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PeriGen Research
ABSTRACTS
Title: Implementation of a System-Wide Policy for Labor Induction
Publication: MCN, Maternal-Child Nursing
Date: September/October 2011
Author: P. Terrence O'Rourke, MD, FACS, Gerald J Girardi, MD, FACOG, Thomas N Balaskas, MD, FACOG, Rebecca A Havlisch, JD, RN, Gay Landstrom, MS, RN, Beth Kirby, MSHL, CPHRM G. Eric Knox, MD, and Kathleen Rice Simpson, PhD, RNC, FAAN
Standardization of key clinical protocols and policies in the inpatient obstetric setting has the potential to improve care processes, ultimately resulting in better patient outcomes and decreased professional liability. Increasingly hospitals and healthcare systems are realizing benefits with adoption of standardization as a strategy for quality care improvement. We describe successful system-wide development and implementation of a policy for labor induction including avoidance of elective births before 39 completed weeks of gestation and standardization of various aspects of the labor induction process, with the goal of providing safer care. Key Words: Elective labor induction; High-alert medication; Oxytocin; Perinatal patient safety; Standardization.
Title: Third- and fourth-degree perineal lacerations: defining high-risk clinical clusters (*Editor's Choice*)
Publication: American Journal of Obstetrics and Gynecology
Date: April 2011
Author: Emily F. Hamilton, MD; Samuel Smith, MD; Lin Yang, MSc; Philip Warrick, PhD; Antonio Ciampi, PhD
OBJECTIVE: Statistical methods that measure the independent contribution of individual factors for third-/fourth-degree perineal laceration (TFPL) fall short when the clinician is faced with a combination of factors. Our objective was to demonstrate how a statistical technique, classification and regression trees (CART), can identify high-risk clinical clusters. STUDY DESIGN: We performed multivariable logistic regression, and CART analysis on data from 25,150 term vaginal births. RESULTS: Multivariable analyses found strong associations with the use of episiotomy, forceps, vacuum, nulliparity, and birthweight. CART ranked episiotomy, operative delivery, and birthweight as the more discriminating factors and defined distinct risk groups with TFPL rates that ranged from 0-100%. For example, without episiotomy, the rate of TFPL was 2.2%. In the presence of an episiotomy, forceps, and birthweight of >3634 g, the rate of TFPL was 68.9%. CONCLUSION: CART showed that certain combinations held low risk, where as other combinations carried extreme risk, which clarified how choices on delivery options can markedly affect the rate of TFPL for specific mothers. Key words: classification and regression, episiotomy, perineal laceration
Title: Quality Improvement Opportunities in Intrapartum Care
Publication: March Of Dimes
Date: December 2010
Author: Steven L. Clark, Eric Knox, Kathleen Rice Simpson, Gary D.V. Hankins
The intrapartum period represents a time of significant risk to both mother and fetus. While small in an absolute sense, risks experienced during the peripartum period (for example, fetal neurologic impairment due to prematurity and maternal death from hemorrhage) are relatively large in relation to those experienced at other times during pregnancy or infancy. The intrapartum period also represents a time of great opportunity for improving patient outcomes by applying quality improvement principles — process standardization and the use of checklists, teamwork training, crew resource management and evidence-based medicine — to the care of the laboring woman.
Title: An evidence-based approach is born: Hospitals, docs use protocols to cut costs from avoidable OB/GYN injuries
Publication: Physician Affairs
Date: December 20/27, 2010
Author: Linda Wilson
Title: Comparison of 5 experts and computer analysis in rule-based fetal heart rate interpretation
Publication: American Journal of Obstetrics and Gynecology
Date: July 14, 2010
Author: Parer JT, Hamilton EF
OBJECTIVE: The purpose of this study was to measure agreement among 5 expert clinicians and a computerized method with the use of a strict fetal heart rate classification method. STUDY DESIGN: Five providers independently scored 769 8-minute segments from the last 3 hours of 30 tracings with the use of a 5-tier color-coded framework that contains pattern descriptions and proposals for management. Computer analysis was performed with PeriCALM Patterns (PeriGen, Princeton, NJ) to detect and classify patterns. RESULTS: The clinicians agreed exactly with the majority opinion in 57% (95% confidence interval [CI], 49-64%) of the segments and were within 1 color code in 89% (95% CI, 81-96%). The average proportion of agreement was 0.83 (95% CI, 0.73-0.94). Weighted Kappa scores averaged 0.58 (range, 0.48-0.68). The computer-based results were not statistically different: 0.87 and 0.52, respectively. CONCLUSION: These 5 clinicians achieved moderate-to-substantial levels of agreement overall using a strictly defined method to classify fetal heart rate tracings. The result of the computerized method was similar to the conclusions of these clinicians.
Title: Perinatal high reliability
Publication: www.AJOG.org
Date: June 2010
Author: G. Eric Knox, MD; Kathleen Rice Simpson, PhD, RN
Perinatal high reliability is achievable with principles of high reliability organizations. Key organizational, leadership, and clinical characteristics that are essential for developing and sustaining a highly reliable perinatal unit are presented. Interdisciplinary collaboration and commitment to safe care that are founded on standardization are the hallmarks of perinatal high reliability.
Title: Graded classification of fetal heart rate tracings: association with neonatal metabolic acidosis and neurologic morbidity
Publication: American Journal of Obstetrics and Gynecology
Date: March 1, 2010
Author: Colm Elliot, MEng; Philip Warrick, PhD; Ernest Graham, MD; Emily F. Hamilton, MD
OBJECTIVE: The objective of the study was to measure the performance of a 5-tier, color-coded graded classification of electronic fetal monitoring (EFM). STUDY DESIGN: We used specialized software to analyze and categorize 7416 hours of EFM from term pregnancies. We measured how often and for how long each of the color-coded levels appeared in 3 groups of babies: (A) 60 babies with neonatal encephalopathy (NE) and umbilical artery base deficit (BD) levels were greater than 12 mmol/L; (I) 280 babies without NE but with BD greater than 12 mmol/L; and (N) 2132 babies with normal gases. RESULTS: The frequency and duration of EFM abnormalities considered more severe in the classification method were highest in group A and lowest in group N. Detecting an equivalent percentage of cases with adverse outcomes required only minutes spent with marked EFM abnormalities compared with much longer periods with lesser abnormalities. CONCLUSION: Both degree and duration of tracing abnormality are related to outcome. We present empirical data quantifying that relationship in a systematic fashion. Copyright 2010 Mosby, Inc. All rights reserved.
Title: A Comprehensive Perinatal Patient Safety Program to Reduce Preventable Adverse Outcomes and Costs of Liability Claims
Publication: The Joint Commission Journal on Quality and Patient Safety
Date: November 2009
Author: Kathleen Rice Simpson, Ph.D., R.N.C.; Carol C. Kortz, C.P.H.R.M., C.H.S.P.; G. Eric Knox, M.D.
Catholic Healthcare Partners (CHP; Cincinnati) conducted on-site risk assess-ments at the 16 hospitals with perinatal units in 2004-2005, with follow-up visits in 2006 through 2008. In addition to assessing overall organizational risk, the assessments provided each hospital a gap analysis demonstrating up-to-date and out- dated practices and strategies and resources necessary to make all practices consistent with current evidence and national guidelines and standards. Review of claims and near-miss data indicate that fetal assessment, labor induction, and second-stage labor care comprise the majority of risk of perinatal harm.
Therefore, these clinical areas were the focus of strategies to promote safety. Beginning in 2004 a variety of strategies were recommended, including interdisciplinary fetal monitoring education and routine medical record reviews to monitor ongoing adherence to appropriate practice and documentation. Success in implementing essential structural and process components of the perinatal patient safety program have resulted in improvement from 2003 to 2008 in specific outcomes for the 16 perinatal units surveyed, including reduction of perinatal harm, number of claims, and costs of claims.
Title: Effect of clinical-decision support on documentation compliance in an electronic medical record
Publication: Obstetrics & Gynecology
Date: August 1, 2009
Author: Shoshana Haberman, MD, PhD; Joseph Feldman, DrPH; Zaher O. Merhi, MD; Glenn Markenson, MD; Wayne Cohen, MD; Howard Minkoff, MD
OBJECTIVE: To investigate the efficacy of enhancing an existing prompt system in our obstetric electronic medical record in regard to documentation of estimated fetal weights and indications for labor induction. METHODS: Preintervention rates of documentation of indications for labor induction and estimated fetal weight were established at two hospital sites that used the same obstetric electronic medical record system. A compliance adherence mechanism with an enhanced prompting system was installed at the intervention hospital. Changes in the percentage of records with completed documentation were then calculated at the intervention and control hospitals. Additionally, the effects of the intervention on the pattern of documentation of indications for labor induction and on the accuracy of estimated fetal weight were tested. RESULTS: In the intervention hospital, the documentation rate increased from 42% to 69.4% for indications for labor induction, and from 55.7% to 77% for estimated fetal weight (both P<.001) during the study period although the estimated fetal weight documentation rate did not reach the level seen at base in the control hospital (92.5%). In the control hospital, there were no significant changes in rates of estimated fetal weight during the study period, but there was a decrease in indications for labor induction documentation rates. The accuracy of estimated fetal weights did not change with the enhanced documentation compliance mechanism. CONCLUSION: Increasing the frequency and modifying the methodology of prompts in an electronic medical record increased the documentation of both estimated fetal weight and indications for labor induction but did not lead to full compliance with documentation. LEVEL OF EVIDENCE: I.
Title: Oxytocin: new perspectives on an old drug
Publication: www.AJOG.org
Date: January 2009
Author: Steven L. Clark, MD; Kathleen Rice Simpson, PhD, RNC; G. Eric Knox, MD; Thomas J. Garite, MD
Oxytocin is the drug most commonly associated with preventable adverse perinatal outcomes and was recently added by the Institute for Safe Medication Practices to a small list of medications "bearing a heightened risk of harm," which may "require special safeguards to reduce the risk of error." A review of available clinical and pharmacologic data suggests that specific, evidence-based guidelines for the intrapartum administration of oxytocin may be derived from available data. If implemented, such practices may reduce the likelihood of patient harm. These suggested guidelines focus on limited elective administration of oxytocin, consideration of strategies that have been shown to decrease the need for indicated oxytocin use, reliance on low-dose oxytocin regimens, adherence to specific semiquantitative definitions of adequate and inadequate labor, and an acceptance that once adequate uterine activity has been achieved, more time rather than more oxytocin is generally preferable. The use of conservative, specific protocols for monitoring the effects of oxytocin on mother and fetus is likely not only to improve outcomes but also reduce conflict between members of the obstetric team. Implementation of these guidelines would seem appropriate in a culture increasingly focused on patient safety.
Title: Is Shoulder Dystocia with Brachial Plexus Injury Preventable?
Publication: Fetal and Maternal Medicine Review
Date: December 1, 2008
Author: Henry Lerner, MD and Emily Hamilton, MD et al.
The sequelae of shoulder dystocia with persistent brachial plexus injury (BPI) are among the most serious of obstetrical complications. Shoulder dystocia with BPI generally places second or third in the list of the top causes of permanent birth-related neonatal injuries. Apart from the devastating medical and social consequences of lifelong impairment for the family, ensuing litigation with its allegations regarding poor care exacts a heavy toll on the medical profession.
Title: Partnering with technology to reduce OB losses
Publication: Journal of Healthcare Risk Management
Date: December 2007
Author: Larry L. Smith, JD and Dorothy Berry, RN, BSN, HRM, CPHRM
Following a catastrophic birth injury that occurred as a result of deviations from the expected standards of care, the OB Risk Reduction Task Force of a healthcare network identified criteria to transform care at the bedside from theory to practice: 1) protocol-driven, real-time alerts to help healthcare providers meet clinical guidelines; and 2) the ability to produce reliable data to monitor and measure adherence to accepted standards of care. The group selected a technological solution to achieve that end. This case study illustrates how a strong partnership model between healthcare and technology solution providers can achieve much when both parties are focused on the same goals of performance improvement and active risk reduction.
Title: Shoulder dystocia: What if you could see it coming?
Publication: CONTEMPORARY OB GYN
Date: November 2007
Author: Henry Lerner, MD, Emily Hamilton, MD
The authors say that this formula—which focuses on the size of both the baby and the mother—allows obstetricians to determine which women are at greatest risk for shoulder dystocia with permanent brachial plexus injury.
Title: Labor Pains Unraveling the Complexity of OB Decision Making
Publication: Critical Care Nursing Quarterly
Date: December 2006
Author: Hamilton A, Wright, E.
While a discussion of technology and childbirth seems paradoxical, the use of statistical modeling can extend the capacity of the human mind to quantify risk, to communicate clearly, and to recognize when action is necessary in an obstetrical setting. These models provide clinicians envelopes that define safe and reasonable clinical paths. They obviate the myriad of environmental, experiential, and individual factors that inevitably affect the process of identifying and responding to unsafe situations. As the number of variables increases, the ability of the human mind to analyze multiple, interrelated factors diminishes and is not consistent across place and time. The top obstetrical problems leading to birth-related injury and litigation are discussed: shoulder dystocia, hypoxic ischemic encephalopathy, and prolonged or difficult labor. Two case histories are presented to demonstrate the factors promoting medical error and the application of these new technologies.
Title: Prediction of risk for shoulder dystocia with neonatal injury
Publication: Journal of Obstetrics and Gynecology
Date: July 17 2006
Author: Dyachenko A, Ciampi A, Fahey J, Mighty H, Oppenheimer L, Hamilton EF
OBJECTIVE: The purpose of this study was to develop a predictive model of risk for shoulder dystocia (ShD) with injury. STUDY DESIGN: Medical records in 3 urban university teaching hospitals were reviewed to identify and characterize 498 cases of ShD, including 90 with neonatal injury and a comparison group with of 622 with vaginal delivery (VgD) without ShD. The data were subjected to logistic regression modeling to find the best combination of variables to discriminate between the injury and VgD groups. RESULTS: The best model included birth weight in combination with maternal height and weight as well as gestational age and parity. A score over 0.5 detected 50.7% of the shoulder dystocia cases with brachial plexus injury along with a false positive rate of 2.7%. CONCLUSION: Using a statistical model it is possible to identify adverse combinations of factors that are associated with ShD and neonatal injury along with a relatively low false positive rate.
Title: Fetal heart rate deceleration detection from the discrete cosine transform spectrum.
Publication: Abstract presentation at EMBS
Date: Jan 1 2005
Author: Philip A. Warrick, Doina Precup, Emily Hamilton, Robert Edward Kearney
Automated detection of decelerations in fetal heart rate (FHR) signals can be posed as a problem of signal detection in the presence of noise. We present an algorithm that adaptively selects the resolution of analysis and uses the discrete cosine transform (DCT) to describe the spectrum at short-term and longer-term scales. In so doing we generate near-orthogonal and scale-invariant features that are presented to a feedforward neural network for classification.
Title: Neural network based detection of fetal heart rate patterns
Publication: Abstract presentation at IJCNN
Date: Jan 1 2005
Author: Philip Warrick, Emily Hamilton, Maciej Macieszczak
Title: Fetal heart rate patterns and hypoxic ischemic encephalopathy
Publication: American Journal of Perinatology
Date: Jan 1 2005
Author: EF Hamilton, RW Platt
Title: The effect of computer-assisted evaluation of labor on cesarean rates
Publication: Journal of Healthcare Quality
Date: Jan 1 2005
Author: Hamilton E, Platt R, Gauthier R, McNamara H, Miner L, Rothenberg S, Asselin G, Sabbah R, Benjamin A, Lake M, Vintzileos
Dystocia, or slow labor, is the leading cause of first-time cesarean sections. Current diagnostic guidelines for dystocia are vague, and there is no clear postoperative confirmatory evidence to assess the correctness of this diagnosis. For several decades, various professional organizations have indicated that cesarean rates could be lowered safely and have recommended levels that are far below national averages. The three major factors, of roughly equal importance, associated with cesarean for slow labor are the baby's weight, the mother's height, and the threshold at which the physician believes it is reasonable to intervene. The last is the only modifiable factor, and quality programs are a major part of changing medical behavior. By using two study designs, the effect of a mathematical method for evaluating labor progress on the rate of cesarean section was measured. In the prospective randomized clinical trial, the relative risk of cesarean in the experimental group was unchanged at 1.04. In the pretest-posttest analysis, the rates fell from 19.54% to 17.04% at 6 months and 16.62% at 12 months.
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