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Objektive
Methode
• A multicenter prospective observational screening
study.
• at 13 hospitals (hospitals 1–13 in Fig 1) between
July 1, 2012, and December 31, 2014, and at 2
hospitals between February 1, 2013, and
December 31, 2014, (hospitals 14 and 15 in Fig 1)
in Shanghai.
• All consecutive asymptomatic newborn infants
were included (irrespective of gestational age), but
newborn infants with prenatally diagnosed CHD
were excluded from the analysis of the current
study. Study Design and Participants
• Screening methodology, POX measurement
criteria, and the definition of CHD severity were
the same as our previous study, but in this study,
we only screened asymptomatic neonates, and
screening modalities included only POX and
cardiac auscultation.
• A positive screen result was defined as presence of
any abnormality in the 2 examinations as presented
in Fig 2.
• Neonates who screened positive for CHD were
referred for echocardiography within 24 hours of
screening.
Procedures
• For infants who had negative screening results,
clinical follow-up was done at 6 weeks of age, in
combination with feedback from parents about
cardiac symptoms such as cyanosis, tachypnea,
and feeding difficulty or CHD diagnosis by any
hospitals after the infant was discharged from the
delivery hospital.
Procedures
• Sensitivity, specificity, positive and negative
predictive values, and positive and negative
likelihood ratios were calculated for POX alone
and in combination with cardiac auscultation.
• 95% confidence interval of sensitivity and
specificity was computed by the Wilson method.
• McNemar’s test was used to compare differences
in sensitivity and specificity.
Statistical Analysis
• A logistic regression model was performed to test
the trend of FPRs across 7 time intervals during
which screening occurred.
• χ2 decomposition analysis was further performed
to identify the difference of the FPRs between
time intervals
Statistical Analysis
Results
• All 15 hospitals that participated in the study
were able to complete routine CHD screening
and complete
Sensitivity, or refer
specificity, for echocardiography
positive and negative predictive in
values,and
a timely and positive
effectiveand negative
manner,likelihood
with aratios were
screening
ratecalculated
of 94.0% for to
POX alone and
99.8% as inshown
combination
in Figwith
1.
cardiac auscultation.
• There was no significant difference in positive
95% confidence interval of sensitivity and specificity was
screening
computed results
by the Wilson between
method. these hospitals
(1.1%–1.8%, P > .05).
McNemar’s test was used to compare differences in
sensitivity and specificity.
The Complete Compliance of POX
Plus Cardiac Auscultation Screening
• POX alone as a screening method detected 34 out
of 44 (77.3%) CCHD cases but only 90 out of
203 (44.3%) major CHD cases. POX plus cardiac
auscultation detected 42 out of 44 (95.5%) cases
of CCHD and 187 out of 203 (92.1%) cases of
major CHD. The addition of cardiac auscultation
to POX significantly improved the sensitivity of
screening for both CCHD and serious CHD
(Table 2).