Dr. James M. Nicholson - Extended Biography
James Nicholson, M.D., Associate Professor
Dr. James A. Nicholson (aka, James M. Nicholson) grew up in the western suburbs of Philadelphia, Pennsylvania. He graduated from Westtown School in 1973 and obtained his undergraduate degree from Earlham College in 1977. He received his medical degree from the University of Pennsylvania in 1981, and completed his internship and residency with the Duke-Watts Family Medicine Residency Program in Durham, North Carolina in 1984. During his residency he obtained excellent training in maternity care at both the Cape Fear Valley Hospital in Fayetteville, NC, and Durham County General Hospital in Durham North Carolina. Following his residency, Dr. Nicholson joined a private practice in North Grosvenordale, Connecticut where he re-started the practice’s provision of maternity care. For the next 13 years, Dr. Nicholson provided prenatal care in his practice and was involved with labor and delivery activities at the near-by Day Kimball Hospital. In 1995, Dr. Nicholson expanded his practice to include a site in Putnam, Connecticut.
While at Day Kimball Hospital, Dr. Nicholson became acquainted with an obstetrician by the name of Dr. David Yeager. In the early 1990s, Dr. Nicholson became aware that Dr. Yeager’s patient panel had an unusually low cesarean delivery rate and, at the same time, had an unusually high induction of labor rate. In discussions with Dr. Yeager, it became clear that the use of labor induction was being used in response to identifiable increased risk states for cesarean delivery. Specifically, pregnant patients with increased risk of either cephalo-pelvic disproportion (CPD) (women with either short stature or a narrow pelvis, or with a fetus that seemed to be larger than usual) or utero-placental insufficiency (women with cigarette use, chronic hypertension, a small for gestational age fetus or anemia) were offered the chance to deliver on or 1-2 weeks prior to their due date. The general idea was to have women enter labor before their fetus had grown too large to fit through the pelvis, or before the placenta had grown too old to support the fetus during labor. Of note, Dr. Yeager started using this proactive approach shortly after Prostaglandin E2 gel was available for use as a cervical ripening agent in women with a low cervical Bishop’s score. This type of medication had not been previously available.
From 1993 to 1997, Dr. Nicholson and several other providers joined Dr. Yeager in an effort to provide optimal birth outcomes through the regular use of risk-based "preventive" labor induction. In 1994 and 1995, the labor and delivery unit of the Day Kimball Hospital had state-leading cesarean delivery rates at just under 10%. Health officials from the State of Connecticut refused to accept a higher induction of labor rate as a possible reason for the low institutional cesarean delivery rates, and pressure was applied to lower the use of "preventive labor induction." Over the next few years the induction of labor rate at Day Kimball Hospital fell somewhat, and the institution’s cesarean delivery rate rose somewhat.
In 1997, Dr. Nicholson closed his practices in North Grosvenordale and Putnam, Connecticut, and returned to the University of Pennsylvania to join the newly formed Department of Family Practice and Community Medicine (later renamed the Department of Family Medicine and Community Health). Dr. Nicholson was asked to assist with the development of a maternity care training program for family medicine residents, but he was also asked to pursue Master's Degree training in Clinical Epidemiology so as to better understand the research mission of the University of Pennsylvania. For his Master's Degree thesis project, Dr. Nicholson chose to perform a retrospective study of the maternity care activity that occurred at Day Kimball Hospital between 1994 and 1997. He was assigned to have as his advisor Dr. George Macones, who was at that time the director of Maternal Fetal Medicine at the University of Pennsylvania.
The Master's Degree Project required the development of a data abstraction instrument and a data entry process. Once developed, Dr. Nicholson and several research assistants accomplished the abstraction and entry of data for over 2000 mother/baby chart pairs from the New England hospital. This research activity eventually reported that patients of physicians who utilized the AMOR-IPAT over a four year period (1994-1997) had a cesarean delivery rate of 5.3% (as compared to 11.8% for the usual care group). Rates of other adverse birth outcomes were either lower or similar in the AMOR-IPAT-exposed group. While this study was being performed, Dr. Nicholson was also applying the use of preventive labor induction to the patients from his practices in Philadelphia. Cases from his first three years of practice at the University of Pennsylvania were used to generate the first published study of AMOR-IPAT, which came out in 2004 as an editor’s choice paper in the American Journal of Obstetrics and Gynecology. In this study, the first 100 Philadelphia patients who were exposed to AMOR-IPAT had a cesarean delivery rate of 4% (as compared to 16.7% for the usual care group).
The Master's Degree work, and the development of the first University of Pennsylvania study, resulted in the fine tuning and quantification of the preventive labor induction method. This included a risk scoring system and the generation of several new terms and concepts including: 1) the variable optimal time of delivery (OTD), 2) the upper limit of the optimal time of delivery (UL-OTD) and 3) the lower limit of the optimal time of delivery (LL-OTD). To generate the UL-OTD for each pregnancy, risk factors were divided into three categories: CPD factors, UPI factors and “X” factors.
CPD Risk Factors:
UPI Risk Factors:
"X" Risk Factors:
For the CPD and UPI groups, risk factors are given a value in Yeager Units, or number of days subtracted from 41 weeks 0 days gestation, based on the relative magnitude of their impact on cesarean delivery likelihood. The UL-OTD for each set of risk factors was then estimated by subtracting the total number of Yeager Units for each risk category from the theoretical UL-OTD for pregnancies without any risk at all – which is estimated to be 41 weeks 0 days based on published randomized clinical trials. For "X" factors, preventive labor induction is offered as soon as the "X" factor is identified within the term period (37w 0d – 40w 6d). The estimation of the UL-OTD for every pregnancy, and the offering of preventive labor induction on or just before any given patient’s UL-OTD, results in the higher use of labor induction. Women desiring a preventive labor induction but who have an unfavorable cervical Bishop’s score are offered pre-induction cervical ripening with PGE2 (dinoprostone), PGE1 (misoprostol) or a Foley bulb catheter.
The AMOR-IPAT concept, based on UL-OTD estimation, was further developed in 2002, and a grant application was submitted to the National Child Health & Human Development (NICHD) of the National Institutes of Health (NIH), which resulted in a 5-year (2004-2008) K-23 Career Development Award. This allowed Dr. Nicholson to complete additional theoretical work on AMOR-IPAT in four main areas: 1) the use of a large UPENN OB database to demonstrate that optimal times for delivery probably exist for patients with and without risk factors, 2) the application of survival curve analysis to the timing of delivery, 3) the use of latent variable/factor analysis modeling to identify related risk factors that lead to certain adverse birth outcomes, and 4) the estimation of the potential for AMOR-IPAT to prevent intra-uterine fetal demise (IUFD). A follow-up to the original University of Pennsylvania study was accomplished and was eventually published. Most importantly, the K-23 support allowed for the development and completion of a 270-subject prospective, randomized clinical trial (RCT) of AMOR-IPAT (the HUP-POP Trial). This trial was based on pregnancies from the OB clinics of both the Hospital of the University of Pennsylvania and the Pennsylvania Hospital. Importantly, the HUP-POP Trial involved induction activity and labor management that was provided by members of the Department of Obstetrics and Gynecology. Although this study reported that the cesarean delivery rates were "not different" in the two study groups (AMOR group – 10.3% vs. usual care group - 14.9%), the study was able to report that the AMOR-IPAT-exposed group, as compared to the group that received usual care, had a statistically significant reduction in the rate of NICU admission, a statistically significant reduction in the Adverse Outcome Index score, and a statistically significant increase in the rate of uncomplicated vaginal delivery.
In 2008, Dr. Nicholson was approached by a group of obstetricians from Merate, Italy. Providers from this area had read about, and had started using, the AMOR-IPAT method of care and had noted dramatic success in lowering their cesarean delivery rate. Dr. Nicholson was invited to lecture in Merate, and over the next few years gave presentations at several Italian OB/GYN conferences. In 2010, data from Merate was presented in poster format at the COGI Conference in Berlin, Germany. At the same time, data showing the association between higher rates of labor induction and lower cesarean delivery rates in a hospital in St. Petersburg, Florida, was also presented.
In March of 2010, Dr. Nicholson travelled to Adelaide, Australia, to present a summation of his research findings at the Royal Australian-New Zealand College of Obstetrics and Gynecology (RANZCOG). He presented two posters at that conference: 1) a meta-analysis of all AMOR-IPAT studies that had been published by that time, and 2) a meta-analysis of all pre-39 week preventive labor inductions (compared to expectant management beyond 39 weeks 0 days). The overall meta-analysis won best poster prize for this conference. However, starting in 2010, providers using AMOR-IPAT began running into a set of obstacles. The USA, and the world as a whole, was developing increasing restrictions on non-indicated labor induction, and by 2011 the use of preventive labor induction at the Hospital of the University of Pennsylvania became quite difficult. In addition, despite three applications to the NICHD of the NIH to fund an adequately powered RCT of AMOR-IPAT – one that had the support of seven members of the MFMU Research Network – funding was not provided. Without funding and with increasing restrictions on preventive labor induction, the AMOR-IPAT project became clinically inactive.
In 2011, Dr. Nicholson was denied tenure at the University of Pennsylvania. This decision was made despite his publication of five editor’s choice articles in the American Journal of Obstetrics and Gynecology (ACOG), three major articles in three other journals, the citation of AMOR-IPAT in Up-To-Date, the production of an ACOG CME course on the benefits of elective labor induction, the presentation of over two dozen posters at various national conferences, the presentation of AMOR-IPAT material in five foreign countries, and the presentation of AMOR-IPAT OB/GYN grand rounds in over 30 USA institutions. The Center for Evidence Based Medicine at the University of Pennsylvania reported that there was not enough evidence in the medical literature to support the use of AMOR-IPAT, but they strangely did not see fit to report that the evidence used to support restrictions of non-indicated labor induction was largely retrospective, was potentially confounded by indication and did not contain any data from randomized clinical trials.
Dr. Nicholson moved to the Milton S. Hershey Medical Center of Penn State University in September of 2012. There he has been re-energized by colleagues in the Department of Family Medicine and Community Medicine, the Department of Obstetrics and Gynecology and the Department of Pediatrics. He is in the process of submitting grant applications to the Patient-Centered Outcomes Research Institute (PCORI) and the NICHD. Just as important, he is in the process of creating for submission to medical journals additional manuscripts that deal with the general concepts of risk-based preventive labor induction – both before and after 39 weeks 0 days of gestation.
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