elsewhere. To the extent possible, original scientific studies have been used to derive the DRIs. Based on a thorough review of the scientific literature, clinical and functional indicators of nutritional adequacy and excess were identified for each nutrient.

The quality of the studies was considered in weighing the evidence. The characteristics examined included the study design and the representativeness of the study population; the validity, reliability, and precision of the methods used for measuring intake and indicators of adequacy or excess; the control of biases and confounding factors; and the power of the study to demonstrate a given difference or correlation. Publications solely expressing opinions were not used in setting DRIs. The assessment acknowledged the inherent reliability of each type of study design as described above and applied standard criteria concerning the strength, dose-response, and temporal pattern of estimated nutrient-disease or adverse effect associations; the consistency of associations among studies of various types; and the specificity and biological plausibility of the suggested relationships (Hill, 1971). For example, biological plausibility would not be sufficient in the presence of a weak association and lack of evidence that exposure preceded the effect.

Data were examined to determine whether similar estimates of the requirement resulted from the use of different indicators and different types of studies. For a single nutrient, the criterion for setting the Estimated Average Requirement (EAR) may differ from one life stage group to another because the critical function or the risk of disease may be different. When no or very poor data were available for a given life stage group, extrapolation was made from the EAR or Adequate Intake (AI) set for another group, by making explicit and logical assumptions about relative requirements. Because EARs can be used for multiple purposes, they were established whenever sufficient supporting data were available.

Data Limitations

Although the reference values are based on data, the data were often scanty or drawn from studies that had limitations in addressing the various questions that confronted the panel. Therefore, many of the questions raised about the requirements for and recommended intakes of these nutrients cannot be answered fully because of inadequacies in the present database. Apart from studies of overt deficiency diseases, there is a dearth of studies that address specific effects of inadequate intakes on specific indicators of health status, and thus a research agenda is proposed (see Chapter 10).

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