Accuracy of pulse oximetry in screening for congenital heart disease in asymptomatic newborns: a systematic review

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Abstract
Objective: To evaluate the accuracy of pulse oximetry as a screening tool for congenital heart disease in asymptomatic newborns. Design, data sources and methods: Systematic review of relevant studies identified through MEDLINE, EMBASE, Cochrane Library, MEDION, and bibliographies of retrieved primary and review articles. Two reviewers independently extracted data on study characteristics, quality and results to construct 2×2 tables with congenital heart disease as the reference standard. A random-effects bivariate model was used to meta-analyse estimates of sensitivity and specificity. Logit pairs of sensitivity and specificity of each study were analysed in a single model, accounting for their correlation due to differences in threshold between studies. Results: Eight studies were included with a total of 35 960 newborns. Pulse oximetry was performed on asymptomatic newborns in all studies; three studies excluding newborns with an antenatal diagnosis of congenital heart disease. Either functional or fractional oxygen saturation was measured by pulse oximetry with oxygen saturation below 95% as the cut-off level in most studies. On the basis of the eight studies, the summary estimates of sensitivity and specificity were 63% (95% CI 39% to 83%) and 99.8% (95% CI 99% to 100%), respectively, yielding a false positive rate of 0.2% (95% CI 0% to 1%). Conclusion: Pulse oximetry was found to be highly specific tool with very low false positive rates to detect congenital heart disease. Large, well-conducted prospective studies are needed to assess its sensitivity with higher precision.