Table 1.

Criteria that should be met in clinical studies and health economics studies that can be used to inform health-care decision-making

Element	Clinical Studies	HE Studies
Design	RCT or well-conducted comparative cohort	Prefer CE or CB, whether modeling employed or not; if other type, rationale clearly stated
Outcomes	Outcomes match the goals of the study, but are also rational and relevant	Outcomes match study goals; appropriate selection of benefit units, if used
Costs	Not applicable unless an HE study is piggybacked on to a clinical study	Clearly state which costs are included, with rationale; describe source costs and assumptions about costs
Analysis	Methods to obtain unadjusted and adjusted results clearly stated	Methods clearly stated; sensitivity analysis conducted for modeling studies
Reporting	Follows CONSORT, STARD, or STROBE guidelines as appropriate	Detailed reporting of data sources, modeling, calculations, and resource utilization
Sponsor involvement	Clearly stated	Clearly stated

HE, health economics; CE, cost-effectiveness; RCT, randomized controlled trial; CB, cost–benefit; CONSORT, Consolidated Standards of Reporting Trials; STARD, Standards for the Reporting of Diagnostic Accuracy Studies; STROBE, Strengthening the Reporting of Observational Studies in Epidemiology.