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1.  The effect of weight loss on changes in health-related quality of life among overweight and obese women with urinary incontinence 
OBJECTIVE
To estimate the effect of change in weight and change in urinary incontinence (UI) frequency on changes in preference-based measures of health-related quality of life (HRQL) among overweight and obese women with UI participating in a weight loss trial.
METHODS
We conducted a longitudinal cohort analysis of 338 overweight and obese women with UI enrolled in a randomized clinical trial comparing a behavioral weight loss intervention to an educational control condition. At baseline, 6, and 18 months, health utilities were estimated using the Health Utilities Index Mark 3 (HUI3), a transformation of the SF-36 to the preference-based SF-6D, and the estimated Quality of Well-Being (eQWB) score (a summary calculated from the SF-36 physical functioning, mental health, bodily pain, general health perceptions, and role limitations-physical subscale scores). Potential predictors of changes in these outcomes were examined using generalized estimating equations.
RESULTS
In adjusted multivariable models, weight loss was associated with improvement in HUI3, SF-6D, and eQWB at 6 and 18 months (p<.05). Increases in physical activity also were independently associated with improvement in HUI3 (p=.01) and SF-6D (p=.006) scores at 18 months. In contrast, reduction in UI frequency did not predict improvements in HRQL at 6 or 18 months.
CONCLUSION
Weight loss and increased physical activity, but not reduction in UI frequency, were strongly associated with improvements in health utilities measured by the HUI3, SF-6D, and eQWB. These findings provide important information that can be used to inform cost-utility analyses of weight loss interventions.
doi:10.1007/s11136-011-0086-2
PMCID: PMC3375350  PMID: 22161726
quality of life; weight loss; urinary incontinence; HUI; eQWB; SF-6D
2.  Strategies to Identify the Lynch Syndrome Among Patients With Colorectal Cancer 
Annals of internal medicine  2011;155(2):69-79.
Background
Testing has been advocated for all persons with newly diagnosed colorectal cancer to identify families with the Lynch syndrome, an autosomal dominant cancer-predisposition syndrome that is a paradigm for personalized medicine.
Objective
To estimate the effectiveness and cost-effectiveness of strategies to identify the Lynch syndrome, with attention to sex, age at screening, and differential effects for probands and relatives.
Design
Markov model that incorporated risk for colorectal, endometrial, and ovarian cancers.
Data Sources
Published literature.
Target Population
All persons with newly diagnosed colorectal cancer and their relatives.
Time Horizon
Lifetime.
Perspective
Third-party payer.
Intervention
Strategies based on clinical criteria, prediction algorithms, tumor testing, or up-front germline mutation testing, followed by tailored screening and risk-reducing surgery.
Outcome Measures
Life-years, cancer cases and deaths, costs, and incremental cost-effectiveness ratios.
Results of Base-Case Analysis
The benefit of all strategies accrued primarily to relatives with a mutation associated with the Lynch syndrome, particularly women, whose life expectancy could increase by approximately 4 years with hysterectomy and salpingo-oophorectomy and adherence to colorectal cancer screening recommendations. At current rates of germline testing, screening, and prophylactic surgery, the strategies reduced deaths from colorectal cancer by 7% to 42% and deaths from endometrial and ovarian cancer by 1% to 6%. Among tumor-testing strategies, immunohistochemistry followed by BRAF mutation testing was preferred, with an incremental cost-effectiveness ratio of $36 200 per life-year gained.
Results of Sensitivity Analysis
The number of relatives tested per proband was a critical determinant of both effectiveness and cost-effectiveness, with testing of 3 to 4 relatives required for most strategies to meet a threshold of $50 000 per life-year gained. Immunohistochemistry followed by BRAF mutation testing was preferred in 59% of iterations in probabilistic sensitivity analysis at a threshold of $100 000 per life-year gained. Screening for the Lynch syndrome with immunohistochemistry followed by BRAF mutation testing only up to age 70 years cost $44 000 per incremental life-year gained compared with screening only up to age 60 years, and screening without an upper age limit cost $88 700 per incremental life-year gained compared with screening only up to age 70 years.
Limitation
Other types of cancer, uncertain family pedigrees, and genetic variants of unknown significance were not considered.
Conclusion
Widespread colorectal tumor testing to identify families with the Lynch syndrome could yield substantial benefits at acceptable costs, particularly for women with a mutation associated with the Lynch syndrome who begin regular screening and have risk-reducing surgery. The cost-effectiveness of such testing depends on the participation rate among relatives at risk for the Lynch syndrome.
Primary Funding Source
National Institutes of Health.
doi:10.7326/0003-4819-155-2-201107190-00002
PMCID: PMC3793257  PMID: 21768580
3.  Decrease in Urinary Incontinence Management Costs in Women Enrolled in a Clinical Trial of Weight Loss to Treat Urinary Incontinence 
Obstetrics and Gynecology  2012;120(2 Pt 1):277-283.
Objective
To estimate the effect of a decrease in urinary incontinence frequency on urinary incontinence management costs among women enrolled in a clinical trial of a weight loss intervention and to identify factors that predict change in cost.
Methods
This is a secondary cohort analysis of 338 obese and overweight women with ≥ 10 weekly episodes of urinary incontinence enrolled in an 18-month randomized clinical trial of a weight loss intervention compared to a structured education program to treat urinary incontinence. Quantities of resources used for incontinence management, including pads, additional laundry, and dry cleaning were reported by participants. Direct costs for urinary incontinence management (“cost”) were calculated by multiplying resources used by national resource costs (in 2006 U.S. dollars). Randomized groups were combined to examine the effects of change in incontinence frequency on cost. Possible predictors of change in cost were examined using generalized estimating equations controlling for factors associated with change in cost in univariable analyses.
Results
Mean (±SD) age was 53±10 years and baseline weight was 97+17 kg. Mean weekly urinary incontinence frequency was 24+18 at baseline and decreased by 37% at 6 months and 60% at 18 months follow-up (both P<0.001). At baseline, adjusted mean cost was $7.76±$14 per week, with costs increasing significantly with greater incontinence frequency. Mean cost decreased by 54% at 6 months and 81% at 18 months (both P<0.001). In multivariable analyses, cost independently decreased by 23% for each decrease of seven urinary incontinence episodes per week and 21% for each 5 kg of weight lost (P<0.001 for both).
Conclusion
In obese and overweight women enrolled in a clinical trial of weight loss for urinary incontinence, incontinence management cost decreased by 81% at 18 months ($327 per woman per year) and was strongly and independently associated with decreasing incontinence frequency.
doi:10.1097/AOG.0b013e31825dd268
PMCID: PMC3404427  PMID: 22825085
4.  Comparison and correlates of three preference-based health-related quality-of-life measures among overweight and obese women with urinary incontinence 
Purpose
To compare three preference-based health-related quality-of-life (HRQL) measures and examine independent correlates of HRQL among overweight and obese women with urinary incontinence (UI) enrolled in a weight loss intervention trial.
Methods
Participants completed baseline questionnaires, which included the Health Utilities Index 3 (HUI3) and Medical Outcomes Study Short Form-36 (SF-36). The SF-36 was used to derive SF-6D and estimated Quality of Well-Being (eQWB) scores. Height, weight, medical history, incontinence measures, and level of physical activity also were assessed. The intraclass correlation coefficient (ICC) was computed, and differences in mean scores across HRQL measures were examined. Potential correlates of HUI3, SF-6D, and eQWB scores were evaluated using multivariable generalized linear models.
Results
Mean ± SD scores for the HUI3, SF-6D, and eQWB were 0.81 ± 0.18, 0.75 ± 0.10, and 0.71 ± 0.06, respectively. Significant differences were observed across measures (P < 0.0001), and the overall ICC was 0.36. In multivariable analyses, BMI was negatively associated with HUI3 (P = 0.003) and eQWB (P < 0.001), and UI episode frequency was negatively associated with eQWB (P = 0.015) and SF-6D (P < 0.001).
Conclusions
Significant differences in mean utilities across the HUI3, SF-6D, and eQWB indicate that these measures do not assess identical dimensions of HRQL. Both BMI and UI episode frequency were related to HRQL in this cohort; however, the magnitude of the relationship depended on the preference-based measure used. These findings highlight the need to consider the method used to generate HRQL values for calculating quality-adjusted life-years in cost-utility analyses, since choice of method may have a substantial impact on the outcome of the analysis.
doi:10.1007/s11136-011-9896-5
PMCID: PMC3174313  PMID: 21461953
Quality of life; Obesity; Urinary incontinence; HUI; eQWB; SF-6D
5.  Influence of Patient Preferences on the Cost-Effectiveness of Screening for Lynch Syndrome 
Journal of Oncology Practice  2012;8(3 Suppl):e24s-e30s.
This cost-utility analysis reports on the effect of quality of life on the value of screening all new patients with colorectal cancer for Lynch syndrome.
Purpose:
Patients and relatives have varying preferences for genetic testing and interventions related to hereditary cancer syndromes. We examined how the impact of these services on quality of life (QoL) affects the cost-effectiveness of screening for Lynch syndrome among probands newly diagnosed with colorectal cancer and their relatives.
Methods:
We constructed a state-transition model comparing screening strategies (clinical criteria, prediction algorithms, tumor testing, and upfront germline testing) with no screening to identify Lynch syndrome. The model incorporated individuals' health state utilities after screening, germline testing, and risk-reducing surgeries, with utilities persisting for 12 months in the base case. Outcomes consisted of quality-adjusted life-years (QALYs), costs, and cost per QALY gained. Sensitivity analyses assessed how the duration and magnitude of changes in QoL influenced results.
Results:
Multiple screening strategies yielded gains in QALYs at acceptable costs compared with no screening. The preferred strategy—immunohistochemistry of tumors followed by BRAF mutation testing (IHC/BRAF)—cost $59,700 per QALY gained in the base case. The duration and magnitude of decreases in QoL after decisions related to germline testing and surgeries were key determinants of the cost-effectiveness of screening. IHC/BRAF cost > $100,000 per QALY gained when decrements to QoL persisted for 21 months.
Conclusion:
Screening for Lynch syndrome in the population is likely to yield long-term gains in life expectancy that outweigh any short-term decreases in QoL, at acceptable costs. Counseling for individuals should aim to mitigate potential negative impact of genetic testing and risk-reducing interventions on QoL.
doi:10.1200/JOP.2011.000535
PMCID: PMC3348599  PMID: 22942831
6.  Long-Term Outcomes of the Total or Supracervical Hysterectomy (TOSH) Trial 
BACKGROUND
Participants in the multi-center, randomized Total or Supracervical Hysterectomy (TOSH) trial showed within-group improvement in pelvic floor symptoms 2 years post-surgery and no differences between supracervical (SCH) versus total hysterectomy (TAH). This study describes longer term outcomes from the largest recruiting site.
STUDY DESIGN
Questionnaires addressing pelvic symptoms, sexual function, and health-related quality of life were administered. Linear models and McNemar’s test were utilized.
RESULTS
Thirty-seven participants (69%) responded (19 TAH, 18 SCH); mean follow up was 9.1±0.7 years. No between-group differences emerged in urinary incontinence, voiding dysfunction, pelvic prolapse symptoms and overall health related quality of life (HRQOL). Within-group analysis showed significant improvement in the ability to have and enjoy sex (P = 0.002) and in the SF-36 physical component summary score (P = 0.03) among women randomized to TAH.
CONCLUSION
9 years after surgery, TOSH participants continue to experience improvement and show no major between-group differences in lower urinary tract or pelvic floor symptoms conferring no major benefit of SCH over TAH.
doi:10.1097/SPV.0b013e3181cec343
PMCID: PMC3252027  PMID: 22229107
7.  Prevalence and incidence of urinary incontinence in a diverse population of women with noncancerous gynecologic conditions 
Objective
To determine the prevalence and incidence of urinary incontinence (UI) in a diverse cohort of women presenting with noncancerous gynecologic conditions and to assess factors associated with UI prevalence and incidence.
Methods
We conducted a secondary analysis of data from SOPHIA (Study of Pelvic Problems, Hysterectomy and Intervention Alternatives), a longitudinal study of women with noncancerous gynecologic conditions (bleeding, pelvic pain, and symptomatic fibroids). UI was defined as incontinence in the last 4 weeks as reported on interviewer-administered annual questionnaires. We also evaluated the type of UI: stress (SUI), urge (UUI) or mixed incontinence (MUI).
Results
The study population of 907 women was 40.8% White, 28.0% African American, 17.3% Latina and 8.1% Asian. The mean age was 44.1 ± 5.4 years and 48.5% had an annual household income of ≤$50,000. The overall prevalence of any UI was 51.1%. At baseline, SUI was the most common at 39.4% followed by UUI at 23.7% and MUI at 18.9%. The average annual incidence for any UI was 4.2%. 13% of the women who underwent hysterectomy developed incident UI after their surgery. In multivariable logistic regression analysis, prevalent UI was associated with the following: age in decades (OR 1.6, 95% CI 1.2, 2.2), Latina race/ethnicity compared to white (OR 2.1, 95% CI 1.3, 3.3), and parity (OR 1.7, 95% CI 1.2, 2.4). None of the factors evaluated were associated with incidence of UI.
Conclusion
Urinary incontinence is very common in women seeking care for noncancerous gynecologic conditions, particularly among older, parous Latinas.
doi:10.1097/SPV.0b013e3181ee6864
PMCID: PMC3060785  PMID: 21423570
Urinary incontinence; epidemiology; prevalence; incidence
8.  Preferences for Surveillance Strategies for Women Treated for High-Grade Precancerous Cervical Lesions 
Gynecologic oncology  2010;118(2):108-115.
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 two 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 .989 (undergoing only a Pap test, receiving normal results) to .666 (invasive cervical cancer treated with radical hysterectomy or radiation and chemotherapy). Undergoing both a Pap and HPV test and receiving normal/negative results had a lower mean utility (.953) then undergoing only a Pap test and receiving normal results (.989). Having both tests and receiving normal Pap but positive HPV results was assigned an even lower mean utility (.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.
doi:10.1016/j.ygyno.2010.05.002
PMCID: PMC2926130  PMID: 20553960
9.  Race/Ethnicity and Pregnancy Decision Making: The Role of Fatalism and Subjective Social Standing 
Journal of Women's Health  2010;19(6):1195-1200.
Abstract
Objective
Rates of unintended pregnancy in the United States differ by race and ethnicity. We examined whether these differences might be explained by maternal fatalism and subjective social standing.
Methods
We used data from 1070 pregnant women of sociodemographically diverse backgrounds enrolled in prenatal care in the San Francisco Bay area. Logistic regression was used to explore the relationship between attitude variables and a measure of pregnancy decision making (“not trying to get pregnant”).
Results
African American women were more likely than others to report not trying to get pregnant with the current pregnancy (adjusted odds ratio [AOR] 2.04, 95% confidence interval [95% CI] 1.22-3.43, p = 0.007). Higher subjective social standing was associated with a lower likelihood of not trying among white and U.S.-born women only (AOR 0.67, p = 0.001 and AOR 0.75, p < 0.001, respectively. Fatalism was associated with not trying in bivariate but not multivariable analyses.
Conclusions
In this population, the likelihood of reporting not trying to get pregnant was higher among racial/ethnic minorities regardless of subjective social standing. Programs aimed at reduction in unintended pregnancy rates need to be targeted to a broader population of women.
doi:10.1089/jwh.2009.1623
PMCID: PMC2924781  PMID: 20469962
10.  Sexual Function and Aging in Racially and Ethnically Diverse Women 
OBJECTIVES
To examine factors influencing sexual activity and functioning in racially- and ethnically-diverse, middle-aged and older women.
DESIGN
Cross-sectional cohort study
SETTING
Integrated health care delivery system
PARTICIPANTS
1,977 women aged 45 to 80 years
MEASUREMENTS
Self-administered questionnaires assessed sexual desire, activity, satisfaction, and problems.
RESULTS
Of the 1,977 participants (including 876 White, 388 African American, 347 Latina, and 351 Asian women), 43% reported at least moderate sexual desire, and 60% were sexually active in the previous 3 months. Half of sexually active participants (n=969) described their overall sexual satisfaction as moderate to high. Among sexually inactive women, the most common reason for inactivity was lack of interest in sex (39%), followed by lack of a partner (36%), physical problem of partner (23%), and lack of interest by partner (11%); only 9% were inactive from personal physical problems. In multivariable analysis, African-American women were more likely than white women to report at least moderate desire (OR=1.65, 95%CI=1.25-2.17) but less likely to report weekly sexual activity (OR=0.68, 95%CI=0.48-0.96); sexually active Latina women were more likely than white women to report at least moderate sexual satisfaction (OR=1.75, 95%CI=1.20-2.55).
CONCLUSION
A substantial proportion of community-dwelling women remain interested and engaged in sexual activity into older age. Lack of a partner capable of or interested in sex may contribute more to sexual inactivity than personal health problems in this population. Racial/ethnic differences in self-reported sexual desire, activity, and satisfaction may influence discussions about sexual difficulties in middle-aged and older women.
doi:10.1111/j.1532-5415.2009.02353.x
PMCID: PMC2749599  PMID: 19558473
female sexual function; aging; race/ethnicity; sexual activity
11.  Challenges To The Translation Of Genomic Information Into Clinical Practice And Health Policy: Utilization, Preferences, And Economic Value 
It is important to understand how knowledge of genomics can be translated from basic research into clinical practice and health policies. The objective of this paper is to review existing evidence on three key factors in the adoption of personalized medicine – utilization, preferences, and economic value - using two cancer examples: HER2/neu testing and trastuzumab (Herceptin®) and genetic testing for Lynch syndrome. Our findings suggest where further research is needed to build an evidence base addressing utilization of, preferences for, and the potential costs and benefits of personalized medicine. Major challenges include a lack of linked data, the need for relevant research frameworks and methodologies, and the clinical complexities of genomic-based diagnostics and treatment.
PMCID: PMC2910510  PMID: 18535933
Personalized medicine; health policy; health services research; economics; utilization; preferences
12.  Finding Autonomy in Birth* 
Bioethics  2009;23(1):1-8.
Over the last several years, as cesarean deliveries have grown increasingly common, there has been a great deal of public and professional interest in the phenomenon of women ‘choosing’ to deliver by cesarean section in the absence of any specific medical indication. The issue has sparked intense conversation, as it raises questions about the nature of autonomy in birth. Whereas mainstream bioethical discourse is used to associating autonomy with having a large array of choices, this conception of autonomy does not seem adequate to capture concerns and intuitions that have a strong grip outside of this discourse. An empirical and conceptual exploration of how delivery decisions ought to be negotiated must be guided by a rich understanding of women’s agency and its placement within a complicated set of cultural meanings and pressures surrounding birth. It is too early to be ‘for’ or ‘against’ women’s access to cesarean delivery in the absence of traditional medical indications - and indeed, a simple pro- or con- position is never going to do justice to the subtlety of the issue. The right question is not whether women ought to be allowed to choose their delivery approach, but rather, taking the value of women’s autonomy in decision-making around birth as a given, what sorts of guidelines, practices, and social conditions will best promote and protect women’s full inclusion in a safe and positive birth process.
doi:10.1111/j.1467-8519.2008.00677.x
PMCID: PMC2628951  PMID: 19076937
birth; autonomy; cesarean section; vaginal delivery; cesarean delivery on maternal request; CDMR
13.  The Day-to-Day Impact of Urogenital Aging: Perspectives from Racially/Ethnically Diverse Women 
ABSTRACT
BACKGROUND
Urogenital symptoms affect up to half of women after menopause, but their impact on women’s day-to-day functioning and wellbeing is poorly understood.
METHODS
Postmenopausal women aged 45 to 80 years reporting urogenital dryness, soreness, itching, or pain during sex were recruited to participate in in-depth focus groups to discuss the impact of their symptoms. Focus groups were homogenous with respect to race/ethnicity and stratified by age (for White or Black women) or language (for Latina women). Transcripts of sessions were analyzed according to grounded theory.
RESULTS
Six focus groups were conducted, involving 44 women (16 White, 14 Black, 14 Latina). Five domains of functioning and wellbeing affected by symptoms were identified: sexual functioning, everyday activities, emotional wellbeing, body image, and interpersonal relations. For some participants, symptoms primarily affected their ability to have and enjoy sex, as well as be responsive to their partners. For others, symptoms interfered with everyday activities, such as exercising, toileting, or sleeping. Participants regarded their symptoms as a sign that they were getting old or their body was deteriorating; women also associated symptoms with a loss of womanhood or sexuality. Additionally, participants reported feeling depressed, embarrassed, and frustrated about their symptoms, and expressed reluctance to discuss them with friends, family, or health care providers.
CONCLUSIONS
Urogenital symptoms can have a marked impact on sexual functioning, everyday activities, emotional wellbeing, body image, and interpersonal relations after menopause. Clinicians may need to question women actively about these symptoms, as many are reluctant to seek help for this problem.
doi:10.1007/s11606-009-1135-1
PMCID: PMC2811605  PMID: 19908103
urogenital atrophy; vaginal dryness; dyspareunia; menopause; quality of life
14.  Mode of Delivery: Toward Responsible Inclusion of Patient Preferences 
Obstetrics and gynecology  2008;112(4):913-918.
Deciding when and how to incorporate patient preferences regarding mode of delivery is challenging for both obstetric providers and policymakers. An analysis of current guidelines in four clinical scenarios (prior cesarean, twin delivery, breech presentation, and maternal request for cesarean) indicates that some guidelines are highly prescriptive, while others are more flexible, based on physicians’ discretion or (less frequently) patient preferences, without consistency or explicit rationale for when such flexibility is permissible, advisable, or obligatory. While patient choice advocates have called for more patient-responsive guidelines, concerns have also been raised, especially in the context of discussions of cesarean delivery on maternal request, about the dangers of unfettered patient preference-driven clinical decisions. In this article, we outline a framework for the responsible inclusion of patient preferences into decision making regarding approach to delivery. We conclude, using this framework, that more explicit incorporation of patient preferences are called for in the first three scenarios, and indicate why expanding access to cesarean delivery on maternal request is more complicated and would require more data and further consideration.
doi:10.1097/AOG.0b013e3181888fd8
PMCID: PMC2643019  PMID: 18827136

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