Preference Elicitation Tool for Abnormal Uterine Bleeding Treatment: A Randomized Controlled Trial

Background It is estimated that one-third of women will experience abnormal menstrual bleeding. The majority of these cases are not due to cancer or pregnancy complications and, as a result, women are faced with a variety of treatment alternatives, the selection of which is largely dependent on personal preferences for care rather than clinical outcomes. Objective This randomized trial was designed to evaluate a preference elicitation tool to promote physician–patient collaborative decision making for treatment of abnormal uterine bleeding (AUB). Methods Adaptive conjoint analysis (ACA) was used to create a preference elicitation tool in English and in Spanish. Women with AUB were enrolled to the study and randomly assigned to ACA or usual counseling at the initial clinic visit at four clinics (three in Indianapolis, IN, USA, and one in Southern Pines, NC, USA). The ACA tool elicited preferences across eight attributes: treatment efficacy; sexual function; medical care; cost; fertility; frequency of medication use; permanence; and recovery time. t tests were used to compare differences in the primary outcomes of decision regret and treatment satisfaction at the follow-up visit. The study was designed to have 80 % power to detect significant differences between groups for the primary outcomes of regret and satisfaction. Results Women were enrolled in the study between September 2009 and March 2012. 183 participants were randomized to ACA and 191 to usual counseling. Overall, mean (standard deviation) treatment satisfaction was high at 35.71 (9.72) (scale of 0–44), and decision regret was low at 25.9 (21.0) (scale of 0–100), creating ceiling effects for the selected outcome variables; there were no significant differences between the ACA and control groups at the follow-up assessment. There was a strong inverse relationship between age and decision regret (p = 0.007). Exploratory subgroup analysis in the youngest quartile comprising 64 women aged 19–35 years showed a statistically non-significant difference in mean regret scores for the ACA group versus usual counseling (24.6 vs. 34.6, respectively; p = 0.08). Conclusions A preference elicitation tool at the initial consultation visit did not reduce decision regret or improve treatment satisfaction among patients with AUB; however, there is a need for additional research to further understand this tool’s potential role in promoting collaborative decision making, which may be particularly important among younger women

Use of medical, surgical and complementary treatments among women with fibroids

OBJECTIVE: To examine the use of medical management, uterus-preserving surgery (UPS), and complementary treatments among women with uterine fibroids. STUDY DESIGN: Prospective cohort study of 933 premenopausal women ages 31-54 years with symptomatic fibroids who participated in the Study of Pelvic Problems, Hysterectomy, and Intervention Alternatives (SOPHIA) for an average of 4.3 years (SD 2.5 years). Incident use of fibroid treatments was determined through annual interviews. Linear regression models were used to compare changes in fibroid-related symptoms among women who underwent UPS versus those who did not undergo surgery. RESULTS: Participants were racially and ethnically diverse, with a mean age of 43 years. During study follow-up, 531 participants (57%) did not undergo UPS or hysterectomy, 250 (27%) had at least one UPS, and 152 (16%) underwent hysterectomy. Complementary and alternative treatments were commonly used, including exercise (45%), diet (34%), herbs (37%), and acupuncture (16%): participants reported significant symptom improvement and few side effects with these interventions. In multivariable linear regression models, women who did not undergo surgery during the study reported improvement in dyspareunia (p<.001), pelvic pain (p<.001), and menstrual cramps (p<.001). However, women who underwent UPS reported greater overall resolution of "pelvic problems" compared with women who did not have surgical treatment (difference in change score 1.18 on a four-point Likert scale, p<.001). CONCLUSION: UPS are effective treatments for women with fibroids, but many women use hormonal or complementary treatments and report significant symptom improvement without surgical intervention

Female Sexual Function Index Short Version: A MsFLASH Item Response Analysis

The Female Sexual Function Index (FSFI) is a psychometrically sound and popular 19-item self-report measure, but its length may preclude its use in studies with multiple outcome measures, especially when sexual function is not a primary endpoint. Only one attempt has been made to create a shorter scale, resulting in the Italian FSFI-6, later translated into Spanish and Korean without further psychometric analysis. Our study evaluated whether a subset of items on the 19-item English-language FSFI would perform as well as the full-length FSFI in peri- and post-menopausal women. We used baseline data from 898 peri- and post-menopausal women recruited from multiple communities, ages 42–62 years, and enrolled in randomized controlled trials for vasomotor symptom management. Goals were to (1) create a psychometrically sound, shorter version of the FSFI for use in peri- and post-menopausal women as a continuous measure and (2) compare it to the Italian FSFI-6. Results indicated that a 9-item scale provided more information than the FSFI-6 across a spectrum of sexual functioning, was able to capture sample variability, and showed sufficient range without floor or ceiling effects. All but one of the items from the Italian 6-item version were included in the 9-item version. Most omitted FSFI items focused on frequency of events or experiences. When assessment of sexual function is a secondary endpoint and subject burden related to questionnaire length is a priority, the 9-item FSFI may provide important information about sexual function in English-speaking peri- and post-menopausal women

Efficacy of yoga for vasomotor symptoms: a randomized controlled trial

OBJECTIVE: This study aims to determine the efficacy of yoga in alleviating vasomotor symptoms (VMS) frequency and bother. METHODS: This study was a three-by-two factorial, randomized controlled trial. Eligible women were randomized to yoga (n = 107), exercise (n = 106), or usual activity (n = 142), and were simultaneously randomized to a double-blind comparison of ω-3 fatty acid (n = 177) or placebo (n = 178) capsules. Yoga intervention consisted of 12 weekly 90-minute yoga classes with daily home practice. Primary outcomes were VMS frequency and bother assessed by daily diaries at baseline, 6 weeks, and 12 weeks. Secondary outcomes included insomnia symptoms (Insomnia Severity Index) at baseline and 12 weeks. RESULTS: Among 249 randomized women, 237 (95%) completed 12-week assessments. The mean baseline VMS frequency was 7.4 per day (95% CI, 6.6 to 8.1) in the yoga group and 8.0 per day (95% CI, 7.3 to 8.7) in the usual activity group. Intent-to-treat analyses included all participants with response data (n = 237). There was no difference between intervention groups in the change in VMS frequency from baseline to 6 and 12 weeks (mean difference [yoga--usual activity] from baseline at 6 wk, -0.3 [95% CI, -1.1 to 0.5]; mean difference [yoga--usual activity] from baseline at 12 wk, -0.3 [95% CI, -1.2 to 0.6]; P = 0.119 across both time points). Results were similar for VMS bother. At week 12, yoga was associated with an improvement in insomnia symptoms (mean difference [yoga - usual activity] in the change in Insomnia Severity Index, 1.3 [95% CI, -2.5 to -0.1]; P = 0.007). CONCLUSIONS: Among healthy women, 12 weeks of yoga class plus home practice, compared with usual activity, do not improve VMS frequency or bother but reduce insomnia symptoms

Menopausal Quality of Life: A RCT of Yoga, Exercise and Omega-3 Supplements

Objective— Determine efficacy of three non-hormonal therapies for improving menopause- related quality of life (QOL) in women with vasomotor symptoms (VMS). Methods— 12-week 3×2 randomized, controlled, factorial design trial. Peri- and postmenopausal women, ages 40-62 years, were randomized to yoga (n=107), exercise (n=106), or usual activity (n=142), and also randomized to double-blind comparison of omega-3 (n=177) or placebo (n=178) capsules. Interventions: 1) weekly 90-minute yoga classes with daily at-home practice; 2) individualized facility-based aerobic exercise training 3 times/week; and 3) 0.615 gram omega-3 supplement, 3 times/day. Outcomes: Menopausal Quality of Life Questionnaire (MENQOL) total and domain (VMS, psychosocial, physical and sexual) scores. Results— Among 355 randomized women, average age 54.7 years, 338 (95%) completed 12- week assessments. Mean baseline VMS frequency was 7.6/day and mean baseline total MENQOL score was 3.8 (range 1-8 from better to worse) with no between-group differences. For yoga compared to usual activity, baseline to 12-week improvements were seen for MENQOL total -0.3 (95% CI -0.6 to 0.0, p=0.02), and VMS (p=0.02) and sexuality (p=0.03) domain scores. For exercise and omega-3 compared to controls, improvements in baseline to 12-week total MENQOL scores were not observed. Exercise showed benefit in the MENQOL physical domain score at 12- weeks (p=0.02). Conclusion— All women become menopausal and many seek medical advice on ways to improve quality of life; little evidence-based information exists. We found, among healthy sedentary menopausal women, yoga appears to improve menopausal QOL - the clinical significance of our finding is uncertain due to modest effect

Maternal and neonatal outcomes by labor onset type and gestational age.

OBJECTIVE: We sought to determine maternal and neonatal outcomes by labor onset type and gestational age. STUDY DESIGN: We used electronic medical records data from 10 US institutions in the Consortium on Safe Labor on 115,528 deliveries from 2002 through 2008. Deliveries were divided by labor onset type (spontaneous, elective induction, indicated induction, unlabored cesarean). Neonatal and maternal outcomes were calculated by labor onset type and gestational age. RESULTS: Neonatal intensive care unit admissions and sepsis improved with each week of gestational age until 39 weeks (P \u3c .001). After adjusting for complications, elective induction of labor was associated with a lower risk of ventilator use (odds ratio [OR], 0.38; 95% confidence interval [CI], 0.28-0.53), sepsis (OR, 0.36; 95% CI, 0.26-0.49), and neonatal intensive care unit admissions (OR, 0.52; 95% CI, 0.48-0.57) compared to spontaneous labor. The relative risk of hysterectomy at term was 3.21 (95% CI, 1.08-9.54) with elective induction, 1.16 (95% CI, 0.24-5.58) with indicated induction, and 6.57 (95% CI, 1.78-24.30) with cesarean without labor compared to spontaneous labor. CONCLUSION: Some neonatal outcomes improved until 39 weeks. Babies born with elective induction are associated with better neonatal outcomes compared to spontaneous labor. Elective induction may be associated with an increased hysterectomy risk

Hypertensive Disorders in Pregnancy

This course is part of a project that aims to reduce maternal mortality in Sub-Saharan Africa by providing specialty training in Obstetrics and Gynecology. This training will be provided in a partnership between high-income and low- and middle-income countries (LMIC). ¶ We hope that you find the course useful in whatever role you play in the reduction of maternal mortality, and that together we will find a way to sustainably improve the lives women, children, and the people who care for them in Sub Saharan Africa.http://deepblue.lib.umich.edu/bitstream/2027.42/120502/1/medical_1000_obgyn_project-hypertensive_disorders_in_pregnancy-Octoboer14.zi

Prevalence and use of complementary health approaches among women with chronic pelvic pain in a prospective cohort study.

ObjectiveThe aim of this study was to examine the prevalence of and factors associated with use of complementary health approaches among women with chronic pelvic pain (CPP).DesignWe analyzed data from the Study of Pelvic Problems, Hysterectomy, and Intervention Alternatives, a prospective cohort study of women seeking care for noncancerous pelvic problems with intact uteri at enrollment. Among a subset of 699 participants who reported having CPP, we analyzed the prevalence of complementary health approaches used and associated patient sociodemographic and clinical characteristics, health-related quality of life, attitudes and beliefs, and conventional health care practices.ResultsAt baseline, slightly over one-half (51%) of women with CPP used at least one complementary health approach in the past year, including acupuncture (8%), special foods or diets (22%), herbs (27%), and vitamins and minerals (29%). During follow-up surveys conducted annually for 4 years, a substantial proportion of women (44.8%) used complementary health approaches at more than half of the assessments. Users of complementary health approaches were more likely to undergo a hysterectomy or oophorectomy or to use gonadotropin-releasing hormone agonists or opioids during the study compared with nonusers. Women with CPP who used complementary health approaches also had more optimal health-related quality of life measured by the Pelvic Problem Impact Questionnaire (31.6 vs 25.6, P &lt; 0.001).Conclusion(s)Many women with CPP consistently use complementary health approaches. The substantial interest in and high prevalence of complementary health approaches used alongside conventional medical approaches highlight the need for better understanding of multimodal approaches to address the complex condition of CPP

Prevalence and use of complementary health approaches among women with chronic pelvic pain in a prospective cohort study.

ObjectiveThe aim of this study was to examine the prevalence of and factors associated with use of complementary health approaches among women with chronic pelvic pain (CPP).DesignWe analyzed data from the Study of Pelvic Problems, Hysterectomy, and Intervention Alternatives, a prospective cohort study of women seeking care for noncancerous pelvic problems with intact uteri at enrollment. Among a subset of 699 participants who reported having CPP, we analyzed the prevalence of complementary health approaches used and associated patient sociodemographic and clinical characteristics, health-related quality of life, attitudes and beliefs, and conventional health care practices.ResultsAt baseline, slightly over one-half (51%) of women with CPP used at least one complementary health approach in the past year, including acupuncture (8%), special foods or diets (22%), herbs (27%), and vitamins and minerals (29%). During follow-up surveys conducted annually for 4 years, a substantial proportion of women (44.8%) used complementary health approaches at more than half of the assessments. Users of complementary health approaches were more likely to undergo a hysterectomy or oophorectomy or to use gonadotropin-releasing hormone agonists or opioids during the study compared with nonusers. Women with CPP who used complementary health approaches also had more optimal health-related quality of life measured by the Pelvic Problem Impact Questionnaire (31.6 vs 25.6, P &lt; 0.001).Conclusion(s)Many women with CPP consistently use complementary health approaches. The substantial interest in and high prevalence of complementary health approaches used alongside conventional medical approaches highlight the need for better understanding of multimodal approaches to address the complex condition of CPP

Use of medical, surgical and complementary treatments among women with fibroids

ObjectiveTo examine the use of medical management, uterus-preserving surgery (UPS), and complementary treatments among women with uterine fibroids.Study designProspective cohort study of 933 premenopausal women ages 31-54 years with symptomatic fibroids who participated in the Study of Pelvic Problems, Hysterectomy, and Intervention Alternatives (SOPHIA) for an average of 4.3 years (SD 2.5 years). Incident use of fibroid treatments was determined through annual interviews. Linear regression models were used to compare changes in fibroid-related symptoms among women who underwent UPS versus those who did not undergo surgery.ResultsParticipants were racially and ethnically diverse, with a mean age of 43 years. During study follow-up, 531 participants (57%) did not undergo UPS or hysterectomy, 250 (27%) had at least one UPS, and 152 (16%) underwent hysterectomy. Complementary and alternative treatments were commonly used, including exercise (45%), diet (34%), herbs (37%), and acupuncture (16%): participants reported significant symptom improvement and few side effects with these interventions. In multivariable linear regression models, women who did not undergo surgery during the study reported improvement in dyspareunia (p&lt;.001), pelvic pain (p&lt;.001), and menstrual cramps (p&lt;.001). However, women who underwent UPS reported greater overall resolution of "pelvic problems" compared with women who did not have surgical treatment (difference in change score 1.18 on a four-point Likert scale, p&lt;.001).ConclusionUPS are effective treatments for women with fibroids, but many women use hormonal or complementary treatments and report significant symptom improvement without surgical intervention