Summary of findings'. '.

Should pulse oximetry be used to diagnose CCHD in asymptomatic newborns?
Patient or population: asymptomatic newborns at the time of pulse oximetry screening
Setting: hospital births
Index test: pulse oximetry
Reference test: Reference standards were both diagnostic echocardiography (echocardiogram) and clinical follow‐up in the first 28 days of life, including postmortem findings and mortality and congenital anomaly databases to identify false‐negative patients.
Studies: We included prospective or retrospective cohorts and cross‐sectional studies. We excluded case reports and studies of case‐control design.
Threshold	Summary accuracy (95% CI)	Number of participants (diseased /non‐diseased) Number of studies	Prevalence median (range)	Implications (in a cohort of 10,000 newborns tested [95% CI])				Certainty of the evidence (GRADE)
					Prevalence 0.6 per 1000	Prevalence 0.1 per 1000	Prevalence 3.7 per 1000
95% (less than or less than or equal to)	Sensitivity 76.3% (69.5 to 82.0) Specificity 99.9% (99.7 to 99.9)	436,758 (345/436,413) 19 studies	0.6 per 1000 (0.1 to 3.7)	True positives (newborns with CCHD)	5 (4 to 5)	1 (1 to 1)	28 (26 to 30)	LOW* ⊕⊕⊝⊝
				False negatives (newborns incorrectly classified as not having CCHD)	1 (1 to 2)	0 (0 to 0)	9 (7 to 11)
				True negatives (newborns without CCHD)	9980 (9966 to 9987)	9985 (9971 to 9992)	9949 (9935 to 9956)	HIGH ⊕⊕⊕⊕
				False positives (newborns incorrectly classified as having CCHD)	14 (7 to 28)	14 (7 to 28)	14 (7 to 28)
CCHD: critical congenital heart defect; CI: confidence interval. Sensitivity: *We have downgraded certainty of the evidence from high to low because the low number of CCHD cases included in the review (serious imprecision) and secondly, there was a serious risk of differential verification bias (ie, diagnosis was established by echocardiography in test positive cases however test negatives were usually confirmed by clinical follow‐up or by accessing congenital malformation registries and mortality databases)."
Certainty of the evidence (Balshem 2011) High certainty: We are very confident that the true effect lies close to that of the estimate of the effect. Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different. Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect. Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.