Table 3

Study Quality of Evidence According to GRADE Guidelines

OutcomesNo. of Studies (No. of Patients)Study DesignDomain
Risk of BiasIndirectnessInconsistencyImprecisionPublication BiasTest of Accuracy
Sensitivity and specificitya
 True positive and false negative6 (3,304)Cross-sectional (cohort type accuracy study)SeriousbNot seriousVery seriouscVery seriousdNoneVery low
 True negative and false positive4 (5,877)Cross-sectional (cohort type accuracy study)SeriousbNot seriousVery seriouseVery seriousdNoneVery low
PPV and NPVf
 True positive and false positive6 (4,581)Cross-sectional (cohort type accuracy study)SeriousbNot seriousVery seriousgVery seriousdNoneVery low
 True negative and false negative4 (4,634)Cross-sectional (cohort type accuracy study)SeriousbNot seriousVery serioushVery seriousdNoneVery low
  • GRADE = Grades of Recommendation Assessment, Development, and Evaluation; NPV = negative predictive value; PPV = positive predictive value.

  • a Sensitivity = 0.51 (95% CI, 0.36–0.67); specificity = 0.59 (95% CI, 0.41–0.76).

  • b According to Quality Assessment of Diagnostic Accuracy Studies 2 tool, all studies included in this meta-analysis were deemed to have significant risk of bias concerns.

  • c Unexplained heterogeneity between studies (I2=98.4%).

  • d The confidence interval is a range that, if the true value were to lie within it, would result in different clinical decisions depending on where it fell.

  • e Unexplained heterogeneity between studies (I2=99.4%).

  • f PPV = 0.41 (95% CI, 0.31–0.52); NPV = 0.64 (95% CI, 0.58–0.70).

  • g Unexplained heterogeneity between studies (I2= 97.2%).

  • h Unexplained heterogeneity between studies (I2= 95.0%).