Iris Pigeot

Leibniz-Institute of Prevention Research and Epidemiology, Bremen, Bremen, Germany

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Publications (231)387.77 Total impact

  • Garrath Williams · Iris Pigeot
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    ABSTRACT: Many attempts have been made to formalize ethical requirements for research. Among the most prominent mechanisms are informed consent requirements and data protection regimes. These mechanisms, however, sometimes appear as obstacles to research. In this opinion paper, we critically discuss conventional approaches to research ethics that emphasize consent and data protection. Several recent debates have highlighted other important ethical issues and underlined the need for greater openness in order to uphold the integrity of health-related research. Some of these measures, such as the sharing of individual-level data, pose problems for standard understandings of consent and privacy. Here, we argue that these interpretations tend to be overdemanding: They do not really protect research subjects and they hinder the research process. Accordingly, we suggest another way of framing these requirements. Individual consent must be situated alongside the wider distribution of knowledge created when the actions, commitments, and procedures of researchers and their institutions are opened to scrutiny. And instead of simply emphasizing privacy or data protection, we should understand confidentiality as a principle that facilitates the sharing of information while upholding important safeguards. Consent and confidentiality belong to a broader set of safeguards and procedures to uphold the integrity of the research process.
    No preview · Article · Feb 2016 · Biometrical Journal
  • Iris Pigeot · Michael Hummel

    No preview · Article · Jan 2016 · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz
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    ABSTRACT: Background: According to recent findings, short sleep duration is associated with overweight in children. However, primary prevention efforts aimed at achieving adequate sleep among children are scarce. Therefore, the 'Identification and prevention of Dietary-induced and lifestyle-induced health EFfects In Children and infantS' (IDEFICS) study implemented a multilevel intervention that included sleep duration as a key behavioural target. The aim of this study is to evaluate sleep duration among children participating in the IDEFICS study. Methods: The IDEFICS nocturnal sleep intervention was included as part of stress reduction educational messages aimed at parents and children. Sleep was assessed by a parental 24-h recall (only weekdays; n = 8,543) and by a diary (weekdays and weekends separately; n = 4,150). Mixed linear models tested the intervention effect on sleep duration change between baseline when children were 2-9.9 years of age (2007/2008) and follow-up (2009/2010). Logistic mix models were used to study the intervention effect on the presence of TV in the children's bedroom (one of the intervention messages; n = 8,668). Additionally, parents provided qualitative data regarding exposure to the intervention. Results: About 51.1% of the parents in the intervention regions reported awareness of the sleep intervention. A small intervention effect was seen on weeknight sleep duration in that the decrease in sleep duration over 2 years was smaller in the intervention (15 min) as compared with control regions (19 min) (p = 0.044). There was no overall intervention effect on weekend sleep duration or on the presence of a TV in the bedroom. A small significant time effect between baseline and follow-up was found on bedroom TV presence depending on self-reported intervention exposure (3% increase in TV presence in exposed versus 6.6% increase in non-exposed). Children without a TV in the bedroom had longer nocturnal sleep duration. Discussion: The sleep component of the intervention did not lead to clinically relevant changes in sleep duration. Future interventions aimed at young children's sleep duration could benefit from more specific and intense messaging than that found in the IDEFICS intervention. Future research should use objective measures of sleep duration as well as intermediate outcomes (sleep knowledge, sleep environment and sleep practices).
    Full-text · Article · Dec 2015 · Obesity Reviews
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    ABSTRACT: Background/objectives: Childhood obesity is a major public health concern but evidence-based approaches to tackle this epidemic sustainably are still lacking. The Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study investigated the aetiology of childhood obesity and developed a primary prevention programme. Here, we report on the effects of the IDEFICS intervention on indicators of body fatness. Subjects/methods: The intervention modules addressed the community, school and parental level, focusing on diet, physical activity and stress-related lifestyle factors. A cohort of 16,228 children aged 2-9.9 years - about 2000 per country - was equally divided over intervention and control regions. (Participating countries were Sweden, Germany, Estonia, Hungary, Cyprus, Italy, Spain and Belgium.) We compared the prevalence of overweight/obesity and mean values of body mass index z-score, per cent body fat and waist-to-height ratio over 2 years of follow-up. Mixed models adjusting for age and socioeconomic status of the parents and with an additional random effect for country accounted for the clustered study design. Results: The prevalence of overweight and obesity increased in both the intervention and control group from 18.0% at baseline to 22.9% at follow-up in the control group and from 19.0% to 23.6% in the intervention group. The difference in changes between control and intervention was not statistically significant. For the cohort as a whole, the changes in indicators of body fatness did not show any clinically relevant differences between the intervention and control groups. Changes in favour of intervention treatment in some indicators were counterbalanced by changes in favour of the control group in some other indicators. Conclusions: Over the 2-year-observation period, the IDEFICS primary prevention programme for childhood obesity has not been successful in reducing the prevalence of overweight and obesity nor in improving indicators of body fatness in the target population as a whole.
    No preview · Article · Dec 2015 · Obesity Reviews
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    ABSTRACT: Objectives: The first aim was to describe the intervention implementation and reception with specific regard to physical activity (PA) within Belgian schools participating in the IDEFICS (Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS) intervention. Second, we examined if a higher intervention process score in schools showed more favourable effects on children's objectively measured PA and sedentary time (ST). Methods: The IDEFICS intervention focused on improving children's health behaviour (including PA) at the community, school/kindergarten and family level. Five process evaluation questionnaires completed by school working groups, and (physical education) teachers were used for the process evaluation of four intervention modules (school working groups, healthy weeks, school environment, health-related physical education and PA). Items were summed to calculate a total intervention process score per school. Schools were subdivided into three groups (low, medium and high score). Multilevel models were used to examine if changes in PA or ST differed between schools with a low, medium or high score. In total, 333 children (54.1% girls, mean age 6.0 ± 1.5 years) from 34 intervention schools (18 pre-schools and 16 primary schools) in the town of Geraardsbergen, Belgium, provided valid accelerometer data for two weekdays and one weekend day. Results: Mean intervention process score (maximum value = 44) was 20.9 ± 5.8 for schools. The breakdown per module showed which components were implemented and received well and which components could have been improved. After the intervention, the decrease in light PA and increase in ST was much higher in children from primary schools with a low intervention process score, whereas the behaviours remained relatively stable in children from primary schools with a medium or high score. The change in moderate to vigorous PA did not differ significantly between schools with a low, medium or high score. Conclusion: The IDEFICS intervention was relatively able to prevent unfavourable changes in ST and light PA in schools with a medium and high intervention process score. Further process evaluation research is needed to obtain a more profound picture of the IDEFICS intervention process.
    No preview · Article · Dec 2015 · Obesity Reviews
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    ABSTRACT: Introduction: One of the major research dimensions of the Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study involved the development, implementation and evaluation of a setting-based community-oriented intervention programme for primary prevention of childhood obesity. In this supplement of Obesity Reviews, a compilation of key results of the IDEFICS intervention is packaged in a series of complementary papers. Objective: This paper describes the overall design and methods of the IDEFICS intervention in order to facilitate a comprehensive reading of the supplement. In addition, some 'best practice' examples are described. Results: The IDEFICS intervention trial was conducted to assess whether the IDEFICS intervention prevented obesity in young children aged 2 to 9.9 years. The study was a non-randomized, quasi-experimental trial with one intervention matched to one control region in each of eight participating countries. The intervention was designed following the intervention mapping framework, using a socio-ecological theoretical approach. The intervention was designed to address several key obesity-related behaviours in children, parents, schools and community actors; the primary outcome was the prevalence of overweight/obesity according to the IOTF criteria based on body mass index. The aim was to achieve a reduction of overweight/obesity prevalence in the intervention regions. The intervention was delivered in school and community settings over a 2-year period. Data were collected in the intervention and control cohort regions at baseline and 2 years later. Conclusion: This paper offers an introductory framework for a comprehensive reading of this supplement on IDEFICS intervention key results.
    Full-text · Article · Dec 2015 · Obesity Reviews
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    ABSTRACT: This paper reports on the effectiveness of the prevention of dietary- and lifestyle-induced health effects in children and infants (IDEFICS) intervention on objectively measured physical activity (PA) and sedentary time (ST) in 2- to 9.9-year-old European boys and girls. METHODS: The intervention was evaluated after 2 years through a non-randomized cluster-controlled trial in eight European countries (one control and one intervention community per country). All children in the intervention group received a culturally adapted childhood obesity prevention programme through the community, schools/kindergartens and family. A random sub-sample of children participating in the IDEFICS study wore an accelerometer at baseline and follow-up for at least 3 days (n = 9,184). Of this sample, 81% provided valid accelerometer data at baseline (n = 7,413; 51% boys; 6.21 ± 1.76 years; boys: 617 ± 170 cpm day(-1) ; girls 556 ± 156 cpm day(-1) ) and 3,010 children provided valid accelerometer data at baseline and during the follow-up survey 2 years later. RESULTS: In boys and girls, no significant differences in PA and ST were found between intervention and control groups over 2 years. Strong temporal effects were found in the total sample of boys and girls: the percentage of time spent in light PA per day decreased by 4 percentage points in both boys and girls between baseline and follow-up (both: p
    Full-text · Article · Dec 2015 · Obesity Reviews
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    ABSTRACT: Background: The Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS (IDEFICS) study investigated the aetiology of childhood obesity and developed a primary prevention programme. Methods: Pre-intervention adherence to key behaviours related to childhood obesity, namely water/sweetened drink, fruit/vegetable consumption, daily TV time, physical activity, family time and adequate sleep duration, was measured at baseline. Adherence to international recommendations was converted into a composite score ranging from 0 (none) to 6 (adhering to all). Data on adherence were available for 7,444 to 15,084 children aged 2-9.9 years, depending on the behaviour. By means of multi-level logistic regression models adjusted for age, sex and country, we calculated odds ratios (OR) and 95% confidence intervals (CI) to estimate the relationship between adherence to these recommendations and the risk of being overweight/obese. Results: Adherence ranged from 15.0% (physical activity) to 51.9% (TV time). As adherence increased, a lower chance of being overweight/obese was observed; adhering to only one key behaviour (score = 1) meant an OR = 0.81 (CI: 0.65-1.01) compared with non-adherence (score = 0), while adhering to more than half of the key behaviours (score ≥ 4) halved the chance for overweight/obesity (OR = 0.54, CI: 0.37-0.80). Adherence to physical activity, TV and sleep recommendations was the main driver reducing the chance of being overweight. Overweight/obese children were more likely not to adhere to at least one of the recommended behaviours (19.8%) than normal-weight/thin children (12.9%) CONCLUSION: The selected key behaviours do not contribute equally to a reduced chance of being overweight. Future interventions may benefit most from moving more, reducing TV time and getting adequate sleep. © 2015 World Obesity.
    Full-text · Article · Dec 2015 · Obesity Reviews
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    ABSTRACT: Built environment studies provide broad evidence that urban characteristics influence physical activity (PA). However, findings are still difficult to compare, due to inconsistent measures assessing urban point characteristics and varying definitions of spatial scale. Both were found to influence the strength of the association between the built environment and PA. We simultaneously evaluated the effect of kernel approaches and network-distances to investigate the association between urban characteristics and physical activity depending on spatial scale and intensity measure. We assessed urban measures of point characteristics such as intersections, public transit stations, and public open spaces in ego-centered network-dependent neighborhoods based on geographical data of one German study region of the IDEFICS study. We calculated point intensities using the simple intensity and kernel approaches based on fixed bandwidths, cross-validated bandwidths including isotropic and anisotropic kernel functions and considering adaptive bandwidths that adjust for residential density. We distinguished six network-distances from 500 m up to 2 km to calculate each intensity measure. A log-gamma regression model was used to investigate the effect of each urban measure on moderate-to-vigorous physical activity (MVPA) of 400 2- to 9.9-year old children who participated in the IDEFICS study. Models were stratified by sex and age groups, i.e. pre-school children (2 to < 6 years) and school children (6–9.9 years), and were adjusted for age, body mass index (BMI), education and safety concerns of parents, season and valid weartime of accelerometers. Association between intensity measures and MVPA strongly differed by network-distance, with stronger effects found for larger network-distances. Simple intensity revealed smaller effect estimates and smaller goodness-of-fit compared to kernel approaches. Smallest variation in effect estimates over network-distances was found for kernel intensity measures based on isotropic and anisotropic cross-validated bandwidth selection. We found a strong variation in the association between the built environment and PA of children based on the choice of intensity measure and network-distance. Kernel intensity measures provided stable results over various scales and improved the assessment compared to the simple intensity measure. Considering different spatial scales and kernel intensity methods might reduce methodological limitations in assessing opportunities for PA in the built environment.
    Preview · Article · Dec 2015 · International Journal of Health Geographics
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    ABSTRACT: Objective: The objective of this paper is to evaluate the behavioural effects, as reported by the parents of the participating boys and girls, of the IDEFICS (Identification and prevention of Dietary- and lifestyle-induced health EFfects In Children and infantS) intervention. Methods: The effectiveness of the IDEFICS intervention was evaluated through a cluster-controlled trial in eight European countries (control and intervention communities in each country) including more than 16,000 children. The 2- to 9.9-year-old children in the intervention group were exposed to a culturally adapted intervention that aimed to prevent childhood obesity through the community, schools/kindergartens and family. Parents completed questionnaires to measure water, soft drink and fruit juice intake; fruit and vegetable intake; daily TV viewing and other sedentary behaviours; daily physical activity levels and strengthening of the parent-child relationships at baseline and follow-up (2 years later). Mixed models with an additional random effect for country were used to account for the clustered study design, and results were stratified by sex. Results: The pan-European analysis revealed no significant time by condition interaction effects, neither for boys nor girls, i.e. the analysis revealed no intervention effects on the behaviours of the IDEFICS children as reported by their parents (F = 0.0 to 3.3, all p > 0.05). Also very few significances were found in the country-specific analyses. Positive intervention effects were only found for sport club participation in Swedish boys, for screen time in weekends for Spanish boys and for TV viewing in Belgian girls. Conclusion: Although no expected intervention effects as reported by the parents on diet, physical activity and sedentary behaviours could be shown for the overall IDEFICS cohort, a few favourable intervention effects were found on specific behaviours in some individual countries. More in-depth analyses of the process evaluation data are needed to obtain more insight into the relationship between the level of exposure to the intervention and its effect. © 2015 World Obesity.
    Full-text · Article · Dec 2015 · Obesity Reviews
  • I. Pigeot · S. de Henauw · T. Baranowski

    No preview · Article · Dec 2015 · Obesity Reviews
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    ABSTRACT: Background: The aim of this study was to explore whether the IDEFICS intervention had a differential effect on 11,041 children's weight trajectories depending on their baseline body mass index status. Methods: Two subgroups of children are considered in the present analysis: those who were overweight or obese prior to the intervention and those who were neither overweight nor obese. Results: Among children in all eight countries who did not have prevalent overweight or obesity (OWOB) at baseline, 2 years later, there was no significant difference between intervention and control groups in risk of having developed OWOB. However, we observed a strong regional heterogeneity, which could be attributed to the presence of one distinctly outlying country, Belgium, where the intervention group had increased risk for becoming overweight. In contrast, among the sample of children with prevalent OWOB at baseline, we observed a significantly greater probability of normalized weight status after 2 years. In other words, a protective effect against persistent OWOB was observed in children in intervention regions compared with controls, which corresponded to an adjusted odds ratio of 0.76 (95% confidence interval: 0.58, 0.98). Discussion: This analysis thus provided evidence of a differential effect of the IDEFICS intervention, in which children with overweight may have benefited without having been specifically targeted. However, no overall primary preventive effect could be observed in children without initial overweight or obesity.
    No preview · Article · Dec 2015 · Obesity Reviews
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    ABSTRACT: Objectives: The primary aim of the present study was to obtain insight into parents' perception of the IDEFICS intervention at the school or preschool/kindergarten and community levels and whether they received specific materials related to the intervention. The secondary aim was to analyse whether parents who reported higher levels of exposure to the IDEFICS intervention had children with more favourable changes in body mass index (BMI) z-scores between baseline and after 2 years of intervention. Methods: Process evaluation of the IDEFICS intervention investigated the implementation of the 2-year intervention in the intervention communities. Intervention group parents (n = 4,180) in seven countries (Belgium, Cyprus, Estonia, Germany, Italy, Spain and Sweden) answered questions about their exposure to the IDEFICS study. To analyse the relationship between exposure and BMI z-score, a composite score was calculated for exposure at the setting and at the community levels. Results: The frequency of parental exposure to the IDEFICS messages not only through the community but also through the (pre)school/kindergarten was lower than what was intended and planned. The dose received by the parents was considerably higher through the (pre)school/kindergarten settings than that through the community in all countries. Efforts by the settings or communities related to fruit and vegetable consumption (range 69% to 97%), physical activity promotion (range 67% to 91%) and drinking water (range 49% to 93%) were more visible and also realized more parental involvement than those related to TV viewing, sleep duration and spending time with the family (below 50%). Results showed no relation of parental exposure at the setting or the community level on more favourable changes in children's BMI z-scores for the total sample. Country-specific analyses for parental exposure at the setting level showed an expected positive effect in German girls and an unexpected negative effect in Italian boys. Conclusion: Parental exposure and involvement in the IDEFICS intervention in all countries was much less than aimed for, which might be due to the diverse focus (six key messages) and high intensity and duration of the intervention. It may also be that the human resources invested in the implementation and maintenance of intervention activities by the study centres, the caretakers and the community stakeholders were not sufficient. Higher levels of parental exposure were not related to more favourable changes in BMI z-scores. © 2015 World Obesity.
    Preview · Article · Dec 2015 · Obesity Reviews
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    ABSTRACT: Older adults are the most sedentary segment of society and high sedentary time is associated with poor health and wellbeing outcomes in this population. Identifying determinants of sedentary behaviour is a necessary step to develop interventions to reduce sedentary time. A systematic literature review was conducted to identify factors associated with sedentary behaviour in older adults. Pubmed, Embase, CINAHL, PsycINFO and Web of Science were searched for articles published between 2000 and May 2014. The search strategy was based on four key elements: (a) sedentary behaviour and its synonyms; (b) determinants and its synonyms (e.g. correlates, factors); (c) types of sedentary behaviour (e.g. TV viewing, sitting, gaming) and (d) types of determinants (e.g. environmental, behavioural). Articles were included in the review if specific information about sedentary behaviour in older adults was reported. Studies on samples identified by disease were excluded. Study quality was rated by means of QUALSYST. The full review protocol is available from PROSPERO (PROSPERO 2014: CRD42014009823). The analysis was guided by the socio-ecological model framework. Twenty-two original studies were identified out of 4472 returned by the systematic search. These included 19 cross-sectional, 2 longitudinal and 1 qualitative studies, all published after 2011. Half of the studies were European. The study quality was generally high with a median of 82 % (IQR 69–96 %) using Qualsyst tool. Personal factors were the most frequently investigated with consistent positive association for age, negative for retirement, obesity and health status. Only four studies considered environmental determinants suggesting possible association with mode of transport, type of housing, cultural opportunities and neighbourhood safety and availability of places to rest. Only two studies investigated mediating factors. Very limited information was available on contexts and sub-domains of sedentary behaviours. Few studies have investigated determinants of sedentary behaviour in older adults and these have to date mostly focussed on personal factors, and qualitative studies were mostly lacking. More longitudinal studies are needed as well as inclusion of a broader range of personal and contextual potential determinants towards a systems-based approach, and future studies should be more informed by qualitative work.
    Full-text · Article · Oct 2015 · International Journal of Behavioral Nutrition and Physical Activity
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    ABSTRACT: To investigate whether physician's prescribing preference is a valid instrumental variable (IV) for patients' actual prescription of selective COX-2 inhibitors in the German Pharmacoepidemiological Research Database (GePaRD). We compared the effect of COX-2 inhibitors vs. traditional NSAIDs (tNSAIDs) on the risk of gastrointestinal complications using physician's preference as IV. We used different definitions of physician's preference for COX-2 inhibitors. A retrospective cohort of new users was built which was further restricted to subcohorts. We compared IV-based risk difference estimates, using a two-stage approach, to estimates from conventional multivariable models. We observed only a small proportion of COX-inhibitor users (3.2%) in our study. All instruments, in the full cohort and in the subcohorts, reduced the imbalance in most of the covariates. However, the IV treatment effect estimates had a highly inflated variance. Compared to the most recent prescription, the proportion of previous patients was a stronger instrument and reduced the variance of the estimates. The proportion of all previous patients is a potential IV for comparing COX-2 inhibitors vs. tNSAIDs in GePaRD. Our study demonstrates that valid instruments in one health care system may not be directly applicable to others. Copyright © 2015 Elsevier Inc. All rights reserved.
    No preview · Article · Sep 2015 · Journal of clinical epidemiology
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    ABSTRACT: Faster growth seems to be a common factor in several hypotheses relating early life exposures to subsequent health. This study aims to investigate the association between body mass index (BMI) trajectories during infancy/childhood and later metabolic risk in order to identify sensitive periods of growth affecting health. In a first step, BMI trajectories of 3301 European children that participated in the multi-centre Identification and Prevention of Dietary and Lifestyle-induced Health Effects in Children and Infants (IDEFICS) study were modelled using linear-spline mixed-effects models. The estimated random coefficients indicating initial subject-specific BMI and rates of change in BMI over time were used as exposure variables in a second step and related to a metabolic syndrome (MetS) score and its single components based on conditional regression models (mean age at outcome assessment: 8.5 years). All exposures under investigation, i.e. BMI at birth, rates of BMI change during infancy (0 to <9 months), early childhood (9 months to <6 years) and later childhood (≥6 years) as well as current BMI z-score were significantly associated with the later MetS score. Associations were strongest for the rate of BMI change in early childhood (1.78 [1.66; 1.90]; β estimate and 99 % confidence interval) and current BMI z-score (1.16 [0.96; 1.38]) and less pronounced for BMI at birth (0.62 [0.47; 0.78]). Results slightly differed with regard to the single metabolic factors. Starting from birth rapid BMI growth, especially in the time window of 9 months to <6 years, is significantly related to later metabolic risk in children. Much of the associations of early BMI growth may further be mediated through the effects on subsequent BMI growth.
    Full-text · Article · Aug 2015 · European Journal of Epidemiology
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    Iris Pigeot · Svenja Jacobs · Uwe Koch-Gromus

    Preview · Article · Jul 2015 · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz
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    ABSTRACT: Overweight/obesity is an important public health burden worldwide, increasing the risk for the development of cardiovascular diseases or the metabolic syndrome. This risk may be reduced by a good aerobic fitness (AF) that can be improved by physical activity but is also influenced by genetic factors. The aim of this study was to test for familial aggregation of AF measured by maximal oxygen uptake (VO2max) and to estimate its heritability. Furthermore, an exploratory analysis of the association between overweight/obesity and AF was performed. In contrast to previous studies, all analyses were adjusted for additional environmental and behavioral factors, in particular for objectively measured physical activity (PA) in addition to body mass index (BMI). 79 families (157 parents, 132 children) performed a maximum exercise test (spiroergometry) to assess maximum oxygen uptake. PA was measured by accelerometry. Familial aggregation of AF was determined using a two-step design: AF was adjusted for age, sex and age*sex using linear regression. Afterwards, the residuals were used to determine the intraclass correlation coefficient (ICC) by ANOVA. Heritability and associations were estimated by generalized linear mixed models. Familial aggregation of AF (ICC = 0.22, p < 0.001) was significant but decreased when adjusted for PA or BMI. Its heritability was estimated as 40 % (adjusted for PA) using the mid-parent-offspring design. Relative to the middle quintile of AF residuals, the odds of being overweight/obese were three- to tenfold reduced in the upper quintile (adjusted for age, sex, age*sex, PA). AF clustered in families after controlling for PA, BMI and parental smoking. Heritability was stronger for mother-child pairs as compared to father-child pairs after controlling for PA and BMI. Above average AF was negatively associated with overweight/obesity.
    Full-text · Article · Jul 2015 · BMC Public Health
  • Edeltraut Garbe · Iris Pigeot
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    ABSTRACT: Large electronic healthcare databases have become an important worldwide data resource for drug safety research after approval. Signal generation methods and drug safety studies based on these data facilitate the prospective monitoring of drug safety after approval, as has been recently required by EU law and the German Medicines Act. Despite its large size, a single healthcare database may include insufficient patients for the study of a very small number of drug-exposed patients or the investigation of very rare drug risks. For that reason, in the United States, efforts have been made to work on models that provide the linkage of data from different electronic healthcare databases for monitoring the safety of medicines after authorization in (i) the Sentinel Initiative and (ii) the Observational Medical Outcomes Partnership (OMOP). In July 2014, the pilot project Mini-Sentinel included a total of 178 million people from 18 different US databases. The merging of the data is based on a distributed data network with a common data model. In the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCEPP) there has been no comparable merging of data from different databases; however, first experiences have been gained in various EU drug safety projects. In Germany, the data of the statutory health insurance providers constitute the most important resource for establishing a large healthcare database. Their use for this purpose has so far been severely restricted by the Code of Social Law (Section 75, Book 10). Therefore, a reform of this section is absolutely necessary.
    No preview · Article · Jun 2015 · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz
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    ABSTRACT: Kohortenstudien liefern unter allen Typen epidemiologischer Beobachtungsstudien die beste Evidenz für das Erkennen von kausalen Zusammenhängen zwischen Risikofaktoren und Krankheiten. Ihr Design kann jedoch auch zu Nachteilen führen, die die Validität und Aussagekraft der Ergebnisse beeinflussen können. Dazu zählen insbesondere systematische Fehler wie Selektionseffekte oder Verzerrungen aufgrund lücken- oder fehlerhafter Erinnerungen. Um diese teilweise auszugleichen, ist es möglich, die Primärdaten aus der Kohortenstudie auf Individualebene mit Sekundär- und Registerdaten zu verlinken. Diese Verknüpfung kann auch zur Validierung der verwendeten Datenquellen genutzt werden. Zu den Sekundär- und Registerdaten, die bisher in Deutschland im Rahmen von Kohortenstudien mit Primärdaten verknüpft wurden, gehören Kranken- und Rentenversicherungsdaten, Angaben der Bundesagentur für Arbeit sowie Krebsregisterdaten. Bei ihnen lassen sich zwei Gemeinsamkeiten erkennen. Zum einen verfügen alle über einen großen Umfang an Detailinformationen, die sich in der Regel auf lange Zeiträume und große Populationen beziehen. Zum anderen sind sie in der Lage, Daten auf Individualebene zur Verfügung zu stellen, sodass prinzipiell eine Verlinkung z. B. mit Primärdaten möglich ist. Jede dieser Datenquellen ist aber auch mit Einschränkungen behaftet, die zu berücksichtigen sind. Gleichzeitig muss in Deutschland eine Reihe rechtlicher Restriktionen beachtet werden, deren Ziel es ist, den Missbrauch der Daten zu vermeiden.
    No preview · Article · Jun 2015 · Bundesgesundheitsblatt - Gesundheitsforschung - Gesundheitsschutz

Publication Stats

2k Citations
387.77 Total Impact Points

Institutions

  • 2012-2015
    • Leibniz-Institute of Prevention Research and Epidemiology
      Bremen, Bremen, Germany
    • Humboldt-Universität zu Berlin
      Berlín, Berlin, Germany
  • 2002-2015
    • Universität Bremen
      • • Faculty 03: Mathematics/Computer Science
      • • Bremen Institute for Prevention Research and Social Medicine (BIPS)
      Bremen, Bremen, Germany
  • 2014
    • University of Zaragoza
      • Department of Pediatrics, Radiology and Physical Medicine
      Caesaraugusta, Aragon, Spain
  • 1999-2002
    • Technische Universität München
      München, Bavaria, Germany
  • 1998-1999
    • Ludwig-Maximilians-University of Munich
      • Institut für Statistik
      München, Bavaria, Germany
  • 1991-1996
    • Technische Universität Dortmund
      • Chair of Computer Science XII
      Dortmund, North Rhine-Westphalia, Germany