The Role of Cryoablation in Breast Cancer Beyond the Oncologic Control: COST and Breast-Q Patient-Reported Outcomes.

BACKGROUND: Cryoablation has been established as a minimally invasive alternative to resection of early-stage breast cancer; however, there are no data on the cost and impact on patients' financial, psychosocial, sexual, physical, and cosmetic outcomes utilizing this approach. This study compares cost-effectiveness and patient-reported quality-of-life factors in cryoablation versus resection. METHODS: Women with early-stage, low-risk infiltrating ductal carcinomas ≤ 1.5 cm underwent cryoablation or resection. Adjuvant therapy was provided according to tumor board recommendations. Direct and indirect costs were tracked for both groups. Financial toxicity and well-being outcome were measured by administering the Comprehensive Score of Financial Toxicity (COST) and BREAST-Q surveys, respectively, at 6-month follow-up. RESULTS: Of the 34 eligible patients, 14 (41.1%) consented for cryoablation and 20 (58.8%) underwent resection. The median (centile) (range) follow-up was 35.0 (21.3) (15-50) months for cryoablation vs. 25 (20.8) (17-50) months for resection [p = 0.6479]. Mean (standard deviation) cost of care for cryoablation versus resection was $2221.70 (615.70) versus $16,896.50 (1332.40) [p < 0.0001], and median financial well-being scores for the cryoablation versus resection groups were 38.0 (34.5, 40.0) versus 10 (5.3, 14.0) [p < 0.0001]. Poor financial well-being was directly correlated with the cost of care [p < 0.0001]. Median psychosocial well-being scores were similar across both groups, however the cryoablation group had higher scores for physical [100 (100, 100) vs. 89 (79, 100); p = 0.0141], sexual [100 (91, 100) vs. 91 (87.5, 91); p = 0.0079], and cosmetic [100 (100, 100) vs. 88 (88, 100); p = 0.0171] outcomes. CONCLUSION: Cryoablation offers a cost-effective and quality-of-life advantage compared with resection for early-stage, low-risk breast cancer.

Multicomponent Pharmacist Intervention Did Not Reduce Clinically Important Medication Errors for Ambulatory Patients Initiating Direct Oral Anticoagulants.

BACKGROUND: Anticoagulants including direct oral anticoagulants (DOACs) are among the highest-risk medications in the United States. We postulated that routine consultation and follow-up from a clinical pharmacist would reduce clinically important medication errors (CIMEs) among patients beginning or resuming a DOAC in the ambulatory care setting. OBJECTIVE: To evaluate the effectiveness of a multicomponent intervention for reducing CIMEs. DESIGN: Randomized controlled trial. PARTICIPANTS: Ambulatory patients initiating a DOAC or resuming one after a complication. INTERVENTION: Pharmacist evaluation and monitoring based on the implementation of a recently published checklist. Key elements included evaluation of the appropriateness of DOAC, need for DOAC affordability assistance, three pharmacist-initiated telephone consultations, access to a DOAC hotline, documented hand-off to the patient's continuity provider, and monitoring of follow-up laboratory tests. CONTROL: Coupons and assistance to increase the affordability of DOACs. MAIN MEASURE: Anticoagulant-related CIMEs (Anticoagulant-CIMEs) and non-anticoagulant-related CIMEs over 90 days from DOAC initiation; CIMEs identified through masked assessment process including two physician adjudication of events presented by a pharmacist distinct from intervention pharmacist who reviewed participant electronic medical records and interview data. ANALYSIS: Incidence and incidence rate ratio (IRR) of CIMEs (intervention vs. control) using multivariable Poisson regression modeling. KEY RESULTS: A total of 561 patients (281 intervention and 280 control patients) contributed 479 anticoagulant-CIMEs including 31 preventable and ameliorable ADEs and 448 significant anticoagulant medication errors without subsequent documented ADEs (0.95 per 100 person-days). Failure to perform required blood tests and concurrent, inappropriate usage of a DOAC with aspirin or NSAIDs were the most common anticoagulant-related CIMEs despite pharmacist documentation systematically identifying these issues when present. There was no reduction in anticoagulant-related CIMEs among intervention patients (IRR 1.17; 95% CI 0.98-1.42) or non-anticoagulant-related CIMEs (IRR 1.05; 95% CI 0.80-1.37). CONCLUSION: A multi-component intervention in which clinical pharmacists implemented an evidence-based DOAC Checklist did not reduce CIMEs. NIH TRIAL NUMBER: NCT04068727.

Prevalence and predictors of shared decision-making in goals-of-care clinician-family meetings for critically ill neurologic patients: a multi-center mixed-methods study.

BACKGROUND: Shared decision-making is a joint process where patients, or their surrogates, and clinicians make health choices based on evidence and preferences. We aimed to determine the extent and predictors of shared decision-making for goals-of-care discussions for critically ill neurological patients, which is crucial for patient-goal-concordant care but currently unknown. METHODS: We analyzed 72 audio-recorded routine clinician-family meetings during which goals-of-care were discussed from seven US hospitals. These occurred for 67 patients with 72 surrogates and 29 clinicians; one hospital provided 49/72 (68%) of the recordings. Using a previously validated 10-element shared decision-making instrument, we quantified the extent of shared decision-making in each meeting. We measured clinicians' and surrogates' characteristics and prognostic estimates for the patient's hospital survival and 6-month independent function using post-meeting questionnaires. We calculated clinician-family prognostic discordance, defined as ≥ 20% absolute difference between the clinician's and surrogate's estimates. We applied mixed-effects regression to identify independent associations with greater shared decision-making. RESULTS: The median shared decision-making score was 7 (IQR 5-8). Only 6% of meetings contained all 10 shared decision-making elements. The most common elements were "discussing uncertainty"(89%) and "assessing family understanding"(86%); least frequent elements were "assessing the need for input from others"(36%) and "eliciting the context of the decision"(33%). Clinician-family prognostic discordance was present in 60% for hospital survival and 45% for 6-month independent function. Univariate analyses indicated associations between greater shared decision-making and younger clinician age, fewer years in practice, specialty (medical-surgical critical care > internal medicine > neurocritical care > other > trauma surgery), and higher clinician-family prognostic discordance for hospital survival. After adjustment, only higher clinician-family prognostic discordance for hospital survival remained independently associated with greater shared decision-making (p = 0.029). CONCLUSION: Fewer than 1 in 10 goals-of-care clinician-family meetings for critically ill neurological patients contained all shared decision-making elements. Our findings highlight gaps in shared decision-making. Interventions promoting shared decision-making for high-stakes decisions in these patients may increase patient-value congruent care; future studies should also examine whether they will affect decision quality and surrogates' health outcomes.

Impact of a pharmacist intervention on DOAC knowledge and satisfaction in ambulatory patients.

Patient education of high-risk medications such as direct oral anticoagulants (DOACs) is limited in ambulatory care settings. Clinical pharmacists are uniquely equipped to educate patients about DOACS but seldom interact with patients in those settings where patient education and satisfaction are often overlooked. Recently, the Anticoagulation Forum endorsed a checklist (DOAC Checklist) to guide and educate patients initiating or resuming DOACs. We assessed the impact on knowledge and satisfaction of an intervention framed around the checklist. Randomized clinical trial. Ambulatory patients starting a DOAC or resuming one after setback (bleeding, stroke, or transient ischemic attack) in an ambulatory setting (office, emergency department, or short stay hospitalization). Three educational clinical pharmacist tele-visits, hotline access to the pharmacist, and coordination with continuity providers in 3 months. Patient knowledge scores from a 15-item DOAC-related questionnaire and satisfaction scores from an abbreviated version of the Duke Anticoagulation Satisfaction Survey (DASS). Of 561 randomized patients, 436 completed our follow-up surveys. Knowledge scores were similar for the 233 intervention patients vs. 203 control patients (63.7% vs 62.2% correct). Satisfaction scores on the 7-point Likert scale were virtually identical (6.24 and 6.22). Our pharmacist-led intervention framed around the DOAC checklist had little impact on knowledge and satisfaction. Delays between intervention end and completion of the follow-up questionnaires may have obscured benefits experienced earlier. More intensive education or strategies other than telephone-based consultation may be required to produce sustained knowledge.TRN: NCT04068727 retrospectively registered on August 22, 2019.

Pharmacist-led, checklist intervention did not improve adherence in ambulatory patients starting/resuming DOACs.

BACKGROUND: High adherence to direct-acting oral anticoagulant (DOAC) is critical to treat and prevent thromboembolic disease. The Anticoagulation Forum recently endorsed a checklist (DOAC checklist) that recommends care processes that may improve adherence. OBJECTIVES: This study aimed to determine whether checklist-driven care from a clinical pharmacist improves adherence in ambulatory patients starting a DOAC or resuming it after a setback. METHODS: This study included ambulatory patients starting a DOAC or resuming it after setback (thromboembolic event or bleeding) in an ambulatory setting. Settings included office, emergency department, and short-stay hospital visit. Following the DOAC checklist, a clinical pharmacist verified DOAC appropriateness, instructed dose de-escalation, educated through 3 tele-visits, fielded hotline calls, and handed off to a continuity provider after 3 months. Intervention and control patients received coupons and help with completing manufacturer-based medication assistance applications. Using pharmacy dispense records, our group measured medication possession ratio (MPR) at 90 days (primary outcome) and proportion of days covered (PDC) at 90 days and MPR and PDC at 180 and 365 days (secondary outcomes). Given skewing, our team analyzed adherence as < 80%, 80%-89%, and 90% or more and conducted ordered logistic regression. RESULTS: Of 561 patients randomized, 427 had sufficient records to analyze. Adherence was high with only 41 patients (9.6%) having MPR less than 80% at 90 days. There was no difference in adherence between intervention and control patients for primary outcome (odds ratio 0.94 [95% CI 0.60-1.49]) or secondary outcomes. CONCLUSION: Our checklist-driven intervention did not appreciably improve adherence beyond that seen in control patients treated with usual care (plus coupons and medication assistance we provided to all patients) in ambulatory patients starting or resuming DOACs, although it should be noted that high levels of adherence in both study groups were noted. Given high adherence, reassessing the DOAC checklist outside of a traditional trial may be more fruitful.

Facilitators and Inhibitors of LPN-to-RN Student Transition: A Cross-Sectional National Survey.

AIM: The aim of the study was to describe the transition conditions (facilitators and inhibitors) encountered by licensed practical nurses in registered nurse educational programs (LPN-to-RN students). BACKGROUND: LPN-to-RN students are important because they may increase diversity and numbers of RNs. However, no prior study has examined transition experiences of LPN-to-RN students across the United States. METHOD: A cross-sectional survey of LPN-to-RN students was conducted using Meleis et al.'s transition theory. RESULTS: Students (n = 873) from 131 nursing programs responded. The most common facilitators were personal motivation and believing the content taught was valuable; the most common inhibitors were juggling multiple responsibilities and personal stress levels. Several significant relationships between transition conditions and program/student characteristics were identified. CONCLUSION: Faculty in LPN-to-RN programs can increase support for students by refining their own actions and addressing potential challenges when LPN and non-LPN nursing students share classes.

Vasomotor symptoms in midlife women with incident breast cancer: pink SWAN.

PURPOSE: We compared trajectories of vasomotor symptoms (VMS) and their risk factors in women with breast cancer (BrCa) to those of cancer-free controls. METHODS: Data were from 15 nearly annual follow-up visits (1996-2017) of the multi-racial/ethnic cohort of midlife women enrolled in the Study of Women's Health Across the Nation (SWAN). We compared women with incident BrCa to controls for patterns of VMS, controlling for risk factors identified in bivariate analyses using multivariable longitudinal analyses. RESULTS: Characteristics at study entry largely did not differ between cases (n = 151) and controls (n = 2161). Adjusted prevalence of any VMS increased significantly among cases from diagnosis to 2.75 years post diagnosis [per-year adjusted odds ratio (aOR) = 1.76, 95% confidence interval (CI) 1.39-2.24], peaking at 2.75 years post diagnosis, whereas prevalence was stable among controls in this interval [aOR = 1.04, 95% CI 0.99-1.11]. Beyond 2.75 years post diagnosis, prevalence declined significantly in cases [aOR = 0.72, 95% CI 0.61-0.84] and less in controls [aOR = 0.96, 95% CI 0.92-1.00]. Patterns were similar for frequent VMS. Adjustment for tamoxifen use slightly reduced the per-year OR for any prevalent VMS post diagnosis, partially explaining excess VMS in cases. Other treatments were unassociated with VMS. CONCLUSIONS: Patterns of prevalent VMS reporting differed significantly between cases and controls, particularly post diagnosis, the latter only partially explained by tamoxifen use among cases. Risk factors for VMS largely did not differ between cases and controls.

Anti-Müllerian hormone levels and breast cancer risk in the study of women's health across the nation.

PURPOSE: The relation of premenopausal anti-Müllerian hormone (AMH) levels with breast cancer risk has been evaluated in a few studies, but primarily in non-Hispanic White women. METHODS: We evaluated the association of AMH levels with breast cancer risk in Study of Women's Health Across the Nation (SWAN), a multi-ethnic cohort of women. At enrollment, participants had an intact uterus and ≥ 1 ovary, and ≥ 1 menstrual period in the last 3 months. AMH at first measurement was assessed in 1,529 pre- or perimenopausal women using a high-sensitivity ELISA assay; values were natural log transformed. Breast cancer diagnoses were assessed at enrollment and subsequent follow-up visits through 2018 (median 6.1 years). RESULTS: In total, 84 women reported an incident breast cancer diagnosis. In multivariable Cox regression models adjusting for age, race and ethnicity, body mass index, and other factors, higher AMH levels were associated with a non-significant increased breast cancer risk. Compared to women in the 1st quartile, the hazard ratio (95% confidence interval) for women in the 4th quartile was 1.77 (0.87-3.60). CONCLUSION: Our results did not suggest a significant association between AMH and breast cancer risk; however, estimates were consistent with prior studies that reported positive associations.

HDL (High-Density Lipoprotein) Subclasses, Lipid Content, and Function Trajectories Across the Menopause Transition: SWAN-HDL Study.

OBJECTIVE: The cardioprotective capacity of HDL (high-density lipoprotein) cholesterol postmenopause has been challenged. HDL subclasses, lipid contents, and function might be better predictors of cardiovascular risk than HDL cholesterol. Changes in these measures have not been characterized over the menopause transition (MT) with respect to timing relative to the final menstrual period. Approach and Results: Four hundred seventy-one women with HDL particle (HDL-P) subclasses (nuclear magnetic resonance spectroscopy total, large, medium, and small HDL-P and HDL size), HDL lipid content (HDL phospholipids and triglycerides), and HDL function (cholesterol efflux capacity [HDL-CEC]) measured for a maximum of 5 time points across the MT were included. HDL cholesterol and total HDL-P increased across the MT. Within the 1 to 2 years bracketing the final menstrual period, large HDL-P and HDL size declined while small HDL-P and HDL-triglyceride increased. Although overall HDL-CEC increased across the MT, HDL-CEC per HDL-P declined. Higher concentrations of total, large, and medium HDL-P and greater HDL size were associated with greater HDL-CEC while of small HDL-P were associated with lower HDL-CEC. Associations of large HDL-P and HDL size with HDL-CEC varied significantly across the MT such that higher large HDL-P concentrations and greater HDL size were associated with lower HDL-CEC within the 1 to 2 years around the final menstrual period. CONCLUSIONS: Although HDL cholesterol increased over the MT, HDL subclasses and lipid content showed adverse changes. While overall HDL-CEC increased, HDL-CEC per HDL-P declined, consistent with reduced function per particle. Large HDL-P may become less efficient in promoting HDL-CEC during the MT.

Associations of HDL metrics with coronary artery calcium score and density among women traversing menopause.

The cardioprotective association of high-density lipoprotein cholesterol (HDL-C) may vary by menopause stage or estradiol level. We tested whether associations of comprehensive HDL metrics (HDL subclasses, phospholipid and triglyceride content, and HDL cholesterol efflux capacity [HDL-CEC]) with coronary artery calcium (CAC) score and density vary by menopause stage or estradiol level in women transitioning through menopause. Participants (N = 294; mean age [SD]: 51.3 [2.9]) had data on HDL metrics and CAC measures at one or two time points during the menopause transition. Generalized estimating equations were used for analyses. Effect modifications by menopause stage or estradiol level were tested in multivariable models. In adjusted models, menopause stage modified the associations of specific HDL metrics with CAC measures. Higher small HDL particles (HDL-P) concentrations (p-interaction = 0.008) and smaller HDL size (p-interaction = 0.02) were associated with greater odds of CAC presence in late perimenopause than in pre/early perimenopause stage. Women in the highest estradiol tertile, but not the lower tertiles, showed a protective association of small HDL-P with CAC presence (p-interaction = 0.007). Lower large HDL-P concentrations (p-interaction = 0.03) and smaller HDL size (p-interaction = 0.03) were associated with lower CAC density in late perimenopause than in postmenopause stage. Associations of HDL phospholipid and triglyceride content and HDL-CEC with CAC measures did not vary by menopause stage or estradiol level. We concluded that HDL subclasses may impact the likelihood of CAC presence and the stability of coronary plaque differently over the menopause transition. Endogenous estradiol levels may contribute to this observation.

Teaching Medical Students to Help Patients Manage Their Weight: Outcomes of an Eight-School Randomized Controlled Trial.

BACKGROUND: Given the rising rates of obesity there is a pressing need for medical schools to better prepare students for intervening with patients who have overweight or obesity and for prevention efforts. OBJECTIVE: To assess the effect of a multi-modal weight management curriculum on counseling skills for health behavior change. DESIGN: A pair-matched, group-randomized controlled trial (2015-2020) included students enrolled in eight U.S. medical schools randomized to receive either multi-modal weight management education (MME) or traditional weight management education (TE). SETTING/PARTICIPANTS: Students from the class of 2020 (N=1305) were asked to participate in an objective structured clinical examination (OSCE) focused on weight management counseling and complete pre and post surveys. A total of 70.1% of eligible students (N=915) completed the OSCE and 69.3% (N=904) completed both surveys. INTERVENTIONS: The MME implemented over three years included a web-based course, a role-play classroom exercise, a web-patient encounter with feedback, and an enhanced clerkship experience with preceptors trained in weight management counseling (WMC). Counseling focused on the 5As (Ask, Advise, Assess, Assist, Arrange) and patient-centeredness. MEASUREMENTS: The outcome was student 5As WMC skills assessed using an objective measure, an OSCE, scored using a behavior checklist, and a subjective measure, student self-reported skills for performing the 5As. RESULTS: Among MME students who completed two of three WMC components compared to those who completed none, exposure was significantly associated with higher OSCE scores and self-reported 5A skills. LIMITATIONS: Variability in medical schools requiring participation in the WMC curriculum. CONCLUSIONS: This trial revealed that medical students struggle with delivering weight management counseling to their patients who have overweight or obesity. Medical schools, though restrained in adding curricula, should incorporate should incorporate multiple WMC curricula components early in medical student education to provide knowledge and build confidence for supporting patients in developing individualized plans for weight management. NIH TRIAL REGISTRY NUMBER: R01-194787.

A Clinical Trial of a Video Intervention Targeting Opioid Disposal After General Surgery: A Feasibility Study.

BACKGROUND: The opioid epidemic continues and although some initiatives have shown promise in reducing the number of opiates prescribed, few studies have focused on education of general surgery patients about home storage and safe disposal. The purpose of this feasibility study was to explore the use of an online video intervention to prepare surgical patients to properly dispose of unused opioids. METHODS: Eligible patients undergoing elective general surgery between August and October 2019 were enrolled into this prospective randomized controlled feasibility study. Patients with reported opioid use preoperatively were excluded from the study. The control group followed usual care, and the intervention group received usual care plus a brief educational video guided by the theory of reasoned action describing safe storage and disposal practices of unused opioid pills. Measures were collected at baseline and 2 wk postoperatively. RESULTS: A total of 40 participants were enrolled in the study; average age was 44.7 (range 21-75 y); most were Caucasian, educated, and employed. Recruitment took 11 wk, and the retention rate was excellent at 85%. Differences in opioid disposal were not significantly different by age, sex, education, or type of surgery. The video intervention was positively received, but the majority (80%) still stored their pills unsecured. CONCLUSIONS: Results demonstrate that a video intervention addressing safe storage and disposal practices of unused opioids is feasible, and more research is needed to determine efficacy in increasing rates of secure storage and disposal of unused opioid pills.

Identifying prescribing cascades in Alzheimer's disease and related dementias: The calcium channel blocker-diuretic prescribing cascade.

PURPOSE: Prescribing cascades occur when a physician prescribes a new drug to address the side-effect of another drug. Persons with Alzheimer's disease and related dementias (ADRD) are at increased risk for prescribing cascades. Our objective was to develop an approach to estimating the proportion of calcium channel blocker-diuretic (CCB-diuretic) prescribing cascades among persons with ADRD in two U.S. health plans. METHODS: We identified patients aged ≥50 on January 1, 2017, dispensed a drug to treat ADRD in the 365-days prior to/on cohort entry date. Patients had medical/pharmacy coverage for 1 year before and through cohort entry. We excluded individuals with an institutional stay encounter in the 45 days prior to cohort entry and censored patients based on: disenrollment from coverage, death, or end of data. We identified incident and prevalent CCB use in the 183-days following cohort entry, and identified subsequent incident diuretic use among incident and prevalent CCB-users within 365-days from cohort entry. RESULTS: There were 121 538 eligible patients. Approximately 62% were female, with a mean age of 79.5 (SD ±8.6). Overall 2.1% of the cohort experienced a prevalent CCB-diuretic prescribing cascade with 1586 incident diuretic-users among 36 462 prevalent CCB-users (4.3%, 95% CI 4.1-4.6%]); and there were161 incident diuretic-users among 3304 incident CCB-users (4.9%, 95% CI 4.2-5.7%) (incident CCB-diuretic cascade). CONCLUSIONS: We describe an approach to identify prescribing cascades in persons with ADRD, which can be used to assess the proportion of prescribing cascades in large cohorts. We determined the proportion of CCB-diuretic prescribing cascades was low.

SUPPORT-AF III: supporting use of AC through provider prompting about oral anticoagulation therapy for AF.

Only half of atrial fibrillation (AF) patients with elevated stroke risk receive anticoagulation (AC). Electronic health record (EHR) alerts have the potential to close the gap. We designed an outpatient EHR alert (linked to an order set for ordering AC, labs, and specialty referrals) that fired when cardiology and primary care providers (PCPs) saw AF patients not on AC. We assigned all untreated patients seen by cardiology providers and PCPs in the 8 months before and after the alert launch to pre- and post-launch intervention cohorts, respectively. Untreated AF patients seeing other types of providers became controls. We then compared the difference in AC starts between intervention and control patients post-launch to the same difference prelaunch (adjusting for covariates). We measured alert responsiveness as how often patients had at least one encounter with a provider, who interacted with the alert. The adjusted percentage of AC starts for the prelaunch cohort was 20% for intervention patients and 17% for controls (difference = 3%); post-launch, the percentage was 13% for both post-launch intervention and controls (difference = 0%). The difference in difference was - 3% (p value 0.63). For half of patients, at least one provider was responsive to our alert. Reasons for no AC commonly included relative contraindications (e.g. fall, gastrointestinal bleed). Our alert did not increase AC starts but responsiveness to it was high. Increasing AC starts will likely require education surrounding relative contraindications.

Attitudes Toward a Potential SARS-CoV-2 Vaccine : A Survey of U.S. Adults.

BACKGROUND: Coronavirus disease 2019 (COVID-19) has rapidly instigated a global pandemic. Vaccine development is proceeding at an unprecedented pace. Once available, it will be important to maximize vaccine uptake and coverage. OBJECTIVE: To assess intent to be vaccinated against COVID-19 among a representative sample of adults in the United States and identify predictors of and reasons for vaccine hesitancy. DESIGN: Cross-sectional survey, fielded from 16 through 20 April 2020. SETTING: Representative sample of adults residing in the United States. PARTICIPANTS: Approximately 1000 adults drawn from the AmeriSpeak probability-based research panel, covering approximately 97% of the U.S. household population. MEASUREMENTS: Intent to be vaccinated against COVID-19 was measured with the question, "When a vaccine for the coronavirus becomes available, will you get vaccinated?" Response options were "yes," "no," and "not sure." Participants who responded "no" or "not sure" were asked to provide a reason. RESULTS: A total of 991 AmeriSpeak panel members responded. Overall, 57.6% of participants (n = 571) intended to be vaccinated, 31.6% (n = 313) were not sure, and 10.8% (n = 107) did not intend to be vaccinated. Factors independently associated with vaccine hesitancy (a response of "no" or "not sure") included younger age, Black race, lower educational attainment, and not having received the influenza vaccine in the prior year. Reasons for vaccine hesitancy included vaccine-specific concerns, a need for more information, antivaccine attitudes or beliefs, and a lack of trust. LIMITATIONS: Participants' intent to be vaccinated was explored before a vaccine was available and when the pandemic was affecting a narrower swath of the United States. Questions about specific information or factors that might increase vaccination acceptance were not included. The survey response rate was 16.1%. CONCLUSION: This national survey, conducted during the coronavirus pandemic, revealed that approximately 3 in 10 adults were not sure they would accept vaccination and 1 in 10 did not intend to be vaccinated against COVID-19. Targeted and multipronged efforts will be needed to increase acceptance of a COVID-19 vaccine when one becomes available. PRIMARY FUNDING SOURCE: Agency for Healthcare Research and Quality.

Feasibility of an online cognitive behavioral therapy program to improve insomnia, mood, and quality of life in bereaved adults ages 55 and older.

The aim of the current study was to assess the feasibility and preliminary efficacy of utilizing an online Cognitive Behavioral Therapy for Insomnia (CBT-I) program in bereaved older adults (ages 55 and older). Participants were randomized to receive either a 6-week online CBT-I program or six weeks of online psychoeducational modules on insomnia and grief. The sample included 30 adults with mild to severe symptoms of insomnia. Results suggest that the study was feasible to conduct, as evidenced by the brief 5-week recruitment time, 87% retention rate, and 100% completion rate of the intervention modules. There were no treatment effects by time difference shown in the study and no significant differences in study outcomes were found between the CBT-I and control groups, as both demonstrated similar improvements in insomnia. However, this study suggests that it is feasible to recruit bereaved older adults for an online educational program and successfully administer an online protocol targeting insomnia and well-being.

Health-related quality of life among breast cancer survivors and noncancer controls over 10 years: Pink SWAN.

BACKGROUND: The goal of this study was to compare health-related quality of life (HRQL) from diagnosis to 10 years postdiagnosis among breast cancer survivors (BCS) and women without cancer over the same period and to identify BCS subgroups exhibiting different HRQL trajectories. METHODS: Our analysis included 141 BCS and 2086 controls from the Study of Women's Health Across the Nation (SWAN), a multiracial/ethnic cohort study of mid-life women assessed approximately annually from 1995 to 2015. Pink SWAN participants reported no cancer at SWAN enrollment and developed (cases) or did not develop (controls) incident breast cancer after enrollment. We assessed HRQL with SF-36 Mental Component Summary and Physical Component Summary scores. We modeled each as a function of case/control status, years since diagnosis, years since diagnosis squared, and the interaction terms between case/control status and the 2 time variables in linear models. We characterized heterogeneity in postdiagnosis HRQL of cases using group-based trajectories. RESULTS: BCS had significantly lower HRQL compared with controls at diagnosis and 1 year postdiagnosis. By 2 years, BCS and controls no longer differed significantly. Among BCS, 2 trajectory groups were identified for both scores. For the Mental Component Summary, 88.4% of BCS had consistently good and 11.6% had very low scores. For the Physical Component Summary, 73.9% had good scores, and 26.1% had consistently low scores. Prediagnosis perceived stress and current smoking were related to being in the low mental trajectory group, and a higher number of comorbidities was related to being in the low physical trajectory group. CONCLUSION: Although the majority of BCS have HRQL similar to non-cancer controls after 2 years, subgroups of BCS continue to have low HRQL. Prediagnosis stress, comorbidities, and smoking are vulnerability factors for long-term, low HRQL in BCS.

Vasomotor menopausal symptoms and risk of cardiovascular disease: a pooled analysis of six prospective studies.

BACKGROUND: Menopausal vasomotor symptoms (ie, hot flashes and night sweats) have been associated with unfavorable risk factors and surrogate markers of cardiovascular disease, but their association with clinical cardiovascular disease events is unclear. OBJECTIVE: To examine the associations between different components of vasomotor symptoms, timing of vasomotor symptoms, and risk of cardiovascular disease. STUDY DESIGN: We harmonized and pooled individual-level data from 23,365 women in 6 prospective studies that contributed to the International Collaboration for a Life Course Approach to Women's Reproductive Health and Chronic Disease Events consortium. Women who experienced cardiovascular disease events before baseline were excluded. The associations between frequency (never, rarely, sometimes, and often), severity (never, mild, moderate, and severe), and timing (before or after age of menopause; ie, early or late onset) of vasomotor symptoms and incident cardiovascular disease were analyzed. Cox proportional hazards models were used to estimate hazard ratios and 95% confidence intervals. RESULTS: In the adjusted model, no evidence of association was found between the frequency of hot flashes and incident cardiovascular disease, whereas women who reported night sweats "sometimes" (hazard ratio, 1.22; 95% confidence interval, 1.02-1.45) or "often" (hazard ratio, 1.29; 95% confidence interval, 1.05-1.58) had higher risk for cardiovascular disease. Increased severity of either hot flashes or night sweats was associated with higher risk of cardiovascular disease. The hazards ratios of cardiovascular disease in women with severe hot flashes, night sweats, and any vasomotor symptoms were 1.83 (95% confidence interval, 1.22-2.73), 1.59 (95% confidence interval, 1.07-2.37), and 2.11 (95% confidence interval, 1.62-2.76), respectively. Women who reported severity of both hot flashes and night sweats had a higher risk for cardiovascular disease (hazard ratio, 1.55; 95% confidence interval, 1.24-1.94) than those with hot flashes alone (hazard ratio, 1.33; 95% confidence interval, 0.94-1.88) and night sweats alone (hazard ratio, 1.32; 95% confidence interval, 0.84-2.07). Women with either early-onset (hazard ratio, 1.38; 95% confidence interval, 1.10-1.75) or late-onset (hazard ratio, 1.69; 95% confidence interval, 1.32-2.16) vasomotor symptoms had an increased risk for incident cardiovascular disease compared with women who did not experience vasomotor symptoms. CONCLUSION: Severity rather than frequency of vasomotor symptoms (hot flashes and night sweats) was associated with increased risk of cardiovascular disease. Vasomotor symptoms with onset before or after menopause were also associated with increased risk of cardiovascular disease.

Obesity, smoking, and risk of vasomotor menopausal symptoms: a pooled analysis of eight cohort studies.

BACKGROUND: Frequent and severe vasomotor symptoms during menopause are linked with adverse health outcomes. Understanding modifiable lifestyle factors for the risk of vasomotor menopausal symptoms is important to guide preventive strategies. OBJECTIVE: We investigated the associations between body mass index and smoking, their joint effects with the risk of vasomotor symptoms, and whether the associations differed by menopausal stage. STUDY DESIGN: The International Collaboration for a Life Course Approach to Reproductive Health and Chronic Disease Events pooled data on 21,460 midlife women from 8 studies (median age, 50 years; interquartile range, 49-51 years) for the cross-sectional analysis. Four studies provided data for the prospective analysis (n=11,986). Multinomial logistic regression models with 4 categories of frequency/severity for the outcome of vasomotor symptoms were used to estimate relative risk ratios and 95% confidence intervals that were adjusted for within-study correlation and covariates. RESULTS: At baseline, nearly 60% of the women experienced vasomotor symptoms. One-half of them were overweight (30%) or obese (21%), and 17% were current smokers. Cross-sectional analyses showed that a higher body mass index and smoking more cigarettes with longer duration and earlier initiation were all associated with more frequent or severe vasomotor symptoms. Never smokers who were obese had a 1.5-fold (relative risk ratio, 1.52; 95% confidence interval, 1.35-1.73) higher risk of often/severe vasomotor symptoms, compared with never smokers who were of normal-weight. Smoking strengthened the association because the risk of often/severe vasomotor symptoms was much greater among smokers who were obese (relative risk ratio, 3.02; 95% confidence interval, 2.41-3.78). However, smokers who quit at <40 years of age were at similar levels of risk as never smokers. Prospective analyses showed a similar pattern, but the association attenuated markedly after adjustment for baseline vasomotor symptoms. Furthermore, we found that the association between body mass index and vasomotor symptoms differed by menopausal status. Higher body mass index was associated with increased risk of vasomotor symptoms in pre- and perimenopause but with reduced risk in postmenopause. CONCLUSION: High body mass index (≥25 kg/m2) and cigarette smoking substantially increased women's risk for experiencing frequent or severe vasomotor symptoms in a dose-response manner, and smoking intensified the effect of obesity. However, the effect of body mass index on the risk of vasomotor symptoms was opposite among postmenopausal women. Maintaining a normal weight before the menopausal transition and quitting smoking at <40 years of age may mitigate the excess risk of vasomotor symptoms in midlife.

Improving stamina and mobility with preop walking in surgical patients with frailty traits -OASIS IV: randomized clinical trial study protocol.

BACKGROUND: Frail older surgical patients face more than a two-fold increase in postoperative complications, including myocardial infarction, deep vein thrombosis, pulmonary embolism, pneumonia, ileus, and others. Many of these complications occur because of postoperative loss of stamina and poor mobility. Preoperative exercise may better prepare these vulnerable patients for surgery. We present the protocol for our ongoing randomized trial to assess the impact of a preoperative walking intervention with remote coaching and pedometer on outcomes of stamina (six-minute walk distance- 6MWD) and mobility (postoperative steps) in older adults with frailty traits. METHODS: We will be conducting a randomized clinical trial with a total of 120 patients permitting up to a 33% rate of attrition, to reach a final sample size of 80 (with 40 patients for each study arm). We will include patients who are age 60 or higher, score 4 or greater on the Edmonton Frailty Scale assessment, and will be undergoing a surgical operation that requires a 2 or more night hospital stay to be eligible for our trial. Using block randomization stratified on baseline 6MWD, we will assign patients to wear a pedometer. At the end of three baseline days, an athletic trainer (AT) will provide a daily step count goal reflecting a 10-20% increase from baseline. Subsequently, the AT will call weekly to further titrate the goal or calls more frequently if the patient is not meeting the prescribed goal. Controls will receive general walking advice. Our main outcome is change in 6MWD on postoperative day (POD) 2/3 vs. baseline. We will also collect 6MWD approximately 4 weeks after surgery and daily in-hospital steps. CONCLUSION: If changes in a 6MWD and step counts are significantly higher for the intervention group, we believe this will confirm our hypothesis that the intervention leads to decreased loss of stamina and mobility. Once confirmed, we anticipate expanding to multiple centers to assess the interventional impact on clinical endpoints. TRIAL REGISTRATION: The randomized clinical trial was registered on clinicaltrials.gov under the identifier NCT03892187 on March 27, 2019.