Background: Undiagnosed congenital heart disease in the prenatal stage can occur in approximately 5 to 15 out of 1000 live births; more than a quarter of these will have critical congenital heart disease (CCHD). Late postnatal diagnosis is associated with a worse prognosis during childhood, and there is evidence that a standardized measurement of oxygen saturation in the newborn by cutaneous oximetry is an optimal method for the detection of CCHD. We conducted a systematic review of the literature and meta-analysis comparing the operational characteristics of oximetry and physical examination for the detection of CCHD. Methods: A systematic review of the literature was conducted on the following databases including published studies between 2002 and 2017, with no language restrictions: Pubmed, Science Direct, Ovid, Scopus and EBSCO, with the following keywords: oximetry screening, critical congenital heart disease, newborn OR oximetry screening heart defects, congenital, specificity, sensitivity, physical examination. Results: A total of 419 articles were found, from which 69 were selected based on their titles and abstracts. After quality assessment, five articles were chosen for extraction of data according to inclusion criteria; data were analyzed on a sample of 404,735 newborns in the five included studies. The following values were found, corresponding to the operational characteristics of oximetry in combination with the physical examination: sensitivity: 0.92 (CI 95%, 0.87-0.95), specificity: 0.98 (CI 95%, 0.89-1.00), for physical examination alone sensitivity: 0.53 (CI 95%, 0.28-0.78) and specificity: 0.99 (CI 95%, 0.97-1.00). Conclusions: Evidence found in different articles suggests that pulse oximetry in addition to neonatal physical examination presents optimal operative characteristics that make it an adequate screening test for detection of CCHD in newborns, above all this is essential in low and middle-income settings where technology medical support is not entirely available.

Background In many countries, economic assessments of the routine use of pulse oximetry in the detection of Critical Congenital Heart Disease (CCHD) at birth has not yet been carried out. CCHDs necessarily require medical intervention within the first months of life. This assessment is a priority in low and medium resource countries. The purpose of this study was to assess the cost-effectiveness (CE) relation of pulse oximetry in the detection of cases of CCHD in Colombia. Methods A full economic assessment of the cost-effectiveness type was conducted from the perspective of society. A decision tree was constructed to establish a comparison between newborn physical examination plus pulse oximetry, versus physical examination alone, in the diagnosis of CCHDs. The sensitivity and specificity of pulse oximetry were estimated from a systematic review of the literature; to assess resource use, micro-costing analyses and surveys were conducted. The time horizon of the economic evaluation was the first week after birth and until the first year of life. The incremental cost-effectiveness ratio (ICER) was determined and, to control for uncertainty, deterministic and probabilistic sensitivity analysis were made, including the adoption of different scenarios of budgetary impact. All costs are expressed in US dollars from 2017, using the average exchange rate for 2017 [$2,951.15 COP for 1 dollar]. Results The costs of pulse oximetry screening plus physical examination were $102; $7 higher than physical examination alone. The effectiveness of pulse oximetry plus the physical examination was 0.93; that is, 0.07 more than the physical examination on its own. The ICER was $100 for pulse oximetry screening; that is, if one wishes to increase 1% the probability of a correct CCHD diagnosis, this amount would have to be invested. A willingness to pay of $26.292 USD (direct medical cost) per probability of a correct CCHD diagnosis was assumed. Conclusions At current rates and from the perspective of society, newborn pulse oximetry screening at 24 h in addition to physical examination, and considering a time horizon of 1 week, is a cost-effective strategy in the early diagnosis of CCHDs in Colombia. Trial registration “retrospectively registered”.

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In Colombia, with current prices, PVP is cost-effective when compared to M-TURP for LUTS due to BPE for a 2-year time horizon.