TABLE 2.
Suggested factors | Low/limited evidence | Moderate evidence | Strong evidence |
Factors for assessing individual studies | |||
Design strength and validity | Extensive limitations of the design | Minor design limitations or uncertainties | Design/implementation of high quality: feasible intervention; appropriate control group; valid duration and measurement of outcome; appropriate statistical analysis used and adequately described |
Risk of bias | Substantial risk of bias | Some presence or potential for risk of bias | Methods are described in detail to disclose that bias is minimized: comparable groups are randomly generated; design includes allocation concealment and blinding; measures of compliance are included; missing data are treated appropriately; outcomes are prespecified or justified |
• Selection | |||
• Performance detection | |||
• Attrition | |||
• Reporting | |||
Impact | Most studied outcomes relate to the question indirectly; effect is small, uncertain, or lacks clinical significance; low confidence that the evidence reflects the true effect, likely to change with future research | Some indirectness of outcomes; doubt about the clinical significance of the effect; moderate confidence that the evidence reflects the true effect but may be changed by further research | Outcomes (validated surrogate endpoints/biomarkers) relate directly to the research question; size of effect is clinically relevant and statistically significant; high confidence that the evidence reflects the true effect; further research very unlikely to change the estimate of effect |
Generalizability | Results are likely not generalizable; narrow study population | Some doubt about generalizability | Study subjects adequately represent the population of interest |
Factors considering the totality of evidence across studies | |||
Consistency | Unexplained inconsistency among results; not similar in direction or size of effect | Minor inconsistency among results in direction and size/significance of effect or degree of association that weaken confidence in relation | Consistent findings in direction and size/significance of effect and degree of association (very minor exceptions) |
Quantity | Limited number of studies and subjects (inadequate sample size) | Moderate number of studies; some variety in investigators; doubts about adequacy of sample size to avoid type I and II errors | Large number of studies and subjects (sufficient for adequate statistical power); multiple investigators |
This table compiles systematic review elements and evaluation criteria commonly used by authoritative and policy organizations. It should be interpreted as a simplified synthesis; inquiries regarding specific organizations review framework should be directed to publicly available information referenced in Table 1.