Fetal macrosomia is a risk factor for the development of obesity late in childhood. We retrospectively evaluated the relationship between maternal conditions associated with fetal macrosomia and actual overweight/obesity in the European cohort of children participating in the IDEFICS study. Anthropometric variables, blood pressure and plasma lipids and glucose were measured. Socio-demographic data, medical history and perinatal factors, familiar and gestational history, maternal and/or gestational diabetes were assessed by a questionnaire. Variables of interest were reported for 10,468 children (M/F = 5,294/5,174; age 6.0 ± 1.8 years, M ± SD). The sample was divided in four groups according to child birth weight (BW) and maternal diabetes: (1) adequate for gestational age offspring (BW between the 10th and 90th percentiles for gestational age) of mothers without diabetes (AGA-ND); (2) adequate for gestational age offspring of mothers with diabetes (AGA-D); (3) macrosomic offspring (BW> 90th percentile for gestational age) of mothers without diabetes (Macro-ND); (4) macrosomic offspring of mothers with diabetes (Macro-D). Children macrosomic at birth showed significantly higher actual values of body mass index, waist circumference, and sum of skinfold thickness. In both boys and girls, Macro-ND was an independent determinant of overweight/obesity, after the adjustment for confounders [Boys: OR = 1.7 95 % CI (1.3;2.2); Girls: OR = 1.6 95 % CI (1.3;2.0)], while Macro-D showed a significant association only in girls [OR = 2.6 95 % CI (1.1;6.4)]. Fetal macrosomia, also in the absence of maternal/gestational diabetes, is independently associated with the development of overweight/obesity during childhood. Improving the understanding of fetal programming will contribute to the early prevention of childhood overweight/obesity.

Post-marketing detection and surveillance of potential safety hazards are crucial tasks in pharmacovigilance. To uncover such safety risks, a wide set of techniques has been developed for spontaneous reporting data and, more recently, for longitudinal data. This paper gives a broad overview of the signal detection process and introduces some types of data sources typically used. The most commonly applied signal detection algorithms are presented, covering simple frequentistic methods like the proportional reporting rate or the reporting odds ratio, more advanced Bayesian techniques for spontaneous and longitudinal data, e.g., the Bayesian Confidence Propagation Neural Network or the Multi-item Gamma-Poisson Shrinker and methods developed for longitudinal data only, like the IC temporal pattern detection. Additionally, the problem of adjustment for underlying confounding is discussed and the most common strategies to automatically identify false-positive signals are addressed. A drug monitoring technique based on Wald’s sequential probability ratio test is presented. For each method, a real-life application is given, and a wide set of literature for further reading is referenced.

A comparison of hd-PS matching versus conventional PS matching resulted in improved point estimates for studying an intended treatment effect of coxibs versus tNSAIDs when benchmarked against results from randomized controlled trials.

Background: During the preparatory phase of the baseline survey of the IDEFICS (Identification and prevention of dietary-and lifestyle-induced health effects in children and infants) study, standardised survey procedures including instruments, examinations, methods, biological sampling and software tools were developed and pretested for their feasibility, robustness and acceptability. Methods: A pretest was conducted of full survey procedures in 119 children aged 2-9 years in nine European survey centres (N per centre ¼ 4-27, mean 13.22). Novel techniques such as ultrasound measurements to assess subcutaneous fat and bone health, heart rate monitors combined with accelerometers and sensory taste perception tests were used. Results: Biological sampling, physical examinations, sensory taste perception tests, parental questionnaire and medical interview required only minor amendments, whereas physical fitness tests required major adaptations. Callipers for skinfold measurements were favoured over ultrasonography, as the latter showed only a low-to-modest agreement with calliper measurements (correlation coefficients of r ¼ À0.22 and r ¼ 0.67 for all children). The combination of accelerometers with heart rate monitors was feasible in school children only. Implementation of the computer-based 24-h dietary recall required a complex and intensive developmental stage. It was combined with the assessment of school meals, which was changed after the pretest from portion weighing to the more feasible observation of the consumed portion size per child. The inclusion of heel ultrasonometry as an indicator of bone stiffness was the most important amendment after the pretest. Discussion: Feasibility and acceptability of all procedures had to be balanced against their scientific value. Extensive pretesting, training and subsequent refinement of the methods were necessary to assess the feasibility of all instruments and procedures in routine fieldwork and to exchange or modify procedures that would otherwise give invalid or misleading results.