1 Pulse oximetry screening for critical congenital heart disease and relevant newborn pathology in the Netherlands Pulse Oximetry Leiden Amsterdam Regional Screening Study POLAR study Project leader Arjan te Pas, neonatologist Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, the Netherlands Principal Investigators Ilona Narayen, PhD researcher Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, the Netherlands Nico Blom, professor of Pediatric cardiology Division of Pediatric Cardiology, Department of Pediatrics, Leiden University Medical Center, Leiden, the Netherlands Co-investigators Anton van Kaam, professor of Neonatology Division of Neonatology, Department of Pediatrics, Emma Children’s Hospital, Amsterdam, the Netherlands Clara Kolster-Bijdevaate, research nurse Department of Obstetrics, Leiden University Medical Center, Leiden, the Netherlands Marjolein Bourgonje-Verhart, research nurse Department of Obstetrics, Leiden University Medical Center, Leiden, the Netherlands Jan van Lith, professor of Obstetrics Department of Obstetrics, Leiden University Medical Center, Leiden, the Netherlands Correspondence and contact: Ilona Narayen, Department of Pediatrics, Division of Neonatology Leiden University Medical Center, J6-S, PO Box 9600, 2300 RC Leiden, the Netherlands. Tel +31 71 5264987, fax +31 71 5248199, pager +3171-52698862, email [email protected]
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Pulse oximetry screening for critical congenital heart …...Pulse Oximetry (PO) is a simple and non-invasive method for screening cyanotic CHD in low risk infants.13,14 Previous studies
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Pulse oximetry screening for critical congenital heart disease and relevant newborn pathology in the Netherlands
Pulse Oximetry Leiden Amsterdam Regional Screening Study
POLAR study
Project leader Arjan te Pas, neonatologist
Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, the Netherlands Principal Investigators
Ilona Narayen, PhD researcher Division of Neonatology, Department of Pediatrics, Leiden University Medical Center, Leiden, the Netherlands Nico Blom, professor of Pediatric cardiology Division of Pediatric Cardiology, Department of Pediatrics, Leiden University Medical Center, Leiden, the Netherlands Co-investigators Anton van Kaam, professor of Neonatology Division of Neonatology, Department of Pediatrics, Emma Children’s Hospital, Amsterdam, the Netherlands Clara Kolster-Bijdevaate, research nurse Department of Obstetrics, Leiden University Medical Center, Leiden, the Netherlands Marjolein Bourgonje-Verhart, research nurse Department of Obstetrics, Leiden University Medical Center, Leiden, the Netherlands Jan van Lith, professor of Obstetrics Department of Obstetrics, Leiden University Medical Center, Leiden, the Netherlands Correspondence and contact: Ilona Narayen, Department of Pediatrics, Division of
Neonatology Leiden University Medical Center, J6-S, PO Box 9600, 2300 RC Leiden, the
Pilot period ........................................................................................................................................ 10
Sensitivity, specificity, false positive rate, false negative rate, positive predictive value and
negative predictive value will be calculated for the protocol with two measurement time
points and for a strategy with only the first measurement point.
Cost-effectiveness
A cost-effectiveness analysis will be performed from the societal perspective. A decision-
analytic model will be used to compare the relative cost-effectiveness of a strategy in which
pulse oximetry screening is added to routine practice with the strategy of routine practice
alone17,18. As prevention of preoperative collapse is likely to be associated with lower
postoperative mortality and morbidity, the primary outcome measure is ‘timely diagnosis’,
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that is diagnosis made preoperatively before collapse or death occurs.17,18 In an explorative
analysis the time horizon will be extended by assessing lifelong effectiveness and costs. In
this analysis quality-adjusted life-years (QALYs) will be used as outcome measure.
The decision-analytic model developed by Knowles et al. will be used as starting point, but
will be adapted to the Dutch situation.18 Data from the implementation study will be used to
adapt the model. Cost of pulse oximetry will be based on a detailed cost price analysis.
Material costs, staff time, transportation costs and treatment costs will be evaluated. In the
last months of the implementation study a time-and-motion study will be performed. In this
study all staff across the study sites will be asked to record the time it took them to carry out
the test and record the result during one week. This study will be done close to the end of
the study, as initial difficulties with equipment, technique or protocol will probably be solved.
Also the time taken for clinical evaluation after positive screenings and timing of
echocardiography in case of persistent hypoxia will be measured. Other resource use will be
valued using standard prices.32
The total costs and effects will be assessed for both strategies and a cost-effectiveness
acceptability curve (CEAC) will be produced comparing the probability that pulse oximetry
screening is cost-effective for different values of the willingness to pay for two screening
measurements and for only the first screening measurement.
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Patient Safety
Pulse oximetry is a non-invasive test and measuring oxygen saturation is considered
standard of care in high risk infants at birth. There are no patient safety issues, but it is
possible that it will cause unnecessary distress in midwives and parents when a referral
follows after a false-positive screening.
Relevance of this study
Compared to the neighbouring countries, the Netherlands lags behind with the
implementation of this screening method. When considering the unique perinatal healthcare
of low risk pregnancies, the question remains if implementing this test in the Netherlands
would be as accurate and cost-effective as previously reported. However, at this moment
every year 125 infants with CCHD are missed and late presentation will certainly decrease
the chance for survival and increase long term morbidity. This implementation study will
answer the question if PO screening for CCHD should be implemented. This study will be a
step in improving the survival and prognosis of infants with CCHD in the Netherlands.
False positive screenings can also detect other pathology, such as infections or persistent
pulmonary hypertension.25 As treatment for these pathologies is also important, pulse
oximetry screening can improve the safety of newborns in the Netherlands, especially those
who are born at home.
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References
1. Knowles R, Griebsch I, Dezateux C, Brown J, Bull C, Wren C. Newborn screening for congenital heart defects: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2005;9:1-iv.
2. Dutch Heart Foundation. Heart disease in children aged 0-14 years. 2011. 3. Wren C, O'Sullivan JJ. Survival with congenital heart disease and need for follow up in
adult life. Heart. 2001;85:438-443. 4. Brown KL, Ridout DA, Hoskote A, Verhulst L, Ricci M, Bull C. Delayed diagnosis of
congenital heart disease worsens preoperative condition and outcome of surgery in neonates. Heart. 2006;92:1298-1302.
5. van Velzen CL, Clur SA, Rijlaarsdam MEB, Bax CJ, Pajkrt E, Heymans MW, et al. National screening program in the Netherlands significantly improves prenatal detection of congenital heart disease. 2013 Unpublished Work
6. Wren C, Richmond S, Donaldson L. Presentation of congenital heart disease in infancy: implications for routine examination. Arch Dis Child Fetal Neonatal Ed. 1999;80:F49-F53.
7. Majnemer A, Limperopoulos C, Shevell M, Rohlicek C, Rosenblatt B, Tchervenkov C. Health and well-being of children with congenital cardiac malformations, and their families, following open-heart surgery. Cardiol Young. 2006;16:157-164.
8. Majnemer A, Limperopoulos C, Shevell M, Rosenblatt B, Rohlicek C, Tchervenkov C. Long-term neuromotor outcome at school entry of infants with congenital heart defects requiring open-heart surgery. J Pediatr. 2006;148:72-77.
9. Majnemer A, Limperopoulos C, Shevell M, Rohlicek C, Rosenblatt B, Tchervenkov C. Developmental and functional outcomes at school entry in children with congenital heart defects. J Pediatr. 2008;153:55-60.
10. Majnemer A, Limperopoulos C, Shevell MI, Rohlicek C, Rosenblatt B, Tchervenkov C. A new look at outcomes of infants with congenital heart disease. Pediatr Neurol. 2009;40:197-204.
11. Marino BS, Lipkin PH, Newburger JW, Peacock G, Gerdes M, Gaynor JW, et al. Neurodevelopmental outcomes in children with congenital heart disease: evaluation and management: a scientific statement from the American Heart Association. Circulation. 2012;126:1143-1172.
12. Mahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, et al. Role of pulse oximetry in examining newborns for congenital heart disease: a scientific statement from the American Heart Association and American Academy of Pediatrics. Circulation. 2009;120:447-458.
13. Ewer AK, Middleton LJ, Furmston AT, Bhoyar A, Daniels JP, Thangaratinam S, et al. Pulse oximetry screening for congenital heart defects in newborn infants (PulseOx): a test accuracy study. Lancet. 2011;378:785-794.
14. Powell R, Pattison HM, Bhoyar A, Furmston AT, Middleton LJ, Daniels JP, et al. Pulse oximetry screening for congenital heart defects in newborn infants: an evaluation of acceptability to mothers. Arch Dis Child Fetal Neonatal Ed. 2013;98:F59-F63.
15. Thangaratinam S, Brown K, Zamora J, Khan KS, Ewer AK. Pulse oximetry screening for critical congenital heart defects in asymptomatic newborn babies: a systematic review and meta-analysis. Lancet. 2012;379:2459-2464.
16. Riede FT, Worner C, Dahnert I, Mockel A, Kostelka M, Schneider P. Effectiveness of neonatal pulse oximetry screening for detection of critical congenital heart disease in daily clinical routine--results from a prospective multicenter study. Eur J Pediatr. 2010;169:975-981.
17. Ewer AK, Furmston AT, Middleton LJ, Deeks JJ, Daniels JP, Pattison HM, et al. Pulse oximetry as a screening test for congenital heart defects in newborn infants: a test
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accuracy study with evaluation of acceptability and cost-effectiveness. Health Technol Assess. 2012;16:v-184.
18. Knowles R, Griebsch I, Dezateux C, Brown J, Bull C, Wren C. Newborn screening for congenital heart defects: a systematic review and cost-effectiveness analysis. Health Technol Assess. 2005;9:1-iv.
19. Mahle WT, Newburger JW, Matherne GP, Smith FC, Hoke TR, Koppel R, et al. Role of pulse oximetry in examining newborns for congenital heart disease: a scientific statement from the AHA and AAP. Pediatrics. 2009;124:823-836.
20. Narayen IC, Blom NA, Verhart MS, Smit M, Posthumus F, van den Broek AJ, et al. Adapted protocol for pulse oximetry screening for congenital heart defects in a country with homebirths. Eur J Pediatr. 2014.
21. Singh A, Rasiah SV, Ewer AK. The impact of routine predischarge pulse oximetry screening in a regional neonatal unit. Arch Dis Child Fetal Neonatal Ed. 2014.
22. Riede FT, Dahnert I, Schneider P, Mockel A. Pulse oximetry screening at 4 hours of age to detect critical congenital heart defects. Pediatrics. 2009;123:e542-e543.
23. Bhola K, Kluckow M, Evans N. Post-implementation review of pulse oximetry screening of well newborns in an Australian tertiary maternity hospital. J Paediatr Child Health. 2014.
24. de-Wahl GA, Wennergren M, Sandberg K, Mellander M, Bejlum C, Inganas L, et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;338:a3037.
25. Ewer AK. Review of pulse oximetry screening for critical congenital heart defects in newborn infants. Curr Opin Cardiol. 2013;28:92-96.
26. Ewer AK. Review of pulse oximetry screening for critical congenital heart defects in newborn infants. Curr Opin Cardiol. 2013;28:92-96.
27. Hom LA, Martin GR. U.S. international efforts on critical congenital heart disease screening: Can we have a uniform recommendation for Europe? Early Hum Dev. 2014;90 Suppl 2:S11-S14.
28. Junghans C, Feder G, Hemingway H, Timmis A, Jones M. Recruiting patients to medical research: double blind randomised trial of "opt-in" versus "opt-out" strategies. BMJ. 2005;331:940.
29. Woolf SH, Rothemich SF, Johnson RE, Marsland DW. Selection bias from requiring patients to give consent to examine data for health services research. Arch Fam Med. 2000;9:1111-1118.
30. Li J, Fine J. On sample size for sensitivity and specificity in prospective diagnostic accuracy studies. Stat Med. 2004;23:2537-2550.
31. Centraal Bureau voor de Statistiek. 2013. 32. Tan SS, Bouwmans CA, Rutten FF, Hakkaart-van RL. Update of the Dutch Manual for
Costing in Economic Evaluations. Int J Technol Assess Health Care. 2012;28:152-158.
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Figures
Figure 1 Flowchart of PO CCHD screening
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Positive screening
Normal at clinical evaluation AND
normalized SpO2 values
Clear non-cardiac pathology
Persistent abnormal SpO2 values without
clear non-cardiac pathology
Referral to hospital
Clinical evaluation including pre- and post-ductal SpO2 measurement