Publications

PURPOSE: Orthostatic intolerance is a category of disorders characterized by inadequate hemodynamic compensation upon standing. In this study, we developed a portable, active abdominal compression binder intended for individuals with orthostatic intolerance. We present proof-of-concept evidence in healthy volunteers demonstrating the binder's ability to provide consistent abdominal compression, reduce tachycardic response upon standing, and maintain user comfort.

METHODS: We designed and fabricated a novel active binder that applies motor-driven abdominal compression upon the detection of standing. Twenty healthy volunteers (ages 18-50 years) completed three randomized supine-to-standing trials: no binder, a commercial passive binder, and the novel active binder. Throughout each trial, compression pressure, heart rate, and respiration were continuously monitored and comfort was assessed via post-trial Likert-scale survey.

RESULTS: The active binder achieved a higher mean compression pressure (≈ 11 mmHg) with significantly lower intersubject variability (standard deviation (SD) ≈ 1 mmHg) than the passive binder (mean ≈ 8 mmHg; SD ≈ 3 mmHg). Active compression reduced the standing heart rate by 4.4 bpm compared to control (p < 0.05) vs. a 1 bpm reduction with the passive binder (p > 0.05). Neither the active nor the passive abdominal binders impeded respiration. Survey responses demonstrated that the active binder was at least as comfortable as the passive and was rated easier to don.

CONCLUSION: These findings suggest that active abdominal compression may serve as a more efficacious, consistent, and user-friendly alternative to passive binders for mitigating orthostatic intolerance.

CLINICAL TRIAL NUMBER: Not applicable.

Vulvodynia, vulvar pain of unknown etiology, lasting 3 months or longer, affects 7% of American women, and has no consistently effective treatment. We aimed to test the efficacy of acupuncture on vulvar pain and dyspareunia and explore the duration of the effect in a double-blind randomized controlled trial of acupuncture for vulvodynia. 89 women, 19-62 years old (mean 30.2 ± 8.3), 70% White, 20% Hispanic; 91% completed a 13-needle, 10-session standardized acupuncture protocol using double-blind acupuncture needles. Average Pain Intensity of vulvar pain (API, 0-10 scale) and dyspareunia (Female Sexual Function Index) were measured at baseline and after the 10th treatment. Participants with a clinically important post-treatment improvement reported weekly Tampon Test scores (0-10), a measure of provoked vulvar pain, until they returned to baseline. Percentage of responders was similar: acupuncture 58%, placebo 57%; no significant differences were found between acupuncture and placebo groups on API or dyspareunia upon completion of treatments. Responders showed a consistently higher rate of return to baseline pain during the 12-week post-treatment follow-up in the placebo group compared to the acupuncture group (hazard ratio: 2.72, 95% CI: 1.13-6.54). Effects of acupuncture on vulvodynia may have been underestimated because of the strong placebo response from the skin-touch placebo needles. Among responders, the relatively large placebo effect did not persist for as many participants as the therapeutic effect of penetrating acupuncture during the 12-week follow up. Findings indicate investigations into the effects among acupuncture responders and non-responders are warranted. Findings also merit larger, pragmatic trials. PERSPECTIVE: Double-blind RCT of acupuncture for vulvodynia tested vulvar pain and dyspareunia and explored the duration of effect. Penetrating acupuncture and skin-touch placebo needle groups had pain reduction, not significantly different between groups. Pain reduction lasted longer for significantly more responders in the penetrating acupuncture vs. skin-touch placebo groups.

INTRODUCTION: Women ≥70 years with low-risk breast cancer face nuanced therapy decisions. Using qualitative analysis, we aimed to determine how oncologists and patients integrate geriatric considerations into complex treatment conversations.

MATERIALS AND METHODS: We recruited women aged ≥70, newly diagnosed with clinical T1-2N0 hormone receptor-positive/HER2-negative disease between October 2020 and March 2023 from a large cancer center and audio-recorded and transcribed their consults with surgical, medical, and radiation oncologists. We identified geriatric issues included in conversational content and the dynamics of patient/oncologist communication. Data collection and analysis were simultaneously performed. We also assessed participant decision-making preferences, frailty, and life expectancy.

RESULTS: Of 48 eligible patients approached, 27 (56 %) participated with eight surgical oncologists, 17 with 11 medical oncologists, and four with three radiation oncologists (n = 48 consultations recorded). Fourteen patients (48 %) were ≥ 75 years, 23 were non-Hispanic White (76 %). Patients preferred to share (n = 15, 58 %) or make their own treatment decisions (n = 10, 39 %), rather than defer to the oncologist. Oncologists presented an explicit treatment choice in 16 conversations (35 %). Chronological age was discussed in 27 (56 %) conversations, comorbidities in 44 (92 %), and multimorbidity in two (4 %). Other geriatric considerations were discussed in the minority of conversations [physiologic age: 20 (42 %); function: 20 (42 %); quality-of-life: 5 (10 %); life expectancy: 5 (10 %); polypharmacy: 2 (4 %)].

DISCUSSION: Despite numerous treatment options, oncologists neither commonly offer older women with low-risk breast cancer explicit treatment choices, nor discuss geriatric issues besides comorbidity. Training oncologists in communication around geriatric issues may lead to more person-centered breast cancer care.

BackgroundMessaging strategies hold promise to reduce breast cancer overscreening. However, it is not known whether they may have differential effects among medical maximizers who prefer to take action about their health versus medical minimizers who prefer to wait and see.MethodsIn a randomized controlled survey experiment that included 2 sequential surveys with 3,041 women aged 65+ y from a US population-based online panel, we randomized participants to 1) no messages, 2) single exposure to a screening cessation message, or 3) 2 exposures over time to the screening cessation message. We assessed support for stopping screening in a hypothetical patient and intention to stop screening oneself on 7-point scales, where higher values indicated stronger support and intentions to stop screening. We conducted stratified analyses by medical-maximizing preference and moderation analysis.ResultsOf the women, 40.7% (n = 1,238) were medical maximizers; they had lower support and intention for screening cessation in all groups compared with the medical minimizers. Two message exposures increased support for screening cessation among medical maximizers, with a mean score of 3.68 (95% confidence interval [CI] 3.51-3.85) compared with no message (mean score 2.20, 95% CI 2.00-2.39, P < 0.001). A similar pattern was seen for screening intention. Linear regression models showed no differential messaging effect by medical-maximizing preference.ConclusionsMedical maximizers, although less likely to support screening cessation, were nonetheless responsive to messaging strategies designed to reduce breast cancer overscreening.HighlightsIt is not known if a message on rationales for stopping breast cancer screening would have differential effects among medical maximizers who prefer to take action when it comes to their health versus medical minimizers who prefer to wait and see.In a 2-wave randomized controlled survey experiment with 3,041 older women, we found that medical maximizers, although less likely to support screening cessation compared with medical minimizers, were nonetheless responsive to the messaging intervention, and the magnitude of the intervention effect was similar between maximizers and minimizers.Medical maximizers reported higher levels of worry and annoyance after reading the message compared with the minimizers, but the absolute levels of worry and annoyance were low.Our findings suggest that messaging can be a useful tool for reducing overscreening even in a highly reluctant population.

Background: Circulating sphingolipids have been implicated in central nervous system degenerative disorders, but their relationship with peripheral neuropathy remains unclear. Objectives: To evaluate associations between plasma sphingolipid levels and subsequent loss of vibration and light pressure sensation in the lower limbs of older adults. Methods: Plasma concentrations of 11 ceramide (Cer) and sphingomyelin (SM) species were measured in stored samples from 4612 participants in the Cardiovascular Health Study. Vibration sensation was assessed 4-6 years later in 2208 individuals using tuning fork testing, and light pressure sensation was evaluated 11-13 years later in 815 participants using monofilament testing. Sensory impairment was graded on a 3-point scale, with higher scores indicating greater loss. Ordinal logistic regression models examined associations between a doubling of sphingolipid levels and sensory decline, with stratification by diabetes status. Results: In primary models, no sphingolipid species showed significant associations with sensory outcomes. However, after adjusting for inflammatory markers, higher SM-16 levels were linked to increased odds of vibration sensation loss (OR 2.08; 95% CI: 1.11-3.90), while higher SM-24 levels were associated with reduced odds (OR 0.68; 95% CI: 0.46-0.998). Significant interactions with diabetes status were observed for light pressure sensation: SM-14 was associated with increased odds of sensory loss in participants with incident diabetes (OR 5.22; 95% CI: 1.58-17.29), and Cer-18 was associated with increased odds in those with prevalent diabetes (OR 2.38; 95% CI: 1.18-4.78). Conclusions: Elevated levels of specific ceramide and sphingomyelin species may be predictive of future peripheral sensory loss in older adults, with diabetes status influencing these associations.

Atherosclerotic renal artery stenosis (RAS) affects nearly 7% of adults over age 65 and is associated with increased cardiovascular and renal morbidity. Although early observational studies suggested benefit from renal artery stenting, subsequent randomized trials failed to show improvement in major clinical endpoints, contributing to substantial declines in procedural use. To characterize contemporary practice, we conducted a retrospective cohort study of Medicare beneficiaries older than 65 years who underwent renal artery stenting for atherosclerotic RAS between 2016 and 2020. Using Medicare claims data, we evaluated baseline characteristics, temporal utilization, and post-procedural outcomes, stratified by race, geographic region, and dual Medicare-Medicaid enrollment status. Among 19,130 patients, the mean age was 76.0 years (±6.4), 59.2% were female, and 90.3% were White; 84.2% had chronic kidney disease and 48.7% had heart failure. Procedural rates declined by 41.1% over the study period. Compared with White patients, Black patients had higher adjusted risks of hypertensive crisis hospitalization (aHR 1.45, 95% CI 1.24-1.70) and dialysis initiation (aHR 1.78, 95% CI 1.39-2.27); patients of Other races also had greater risk of dialysis initiation (aHR 1.98, 95% CI 1.50-2.63). Patients in the South experienced higher unadjusted cardiovascular event rates (50.0%) but similar adjusted mortality compared with those in the Northeast (aHR 1.09, 95% CI 0.98-1.21). Dual enrollment was associated with increased all-cause mortality (aHR 1.31, 95% CI 1.20-1.43). In conclusion, renal artery stenting rates continued to decline in recent years, and contemporary recipients constitute an older, comorbid population with substantial cardiovascular risk. Outcomes differed markedly by race, socioeconomic status, and geography, highlighting the need for improved risk stratification and prospective evaluation of stenting in high-risk cohorts.

PURPOSE: Fear of cancer recurrence (FCR) is highly common and, if poorly managed, can be distressing and impairing. We developed a virtual, mind-body resiliency intervention for fear of cancer recurrence in survivorship (IN FOCUS), which was shown to be feasible and improved FCR post-intervention. This report aimed to describe coping processes associated with FCR and effects of IN FOCUS on coping over time.

METHOD: A single-blinded, 2-arm, randomized controlled trial was conducted from July 2021 to March 2022 comparing IN FOCUS (8 weekly, 90-minute, synchronous virtual group classes teaching cognitive behavioral techniques, relaxation training, meditation, adaptive health behaviors, and positive psychology skills) to usual care (synchronous virtual community group support referral) among cancer survivors with non-metastatic disease and clinically elevated FCR (FCR Inventory severity ≥16). Measures included coping styles (Brief COPE) and perceived coping skills (Measure of Current Status-Part A). Intent-to-treat analyses with separate general linear mixed models were used to identify group-by-time effects (Cohen's d; 0.5 a medium effect, 0.8 a large effect) from baseline through 2 months and 5 months.

RESULTS: Sixty-four survivors enrolled (age M = 52 years, time since completing primary cancer treatment M = 5 years). By 5 months, survivors randomized to IN FOCUS (vs usual care) demonstrated multiple effects on coping in the medium to large range. Compared to usual care, IN FOCUS increased problem-focused coping, such as using instrumental support (d = 0.60), planning (d = 0.60), positive reframing (d = 0.48), and active coping (d = 0.45). Similarly, IN FOCUS improved emotion-focused coping, specifically venting (d = 0.70), acceptance (d = 0.58), humor (d = 0.50), and religion (d = 0.48). IN FOCUS also enhanced survivors' coping confidence (d = 0.79), relaxation skills (d = 0.57), and assertiveness (d = 0.46). Avoidance-focused coping and awareness of physical tension exhibited less robust changes by 5 months.

CONCLUSIONS: Cancer survivors can enhance multiple aspects of coping with FCR through interventions such as IN FOCUS that teach mind-body resiliency techniques.

BACKGROUND: There is growing interest in understanding the link between early life exposures to ambient air pollution and childhood blood pressure; however, existing findings, largely from single site/cohort studies, are inconclusive.

METHODS: We examined the association between exposures to fine particulate matter (PM2.5) and nitrogen dioxide (NO2) and blood pressure measured at age 5-12 years in 4863 U.S. children from 20 pregnancy cohorts of the NIH ECHO cohort. Point-based residential exposures were derived from spatiotemporal models with a biweekly resolution and averaged over each trimester, the whole pregnancy, and child age 0-2 years. We converted systolic (SBP) and diastolic blood pressure (DBP) to age-, sex-, and height-specific percentiles and classified children with SBP and/or DBP ≥ 90th percentile as high blood pressure (HBP). Associations of PM2.5 (per 5-μ g/m3) or NO2 (per 10-ppb) exposures with blood pressure outcomes were estimated using linear and Poisson regressions adjusted for sociodemographic, lifestyle, temporal, and spatial confounders.

RESULTS: Across windows, mean PM2.5 ranged from 7.6 to 7.9 μ g/m3, and mean NO2 ranged was 8.1-8.8 ppb. We found positive associations of PM2.5 in the first trimester with SBP percentile (β: 1.92, 95 %CI: 0.02, 3.83) and risk of HBP (RR: 1.16, 95 %CI: 1.02, 1.33). Higher PM2.5 exposures averaged over pregnancy and age 0-2 years were also related to elevated SBP percentiles and a higher risk of HBP, but with lower precision. Contrary to our hypotheses, inverse associations of pregnancy average NO2 with both SBP (β: -2.42, 95 %CI: -4.70, -0.14) and DBP (β: -1.94, 95 %CI: -3.81, -0.08) percentiles were suggested.

CONCLUSION: Results reinforce the detrimental effects of PM2.5 on childhood cardiometabolic health, even at low exposure levels. Such findings can inform regulatory policy on acceptable air pollution levels and appropriate controls. The inverse association between prenatal NO2 and blood pressure was counterintuitive and warrants further investigation.

BACKGROUND: Hypertension, a major contributor to cardiovascular mortality, requires multimodal monitoring and management strategies for optimal blood pressure (BP) control. Patients are turning toward mobile health (mHealth) applications to manage hypertension which vary widely in design and regulation. This study examines the landscape of hypertension mHealth applications on Apple's App Store and Google's Play Store and qualitatively evaluates their functionality and security features from patient and clinician perspectives.

METHODS: Publicly available applications were identified using keyword "hypertension" on the Apple App Store and Google Play Store or in a recent meta-analysis that met specific review criteria. Applications with <1,000 reviews (Apple Store) or < 10,000 reviews (Google Play Store) were excluded to capture the top 5% of applications with high public use. Of > 700 applications, 43 underwent full application screening and eighteen were reviewed for general information, storage, revenue models, security, patient/clinician interfaces, and associated research. Discrepancies were resolved through consensus and available manufacturer confirmation.

RESULTS: Clinician interfaces were largely absent, with limited EMR integration and alert systems. Revenue models ranged from free to subscription-based. Security and data privacy policies varied with applications lacking clear opt-out options for data collection. Patient interfaces offered BP tracking and reminders, and accessibility features. Sentiment analysis showed an overall positive view of frequently reviewed Google Play Store applications.

CONCLUSIONS: Current mHealth applications lack several features for optimal hypertension monitoring and management. Based on the range of qualitative application features assessed, we formulate a framework for developing an ideal mHealth application for optimal hypertension management.

BACKGROUND: Frailty is a proxy for biologic aging that confers risk independently of chronologic age. Most frailty indices correlate strongly with chronologic age, making independent features of biologic aging challenging to identify.

METHODS: We aimed to create a novel Age Less-Dependent Frailty (AGELESS) Score less-associated with chronologic age than the Fried frailty phenotype. Among Cardiovascular Health Study participants with available echocardiographic data, we identified demographic, clinical, serologic, and echocardiographic variables more correlated with a continuous version of the Fried frailty phenotype than age, then used LASSO regression for variable selection. In a 25% leave-out sample, we internally validated the score's association with age-adjusted all-cause and cardiovascular mortality and compared model characteristics with the Fried frailty phenotype.

RESULTS: In 4,029 individuals (mean age 72 ± 5.0 years, 59.6% female), serum cystatin C, depression, diabetes, educational attainment, forced expiratory volume in 1 s, and income were more associated with frailty than age and selected for inclusion in the AGELESS Score. Adjusted for age, individuals in the highest vs. lowest quartiles of the AGELESS Score had a higher risk of all-cause (HR: 1.44, 95% CI: 1.17-1.79, p < 0.001) and CV death (HR: 1.64, 95% CI: 1.43-1.87, p = 0.002). The AGELESS Score was less correlated with age (AGELESS r = 0.23, 95% CI: 0.16-0.30; Fried r = 0.28, 95% CI: 0.21-0.34; p-value for comparison of correlations < 0.001) and more closely associated with all-cause and CV mortality within each age quartile than the Fried frailty phenotype.

CONCLUSIONS: We derived and internally validated a novel frailty score that is less associated with chronologic age than existing indices and predicts mortality within age strata better than the existing reference standard for phenotypic frailty. This score could help identify high-risk patients with frailty across the age spectrum and may provide insights into mechanisms of biologic aging.