The role of contraceptive attributes in women's contraceptive decision making.

OBJECTIVE: Contraceptive methods have differing attributes. Women's preferences for these attributes may influence contraceptive decision making. Our objective was to identify women's contraceptive preferences among women initiating a new contraceptive method. STUDY DESIGN: We conducted a cross-sectional, self-administered survey of women's contraceptive preferences at the time of enrollment into the Contraceptive CHOICE Project. Participants were asked to rank the importance of 15 contraceptive attributes on a 3-point scale (1 = not at all important, 2 = somewhat important, and 3 = very important) and then to rank the 3 attributes that were the most important when choosing a contraceptive method. The survey also contained questions about prior contraceptive experience and barriers to contraceptive use. Information about demographic and reproductive characteristics was collected through the CHOICE Project baseline survey. RESULTS: There were 2590 women who completed the survey. Our sample was racially and socioeconomically diverse. Method attributes with the highest importance score (mean score [SD]) were effectiveness (2.97 [0.18]), safety (2.96 [0.22]), affordability (2.61 [0.61]), whether the method is long lasting (2.58 [0.61]), and whether the method is "forgettable" (2.54 [0.66]). The attributes most likely to be ranked by respondents among the top 3 attributes included effectiveness (84.2%), safety (67.8%), and side effects of the method (44.6%). CONCLUSION: Multiple contraceptive attributes influence decision making and no single attribute drives most women's decisions. Tailoring communication and helping women make complex tradeoffs between attributes can better support their contraceptive decisions and may assist them in making value-consistent choices. This process could improve continuation and satisfaction.

Evaluation of a computerized contraceptive decision aid: A randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness of a contraceptive decision aid in reducing decisional conflict among women seeking reversible contraception. STUDY DESIGN: We conducted a randomized trial of a computer-based decision aid compared to a control group for women presenting for reversible contraception at two clinics affiliated with an academic medical center. The primary outcome was change in decisional conflict, measured before and after the healthcare visit using the validated Decisional Conflict Scale. We hypothesized the decision aid would reduce the decisional conflict score by 10 points on a 100-point scale (0 = no conflict, 100 = high conflict) compared to the control group. Secondary outcomes included contraceptive method chosen and satisfaction with the healthcare visit. RESULTS: We enrolled and randomized 253 women, and 241 had complete data for our primary outcome. Overall, pre-visit decisional conflict scores were low, reflecting low levels of decisional conflict in our sample; median score 15 (range 0-80) in the decision aid and 10 (0-85) in the control group (p = 0.45). Both groups had a similar reduction in median decisional conflict after the healthcare visit: -10 (-80 to 25) and -10 (-60 to 5) in the decision aid and control groups respectively (p = 0.99). Choice of contraception (p = 0.23) and satisfaction with healthcare provider (p = 0.79) also did not differ by study group. CONCLUSIONS: Decisional conflict around contraception was low in both groups at baseline. Use of a computerized contraceptive decision aid did not reduce decisional conflict, alter method choice, or impact satisfaction compared to the control group among women choosing reversible contraception. IMPLICATIONS: Use of a computerized contraceptive decision aid did not reduce decisional conflict or alter method choice compared to the control group among women choosing reversible contraception. Future studies could focus on testing the decision aid in different clinical settings, especially where barriers to providing comprehensive contraceptive counseling exist.

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.

The impact of anchor point on utilities for 5 common ophthalmic diseases.

PURPOSE: To elicit utilities on a perfect health and perfect vision scale for 5 common eye diseases. DESIGN: Cross-sectional observational preference study. PARTICIPANTS: We included 434 patients: 58 with diabetic retinopathy, 99 with glaucoma, 44 with age-related macular degeneration (AMD), 124 with cataract; 109 with refractive error. TESTING: Standard gamble utilities were estimated using a computer-based preference assessment interview platform. MAIN OUTCOME MEASURES: Standard gamble utilities, a quality-of-life measure that examines the willingness to accept a risk of death or unilateral blindness in return for perfect health or perfect vision. RESULTS: Using the standard policy scale, where health equivalent to death is 0 and perfect health is 1, participants with asymptomatic diabetic retinopathy had a utility of 0.93. By comparison, symptomatic diabetics had a further utility loss of 0.14. Asymptomatic glaucoma participants had a utility of 0.92 with a decrease of 0.03 for early field loss and a further decrease of 0.03 with central field loss. Participants with AMD who had > or =20/100 better-eye visual acuity reported a utility of 0.89, whereas those with more severe AMD reported 0.76. However, neither clinical cataract opacity score nor refractive error correlated with utility. Adjustment for age and comorbidity did not alter these relationships. For the same participants, utilities measured with different anchor points-monocular blindness as 0 and perfect vision as 1-were lower, especially among participants with increased disease severity. The difference between utility assessed on this perfect vision-blindness scale and the perfect health-death scale ranged from 0.04 for those with severe refractive error to 0.19 for symptomatic diabetics and 0.37 for those with severe AMD. CONCLUSIONS: This paper elicits utilities with different anchor points from a previously unreported sample of 434 patients. Lower utility scores normally imply greater benefit with successful treatment or prevention of disease, but switching from the conventional policy scale to the perfect vision scale also consistently results in lower scores. Because most previous ophthalmic studies have used perfect vision as the upper anchor, the resulting utilities may not have been accurate.

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.

Quality-of-life-adjusted survival analysis of high-dose adjuvant interferon alpha-2b for high-risk melanoma patients using intergroup clinical trial data.

PURPOSE: High-dose adjuvant interferon alpha-2b (IFN alpha 2b) for high-risk melanoma is a 1-year regimen that improves relapse-free and overall survival but has significant toxicity. A quality-of-life--adjusted survival (QAS) analysis analysis of two cooperative group phase III trials, E1684 and E1690/S9111/C9190, was performed, incorporating patient values (utilities) for the toxicity of IFN alpha 2b treatment and melanoma recurrence. PATIENTS AND METHODS: Quality-Adjusted Time Without Symptoms or Toxicity methodology was used with melanoma patient utilities and trial data to estimate the effect of IFN alpha 2b on QAS. The increase or decrease in QAS that patients could expect from treatment was estimated based on their utilities. Eleven utility predictor questions were tested to identify patients with utilities that result in decreased QAS. RESULTS: Using E1684 data, IFN alpha 2b would result in an increase in QAS for all sets of patient utilities. This benefit was significant (P <.05) for 16% of patients. Using E1690/S9111/C9190 data, 77% of patients would experience a benefit in QAS from IFN alpha 2b and 23% would experience a decrease in QAS; neither of these effects was statistically significant. Using utility predictors and the E1690/S9111/C9190 analysis, a decision rule was formulated that helps identify patients in whom IFN alpha 2b may detract from QAS. CONCLUSION: Most patients experienced improvement in QAS in both trials, but this benefit was statistically significant in only 16% of patients in E1684. Change in QAS depends more on the utility for IFN alpha 2b toxicity than on the utility for melanoma recurrence. Cancer patients probably have higher utilities for IFN alpha 2b toxicity than members of the general population and will tend to favor IFN alpha 2b treatment as a result.

Cost utility of prenatal diagnosis and the risk-based threshold.

BACKGROUND: Prenatal testing guidelines recommend offering amniocentesis or chorionic villus sampling to women aged 35 years or older, or who have been found by screening to be at a similarly high risk of giving birth to an infant with Down's syndrome or another chromosomal abnormality. This threshold was chosen, in part, because 35 was the approximate age at which amniocentesis was cost beneficial when testing guidelines were developed in the USA in the 1970s. We aimed to assess the economic validity of thresholds based on age or risk for offering invasive prenatal diagnosis. METHODS: We did a cost-utility analysis of chorionic villus sampling and amniocentesis versus no invasive testing using data from randomised trials, case registries, and a utility assessment of 534 diverse pregnant women aged 16-47 years. FINDINGS: In the USA, compared with no diagnostic testing, amniocentesis costs less than US15000 dollars per quality-adjusted life year gained for women of all ages and risk levels. The results do not depend on maternal age or risk of Down's syndrome-affected birth. The cost-utility ratio for any individual woman depends on her preferences for reassurance about the chromosomal status of her fetus, and, to a lesser extent, for miscarriage. INTERPRETATION: Prenatal diagnostic testing can be cost effective at any age or risk level. Current guidelines should be changed to offer testing to all pregnant women, not just those whose risk of carrying an affected fetus exceeds a specified threshold.

Choice architecture is a better strategy than engaging patients to spur behavior change.

Patient engagement is increasingly seen as a potentially effective way to improve quality and lower costs in health care. We review and synthesize current research, including our work with patients' use of prescription medications, to explore whether and in what settings patient engagement may not be realistic or even necessary. Our commentary argues that a more tempered assessment of patient engagement is warranted for the following three reasons: Evidence of the effectiveness of interventions to increase patient engagement on health outcomes is not definitive; ongoing and sustained patient engagement conflicts with cognitive limitations that are the hallmark of basic human nature; and, in some settings, choice architecture and associated strategies provide a clear alternative for improving behavior and decisions without relying on ongoing engagement. We recommend the use of such strategies when possible, including the marriage of patient engagement strategies with choice architecture solutions.

Lack of comprehension of common prostate cancer terms in an underserved population.

PURPOSE: To assess the comprehension of common medical terms used in prostate cancer in patient education materials to obtain informed consent, and to measure outcomes after prostate cancer treatment. We address this issue among underserved, African-American men because of the increased cancer incidence and mortality observed in this population. PATIENTS AND METHODS: We reviewed patient education materials and prostate-specific quality-of-life instruments to identify technical terms describing sexual, urinary, and bowel function. Understanding of these terms was assessed in face-to-face interviews of 105, mostly African-American men, age > or = 40, from two low-income clinics. Comprehension was evaluated using semiqualitative methods coded by two independent investigators. Demographics were collected and literacy was measured. RESULTS: Fewer than 50% of patients understood the terms "erection" or "impotent." Only 5% of patients understood the term "incontinence" and 25% understood the term "bowel habits." More patients recognized word roots than related terms or compound words (eg, "rectum" v "rectal urgency," "intercourse" v "vaginal intercourse"). Comprehension of terms from all domains was statistically significantly correlated with reading level (P < .001). Median literacy level was fourth to sixth grade. Prostate cancer knowledge was poor. Many patients had difficulty locating key anatomic structures. CONCLUSION: Limited comprehension of prostate cancer terms and low literacy create barriers to obtaining informed consent for treatment and to measuring prostate cancer outcomes accurately in our study population. In addition, the level of prostate cancer knowledge was poor. These results highlight the need for prostate cancer education efforts and outcomes measurements that consider literacy and use nonmedical language.

The effect of diagnosis with HIV infection on health-related quality of Life.

We sought to understand how diagnosis with HIV affects health-related quality of life. We assessed health-related quality of life using utility-based measures in a Department of Veterans Affairs (VA) clinic and a University-based clinic. Respondents assessed health-related quality of life regarding their current health, and retrospectively assessed their health 1 month prior to and 2 months after diagnosis with HIV infection. Sixty-six patients completed the study. The overall mean utilities for health 1 month before and 2 months after diagnosis were 0.87 (standard error 0.037), and 0.80 (0.043) (p<0.005 by rank sign test), but the effect of diagnosis differed between the two clinics, with a substantial decrease in the university clinic and a small non-significant decrease in the VA clinic. The overall mean utility for current health was 0.85 (0.034), assessed on average 7.5 years after diagnosis. When asked directly whether diagnosis of HIV decreased health-related quality of life, 47% agreed, but 35% stated that HIV diagnosis positively affected health-related quality of life. Diagnosis with HIV decreased health-related quality of life at 2 months on average, but this effect diminished over time, and differed among patient populations. Years after diagnosis, although half of the patients believed that diagnosis reduced health-related quality of life, one-third reported improved health-related quality of life.

Intermediate term biochemical progression rates after radical prostatectomy and radiotherapy in patients with screen detected prostate cancer.

PURPOSE: We compared biochemical progression rates measured by increasing prostate specific antigen (PSA) levels using a standard definition of biochemical recurrence among patients with screen detected prostate cancer treated with radical prostatectomy (RP) or radiotherapy (RT). MATERIALS AND METHODS: A total of 1,939 patients diagnosed with clinically localized prostate cancer in a community based screening study from 1989 to 1998, followed through 2001, were treated with RP or RT and agreed to enroll in a followup study. This prospective cohort study (median followup 62 months, range 0.2 to 141) used adjusted Cox proportional hazards models to examine time to progression. Selection bias was addressed with propensity scores. Biochemical evidence of cancer progression was defined as PSA greater than 0.2 ng/ml in patients who underwent RP and 3 consecutive PSA increases as recommended by the American Society for Therapeutic Radiology and Oncology criteria for radiotherapy. RESULTS: Of the patients 17% had evidence of cancer progression. The percentage with progression-free survival at 5 and 9 years for RP was 84% and 76%, respectively, and for RT 80% and 70%, respectively. Cox proportional hazards models produced a hazard ratio of 1.63 (95% CI, 1.12, 2.38) for RT compared with RP, adjusting for clinical stage, Gleason grade, preoperative PSA, biopsy age, treatment year and propensity for treatment type. CONCLUSIONS: With intermediate term followup, patients treated with RT were more likely to have cancer progression than with RP adjusting for demographics, clinical factors, selection bias and treatment year.

Evidence for the rapid construction of preference during utility assessments.

Subjects often construct preferences during the elicitation process. This could have implications for the processes automated utility assessments use to find indifference points. In particular, if subjects frequently shift preferences during elicitation processes, then reversible and irreversible procedures might reach different results. We analyzed series of choices made by two groups of subjects during computerized standard gambles for monocular and binocular blindness, comparing the utility assessed in a reversible search process with the utility that would have resulted from an irreversible search process. A minority of subjects reversed their choices during the assessments. The mean differences between these utilities and the predicted results of an irreversible search were quite small. Consequently, automated standard gamble surveys can terminate quickly, using irreversible searches, with little likelihood of skewing population results. Clinical decision support systems can use simple mechanisms to accommodate infrequent preference reversals, such as restarting a search.

Patient preferences for outcomes associated with surgical management of prostate cancer.

PURPOSE: We used utility assessment to evaluate patient preferences for current urinary and sexual function after radical prostatectomy. MATERIALS AND METHODS: We measured preferences in 209 community volunteers enrolled in a prostate cancer screening study who underwent radical prostatectomy between 1994 and 1998. We compared preferences in 3 outcome groups, namely men bothered by current urinary and sexual functioning, only bothered by current sexual functioning and not bothered by current sexual or urinary functioning. Preferences were assessed via a computer based interview using time trade-off and standard gamble methods. Current functioning was assessed via a standardized questionnaire. RESULTS: Median time trade-off and standard gamble utilities were high at 0.9 across outcome groups, indicating that men were not willing to give up many remaining life years (10% of remaining life expectancy) with current functioning to achieve ideal functioning. However, mean time trade-off and standard gamble scores significantly decreased as the burden increased in men bothered by current sexual and urinary function (0.77 and 0.82), bothered by current sexual function only (0.87 and 0.89) and not bothered by sexual or urinary function (0.92 and 0.96, respectively). CONCLUSIONS: Health related quality of life was generally good in this observational study of patients treated for prostate cancer with radical prostatectomy. In addition, those bothered by urinary and/or sexual function would not be willing to trade much of the remaining life span to achieve perfect functioning. However, the perception of side effects was bothersome enough in some men to warrant appropriate patient counseling regarding the potential risks and benefits.

Automated current health time-trade-off assessments in women's health.

OBJECTIVE: To motivate the role for preference assessment in women's health and to report pilot data addressing the performance of automated time-trade-off (TTO) valuations of current health, which were developed to estimate quality-adjusted life years (QALYs) in the women's health setting. METHODS: Values for current health relative to perfect health and death were assessed using an annual time trade-off (1-year horizon and sleep as the trading metaphor), a lifetime time trade-off, and a visual analog scale (VAS). All instruments were administered twice within a 12- to 14-day window among a convenience sample of 27 women. RESULTS: Valuation of health was similar for both time trade-offs (mean of 0.95 for both), but was significantly lower for the VAS (mean of 0.84, Wilcoxon signed-rank p-value < 0.001). Reliability using the intraclass correlation coefficient was 0.67 +/- 0.09 and 0.75 +/- 0.07 for the annual and lifetime time trade-offs, respectively, and 0.89 +/- 0.03 for the VAS. Construct validity was supported by consistent trends in time-trade-off utilities across tertiles of the Short Form 36 (SF-36) general health subscale (trend test p-value < 0.001). CONCLUSION: Automated time trade-offs for current health provide a promising approach for use in women's health studies where impact on QALYs must be measured. Natural areas of application include the economic evaluation of preventive interventions in postmenopausal women.

How do women of diverse backgrounds value prenatal testing outcomes?

OBJECTIVES: To describe women's preferences for prenatal testing outcomes and to explore their association with sociodemographic characteristics and attitudes. METHODS: We conducted a cross-sectional study of 584 racially/ethnically and socioeconomically diverse pregnant women aged 16 to 47 years recruited from 23 San Francisco Bay Area practices. We assessed preferences for 12 potential prenatal testing outcomes using the time trade-off metric for all outcomes and the standard gamble metric for two outcomes. Preferences were calculated on a scale of 0 (death) to 1 (perfect health). Participants also completed a sociodemographic and attitude survey. RESULTS: Highest preference scores were assigned to outcomes resulting in the birth of a chromosomally normal infant (mean = 0.91-0.93; median = 0.99-1.00). Lower scores were obtained for outcomes involving pregnancy loss (mean = 0.69-0.87; median = 0.76-0.92), which were correlated with attitudes regarding miscarriage, pregnancy termination, and Down syndrome. The lowest scores were assigned to Down syndrome-affected births (mean = 0.67-0.69; median = 0.73-0.75), which also were correlated with attitudes toward Down syndrome. We did not find a statistically significant relationship between participants' preference scores and age. CONCLUSION: Preferences for prenatal testing outcomes vary according to the pregnant women's underlying attitudes about pregnancy loss and Down syndrome, and not according to her age. Current age/risk-based guidelines should account for individual variation in patient preferences.

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 subject's 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, R(2) 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.