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Item Association Between Intrauterine Device Type and Risk of Perforation and Device Expulsion: Results From the APEX-IUD Study(ScienceDirect, 2022) Gatz, Jennifer L.; Armstrong, Mary Anne; Postlethwaite, Debbie; Raine-Bennett, Tina; Chillemi, Giulia; Alabaster, Amy; Merchant, Maqdooda; Reed, Susan D.; Ichikawa, Laura; Getahun, Darios; Fassett, Michael J.; Shi, Jiaxiao M.; Xie, Fagen; Chiu, Vicki Y.; Im, Theresa M.; Takhar, Harpreet S.; Wang, Jinyi; Saltus, Catherine W.; Ritchey, Mary E.; Asiimwe, Alex; Pisa, Federica; Schoendorf, Juliane; Wahdan, Yesmean; Zhou, Xiaolei; Hunter, Shannon; Anthony, Mary S.; Peipert, Jeffrey F.; Medicine, School of MedicineBackground Intrauterine devices, including levonorgestrel-releasing and copper devices, are highly effective long-acting reversible contraceptives. The potential risks associated with intrauterine devices are low and include uterine perforation and device expulsion. Objective This study aimed to evaluate the risk of perforation and expulsion associated with levonorgestrel-releasing devices vs copper devices in clinical practice in the United States. Study Design The Association of Perforation and Expulsion of Intrauterine Devices study was a retrospective cohort study of women aged ≤50 years with an intrauterine device insertion during 2001 to 2018 and information on intrauterine device type and patient and medical characteristics. Of note, 4 research sites with access to electronic health records contributed data for the study: 3 Kaiser Permanente–integrated healthcare systems (Northern California, Southern California, and Washington) and 1 healthcare system using data from a healthcare information exchange in Indiana (Regenstrief Institute). Perforation was classified as any extension of the device into or through the myometrium. Expulsion was classified as complete (not visible in the uterus or abdomen or patient reported) or partial (any portion in the cervix or malpositioned). We estimated the crude incidence rates and crude cumulative incidence by intrauterine device type. The risks of perforation and expulsion associated with levonorgestrel-releasing intrauterine devices vs copper intrauterine devices were estimated using Cox proportional-hazards regression with propensity score overlap weighting to adjust for confounders. Results Among 322,898 women included in this analysis, the incidence rates of perforation per 1000 person-years were 1.64 (95% confidence interval, 1.53–1.76) for levonorgestrel-releasing intrauterine devices and 1.27 (95% confidence interval, 1.08–1.48) for copper intrauterine devices; 1-year and 5-year crude cumulative incidence was 0.22% (95% confidence interval, 0.20–0.24) and 0.63% (95% confidence interval, 0.57–0.68) for levonorgestrel-releasing intrauterine devices and 0.16% (95% confidence interval, 0.13–0.20) and 0.55% (95% confidence interval, 0.44–0.68) for copper intrauterine devices, respectively. The incidence rates of expulsion per 1000 person-years were 13.95 (95% confidence interval, 13.63–14.28) for levonorgestrel-releasing intrauterine devices and 14.08 (95% confidence interval, 13.44–14.75) for copper intrauterine devices; 1-year and 5-year crude cumulative incidence was 2.30% (95% confidence interval, 2.24–2.36) and 4.52% (95% confidence interval, 4.40–4.65) for levonorgestrel-releasing intrauterine devices and 2.30% (95% confidence interval, 2.18–2.44) and 4.82 (95% confidence interval, 4.56–5.10) for copper intrauterine devices, respectively. Comparing levonorgestrel-releasing intrauterine devices with copper intrauterine devices, the adjusted hazard ratios were 1.49 (95% confidence intervals, 1.25–1.78) for perforation and 0.69 (95% confidence intervals, 0.65–0.73) for expulsion. Conclusion After adjusting for potential confounders, levonorgestrel-releasing intrauterine devices were associated with an increased risk of uterine perforation and a decreased risk of expulsion relative to copper intrauterine devices. Given that the absolute numbers of these events are low in both groups, these differences may not be clinically meaningful.Item Association Between Menorrhagia and Risk of Intrauterine Device-Related Uterine Perforation and Device Expulsion: Results from the APEX-IUD Study(ScienceDirect, 2022) Getahun, Darios; Fassett, Michael J.; Gatz, Jennifer; Armstrong, Mary Anne; Peipert, Jeffrey F.; Raine-Bennett, Tina; Reed, Susan D.; Zhou, Xiaolei; Schoendorf, Juliane; Postlethwaite, Debbie; Shi, Jiaxiao M.; Saltus, Catherine W.; Wang, Jinyi; Xie, Fagen; Chiu, Vicki Y.; Merchant, Maqdooda; Alabaster, Amy; Ichikawa, Laura E.; Hunter, Shannon; Im, Theresa M.; Takhar, Harpreet S.; Ritchey, Mary E.; Chillemi, Giulia; Pisa, Federica; Asiimwe, Alex; Anthony, Mary S.; Regenstrief Institute, School of MedicineBackground Intrauterine devices are effective contraception, and one levonorgestrel-releasing device is also indicated for treatment of heavy menstrual bleeding (menorrhagia). Objective To compare the incidence of intrauterine device expulsion and uterine perforation in women with and without a diagnosis of menorrhagia within the 12 months before device insertion. Study Design Retrospective cohort study conducted in 3 integrated healthcare systems (Kaiser Permanente Northern California, Southern California, and Washington) and a healthcare information exchange (Regenstrief Institute) in the United States, using electronic health records. Nonpostpartum women aged ≤50 years with intrauterine device (e.g., levonorgestrel or copper) insertions from 2001–2018 without a delivery in the prior 12 months were studied in this analysis. Recent menorrhagia diagnosis (i.e., recorded ≤12 months before insertion) was ascertained from International Classification of Diseases, Ninth/Tenth Revision, Clinical Modification codes. Study outcomes—device expulsion and device-related uterine perforation (complete or partial)—were ascertained from electronic medical records and validated in data sources. Cumulative incidence and crude incidence rates with 95% confidence intervals were estimated. Cox proportional hazards models estimated crude and adjusted hazard ratios using propensity score overlap weighting (13-16 variables) and 95% confidence intervals. Results Among 228,834 nonpostpartum women, mean age was 33.1 years, 44.4% were White, and 31,600 (13.8%) had a recent menorrhagia diagnosis. Most women had a levonorgestrel-releasing device (96.4% of those with and 78.2% of those without a menorrhagia diagnosis). Women with a menorrhagia diagnosis were likely to be older, obese, and have dysmenorrhea or fibroids. Women with vs. without a menorrhagia diagnosis had a higher intrauterine device expulsion rate (40.01 vs. 10.92 per 1,000 person-years), especially evident in the few months after insertion. Women with a menorrhagia diagnosis had higher cumulative incidence (95% confidence interval) of expulsion (7.00% [6.70%, 7.32%] at 1 year, 12.03% [11.52%, 12.55%] at 5 years) vs. without (1.77% [1.70%, 1.84%] at 1 year, 3.69% [3.56%, 3.83%] at 5 years). Risk of expulsion was increased for women with a menorrhagia diagnosis vs. without (adjusted hazard ratio, 2.84 [95% confidence interval: 2.66, 3.03]). Perforation rate was low overall (<1/1,000 person-years) but higher in women with a diagnosis of menorrhagia vs. without (0.98 vs. 0.63 per 1,000 person-years). Cumulative incidence (95% confidence interval) of uterine perforation was slightly higher for women with a menorrhagia diagnosis (0.09% [0.06%, 0.14%] at 1 year, 0.39% [0.29%, 0.53%] at 5 years) vs. without (0.07% [0.06%, 0.08%], at 1 year, 0.28% [0.24%, 0.33%] at 5 years). Risk of perforation was slightly increased in women with a menorrhagia diagnosis vs. without (adjusted hazard ratio, 1.53; 95% confidence interval, 1.10, 2.13). Conclusion The risk of expulsion is significantly higher in women with a recent diagnosis of menorrhagia. Patient education and counseling regarding potential expulsion risk is recommended at insertion. The absolute risk of perforation for women with a recent diagnosis of menorrhagia is very low. Increased expulsion and perforation rates observed are likely due to causal factors of menorrhagia.Item Association of the Timing of Postpartum Intrauterine Device Insertion and Breastfeeding With Risks of Intrauterine Device Expulsion(American Medical Association, 2022-02-01) Armstrong, Mary Anne; Raine-Bennett, Tina; Reed, Susan D.; Gatz, Jennifer; Getahun, Darios; Schoendorf, Juliane; Postlethwaite, Debbie; Fassett, Michael J.; Peipert, Jeffrey F.; Saltus, Catherine W.; Merchant, Maqdooda; Alabaster, Amy; Zhou, Xiaolei; Ichikawa, Laura; Shi, Jiaxiao M.; Chiu, Vicki Y.; Xie, Fagen; Hunter, Shannon; Wang, Jinyi; Ritchey, Mary E.; Chillemi, Giulia; Im, Theresa M.; Takhar, Harpreet S.; Pisa, Federica; Asiimwe, Alex; Anthony, Mary S.; Obstetrics and Gynecology, School of MedicineImportance: Intrauterine device (IUD) expulsion increases the risk of unintended pregnancy; how timing of postpartum IUD insertion and breastfeeding are associated with risk of expulsion is relevant to the benefit-risk profile. Objective: To evaluate the association of postpartum timing of IUD insertion and breastfeeding status with incidence and risk of IUD expulsion. Design, setting, and participants: The Association of Perforation and Expulsion of Intrauterine Devices (APEX-IUD) cohort study included women aged 50 years or younger with an IUD insertion between 2001 and 2018. The breastfeeding analysis focused on a subcohort of women at 52 or fewer weeks post partum with known breastfeeding status. The study was conducted using data from electronic health records (EHRs) at 4 research sites with access to EHR: 3 Kaiser Permanente sites (Northern California, Southern California, Washington) and the Regenstrief Institute (Indiana). Data analysis was conducted from June to November 2019. Exposures: Timing of IUD insertion post partum was categorized into discrete time periods: 0 to 3 days, 4 days to 6 or fewer weeks, more than 6 weeks to 14 or fewer weeks, more than 14 weeks to 52 or fewer weeks, and non-post partum (>52 weeks or no evidence of delivery). Breastfeeding status at the time of insertion was determined from clinical records, diagnostic codes, or questionnaires from well-baby visits. Main outcomes and measures: Incidence rates and adjusted hazard ratios (aHRs) were estimated using propensity scores to adjust for confounding. Results: The full cohort included 326 658 women (mean [SD] age, 32.0 [8.3] years; 38 911 [11.9%] Asian or Pacific Islander; 696 [0.2%] Hispanic Black; 56 180 [17.2%] Hispanic other; 42 501 [13.0%] Hispanic White; 28 323 [8.7%] non-Hispanic Black; 137 102 [42.0%] non-Hispanic White), and the subcohort included 94 817 women. Most IUDs were levonorgestrel-releasing (259 234 [79.4%]). There were 8943 expulsions. The 5-year cumulative incidence of IUD expulsion was highest for insertions 0 to 3 days post partum (10.73%; 95% CI, 9.12%-12.61%) and lowest for insertions more than 6 weeks to 14 or fewer weeks post partum (3.18%; 95% CI, 2.95%-3.42%). Adjusted HRs using women with non-post partum IUD insertion as the referent were 5.34 (95% CI, 4.47-6.39) for those with postpartum insertion at 0 to 3 days; 1.22 (95% CI, 1.05-1.41) for those with postpartum insertion at 4 days to 6 or fewer weeks; 1.06 (95% CI, 0.95-1.18) for those with postpartum insertion at more than 6 to 14 or fewer weeks; and 1.43 (95% CI, 1.29-1.60) for those with postpartum insertion at more than 14 to 52 or fewer weeks. In the subcohort, 5-year cumulative incidence was 3.49% (95% CI, 3.25%-3.73%) for breastfeeding women and 4.57% (95% CI, 4.22%-4.95%) for nonbreastfeeding women; the adjusted HR for breastfeeding vs not breastfeeding was 0.71 (95% CI, 0.64-0.78). Conclusions and relevance: In this study of real-world data, IUD expulsion was rare but more common with immediate postpartum insertion. Breastfeeding was associated with lower expulsion risk.Item Demographic, Reproductive, and Medical Risk Factors for Intrauterine Device Expulsion(Wolters Kluwer, 2022-12) Anthony, Mary S.; Zhou, Xiaolei; Schoendorf, Juliane; Reed, Susan D.; Getahun, Darios; Armstrong, Mary Anne; Gatz, Jennifer; Peipert, Jeffrey F.; Raine-Bennett, Tina; Fassett, Michael J.; Saltus, Catherine W.; Ritchey, Mary E.; Ichikawa, Laura; Shi, Jiaxiao M.; Alabaster, Amy; Wahdan, Yesmean; Wang, Jinyi; Xie, Fagen; Merchant, Maqdooda; Hunter, Shannon; Chiu, Vicki Y.; Postlethwaite, Debbie; Rothman, Kenneth J.; Im, Theresa M.; Chillemi, Giulia; Takhar, Harpreet S.; Asiimwe, Alex; Pisa, Federica; Obstetrics and Gynecology, School of MedicineObjective: To explore to what extent intrauterine device (IUD) expulsion is associated with demographic and clinical risk factors. Methods: The APEX-IUD (Association of Perforation and Expulsion of IntraUterine Devices) study was a U.S. cohort study using electronic health records from three integrated health care systems (Kaiser Permanente Northern California, Southern California, and Washington) and a health care information exchange (Regenstrief Institute). These analyses included individuals aged 50 years or younger with IUD insertions from 2001 to 2018. Intrauterine device expulsion cumulative incidence and incidence rates were estimated. Using Cox regression models, hazard ratios with 95% CIs were estimated before and after adjustment for risk factors of interest (age, race and ethnicity, parity, body mass index [BMI], heavy menstrual bleeding, and dysmenorrhea) and potential confounders. Results: In total, 228,834 individuals with IUD insertion and no delivery in the previous 52 weeks were identified (184,733 [80.7%] with levonorgestrel-releasing intrauterine system). Diagnosis of heavy menstrual bleeding-particularly a diagnosis in both recent and past periods-was the strongest risk factor for IUD expulsion. Categories with the highest risk of IUD expulsion within each risk factor included individuals diagnosed with overweight, obesity, and morbid obesity; those in younger age groups, especially among those aged 24 years or younger; and in those with parity of four or more. Non-Hispanic White individuals had the lowest incidence and risk, and after adjustment, Asian or Pacific Islander individuals had the highest risk. Dysmenorrhea was not independently associated with expulsion risk when adjusting for heavy menstrual bleeding. Conclusion: Most risk factors for expulsion identified in this study appear consistent with known physiologic factors that affect uterine anatomy and physiology (age, BMI, heavy menstrual bleeding, parity). The increased risk of IUD expulsion among individuals of color warrants further investigation. Intrauterine devices are an effective long-term contraceptive; expulsion is uncommon, but patients should be counseled accordingly.Item Design of the Association of Uterine Perforation and Expulsion of Intrauterine Device study: a multisite retrospective cohort study(Elsevier, 2021) Anthony, Mary S.; Reed, Susan D.; Armstrong, Mary Anne; Getahun, Darios; Gatz, Jennifer L.; Saltus, Catherine W.; Zhou, Xiaolei; Schoendorf, Juliane; Postlethwaite, Debbie A.; Raine-Bennett, Tina; Fassett, Michael J.; Peipert, Jeffrey F.; Ritchey, Mary E.; Ichikawa, Laura E.; Lynen, Richard; Alabaster, Amy L.; Merchant, Maqdooda; Chiu, Vicki Y.; Shi, Jiaxiao M.; Xie, Fagen; Hui, Siu L.; Wang, Jinyi; Hunter, Shannon; Bartsch, Jennifer; Frenz, Ann-Kathrin; Chillemi, Giulia; Im, Theresa M.; Takhar, Harpreet S.; Asiimwe, Alex; Obstetrics and Gynecology, School of MedicineBackground Intrauterine devices are effective and safe, long-acting reversible contraceptives, but the risk of uterine perforation occurs with an estimated incidence of 1 to 2 per 1000 insertions. The European Active Surveillance Study for Intrauterine Devices, a European prospective observational study that enrolled 61,448 participants (2006–2012), found that women breastfeeding at the time of device insertion or with the device inserted at ≤36 weeks after delivery had a higher risk of uterine perforation. The Association of Uterine Perforation and Expulsion of Intrauterine Device (APEX-IUD) study was a Food and Drug Administration–mandated study designed to reflect current United States clinical practice. The aims of the APEX-IUD study were to evaluate the risk of intrauterine device–related uterine perforation and device expulsion among women who were breastfeeding or within 12 months after delivery at insertion. Objective We aimed to describe the APEX-IUD study design, methodology, and analytical plan and present population characteristics, size of risk factor groups, and duration of follow-up. Study Design APEX-IUD study was a retrospective cohort study conducted in 4 organizations with access to electronic health records: Kaiser Permanente Northern California, Kaiser Permanente Southern California, Kaiser Permanente Washington, and Regenstrief Institute in Indiana. Variables were identified through structured data (eg, diagnostic, procedural, medication codes) and unstructured data (eg, clinical notes) via natural language processing. Outcomes include uterine perforation and device expulsion; potential risk factors were breastfeeding at insertion, postpartum timing of insertion, device type, and menorrhagia diagnosis in the year before insertion. Covariates include demographic characteristics, clinical characteristics, and procedure-related variables, such as difficult insertion. The first potential date of inclusion for eligible women varies by research site (from January 1, 2001 to January 1, 2010). Follow-up begins at insertion and ends at first occurrence of an outcome of interest, a censoring event (device removal or reinsertion, pregnancy, hysterectomy, sterilization, device expiration, death, disenrollment, last clinical encounter), or end of the study period (June 30, 2018). Comparisons of levels of exposure variables were made using Cox regression models with confounding adjusted by propensity score weighting using overlap weights. Results The study population includes 326,658 women with at least 1 device insertion during the study period (Kaiser Permanente Northern California, 161,442; Kaiser Permanente Southern California, 123,214; Kaiser Permanente Washington, 20,526; Regenstrief Institute, 21,476). The median duration of continuous enrollment was 90 (site medians 74–177) months. The mean age was 32 years, and the population was racially and ethnically diverse across the 4 sites. The mean body mass index was 28.5 kg/m2, and of the women included in the study, 10.0% had menorrhagia ≤12 months before insertion, 5.3% had uterine fibroids, and 10% were recent smokers; furthermore, among these women, 79.4% had levonorgestrel-releasing devices, and 19.5% had copper devices. Across sites, 97,824 women had an intrauterine device insertion at ≤52 weeks after delivery, of which 94,817 women (97%) had breastfeeding status at insertion determined; in addition, 228,834 women had intrauterine device insertion at >52 weeks after delivery or no evidence of a delivery in their health record. Conclusion Combining retrospective data from multiple sites allowed for a large and diverse study population. Collaboration with clinicians in the study design and validation of outcomes ensured that the APEX-IUD study results reflect current United States clinical practice. Results from this study will provide valuable information based on real-world evidence about risk factors for intrauterine devices perforation and expulsion for clinicians.Item Efficacy of yoga for vasomotor symptoms: a randomized controlled trial(Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins, 2014-04) Newton, Katherine M.; Reed, Susan D.; Guthrie, Katherine A.; Sherman, Karen J.; Booth-LaForce, Cathryn; Caan, Bette; Sternfeld, Barbara; Carpenter, Janet S.; Learman, Lee A.; Freeman, Ellen W.; Cohen, Lee S.; Joffe, Hadine; Anderson, Garnet L.; Larson, Joseph C.; Hunt, Julie R.; Ensrud, Kristine E.; LaCroix, Andrea Z.; IU School of NursingOBJECTIVE: 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.Item Female Sexual Function Index Short Version: A MsFLASH Item Response Analysis(Springer, 2016-11) Carpenter, Janet S.; Jones, Salene M. W.; Studts, Christina R.; Heiman, Julia R.; Reed, Susan D.; Newton, Katherine M.; Guthrie, Katherine A.; Larson, Joseph C.; Cohen, Lee S.; Freeman, Ellen W.; Lau, R. Jane; Learman, Lee A.; Shifren, Jan L.; School of NursingThe 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.Item Menopausal Quality of Life: A RCT of Yoga, Exercise and Omega-3 Supplements(Elsevier B.V., 2014-03) Reed, Susan D.; Guthrie, Katherine A.; Newton, Katherine M.; Anderson, Garnet L.; Booth-LaForce, Cathryn; Caan, Bette; Carpenter, Janet S.; Cohen, Lee S.; Dunn, Andrea L.; Ensrud, Kristine E.; Freeman, Ellen W.; Hunt, Julie R.; Joffe, Hadine; Larson, Joseph C.; Learman, Lee A.; Rothenberg, Robin; Seguin, Rebecca A.; Sherman, Karen J.; Sternfeld, Barbara S.; LaCroix, Andrea Z.; IU School of NursingObjective— 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.Item MsFLASH Analysis of Diurnal Salivary Cortisol and Palpitations in Peri and Postmenopausal Women(Wolters Kluwer, 2021-11-29) Carpenter, Janet S.; Tisdale, James E.; Larson, Joseph C.; Sheng, Ying; Chen, Chen X.; Von Ah, Diane; Kovacs, Richard; Reed, Susan D.; Thurston, Rebecca C.; Guthrie, Katherine A.; School of NursingObjective: To evaluate the relationship between diurnal salivary cortisol patterns and distress from heart palpitations in midlife women. Methods: We analyzed baseline data from 293 women who were eligible for a 3 × 2 factorial trial of exercise or yoga versus routine activity, and omega-3 fish oil versus placebo for vasomotor symptoms. Women self-collected salivary cortisol using swabs at four time points over 2 consecutive days and reported distress from heart racing or pounding during the past 2 weeks using a single item. Sample description and covariate data included demographics, clinical data, vasomotor symptom frequency from daily diaries, medication use, and validated questionnaires on depression, stress, and insomnia (Patient Health Questionnaire-8, Perceived Stress Scale, and Insomnia Severity index). Data were analyzed using descriptive statistics, chi-square and t tests, and repeated measure linear regression models. Results: Participants were on average 54.6 (SD = 3.6) years old, most were White (67%) postmenopausal (84%), and 26% reported distress related to palpitations. In adjusted models, the morning (wake plus 30-min) geometric mean daily salivary cortisol concentrations were significantly more blunted in those with distress from palpitations compared with those without distress (P ≤ 0.03). When all covariates were controlled, distress from palpitations was the sole significant predictor of wake plus 30-minute cortisol (-0.25 [-0.45 to -0.04], P = 0.02). Conclusions: Palpitations among midlife women may be associated with blunted morning cortisol, and this relationship is not explained by demographics, clinical variables, vasomotor symptoms, medications, depression, stress, or insomnia.Item MsFLASH Participants’ Priorities for Alleviating Menopausal Symptoms(Taylor and Francis, 2015) Carpenter, Janet S.; Woods, Nancy Fugate; Otte, Julie L.; Guthrie, Katherine A.; Hohensee, Chancellor; Newton, Katherine M.; Joffe, Hadine; Cohen, Lee; Sternfeld, Barbara; Lau, R. Jane; Reed, Susan D.; LaCroix, Andrea Z.; Department of Nursing, IU School of NursingObjective To describe self-reported menopausal symptom priorities and their association with demographics and other symptoms among participants in an intervention trial for vasomotor symptoms (VMS). Methods Cross-sectional study embedded in the MsFLASH 02 trial, a three-by-two factorial design of yoga vs. exercise vs. usual activity and omega-3-fatty acid vs. placebo. At baseline, women (n = 354) completed hot flush diaries, a card sort task to prioritize symptoms they would most like to alleviate, and standardized questionnaires. Results The most common symptom priorities were: VMS (n = 322), sleep (n = 191), concentration (n = 140), and fatigue (n = 116). In multivariate models, women who chose VMS as their top priority symptom (n = 210) reported significantly greater VMS severity (p = 0.004) and never smoking (p = 0.012), and women who chose sleep as their top priority symptom (n = 100) were more educated (p ≤ 0.001) and had worse sleep quality (p < 0.001). ROC curves identified sleep scale scores that were highly predictive of ranking sleep as a top priority symptom. Conclusions Among women entering an intervention trial for VMS and with relatively low prevalence of depression and anxiety, VMS was the priority symptom for treatment. A card sort may be a valid tool for quickly assessing symptom priorities in clinical practice and research.