American heart journal
-
American heart journal · Aug 2012
Randomized Controlled TrialMinimally clinically important difference in chronic breathlessness: every little helps.
The aim of the study was to determine the minimally clinically important difference (MCID) for breathlessness due to chronic heart failure (CHF). ⋯ A 1-point change in NRS or mBorg score is a reasonable estimate of the MCID in average daily chronic breathlessness in CHF.
-
American heart journal · Aug 2012
Randomized Controlled TrialThe rationale and design of the Shockless IMPLant Evaluation (SIMPLE) trial: a randomized, controlled trial of defibrillation testing at the time of defibrillator implantation.
Defibrillation testing (DT) has been an integral part of defibrillator (implantable cardioverter defibrillator [ICD]) implantation; however, there is little evidence that it improves outcomes. Surveys show a trend toward ICD implantation without DT, which now exceeds 30% to 60% in some regions. Because there is no evidence to support dramatic shift in practice, a randomized trial is urgently needed. ⋯ Several secondary outcomes will be evaluated, including all-cause mortality and heart failure hospitalization. Enrollment of 2,500 patients with 3.5-year mean follow-up will provide sufficient statistical power to demonstrate noninferiority. The study is being performed at approximately 90 centers in Canada, Europe, Israel, and Asia Pacific with final results expected in 2013.