are not understood. Studies so far have been retrospective, and there is a lack of population-based prospective studies. The possibility identifying children at type 1 diabetes risk among first-degree relatives has resulted in prospective studies aimed at identifying postnatal events associated with the appearance of autoantibody markers for type 1 diabetes and a possible later onset of diabetes. However, the majority (85%) of new onset type 1 diabetes children do not have a first-degree relative with the disease. Population-based studies are therefore designed to prospectively analyse pregnant mothers and their offspring. One such study is DiPiS (Diabetes Prediction in Skane), which is examining a total of about 10 000 pregnancies expected every year in the Skane (Scania) region of Sweden that has 1.1 million inhabitants. Blood samples from all mothers in this region are obtained during pregnancy and at the time of delivery. Cord blood is analysed for HLA high-risk alleles and for autoantibodies against the 65 kD isoform of glutamic acid decarboxylase (GADA), the protein tyrosine phosphatase-related IA-2 antigen (IA-2A) and insulin (IAA) as a measure of prenatal autoimmune exposure. Identifying high-risk children by genetic, autoimmune and gestational risk factors followed by prospective analyses will make it possible to test the hypothesis that gestational events may trigger beta cell autoimmunity as a prerequisite for childhood type 1 diabetes. Copyright (C) 2004 John Wiley Sons, Ltd.
9.	Lernmark, Barbro, et al. (author) Cord blood islet autoantibodies are related to stress in the mother during pregnancy. 2006 In: Annals of the New York Academy of Sciences. - : Wiley. - 0077-8923. ; 1079:1079, s. 345-349 Journal article (peer-reviewed)abstract A 2-month psychological questionnaire concerning pregnancy was answered by 20,920 nondiabetic mothers of singletons. Retrospective analysis showed increased levels of islet autoantibodies (1A) in 290 (1.4%) newborns. High IA levels in the child's cord blood correlated strongly with IA levels in the mother (GADA r = 0.91, P < 0.0001; IA-2A r = 0.75, P = 0.0001). High IA levels were found in newborns whose mothers during pregnancy had been more worried than usual (P = 0.04), had worried that the child would be sick (P = 0.01) or not survive (P = 0.002), or had experienced serious life events, like "serious accident in the family" (P < 0.0001) or "experienced violence" (P = 0.02). Associations with increased worries by the mother remained in newborns with high type 1 diabetes mellitus (T1DM)-human leukocyte antigen (HLA) risk, but not in non-HLA risk children. ne prospective follow-up of these children will determine the importance of this early 1A for postnatal islet autoimmunity, type I diabetes, or both.
10.	Lynch, Kristian, et al. (author) Cord blood islet autoantibodies and seasonal association with the type 1 diabetes high-risk genotype. 2008 In: Journal of Perinatology. - : Springer Science and Business Media LLC. - 0743-8346 .- 1476-5543. ; 28:3, s. 211-217 Journal article (peer-reviewed)abstract Objective:Human leukocyte antigen DQ (HLA-DQ) genetic factors and islet autoantibodies are strongly associated with type 1 diabetes (T1D) and are currently used to predict T1D. This study examined whether islet autoantibodies in the cord blood of newborns to nondiabetic mothers were associated with the (T1D) high-risk genotype HLA-DQ2/8, gestational infections or both.Study Design:Cord blood samples were taken from 33 683 newborns and used for HLA typing and analyses of islet autoantibodies. Parents completed questionnaires when the child was 2 months of age.Result:The prevalence of newborn islet autoantibodies consistently varied with season over 4 years (P<0.0001); lowest in first quarter (1.2%) and highest in third (2.4%). Cord blood islet autoantibodies were associated with HLA-DQ2/8 in the second (OR, 2.30; P=0.02), third (OR, 2.12; P=0.008) and fourth quarters (OR, 2.49; P=0.007), but not in the first (OR, 1.13). Reported gastroenteritis was additionally associated with islet autoantibodies in the third quarter (OR, 1.80, P=0.04).Conclusion:An association between HLA and islet autoimmunity may depend on environmental exposure during pregnancy. Follow-up of mothers and children will determine risk of T1D.Journal of Perinatology (2008) 28, 211-217; doi:10.1038/sj.jp.7211912; published online 14 February 2008.
11.	Papadopoulou, Anastasia, et al. (author) The type 1 diabetes protective HLA DQB10602 allele is less frequent in gestational diabetes mellitus. 2009 In:* Diabetologia. - : Springer Science and Business Media LLC. - 1432-0428 .- 0012-186X. ; 52, s. 1339-1342 Journal article (peer-reviewed)abstract AIMS/HYPOTHESIS: We tested whether gestational diabetes mellitus (GDM) is associated with HLA-DQ genotypes. METHODS: A total of 764 mothers with non-autoimmune (GAD65, insulinoma-associated protein 2 [IA-2] and insulin autoantibody-negative) GDM were ascertained between September 2000 and August 2004 in the population-based Diabetes Prediction in Skåne (DiPiS) study. HLA-DQB1 genotypes were determined in these mothers and in 1191 randomly selected non-diabetic control mothers also negative for islet autoantibodies. The data were analysed in relation to maternal age, country of birth, number of pregnancies/siblings and pregnancy weight gain. RESULTS: The frequency of type 1 diabetes high-risk HLA-DQ alleles (DQB10201, DQB10302) did not differ between GDM mothers and controls. In contrast, the low-risk DQB10602 allele was less prevalent (OR 0.64, 95% CI = 0.51-0.80, p = 0.0006) in GDM than in control mothers. The difference in DQB10602 frequency between GDM mothers and controls remained after multiple logistic regression analysis correcting for maternal age, country of birth, number of pregnancies/siblings and weight gain during pregnancy (OR 0.67, 95% CI 0.51-0.88, p = 0.009). CONCLUSIONS/INTERPRETATION: The negative association between mothers who have non-autoimmune GDM and HLA-DQ*0602 suggest that this allele may protect not only from type 1 diabetes but also from GDM.
12.	Baxter, Judith, et al. (author) Differences in recruitment and early retention among ethnic minority participants in a large pediatric cohort: The TEDDY Study 2012 In: Contemporary Clinical Trials. - : Elsevier BV. - 1551-7144. ; 33:4, s. 633-640 Journal article (peer-reviewed)abstract 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. (C) 2012 Elsevier Inc. All rights reserved.
13.	Johnson, Suzanne Bennett, et al. (author) At high risk for early withdrawal: using a cumulative risk model to increase retention in the first year of the TEDDY study. 2014 In: Journal of Clinical Epidemiology. - : Elsevier BV. - 1878-5921 .- 0895-4356. ; 67:6, s. 609-611 Journal article (peer-reviewed)
14.	Johnson, Suzanne Bennett, et al. (author) Predicting Later Study Withdrawal in Participants Active in a Longitudinal Birth Cohort Study for 1 Year: The TEDDY Study. 2016 In: Journal of Pediatric Psychology. - : Oxford University Press (OUP). - 1465-735X .- 0146-8693. ; 41:3, s. 373-383 Journal article (peer-reviewed)abstract OBJECTIVE : To identify predictors of later study withdrawal among participants active in The Environmental Determinants of Diabetes in the Young (TEDDY) for 1 year. METHODS : Multiple logistic regression was used to discriminate 3,042 children active in TEDDY for the first 3 years from 432 children who withdrew in Years 2 or 3. Predictor variables were tested in blocks-demographic, maternal lifestyle behaviors, stress and child illness, maternal reactions to child's increased diabetes risk, in-study behaviors-and a final best model developed. RESULTS : Few demographic factors predicted study withdrawal. Maternal lifestyle behaviors, accuracy of the mother's risk perception, and in-study behaviors were more important. Frequent child illnesses were associated with greater study retention. CONCLUSIONS : Demographic measures are insufficient predictors of later study withdrawal among those active in a study for at least 1 year; behavioral/psychological factors offer improved prediction and guidance for the development of retention strategies.
15.	Johnson, Suzanne Bennett, et al. (author) The Environmental Determinants of Diabetes in the Young (TEDDY) Study: predictors of early study withdrawal among participants with no family history of type 1 diabetes. 2011 In: Pediatric Diabetes. - : Hindawi Limited. - 1399-543X. ; 12, s. 165-171 Journal article (peer-reviewed)abstract Johnson SB, Lee H-S, Baxter J, Lernmark B, Roth R, Simell T for the TEDDY Study Group. The Environmental Determinants of Diabetes in the Young (TEDDY) Study: predictors of early study withdrawal among participants with no family history of type 1 diabetes. 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.
16.	Lernmark, Barbro, et al. (author) Does genetic screening for Type 1 diabetes in newborns affect mothers and fathers in the same way? 2003 In: Diabetologia. - : Springer Science and Business Media LLC. - 1432-0428 .- 0012-186X. ; 46:Suppl 2, s. 114-115 Conference paper (peer-reviewed)
17.	Lernmark, Barbro, et al. (author) Enrollment experiences in a pediatric longitudinal observational study: The Environmental Determinants of Diabetes in the Young (TEDDY) study. 2011 In: Contemporary Clinical Trials. - : Elsevier BV. - 1551-7144. ; 32, s. 517-523 Journal article (peer-reviewed)abstract 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.
18.	Lernmark, Barbro, et al. (author) Parent responses to participation in genetic screening for diabetes risk. 2004 In: Pediatric Diabetes. - 1399-543X. ; 5:4, s. 174-181 Journal article (peer-reviewed)abstract Screening for type 1 diabetes (T1DM) risk in newborns has little negative emotional impact on mothers. In this study, the impact on the mother and the father was evaluated both in the general population and in families with diabetes. All parents with a newborn in Skåne, Sweden, were invited to a screening for T1DM risk in their children (the Diabetes Prediction in Skåne (DiPiS)). Blood was obtained at delivery from the mother and the child. When the child was 2 months old, parents gave written consent and filled out questionnaires, but were not informed about the genetic risk. Of the 10 538 invited families, 6831 (64.8%) consented and 806 (7.7%) declined participation. Five questions addressing both parents were filled out by 6676 (63.4%) mothers and 6099 (57.8%) fathers. In 146/6676 (2.2%) families, one family member had diabetes (D-families). Participation in DiPiS did not affect most parents and the majority was satisfied with the information. The majority of parents (28.9%) were reassured and only 1.1% (140/12 670) reported increased worries because of participation, compared to 2.8% of the mothers in D-families. Parents in D-families more often ascribed diabetes risk to their child as well as the risk being higher. Mothers and fathers differed in their answers on four of the five study questions, with mothers being more satisfied with the information, reporting more knowledge of diabetes, estimating lower risk of their child to get diabetes, but reporting more worries of possible future chronic disease in the child. Parents with lower education, being born abroad, or being younger who reported worries of chronic disease in the child were also reassured by participation in the study. These results confirm that screening for T1DM risk in newborns does not create worries in most parents, but stress that fathers differ from mothers in opinions and reactions, that parents' reactions are affected by diabetes in the family, and that demographic factors might be important for the parents' reports.
19.	Lernmark, Barbro, et al. (author) Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing. 2016 In: Journal of Diabetes Research. - : Hindawi Limited. - 2314-6753 .- 2314-6745. ; 2016 Journal article (peer-reviewed)abstract Background. To characterize participant reasons for withdrawing from a diabetes focused longitudinal clinical observational trial (TEDDY) during the first three study years. Methods. 8677 children were recruited into the TEDDY study. At participant withdrawal staff recorded any reason parents provided for withdrawal. Reasons were categorized into (1) family characteristics and (2) protocol reasons. Families who informed staff of their withdrawal were classified as active withdrawals (AW); families without a final contact were considered passive withdrawals (PW). Results. Withdrawal was highest during the first study year (n = 1220). Most families were AW (n = 1549; 73.4%). PW was more common in the United States (n = 1001; 37.8%) and among young mothers (p = 0.001). The most frequent protocol characteristic was blood draw (55%) and the most common family reason was not having enough time (66%). The blood draw was more common among female participants; being too busy was more common among males. Both reasons were associated with study satisfaction. Conclusions. Results suggest that, for families of children genetically at risk for diabetes, procedures that can be painful/frightening should be used with caution. Study procedures must also be considered for the demands placed on participants. Study satisfaction should be regularly assessed as an indicator of risk for withdrawal.
20.	Lernmark, Barbro, et al. (author) Reasons for Staying as a Participant in the Environmental Determinants of Diabetes in the Young (TEDDY) Longitudinal Study. 2012 In: Journal of clinical trials. - : OMICS Publishing Group. - 2167-0870. ; 2:2 Journal article (peer-reviewed)abstract To assess parents' opinions about their participation in the longitudinal, multicenter study - The Environmental Determinants of Diabetes in the Young (TEDDY) consortium.
21.	Lernmark, Barbro (author) Studies on children’s psychological adjustment to diabetes 1999 Doctoral thesis (other academic/artistic)abstract Type I diabetes is a chronic disease that affects the daily life of the individual from diagnosis and for the rest of life. The patient is constantly reminded of the diabetes because of a daily, self-managed and demanding treatment. Good psychological adjustment to diabetes is important for psychological well-being and might influence the medical consequences of the disease. How the treatment is performed might affect both short-term as well as long-term outcome of the disease. It is also possible that psychological and behavioral factors early in the course diabetes of may predict the long-term outcome of the disease. The overall aim of this study was to investigate psychological adjustment to Type I diabetes in children and adolescents. The aims were addressed in two studies, one cross-sectional (C-study) and one longitudinal, multi-center study (M-study). The M-study investigated a cohort children up to 15 years of age who were admitted to five pediatric clinics after onset of diabetes. Psychological data was collected at diagnosis, after nine months disease duration and after five years from onset (n=51). Medical data for diabetes outcome (mainly Haemoglobin bA1c) were collected at two years after diagnosis and in parallel with the followup assessment at five-year disease duration. The C-study was performed at one diabetes clinic of children nine to 18 years of age with varying length of diabetes duration (n=62). The objectives of performing two studies were to complement one another as well as to form a group of children sufficiently large to explore psychological adjustment to diabetes. The methods in the M-study were behavioral ratings and interviews of children performed by hospital staff and investigators, and psychological tests and questionnaires completed by the children. In the C-study, parents and children filled out questionnaires. Psychological adjustment to diabetes was studied by diabetes-specific emotional and behavioral adaptation, by the child's perception of family support and own competence in taking care of diabetes. Methods for studying diabetes-related psychological adjustment were developed for both studies. Affective reactions during the first weeks after diagnosis were predictive of difficulties in psychological adjustment to diabetes at five years of disease duration. Diabetes-related psychological adjustment in the children was associated to general psychological factors in both children and parent. Depressive symptoms in the child were associated with increased emotional and behavioral problems of adaptation as well as less support from the family. Metabolic control was more associated with diabetes-related behavioral adaptation than with general psychological functioning of the child. Children's metabolic control was more associated with family factors than with parents' psychological well-being. The level of later metabolic control was predicted by psychological factors assessed during first year after diagnosis and by level of early metabolic control. Also, it was found that physicians were not always aware of the children's emotional difficulties with the adaptation to diabetes. By identifying children who are at risk for developing problems or by early recognition of problems, it might be possible to reduce or prevent emotional suffering and future risk for diabetes complications.
22.	Roth, Roswith, et al. (author) Maternal anxiety about a child's diabetes risk in the TEDDY study: the potential role of life stress, postpartum depression, and risk perception 2015 In: Pediatric Diabetes. - : Hindawi Limited. - 1399-543X. ; 16:4, s. 287-298 Journal article (peer-reviewed)abstract ObjectiveTo understand the association between life stress, postpartum depression (PD), maternal perception of her child's risk for type 1 diabetes (T1D) and a mother's anxiety about her child's T1D risk in mothers of genetically at risk children in The Environmental Determinants of Diabetes in the Young (TEDDY) study. MethodsA short form of the state component (SAI) of the State-Trait Anxiety Inventory, negative life events (LE), the Edinburgh Postnatal Depression Scale (EPDS), and one question about the child's risk of developing T1D risk perceptions (RP) were given to mothers at the 6-month TEDDY clinic visit. The relationship between the four measures was modeled using multiple regressions. ResultsControlling for sociodemographic factors, significant country differences in SAI, LE, EPDS, and RP emerged. LE - particularly interpersonal LE - had a strong association to maternal anxiety about the baby's risk of diabetes. Both evidence of PD and accurate risk perceptions (RPs) about the child's T1D risk were associated with increased maternal anxiety about the child's T1D risk. ConclusionHeightened maternal anxiety in response to the news that a child is at increased risk for T1D is common. Mothers who have experienced recent negative LE, who experience PD and who accurately understand their child's risk may be particularly vulnerable to high levels of anxiety. The findings reported here need to be confirmed in future prospective studies.
23.	Roth, Roswith, et al. (author) Psychosocial stress: Negative life events in TEDDY (The Environmental Determinants of Diabetes in the Young) 2008 In: International Journal of Psychology. - 1464-066X. ; 43:3-4, s. 806-806 Conference paper (peer-reviewed)
24.	Smith, Laura B., et al. (author) Factors Associated With Maternal-Reported Actions to Prevent Type 1 Diabetes in the First Year of the TEDDY Study 2014 In: Diabetes Care. - : American Diabetes Association. - 1935-5548 .- 0149-5992. ; 37:2, s. 325-331 Journal article (peer-reviewed)abstract OBJECTIVEMothers of children at risk for type 1 diabetes report engaging in preventive behaviors. The purpose of this study is to further document these actions in an international, longitudinal sample and examine variables that predict whether mothers engage in these behaviors.RESEARCH DESIGN AND METHODSThis study examined an international sample (from Finland, Germany, Sweden, and the U.S.) from the naturalistic, longitudinal The Environmental Determinants of Diabetes in the Young (TEDDY) study, which tracked children genetically at risk for type 1 diabetes from birth to age 15 years. Mothers of 7,613 infants aged 6 months and 6,503 infants aged 15 months completed questionnaires assessing psychosocial factors and actions intended to prevent diabetes.RESULTSMany mothers (29.9% at 6 months and 42.8% at 15 months) reported engaging in a behavior intended to prevent type 1 diabetes, with the largest percentages (20.9-29.2%) reporting making changes to their child's diet (e.g., reducing the consumption of sweets and carbohydrates). Factors related to engaging in preventive behaviors include older maternal age; higher maternal education; minority status; having only one child; having a first-degree relative with type 1 diabetes; being from a country other than Sweden; having an accurate perception of the child's increased risk for developing diabetes; having postpartum depression, maternal anxiety, and worry about the risk of diabetes; and believing that diabetes can be prevented.CONCLUSIONSThe findings of this study suggest that many mothers engage in actions to prevent diabetes and highlight the importance of tracking these behaviors to ensure the validity of naturalistic observational studies.
25.	Åkesson, K, et al. (author) The non-inherited maternal HLA haplotype affects the risk for type 1 diabetes 2009 In: International journal of immunogenetics. - 1744-3121 .- 1744-313X. ; 36:1, s. 1-8 Journal article (peer-reviewed)abstract The aim was to test the hypothesis that the human leucocyte antigen (HLA) haplotype that is not inherited from the mother, that is, the non-inherited maternal antigen (NIMA) affects the risk for type 1 diabetes (T1D). A total of 563 children with T1D and 286 non-diabetic control children from Sweden were genotyped for DRB1, DQA1 and DQB1 alleles. The frequency of positively (DR4-DQA10301-B10302 and DR3-DQA10501-B10201), negatively (DR15-DQ A10102-B10602) or neutrally (all other) T1D associated HLA haplotypes were compared between NIMA and non-inherited paternal antigen (NIPA). All comparisons were carried out between HLA-matched patients and controls. The frequency of positively associated NIMA was higher among both DR4/X-positive healthy individuals compared wit DR4/X-positive patients (P < 0.00003) and DR3/X-positive healthy individuals compared with DR3/X-positive patients (P < 0.009). No such difference was observed for NIPA. High-risk NIMA was increased compared to NIPA among healthy DR3/X- and DR4/X-positive children (P < 0.05). There was no difference in frequency of positively associated haplotypes between patient NIMA and NIPA. The NIMA but not the NIPA affects the risk for T1D, suggesting that not only the inherited but also non-inherited maternal HLA haplotypes, perhaps through microchimerism or other mechanisms, may influence the risk for the disease.

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