Randomized Clinical Trial on Prevention of Radial Occlusion After Transradial Access Using Nitroglycerin: PATENS Trial

ObjectivesThe aim of this study was to evaluate whether administration of nitroglycerin at the beginning or end of a transradial approach (TRA) procedure would preserve radial patency.BackgroundThe TRA is becoming the preferred vascular access route in coronary interventions. Radial artery occlusion (RAO) is the most frequent complication. Routine vasodilator treatment aims to reduce spasm and possibly prevent RAO.MethodsThe authors designed a prospective, multicenter, randomized, double-blind, 2-by-2 factorial, placebo-controlled trial encompassing patients undergoing the TRA. Patients were randomized to either 500 μg nitroglycerin or placebo; each arm was also subrandomized to early (upon sheath insertion) or late (right before sheath removal) nitroglycerin administration to evaluate the superiority of nitroglycerin in the prevention of RAO with 24 hours on Doppler ultrasound.ResultsA total of 2,040 patients were enrolled. RAO occurred in 49 patients (2.4%). Fifteen of these patients (30.6%) showed re-establishment of flow at 30 days. Nitroglycerin, compared with placebo, did not reduce the risk for RAO at either of the 2 time points (early, 2.5% vs 2.3% [P = 0.66]; late, 2.3% vs 2.5% [P = 0.66]). By multivariable analysis, the presence of spasm (OR: 3.53; 95% CI: 1.87-6.65; P < 0.001) and access achieved with more than 1 puncture attempt (OR: 2.58; 95% CI: 1.43-4.66; P = 0.002) were independent predictors of RAO.ConclusionsThe routine use of nitroglycerin was not associated with a reduction in the rate of RAO, regardless of the time of administration (at the beginning or end of the TRA procedure).     

Pediatric Heart Transplantation: Transitioning to Adult Care (TRANSIT): Feasibility of a Pilot Randomized Controlled Trial

Background:Young-adult heart transplant recipients transferring to adult care are at risk for poor health outcomes. We conducted a pilot randomized controlled trial to determine the feasibility of and to test a transition intervention for young adults who underwent heart transplantation as children and then transferred to adult care.Methods:Participants were randomized to the transition intervention (4 months long, focused on heart-transplant knowledge, self-care, self-advocacy, and social support) or usual care. Self-report questionnaires and medical records data were collected at baseline and 3 and 6 months after the initial adult clinic visit. Longitudinal analyses comparing outcomes over time were performed using generalized estimating equations and linear mixed models.Results:Transfer to adult care was successful and feasible (ie, excellent participation rates). The average patient standard deviation of mean tacrolimus levels was similar over time in both study arms and < 2.5, indicating adequate adherence. There were no between-group or within-group differences in percentage of tacrolimus bioassays within target range (> 50%). Average overall adherence to treatment was similarly good in both groups. Rates of appointment keeping through 6 months after transfer declined over time in both groups.Conclusions:The feasibility of the study was demonstrated. Our transition intervention did not improve outcomes.     

A Multisite Randomized Controlled Trial of a Patient-Centered Ventricular Assist Device Decision Aid (VADDA Trial)

Background

Studies indicate that decision making and informed consent among patients considering left ventricular assist device (LVAD) support for advanced heart failure could be improved. In the VADDA (Ventricular Assist Device Decision Aid) trial, we tested a patient-centered decision aid (DA) to enhance the quality of decision making about LVAD therapy.

Randomized Controlled Crossover Trial of a New Oscillatory Device as Add-On Therapy for COPD

Abstract

A new oscillatory device administers predetermined pressure oscillation sequences into the chest cavity over inhaled/exhaled air streams at low positive pressure. We assessed device safety and effect on 6MW performance, pulmonary function, and health-related quality-of-life (HRQOL) in moderate-to-very severe COPD in a randomized, double-blind, controlled, crossover study. Outcomes with an oscillatory device (Pulsehaler^TM, Respinova Ltd, Herzliya, Israel) and a “muted” sham device (control) of identical appearance that delivered continuous positive air pressure were compared in two groups receiving opposite treatment sequences: 2-week oscillatory device/control, 2-week washout, 2-week control/oscillatory device, 2-week washout. The clinical trial was registered (www.clinicaltrials.gov, NCT00821418) and approved by the Hadassah—Hebrew University Medical Center Institutional Review Board (08–608). All participants signed informed consent; 22 patients completed the study with no marked differences in COPD exacerbations or side effects. A total of 91% of patients treated with the oscillatory device had a clinically significant improvement (increase >40 m) in 6MW performance. The 6MW distance with the oscillatory device increased significantly after 1 week of treatment (51.6 ± 7.6 m, +13.5 ± 2.3%, p < 0.001), and more after 2 weeks (61.8 ± 9.0 m, 16.3 ± 2.7%, p < 0.001). This increase with the oscillatory device was significantly greater (p < 0.001) than the 15.4 ± 10.4 m increase (4.2 ± 2.6%, NS) with control. FVC and inspiratory capacity (IC) improved significantly (p = 0.03 for each) with the oscillatory device but not with control. HRQL improved markedly (≥1 point) for dyspnea and mastery with the oscillatory device (p = 0.02) but not control. Treatment with a new oscillatory device appears to be safe, and to improve 6MW performance, pulmonary function, and HRQL in COPD. Further evaluation is warranted.     

Feasibility and Outcomes in a Pilot Randomized Controlled Trial of a Psychosocial Intervention for Adults With Congenital Heart Disease

Background

North American adults with congenital heart disease (CHD) are known to be at elevated risk of mood and anxiety disorders. This was the first trial of a group psychosocial intervention targeting this patient population.

Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial

ObjectivesThe aim of this study was to compare transradial access (TRA) with transfemoral access (TFA) for chronic total occlusion (CTO) percutaneous coronary intervention (PCI).BackgroundTRA reduces the risk for vascular access complications but may make complex PCI, such as CTO PCI, more challenging.MethodsFORT CTO (Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion) (NCT03265769) was a prospective, noninferiority, randomized controlled study of TRA vs TFA for CTO PCI. The primary study endpoint was procedural success, defined as technical success without any in-hospital major adverse cardiovascular events. The secondary study endpoint was major access-site complications.ResultsBetween 2017 and 2021, 610 of 800 patients referred for CTO PCI at 4 centers were randomized to TRA (n = 305) or TFA (n = 305). Mean J-CTO (Multicenter CTO Registry in Japan) (2.1 ± 0.1 vs 2.2 ± 0.1; P = 0.279), PROGRESS CTO (Prospective Global Registry for the Study of Chronic Total Occlusion Intervention) (1.3 ± 0.9 vs 1.1 ± 1.0; P = 0.058) and PROGRESS CTO complication (2.4 ± 1.8 vs 2.3 ± 1.8; P = 0.561) scores and use of the retrograde approach (11% vs 14%; P = 0.342) were similar in the TRA and TFA groups. TRA was noninferior to TFA for procedural success (84% vs 86%; P = 0.563) but had fewer access-site complications (2.0% vs 5.6%; P = 0.019). There was no difference between TFA and TRA in procedural duration, contrast volume, or radiation dose.COnclusionsTRA was noninferior to TFA for CTO PCI but had fewer access-site complications.     

Efficacy of Corticosteroid Therapy for HTLV-1-Associated Myelopathy: A Randomized Controlled Trial (HAMLET-P)

Corticosteroids are most commonly used to treat HTLV-1-associated myelopathy (HAM); however, their clinical efficacy has not been tested in randomized clinical trials. This randomized controlled trial included 8 and 30 HAM patients with rapidly and slowly progressing walking disabilities, respectively. Rapid progressors were assigned (1:1) to receive or not receive a 3-day course of intravenous methylprednisolone in addition to oral prednisolone therapy. Meanwhile, slow progressors were assigned (1:1) to receive oral prednisolone or placebo. The primary outcomes were a composite of ≥1-grade improvement in the Osame Motor Disability Score or ≥30% improvement in the 10 m walking time (10 mWT) at week 2 for rapid progressors and changes from baseline in 10 mWT at week 24 for slow progressors. In the rapid progressor trial, all four patients with but only one of four without intravenous methylprednisolone achieved the primary outcome (p = 0.14). In the slow progressor trial, the median changes in 10 mWT were −13.8% (95% CI: −20.1–−7.1; p < 0.001) and −6.0% (95% CI: −12.8–1.3; p = 0.10) with prednisolone and placebo, respectively (p for between-group difference = 0.12). Whereas statistical significance was not reached for the primary endpoints, the overall data indicated the benefit of corticosteroid therapy. (Registration number: UMIN000023798, UMIN000024085)     

Efficacy of the Common Elements Treatment Approach (CETA) for Unhealthy Alcohol Use Among Adults with HIV in Zambia: Results from a Pilot Randomized Controlled Trial

AIDS and Behavior - This randomized controlled trial tested the efficacy of a multi-session, evidence-based, lay counselor-delivered transdiagnostic therapy, the Common Elements Treatment Approach...     

Budesonide Enema in Distal Ulcerative Colitis: a Randomized Dose-Response Trial with Prednisolone Enema as Positive Control

The effect of budesonide, 1, 2, and 4mg/l00ml in daily enemas, on active distal ulcerative colitis was compared with that of prednisolone disodium phosphate enemas, 25 mg/100 ml, in a multicentre, randomized, group-comparative trial. A total of 146 patients with active disease were treated for 2 weeks. Data from 139 were valid for statistical analyses. Bowel habits, proctoscopy findings, and histologic pictures were evaluated, and plasma Cortisol was determined for measurement of influence on the hypothalamic-pituitary-adrenal axis. Clinical symptoms and proctoscopy findings improved within all treatment groups. The improvement of these effect variables tended to be less after treatment with the lowest dose of budesonide, 1 mg/100 ml, than after the other treatments. Plasma Cortisol did not change in any of the budesonide groups, whereas a mean reduction of 30% (P = 0.07) was observed after prednisolone. It can be concluded that budesonide enemas of 2 mg/100 ml constitute an attractive alternative to prednisolone enemas for topical treatment of distal ulcerative colitis.     

Self-care Management Intervention in Heart Failure (SMART-HF): A Multicenter Randomized Controlled Trial

BackgroundSelf-care behavior is important in avoiding hospitalization for patients with heart failure (HF) and refers to those activities performed with the intention of improving or restoring health and well-being, as well as treating or preventing disease. The purpose was to study the effects of a home-based mobile device on self-care behavior and hospitalizations in a representative HF-population.Methods and ResultsSMART-HF is a randomized controlled multicenter clinical trial, where patients were randomized 1:1 to receive standard care (control group [CG]) or intervention with a home-based tool designed to enhance self-care behavior (intervention group [IG]) and followed for 240 days. The tool educates the patient about HF, monitors objective and subjective symptoms and adjusts loop diuretics. The primary outcome is self-care as measured by the European Heart Failure Self-care behavior scale and the secondary outcome is HF related in-hospital days.A total of 124 patients were recruited and 118 were included in the analyses (CG: n = 60, IG: n = 58). The mean age was 79 years, 39% were female, and 45% had an ejection fraction of less than 40%. Self-care was significantly improved in the IG compared to the CG (median (interquartile range) (21.5 [13.25; 28] vs 26 [18; 29.75], p = 0.014). Patients in the IG spent significantly less time in the hospital admitted for HF (2.2 days less, relative risk 0.48, 95% confidence interval 0.32–0.74, P = .001).ConclusionsThe device significantly improved self-care behavior and reduced in-hospital days in a relevant HF population.     

Transition Care in Anorexia Nervosa Through Guidance Online from Peer and Carer Expertise (TRIANGLE): Study Protocol for a Randomised Controlled Trial

TRIANGLE is a multicentre trial investigating whether the addition of a novel intervention for patients and carers (ECHOMANTRA) to treatment as usual (TAU) improves outcomes for people with anorexia nervosa (AN). ECHOMANTRA is based on the cognitive interpersonal model of AN and includes assessments, workbooks, videos, online groups and joint Skype sessions for patients and carers. People receiving intensive hospital treatment (N = 380) will be randomised to TAU or TAU plus ECHOMANTRA. Participants will be assessed over an 18‐month period following randomisation. The primary outcome is patient psychological well‐being at 12 months postrandomisation. Secondary outcomes include (i) patient's weight, eating disorder symptoms, motivation to change, quality of life and number of days in hospital at 12 months postrandomisation and (ii) carer's psychological well‐being, burden and skills at 12 months (some outcomes will be assessed at 18 months postrandomisation). The results from this trial will establish the effectiveness of ECHOMANTRA. Trial registration : ISRCTN registry ISRCTN14644379, 08/12/2016. Copyright © 2017 John Wiley & Sons, Ltd and Eating Disorders Association.     

Empathy Training for Resident Physicians: A Randomized Controlled Trial of a Neuroscience-Informed Curriculum

Background

Physician empathy is an essential attribute of the patient–physician relationship and is associated with better outcomes, greater patient safety and fewer malpractice claims.

Objective

We tested whether an innovative empathy training protocol grounded in neuroscience could improve physician empathy as rated by patients.

Design

Randomized controlled trial.

Intervention

We randomly assigned residents and fellows from surgery, medicine, anesthesiology, psychiatry, ophthalmology, and orthopedics (N = 99, 52% female, mean age 30.6 ± 3.6) to receive standard post-graduate medical education or education augmented with three 60-minute empathy training modules.

Main Measure

Patient ratings of physician empathy were assessed within one-month pre-training and between 1–2 months post-training with the use of the Consultation and Relational Empathy (CARE) measure. Each physician was rated by multiple patients (pre-mean = 4.6 ± 3.1; post-mean 4.9 ± 2.5), who were blinded to physician randomization. The primary outcome was change score on the patient-rated CARE.

Key Results

The empathy training group showed greater changes in patient-rated CARE scores than the control (difference 2.2; P = 0.04). Trained physicians also showed greater changes in knowledge of the neurobiology of empathy (difference 1.8; P < 0.001) and in ability to decode facial expressions of emotion (difference 1.9; P < 0.001).

Conclusions

A brief intervention grounded in the neurobiology of empathy significantly improved physician empathy as rated by patients, suggesting that the quality of care in medicine could be improved by integrating the neuroscience of empathy into medical education.KEY WORDS: empathy, randomized controlled trial, communication skills, graduate medical education, patient–physician relationship