Randomized Trials in Cardiac Surgery: JACC Review Topic of the Week.

Compared with randomized controlled trials (RCTs) in medical specialties, RCTs in cardiac surgery face specific issues. Individual and collective equipoise, rapid evolution of the surgical techniques, as well as difficulties in obtaining funding, and limited education in clinical epidemiology in the surgical community are among the most important challenges in the design phase of the trial. Use of complex interventions and learning curve effect, differences in individual operators' expertise, difficulties in blinding, and slow recruitment make the successful completion of cardiac surgery RCTs particularly challenging.

"It's Like They Forget That the Word 'Health' Is in 'Home Health Aide'": Understanding the Perspectives of Home Care Workers Who Care for Adults With Heart Failure.

Background Home care workers ( HCW s) increasingly provide long-term and posthospitalization care for community-dwelling adults with heart failure ( HF ). They observe, assist, and advise these patients, yet few studies have examined their role in HF . As the foundation for future interventions, we sought to understand the perspectives of HCW s caring for adults with HF .

Innovative approaches to weight loss in a high-risk population: The small changes and lasting effects (SCALE) trial.

Objective: To evaluate the efficacy of a small change behavioral weight loss intervention with or without a positive affect/self-affirmation (PA/SA) component on weight loss at 12 months.

Methods: Black and Hispanic adults (N = 405) with body mass index 25-50 kg/m selected one of ten small change eating strategies and a physical activity goal, randomly with/without PA/SA. Participants were followed by community health workers at set intervals (weekly in months 1-3; biweekly in months 4-9; once monthly in months 10-12).

Small Changes and Lasting Effects (SCALE) Trial: the formation of a weight loss behavioral intervention using EVOLVE.

Background: Obesity is a major health problem that disproportionately affects Black and Hispanic adults. This paper presents the rationale and innovative design of a small change eating and physical activity intervention (SC) combined with a positive affect and self-affirmation (PA/SA) intervention versus the SC intervention alone for weight loss.

Methods: Using a mixed methods translational model (EVOLVE), we designed and tested a SC approach intervention in overweight and/ or obese African American and Hispanic adults.