Changing practice to improve patient safety and quality of care in perinatal medicine.

Despite an increased focus on the quality and safety of care, the United States health care system does not reliably deliver safe, high-quality care for all women and infants. In many cases, a gap still exists between best evidence and routine practice and pregnant women and neonates continue to experience preventable harm. Effective change strategies targeting individuals, groups or teams, organizations, and the larger system or environment have been used in the setting of perinatal care to improve quality and safety. In addition, strategies focused on aligning change efforts across multiple levels are increasingly being used to more effectively change practice in the context of the complex health care system. This review examines some of the single-level and multilevel approaches to changing practice that have been used in perinatal safety and quality improvement. Although progress has been slow, improvements in quality and safety measurement, widespread commitment to implementing effective practice change interventions, and advances in perinatal improvement and implementation research will help ensure that the dramatic improvements in perinatal quality and safety that have been anticipated will truly be realized.

Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes.

OBJECTIVE: To evaluate the impact of a sumatriptan/naproxen sodium combination tablet on patient satisfaction, productivity, and functional disability in menstrual migraine treated during the mild pain phase of a single menstrual migraine attack associated with dysmenorrhea. BACKGROUND: Menstrual migraineurs with dysmenorrhea represent a unique patient population not previously studied. When health outcomes end points are analyzed alongside traditional efficacy end points in migraine studies, a more comprehensive and robust understanding of the many factors that may influence patients' choice of and adherence to pharmacological treatments for migraine is observed. METHODS: In 2 replicate, multicenter, randomized, double-blind, placebo-controlled trials, participants with menstrual migraine and dysmenorrhea treated a single menstrual migraine attack with a single fixed-dose tablet of sumatriptan 85 mg formulated with RT Technology™ and naproxen sodium 500 mg (sumatriptan-naproxen sodium) or placebo. RESULTS: Participants randomized to sumatriptan-naproxen sodium were significantly more satisfied than those randomized to placebo at 24 hours post dose, as demonstrated by higher satisfaction subscale scores for efficacy (P < .001 for both studies), functionality (P = .003 for study 1; P < .001 for study 2), and ease of use (P = .027 for study 1; P = .011 for study 2). There was little bothersomeness of side effects associated with either treatment. Use of sumatriptan-naproxen sodium was also associated with lower reported "lost-time equivalents" in work and leisure time (pooled analysis, P = .003) and lower rates of functional disability (P = .05, study 1; P < .001, study 2) compared with placebo. CONCLUSION: A fixed-dose combination tablet containing sumatriptan and naproxen sodium significantly improved patient satisfaction, productivity, and restoration of normal functioning in menstrual migraineurs with dysmenorrhea.

Pilot studies of estrogen-related physical findings in infants.

BACKGROUND: Soy formula containing estrogenic isoflavones is widely used in the United States. Infants consuming soy formula exclusively have high isoflavone exposures. We wanted to study whether soy formula prolonged the physiologic estrogenization of newborns, but available quantitative descriptions of the natural history of breast and genital development are inadequate for study design. OBJECTIVE: We piloted techniques for assessing infants' responses to the withdrawal from maternal estrogen and gathered data on breast and genital development in infants at different ages. METHODS: We studied 37 boys and 35 girls, from term pregnancies with normal birth weights, who were < 48 hr to 6 months of age, and residents of Philadelphia, Pennsylvania, during 2004-2005. One-third of the children of each sex and age interval were exclusively fed breast milk, soy formula, or cow-milk formula. Our cross-sectional study measured breast adipose tissue, breast buds, and testicular volume; observed breast and genital development; and collected vaginal wall cells and information on vaginal discharge. We assessed reliability of the measures. RESULTS: Breast tissue was maximal at birth and disappeared in older children, consistent with waning maternal estrogen. Genital development did not change by age. Breast-milk secretion and withdrawal bleeding were unusual. Vaginal wall cells showed maximal estrogen effect at birth and then reverted; girls on soy appeared to show reestrogenization at 6 months. CONCLUSIONS: Examination of infants for plausible effects of estrogens is valid and repeatable. Measurement of breast tissue and characterization of vaginal wall cells could be used to evaluate exposures with estrogen-like effects.

Electronic health records in an outpatient breastfeeding medicine clinic.

The Institute of Medicine has issued a call for the implementation of computer-based patient records. The purpose of this overview is to describe the content developed for an electronic health record in an outpatient breastfeeding medicine clinic at a pediatric health care facility. Additional features of the computer system, including electronic prescriptions, printed patient handouts, and follow-up telephone notes, utilized in this setting are also described. As more hospital systems and outpatient offices adopt electronic medical record systems, the authors recommend that lactation personnel work with administrators and computer professionals at their institution to incorporate the special needs of an outpatient lactation clinic into their system.

The development of a research human milk bank.

Although there are well-established clinical human milk banks in the United States, there are no milk banks specifically intended to foster research on human milk. The authors' goal was to establish a milk bank with a core data set to support exploratory and hypothesis-driven studies on human milk. Donations to the Cincinnati Children's Research Human Milk Bank are accepted within the context of ongoing, hypothesis-driven research or on an ad hoc basis. Donors must give informed consent, and scientists wishing to use the samples must have Institutional review board approval for their use. Development of more research human milk banks can potentially provide resources for multidisciplinary collaboration and advance the study of human milk and lactation.

Relief of menstrual symptoms and migraine with a single-tablet formulation of sumatriptan and naproxen sodium.

BACKGROUND: Dysmenorrhea and menstrual migraine may share a common pathogenic pathway. Both appear to be mediated, in part, by an excess of prostaglandin production that occurs during menstruation. METHODS: Data were pooled from two replicate randomized controlled trials of 621 adult menstrual migraineurs with dysmenorrhea who treated migraine with sumatriptan-naproxen or placebo. Along with headache symptoms, nonpain menstrual symptoms (bloating, fatigue, and irritability) and menstrual pain symptoms (abdominal and back pain) were recorded at the time periods of 30 minutes and 1, 2, 4, and 4-24 hours. Relief of menstrual symptoms was compared using a Cochran-Mantel-Haenszel test. Logistic regression was used to determine the odds of a headache response with increasing numbers of moderate to severe dymenorrheic symptoms. RESULTS: Sumatriptan-naproxen was superior to placebo for relief of tiredness, irritability, and abdominal pain at the time periods of 2, 4, and 4-24 hours (p≤0.023); back pain at the time periods of 4 and 4-24 hours (p≤0.023); and bloating at 4-24 hours endpoint (p=0.01). The odds ratios (ORs) of attaining migraine pain freedom for 2 hours and for sustained 2-24 hours decreased as moderate to severe dysmenorrhea symptoms increased with sumatriptan-naproxen versus placebo. CONCLUSIONS: Treatment with sumatriptan-naproxen may provide relief of menstrual symptoms and migraine in female migraineurs with dysmenorrhea. The presence of moderate to severe dysmenorrhea symptoms is associated with decreased response rates for menstrual migraine, suggesting that the co-occurrence of these disorders may negatively impact the results of migraine-abortive therapy.

Harnessing a health information exchange to identify surgical device adverse events for urogynecologic mesh.

We sought to create an automated means to conduct surveillance of complications related to urogynecologic mesh because current postmarket surveillance fails to detect the true incidence of device-related adverse events. Using health information exchange data, we developed a search algorithm to identify urogynecologic surgeries with mesh implantation and associated inpatient adverse events. We validated the algorithm search results against those obtained from a manual case review of mesh surgical records. Our refined automated search strategy matched 93% of the 2874 mesh cases manually identified, and further identified 97% of 2103 vaginal mesh cases. Complications were identified in 380 of the 2874 mesh cases. This is the first known report of an automated process for identifying urogynecologic surgical mesh implantation cases from a health information exchange. Automated surveillance of health information exchange data may contribute to tracking of device-related adverse events.

Treatment of neonatal abstinence syndrome with breast milk containing methadone.

This article addresses the management of pregnant women participating in a methadone maintenance program. An approach to management of the labor of a woman on a methadone maintenance program is described along with a summary of what to anticipate at delivery and postpartum, and options for management of the infant who manifests symptoms of the neonatal abstinence syndrome.

Ankyloglossia: assessment, incidence, and effect of frenuloplasty on the breastfeeding dyad.

OBJECTIVE: Ankyloglossia in breastfeeding infants can cause ineffective latch, inadequate milk transfer, and maternal nipple pain, resulting in untimely weaning. The question of whether the performance of a frenuloplasty benefits the breastfeeding dyad in such a situation remains controversial. We wished to 1) define significant ankyloglossia, 2) determine the incidence in breastfeeding infants, and 3) measure the effectiveness of the frenuloplasty procedure with respect to solving specific breastfeeding problems in mother-infant dyads who served as their own controls. METHODS: We examined 2763 breastfeeding inpatient infants and 273 outpatient infants with breastfeeding problems for possible ankyloglossia and assessed each infant with ankyloglossia, using the Hazelbaker Assessment Tool for Lingual Frenulum Function. We then observed each dyad while breastfeeding. When latch problems were seen, we asked the mother to describe the sensation and quality of the suck at the breast. When pain was described, we asked the mother to grade her pain on a scale of 1 to 10. When lingual function was impaired, we discussed the frenuloplasty procedure with the parent(s) and obtained informed consent. After the procedure, the infants were returned to their mothers for breastfeeding. Infant latch and maternal nipple pain were reassessed at this time. RESULTS: Ankyloglossia was diagnosed in 88 (3.2%) of the inpatients and in 35 (12.8%) of the outpatients. Mean Hazelbaker scores were similar for the presenting symptoms of poor latch and nipple pain. Median infant age (25th and 75th percentiles) at presentation was lower for poor latch than for nipple pain: 1.2 days (0.7, 2.0) versus 2.0 days (1.0, 12.0), respectively. All frenuloplasties were performed without incident. Latch improved in all cases, and maternal pain levels fell significantly after the procedure: 6.9 +/- 2.31 down to 1.2 +/- 1.52. CONCLUSION: Ankyloglossia is a relatively common finding in the newborn population and represents a significant proportion of breastfeeding problems. Poor infant latch and maternal nipple pain are frequently associated with this finding. Careful assessment of the lingual function, followed by frenuloplasty when indicated, seems to be a successful approach to the facilitation of breastfeeding in the presence of significant ankyloglossia.