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.

Effect of noncancerous pelvic problems on health-related quality of life and sexual functioning.

OBJECTIVE: To assess the effect of abnormal uterine bleeding and pelvic pain and pressure on health-related quality of life and sexual functioning and assess treatment satisfaction. METHODS: This is a cross-sectional study of 1,493 sociodemographically diverse women who were seeking care for noncancerous pelvic problems and who had not undergone hysterectomy. Participants were asked about symptoms, attitudes, health-related quality of life, sexual functioning, and treatment satisfaction. Preference for current health was measured using the time tradeoff metric, which asked respondents to estimate the number of years of life they would be willing to trade off to not have a uterine condition. Multivariable logistic regression was used to identify determinants of treatment satisfaction. RESULTS: Most (82.7%) participants reported a complete lack of or only partial symptom resolution, and 42.3% reported that their pelvic problems interfered with their ability to have and enjoy sex. Mean Short Form-12 Physical (43-49) and Mental (41-44) Component Summary scores were substantially lower than population norms for women aged 40-49 years. Mean current health time tradeoff scores ranged from 0.78 to 0.88. Satisfaction with Western medicines ranged from 31.3% (progestin intrauterine device) to 58.2% (opiates) and with uterine-preserving surgery from 20.0% (dilation and curettage) to 51.0% (myomectomy); 27.7 % of the women who used acupuncture were satisfied. Participants with lower educational attainment, greater symptom resolution, and less interference of pelvic problems with sex were more likely to be satisfied. CONCLUSION: Noncancerous pelvic problems are associated with serious decrements in health-related quality of life and sexual functioning and low rates of treatment satisfaction. LEVEL OF EVIDENCE: II.

Predictors of hysterectomy in women with common pelvic problems: a uterine survival analysis.

BACKGROUND: Comprising over 600,000 patients per year, hysterectomy is the most common nonobstetrical operation performed in US women. Little is known about the natural history of the noncancerous uterine conditions leading to hysterectomy. We followed a prospective cohort of women with common pelvic problems to determine whether simple clinical characteristics could predict a subsequent hysterectomy. STUDY DESIGN: We recruited 762 women seeking care for abnormal uterine bleeding, chronic pelvic pain, or symptomatic uterine fibroids and ascertained their hysterectomy status during 4 years of surveillance. We collected baseline patient-reported sociodemographic and clinical data and fit Cox models to predict the effects of covariates on hysterectomy across patient age. RESULTS: There were 99 hysterectomies, resulting in 0.044 hysterectomies per person-year of observation and a 13.5% cumulative hysterectomy rate. Hysterectomy was independently predicted by multiple pelvic symptoms or symptomatic fibroids (hazard ratio [HR], 1.97; 95% CI, 1.18-3.28), previous use of a gonadotropin-releasing hormone agonist (HR, 2.54; 95% CI, 1.53-4.24), and an absence of symptom resolution (HR, 2.24; 95% CI, 1.46-3.44). Survival curves plotted for subgroups with combinations of these predictors showed an escalating risk of hysterectomy with each additional risk factor. Predicted hysterectomy rates ranged from 20%, if all 3 predictors were absent, to 95%, if all 3 were present. CONCLUSIONS: For women with common pelvic problems, three easily measured clinical characteristics (symptom combination, degree of resolution, and earlier use of a gonadotropin-releasing hormone agonist) predict the likelihood of subsequent hysterectomy and can be used to inform counseling about the likely success of alternative treatments.

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.

Informed consent in human oocyte, embryo, and embryonic stem cell research.

Research with human oocytes, embryos, and additional embryonic stem cell lines is needed to address important scientific questions and to fulfill the promise of stem cell transplantation for degenerative diseases. Proponents need to develop guidelines for the appropriate conduct of embryonic stem cell research. Such guidelines will help build public trust and acceptance for this research. In this article, we offer recommendations for informed consent, discussing who should give consent, what the consent process should cover, when consent should be obtained, and who should obtain consent. Consent to use embryos for research should be obtained from oocyte and sperm donors as well as from the woman or couple undergoing infertility treatment. The consent discussion must cover information that donors need to know to make an informed decision about various types of research. Donations for research should be discussed at the initiation of advanced infertility treatment and reconfirmed if possible at the time of actual donation for research. Treating assisted reproduction technology physicians can help with the consent process, provided that they are not involved in the research.