Citations

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.

Introduction: The epidemiology and pathophysiology of heart failure (HF) differs in women and men. However, it is not well defined whether these differences extend to the subgroup of patients that develop advanced HF or if they translate to differences in outcomes. Aim: To compare the clinical characteristics and outcomes of advanced HF in women and men. Methods: This is a retrospective cohort study of all adult residents of Olmsted County, Minnesota with advanced HF (as defined by European Society of Cardiology Criteria) from 2007-2017. Differences in survival and hospitalization risks following advanced HF development in women and men were examined using Cox proportional hazard regression and Andersen Gill models, respectively. Results: Of 936 individuals with advanced HF, 417 (44.6%) were women and 519 (55.4%) were men. Women were older (mean 79 vs 75 years) with a lower overall comorbidity burden (Charlson comorbidity index 4.7 vs 5.2), less often had coronary artery disease (60% vs 79%) and hyperlipidemia (69% vs 77%), but more often had hypertension (91% vs 87%) and depression (32% vs 24%), and more often had advanced HF with preserved ejection fraction (60% vs. 30%) compared with men ( p<0.05 for each). After adjustment for age, ejection fraction and comorbidities, there were no differences in risks of survival or hospitalizations ( Figure ) between women and men (p> 0.10 for each). Conclusion: While advanced HF can occur in both women and men, their phenotypes differ; women more often present with advanced HFpEF and men with more atherosclerotic disease and advanced HFrEF. Despite these differences, survival is similar in women and men with advanced HF.