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More Comparative Research Needed For Devices – Duke University’s Kramer

This article was originally published in The Gray Sheet

Executive Summary

The Agency for Healthcare Research & Quality should conduct more comparative research on devices because less is known about their benefits, risks and clinical outcomes than pharmaceuticals, according to Duke University's Judith Kramer, MD

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PREVENT-HF: CardioDynamics, manufacturer of the BioZ impedance cardiography system, launches the randomized, controlled PREVENT-HF trial to compare BioZ monitoring to standard clinical care for management of chronic heart failure. The trial is designed to demonstrate the value of impedance cardiography data in guiding treatment decisions and reduce hospitalizations of heart failure patients. The trial will enroll about 500 patients at 35 centers, and each patient will be followed from six to 12 months. The exact number of patients will be determined by the rate of adverse events; the trial will be complete when 212 heart failure-related hospitalizations have been recorded. PREVENT-HF is a follow-on trial to CardioDynamics' PREDICT study, which demonstrated that the proprietary BioZ scoring algorithm was a powerful and independent measure of risk for near-term, heart failure-related adverse events, including hospitalization, emergency room visits and death (1"The Gray Sheet" Sept. 20, 2004, p. 18)...

Research News In Brief

PREVENT-HF: CardioDynamics, manufacturer of the BioZ impedance cardiography system, launches the randomized, controlled PREVENT-HF trial to compare BioZ monitoring to standard clinical care for management of chronic heart failure. The trial is designed to demonstrate the value of impedance cardiography data in guiding treatment decisions and reduce hospitalizations of heart failure patients. The trial will enroll about 500 patients at 35 centers, and each patient will be followed from six to 12 months. The exact number of patients will be determined by the rate of adverse events; the trial will be complete when 212 heart failure-related hospitalizations have been recorded. PREVENT-HF is a follow-on trial to CardioDynamics' PREDICT study, which demonstrated that the proprietary BioZ scoring algorithm was a powerful and independent measure of risk for near-term, heart failure-related adverse events, including hospitalization, emergency room visits and death (1"The Gray Sheet" Sept. 20, 2004, p. 18)...

Medicare Experts Mull Idea Of U.S. Comparative Effectiveness Review Agency

Impressed by the success of the UK's comparative effectiveness health care agency NICE, Medicare payment expert Gail Wilensky is leading a push for a similar body in the United States - and at least one major stakeholder, Johnson & Johnson, appears willing to contemplate the idea

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