Ethics in Narrative Health Interventions.

The thrust of narrative medicine is that patients and communities construct stories that guide their lives and give meaning to both health and illness. The responsibility of health care practitioners, therefore, is to learn how to read these local narratives to provide care that is relevant to an individual or community. Given the recognition that interaction must be tailored to the subjective experiences of patients and their communities, can there be universal ethical standards in the treatment of illness? We argue that the constructed nature of patient experiences does not pose a threat to making ethical clinical judgments. The solution to this dilemma requires that the traditional distinction between objectivity and subjectivity be eschewed by clinicians in favor of establishing dialogue with patients. Narratives are never created alone and are therefore not esoteric. Listening carefully to patients' stories is an ethical practice that can be fostered in health care settings. Subjectivity can be embraced by clinicians without jeopardizing ethical or evidence-based patient care.

The Role of Reflection in Narrative Medicine.

Reflection has become an important tool for physicians and other medical practitioners. However, many forms of reflection exist in the health care literature, with each having particular implications for successful clinical practice. Very little attention has been given to whether reflection is a vital part of narrative medicine and which forms of reflection might be compatible with this approach to patient care. In this article, the most common types of reflection are compared and discussed, specifically regarding their potential role in narrative medicine. Reflection that encourages practitioners to focus on the various perspectives shared within a medical encounter is both in line with the tenets of narrative medicine and has important consequences for patient empowerment.

The Patient-Centered Medical Home as a Community-based Strategy.

Increasing attention has been devoted to the important role that primary care will play in improving population health. One innovation, the patient-centered medical home (PCMH), aims to unite a variety of professionals with patients in the prevention and treatment of illness. Although patient perspectives are critical to this model, this article questions whether the PCMH in practice is truly community-based. That is, do physicians, planners, and other health care professionals take seriously the value of integrating local knowledge into medical care? The argument presented is that community-based philosophy contains a foundational principle that the perspectives of health care practitioners and community members must be integrated. Although many proponents of the PCMH aim to offer patient-centered and sustainable health care, focusing on this philosophical shift will ensure that services are organized by communities in collaboration with health care professionals.

Narrative medicine in a hectic schedule.

The move to patient-centered medical practice is important for providing relevant and sustainable health care. Narrative medicine, for example, suggests that patients should be involved significantly in diagnosis and treatment. In order to understand the meaning of symptoms and interventions, therefore, physicians must enter the life worlds of patients. But physicians face high patient loads and limited time for extended consultations. In current medical practice, then, is narrative medicine possible? We argue that engaging patient perspectives in the medical visit does not necessarily require a lengthy interview. Instead, a new orientation to this process that emphasizes dialogue between practitioners and patients should be considered. In this new model, the purpose of the visit is to communicate successfully and develop a mutual understanding of illness and care.

Group Maturity in a Community-Based Project.

Community-based projects have become popular as a method to address various community problems. Specifically important is that community members take an active role in these interventions resulting in sustainable social change. Although considerable literature exists on the dynamics of small group interaction, this article addresses how group processes differ in community-based projects. Instead of constructing a static model for group interaction, this discussion focuses on experiences from a recent community-based health project on the island of Grenada. Because community-based projects are directed by a diverse group of community members, maturity is described as a process of negotiation rather than consensus.

Changing medical relationships after the ACA: Transforming perspectives for population health.

American health care has undergone significant organizational change in recent decades. But what is the state of core medical relationships in the wake of these changes? Throughout ACA-era health care reform, the doctor-patient relationship was targeted as a particularly important focus for improving communication and health outcomes. Recent developments however have shifted the focus from individual-level outcomes to the wellbeing of populations. This, we argue, requires a fundamental rethinking of health care reform as an opportunity to renegotiate relationships. For example, the move to population medicine requires that the very concept of a patient be resituated and the scope of relevant relationships expanded. Medical relationships in this era of health care are likely to include partnerships between various types of clinicians and the communities in which patients reside, as well as a host of new actors, from social workers and navigators to scribes and community health workers. To address the upstream determinants of population health, providers must be increasingly willing and trained to collaborate with community stakeholders to address both medical and non-medical issues. These community-based partnerships are critical to providing health care that is both relevant and appropriate for addressing problems, and sustainable. Approaching health care reform, and the focus on population health, as a fundamental reworking of relationships provides scholars with a sharper theoretical lens for understanding 21st century American health care.

Ten-year experience with preimplantation genetic diagnosis (PGD) at the New York University School of Medicine Fertility Center.

We describe our experience of over 300 cycles of preimplantation genetic diagnosis (PGD) and report clinical pregnancy rates (35%-67%) that support using this technology to screen for genetic disorders and chromosomal abnormalities. In clinical practice for over ten years, PGD offers couples the earliest form of genetic screening and may help improve ongoing pregnancy rates in poor-prognosis patients.

Factors useful in predicting the success of oocyte donation: a 3-year retrospective analysis.

OBJECTIVE: To establish prognostic relevance of parameters assessed in oocyte donation cycles. DESIGN: Retrospective analysis. SETTING: Large university-based donor oocyte program. PATIENT(S): All oocyte recipient cycles achieving embryo transfer from September 1995 to October 1998. INTERVENTION(S): None. MAIN OUTCOME MEASURE(S): Pregnancy. RESULT(S): Recipient age and reproductive status, day 9 and 12 serum estradiol (E(2)) levels and a progesterone (P) level obtained 2 days after initiation of hormonal therapy did not correlate with pregnancy. Endometrial thickness, but not endometrial pattern, was useful in predicting pregnancy outcome. The clinical pregnancy and live-birth rate in cycles where the endometrial thickness was less than 8 mm was significantly lower when compared to cycles with an endometrial thickness > or =9 mm. Cycles where optimal quality embryos were transferred had the highest implantation (36%), clinical pregnancy (63%) and live birth (54%) rates and these rates were significantly higher than those of cycles where only poor quality embryos were available for transfer (10% implantation, 17% clinical pregnancy, and 8% live birth rates, respectively; P<.05). CONCLUSION(S): The most reliable predictive factors for pregnancy in oocyte donation cycles are the quality of the embryos transferred and the recipient's mid-cycle endometrial thickness. Recipient monitoring should minimally include ultrasound assessment of endometrial thickness.

A two- versus three-embryo transfer: the oocyte donation model.

OBJECTIVE: To compare implantation and pregnancy rates in oocyte recipients undergoing a two-embryo versus three-embryo transfer, 3 days after retrieval. DESIGN: Retrospective comparative analysis. SETTING: University-based in vitro fertilization center. PATIENT(S): All oocyte recipients undergoing embryo transfer from January 1, 1997 through August 31, 1999. INTERVENTION(S): Recipients received two or three embryos. MAIN OUTCOME MEASURE(S): Implantation, and clinical and multiple pregnancy rates. RESULT(S): Seventy-three recipients underwent a two-embryo transfer, and 376 had three embryos replaced. The numbers of oocytes retrieved (12.7 +/- 0.89 vs. 13.1 +/- 0.36) and embryos obtained (8.05 +/- 0.65 vs. 8.77 +/- 0.27) did not differ between the two-embryo and three-embryo transfer groups, nor did the proportion of patients with embryo cryopreservation (54.3% vs. 42.6%, respectively). There was no significant difference in pregnancy or implantation rates when comparing those patients with a two-embryo transfer to those with a three-embryo transfer. Significantly, 13.8% of the pregnancies in the three-embryo transfer group were triplet. CONCLUSION(S): Reducing the number of embryos transferred in an oocyte donation cycle can lower the incidence of triplet pregnancies without significantly lowering the overall pregnancy rate.

Conflict-of-interest policies for investigators in clinical trials.

BACKGROUND: There is substantial concern that financial conflicts of interest on the part of investigators conducting clinical trials may compromise the well-being of research subjects. METHODS: We analyzed policies governing conflicts of interest at the 10 medical schools in the United States that receive the largest amount of research funding from the National Institutes of Health. These institutions are Baylor College of Medicine, Columbia University College of Physicians and Surgeons, Harvard Medical School, Johns Hopkins University School of Medicine, the University of Pennsylvania School of Medicine, the University of California at Los Angeles School of Medicine, the University of California at San Francisco School of Medicine, the University of Washington School of Medicine, Washington University School of Medicine at St. Louis, and Yale University School of Medicine. RESULTS: All 10 universities required that faculty members disclose financial interests to university officials. Only four required disclosure by all members of the research staff. Five universities required disclosure of all financial interests, even though federal regulations specify a threshold for disclosure. Six universities required disclosure to the institutional review board as well as to a committee on conflicts of interest or a university official. Four universities had stricter requirements for investigators conducting clinical trials than required by federal regulations. One university prohibited investigators from having stock, stock options, consulting agreements, or decision-making positions involving a company that sponsored the research. A second university prohibited researchers from trading stock or stock options in a company that sponsored the research or sold the product or device under study. Two universities ordinarily did not allow faculty members to participate in clinical research if they had what federal regulations refer to as a "significant" financial interest in the company owning the product or device being studied, but exceptions were allowed. CONCLUSIONS: Policies governing conflicts of interest at leading medical schools in the United States vary widely. We suggest that university-based investigators and research staff be prohibited from holding stock, stock options, or decision-making positions in a company that may reasonably appear to be affected by the results of their clinical research. Of the 10 medical schools we studied, only 1 had a policy that was close to this standard.

In vitro fertilization outcome relative to embryo transfer difficulty: a novel approach to the forbidding cervix.

OBJECTIVE: To assess the impact of ET difficulty on IVF outcome and to optimize the ET procedure. DESIGN: Retrospective analysis of IVF outcome by ET catheter type and ET difficulty. Prospective treatment and follow-up of patients with a history of extremely difficult cervical passage. SETTING: Large university-based IVF program. PATIENT(S): All patients < 40 years of age undergoing IVF-ET from September 1995 to May 1998. INTERVENTION(S): Surgical correction of cervical stenosis. MAIN OUTCOME MEASURE(S): Pregnancy and embryo implantation rates. RESULT(S): Only 0.6% of ETs were "extremely difficult." Pregnancy rates were not statistically significantly different among ETs graded easy, moderate, and difficult. In contrast, no pregnancies occurred in the rare "extremely difficult" ET group. Eight patients with a history of extremely difficult cervical passage underwent surgical correction of their cervical stenosis. Twelve postoperative IVF-ET in these women resulted in eight clinical pregnancies, six of which were multiple gestations. The embryo implantation rate of these cycles was 42.2%. CONCLUSION(S): Patients with a history of extremely difficult ET may benefit from hysteroscopic evaluation and possible modification of their cervical canal before a future IVF attempt.

Fertility after hysteroscopic resection of submucous myomas.

STUDY OBJECTIVE: To analyze fertility outcomes after resection of submucous myomas by operative hysteroscopy in infertile women. DESIGN: Retrospective analysis (Canadian Task Force classification II-2). SETTING: Academic tertiary referral center. PATIENTS: Forty-one women (age 28-42 yrs) old with primary and secondary infertility, and histologically proved submucous myomas. Intervention. Hysteroscopic myomectomy performed with a rigid resectoscope. MEASUREMENTS AND MAIN RESULTS: Of the 41 patients, 25 (60.9%) became pregnant overall and 20 (48.7%) delivered at term. Seventeen patients delivered a single fetus. Five delivered twins, three at term and two at 33 and 35 weeks. One woman delivered triplets at 31 weeks. The total delivery rate was 56.0%. Two women miscarried, at 6 and 8 weeks. One patient developed postoperative Asherman's syndrome. CONCLUSION: Our results indicate that hysteroscopic myomectomy improves fertility in previously infertile women. Resection is a viable alternative to abdominal myomectomy for submucous myomas. (J Am Assoc Gynecol Laparosc 6(2):155-158, 1999)

Oral versus intramuscular progesterone for in vitro fertilization: a prospective randomized study.

OBJECTIVE: To evaluate the efficacy of oral micronized progesterone compared with IM progesterone in oil for luteal support in patients undergoing IVF who are treated with a GnRH agonist. DESIGN: Randomized prospective clinical trial. SETTING: University-based IVF center. PATIENT(S): Women <40 years of age who were undergoing IVF with luteal GnRH pituitary down-regulation. INTERVENTION(S): Patients were randomized to receive either oral micronized progesterone (200 mg three times daily) or IM progesterone (50 mg daily). MAIN OUTCOME MEASURE(S): Progesterone levels at standardized days 21 and 28, and pregnancy and embryo implantation rates. RESULT(S): Day 21 progesterone levels were 77.6+/-13.2 ng/mL in the IM group and 81.5+/-16.2 ng/mL in the oral group. Day 28 progesterone levels were 76.3+/-15.0 ng/mL in the IM group and 53.6+/-10.1 ng/mL in the oral group. The clinical pregnancy rates were 57.9% and 45.8% for the IM and oral groups, respectively. The implantation rate per embryo was significantly higher in the IM group (40.9%) than in the oral group (18.1%). CONCLUSION(S): When used according to our protocols, oral progesterone and IM progesterone result in comparable levels of circulating progesterone. However, oral progesterone results in a reduced implantation rate per embryo.

Genetic screening of prospective oocyte donors.

OBJECTIVE: To report our experience with genetic screening of oocyte donor candidates and to determine the frequency with which significant genetic issues are identified. DESIGN: Prospective genetic screening of oocyte donor candidates. SETTING: University hospital oocyte donation program. PATIENT(S): Women presenting consecutively as volunteer oocyte donors. INTERVENTION(S): Genetic screening was performed by pedigree analysis and laboratory studies. MAIN OUTCOME MEASURE(S): Inclusion in the oocyte donor pool based on the results of clinical evaluation and laboratory tests consisting of polymerase chain reaction based mutational analysis for cystic fibrosis carrier status, cytogenetic analysis for karyotype, enzymatic assay for Tay-Sachs disease carrier status, and complete blood count and hemoglobin electrophoresis. RESULT(S): Eight (11%) of 73 oocyte donor candidates were excluded from the donor pool because of a potentially serious genetic finding. Cystic fibrosis mutations were identified in 5 candidates (7%), abnormal karyotypes were found in 2 (3.5%), and an autosomal dominant skeletal dysplasia was identified in 1 (1.4%). CONCLUSION(S): A significant proportion of women who present as candidates for oocyte donation are inappropriate for donation because of their genetic history or genetic testing results. A thorough genetic evaluation, including a history and laboratory screening, is essential to any oocyte donation program to maximize positive outcomes in pregnancies achieved through assisted means.

Preimplantation genetic diagnosis of human embryos for Marfan's syndrome.

PURPOSE: Single-cell nested polymerase chain reaction (PCR) and Ddel endonuclease digestion were used to detect the presence of a Marfan's syndrome mutation in human preimplantation embryos derived from in vitro fertilization (IVF). These procedures were conducted to eliminate the possibility of transmission of the affected allele from the father to his offspring. The mutation on chromosome 15 is transmitted as an autosomal dominant trait, and the chance of having a child affected with the disease is 50%. METHODS: A couple presented to the Program for In Vitro Fertilization, Reproductive Surgery and Infertility for preimplantation genetic diagnosis. IVF was performed and embryo biopsy was done on day 3 embryos. Single blastomeres were removed from embryos and subjected to nested PCR analysis and endonuclease digestion to detect a Marfan's syndrome mutation located on chromosome 15 inherited from the father. RESULTS: Thirteen oocytes were injected with spermatozoa using intracytoplasmic sperm injection, and nine fertilized normally. Following embryo biopsy and polymerase chain reaction amplification-Ddel endonuclease digestion, five embryos were detected that were positive for the mutation. The four non-affected embryos were transferred to the uterus, resulting in a healthy and normal ongoing pregnancy.

Incidence of postpartum endomyometritis following single-dose antibiotic prophylaxis with either ampicillin/sulbactam, cefazolin, or cefotetan in high-risk cesarean section patients.

OBJECTIVE: To assess the efficacy of single-dose antibiotic prophylaxis against postpartum endomyometritis in high-risk cesarean section patients. DESIGN: Patients were administered one of three single-dose antibiotic regimens following umbilical cord clamping after cesarean section delivery. SETTING: Prospective randomized trial at a university-based hospital. PATIENTS: The study evaluated 293 consenting women undergoing cesarean section who had either experienced labor for a duration of > or = 6 hr or rupture of amniotic membranes. MAIN OUTCOME MEASURES: Development of postpartum endomyometritis. RESULTS: The incidence of postpartum endomyometritis was 7/95 (7.4%) following the ampicillin/sulbactam regimen, 14/98 (14.3%) after the cefazolin regimen, and 11/99 (11.1%) after the cefotetan regimen. There was no significant difference in postpartum infection among the three study arms. In addition, the incidence of endomyometritis in the three single-dose study arms was not higher than previously noted in studies where three doses of antibiotic were administered. CONCLUSION: Single-dose antibiotic prophylaxis should replace the standard triple-dose therapy for uninfected women undergoing cesarean section who are at risk for postoperative endomyometritis. Ampicillin/sulbactam, cefazolin, and cefotetan are all reasonable antibiotic choices for single-dose therapy.

Midfollicular anticardiolipin and antiphosphatidylserine antibody titers do not correlate with in vitro fertilization outcome.

OBJECTIVE: To determine the prevalence of anticardiolipin and antiphophatidylserine antibodies in an IVF population and to correlate their presence and specific isotype with IVF cycle outcome. DESIGN: Retrospective clinical study using stored midfollicular sera for determination of antibody status. SETTING: University hospital infertility clinic. PATIENT(S): Women who underwent IVF treatment in 1991. INTERVENTION(S): Midfollicular sera were used to assess antibody status during the time of stimulation for IVF. MAIN OUTCOME MEASURE(S): Anticardiolipin and antiphosphatidylserine antibody titers and biochemical or sonographic documentation of IVF cycle outcome. RESULT(S): The overall prevalence of anticardiolipin and antiphosphatidylserine antibodies in IVF patients was 7.0% and 11.2%, respectively. There was no statistically significant difference in the prevalence of these antibodies in the groups of patients with a biochemical pregnancy (0 for anticardiolipin and 2.8% for antiphosphatidylserine), spontaneous miscarriage (11.4% for anticardiolipin and 20% for antiphosphatidylserine), ongoing pregnancy (7.3% for anticardiolipin and 11.6% for antiphosphatidylserine), and patients who failed to conceive (7.2% for anticardiolipin and 10.8% for antiphosphatidylserine). There was no correlation between outcome and the antibody isotype expressed. CONCLUSION(S): Anticardiolipin and antiphosphatidylserine antibodies are poorly predictive of the IVF cycle outcome. Routine testing of IVF patients for the presence of these antibodies is of limited clinical utility.

Variability of day 3 follicle-stimulating hormone levels in eumenorrheic women.

OBJECTIVE: To assess the intercycle variability of early follicular follicle-stimulating hormone (FSH) and estradiol (E2) levels in eumenorrheic women according to age. STUDY DESIGN: Forty-eight female volunteers with regular menstrual cycles were studied. Serum samples were obtained on cycle day 3 in multiple cycles over a one-year period. Serum was also obtained on consecutive cycle days 2, 3 or 4 in a single cycle in 20 participants. All samples were assayed for FSH and E2 by radioimmunoassay. RESULTS: In women under 40 years of age, all initial day 3 FSH levels were < 20 mIU/mL, and 15% of subjects had a subsequently elevated day 3 FSH level (> or = 20 mIU/mL) within the year. In eight women 40-44 years of age, 75% had an initial day 3 FSH level < 20 mIU/mL, but half of them subsequently had an elevated level, > 20 mIU/mL, within the year. Between cycle days 2, 3 and 4, FSH (coefficient of variation [CV] = 14.8%, 95% confidence interval (CI) = 11.4-18.3%) varied less than E2 (CV = 31.1%, 95% CI = 21.5-40.6%). CONCLUSION: A single day 3 FSH level < 20 mIU/mL is highly predictive of all subsequent values within a year and occurred only in women under 40. An FSH level drawn on cycle day 2 or 4 will probably be within 18% of the day 3 value, but the E2 level may vary by up to 40%.

Comparison of three regimens recommended by the Centers for Disease Control and Prevention for the treatment of women hospitalized with acute pelvic inflammatory disease.

This six-center, prospective, open-label clinical trial compared the efficacy and safety of three regimens recommended by the Centers for Disease Control and Prevention (CDC) for the treatment of women hospitalized for acute pelvic inflammatory disease (PID). The study focused on the response to inpatient therapy, not on long-term prevention of sequelae. A severity score was used for objective comparison of the degree of illness before and after therapy. Women were randomly assigned (in a 1:1:1 ratio) to treatment with cefoxitin plus doxycycline, clindamycin plus gentamicin, or cefotetan plus doxycycline. Two hundred seventy-five (94.2%) of 292 evaluable women required no alteration in therapeutic regimen. The three regimens produced almost identical cure rates. No serious adverse clinical or laboratory events were observed. In short, the three regimens recommended by the CDC for inpatient therapy of acute PID were similarly effective and safe.

Epididymal micropuncture with in vitro fertilization and oocyte micromanipulation for the treatment of unreconstructable obstructive azoospermia.

OBJECTIVE: To provide fertility to couples in whom the man has surgically unreconstructable obstructive azoospermia. DESIGN: Prospective. SETTING: Hospital-based IVF unit, including associated division of urologic microsurgery. PATIENTS: Couples referred to our fertility unit for treatment of men with surgically unreconstructable reproductive tract obstruction, including congenital absence of the vas deferens. MAIN OUTCOME MEASURES: Fertilization, pregnancies, and live births. RESULTS: Of 51 cycles in which sperm and eggs were retrieved, 67% (34/51) resulted in fertilization and 27.5% (14/51) developed clinical pregnancy. Clinical pregnancy rate per couple was 33% (14/43). A total of 15 live births have been obtained in 11 couples with one ongoing pregnancy. Epididymal length was the best predictor of sperm quality and pregnancy results. For couples with at least the corpus epididymis present, 41% (9/22) of cycles resulted in clinical pregnancies. CONCLUSIONS: Pregnancy rates are optimized using sperm retrieved from the epididymis by micropuncture and when micromanipulation is available for use during IVF.