Pulse oximetry screening for critical congenital heart defects

Maria N Plana; Javier Zamora; Gautham Suresh; Luis Fernandez‐Pineda; Shakila Thangaratinam; Andrew K Ewer

doi:10.1002/14651858.CD011912.pub2

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Figure 1

Flow of studies through the screening process. CCHD: critical congenital heart defect.

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Figure 2

Risk of bias and applicability concerns summary: review authors' judgements about each domain for each included study.

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Figure 3

Risk of bias and applicability concerns graph: review authors' judgements about each domain presented as percentages across included studies.

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Figure 4

Forest plot of sensitivity and specificity. The figure shows the estimated sensitivity and specificity of the study (blue square) and its 95% confidence interval (black horizontal line). Studies are ordered by ascending specificity.

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Figure 5

Summary ROC plot for pulse oximetry using a threshold lower than or lower than or equal to 95% (n = 19 studies). The solid circle corresponds to the summary estimate of sensitivity and specificity, and is shown with a 95% prediction region (dashed line).

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Test 1

All studies.

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Test 2

Primary analysis (threshold < 95% or ≤ 95%).

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Should pulse oximetry be used to diagnose CCHD in asymptomatic newborns?

Patient or population: asymptomatic newborns at the time of pulse oximetry screening

Setting: hospital births

Index test: pulse oximetry

Reference test: Reference standards were both diagnostic echocardiography (echocardiogram) and clinical follow‐up in the first 28 days of life, including postmortem findings and mortality and congenital anomaly databases to identify false‐negative patients.

Studies: We included prospective or retrospective cohorts and cross‐sectional studies. We excluded case reports and studies of case‐control design.

Threshold

Summary accuracy

(95% CI)

Number

of participants (diseased

/non‐diseased)

Number

studies

Prevalence median

(range)

Implications

(in a cohort of 10,000 newborns tested [95% CI])

Certainty

of the evidence (GRADE)

Prevalence

0.6 per 1000

Prevalence

0.1 per 1000

Prevalence

3.7 per 1000

95%

(less than or less than or equal to)

Sensitivity

76.3%

(69.5 to 82.0)

Specificity

99.9%

(99.7 to 99.9)

436,758

(345/436,413)

19 studies

0.6 per 1000

(0.1 to 3.7)

True positives

(newborns with CCHD)

(4 to 5)

(1 to 1)

(26 to 30)

LOW*

⊕⊕⊝⊝

False negatives

(newborns incorrectly classified as not having CCHD)

(1 to 2)

(0 to 0)

(7 to 11)

True negatives

(newborns without CCHD)

9980

(9966 to 9987)

9985

(9971 to 9992)

9949

(9935 to 9956)

HIGH

⊕⊕⊕⊕

False positives

(newborns incorrectly classified as having CCHD)

(7 to 28)

CCHD: critical congenital heart defect; CI: confidence interval.

Sensitivity:

*We have downgraded certainty of the evidence from high to low because the low number of CCHD cases included in the review (serious imprecision) and secondly, there was a serious risk of differential verification bias (ie, diagnosis was established by echocardiography in test positive cases however test negatives were usually confirmed by clinical follow‐up or by accessing congenital malformation registries and mortality databases)."

Certainty of the evidence (Balshem 2011)
High certainty: We are very confident that the true effect lies close to that of the estimate of the effect.
Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different.
Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect.
Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect.

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Table 1. Main studies characteristics

Study	Population	Index test					Reference standard(s)
Study	Antenatal diagnosis of CHD	Pulse oximeter	Limb	Test timing	Oxygen saturation	Threshold	Positive pulse oximetry	Negative pulse oximetry
Arlettaz 2006	included	Nellcor NPB‐40	post‐ductal	within 24 hours	functional	< 95%	echocardiography	NA
Bakr 2005	excluded	Digioxi PO 920	pre‐ductal and post‐ductal	longer than 24 hours	fractional	≤ 94%	echocardiography	cardiology database
Bhola 2014	included	Masimo Radical 5	post‐ductal	longer than 24 hours	functional	< 95%	echocardiography	cardiology database
De‐Wahl 2009	excluded	Radical SET v4	pre‐ductal and post‐ductal	longer than 24 hours	functional	< 95%	echocardiography	mortality data
Ewer 2011	included	Radical‐7	pre‐ductal and post‐ductal	within 24 hours	functional	< 95%	echocardiography	clinical follow‐up, cardiology database & congenital registry
Gomez‐Rodriguez 2015	excluded	Radical‐5	post‐ductal	within 24 hours	functional	< 95%	echocardiography	clinical follow‐up
Jones 2016	excluded	NA	pre‐ductal and post‐ductal	within 24 hours	NA	≤ 95%	echocardiography	National Congenital Heart Disease Audit
Klausner 2017	excluded	NA	pre‐ductal and post‐ductal	longer than 24 hours	NA	< 95%	echocardiography	clinical follow‐up
Koppel 2003	excluded	Ohmeda Medical	post‐ductal	longer than 24 hours	functional	≤ 95%	echocardiography	clinical follow‐up & congenital registry
Meberg 2008	excluded	RAD‐5v	post‐ductal	within 24 hours	functional	< 95%	echocardiography	clinical follow‐up
Oakley 2015	excluded	Nellcor NPB 40	post‐ductal	longer than 24 hours	functional	< 95%	echocardiography	cardiology database & mortality data
Ozalkaya 2016	excluded	Nellcor	pre‐ductal and post‐ductal	longer than 24 hours	functional	≤ 95%	echocardiography	echocardiography
Richmond 2002	included	Oxi machine	post‐ductal	within 24 hours	fractional	< 95%	echocardiography	mortality data & congenital registry
Riede 2010	excluded	NA	post‐ductal	longer than 24 hours	functional	≤ 95%	echocardiography	congenital registry
Rosati 2005	excluded	NA	post‐ductal	longer than 24 hours	functional	≤ 95%	echocardiography	clinical follow‐up
Sendelbach 2008	excluded	Nellcor N‐395	post‐ductal	within 24 hours	functional	< 96%	echocardiography	clinical follow‐up
Singh 2014	excluded	NA	pre‐ductal and post‐ductal	within 24 hours	functional	< 95%	echocardiography	mortality data & congenital registry & cardiology database
Turska 2012	excluded	Novametrix, Nellcor & Masimo	post‐ductal	within 24 hours	functional	< 95%	echocardiography	clinical follow‐up and Public Health registries
Van Niekerk 2016	excluded	Nellcor	pre‐ductal and post‐ductal	longer than 24 hours	functional	< 95%	echocardiography	NA
Zhao 2014	excluded	RAD‐5V	pre‐ductal and post‐ductal	longer than 24 hours	functional	< 95%	echocardiography	clinical follow‐up
Zuppa 2015	excluded	Ohmeda 3900	post‐ductal	longer than 24 hours	functional	< 95%	echocardiography	NA
NA: not available

Table 1. Main studies characteristics

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Table 2. Subgroup analysis

	N	Sensitivity (95% CI)	Relative sensitivity P value	False‐positive rate (FPR) (95% CI)	Relative FPR P value
Antenatal diagnosis
Included	4	86.3% (71.8 to 94.0)	0.071	0.46% (0.13 to 1.59)	0.231
Excluded	15	74.1% (65.7 to 81.1)	0.071	0.10% (0.05 to 0.21)	0.231
Test timing
Longer than 24 hours	11	73.6% (62.8 to 82.1)	0.393	0.06% (0.03 to 0.13)	0.027
Within 24 hours	8	79.5% (70.0 to 86.6)	0.393	0.42% (0.20 to 0.89)	0.027
Limb
Foot only	11	81.2% (70.9 to 88.4)	0.197	0.13% (0.05 to 0.31)	0.718
Foot and right hand	8	71.2% (58.5 to 81.3)	0.197	0.17% (0.06 to 0.46)	0.718
Risk of bias ("flow and timing")
Unclear risk of bias	9	77.8% (64.1 to 87.3)	0.937	0.05% (0.02 to 0.12)	0.016
Low risk of bias	10	77.3% (68.8 to 84.0)	0.937	0.34% (0.17 to 0.66)	0.016

Table 2. Subgroup analysis

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Table Tests. Data tables by test

Test	No. of studies	No. of participants
1 All studies Show forest plot	21	457202

2 Primary analysis (threshold < 95% or ≤ 95%) Show forest plot	19	436758

Table Tests. Data tables by test

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