The Integration of Clinical Trials With the Practice of Medicine: Repairing a House Divided.

Importance: Optimal health care delivery, both now and in the future, requires a continuous loop of knowledge generation, dissemination, and uptake on how best to provide care, not just determining what interventions work but also how best to ensure they are provided to those who need them. The randomized clinical trial (RCT) is the most rigorous instrument to determine what works in health care. However, major issues with both the clinical trials enterprise and the lack of integration of clinical trials with health care delivery compromise medicine's ability to best serve society. Observations: In most resource-rich countries, the clinical trials and health care delivery enterprises function as separate entities, with siloed goals, infrastructure, and incentives. Consequently, RCTs are often poorly relevant and responsive to the needs of patients and those responsible for care delivery. At the same time, health care delivery systems are often disengaged from clinical trials and fail to rapidly incorporate knowledge generated from RCTs into practice. Though longstanding, these issues are more pressing given the lessons learned from the COVID-19 pandemic, heightened awareness of the disproportionate impact of poor access to optimal care on vulnerable populations, and the unprecedented opportunity for improvement offered by the digital revolution in health care. Four major areas must be improved. First, especially in the US, greater clarity is required to ensure appropriate regulation and oversight of implementation science, quality improvement, embedded clinical trials, and learning health systems. Second, greater adoption is required of study designs that improve statistical and logistical efficiency and lower the burden on participants and clinicians, allowing trials to be smarter, safer, and faster. Third, RCTs could be considerably more responsive and efficient if they were better integrated with electronic health records. However, this advance first requires greater adoption of standards and processes designed to ensure health data are adequately reliable and accurate and capable of being transferred responsibly and efficiently across platforms and organizations. Fourth, tackling the problems described above requires alignment of stakeholders in the clinical trials and health care delivery enterprises through financial and nonfinancial incentives, which could be enabled by new legislation. Solutions exist for each of these problems, and there are examples of success for each, but there is a failure to implement at adequate scale. Conclusions and Relevance: The gulf between current care and that which could be delivered has arguably never been wider. A key contributor is that the 2 limbs of knowledge generation and implementation-the clinical trials and health care delivery enterprises-operate as a house divided. Better integration of these 2 worlds is key to accelerated improvement in health care delivery.

Menopause hormone therapy prescribing in ambulatory care visits among midlife and older U.S. women from 2018 to 2019.

The rates of prescription for menopause hormone therapy have been low in the U.S. since the 2002 Women's Health Initiative study, but no recent studies have assessed the prescribing of hormone therapy in the U.S. Using the National Ambulatory Medical Care Survey data from 2018 to 2019, we found that hormone therapy was prescribed in 3.8 % of U.S. visits by midlife and older women, with 60 % of these visits including estradiol-only prescriptions. Older age and Hispanic/Latina ethnicity were associated with decreased odds of prescribing, while White race and depression were associated with increased odds, indicating possible disparities in menopause care.

Older adults with overlapping caregiving responsibilities and care needs in a U.S. national community-based sample.

BACKGROUND: Community-dwelling older adults often serve as caregivers despite having their own health concerns and disabilities, yet little is known about their care needs. METHODS: Cross-sectional analysis including community-dwelling U.S. adults over age 60 years who self-identified as caregivers in the National Social Life, Health, and Aging Project in 2015-2016. Caregiving was defined by self-reported assistance of another adult with day-to-day activities due to age or disability; overlapping care-receiving was defined by simultaneous receipt of help for at least one activity of daily living (ADL) or independent ADL (IADL). Multivariable logistic regression models examined attributes associated with overlapping care-receiving among older caregivers, adjusted for caregiver characteristics (age, gender, spousal caregiving, self-reported physical and mental health, cognitive function, and household assets). RESULTS: Among the 444 caregivers, the mean age was 67.8 (SD 0.29) years, 55.8% were women, 78.1% were non-Hispanic White, 54.7% self-identified as primary caregivers, and 30.7% were caring for a spouse. Thirty-two percent of older caregivers were caregiving while themselves receiving assistance with at least one ADL or IADL. Thirty-four percent of caregivers reported <$50,000 in household assets and 10% did not answer the question. Given prior research that supports that most nonrespondents fall into the low-income group, subjects were combined. Analyses with and without nonrespondents did not substantially change the results. Compared to caregivers who were not simultaneously receiving care, caregivers reporting overlapping care-receiving had greater odds of being older (AOR 1.30, 95% confidence interval [CI] [1.14, 1.48] per each 5-year age increase), caregiving for a spouse (AOR 1.93, 95% CI [1.20, 3.13]), having limited household assets (AOR 2.10, 95% CI [1.17, 3.80], for <$50,000 compared to ≥$50,000), and having poor or fair self-reported physical health (AOR 2.94, 95% CI [1.43, 6.02]). CONCLUSIONS: Over 30% of older adult caregivers report simultaneously receiving care for their own daily activities. Older caregivers who receive care are more likely to be older, spousal caregivers, and have limited assets and worse physical health. Targeted strategies are needed to support older caregivers who are uniquely vulnerable due to their overlapping care needs.

Military Sexual Trauma and Menopause Symptoms Among Midlife Women Veterans.

BACKGROUND: Sexual assault and/or sexual harassment during military service (military sexual trauma (MST)) can have medical and mental health consequences. Most MST research has focused on reproductive-aged women, and little is known about the long-term impact of MST on menopause and aging-related health. OBJECTIVE: Examine associations of MST with menopause and mental health outcomes in midlife women Veterans. DESIGN: Cross-sectional. PARTICIPANTS: Women Veterans aged 45-64 enrolled in Department of Veterans Affairs (VA) healthcare in Northern California between March 2019 and May 2020. MAIN MEASURES: Standardized VA screening questions assessed MST exposure. Structured-item questionnaires assessed vasomotor symptoms (VMS), vaginal symptoms, sleep difficulty, depressive symptoms, anxiety symptoms, and posttraumatic stress disorder (PTSD) symptoms. Multivariable logistic regression analyses examined associations between MST and outcomes based on clinically relevant menopause and mental health symptom thresholds. KEY RESULTS: Of 232 participants (age = 55.95 ± 5.13), 73% reported MST, 66% reported VMS, 75% reported vaginal symptoms, 36% met criteria for moderate-to-severe insomnia, and almost half had clinically significant mental health symptoms (33% depressive symptoms, 49% anxiety, 27% probable PTSD). In multivariable analyses adjusted for age, race, ethnicity, education, body mass index, and menopause status, MST was associated with the presence of VMS (OR 2.44, 95% CI 1.26-4.72), vaginal symptoms (OR 2.23, 95% CI 1.08-4.62), clinically significant depressive symptoms (OR 3.21, 95% CI 1.45-7.10), anxiety (OR 4.78, 95% CI 2.25-10.17), and probable PTSD (OR 6.74, 95% CI 2.27-19.99). Results did not differ when military sexual assault and harassment were disaggregated, except that military sexual assault was additionally associated with moderate-to-severe insomnia (OR 3.18, 95% CI 1.72-5.88). CONCLUSIONS: Exposure to MST is common among midlife women Veterans and shows strong and independent associations with clinically significant menopause and mental health symptoms. Findings highlight the importance of trauma-informed approaches to care that acknowledge the role of MST on Veteran women's health across the lifespan.

Spatial clusters of extended-spectrum beta-lactamase-producing Escherichia coli causing community-onset bacteriuria due to repeat infections: cluster analysis from a large urban medical center, San Francisco, 2014-2020.

BACKGROUND: Urinary tract infections caused by extended-spectrum beta-lactamase (ESBL)-producing Escherichia coli (ESBL-E. coli) may occur as outbreaks due to common-source exposures. Yet, it is currently unknown if they cluster geographically as would be expected as part of an outbreak. METHODS: We collected electronic health record data on all patients living in San Francisco with culture-documented community-onset E. coli bacteriuria in a safety-net public healthcare system from January 2014 to March 2020 (diagnosed < 48 h after hospital admission or in outpatient clinical settings without a hospitalization in the past 90 days). We assessed the presence of spatial clusters of (1) ESBL-E. coli bacteriuria episodes, and (2) individuals with any ESBL-E. coli bacteriuria episode, with Global and Local Moran's I. We evaluated differences in prevalence of bacteriuria recurrence by ESBL-production by Poisson regression. RESULTS: Out of 4,304 unique individuals, we identified spatial clusters of ESBL-E. coli bacteriuria episodes (n = 461) compared to non-ESBL-E. coli bacteriuria episodes (n = 5477; Global Moran's p < 0.001). Spatial clusters of individuals with any bacteriuria caused by ESBL-E. coli were not identified (p = 0.43). Bacteriuria recurrence was more likely to occur with ESBL-E. coli (odds ratio [OR] 2.78, 95% confidence interval [95% CI] 2.10, 3.66, p < 0.001), particularly after an initial ESBL-E. coli bacteriuria episode (OR 2.27, 95% CI 1.82, 2.83, p < 0.001). CONCLUSION: We found spatial clusters of ESBL-E. coli bacteriuria episodes. However, this was partly explained by clustering within individuals more than between individuals, as having an ESBL-E. coli bacteriuria was associated with recurrence with ESBL-E. coli. These findings may help better tailor clinical treatment of patients with recurrent urinary tract infections after an initial episode caused by ESBL-E. coli.

Adverse Childhood Experiences and Aging-Associated Functional Impairment in a National Sample of Older Community-Dwelling Adults.

BACKGROUND: Prior research on the health implications of adverse childhood experiences (ACEs) has focused on early or midlife adults, not older adults who bear the greatest burden of health-related functional impairment. OBJECTIVE: To examine associations between ACEs, objectively measured physical mobility and cognitive impairment, and functional disability in older community-dwelling adults. DESIGN: Cross-sectional analysis. PARTICIPANTS: Community-dwelling older U.S. adults ages 50 years and older. MAIN MEASURES: Participants completed structured questionnaires assessing history of ACEs (childhood experience of violence/abuse, witnessing of violence, financial insecurity, parental separation, or serious illness), underwent standardized physical performance testing (tandem balance, 3-m walk, chair stand test) and cognitive testing (survey adaptation of the Montreal Cognitive Assessment), and reported functional disability (difficulty with activities of daily living). KEY RESULTS: Among the 3387 participants (aged 50 to 97 years; 54% female), 44% reported a history of one or more types of ACEs. Thirty-five percent met criteria for physical mobility impairment, 24% for cognitive impairment, and 24% for functional disability. After adjusting for age, gender, race, and ethnicity, participants reporting any ACE history were more likely to demonstrate physical mobility impairment (OR 1.30, 95% CI 1.11-1.52) and cognitive impairment (OR 1.26, 95% CI 1.03-1.54) and report functional disability (OR 1.69, 95% CI 1.38-2.07), compared to those with no ACE history. Childhood experience of violence was associated with greater physical mobility impairment (OR 1.38, 95% CI 1.11-1.71) and functional disability (OR 1.86, 95% CI 1.49-2.33). CONCLUSIONS: Older adults with a history of ACEs are more likely to experience physical and cognitive functional impairment, suggesting that efforts to mitigate ACEs may have implications for aging-associated functional decline. Findings support the need for trauma-informed approaches to geriatric care that consider the potential role of early life traumatic experiences in shaping or complicating late-life functional challenges.

Total and free 25-hydroxyvitamin D concentrations and risk of urinary incontinence in women participating in Nurses Health Studies I & II.

BACKGROUND: Urgency urinary incontinence (UUI) occurs in >40% of older women. Our objective was to examine the relationship of total and free plasma 25-hydroxyvitamin D (25(OH)D) and UUI to evaluate vitamin D status as a novel target for prevention of UUI. METHODS: We conducted a nested case control study using the Nurses' Health Study (NHS) and NHS II. Using stored plasma samples from 2000, we measured total 25(OH)D, free 25(OH)D, and intact parathyroid hormone (PTH) levels and examined their relationship to incident UUI from 2000 to 2013. Plasma biomarker levels were categorized as quartiles. Multivariable-adjusted odds ratios of UUI were estimated by conditional logistic regression models (with matching by age) across categories of each biomarker and covariates. RESULTS: The analytic sample included 398 cases of incident UUI and 398 matched controls with a mean age of 50 years. We found a strong correlation of plasma levels of total 25(OH)D with free 25(OH)D (r=0.5). Plasma total 25(OH)D and free 25(OH)D concentrations were negatively correlated with PTH (r=-0.08 AND -0.09, respectively). Overall, we found no evidence that levels of total plasma 25(OH)D, free 25(OH)D, or PTH were related to incident UUI after adjustment for obesity, physical activity, cigarette smoking, menopausal status, hypertension, and type 2 diabetes. CONCLUSIONS: Free plasma 25(OH)D by quartile, as well as total plasma 25(OH)D, was not associated with incident UUI in women. We found that plasma total and free 25(OH)D were highly correlated with each other and inversely correlated with PTH. Plasma free 25(OH)D did not provide additional predictive value in determining risk of UUI.

Efficacy of Continuous Transdermal Nitroglycerin for Treating Hot Flashes by Inducing Nitrate Cross-tolerance in Perimenopausal and Postmenopausal Women: A Randomized Clinical Trial.

Importance: Due to the potential risks of long-term systemic estrogen therapy, many menopausal women are interested in nonhormonal treatments for vasomotor symptoms. Physiologic studies indicate that nitric oxide plays a key role in mediating hot flash-related vasodilation, suggesting that nonhormonal medications that induce nitrate tolerance in the vasculature may offer therapeutic benefit for vasomotor symptoms. Objective: To determine whether uninterrupted administration of transdermal nitroglycerin (NTG) to induce nitrate cross-tolerance decreased the frequency or severity of menopause-related hot flashes. Design, Setting, and Participants: This randomized, double-blinded, placebo-controlled clinical trial included perimenopausal or postmenopausal women reporting 7 or more hot flashes per day who were recruited from northern California by study personnel at a single academic center. Patients were randomized between July 2017 and December 2021, and the trial ended in April 2022 when the last randomized participant completed follow-up. Interventions: Uninterrupted daily use of transdermal NTG (participant-directed dose titration from 0.2-0.6 mg/h) or identical placebo patches. Main Outcome Measures: Validated symptom diaries assessing changes in any hot flash frequency (primary outcome) and moderate-to-severe hot flash frequency over 5 and 12 weeks. Results: Among the 141 randomized participants (70 NTG [49.6%], 71 placebo [50.4%]; 12 [85.8%] Asian, 16 [11.3%] Black or African American, 15 [10.6%] Hispanic or Latina, 3 [2.1%] multiracial, 1 [0.7%] Native Hawaiian or Pacific Islander, and 100 [70.9%] White or Caucasian individuals), a mean (SD) of 10.8 (3.5) hot flashes and 8.4 (3.6) moderate-to-severe hot flashes daily was reported at baseline. Sixty-five participants assigned to NTG (92.9%) and 69 assigned to placebo (97.2%) completed 12-week follow-up (P = .27). Over 5 weeks, the estimated change in any hot flash frequency associated with NTG vs placebo was -0.9 (95% CI, -2.1 to 0.3) episodes per day (P = .10), and change in moderate-to-severe hot flash frequency with NTG vs placebo was -1.1 (95% CI, -2.2 to 0) episodes per day (P = .05). At 12 weeks, treatment with NTG did not significantly decrease the frequency of any hot flashes (-0.1 episodes per day; 95% CI, -1.2 to 0.4) or moderate-to-severe hot flashes (-0.5 episodes per day; 95% CI, -1.6 to 0.7) relative to placebo. In analyses combining 5-week and 12-week data, no significant differences in change in the frequency of any hot flashes (-0.5 episodes per day; 95% CI, -1.6 to 0.6; P = .25) or moderate-to-severe hot flashes (-0.8 episodes per day; 95% CI, -1.9 to 0.2; P = .12) were detected with NTG vs placebo. At 1 week, 47 NTG (67.1%) and 4 placebo participants (5.6%) reported headache (P < .001), but only 1 participant in each group reported headache at 12 weeks. Conclusions and Relevance: This randomized clinical trial found that continuous use of NTG did not result in sustained improvements in hot flash frequency or severity relative to placebo and was associated with more early but not persistent headache. Trial Registration: Clinicaltrials.gov Identifier: NCT02714205.

TReating Incontinence for Underlying Mental and Physical Health (TRIUMPH): a study protocol for a multicenter, double-blinded, randomized, 3-arm trial to evaluate the multisystem effects of pharmacologic treatment strategies for urgency-predominant urinary incontinence in ambulatory older women.

BACKGROUND: Urgency-type urinary incontinence affects one in four older community-dwelling women and overlaps with other common aging-associated health syndromes such as cognitive impairment, physical mobility impairment, and depression. Observational studies have raised concern about potentially higher rates of delirium and dementia in older adults taking anticholinergic bladder medications, but few prospective data are available to evaluate the effects of these and other pharmacologic treatments for urgency incontinence on cognition and other multisystem functional domains important to older women. METHODS: The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial comparing the multisystem effects of anticholinergic versus beta-3-adrenergic agonist bladder therapy and versus no active bladder anti-spasmodic pharmacotherapy in older women with urgency incontinence. Women aged 60 years and older (target N = 270) who have chronic urgency-predominant urinary incontinence and either normal or mildly impaired cognition at baseline are recruited from the community by investigators based in northern California, USA. Participants are randomized in equal ratios to take identically encapsulated oral anticholinergic bladder therapy (in the form of tolterodine 2 mg extended release [ER]), oral beta-3 adrenergic agonist bladder therapy (mirabegron 25 mg ER), or placebo daily for 24 weeks, with the option of participant-directed dose titration (to tolterodine 4 mg ER, mirabegron 50 mg ER, or matching placebo daily). Participants also receive patient-oriented information and instructions about practicing first-line behavioral management strategies for incontinence. The primary outcome is change in composite cognitive function over 24 weeks assessed by a comprehensive battery of cognitive tests, with a secondary exploration of the persistence of change at 36 weeks. Secondary outcomes include changes over 24 and 36 weeks in domain-specific cognitive function; frequency, severity, and impact of urgency-associated urinary symptoms; physical function and balance; sleep quality and daytime sleepiness; psychological function; and bowel function. DISCUSSION: The TRIUMPH trial addresses the need for rigorous evidence to guide counseling and decision-making for older women who are weighing the potential multisystem benefits and risks of pharmacologic treatments for urgency incontinence in order to preserve their day-to-day functioning, quality of life, and independence in older age. TRIAL REGISTRATION: ClinicalTrials.gov NCT05362292. Registered on May 5, 2022.

Lifetime history of interpersonal partner violence is associated with insomnia among midlife women veterans.

OBJECTIVE: Over a third of women in the United States report a lifetime history of intimate partner violence. Although a recent review found that intimate partner violence is related to poor subjective sleep, the majority of studies involved reproductive-aged women and used suboptimal measures of interpersonal violence and/or insomnia. We examined the relationship between lifetime intimate partner violence and current clinical insomnia in a cross-sectional sample of midlife women veterans. METHODS: Cross-sectional data were drawn from the Midlife Women Veterans Health Survey. Women Veterans (N = 232) aged 45 to 64 years enrolled in Department of Veterans Affairs health care in Northern California completed an adapted version of the Extended-Hurt, Insult, Threaten, Scream to assess lifetime history of intimate partner violence (screening threshold score and any physical, sexual, and psychological intimate partner violence) and the Insomnia Severity Index to assess current insomnia. RESULTS: In multivariable analyses, lifetime history of intimate partner violence was associated with twofold to fourfold odds of current clinical insomnia, including overall intimate partner violence (odds ratio, 3.24; 95% confidence interval, 1.57-6.69), physical intimate partner violence (odds ratio, 2.01; 95% confidence interval, 1.09-3.70), psychological intimate partner violence (odds ratio, 3.98; 95% confidence interval, 2.06-7.71), and sexual intimate partner violence (odds ratio, 2.09; 95% confidence interval, 1.08-4.07). CONCLUSIONS: Lifetime history of intimate partner violence is common and may be associated with clinical insomnia during midlife. Findings highlight the importance of screening midlife women for intimate partner violence and recognizing the potential role of this traumatic exposure on women's health.

Elder Mistreatment Experienced by Older Caregiving Adults: Results from a National Community-Based Sample.

BACKGROUND: With an aging population, older adults are increasingly serving as caregivers to others, which may increase their risk of adverse interpersonal experiences. OBJECTIVE: To investigate the prevalence and types of elder mistreatment experienced by older caregiving adults. DESIGN: Cross-sectional analysis PARTICIPANTS: National sample of community-dwelling US adults over age 60 in 2015-2016. MAIN MEASURES: Caregiving (assisting another adult with day-to-day activities) was assessed by interviewer-administered questionnaires. Experience of elder mistreatment was assessed by participant-reported questionnaire in three domains: emotional, physical, and financial. Multivariable logistic regression models examined associations between caregiving status and each domain of elder mistreatment, adjusting for age, race, ethnicity, gender, education, marital status, concomitant care-receiving status, overall physical and mental health, and cognitive function. Additional logistic regression models examined associations between being the primary caregiver (rather than a secondary caregiver) and each domain of mistreatment among older caregivers. KEY RESULTS: Of the 1898 participants over age 60 (including 1062 women and 836 men, 83% non-Hispanic white, and 64% married or partnered), 14% reported serving as caregivers for other adults, including 8% who considered themselves to be the primary caregiver. Among these older caregivers, 38% reported experiencing emotional, 32% financial, and 6% physical mistreatment after age 60. In multivariable models, caregiving was associated with experiencing both emotional mistreatment (AOR 1.61, 95% CI 1.15-2.25) and financial mistreatment (AOR 1.72, 95% CI 1.18-2.50). In analyses confined to caregiving older adults, those who served as primary rather than secondary caregivers for other adults had an over two-fold increased odds of emotional mistreatment (AOR 2.17, 95% CI 1.07, 4.41). CONCLUSION: In this national cohort of older community-dwelling adults, caregiving was independently associated with experiencing emotional and financial mistreatment after age 60. Findings suggest that efforts to prevent or mitigate elder mistreatment should put more emphasis on vulnerable older caregivers.

Effect of Vitamin D Supplementation on Overactive Bladder and Urinary Incontinence Symptoms in Older Men: Ancillary Findings From a Randomized Trial.

PURPOSE: Our goal was to evaluate vitamin D supplementation for preventing or treating overactive bladder and urinary incontinence in men. MATERIALS AND METHODS: Ancillary study of men aged ≥55 years in VITAL (VITamin D and OmegA-3 TriaL). Randomized treatments included: vitamin D3 (cholecalciferol), marine omega-3 fatty acids, or matching placebo. Structured urinary incontinence questions measured the prevalence of overactive bladder at year 5 and urinary incontinence at years 2 and 5, along with incidence and progression of urinary incontinence from years 2 to 5. Prespecified subgroup analyses examined men with low baseline serum 25-hydroxyvitamin D (<20 ng/mL). RESULTS: Among the 11,486 men who provided data at year 2 and 10,474 at year 5, mean age was 68 years at year 2, with 23% racial/ethnic minorities. In primary analyses, vitamin D supplementation compared to placebo did not lower odds of overactive bladder at year 5 (OR 0.97, 95% CI 0.87-1.08) or weekly urinary incontinence at year 2 (OR 0.94, 95% CI 0.83-1.05) or year 5 (OR 0.98, 95% CI 0.88-1.09). We found interactions of baseline serum 25-hydroxyvitamin D level with vitamin D supplementation for overactive bladder (P value for interaction = .001), and secondarily, for any urinary incontinence at year 2 (P value for interaction = .05). Men with baseline 25-hydroxyvitamin D <20 ng/mL, who were assigned to vitamin D supplements, had lower odds of overactive bladder (OR 0.51, 95% CI 0.35-0.76) compared to placebo, yet higher odds of any urinary incontinence (OR 1.24, 95% CI 0.93-1.64). CONCLUSIONS: Overall, vitamin D supplementation did not improve overactive bladder or urinary incontinence compared to placebo. However, specific use of vitamin D in men with lower 25-hydroxyvitamin D levels had inconsistent findings.

Vitamin D supplements and prevalent overactive bladder in women from midlife through older ages.

OBJECTIVE: The objective of this study is to determine if vitamin D supplementation is associated with prevalent overactive bladder (OAB) in women across the aging spectrum. METHODS: We used the Nurses' Health Study (NHS) I (initiated in 1976) and NHS II (initiated in 1989) cohorts to evaluate the association of vitamin D supplements with prevalent OAB, all of which were reported by participants in 2019 in both NHS cohorts. OAB was defined as the self-reported need to rush to toilet to urinate at least sometimes. Further, OAB/wet included incontinence at least monthly because of urgency, whereas OAB/dry included incontinence once per month or less, or stress-predominant incontinence. Multivariable-adjusted odds ratios and 95% confidence intervals of OAB/dry and OAB/wet subtypes were estimated using logistic regression models. RESULTS: Among the 75,316 women (age range, 55-98 y) from NHS and NHS II OAB prevalence was 26%. Increasing prevalence was observed across each older age group, with 41% of women 85 years or older reporting OAB symptoms. OAB/dry was more common (18%) than OAB/wet (8%). After multivariable adjustment, no clinically significant association between vitamin D supplementation and prevalent OAB or OAB type was observed. CONCLUSIONS: OAB symptoms are highly prevalent across adult women, including the oldest old, who are often excluded from treatment trials. Despite interest in vitamin D supplementation as a low-cost strategy to address OAB, our findings indicate oral vitamin D is not associated with prevalent OAB in middle-aged and older women.

Racial/ethnic disparities in the diagnosis and management of menopause symptoms among midlife women veterans.

OBJECTIVE: Racial/ethnic disparities in menopause symptoms and hormone therapy management remain understudied among women served by the Veteran's Health Administration, despite the unique racial/ethnic diversity of this population. Thus, we determined racial/ethnic disparities in medical record-documented menopause symptoms and prescribed menopausal hormone therapy among women veterans. METHODS: We conducted cross-sectional analyses of national Veteran's Health Administration electronic health record data from 2014 to 2015. We used logistic regression models to compare medical-record documented menopause symptoms and treatment (eg, vaginal estrogen or systemic hormone therapy) by self-identified race/ethnicity, adjusting for age, body mass index, and depression. Models examining hormone treatment were adjusted for menopause symptoms. RESULTS: Among 200,901 women veterans (mean age 54.3, SD 5.4 y; 58% non-Hispanic/Latinx White, 33% non-Hispanic/Latinx Black, 4% Hispanic/Latinx, and 4% other), 5% had documented menopause symptoms, 5% were prescribed vaginal estrogen, and 5% were prescribed systemic hormone therapy. In fully adjusted multivariable models, non-Hispanic/Latinx Black women veterans had lower odds of documented menopause symptoms relative to non-Hispanic/Latinx White women (OR 0.82, 95% CI: 0.78-0.86). Moreover, non-Hispanic/Latinx Black women (OR 0.74, 95% CI: 0.70-0.77), as well as Hispanic/Latinx women (OR 0.68, 95% CI: 0.61-0.77), had lower likelihood of systemic hormone therapy prescription. Hispanic/Latinx women had higher odds of vaginal estrogen prescription (OR 1.12 95% CI: 1.02-1.24) than non-Hispanic/Latinx White women. Non-Hispanic/Latinx Black women had lower likelihood of estrogen use (OR 0.78 95% CI: 0.74-0.81) than non-Hispanic/Latinx White women. CONCLUSION: Despite evidence suggesting higher menopause symptom burden among Black women in community samples, documented menopause symptoms and hormone therapy were less common among Black, compared with White, women veterans. Additionally, Hispanic/Latinx women veterans had lower odds of prescribed systemic menopause therapy and yet higher odds of prescribed vaginal estrogen, despite no difference in documented symptoms. These findings may signal important disparities in symptom reporting, documentation, and/or treatment for minority women veterans.

Veterans Health Administration Screening for Military Sexual Trauma May Not Capture Over Half of Cases Among Midlife Women Veterans.

BACKGROUND: Approximately 1 in 3 women veterans endorse military sexual trauma (MST) during Veterans Health Administration (VHA) screening. Higher rates have been reported in anonymous surveys. OBJECTIVE: We compared MST identified by VHA screening to survey-reported MST within the same sample and identified participant characteristics associated with discordant responses. METHODS: Cross-sectional data were drawn from an observational study of women veterans aged 45-64 enrolled in VHA care in Northern California, with data from mail- and web-based surveys linked to VHA electronic health records (EHRs). Between March 2019 and May 2020, participants reported sociodemographic characteristics, current depressive (Patient Health Questionnaire-9) and posttraumatic stress (PTSD checklist for DSM-5) symptoms, and MST (using standard VHA screening questions) in a survey; depression and posttraumatic stress disorder diagnoses (ICD-10 codes) and documented MST were identified from EHRs. Associations between sociodemographic characteristics, mental health symptoms and diagnoses, and discordant MST reports (EHR-documented MST vs. MST reported on survey, not in EHR) were examined with multivariable logistic regression. RESULTS: In this sample of midlife women veterans (n = 202; mean age 56, SD = 5), 40% had EHR-documented MST, and 74% reported MST on the survey. Sociodemographic characteristics, mental health symptoms, and diagnosed depression were not associated with discordant MST responses. Women with an EHR-documented PTSD diagnosis had fivefold higher odds of having EHR-documented MST (vs. survey only; odds ratio 5.2; 95% confidence interval 2.3-11.9). CONCLUSIONS: VHA screening may not capture more than half of women who reported MST on the survey. VHA screening may underestimate true rates of MST, which could lead to a gap in recognition and care for women veterans.

Considerations for integrated cognitive behavioural treatment for older adults with coexisting nocturia and insomnia.

Nocturia and chronic insomnia disorder are common conditions that frequently coexist in older adults. Existing medication treatments for each condition have risks, particularly in older adults. While treatment guidelines recommend starting with behavioural therapy for each condition, no existing program simultaneously addresses nocturia and insomnia. Existing behavioural interventions for nocturia or insomnia contain concordant and discordant components. An expert panel (including geriatricians with sleep or nocturia research expertise, sleep psychologists and a behavioural psychologist) was convened to combine and reconcile elements of behavioural treatment for each condition. Concordant treatment recommendations involve using situational self-management strategies such as urge suppression or techniques to influence homeostatic drive for sleep. Fluid modification such as avoiding alcohol and evening caffeine and regular self-monitoring through a daily diary is also appropriate for both conditions. The expert panel resolved discordant recommendations by eliminating overnight completion of voiding diaries (which can interfere with sleep) and discouraging routine overnight voiding (a stimulus control strategy). The final product is an integrated cognitive behavioural treatment that is delivered by advanced practice providers weekly over 5 weeks. This integrated program addresses the common scenario of coexisting nocturia and chronic insomnia disorder.