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Background
Until now, there had been no compelling evidence demonstrating the neonatal benefit of electronic fetal monitoring (EFM). It had been the medicolegal climate in the United States that required obstetricians to integrate continuous intrapartum surveillance into their care of the laboring patient.1 But at the February 2011 Society for Maternal Fetal Medicine Annual Meeting in San Francisco, Dr. Suneet Chauhan and his colleagues presented research concluding that EFM resulted in a 53% reduction in neonatal mortality based on a sample of 1,945,789 singleton infant birth and death records from the 2004 National Birth Cohort. 2 At least 85% of the live births in the United States are assessed with continuous cardiotocography (CTG), making it the most commonly performed obstetric procedure. 3 A full description of a cardiotocograph requires a qualitative and quantitative description of uterine contractions, baseline fetal heart rate, baseline CTG variability, presence of accelerations, periodic or episodic decelerations, and changes or trends of CTG patterns over time. 4 According to the National Institute of Child Health Development (NICHD), visual assessment of these data is a key requirement for accurate interpretation. 5
Use of Cardiotocography
ACOG and NICHD have promulgated definitions that assist hospitals in encouraging meaningful communication between caregivers with respect to CTG patterns, uterine activity, variability, and designations of elective versus emergency interventions. In 2008 reassuring and non-reassuring were abandoned in favor of the NICHD 3 tier terminology system, which includes Normal (Category I), Abnormal (Category III) and Indeterminate (Category II).4 In terms of medical management, with Category I expectant management is acceptable; Category III patterns are abnormal and demand successful correction or delivery; with Category II (indeterminate or equivocal) patterns, providers may continue to observe if there is moderate FHR variability and/or accelerations, spontaneous or induced. It remains unclear how to manage equivocal patterns with decreased variability and absence of accelerations. 4
Supporting Data
The data show that patient safety issues arise from the way providers are currently assessing, interpreting, and intervening with laboring patients. AirStrip OB is designed to help overcome the most frequently observed problems. HCA studied a total of 189 perinatal claims that were closed during the calendar years 2000 to 2005. The total value of all claims was $168 million. Seventy percent of all obstetric claims involved substandard care that was causally related to the injury. These cases accounted for 79% of all costs associated with the 189 claims. Thirty four percent of all cases involved fetal monitoring in nonvaginal birth after cesarean (VBAC) patients and represented 53% of the total losses. Substandard care was noted in 94% of the non-VBAC fetal monitoring cases. In each of these cases, delayed physician evaluation of a nonreassuring fetal heart rate tracing and delayed delivery was the primary issue associated with the adverse outcome and resulting litigation. 6 Similar studies have been conducted within other health systems. At Wayne State University, failure to monitor the fetus in accordance with the accepted clinical pathway was the most frequent departure from compliance with OB clinical pathways and resulted in a nearly six-fold increase in the odds of a malpractice claim. 7 Among Harvard hospitals, failure to or delay in diagnosis and treatment of fetal distress was a factor in up to 31% of obstetrical medical malpractice cases, a problem rooted in clinical judgment failures involving selection and management of therapy in labor and delivery, and failure to note and act upon relevant findings. Misinterpretation of fetal monitoring data was a factor in 20% of meritorious cases, and most frequently involved clinical judgment failures involving lack of or inadequate assessment and patient monitoring. 8, 9, 10 Similar findings have been noted by others 11, 12, 13, 14, 15 such that the Joint Commission has called upon hospitals and providers to improve perinatal safety 16, and the use of standards has been recommended.6, 17 A recent RAND study showed a highly significant correlation between the frequency of adverse events and malpractice claims: On average, a decrease of 10 adverse events in a given year would also see a decrease of 3.7 malpractice claims. Likewise, an increase of 10 adverse events in a given year would also see, on average, an increase of 3.7 malpractice claims. According to the statistical analysis, nearly threefourths of the variation in annual malpractice claims could be accounted for by the changes in patient safety outcomes. This correlation held true when they conducted similar analyses for medical specialtiesspecifically, surgeons, nonsurgical physicians, and obstetrician/gynecologists (OB-GYNs). Nearly two-thirds of the variation in malpractice claiming against physicians can be explained by changes in safety. The association is weaker for OB-GYNs, but still significant. RAND researchers used a malpractice database of 27,244 claims based on alleged events that occurred during 20012005 as well as 365,834 patient safety events observed during the same interval. 18 Patient safety improvements work.
Alfirevic Z, Devane D, Gyte GM, et al. Continuous tocography (CTG) as a form of electronic fetal monitoring (EFM) for fetal assessment during labor. Cochrane Database Syst Rev. 2006;3:CD006066.
Society for Maternal-Fetal Medicine (2011, February 14). Electronic fetal heart rate monitoring greatly reduces infant mortality, study finds. ScienceDaily. Retrieved March 11, 2011, from http://www.sciencedaily.com/releases/2011/02/110212094609.htm
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Martin JA, Hamilton BE, Sutton PD, et al. Births: final data for 2002. Natl Vital Stat Rep.2003;52(10):1-113.
Robinson, B., Nelson, L. A Review of the Proceedings from the 2008 NICHD Workshop on Standardized Nomenclature for Cardiotocography. Update on Definitions, Interpretative Systems With Management Strategies, and Research Priorities in Relation to Intrapartum Electronic Fetal Monitoring. Rev Obstet Gynecol. 2008;1(4):186192. 2008 MedReviews, LLC. Macones GA, Hankins GD, Spong CY, et al. The 2008 National Institute of Child Health and Human Development workshop report on electronic fetal monitoring: update on definitions, interpretation, and research guidelines. Obstet Gynecol. 2008;112:661-666. Clark, S., Belfort, M., Dildy, G., Meyers, J. 2008. Reducing Obstetric Litigation Though Alterations in Practice Patterns. American Journal of Obstetrics and Gynecology Vol. 112, No. 6, December 2008. pp 1279-83. Ransom, S., Studdert, D., Dombrowski, M., Mello, M., Brennan, T. Reduced Medicolegal Risk by Compliance With Obstetric Clinical Pathways: A CaseControl Study American Journal of Obstetrics and Gynecology VOL. 101, NO. 4, APRIL 2003. Groff, H. Understanding CRICO's Perinatal Claims. FORUM. March 2001. Volume 21. No. 1. Pp. 1-3. Gardner, R. Obstetrics-related Claims. FORUM. February 2006. Volume 24. No. 1. Pp. 10-11; 18.
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Lavalley, D., Hoffman, J. Obstetrics-related Claims 1997-2007. FORUM. September 2007. Volume 25. No. 3. Pp. 2-5.
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Chandra, A. Nundy, S., Seabury, S. The Growth Of Physician Medical Malpractice Payments: Evidence From The National Practitioner Data Bank Health Affairs Web Exclusive, May 31, 2005. American College of Obstetricians and Gynecologists. Preserving patient access to womens health care: the facts and figures behind the liability crisis. 2004. National Practitioner Data Bank 2005 Annual Report. U.S. Department of Health and Human Services Health Resources and Services Administration. Bureau of Health Professions Practitioner Data Banks Branch White AA, Pichert JW, Bledsoe SH, Irwin C, Entman SS. Cause and effect analysis of closed claims in obstetrics and gynecology. Obstet Gynecol. 2005;105(5 Pt 1):1031-1038. More than one-third of OB adverse events were associated with communication problems.
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Simpson KR, Knox GE. Common areas of litigation related to care during labor and birth: Recommendations to promote patient safety and decrease risk exposure. J Perinat Neonat Nurs. 2003;17:110-125.
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Greenberg, M., Haviland, A., Ashwood, J., Main, R. 2010. Is Better Patient Safety Associated with Less Malpractice Activity? Evidence from California. Rand Institute for Clinical Justice. Available online at http://www.rand.org/pubs/technical_reports/TR824/ Brennan T., Mello, M., Patient Safety and Medical Malpractice: A Case Study. Quality Grand Rounds. Ann Intern Med. 2003;139:267-273.
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