Study Quality of Evidence According to GRADE Guidelines
| Outcomes | No. of Studies (No. of Patients) | Study Design | Domain | |||||
|---|---|---|---|---|---|---|---|---|
| Risk of Bias | Indirectness | Inconsistency | Imprecision | Publication Bias | Test of Accuracy | |||
| Sensitivity and specificitya | ||||||||
| True positive and false negative | 6 (3,304) | Cross-sectional (cohort type accuracy study) | Seriousb | Not serious | Very seriousc | Very seriousd | None | Very low |
| True negative and false positive | 4 (5,877) | Cross-sectional (cohort type accuracy study) | Seriousb | Not serious | Very seriouse | Very seriousd | None | Very low |
| PPV and NPVf | ||||||||
| True positive and false positive | 6 (4,581) | Cross-sectional (cohort type accuracy study) | Seriousb | Not serious | Very seriousg | Very seriousd | None | Very low |
| True negative and false negative | 4 (4,634) | Cross-sectional (cohort type accuracy study) | Seriousb | Not serious | Very serioush | Very seriousd | None | Very 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%).