Elena Gates

Procedure-related miscarriages and Down syndrome-affected births: implications for prenatal testing based on women's preferences.

Objective To determine how pregnant women of varying ages, races, ethnicities, and socioeconomic backgrounds value procedure-related miscarriage and Down–syndrome-affected birth. Methods We studied cross-sectionally 534 sociodemographically diverse pregnant women who sought care at obstetric clinics and practices throughout the San Francisco Bay area. Preferences for procedure-related miscarriage and the birth of an infant affected by Down syndrome were assessed using the time trade-off and standard gamble metrics. Because current guidelines assume that procedure-related miscarriage and Down syndrome–affected birth are valued equally, we calculated the difference in preference scores for those two outcomes. We also collected detailed information on demographics, attitudes, and beliefs. Results On average, procedure-related miscarriage was preferable to Down syndrome–affected birth, as evidenced by positive differences in preference scores for them (time trade-off difference: mean = 0.09, median = 0.06; standard gamble difference: mean = 0.11, median = 0.02; P < .001 for both, one-sample sign test). There was substantial subject-to-subject variation in preferences that correlated strongly with attitudes about miscarriage, Down syndrome, and diagnostic testing. Conclusion Pregnant women tend to find the prospect of a Down syndrome–affected birth more burdensome than a procedure-related miscarriage, calling into question the equal risk threshold for prenatal diagnosis. Individual preferences for those outcomes varied profoundly. Current guidelines do not appropriately consider individual preferences in lower-risk women, and the process for developing prenatal testing guidelines should be reconsidered to better reflect individual values.

Beyond race or ethnicity and socioeconomic status : Predictors of prenatal testing for down syndrome

OBJECTIVE: To identify predictors of prenatal genetic testing decisions and explore whether racial or ethnic and socioeconomic differences are explained by knowledge, attitudes, and preferences. METHODS: This was a prospective cohort study of 827 English-, Spanish-, or Chinese-speaking pregnant women presenting for care by 20 weeks of gestation at 1 of 23 San Francisco Bay–area obstetrics clinics and practices. Our primary outcome measure for women aged less than 35 years was any prenatal genetic testing use compared with none, and for women aged 35 years or older, prenatal testing strategy (no testing, screening test first, straight to invasive diagnostic testing). Baseline questionnaires were completed before any prenatal test use; test use was assessed after 30 gestational weeks. RESULTS: Among women aged less than 35 years, no racial or ethnic differences in test use emerged. Multivariable analyses yielded three testing predictors: prenatal care site (P = .024), inclination to terminate pregnancy of a Down-syndrome–affected fetus (odds ratio 2.94, P = .002) and belief that modern medicine interferes too much in pregnancy (odds ratio .85, P = .036). Among women aged 35 years or older, observed racial or ethnic and socioeconomic differences in testing strategy were mediated by faith and fatalism, value of testing information, and perceived miscarriage risk. Multivariable predictors of testing strategy included these 3 mediators (P = .035, P < .001, P = .037, respectively) and health care system distrust (P = .045). A total of 29.5% of screen-positive women declined amniocentesis; 6.6% of women screening negative underwent amniocentesis. CONCLUSION: Racial or ethnic and socioeconomic differences in prenatal testing strategy are mediated by risk perception and attitudes. Screening is not the best choice for many women. Optimal prenatal testing counseling requires clarification of risks and consideration of key attitudes and preferences regarding the possible sequence of events after testing decisions. LEVEL OF EVIDENCE: II-2

Racial-ethnic differences in prenatal diagnostic test use and outcomes: Preferences, socioeconomics, or patient knowledge?*

Objective To determine whether use of chorionic villus sampling and amniocentesis varies by racial-ethnic group and, if so, whether this variation is reflected in the prevalence of Down syndrome-affected births to women age 35 and older, the ages at which prenatal diagnosis is offered currently. Methods Medical charts of 238 women 35 years of age and older presenting for care at the University of California at San Francisco by 20 gestational weeks in 1993 and 1994 were reviewed to assess prenatal diagnostic test use. The prevalence of Down syndrome-affected births in California during 1983–1991 was obtained from the Birth Defects Monitoring Program. Results Latinas and African-American women were much less likely to undergo prenatal diagnosis than were whites and Asians. Odds ratios (OR) and 95% confidence intervals (CI), with white women serving as the reference group, were as follows: Asians 1.16 (0.57–2.36), Latinas 0.19 (0.08–043), and African-Americans 0.19 (0.07–0.49). Trends persisted, at diminished magnitude, after adjustment for socioeconomic characteristics: OR for Asians 1.77 (0.78–3.98), Latinas 0.28 (0.09–0.83), and African-Americans 0.33 (0.10–1.10). Non-white women age 35 and older were significantly more likely than white women to give birth to a Down syndrome-affected infant: risk ratios for Asians 1081 (1.61–2.03), Latinas 3.00 (2.74–3.28), African-Americans 1.86 (1.63–2.11). Conclusion Racial-ethnic differences exist in prenatal diagnostic test use and associated outcomes in women age 35 and older. Socioeconomic factors are partially responsible; patient education and preferences may play a role.

New surgical procedures: can our patients benefit while we learn?

Several forces have combined to encourage gynecologic surgeons to acquire the skills they need to perform new endoscopic procedures. Pressures from health care institutions, industry, and, most important, from patients lead to increased demand for less invasive approaches to the treatment of gynecologic conditions. This demand may outstrip the professions ability to demonstrate the safety and effectiveness of new procedures through rigorous clinical trials. Early on, the benefits expected from laparoscopic surgery may be limited by harms resulting from surgical inexperience. Physicians will struggle to achieve a balance between their ethical obligation to benefit patients while avoiding harm to them and their professional expectation of continued learning. Acquisition of new techniques involves a learning curve, across which complications and operating time decrease while the potential for benefit rises. To minimize harm to patients during the surgeons learning process, peer review should play an expanded role. Surgeons should discuss their own surgical experience and level of skill openly with their patients as part of the process of informed consent. A relationship of trust is vital when one engages patients in a cooperative educational venture.

Cervical ectopic pregnancy: review of the literature and report of a case treated by single-dose methotrexate therapy.

Methotrexate with folinic acid rescue was used to terminate a clinically diagnosed cervical pregnancy while preserving reproductive capability in a young female patient. The chemotherapy was well tolerated except for transient elevation of liver enzymes. Beta HCG titers fell rapidly and became negative by 13 days. This is the first report showing successful treatment of a cervical pregnancy with single-dose chemotherapy. The literature is reviewed and discussed.

Preferences of women facing a prenatal diagnostic choice : Long-term outcomes matter most

Women aged 35 or older who wish to undergo prenatal diagnosis for chromosomal disorders are typically offered a choice between chorionic villus sampling or amniocentesis. These two tests are performed at different times and impose differing miscarriage risks. In deciding which test to use, therefore, women need to consider both short‐term consequences (e.g. timing of pregnancy loss, should it occur) and long‐term consequences (e.g. whether a pregnancy loss is followed by a future birth). We examined how women seeking prenatal diagnostic services value the outcomes of testing.

Social and familial context of prenatal genetic testing decisions: are there racial/ethnic differences?

The purpose of this cross‐sectional study of 999 socioeconomically and racially/ethnically diverse pregnant women was to explore prenatal genetic testing attitudes and beliefs and the role of external influences. Surveys in English, Spanish, and Chinese included questions regarding the value of testing, pregnancy, and motherhood; the acceptability of Down syndrome in the subjects community; and the role of social and cultural influences in prenatal testing decisions. We analyzed racial/ethnic differences in all attitudinal and external influence variables, controlling for age, relationship status, and socioeconomic status. We found statistically significant racial/ethnic group differences in familiarity with an individual with Down syndrome and in 10 of 12 attitude, belief, and external influence variables, even after controlling for other sociodemographic characteristics. We also observed substantial variation within racial/ethnic groups for each of these measures. Despite the statistically significant group differences observed, R2 values for all multivariate models were modest and response distributions overlapped substantially. Social and familial contexts for prenatal testing decisions differ among racial/ethnic groups even after accounting for age, marital status, and other socioeconomic factors. However, substantial variation within groups and overlap between groups suggest that racial/ethnic differences play a small role in the social and familial context of prenatal genetic testing decisions.

Computerized Prenatal Genetic Testing Decision-assisting Tool: A Randomized Controlled Trial

OBJECTIVE: Guidelines for fetal aneuploidy testing recommend that screening and diagnostic testing be made available to pregnant women of all ages and that providers explain the differences between these tests to help their patients make informed testing decisions. We sought to estimate the effect of a computerized, interactive prenatal testing decision tool on prenatal testing decision making. METHODS: Four hundred ninety-six English- or Spanish-speaking women at 20 or fewer weeks of gestation were randomly assigned to view the interactive prenatal testing decision tool or the California Department of Health Services’ educational booklet. Primary outcomes were knowledge, risk awareness, intervention satisfaction, decisional conflict, and among women aged at least 35 years, use of invasive diagnostic testing. RESULTS: Women assigned to the interactive prenatal testing decision tool had higher knowledge scores (79.5% compared with 64.9%, P<.001), were more likely to correctly estimate their risk of procedure-related miscarriage (64.9% compared with 48.1%, P=.002) and carrying a Down syndrome-affected fetus (63.5% compared with 15.1%, P<.001), were more satisfied with the intervention (P<.001), and had less decision uncertainty (P<.001) than controls after viewing the intervention. Most of these differences persisted over time. Among women aged at least 35 years, the interactive prenatal testing decision tool viewers who were originally less inclined to undergo invasive testing were ultimately more likely than similarly inclined controls to have amniocentesis or chorionic villus sampling (44.8% compared with 29.2%), whereas those who were originally more inclined to undergo an invasive procedure ultimately were less likely than similarly inclined controls to have a diagnostic procedure (84.6% compared with 94.9%; P=.015 for interaction). CONCLUSION: Using an interactive prenatal testing decision tool results in more informed prenatal genetic testing decisions than viewing standard educational booklets. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00686062 LEVEL OF EVIDENCE: I

A New Era in the Ethics of Human Embryonic Stem Cell Research

Scientific progress in human embryonic stem cell (hESC) research and increased funding make it imperative to look ahead to the ethical issues generated by the expected use of hESCs for transplantation. Several issues should be addressed now, even though phase I clinical trials of hESC transplantation are still in the future. To minimize the risk of hESC transplantation, donors of materials used to derive hESC lines will need to be recontacted to update their medical history and screening. Because of privacy concerns, such recontact needs to be discussed and agreed to at the time of donation, before new hESC lines are derived. Informed consent for phase I clinical trials of hESC transplantation also raises ethical concerns. In previous phase I trials of highly innovative interventions, allegations that trial participants had not really understood the risk and benefits caused delays in subsequent trials. Thus, researchers should consider what information needs to be discussed during the consent process for hESC clinical trials and how to verify that participants have a realistic understanding of the study. Lack of attention to the special ethical concerns raised by clinical trials of hESC transplantation and their implications for the derivation of new hESC lines may undermine or delay progress toward stem cell therapies.

Laparoscopic diagnosis and methotrexate treatment of an ovarian pregnancy : a case report

This report suggests an alternative for dealing with the diagnostic dilemma of differentiating an ovarian pregnancy from a ruptured CL cyst and suggests a conservative management approach that will possibly minimize adhesion formation and optimize future fertility. This new approach is based on a single case reported here, and therefore needs further verification. However, use of this revised set of diagnostic criteria, combined with the judicious use of MTX, may be an alternative therapy for selected ovarian pregnancies.