CORE QUESTION

Are the results presented in a way that makes the data usable and transparent?

PROMPTING QUESTIONS

For each endpoint/outcome or grouping of endpoints/outcomes in a study:

Does the level of detail allow for an informed interpretation of the results?
Are the data analyzed, compared, or presented in a way that is inappropriate or misleading?

BASIC CONSIDERATIONS

Considerations for this domain are highly variable depending on the outcomes of interest and must be refined by assessment teams.

A judgment and rationale for this domain should be given for each endpoint/outcome or group of endpoints/outcomes investigated in the study.

Is there concern that different types of tumors were inappropriately combined in the analysis?

Analyses of benign and malignant tumors from the same tissue type should be reported both separately and combined; tumors of the same cellular origin, which may appear at different organ sites, should be combined (McConnell et al. 1986).

Is there concern that statistical analyses are inadequate or were not conducted for evaluating the results?

If statistical analyses were not conducted, were the results reported in sufficient detail for ad hoc analysis?

If statistical analyses are not reported, the study should at a minimum present incidence data for specific tumors, so that statistical tests (e.g. Fisher’s exact test for pairwise comparisons) can be conducted.

If there is evidence of a decreased survival effect, the studies should use adequate statistical methods, such as the poly-3 test (Bailer and Portier 1988), to control for decreased survival.

Name	Type	Comments
Initiation-(co) promotion	Chronic (>90 days)
Initiation-(co) promotion	Chronic (>90 days)

Heikkinen et al., 2001

Risk of bias

Animal bioassay experiments

HAWC