Sociodemographic and attitudinal predictors of simultaneous and redundant multiple marker and cell-free DNA screening among women aged ⩾35 years.

OBJECTIVE: To identify characteristics associated with undergoing cell-free DNA (cfDNA) and multiple marker screening (MMS) simultaneously or redundantly (after receiving negative results from the first screening test) among women aged ⩾35 years. STUDY DESIGN: Participants presenting for prenatal testing completed a questionnaire that included measures of pregnancy worry and attitudes toward potential testing outcomes; data on prenatal test use was obtained via medical record review. We used multivariable logistic regression to identify factors associated with redundant or simultaneous screening. RESULTS: Among 164 participants, 69 (42.1%) had cfDNA redundantly (n=51) to, or simultaneously (n=18) with, MMS. Compared with the 46 MMS-negative women who did not undergo further testing, those who underwent redundant or simultaneous cfDNA/MMS screening were more likely to have annual family incomes >$150 000, to feel having a miscarriage would be worse than having an intellectually disabled child, to desire comprehensive testing for intellectual disability and to have more pregnancy worry. CONCLUSION: Providers who counsel patients on prenatal aneuploidy screening tests should explain the appropriate utilization of these screening tests to avoid unnecessary or minimally informative use of multiple tests.

Dynamic outcome prediction in a socio-demographically diverse population-based cohort of extremely preterm neonates.

OBJECTIVE: Accurate outcome prediction is crucial for counseling parents and providing individualized treatment to extremely premature infants. We sought to improve upon existing prediction model by using a diverse population-based cohort of extremely premature live births (⩽28 weeks' gestation) for survival and survival without severe neonatal morbidity at different times throughout the first week of life and to evaluate potential differences by race/ethnicity and maternal education. STUDY DESIGN: Retrospective cohort study of all California live births from 2007 through 2011 with linked birth, death and hospital discharge records. RESULTS: A total of 6009 infants were included. In the validation data set at time of delivery, the area under the receiver-operating characteristic curve for the model containing all predictors was 0.863 for survival and 0.789 for survival without severe morbidity. The marginal probability of survival without severe neonatal morbidity of an Asian infant born to a mother with <12 years of education compared with the reference (Caucasian infant, mother with ⩾12 years of education) was -0.23 (95% confidence interval (CI) -0.31 to -0.15) for all infants at time of birth and -0.28 (95% CI -0.39 to -0.18) for infants with attempted resuscitation. Notably, no other differences by racial/ethnic category and maternal education emerged. CONCLUSIONS: Probabilities of survival and survival without major morbidity change rapidly throughout the first week of life. Extremely premature infants born to Asian mothers with less than a high school education appear to have a lower probability to survive without significant morbidity compared with their Caucasian peers.

Population-based risks of mortality and preterm morbidity by gestational age and birth weight.

OBJECTIVE: The objective of this study is to examine the effect of small or large for gestational age (SGA/LGA) status on mortality and morbidity by gestational age. STUDY DESIGN: Logistic binomial regression was used to calculate relative risks (RRs) and 95% confidence intervals for infant mortality and preterm morbidities for SGA or LGA compared with appropriately grown (AGA) deliveries stratified by gestational age group. RESULTS: Compared with AGA infants of similar gestational age, SGA infants were at increased risk for infant mortality. Mortality risk was decreased for LGA infants born between 25 and 27 weeks (RR: 0.6) but increased for LGA infants born between 28 and 31 weeks (RR: 1.9). Risk of preterm morbidity was increased for SGA infants born between 28 and 38 weeks, but decreased for LGA infants born before 37 weeks. CONCLUSION: This study demonstrates the importance of considering birth weight for gestational age when evaluating morbidity and mortality risks.

Receiving or believing in family support? Contributors to the life quality of Latino and non-Latino families of children with intellectual disability.

BACKGROUND: Previous studies have identified the role of family support in mitigating the stress of parents caring for a child with intellectual disability. Less is known about families whose members are willing but unable to support each other because of geographical, structural and economic barriers. Our study examined the contribution to family quality of life (FQL) of family support beliefs, actual assistance from family members, as well as the moderating effects of ethnicity and household income. METHOD: We conducted telephone interviews with 84 Latino and 61 non-Latino mothers. RESULTS: Mothers who received more emotional support from partners and other family members reported a higher FQL, controlling for family characteristics. Familism beliefs were also associated with FQL, particularly for Latino mothers. Income was not a significant moderator. CONCLUSIONS: These findings suggest that some predictors of FQL are partially moderated by ethnicity, while others may be powerful across diverse communities.

Decisional conflict and the disposition of frozen embryos: implications for informed consent.

BACKGROUND: Fertility patients often struggle with decisions about disposition of embryos remaining after fertility treatment. We aimed to identify predictors and correlates of decisional conflict among patients facing these decisions. METHODS: We analyzed results from a survey of 2210 patients from nine geographically diverse US fertility clinics. The main outcome measure was decisional conflict about embryo disposition, as measured by the decisional conflict scale (DCS). RESULTS: Of 1244 respondents who returned the survey, 1005 with cryopreserved embryos and DCS scores were included in the analysis. Of the respondents, 39% reported high decisional conflict (DCS ≥ 37.5). Thoughts about future childbearing were associated with high decisional conflict: respondents who were either uncertain about whether to have a baby in the future or sure they did not want to have a baby were at higher odds of high decisional conflict than participants who desired a baby [adjusted odds ratio (aOR) = 3.93, P < 0.001 and aOR = 1.69, P = 0.04, respectively]. Also associated with high decisional conflict were being likely to have embryos thawed and discarded (aOR = 2.08, P < 0.001), donated for research (aOR = 1.66, P = 0.01) or frozen 'forever' (aOR = 1.90, P = 0.01); being likely to choose compassionate transfer if it were available (aOR = 1.65, P = 0.03); attributing high, but not full, moral status to human embryos; not having enough information; and not being satisfied with the informed consent process. CONCLUSIONS: Decisional conflict about frozen embryo disposition differs according to reproductive preferences that may vary according to stage of treatment. Informed consent for embryo disposition should be revisited periodically, with serious discussions about disposition after childbearing is complete.

Preferences for surveillance strategies for women treated for high-grade precancerous cervical lesions.

OBJECTIVES: Data are lacking on how women view alternative approaches to surveillance for cervical cancer after treatment of high-grade cervical intraepithelial neoplasia. We measured and compared patient preferences (utilities) for scenarios with varying surveillance strategies and outcomes to inform guidelines and cost-effectiveness analyses of post-treatment surveillance options. METHODS: English- or Spanish-speaking women who had received an abnormal Pap test result within the past 2 years were recruited from general gynecology and colposcopy clinics and newspaper and online advertisements in 2007 and 2008. Participation consisted of one face-to-face interview, during which utilities for 11 different surveillance scenarios and their associated outcomes were elicited using the time tradeoff metric. A sociodemographic questionnaire also was administered. RESULTS: 65 women agreed to participate and successfully completed the preference elicitation exercises. Mean utilities ranged from 0.989 (undergoing only a Pap test, receiving normal results) to 0.666 (invasive cervical cancer treated with radical hysterectomy or radiation and chemotherapy). Undergoing both Pap and HPV tests and receiving normal/negative results had a lower mean utility (0.953) then undergoing only a Pap test and receiving normal results (0.989). Having both tests and receiving normal Pap but positive HPV results was assigned an even lower mean utility (0.909). 15.9% of the respondents gave higher utility scores to the Pap plus HPV testing scenario (with normal/negative results) than to the "Pap test alone" scenario (with normal results), while 17.5% gave the Pap test alone scenario a higher utility score. CONCLUSIONS: Preferences for outcomes ending with normal results but involving alternative surveillance processes differ substantially. The observed differences in utilities have important implications for clinical guidelines and cost-effectiveness analyses.

Decision analysis of prenatal testing for chromosomal disorders: what do the preferences of pregnant women tell us?

Current guidelines recommend offering invasive testing for chromosomal disorders only to women who are aged 35 or older, or who are at similarly elevated risk (as determined by maternal serum and/or ultrasonographic screening). We conducted a decision analysis, using preference scores obtained from pregnant women, to determine whether current guidelines maximize the health-related quality of life of these women. If only miscarriage and chromosomal abnormalities are considered, the expected value of testing exceeds that of not testing for women 30 years of age or older. However, if a comprehensive range of relevant testing outcomes is considered, testing offers a higher expected value than not testing, regardless of age. Furthermore, patient preferences for specific testing outcomes play a much more substantial role in determining the course of action with the highest expected value than does the probability of any of the possible testing outcomes. The current age- and risk-based guideline for prenatal diagnosis does not maximize expected value and fails to appropriately consider individual patient preferences. For counseling purposes, how an individual values the presence and timing of fetal chromosomal information should be carefully understood.

Objective and subjective assessments of socioeconomic status and their relationship to self-rated health in an ethnically diverse sample of pregnant women.

A new measure of subjective socioeconomic status (SES) was examined in relation to self-rated physical health in pregnant women. Except among African Americans, subjective SES was significantly related to education, household income, and occupation. Subjective SES was significantly related to self-rated health among all groups. In multiple regression analyses, subjective SES was a significant predictor of self-rated health after the effects of objective indicators were accounted for among White and Chinese American women; among African American women and Latinas, household income was the only significant predictor of self-rated health. After accounting for the effects of subjective SES on health, objective indicators made no additional contribution to explaining health among White and Chinese American women; household income continued to predict health after accounting for subjective SES among Latinas and African American women.

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.

Parents' preferences for outcomes associated with childhood vaccinations.

BACKGROUND: The number of shots in the childhood immunization schedule has been increasing and is likely to continue to increase in the coming years. Consideration of the psychologic costs of multiple injections, adverse events and vaccine-preventable disease is therefore growing in importance. METHODS: We assessed parent preferences, using both the time tradeoff (i.e. amount of parent time willing to trade) and willingness-to-pay (i.e. dollars willing to pay) metrics, for possible outcomes of vaccination among 206 parents of infants receiving care at Kaiser, Northern California Region. We also explored the relationship between preferences and subject characteristics. RESULTS: In general the amount of time subjects were willing to give up and the quantity of money they were willing to spend to avoid an outcome increased with the severity of the outcome. Preferences for our six main outcomes of interest all differed from one another (P < 0.0001, Tukey's multiple comparisons procedure). Rank correlation coefficients between time tradeoff and willingness-to-pay values for the six main outcomes ranged from 0.42 to 0.52 (all P < 0.004). Subject characteristics, including education, income, race/ethnicity and the child's birth order, did not explain the variation in parent preferences. CONCLUSIONS: In general subjects were willing to give up more money or time to avoid less desired outcomes. They were willing to give up only very small amounts of their own life expectancy or money to avoid minor, temporary outcomes (e.g. moderate fussiness, fever and pain) whereas they were willing to forego substantial lengths of their life or amounts of money to avoid a major, permanent outcome (i.e. permanent disability). Nonetheless much variation surfaced in the amount of time (or money) subjects were willing to trade to avoid outcomes. If this variation represents true differences in preferences, guideline developers must consider the role of individual parent preferences in decisions concerning vaccination.

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. We conducted a cross-sectional study of 72 women seeking genetic counselling at the University of California at San Francisco or Kaiser San Francisco. We measured preferences for outcomes (utilities) of prenatal diagnosis using the standard gamble metric. We also assessed demographics and attitudes via questionnaire. We observed no differences in mean utilities assigned to first- versus second-trimester pregnancy losses with similar long-term sequelae. Utilities for losses followed by future birth, however, were significantly higher than utilities for losses without future birth (range 0.91 to 0.93 versus 0.84 to 0.86, p<0.05 for all comparisons). In addition, we observed substantial variation in utilities across women. Long-term outcomes matter most to these women. In presenting prenatal diagnostic options to their patients, clinicians should include discussion of outcomes such as the likelihood of future birth in the event of a pregnancy loss. Furthermore, the substantial variation in utilities we observed suggests that future prenatal testing policies should account for the preferences of the individual woman.

Who should be offered prenatal diagnosis? The 35-year-old question.

Prenatal diagnosis of chromosomal disorders is generally offered to women who will be 35 years or older at the time of delivery or who have been determined via serum screening to be at risk similar to that of a woman older than 35 years. This age threshold was based on 4 major rationales that reflect considerations of resources and effectiveness. In this paper, we explore the current screening recommendations and consider new information that calls the 35-years threshold into question. We conclude that guidelines regarding use of prenatal diagnosis account for the preferences of the individual patient as well as for individual risk.

Decisions about prenatal testing for chromosomal disorders: perceptions of a diverse group of pregnant women.

We conducted a study to elucidate factors influencing women's decisions regarding prenatal genetic screening for and diagnosis of chromosomal disorders and to learn about their experiences with these tests and with the medical system. Using focus group interviews and questionnaire assessments, we obtained detailed impressions of a diverse group of 75 pregnant women. Participants varied with respect to race/ethnicity, religious background, and reproductive history, as well as in their decisions about use of prenatal screening and diagnostic testing. Substantial variation surfaced in attitudes toward testing. Factors influencing women's views included available resources, feelings about having a child with Down syndrome, moral beliefs, family and social influences, perceptions of one's own health, the difficulty of becoming pregnant, and willingness to put the fetus at elevated miscarriage risk. Such findings indicate that age-based policies regarding access to prenatal diagnoses that, among other reasons, are based on the balance of risks between bearing a child with a chromosomal abnormality versus procedure-related loss are incompatible with the range of concerns that women bring to this decision and the weight individual women may assign to the outcomes.

Urge incontinence: the patient's perspective.

Urge incontinence has a profound effect on the day-to-day lives of women. The purpose of this study was to identify specific aspects of functioning and well-being affected by urge incontinence or mixed incontinence with a primary urge component. We conducted six focus groups of 65 racially and age diverse, community-dwelling women with urge incontinence. Transcripts of the focus groups were quantitatively analyzed for word use frequency with QSR NUD*IST software. Demographics, symptomatology, and the impact of incontinence on daily activities and feelings were assessed by questionnaire. Participants in the focus groups were on average 62 years of age; 52% were nonwhite, and 26% had a high school or less education. In the three identified broad domains, 52% of domain-related words were associated with feelings, 40% with activities, and 8% with relationships. Frequently identified references were bathroom availability (24%), loss of control (14%), anxiety (11%), and sleep disturbance (10%). Women under the age of 70 compared with older women more commonly identified feeling unattractive and low self-esteem (12% versus 2%, p < 0.007) and adverse effects on dating and sexual activity (45% versus 0%, p < 0.02). The effect of incontinence on quality of life correlated with frequency, nocturia, and pad use (Kendall's tau beta 0.02-0.32, p < 0.05). Urge incontinence affects many quality of life issues and contributes to limitation of activities, loss of control, and negative self-perception. Focus groups of diverse women with urge incontinence symptomatology are useful in understanding these effects.

Proton pump inhibitors or histamine-2 receptor antagonists for the prevention of recurrences of erosive reflux esophagitis: a cost-effectiveness analysis.

OBJECTIVES: Erosive esophagitis is a recurring condition for which many patients require preventive therapy. If maintenance therapy must be provided, the most cost-effective treatment strategy should be established. We evaluated the costs and benefits associated with three treatment strategies: 1) maintenance therapy with a proton pump inhibitor (PPI) strategy, 2) maintenance therapy with a high-dose histamine-2 receptor antagonist (H2RA) strategy, and 3) maintenance therapy with a standard-dose H2RA. If patients experience a symptomatic recurrence on the H2RA strategies, they then receive PPI maintenance. METHODS: We used a cost-effectiveness model with a 1-yr time frame; data were obtained from randomized trials of lansoprazole and ranitidine, from case series, and expert opinion. RESULTS: In most situations, the high-dose H2RA strategy is the most costly, yet it is less effective than the PPI strategy. Among the remaining two options, the PPI strategy is more costly and more effective than the standard-dose H2RA strategy, requiring an additional $52-688 per recurrence prevented, depending on drug acquisition costs. The greater the degree to which esophagitis decreases quality of life, the more cost effective is the PPI strategy. For example, with a $50,000 per quality-adjusted life year cost-effectiveness threshold and a market-weighted average of drug costs, the PPI strategy appears cost effective for those patients who report that symptoms of esophagitis cause greater than a 9% decrement in quality of life. CONCLUSIONS: The high-dose H2RA strategy is not preferred in terms of either costs or benefits. The PPI strategy appears cost effective relative to the standard-dose H2RA strategy in the following situations: when patients are significantly bothered by esophagitis and in institutional settings where the difference in drug costs between PPIs and H2RAs is small.

Prevention of recurrences of erosive reflux esophagitis: a cost-effectiveness analysis of maintenance proton pump inhibition.

PURPOSE: To determine the cost-effectiveness of three management strategies for healed erosive reflux esophagitis: maintenance therapy with a proton pump inhibitor (PPI) from the outset; no maintenance therapy unless a patient's symptoms recur once over a year; and no maintenance therapy unless a patient's symptoms recur twice over a year. MATERIALS AND METHODS: Decision analysis using data from randomized trials of lansoprazole, case series, and expert opinion. RESULTS: For patients with grade 4 esophagitis, maintenance from the outset is the most efficient approach. For all other patients, providing maintenance PPI after a patient experiences two recurrences is the least costly but least effective approach. The other two approaches prevent more recurrences: waiting to initiate maintenance therapy until symptoms recur once requires an additional $73 for each recurrence prevented whereas maintenance PPI from the outset requires an additional $819 for each recurrence prevented. Maintenance therapy from the outset is cost effective if symptoms of esophagitis cause a 22% or greater decrement in quality of life (using $50,000 per quality-adjusted life year gained as a cost-effectiveness definition). However, withholding maintenance until the time of a first recurrence is cost effective if symptoms cause a 2% or greater decrement in quality of life. CONCLUSION: For grades 2 and 3 esophagitis, providing maintenance therapy after a patient experiences a further recurrence is a preferred option that appears cost-effective across a wide array of assumptions. Maintenance therapy from the outset, however, appears cost-effective only for those patients who report a significant decline in quality of life associated with esophagitis or for those patients with baseline grade 4 esophagitis.

Can preference scores for discrete states be used to derive preference scores for an entire path of events? An application to prenatal diagnosis.

The authors conducted a study exploring whether preferences for sequences of events can be approximated by preferences for component discrete states. Visual-analog-scale (VAS) and standard-gamble (SG) scores for a subset of the possible sequences of events (path states) and component temporary and chronic outcomes (discrete states) that can follow prenatal diagnostic decisions were elicited from 121 pregnant women facing a choice between chorionic villus sampling and amniocentesis. For individuals, preference scores for path states could not be predicted easily from discrete-state scores. Mean path-state VAS scores, however, were predicted reasonably accurately by multiple regression models (R2 = 0.85 and 0.82 for two different anchoring schemes), with most measured scores lying within the 95% confidence intervals of the derived scores. It is concluded that, for individual patient decision making, preferences for path states should be elicited. When mean preference values for a population are sought, however, it may be reasonable to derive regression weights from a subset of respondents and then to apply those weights to preferences for discrete states elicited from a larger group.

Concurrent hysterectomy at bilateral salpingo-oophorectomy: benefits, risks, and costs.

OBJECTIVE: To evaluate the medical and economic consequences of concurrent hysterectomy at the time of bilateral salpingo-oophorectomy (BSO) for benign ovarian disease in peri- and postmenopausal women. METHODS: Decision analysis was used to compare the health outcomes and economic costs of performing BSO with concurrent hysterectomy versus BSO alone in theoretic cohorts of 10,000 women undergoing surgery for benign adnexal disease. A model was constructed incorporating probabilities of possible outcomes from the National Hospital Discharge Database, the National Cancer Institute SEER Program, and the literature. Data on associated costs were obtained from the California State Discharge Database, Medicare, and the literature. RESULTS: Performing concurrent hysterectomy in a cohort of 10,000 45-year-old women would prevent approximately 71 future deaths from gynecologic disease at a cost of five immediate deaths from the surgery. However, short-term complications are much more frequent in women undergoing hysterectomy. On average, hysterectomy at age 45 adds approximately 0.071 years of life expectancy; at age 55, it adds 0.026 years. The procedure results in cost savings of approximately $1913 per patient at age 45 and $1112 at age 55. CONCLUSION: Concurrent hysterectomy causes short-term morbidity, but appears to increase average life expectancy slightly among perimenopausal women and is cost-saving. Medical outcomes and economic consequences only marginally favor the procedure. Patient preferences for the potential outcomes should play a key role in determining the appropriateness of its use.

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 ratio (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 (0.08-0.43), and African-Americans 0.19 (0.04-0.49). 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 1.81 (1.61-2.03), Latinas 3.00 (2.74-3.28), and African-Americans 1.86 (1.63-2.11). CONCLUSION: Racial-ethnic differences exist in prenatal diagnostic test use and associated outcomes in women aged 35 and older. Socioeconomic factors are partially responsible; patient education and preferences may play a role.