Epidemiological criteria for evidence of beneficial or adverse effects of elevated dosages of vitamins.

Criteria for epidemiological evidence of effects of elevated dosages of vitamins are basically the same as those for the evidence of effects of other exposures. Given the unambiguous classifications of both exposure and cases, they comprise strength, significance, specificity, and consistency of the statistical association, plausible time relationship as well as dose-effect relationship and consistency with other evidence. Today, the term epidemiological evidence usually refers to field experience, often to "observational," i.e., non-experimental, evidence. An extreme example for this are the so-called "ecological studies," which are frequently criticized because of their potential for exaggerated interpretations, though they can be very helpful in constructing and supporting hypotheses. For very rare and long-term effects the description and evaluation of individual cases are often combined with attempts of quantification, by relating them to the estimated exposure of the source population. This is subject to numerous sources of errors. If it is difficult to confirm the existence of rare and late effects, as the collection and interpretation of data on the prevention of such effects often present almost insurmountable methodological challenges. However, with correct interpretation and by keeping the quantitative perspective in mind, epidemiological evidence can be extremely helpful in the assessment of the overall importance, i.e., the public health significance, of such effects.