Publications by authors named "Daniel Schaber"
Article Synopsis
- The study investigates the effectiveness of adaptive cardiac resynchronisation therapy (CRT) compared to conventional CRT in patients with heart failure and left bundle branch block, aiming to see if adaptive CRT provides better outcomes.
- Conducted across 227 hospitals in 27 countries, the trial involved 3,797 patients who were randomized into two treatment groups, focusing on primary outcomes related to all-cause death and heart failure interventions.
- The trial was halted early due to crossing the futility boundary, indicating that adaptive CRT did not demonstrate a significant benefit compared to conventional CRT after analyzing the data.
Background: The statistical significance of clinical trial outcomes is generally interpreted quantitatively according to the same threshold of 2.5% (in one-sided tests) to control the false-positive rate or type I error, regardless of the burden of disease or patient preferences. The clinical significance of trial outcomes-including patient preferences-are also considered, but through qualitative means that may be challenging to reconcile with the statistical evidence.
View Article and Find Full Text PDFThe Heart Failure Academic Research Consortium is a partnership between the Heart Failure Collaboratory (HFC) and the Academic Research Consortium (ARC) composed of patients, academic investigators from the United States and Europe, the U.S. Food and Drug Administration, the National Institutes of Health, payers, and industry.
View Article and Find Full Text PDFBackground: Regulatory and clinical decisions involving health technologies require judgements about relative importance of their expected benefits and risks. We sought to quantify heart-failure patients' acceptance of therapeutic risks in exchange for improved effectiveness with implantable devices.
Methods: Individuals with heart failure recruited from a national web panel or academic medical center completed a web-based discrete-choice experiment survey in which they were randomized to one of 40 blocks of 8 experimentally controlled choice questions comprised of 2 device scenarios and a no-device scenario.
Article Synopsis
- Cardiac resynchronization therapy (CRT) is beneficial for some heart failure patients, but significant knowledge gaps still exist regarding its effectiveness, especially in certain populations and conditions.
- A study aimed to identify and prioritize these evidence gaps by involving a diverse group of stakeholders, including researchers and patients, to develop a comprehensive research plan.
- The analysis revealed 18 key evidence gaps, focusing on specific populations, the comparative effectiveness and safety of CRT, and how comorbidities affect CRT outcomes, emphasizing the need for further research in these areas.
The development of treatments for heart failure (HF) is challenged by burdensome clinical trials. Reducing the need for extensive data collection and increasing opportunities for data compatibility between trials may improve efficiency and reduce resource burden. The Heart Failure Collaboratory (HFC) multi-stakeholder consortium sought to create a lean case report form (CRF) for use in HF clinical trials evaluating cardiac devices.
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