Derivation of the minimal magnitude of the Critical Effect Size for continuous toxicological parameters from within-animal variation in control group data.

Assuming that temporal fluctuations in physiological parameters (e.g. haematology, biochemistry) in individual healthy non-exposed animals are non-adverse, the minimal magnitude of the Critical Effect Size (CES) for a number of continuous parameters of toxicity studies was derived. A total of 36 studies (19 pharmaceutical preclinical studies in dogs and 17 chemical risk assessment studies in rats) were analysed to determine within-animal variation in their control groups. Minimal CES-values were derived for each group of studies, differentiating where necessary between strains and sexes, using the 2.5 percentile (lower limit) and/or 97.5 percentile (upper limit) of the distribution of the within-animal variation around the mean of each parameter. We concluded that minimal CES-values for continuous clinical chemistry and haematology parameters should be established separately per species, strain, sex and study duration investigated. Grouping of minimal CES-values, leading to more or less "general" values, seems possible for those parameters that are subject to tight homeostatic control and consequently show little within-animal variation. Nearly a quarter of the proposed CES-values is 5%, nearly a quarter range from 6% to 10%, a quarter is 15% or 20%, and nearly 30% of the proposed values is 20% of the mean of the control animals.

Socio-economic status, dietary intake and 10 y trends: the Dutch National Food Consumption Survey.

OBJECTIVE: To study differences in dietary intake between adults with different socioeconomic status (SES) and trends over time. DESIGN: Cross-sectional study based on data of three Dutch National Food Consumption Surveys (DNFCS-1 1987/88; DNFCS-2 1992; DNFCS-3 1997/98), obtained from a panel by a stratified probability sample of the non-institutionalized Dutch population. SUBJECTS: A total of 6008 men and 6957 women aged 19 y and over. METHODS: Dietary intake was assessed with a 2 day dietary record. Background information was obtained by structured questionnaire. Sociodemographic variables were available from panel information. SES, based on educational level, occupation and occupational position was categorized into (very) low, middle and high. Analysis of variance with age as covariable was used to explore the effects of SES on dietary intake and anthropometry. Statistical tests for trend were carried out with models in which week-weekend-day effects and an interaction term of time with SES were also included. RESULTS: The prevalence of obesity and skipping of breakfast was higher among people with a low SES. In all three surveys, subjects in the (very) low SES group reported having a higher consumption of potatoes, meat and meat products, visible fats, coffee and soft drinks (men only). Subjects with a high SES reported consuming more vegetables, cheese and alcohol. As regards nutrients, in all surveys a higher SES was associated with higher intake of vegetable protein, dietary fibre and most micronutrients. A higher SES was also associated with a lower fat intake but the differences between social classes were rather small and not consistent when the contribution of alcohol to energy intake was taken into account. CONCLUSION: In general, dietary intake among subjects in higher SES groups tended to be closer to the recommendations of the Netherlands Food and Nutrition Council and this phenomenon was quite stable over a period of 10 y.

Estimating the distribution of usual dietary intake by short-term measurements.

OBJECTIVE: To estimate the habitual dietary intake distribution in a population on the basis of repeated short-term measurements, especially of multiple 24 h diet recalls. METHODS: Six different statistical methods were evaluated and compared. The comparison referred to theoretical assumptions, admitted data transformations, statistical foundations, available software packages, and applications to real data of dietary intake. RESULTS: The Nusser method and a simplified version of it proposed in the paper have proved to be universally applicable methods for estimating the usual intake distribution for food groups and nutrients. Also, the Buck method seemed to be a robust estimation procedure suitable for the description of food consumption data, whereas the other considered methods were only applicable for log-normally distributed intake data or required a comprehensive data simulation. Characteristics of the estimated usual intake distribution were a decreased standard deviation, increased lower percentiles, and decreased upper percentiles compared to the observed sample distribution of individual means. Empirical results concerning total fat and vegetable intake in three different European consumption surveys showed that the estimated percentiles of the usual intake distribution did not depend markedly on the number of sampling days. CONCLUSIONS: Repeated short-term measurements like 24 h diet recalls can be used to describe the habitual dietary intake distribution in food consumption surveys. Recommended is a sampling design of two non-consecutive sampling days. The sampling days of all participants should be selected in such a way that they cover all seasons and days of the week.