IntroductionFrailty is a geriatric syndrome characterised by reductions in muscle mass, strength, endurance and activity level. The frailty syndrome, prevalent in 25–50% of patients undergoing cardiac surgery, is associated with increased rates of mortality and major morbidity as well as function decline postoperatively. This trial will compare a preoperative, interdisciplinary exercise and health promotion intervention to current standard of care (StanC) for elective coronary artery bypass and valvular surgery patients for the purpose of determining if the intervention improves 3-month and 12-month clinical outcomes among a population of frail patients waiting for elective cardiac surgery.Methods and analysisThis is a multicentre, randomised, open end point, controlled trial using assessor blinding and intent-to-treat analysis. Two-hundred and forty-four elective cardiac surgical patients will be recruited and randomised to receive either StanC or StanC plus an 8-week exercise and education intervention at a certified medical fitness facility. Patients will attend two weekly sessions and aerobic exercise will be prescribed at 40–60% of heart rate reserve. Data collection will occur at baseline, 1–2 weeks preoperatively, and at 3 and 12 months postoperatively. The primary outcome of the trial will be the proportion of patients requiring a hospital length of stay greater than 7 days.Potential impact of studyThe healthcare team is faced with an increasingly complex older adult patient population. As such, this trial aims to provide novel evidence supporting a health intervention to ensure that frail, older adult patients thrive after undergoing cardiac surgery.Ethics and disseminationTrial results will be published in peer-reviewed journals, and presented at national and international scientific meetings. The University of Manitoba Health Research Ethics Board has approved the study protocol V.1.3, dated 11 August 2014 (H2014:208).Trial registration numberThe trial has been registered on ClinicalTrials.gov, a registry and results database of privately and publicly funded clinical studies (NCT02219815).

IMPORTANCE Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial. OBJECTIVE To evaluate e-cigarettes with individual counseling for smoking cessation. DESIGN, SETTING, AND PARTICIPANTS A randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported. INTERVENTIONS Randomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling. MAIN OUTCOMES AND MEASURESThe primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence. RESULTS Among 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI,). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, -0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%).CONCLUSIONS AND RELEVANCE Among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed.

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Study purposeDistrust of the healthcare system is longstanding in the black community. This may especially threaten the health of the population when a highly contagious infection strikes. This study aims to compare COVID-19-related perspectives and behaviours between hospitalised black patients who trust versus distrust doctors and healthcare systems.Study designCross-sectional study at a tertiary care academic hospital in Baltimore, Maryland. Hospitalised adult black patients without a history of COVID-19 infection were surveyed between November 2020 and March 2021 using an instrument that assessed COVID-19-related matters. Analyses compared those who trusted versus mistrusted doctors and healthcare systems.Results37 distrusting hospitalised black patients were compared with 103 black patients who trusted doctors and healthcare systems. Groups had similar sociodemographics (all p>0.05). Distrustful patients were less likely to think that they were at high risk of contracting COVID-19 (54.0% vs 75.7%; p=0.05), less likely to believe that people with underlying medical conditions were at higher risk of dying from the virus (86.4% vs 98.0%; p=0.01) and less likely to be willing to accept COVID-19 vaccination (when available) (51.3% vs 77.6%; p<0.01) compared with those who were trusting.ConclusionHealthcare distrustful hospitalised black patients were doubtful of COVID-19 risk and hesitant about vaccination. Hospitalisations are concentrated exposures to the people and processes within healthcare systems; at these times, seizing the opportunity to establish meaningful relationships with patients may serve to gain their trust.