Improving Quality of Care Using a Small Systems Approach

At tertiary hospitals around the world, a team-centered systems approach has evolved to help physicians provide more evidence-based care to improve patient outcomes. A major challenge toward implementing systems change is the sheer size and scope of any such organization.

Using a unique alternative approach, Penn State Hershey Obstetrics and Gynecology has begun two quality initiatives. The first places the power to define and enact systematic changes to care within each of its six smaller subdivisions (see Text Box for initiatives overview), led by Matthew F. Davies, M.D., FACOG, chief of female pelvic medicine and reconstructive surgery, and vice chair of quality and patient safety. A key feature of the program focuses on small teams as drivers of change. Dr. Davies states, “I’ve been impressed by how many great ideas for change have come out of the small group approach; with a few people acting as drivers, there is very little bureaucratic inertia and teams can make changes to patient care in a relatively short period of time.” Dr. Davies and each quality team member gathers patient outcomes data to evaluate the impact of each quality initiative. The teams also define precise timelines for examining the impact of process. Continue reading

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New Study Explores Pre-Treatment Lifestyle Modification for Obese Women with Unexplained Infertility

Obesity in women is associated with a negative impact on ovulation, delayed time to conception, increased pregnancy loss, and an increased risk of serious adverse maternal pregnancy and neonatal outcomes.1 A new randomized controlled trial recently began enrolling patients, aimed at evaluating the impact of two varying 16-week lifestyle modification interventions (see chart) on the frequency of healthy births (e.g., live birth at 37 or more weeks gestation with no major congenital anomaly, birth weight between 2500g to 4000g). To achieve a weight loss of approximately 7 percent of total body weight, the intensive intervention promotes increased physical activity combined with calorie restriction and a weight loss medication. The other standard intervention group promotes activity alone. Richard Legro, M.D., Penn State Hershey Obstetrics and Gynecology (lead study site), the lead investigator of this nationwide study explains, “Although the epidemiology of obesity and adverse fertility outcomes is well established, there is no evidence that losing weight or achieving fitness prior to pregnancy improves fertility. In fact, there are studies that show excessive weight loss or activity can harm the chances for pregnancy. We are doing this study to answer the question of what is safe and best for women seeking pregnancy.” Continue reading

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Perinatal Program for Infants with Congenital Abnormalities

Approximately one in 33 babies in the U.S. is born with a birth defect. Among the most common of these are atrioventricular septal defects, spina bifida, and intestinal atresia or stenosis.1 Many major defects are detected early in pregnancy during routine ultrasound imaging. “For women with a complex, high-risk pregnancy, a multidisciplinary team is usually needed to manage the needs of the mother and baby, throughout pregnancy, delivery and in the postpartum period,” explains Jaimey M. Pauli, M.D., a maternal-fetal medicine specialist, Penn State Hershey Obstetrics and Gynecology. Dr. Pauli and Thomas Chin, M.D., chief, pediatric cardiology, are co-directors of the Penn State Hershey Perinatal Program at Penn State Hershey Medical Center and the Children’s Hospital, an active outreach program for pregnant women at high risk or patients who have newborns with birth defects or abnormalities.

“Expectant parents are often overwhelmed when they learn about these types of serious fetal abnormalities. Aside from help coping with the obvious emotional impact, they need help obtaining the complex care their baby requires. With our program, a team of specialists handles everything and provides highly coordinated care at a single center, which reduces a lot of stress and supports the parents,” adds Dr. Pauli. Through the perinatal program, Drs. Pauli and Chin assemble a team of maternal-fetal medicine specialists and pediatric specialists. This team can include pediatric cardiologists, cardiothoracic surgeons, neonatologists, neurosurgeons, pediatric surgeons, nephrologists, urologists, orthopaedic surgeons, radiologists and social workers, based on the needs of each individual infant and aimed at achieving the best possible outcomes. Continue reading

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Overcoming the Challenges to Preserving Fertility in Women with Cancer

Preserving Fertility in Women with CancerFertility preservation is now within reach for nearly all post-pubertal, premenopausal female cancer patients. In 2013, the American Society for Reproductive Medicine published a clear opinion, stating “Clinicians should inform patients…about options for fertility preservation and future reproduction prior to the initiation of [gonadotoxic therapies].”¹ Oocyte and embryo cryopreservation are considered non-experimental procedures, thanks to significant technological advances achieved in the past ten years. With this, insurance payer coverage for the procedures is available in many states. In others, like Pennsylvania, private charitable organizations are stepping forward. According to Stephanie Estes, M.D., of Penn State Hershey Obstetrics and Gynecology, “At Penn State Hershey Medical Center, Four Diamonds covers fertility costs for Penn State Hershey pediatric cancer patients younger than 22 years-old who qualify to benefit from Four Diamonds. This coverage includes harvesting of eggs or semen for future fertility use and the annual storage fees for cryopreserved eggs or semen until the childhood cancer patient reaches five years off treatment.” Continue reading

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The First Baby Study: A Prospective, Longitudinal Investigation of the Relationship between Mode of First Delivery and Subsequent Fertility

First Baby Study Data

Data from retrospective study conducted 2000-2008 with reported deficits in childbearing subsequent to Cesarean delivery, prior to the First Baby Study. Cumulative percentage of women who had at least one further live birth over eight to nine years follow-up after first birth.1

While retrospective studies conducted in countries throughout the world have reported deficits in childbearing subsequent to Cesarean delivery (including a study conducted from 2000 to 2008,* see figure), the First Baby Study (FBS), conducted by researchers at Penn State Hershey Medical Center, is the first prospective interview study designed specifically to investigate the effect of Cesarean delivery on subsequent childbearing and understand why the post-Cesarean fertility deficit occurs. More than 3,000 women were interviewed during their third trimester, and again at one, six, twelve, eighteen, twenty-four, thirty and thirty-six months postpartum. These women delivered between 2009 and 2011 at seventy-six hospitals in Pennsylvania, and approximately one-third had a Cesarean delivery. The primary goal of the interviews was to measure factors related to subsequent childbearing – including marital and relationship issues, use of birth control, subsequent pregnancy intentions, unprotected intercourse over the three years of follow-up, and difficulty conceiving or carrying subsequent pregnancies. Continue reading

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Dr. MILK® Supports Physician Moms, Recognizes Unique Challenges to Breastfeeding in the Health Care Work Place

Dr. M.I.L.K. Mentoring ClubThe transition back to work can spell trouble for continued breastfeeding among physician moms.¹ In October 2014, Penn State Hershey Medical Center started one of only four United States’ chapters of Dr. MILK (Mothers Interested in Lactation Knowledge), a monthly support group for breastfeeding moms who are also physicians, mid-level providers, residents, or medical students.

Jointly led by two Penn State Hershey Obstetrics and Gynecology physicians, Nicole Hackman, M.D., and Sarah Louise Juza, M.D., the goal is to make breastfeeding a positive experience for these moms so they can promote it whole-heartedly with their own patients. Kerri Brackney, M.D., FACOG, who started and formerly led the program, points out, “There is very little formal medical education around breastfeeding. Most physicians know that breastfeeding is good for babies and moms. What they don’t realize is how physically and emotionally challenging breastfeeding can be. When physician moms choose to breastfeed, they have a unique opportunity to more effectively help their patients be successful too.” Continue reading

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A Resident-Based Multi-Center Research Study of Women in Active Labor

A group of investigators at Penn State Hershey Medical Center, including OB/GYN resident physicians as site investigators, have recently completed a multi-center clinical trial and published the results in the Journal of Maternal Fetal and Neonatal Medicine (March 2015). The objective of the study was to determine if the intrapartum use of a 5 percent glucose-containing intravenous solution decreases the chance of a Cesarean delivery for women presenting in active labor, under the theory that the glucose would provide adequate energy for the contracting uterus and prevent Cesarean delivery. Another objective was to bring together other Pennsylvania medical centers with obstetric residency training programs (Lehigh Valley Hospital, Reading Hospital, and St. Luke’s Hospital in Bethlehem) in this prospective and randomized study that analyzed 309 women. There was no significant difference in the Cesarean delivery rate for the glucose group (23/153 or 15 percent) versus the non-glucose group (18/156 or 11.5 percent). The authors concluded that the use of intravenous fluid containing 5 percent glucose does not lower the chance of Cesarean delivery for women admitted in active labor.

Jaimie Maines, M.D., former resident physician and soon-to-be faculty member in Penn State Hershey Women’s Health at the Medical Center, performed a key role in launching the study and co-authored the paper with Mary Anne Carrillo, M.D., a fourth-year resident in the department.

Jaimie Maines, M.D.

Jaimie Maines, M.D.

Mary Anne Carillo, M.D.

Mary Anne Carillo, M.D.

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When is Robotic Minimally Invasive Surgery the Approach of Choice?

RoboticSurgeryEquipmentA 42 year-old woman presents in the outpatient obstetrics and gynecology clinic with severe, uncontrolled pelvic pain, painful bowel movements, and constipation. The patient has a history of stage IV endometriosis and had conceived via in-vitro fertilization (IVF). The patient now desires definitive therapy; she has completed childbearing and she had unsuccessful medical management of her symptoms with oral contraceptives and a progestin IUD. Recent ultrasound revealed a large endometrioma in the right ovary. Colonoscopy results indicated deep endometriosis of the sigmoid colon.

Stephanie Estes, M.D., of Penn State Hershey Obstetrics and Gynecology says, “In complex cases like this, a minimally invasive surgical procedure using robotic technology in a single operation offers the best odds for success, both procedurally and with a good recovery. A gynecologic surgeon would begin with a hysterectomy, and then a colorectal surgeon would resect the affected portion of sigmoid colon en bloc, to complete the procedure.” Estes continues, “With the robotic surgical tools we use, there is definitely better dexterity and enhanced 3D visualization of tissue and organs, compared to an open abdominal approach. This minimally invasive approach is really key for complex cases with widespread pathology, to avoid injury to delicate surrounding tissues.” Continue reading

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Preclinical Findings Lay the Groundwork for Translational Research Program in Cervical Cancer

“Cervical cancers bear a viral antigen fingerprint that can serve as a target for radioimmunotherapy [RIT] that specifically destroys malignant tumor cells,” says Rebecca Phaëton, M.D., of Penn State Hershey Obstetrics and Gynecology. More than 95 percent of human cervical cancers express human papilloma virus (HPV) oncoproteins E6 and E7 (E=early transformation), which herald the beginning of malignant growth sequences. E6 and E7 are necessary for the malignant transformation and without their presence HPV would be incapable of being cancerogenic. In vitro and in vivo, proliferation of human cervical cancer cells reliably expressing E6 and E7 oncoproteins is significantly inhibited by C1P5, a murine monoclonal antibody (mAB) against E6.¹ Phaëton’s research, conducted with colleagues while a fellow at Albert Einstein College of Medicine, Montefiore, New York, demonstrated the ability of twenty μCi of the beta-emitting 188Rhenium-labeled C1P5 (i.p.) to selectively accumulate within HPV-16 positive human cervical cancer tumor cells in adult mice and to suppress tumor growth for up to twenty days after treatment.2,3 “Rhenium-labeled C1P5 accumulated in the cervical cancer cells of the mice, with limited to no accumulation in the liver, kidneys, and bone marrow. There was no sign of neutropenia in any of the subjects,” reports Phaëton. As shown in the diagram below, cross-linking C1P5, which targets intranuclear E6 with the beta-emitting 188Rhenium creates a chain reaction of cell death that may allow treatment to penetrate deep within the tumor. Continue reading

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Letrozole: New Oral Fertility Option for Women with Polycystic Ovary Syndrome (PCOS)

Letrozole: New Oral Fertility Option for Women with Polycystic Ovary Syndrome

Data were analyzed based on the intent-to-treat population. P values were calculated with the use of the chi-square test or Fisher’s exact test for categorical data.

In the Pregnancy in Polycystic Ovary Syndrome II (PPCOS II)¹ clinical trial, the aromatase inhibitor letrozole (Femara) demonstrated significantly greater rates of ovulation, conception, pregnancy, and live birth, compared with the selective estrogen receptor modulator clomiphene citrate (Clomid) when given for up to five menstrual cycles in women with PCOS (Figure). The main findings of PPCOS II were published in the New England Journal of Medicine last summer (2014).¹ The trial, initiated and led by Richard Legro, M.D., of Penn State Hershey Obstetrics and Gynecology, sought to identify and compare safer, more cost-effective, oral infertility treatments that could be used as first-line options for women with PCOS. Both treatments were fairly well tolerated; the most common adverse events were hot flushes (clomiphene), dizziness, and fatigue (letrozole). Continue reading

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