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| 2. |
- Helgesson, Gert, et al.
(författare)
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Limited Relevance of the Right Not to Know : Reflections on a Screening Study
- 2007
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Ingår i: Accountability in Research. - : Informa UK Limited. - 0898-9621 .- 1545-5815. ; 14:3, s. 197-209
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Tidskriftsartikel (refereegranskat)abstract
- The right not to know personal health-related information has been included in prominent human rights documents and subsequently in national legislation since the middle of the 1990s. Apart from situations where another life is at stake, the right not to know has in these documents been formulated as if it should have precedence over other interests. This article argues against giving the right not to know such a prominent position. It does so by questioning the ethical relevance of the concept for both theoretical and empirical reasons. The main focus of the article is on empirical data from a prospective population screening for Type 1 diabetes. Data indicate that research participants are not as autonomous as is generally assumed by the defenders of the right not to know.
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| 3. |
- Helgesson, Gert, et al.
(författare)
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Practical matters, rather than lack of trust, motivate non-participation in a long-term cohort trial
- 2009
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Ingår i: Pediatric Diabetes. - : Hindawi Limited. - 1399-543X .- 1399-5448. ; 10:6, s. 408-412
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Tidskriftsartikel (refereegranskat)abstract
- Objective: The objective of this study was to investigate the importance of trust in researchers and other reasons that participating parents, former participants, and non-participants had for participating, or not participating, in a longitudinal cohort study on prediction and development of diabetes in children. Study design: A questionnaire addressing each of these groups, where respondents graded the importance of a set of listed reasons for participating/not participating, was randomly distributed to 2500 families in the All Babies in Southeast Sweden (ABIS) study region with children born between 1997 and 1999. Results: Lack of trust was not a central factor to a great majority of respondents who decided not to participate in the ABIS study or who later decided to opt out. Practical matters, like blood sampling and lack of time, were important factors to many more. Yet, four fifths of those who still participate in the ABIS study stated trust in the researchers to be an important factor to their initial decision to participate. Conclusions: Trust in researchers may be a necessary prerequisite in order for people to be willing to participate in research, but practical matters such as time that has to be spent or pain involved in collecting blood were more important factors than lack of trust in explaining opt out in relation to the ABIS study.
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| 4. |
- Helgesson, Gert, et al.
(författare)
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Views on data use, confidentiality and consent in a predictive screening involving children
- 2008
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Ingår i: Journal of Medical Ethics. - : BMJ. - 0306-6800 .- 1473-4257. ; 34:3, s. 206-209
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Tidskriftsartikel (refereegranskat)abstract
- Data from the 5-6 year control questionnaire of the ABIS study, a Swedish prospective screening of children for Type 1 diabetes, indicates a genuine trust in the researchers - very few participating families expressed concern about their participation. Nevertheless, a majority do not want their research data to be used beyond the agreement of the original consent. They want to be asked for renewed consent in such cases. A vast majority also want potential high-risk information about their child to be communicated to them. Most participating families want this regardless of whether any preventive treatment is available. Although potential benefits for their child is a motivation for participation for a majority of the respondents, they also claim to be motivated by altruistic reasons. These results are compared to results from two similar studies in the UK.
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| 5. |
- Lernmark, Barbro, et al.
(författare)
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Participant Experiences in the Environmental Determinants of Diabetes in the Young Study: Common Reasons for Withdrawing.
- 2016
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Ingår i: Journal of Diabetes Research. - : Hindawi Limited. - 2314-6753 .- 2314-6745. ; 2016
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Tidskriftsartikel (refereegranskat)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.
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| 6. |
- Lundgren, Markus, et al.
(författare)
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Analgesic antipyretic use among young children in the TEDDY study : No association with islet autoimmunity
- 2017
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Ingår i: BMC Pediatrics. - : Springer Science and Business Media LLC. - 1471-2431. ; 17:1
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Tidskriftsartikel (refereegranskat)abstract
- Background: The use of analgesic antipyretics (ANAP) in children have long been a matter of controversy. Data on their practical use on an individual level has, however, been scarce. There are indications of possible effects on glucose homeostasis and immune function related to the use of ANAP. The aim of this study was to analyze patterns of analgesic antipyretic use across the clinical centers of The Environmental Determinants of Diabetes in the Young (TEDDY) prospective cohort study and test if ANAP use was a risk factor for islet autoimmunity. Methods: Data were collected for 8542 children in the first 2.5 years of life. Incidence was analyzed using logistic regression with country and first child status as independent variables. Holm's procedure was used to adjust for multiplicity of intercountry comparisons. Time to autoantibody seroconversion was analyzed using a Cox proportional hazards model with cumulative analgesic use as primary time dependent covariate of interest. For each categorization, a generalized estimating equation (GEE) approach was used. Results: Higher prevalence of ANAP use was found in the U.S. (95.7%) and Sweden (94.8%) compared to Finland (78.1%) and Germany (80.2%). First-born children were more commonly given acetaminophen (OR 1.26; 95% CI 1.07, 1.49; p = 0.007) but less commonly Non-Steroidal Anti-inflammatory Drugs (NSAID) (OR 0.86; 95% CI 0.78, 0.95; p = 0.002). Acetaminophen and NSAID use in the absence of fever and infection was more prevalent in the U.S. (40.4%; 26.3% of doses) compared to Sweden, Finland and Germany (p < 0.001). Acetaminophen or NSAID use before age 2.5 years did not predict development of islet autoimmunity by age 6 years (HR 1.02, 95% CI 0.99-1.09; p = 0.27). In a sub-analysis, acetaminophen use in children with fever weakly predicted development of islet autoimmunity by age 3 years (HR 1.05; 95% CI 1.01-1.09; p = 0.024). Conclusions: ANAP use in young children is not a risk factor for seroconversion by age 6 years. Use of ANAP is widespread in young children, and significantly higher in the U.S. compared to other study sites, where use is common also in absence of fever and infection.
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| 7. |
- Roth, Roswith, et al.
(författare)
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Maternal anxiety about a child's diabetes risk in the TEDDY study: the potential role of life stress, postpartum depression, and risk perception
- 2015
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Ingår i: Pediatric Diabetes. - : Hindawi Limited. - 1399-543X. ; 16:4, s. 287-298
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Tidskriftsartikel (refereegranskat)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.
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| 8. |
- Smith, Laura B., et al.
(författare)
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Psychological manifestations of celiac disease autoimmunity in young children
- 2017
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Ingår i: Pediatrics. - : American Academy of Pediatrics (AAP). - 0031-4005 .- 1098-4275. ; 139:3
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Tidskriftsartikel (refereegranskat)abstract
- BACKGROUND AND OBJECTIVES: Psychological symptoms can be associated with celiac disease; abstract however, this association has not been studied prospectively in a pediatric cohort. We examined mother report of psychological functioning in children persistently positive for tissue transglutaminase autoantibodies (tTGA), defined as celiac disease autoimmunity (CDA), compared with children without CDA in a screening population of genetically at-risk children. We also investigated differences in psychological symptoms based on mothers' awareness of their child's CDA status. METHODS: The Environmental Determinants of Diabetes in the Young study followed 8676 children to identify triggers of type 1 diabetes and celiac disease. Children were tested for tTGA beginning at 2 years of age. The Achenbach Child Behavior Checklist assessed child psychological functioning at 3.5 and 4.5 years of age. RESULTS: At 3.5 years, 66 mothers unaware their child had CDA reported more child anxiety and depression, aggressive behavior, and sleep problems than 3651 mothers of children without CDA (all Ps ≤ .03). Unaware-CDA mothers also reported more child anxiety and depression, withdrawn behavior, aggressive behavior, and sleep problems than 440 mothers aware of their child's CDA status (all Ps ≤.04). At 4.5 years, there were no differences. CONCLUSIONS: In 3.5-year-old children, CDA is associated with increased reports of child depression and anxiety, aggressive behavior, and sleep problems when mothers are unaware of their child's CDA status. Mothers' knowledge of their child's CDA status is associated with fewer reports of psychological symptoms, suggesting that awareness of the child's tTGA test results affects reporting of symptoms.
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| 9. |
- Swartling, Ulrica, et al.
(författare)
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Children's Views on Long-Term Screening for Type 1 Diabetes.
- 2014
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Ingår i: Journal of Empirical Research on Human Research Ethics. - : SAGE Publications. - 1556-2654 .- 1556-2646. ; 9:4, s. 1-9
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Tidskriftsartikel (refereegranskat)abstract
- 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.
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| 10. |
- Swartling, Ulrica, 1965-, et al.
(författare)
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Concern, pressure and lack of knowledge affect choice of not wanting to know high-risk status
- 2007
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Ingår i: European Journal of Human Genetics. - : Springer Science and Business Media LLC. - 1018-4813 .- 1476-5438. ; 15:5, s. 556-562
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Tidskriftsartikel (refereegranskat)abstract
- The 'right not to know' one's genetic status has been increasingly more recognised in ethical and legal instruments. Yet empirical research is limited, leaving discussion on a theoretical level. There are also divergent ideas as to what extent it should be respected. In this study, we explored the clinical preconditions for disclosure of increased risk of getting diabetes in children. We included questions in the clinical 5-year questionnaire of a predictive screening for the risk of type 1 diabetes (T1DM), asking the respondents (n=7206) whether they wished to be informed of their children's potential risk status. The group of 2% of the respondents who did not want to know about risk status proved to be significantly associated to concern with natural history data (OR 4.03), lack of knowledge (OR 3.17), pressure to participate (OR 2.99) and the child's disease development (OR 2.18). We discuss whether parents'/participants' 'no' to high-risk information may call for a more nuanced response such as information and support, rather than simply respect their wish not to know. We furthermore argue that it is ethically questionable whether the parents' expressed wish not to know should prima facie override the potential benefits for their child. We conclude that this constitutes sufficient reason not to promote a default solution where people's expressed wishes not to know are taken at face value.
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