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Observational epidemiological surveys (WG 3) page 6<br />

_________________________________________________________________________________________<br />

Evaluation of epidemiological data will be based on the causal inference criteria as described<br />

first by Hill (1965) as follows:<br />

• Consistency of the results<br />

• Strength of the association<br />

• Dose- response<br />

• Biological plausibility<br />

• Analogy<br />

We did not use either experimental data, because animal models are not necessarily relevant<br />

to the study of nutritional risk factors in humans, or temporality relationship because of the<br />

difficulty in assessing retrospective nutritional intake. However, we included large<br />

intervention trials, in which epidemiological observations could be made, and they represent<br />

some types of experimental data.<br />

Vocabulary<br />

To characterise the relationship between cancer and food or nutriment we used the vocabulary<br />

of the three books mentioned above:<br />

• no data reported: the authors ignored any data related to this relationship<br />

• no relationship: no effect of the food or nutriment was considered on cancer<br />

• insufficient: not enough data to draw a conclusion (less than three studies)<br />

• consistent: good agreement of data<br />

• inconsistent: heterogeneity of data, no major trends in the results.<br />

• convincing: the evidence of a causal relationship is conclusive and sufficient for<br />

being the basis for dietary recommendations<br />

• probable: the causal relationship is likely and sufficient for being the basis for<br />

dietary recommendations<br />

• possible: a causal relationship may exist, but the evidence is not strong enough to<br />

be a basis for recommendations. This qualification covers inconsistent results, but<br />

with a tendency of more results showing an effect.<br />

Part 1: Tomatoes and tomato products, lycopene, other tomato<br />

microcompouds and cancers

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