title: Reliability of a single pulse oximetry reading as a screening test for congenital heart disease in otherwise asymptomatic newborn infants: the importance of human factors.
abstract: BACKGROUND
  The use of routine pulse oximetry to detect neonates with undiagnosed congenital heart disease before nursery discharge has been studied. The reported sensitivities with asymptomatic patients have been less than expected and vary widely, bringing into question the reliability of the test. This study aimed to assess whether routine pulse oximetry contributes to identifying patients with critical congenital heart disease, and to determine the reliability of a single pulse oximeter reading for screening asymptomatic newborn infants.
  
  
  METHODS
  Between December 26, 2003 and December 31, 2005, three hospitals in west central Florida performed pulse oximetry routinely on all newborns at the time of discharge. Patients who received a diagnosis of critical congenital heart disease during the study period were identified to assess whether the pulse oximetry reading initiated their diagnosis. In one hospital, the pulse oximeter data were evaluated for reliability. Downloaded data were compared to a log compiled by the nursery personnel, first without (Phase 1) and then with (Phase 2) their knowledge and additional training. The results were characterized as reliable, probe placed but reading not verifiable, or no evidence of probe placement.
  
  
  RESULTS
  Among the 7,962 infants who received oximetry testing, there were 12 postnatal diagnoses of critical congenital heart disease. None was initially identified by routine pulse oximetry. Pulse oximetry reliability improved substantially between Phases 1 and 2 (38% vs 60%; p < 0.0001). Optimal reliability (>95%) was obtained by a nurse with a licensed practical nurse degree or higher performing an assessment of at least 360 s.
  
  
  CONCLUSIONS
  Routine pulse oximetry was neither reliable nor an important diagnostic tool for our cohort. Important human factors (probe placement time, oximetry training, and nursing degree) have an impact on single-determination pulse oximetry reliability. With routine surveillance and quality improvement, the reliability of this test can be increased. Future studies to determine the effectiveness of pulse oximetry screening for the diagnosis of congenital heart disease in the asymptomatic newborn population must address these factors. Until such a study demonstrates acceptable sensitivity and clinical value, universal screening should not be instituted.
authors.affiliation: The Watson Clinic LLP, The Watson Clinic Center for Research, 1600 Lakeland Hills Boulevard, Lakeland, FL 33805, USA. jdreich@hotmail.com
authors.forename: J D
authors.initials: JD
authors.lastname: Reich
authors.forename: B
authors.initials: B
authors.lastname: Connolly
authors.forename: G
authors.initials: G
authors.lastname: Bradley
authors.forename: S
authors.initials: S
authors.lastname: Littman
authors.forename: W
authors.initials: W
authors.lastname: Koeppel
authors.forename: P
authors.initials: P
authors.lastname: Lewycky
authors.forename: M
authors.initials: M
authors.lastname: Liske
mesh_terms: D003937:Diagnosis, Differential; D005431:Florida / Q000453:epidemiology; D006330:Heart Defects, Congenital / Q000175:diagnosis* / Q000453:epidemiology; D006801:Humans; D007231:Infant, Newborn; D008403:Mass Screening / Q000379:methods*; D009017:Morbidity; D010092:Oximetry / Q000379:methods*; D015203:Reproducibility of Results; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D015996:Survival Rate