The accuracy of pulse oximetry in screening for congenital heart disease in asymptomatic newborns: A systematic review

Shakila Thangaratinam ^1*, Jane Daniels ¹, Andrew K Ewer ², Javier Zamora ³ and Khalid S Khan ¹

¹ Birmingham Women's Hospital, United Kingdom
² University of Birmingham, United Kingdom
³ University Complutense of Madrid, Spain

^* To whom correspondence should be addressed. E-mail: s.thangaratinam{at}bham.ac.uk.

Accepted 6 February 2007

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, PsycINFO, Cochrane Library. SCISEARCH, conference papers, and bibliographies of retrieved primary and review articles. Two reviewers independently extracted data on study characteristics, quality, and results to construct 2x 2 tables with congenital heart disease as the reference standard. We used a random- effects bivariate model 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: We extracted 8 studies with a total of 35,960 newborns. Pulse oximetry was performed on asymptomatic newborns in all studies, with three studies excluding newborns with an antenatal diagnosis of congenital heart disease. The studies measured either functional or fractional oxygen saturation by pulse oximetry with oxygen saturation below 95% considered as the cut off level in most studies. Based on 8 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 has been shown to be highly specific tool with very low false positive rates to detect congenital heart disease. Further large well conducted prospective studies are needed to assess its sensitivity with higher precision.

Keywords: clinical epidemiology, congenital heart disease, newborns, pulse oximetry, screening

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