Smith, Jamie L

Background Menopause-related symptoms are common but undertreated. Digital tools that support symptom assessment and patient education may improve engagement. Objective To assess whether a previsit digital menopause symptom assessment and education tool increased treatment initiation and patient engagement compared to an educational pamphlet. Design Women aged 45–55 years with upcoming primary care appointments were invited to participate. Those with a total Menopause Rating Scale (MRS) score ≥5 indicating bothersome menopause symptoms were included. Participants were randomized to a digital menopause symptom assessment tool or a digital educational pamphlet and completed a post-visit survey (NCT06919887). Participants Of the 14,726 women invited to participate between May 12, 2025, and December 5, 2025, there were 653 (4.4%) enrolled that met eligibility criteria. Interventions Randomized to an mHealth app called emmii or a standard digital menopause educational pamphlet. Main measures Menopause treatment initiation within 30 days of the clinical visit was assessed by electronic health data. Baseline and post-visit surveys were collected assessing patient experience, engagement, and perceived usefulness. Rates of menopause hormone therapy (HT) prescribing were compared with a reference population of nonparticipants aged 45–55 who had a primary care appointment at Mayo Clinic during the same period and received no study education materials. Key results Of 653 participants enrolled and randomized, 383 completed both the baseline and post-surveys (171 intervention and 212 control). HT initiation among study participants was significantly higher than in the reference population of women (9.3% vs. 4.4%, p < 0.001). There was no difference in HT initiation between the intervention (9.1%) and control groups (9.6%) ( p = 0.83). Initiation rates were 3.8% and 4.5%, respectively ( p = 0.64) for nonhormone therapies. Conclusions Among women with bothersome menopause symptoms, those who underwent previsit symptom screening and received educational materials had higher rates of HT initiation than women who did not participate in the study. These findings suggest that structured menopause education may improve recognition and management of menopause symptoms in routine clinical practice.

Background Heart failure self‐care can contribute to a high daily workload and treatment burden. The goal of this cohort study was to assess the characteristics and outcomes associated with burden of treatment (BoT). Methods Surveys comprising validated instruments to measure BoT and other constructs were mailed to patients with heart failure in Southeastern Minnesota. Participants were divided into tertiles by BoT scores. Associations of clinical variables with BoT were examined using multinomial logistic regression. Associations of BoT with mortality and hospitalizations were examined using Cox proportional hazard regression and Andersen–Gill models, respectively. Results A total of 609 participants (mean age 76.3 years, 60.3% men, 55.2% urban, 64.3% preserved ejection fraction) completed surveys. Higher BoT was associated with worse health status, more depressive symptoms, lower resilience, less social support, lower medication adherence, and worse health literacy. Mean±SD follow‐up was 14.4 (4.1) months. Estimated 1‐year mortality (8.3% [95% CI, 4.3%–12.1%], 11.0% [95% CI, 6.5%–15.2%], 16.0% [95% CI, 10.8%–21.0%]) and 1‐year mean cumulative hospitalizations (0.57 [95% CI, 0.45–0.72], 0.83 [95% CI, 0.66–1.05], 1.15 [95% CI, 0.93–1.42]) increased across patients reporting low, medium, and high BoT, respectively. Adjustment for health status eliminated any significant association of BoT with risks of death and hospitalization (adjusted hazard ratio [HR], 1.10 [95% CI, 0.58–2.07] and 1.09 [95% CI, 0.74–1.61], respectively, highest versus lowest BoT tertile). Conclusions BoT in heart failure varies by clinical and psychosocial factors. Higher BoT identifies patients at increased risk of adverse health outcomes due to their worse health status. These findings can serve as a foundation for interventions to minimize workload and improve quality of life.

Chronic pain is common with aging. Yet, little is known about the attitudes, beliefs, and experiences of older adults with chronic pain regarding opioids, particularly in regard to effects on daily functioning and cognition. This qualitative analysis employed semi-structured interviews in 25 community-dwelling older adults with chronic pain and current or recent prescription opioid use. Interviews focused on perceptions, beliefs, and experiences of living with chronic pain, use of prescription opioids, and the impact of opioids on pain control, cognition, and daily function. Older adults display adaptability and acceptance in living with chronic pain, desire person-centered pain care, approach the risks-benefits of opioids with regards to cognition differently, and perceive stigma as a barrier to effective partnership with clinicians.

BACKGROUND: Validly measuring disease-specific health status is critical in patients with severe tricuspid regurgitation (TR) to quantify the benefit of different interventions. The Kansas City Cardiomyopathy Questionnaire (KCCQ) has been used to assess health status in patients with severe TR, but its content validity in this patient population is unknown, including whether additional questions are needed to supplement the KCCQ. METHODS: Twenty participants with symptomatic severe TR from 2 midwestern clinical sites were interviewed in 2023 using a semistructured guide. The interview guide addressed symptoms, physical and social functioning, and quality of life concepts of the KCCQ, as well as other potential TR symptoms not represented in the KCCQ. Interview transcripts were analyzed using inductive and deductive coding and content analysis, with additional participants recruited until thematic saturation occurred. RESULTS: Mean age of the participants was 80 (41–89), and 75% were female. Shortness of breath and fatigue were reported by virtually all participants (n=20 and n=19, respectively) and had a marked negative impact on their physical and social functioning and quality of life. Lower limb edema was also reported by 10 participants. Although these concepts are captured by the KCCQ, other symptoms were also reported, including appetite loss (n=8) and upper body edema (n=4), but did not seem to markedly affect participants’ function or quality of life. In addition, all participants who experienced these other symptoms reported symptoms that were already captured by the KCCQ. CONCLUSIONS: All participants experienced symptoms captured by the KCCQ, and these symptoms had a substantial impact on their physical and social functioning and quality of life. Although some participants reported additional symptoms not assessed by the KCCQ, their incorporation would only marginally improve content validity. Thus, the current KCCQ appears to be appropriate for capturing the disease-specific health status of patients with severe TR.

Objective Patients with heart failure (HF) perform a variety of self-care activities to control symptoms and minimise the risk of HF decompensations. The objective of this study was to understand how patients build capacity and manage the work of living with HF. Design A qualitative study using semi-structured telephone interviews. The interview guide was informed by the Cumulative Complexity Model, a conceptual framework that focuses on a patient’s workload and their capacity to manage that work. Interview transcripts were analysed using a mixed inductive and deductive coding approach with organisation into larger thematic categories. Setting Southeastern Minnesota USA (11 counties) with capture of data from local community healthcare providers under the auspices of the Rochester Epidemiology Project. Participants Intentional sampling of local patients with HF (n=24, median age 69.5 years, 54% women, 63% rural, 54% preserved ejection fraction) who reported high treatment burden and/ or poor health status on a questionnaire. Results Three major themes emerged: using capacity to manage workload, disruptions resulting in workload exceeding capacity and regaining workload-capacity balance. Participants described routinising the daily tasks associated with living with HF to minimise the associated burden and identified disruptions to their routines, including hospitalisations, emergency room visits, worsening health status and changes in healthcare access. To accommodate disruptions and regain workload-capacity balance, participants decreased workload and/or transferred tasks to others to maximise capacity. Conclusions Participants with HF described managing patient workload in times of stable health, but they sometimes struggled to accommodate disruptions and worsening health status. These findings can inform the design of interventions to minimise workload, maximise capacity and improve quality of life for patients with HF.

Abstract Introduction: Pragmatic trials aim to speed translation to practice by integrating study procedures in routine care settings. This study evaluated implementation outcomes related to clinician and patient recruitment and participation in a trial of community paramedicine (CP) and presents successes and challenges of maintaining pragmatic study features. Methods: Adults in the pre-hospital setting, emergency department (ED), or hospital being considered for referral to the ED/hospital or continued hospitalization for intermediate-level care were randomized 1:1 to CP care or usual care. Referral and enrollment data were tracked administratively, and patient characteristics were abstracted from the electronic health record (EHR). Enrolled patients completed baseline surveys, and a subset of intervention patients were interviewed. All CPs and a sample of clinicians and administrators were invited to complete a survey and interview. Results: Between January 2022 and February 2023, 240 enrolled patients (42% rural) completed surveys, and 22 completed an interview; 63 staff completed surveys and 20 completed an interview. Ninety-three clinicians in 27 departments made at least one referral. Factors related to referrals included program awareness and understanding the CP practice scope. Most patients were enrolled in the hospital, but characteristics were similar to the primary care population and included older and medically complex patients. Challenges to achieving representativeness included limited EHR infrastructure, constraints related to patient consenting, and clinician concerns about patient randomization disrupting preferred care. Conclusion: Future pragmatic trials in busy clinical settings may benefit from regulatory policies and EHR capabilities that allow for real-world study conduct and representative participation. Trial registration: NCT05232799.

Background The epidemiology and pathophysiology of heart failure (HF) differ in women and men. Whether these differences extend to the subgroup of patients with advanced HF is not well defined. Methods and Results This is a retrospective cohort study of all adult Olmsted County, Minnesota residents with advanced HF (European Society of Cardiology criteria) from 2007 to 2017. Differences in survival and hospitalization risks in women and men following advanced HF development were examined using Cox proportional hazard regression and Andersen‐Gill models, respectively. Of 936 individuals with advanced HF, 417 (44.6%) were women and 519 (55.4%) were men (self‐reported sex). Time from development of HF to advanced HF was similar in women and men (median 3.2 versus 3.6 years). Women were older at diagnosis (mean age 79 versus 75 years), less often had coronary disease and hyperlipidemia, but more often had hypertension and depression ( P <0.05 for each). Advanced HF with preserved ejection fraction was more prevalent in women than men (60% versus 30%, p<0.001). There were no differences in adjusted risks of all‐cause mortality (hazard ratio [HR], 0.89 [95% CI, 0.77–1.03]), cardiovascular mortality (HR, 0.85 [95% CI, 0.70–1.02]), all‐cause hospitalizations (HR, 1.04 [95% CI, 0.90–1.20]), or HF hospitalizations (HR, 0.91 [95% CI, 0.75–1.11]) between women and men. However, adjusted cardiovascular mortality was lower in women versus men with advanced HF with reduced ejection fraction (HR, 0.72 [95% CI, 0.56–0.93]). Conclusions Women more often present with advanced HF with preserved ejection fraction and men with atherosclerotic disease and advanced HF with reduced ejection fraction. Despite these differences, survival and hospitalization risks are largely comparable in women and men with advanced HF.