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

Cochrane Database of Systematic Reviews

Cribado con oximetría de pulso para los defectos cardíacos congénitos graves

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DOI:

https://doi.org/10.1002/14651858.CD011912.pub2 Copiar DOI

Base de datos:

Cochrane Database of Systematic Reviews

Versión publicada:

01 marzo 2018see what's new

Tipo:

Diagnostic

Etapa:

Review

Grupo Editorial Cochrane:

Grupo Cochrane de Neonatología

Copyright:

Copyright © 2018 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

Maria N Plana

Clinical Biostatistics Unit, Ramón y Cajal Hospital (IRYCIS), CIBER Epidemiology and Public Health (CIBERESP), Madrid, Spain
Javier Zamora

Clinical Biostatistics Unit, Ramon y Cajal Institute for Health Research (IRYCIS), CIBER Epidemiology and Public Health (CIBERESP), Madrid (Spain) and Women’s Health Research Unit, Centre for Primary Care and Public Health, Queen Mary University of London, London, UK
Gautham Suresh

Section of Neonatology, Department of Pediatrics, Baylor College of Medicine, Houston, USA
Luis Fernandez‐Pineda

Pediatric Cardiology Unit, Hospital Ramon y Cajal, Madrid, Spain
Shakila Thangaratinam

Centre for Primary Care and Public Health, Women's Health Research Unit, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, UK
Andrew K Ewer

Correspondencia a: Institute of Metabolism and Systems Research, University of Birmingham, Birmingham, UK

[email protected]

Contributions of authors

Protocol development: Shakila Thangaratinam, Andrew K. Ewer, Maria Nieves Plana, Javier Zamora, Gautham Suresh.

Selection of studies and data extraction: Maria Nieves Plana, Andrew K. Ewer.

Quality assessment: Maria Nieves Plana, Luis Fernandez‐Pineda, Andrew K. Ewer.

Statistical analysis and interpretation of data: Javier Zamora, Maria Nieves Plana, Shakila Thangaratinam, Andrew K. Ewer.

Drafting of the manuscript: Maria Nieves Plana, Javier Zamora, Shakila Thangaratinam, Andrew K. Ewer.

Critical revision: Shakila Thangaratinam, Andrew K. Ewer, Maria Nieves Plana, Javier Zamora, Gautham Suresh, Luis Fernandez‐Pineda.

Sources of support

Internal sources

IRYCIS, Spain.

Instituto Ramón y Cajal de Investigaciones Sanitarias, Madrid
Universidad Rey Juan Carlos, Madrid, Spain.

External sources

CIBERESP, Spain.

CIBER Epidemiology and Public Heath
Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, USA.

Editorial support of the Cochrane Neonatal Review Group has been funded with Federal funds from the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Department of Health and Human Services, USA, under Contract No. HHSN275201600005C

Declarations of interest

Maria Nieves Plana: none to declare.

Javier Zamora: none to declare.

Gautham Suresh: none to declare.

Luis Fernandes‐Pineda: none to declare.

Shakila Thangaratinam: an author of one of the primary studies ‐ Ewer 2011.

Andrew K. Ewer: an author of one of the primary studies ‐ Ewer 2011.

Acknowledgements

We would like to thank Colleen Ovelman (Managing Editor and Assistant Information Specialist), Yolanda Brosseau (Webmaster), and Jennifer Spano (Information Specialist) of the Neonatal Group for their kind and efficient support during preparation of this review.

Version history

Published

Title

Stage

Authors

Version

2018 Mar 01

Pulse oximetry screening for critical congenital heart defects

Review

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

https://doi.org/10.1002/14651858.CD011912.pub2

2015 Oct 28

Diagnostic accuracy of pulse oximetry screening for critical congenital heart defects

Protocol

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

https://doi.org/10.1002/14651858.CD011912

Differences between protocol and review

Searching other resources

The protocol describes our plan to search the MEDION database (www.mediondatabase.nl), but this resource is not longer available.

Statistical analysis

We planned to use a 95% saturation level as the primary threshold for the analysis and to perform separate analyses for other thresholds categorized as < 95% and > 95% saturation levels. However, at editorial phase, it was suggested to group thresholds. As many studies used a lower than or lower than or equal to 95% threshold, we decided to group all these studies for the main analysis.

The protocol describes our plan to switch the modeling strategy to fit two univariate random‐effects logistic regression models by assuming no correlation between sensitivity and specificity if the number of studies was small (fewer than four), or if the proposed modeling strategy led to problems in achieving convergence. We identified sufficient studies to fit a bivariate model and had no problem achieving model convergence.

Certainty of the evidence

We decided post hoc to assess the certainty of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach (Schunemann 2008).

Subgroup analysis

We did not perform subgroup analyses by oxygen saturation or study design, given the low power of these subgroup analyses.

Sensitivity analysis

Additionally, we decided to perform ad hoc sensitivity analyses to describe how sensitivity and specificity vary by including or excluding studies with different thresholds.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Humans; Infant, Newborn;

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

of

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)

5

(4 to 5)

1

(1 to 1)

28

(26 to 30)

LOW*

⊕⊕⊝⊝

False negatives

(newborns incorrectly classified as not having CCHD)

1

(1 to 2)

0

(0 to 0)

9

(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)

14

(7 to 28)

14

(7 to 28)

14

(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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