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. 2010 Mar 1;10(3):1–55.

Table 12: Factors Affecting GRADE Quality of Evidence.

Factor Explanation Effect on GRADE
Risk of Bias
Study design
  • 11 non-randomized clinical trials (observational studies)

High
Limitations
  • Same woman exposed to both MRI and FM, therefore, estimates of accuracy for one test not necessarily independent of the other test.

Unchanged
Indirectness
Outcomes
  • Estimates of accuracy are considered as proxy measures for the more important outcome of mortality. No evidence exists in the literature for effects on mortality based on screening of women at high risk with MRI (or MRI plus FM).

High → Moderate
Patient populations, diagnostic test, comparison test, and indirect comparisons
  • Direct comparisons of MRI plus FM to either MRI or FM alone.

Unchanged
Important inconsistency in study results
  • No inconsistency

Unchanged
Imprecise evidence
  • Confidence intervals for sensitivity, specificity were sufficiently precise.

Unchanged
Publication bias
  • No obvious publication bias.

Unchanged
Quality of evidence Moderate