Table 2.

Levels of Certainty Regarding Net Benefit

Level of Certainty	Description
High	The available evidence includes consistent results from well-designed, well-conducted studies in representative primary care populations. These studies assess the effects of the preventive service on health outcomes. This conclusion is therefore unlikely to be strongly affected by the results of future studies. Evidence Level I-A: At least one controlled and randomized clinical trial, properly designed
Moderate	The available evidence is sufficient to determine the effects of the preventive service on health outcomes, but confidence in the estimate is constrained by such factors as:  ● The number, size, or quality of individual studies.  ● Inconsistency of findings across individual studies.  ● Limited generalizability of findings to routine primary care practice.  ● Lack of coherence in the chain of evidence. As more information becomes available, the magnitude or direction of the observed effect could change, and this change may be large enough to alter the conclusion. Evidence Level I-B: Well-designed, controlled, non-randomized clinical trials (prospective observational studies conforming to STROBE criteria) or Evidence Level I-C: Retrospective cohort or large case studies (>20 subjects)
Low	The available evidence is insufficient to assess effects on health outcomes. Evidence is insufficient because of:  ● The limited number or size of studies.  ● Important flaws in study design or methods.  ● Inconsistency of findings across individual studies.  ● Gaps in the chain of evidence.  ● Findings not generalizable to routine primary care practice.  ● Lack of information on important health outcome. Evidence Level II: Expert opinion based on risk:benefit or based upon case reports