Browsing by Author "Guthrie, Katherine A."
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Item Confirmatory factor analysis of the Insomnia Severity Index (ISI) and invariance across race: a pooled analysis of MsFLASH data(Wolters Kluwer, 2019-08-01) Otte, Julie L.; Bakoyannis, Giorgos; Rand, Kevin L.; Ensrud, Kristine E.; Guthrie, Katherine A.; Joffe, Hadine; McCurry, Susan M.; Newton, Kathrine M.; Carpenter, Janet S.; School of NursingObjective: Women's sleep at menopause is widely reported to be problematic. The Insomnia Severity Index is a commonly used tool for quantifying sleep problems in clinical and research settings, but psychometric properties in menopausal women have not been reported. Our study aim was to examine the factor structure of the Insomnia Severity Index in a large and diverse sample of midlife women with hot flashes. Methods: Baseline data were from 899 women enrolled in one of the three clinical trials using similar entry criteria conducted by the Menopause Strategies Finding Lasting Answers to Symptoms and Health (MsFLASH) research network. We conducted confirmatory factor analyses for the total sample and within strata defined by race/ethnicity (Black and White women). Results: The Insomnia Severity Index had two factors in the total sample. The 2-factor structure was consistent across Black and White women, with the exception of one item “Difficulty falling asleep”. Conclusions: The Insomnia Severity Index in midlife women with hot flashes is composed of two factors that capture dimensions of the insomnia severity and daytime impact. The instrument is a psychometrically sound scale appropriate for use in research and clinical practice to capture the severity and daytime impact of insomnia symptoms in diverse samples of midlife women with hot flashes. An abbreviated screening of two items could be considered to determine if further evaluation is needed of sleep complaints.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 A Menopause Strategies–Finding Lasting Answers for Symptoms and Health (MsFLASH) Investigation of Self-Reported Menopausal Palpitation Distress(Liebert, 2021-04) Carpenter, Janet S.; Tisdale, James E.; Chen, Chen X.; Kovacs, Richard; Larson, Joseph C.; Guthrie, Katherine A.; Ensrud, Kristine E; Newton, Katherine M.; LaCroix, Andrea Z.Background: Study to describe the degree of menopausal palpitation distress and its demographic, clinical, symptom, and quality-of-life (QOL) correlates. Analysis of existing, baseline, data from peri- and postmenopausal women, 42 to 62 years of age, who participated in the Menopause Strategies–Finding Lasting Answers for Symptoms and Health (MsFLASH) clinical trials testing interventions for vasomotor symptoms (n = 759). Up to 46.8% of menopausal women report having palpitations, yet the symptom is relatively understudied. Little is known about palpitation distress or its correlates. Materials and Methods: Degree of distress from “heart racing or pounding” was self-reported over the past two weeks as “not at all,” “a little bit,” “moderately,” “quite a bit,” or “extremely.” Other measures included self-report forms, clinic-verified body mass index (BMI), vasomotor symptom diaries, and validated symptom and QOL tools. Results: The percentage who reported palpitation distress was 19.6%, 25.2%, and 33.5% in the three trials or 25.0% overall. In multivariate analysis, the odds of reporting palpitation distress was lower in past smokers (odds ratio [OR] = 0.59 [95% confidence interval (CI) 0.38–0.90]) and current smokers (OR = 0.48 [0.27–0.87]) relative to never-smokers and lower with every 5 kg/m2 higher BMI (OR = 0.82 [0.69–0.98]).The odds of reporting palpitation distress was higher with every five point more severe insomnia (OR = 1.28 [1.05–1.54]), five point worse depressive symptoms (OR = 1.47 [1.11–1.95]), five point worse perceived stress (OR = 1.19 [1.01–1.39]), and one point worse menopausal QOL (OR = 1.29 [1.06–1.57]). Conclusions: Menopausal palpitation distress is common and associated with demographic, clinical, symptom, and QOL factors. Findings can be used for screening in clinical practice and to justify additional research on this understudied symptom.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.Item Pooled Analysis of Six Pharmacologic and Nonpharmacologic Interventions for Vasomotor Symptoms(Wolters Kluwer, 2015-08) Guthrie, Katherine A.; LaCroix, Andrea Z.; Ensrud, Kristine E.; Joffe, Hadine; Newton, Katherine M.; Reed, Susan D.; Caan, Bette; Carpenter, Janet S.; Cohen, Lee S.; Freeman, Ellen W.; Larson, Joseph C.; Manson, JoAnn E.; Rexrode, Kathy; Skaar, Todd C.; Sternfeld, Barbara; Anderson, Garnet L.; School of NursingObjective: To describe the effects of six interventions for menopausal vasomotor symptoms relative to control in a pooled analysis, facilitating translation of the results for clinicians and symptomatic women. The Menopause Strategies: Finding Lasting Answers for Symptoms and Health network tested these interventions in three randomized clinical trials. Methods: An analysis of pooled individual-level data from three randomized clinical trials is presented. Participants were 899 perimenopausal and postmenopausal women with at least 14 bothersome vasomotor symptoms per week. Interventions included 10-20 mg escitalopram per day, nonaerobic yoga, aerobic exercise, 1.8 g per day omega-3 fatty acid supplementation, 0.5 mg low-dose oral 17-beta-estradiol (E2) per day, and 75 mg low-dose venlafaxine XR per day. The main outcome measures were changes from baseline in mean daily vasomotor symptom frequency and bother during 8-12 weeks of treatment. Linear regression models estimated differences in outcomes between each intervention and corresponding control group adjusted for baseline characteristics. Models included trial-specific intercepts, effects of the baseline outcome measure, and time. Results: The 8-week reduction in vasomotor symptom frequency from baseline relative to placebo was similar for escitalopram at -1.4 per day (95% confidence interval [CI] -2.7 to -0.2), low-dose E2 at -2.4 (95% CI -3.4 to -1.3), and venlafaxine at -1.8 (95% CI -2.8 to -0.8); vasomotor symptom bother reduction was minimal and did not vary across these three pharmacologic interventions (mean -0.2 to -0.3 relative to placebo). No effects on vasomotor symptom frequency or bother were seen with aerobic exercise, yoga, or omega-3 supplements. Conclusion: These analyses suggest that escitalopram, low-dose E2, and venlafaxine provide comparable, modest reductions in vasomotor symptom frequency and bother among women with moderate hot flushes.Item Toward a Better Measure of Midlife Sexual Function: Pooled Analyses in Nearly 1000 Women Participating in MsFLASH Randomized Trials(Wolters Kluwer, 2022-01-31) Reed, Susan D.; Carpenter, Janet S.; Larson, Joseph; Mitchell, Caroline M.; Shifren, Jan; Heiman, Julia; Fugate Woods, Nancy; Tessler Lindau, Stacy; LaCroix, Andrea Z.; Guthrie, Katherine A.; School of NursingObjective: Evaluate appropriateness of the current Female Sexual Function Index (FSFI)-19 value of <26.6 to designate female sexual dysfunction (FSD) in postmenopausal women, using the Female Sexual Distress-Revised (FSDS-R) scale to measure distress. Methods: Participant-level data containing standardized measures from five completed Menopause Strategies: Finding Lasting Answers for Symptoms and Health trials was pooled. Baseline characteristics and FSFI-19 scores were compared across trials (F-test, homogeneity). FSFI-19 score associations with the FSDS-R were described. Receiver operating characteristic (ROC) curves were plotted to illustrate the choice of optimal FSFI-19 value to predict sexual distress. ROC curves were also estimated adjusting for trial number, clinical center, age, education, race, smoking, and BMI. Results: Nine hundred ninety eight women (79.2% postmenopausal), mean age 55.9 (SD 4.8) had complete FSFI-19, FSDS-R, and covariate data. Baseline mean FSFI-19 score among all participants and sexually active participants was 18.7 (SD 9.5) and 22.0 (SD 7.2), respectively. There was a consistent pattern across the trials of inverse association between poorer sexual function (FSFI-19) and greater sexual distress. Based on the ROC curve showing the likelihood of FSDS-R frequent or greater distress according to cut points of FSFI, the optimal cut point for FSD was FSFI-19 <21 for all participants. This cut point corresponded to sensitivity 87.2% (95% CI, 83.4-91.0), specificity 57.9% (95% CI, 54.3-61.6) and adjusted area under the ROC curve 78.8% (95% CI, 75.8-81.8). Conclusions: A new FSFI-19 cut point of ≥21 should be considered to describe normal sexual function in periand postmenopausal women as opposed to the standard cut point of >26.6. Video summary: http://links.lww.com/MENO/A915.Item Using an FSDS-R Item to Screen for Sexually Related Distress: A MsFLASH Analysis(2015) Carpenter, Janet S.; Reed, Susan D.; Guthrie, Katherine A.; Larson, Joseph C.; Newton, Katherine M.; Lau, R. Jane; Learman, Lee A.; Shifren, Jan L.Introduction The Female Sexual Distress Scale-Revised (FSDS-R) was created and validated to assess distress associated with impaired sexual function, but it is lengthy for use in clinical practice and research when assessing sexual function is not a primary objective. Aim The study aims to evaluate whether a single item from the FSDS-R could be identified to use to screen midlife women for bothersome diminution in sexual function based on three criteria: (i) highly correlated with total scores; (ii) correlated with commonly assessed domains of female sexual functioning; and (iii) able to differentiate between women reporting high and low sexual concerns during the prior month. Methods Data from 93 midlife women were collected by the Menopause Strategies Finding Lasting Answers to Symptoms and Health (MsFLASH) research network. Main Outcome Measures Women completed the FSDS-R, Female Sexual Function Index (FSFI), and Menopausal Quality of Life Scale (MENQOL). Those who reported a change in the past month on the MENQOL sexual were categorized into a high sexual concerns group, while all others were categorized into a low sexual concerns group. Results Women were an average of 54.6 years old (SD 3.1) and mostly Caucasian (77.4%), college educated (60.2%), married/living as married (64.5%), and postmenopausal (79.6%). The FSDS-R item number 1 “Distressed about sex life” was: (i) highly correlated with FSDS-R total scores (r = 0.90); (ii) moderately correlated with FSFI total scores (r = −0.38) and FSFI desire (r = −0.37) and satisfaction domains (r = −0.40); and (iii) showed one of the largest mean differences between high and low sexual concerns groups (P < 0.001). Other FSDS-R items met one or two, but not all three of the prespecified criteria (i, ii, iii). Conclusions A single FSDS-R item may be a useful screening tool to quickly identify midlife women with sexually related distress when it is not feasible to administer the entire scale, though further validation is warranted.