Newborn Pulse Oximetry Screening to Detect Critical Congenital Heart Disease Matthew A. Studer, MD1, Ashley E. Smith, MD1, Michael B. Lustik2, and Michael R. Carr, MD3 Objectives To describe current practice and clarify provider opinion in the US with regard to newborn pulse oximetry screening (NPOx) for critical congenital heart disease.
Study design An internet-based questionnaire was forwarded to general pediatricians, neonatologists, and family medicine physicians. Physicians were surveyed regarding involvement in newborn medicine, knowledge of NPOx recommendations, and opinions regarding screening. NPOx protocol specifics were also queried. Results Survey responses (n = 481) were received with 349 respondents involved in newborn medicine. Forty-nine percent (95% CI 44%-54%) of those involved in newborn medicine practice at a hospital with a NPOx protocol. Sixty-six percent of providers endorsed it as an effective tool, 20% required more education, 11% questioned its sensitivity, and 3% had no opinion. Sixty-five percent of providers were aware of recent state legislation mandating its use and 46% reported awareness of the addition of NPOx to the Recommended Uniform Screening Panel. Eighty-four percent of providers who practice at a hospital without a NPOx protocol were interested in its implementation. NPOx protocols varied and were not uniform with differences in time of test, location of probe, and values considered positive. Conclusions NPOx has grown in its prevalence and acceptance in clinical practice, yet is far from universal in its application and design despite the recent American Academy of Pediatrics endorsement and its addition to the Recommended Uniform Screening Panel. The majority of physicians involved in newborn medicine deemed it an effective tool. (J Pediatr 2014;164:505-9).
C
ritical congenital heart disease accounts for approximately 10%-15% of all forms of congenital heart disease (frequency of 1.2-1.7 per 1000 live births) and is defined as cardiac conditions that would require surgery or a catheter-based intervention in the first few weeks of life.1-3 Delays in the identification of infants born with ductal-dependent critical congenital heart disease have been reported to occur in 20%-25% of infants with 1 study identifying 43% of those infants presenting in shock after having been discharged from the newborn nursery, and another reporting 5% identified at autopsy.4-6 Conversely, early diagnosis with timely surgical intervention has been shown to improve outcomes.7,8 To that end, the challenge of early diagnosis primarily falls to general practitioners who have historically relied on the physical examination to detect critical congenital heart disease. However, a large percentage of infants do not present with murmurs, vital sign abnormalities, or obvious cyanosis in the immediate postnatal period, resulting in missed diagnoses.9-12 In an effort to improve detection of asymptomatic infants born with critical congenital heart disease, pulse oximetry screening (POx) in the newborn nursery has been proposed with the benefit and feasibility of its use well reported in the literature.13-18 Universal newborn pulse oximetry screening (NPOx) to detect critical congenital heart disease was added to the Recommended Uniform Screening Panel (RUSP) by the Health and Human Services Secretary in September 2011.19 It has also been endorsed by the American Academy of Pediatrics, American Heart Association, American College of Cardiology, and the March of Dimes.20-22 And finally, a number of states have approved or proposed legislation surrounding its use with New Jersey being the first state to implement legislatively mandated POx in June 2011.23,24 Despite these recommendations and state legislation, details about current use of NPOx nationwide and provider opinions regarding this practice remain limited. The aim of this study was to describe current practice and clarify provider opinion in the US with regard to NPOx for critical congenital heart disease.
Methods Healthcare providers involved in newborn medicine were the targeted demographic. An internet-based questionnaire was forwarded to 5000 providers, including general pediatricians (3500), neonatologists (750), and family medicine
NPOx POx RUSP
Newborn pulse oximetry screening Pulse oximetry screening Recommended Uniform Screening Panel
From the Departments of 1Pediatrics and 2Clinical Investigation, Tripler Army Medical Center, Honolulu, HI; and 3Department of Pediatrics, Pediatric Cardiology, Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL The views expressed in this publication/presentation are those of the author(s) and do not reflect the official policy or position of the Department of the Army, Department of Defense, or the US Government. The authors declare no conflicts of interest. 0022-3476/$ - see front matter. Published by Mosby Inc. All rights reserved. http://dx.doi.org/10.1016/j.jpeds.2013.10.065
505
THE JOURNAL OF PEDIATRICS
www.jpeds.com
physicians (750) across all regions of the US (Appendix; available at www.jpeds.com). A reminder e-mail was sent 3 weeks after the original e-mail. The majority of responses were collected from February through May of 2012. The study protocol was approved by the Human Use Committee at Tripler Army Medical Center. Investigators adhered to the policies for protection of human subjects as prescribed in 45 Code of Federal Regulation 46. Providers were identified utilizing the American Medical Association Masterfile Database. This is a database of >900 000 physicians in the US of all specialties. Providers selected were done so at random though provider specialties, and other unique identifiers were intentionally chosen in an effort to identify the greatest number of providers involved in newborn medicine. The distribution of providers was intentionally weighted toward general pediatricians, but included neonatologists and family medicine providers in an effort to provide a representative sample of each specialty involved in newborn medicine. Participation in newborn medicine itself was not an identifier in the database. We requested a representative sample of providers from all regions of the US, but did not specifically inquire about region of practice in the questionnaire. Only physicians involved in newborn medicine were included in the analysis. Physicians were surveyed regarding involvement in newborn medicine, demographic data, knowledge of POx recommendations, and opinions regarding this screening technique. Questions pertaining to the use of NPOx and specifics of the protocol were posed. If a provider did not practice at a hospital with POx they were asked about their interest in initiating this screening tool along with any perceived barriers to its implementation. If a provider practiced at more than 1 hospital or specified a hospital setting not included in the primary list, the site of their primary hospital location or the hospital size which was closest in similarity was chosen. Providers who omitted a question were not included in the analysis of that particular question. Descriptive data were reported using percentages. Group responses were compared using the Fisher exact test or chisquare test as applicable. Statistical significance was determined by a P value
Study design An internet-based questionnaire was forwarded to general pediatricians, neonatologists, and family medicine physicians. Physicians were surveyed regarding involvement in newborn medicine, knowledge of NPOx recommendations, and opinions regarding screening. NPOx protocol specifics were also queried. Results Survey responses (n = 481) were received with 349 respondents involved in newborn medicine. Forty-nine percent (95% CI 44%-54%) of those involved in newborn medicine practice at a hospital with a NPOx protocol. Sixty-six percent of providers endorsed it as an effective tool, 20% required more education, 11% questioned its sensitivity, and 3% had no opinion. Sixty-five percent of providers were aware of recent state legislation mandating its use and 46% reported awareness of the addition of NPOx to the Recommended Uniform Screening Panel. Eighty-four percent of providers who practice at a hospital without a NPOx protocol were interested in its implementation. NPOx protocols varied and were not uniform with differences in time of test, location of probe, and values considered positive. Conclusions NPOx has grown in its prevalence and acceptance in clinical practice, yet is far from universal in its application and design despite the recent American Academy of Pediatrics endorsement and its addition to the Recommended Uniform Screening Panel. The majority of physicians involved in newborn medicine deemed it an effective tool. (J Pediatr 2014;164:505-9).
C
ritical congenital heart disease accounts for approximately 10%-15% of all forms of congenital heart disease (frequency of 1.2-1.7 per 1000 live births) and is defined as cardiac conditions that would require surgery or a catheter-based intervention in the first few weeks of life.1-3 Delays in the identification of infants born with ductal-dependent critical congenital heart disease have been reported to occur in 20%-25% of infants with 1 study identifying 43% of those infants presenting in shock after having been discharged from the newborn nursery, and another reporting 5% identified at autopsy.4-6 Conversely, early diagnosis with timely surgical intervention has been shown to improve outcomes.7,8 To that end, the challenge of early diagnosis primarily falls to general practitioners who have historically relied on the physical examination to detect critical congenital heart disease. However, a large percentage of infants do not present with murmurs, vital sign abnormalities, or obvious cyanosis in the immediate postnatal period, resulting in missed diagnoses.9-12 In an effort to improve detection of asymptomatic infants born with critical congenital heart disease, pulse oximetry screening (POx) in the newborn nursery has been proposed with the benefit and feasibility of its use well reported in the literature.13-18 Universal newborn pulse oximetry screening (NPOx) to detect critical congenital heart disease was added to the Recommended Uniform Screening Panel (RUSP) by the Health and Human Services Secretary in September 2011.19 It has also been endorsed by the American Academy of Pediatrics, American Heart Association, American College of Cardiology, and the March of Dimes.20-22 And finally, a number of states have approved or proposed legislation surrounding its use with New Jersey being the first state to implement legislatively mandated POx in June 2011.23,24 Despite these recommendations and state legislation, details about current use of NPOx nationwide and provider opinions regarding this practice remain limited. The aim of this study was to describe current practice and clarify provider opinion in the US with regard to NPOx for critical congenital heart disease.
Methods Healthcare providers involved in newborn medicine were the targeted demographic. An internet-based questionnaire was forwarded to 5000 providers, including general pediatricians (3500), neonatologists (750), and family medicine
NPOx POx RUSP
Newborn pulse oximetry screening Pulse oximetry screening Recommended Uniform Screening Panel
From the Departments of 1Pediatrics and 2Clinical Investigation, Tripler Army Medical Center, Honolulu, HI; and 3Department of Pediatrics, Pediatric Cardiology, Ann and Robert H. Lurie Children’s Hospital of Chicago, Northwestern University Feinberg School of Medicine, Chicago, IL The views expressed in this publication/presentation are those of the author(s) and do not reflect the official policy or position of the Department of the Army, Department of Defense, or the US Government. The authors declare no conflicts of interest. 0022-3476/$ - see front matter. Published by Mosby Inc. All rights reserved. http://dx.doi.org/10.1016/j.jpeds.2013.10.065
505
THE JOURNAL OF PEDIATRICS
www.jpeds.com
physicians (750) across all regions of the US (Appendix; available at www.jpeds.com). A reminder e-mail was sent 3 weeks after the original e-mail. The majority of responses were collected from February through May of 2012. The study protocol was approved by the Human Use Committee at Tripler Army Medical Center. Investigators adhered to the policies for protection of human subjects as prescribed in 45 Code of Federal Regulation 46. Providers were identified utilizing the American Medical Association Masterfile Database. This is a database of >900 000 physicians in the US of all specialties. Providers selected were done so at random though provider specialties, and other unique identifiers were intentionally chosen in an effort to identify the greatest number of providers involved in newborn medicine. The distribution of providers was intentionally weighted toward general pediatricians, but included neonatologists and family medicine providers in an effort to provide a representative sample of each specialty involved in newborn medicine. Participation in newborn medicine itself was not an identifier in the database. We requested a representative sample of providers from all regions of the US, but did not specifically inquire about region of practice in the questionnaire. Only physicians involved in newborn medicine were included in the analysis. Physicians were surveyed regarding involvement in newborn medicine, demographic data, knowledge of POx recommendations, and opinions regarding this screening technique. Questions pertaining to the use of NPOx and specifics of the protocol were posed. If a provider did not practice at a hospital with POx they were asked about their interest in initiating this screening tool along with any perceived barriers to its implementation. If a provider practiced at more than 1 hospital or specified a hospital setting not included in the primary list, the site of their primary hospital location or the hospital size which was closest in similarity was chosen. Providers who omitted a question were not included in the analysis of that particular question. Descriptive data were reported using percentages. Group responses were compared using the Fisher exact test or chisquare test as applicable. Statistical significance was determined by a P value
