The federal Patient-Centered Outcomes Research Institute just approved $30 million in funding for comparative outcomes studies related to med tech, as part of the $65 million in research awards the agency doled out to 6 teams.
More than $13 million was awarded to the Medical University of South Carolina to study embolism prevention after hip and knee replacement. The purpose of the study "is to combine information about effectiveness in preventing blood clots in the lungs and legs, which is important to how patients do after total hip and knee replacement, with the opinions of patients about the safety of the most commonly employed blood thinners with respect to the chance of bleeding problems that each drug might cause after the operation," PCORI says.
Embolisms only occur in 0.1% to 0.5% of patients after hip and knee replacements, but that still results between 1,000 and 5,000 deaths each year. "These events are so uncommon that no clinical trial is large enough to provide an answer as to whether the strongest of blood thinners, or weaker medicines, are the best to use in this setting," PCORI says.
In addition, nearly $13 million was given to the University of Washington to compare the outcomes of drugs versus appendectomy (the surgical removal of the appendix), to treat appendicitis. Surgery has been the standard of care, but PCORI says that "recent studies from Europe have challenged the notion that surgery is the best option by showing that antibiotics alone can work to treat appendicitis." Still, in the U.S., less than 2% of appendicitis patients receive antibiotics.
Finally, the nonprofit Group Health Cooperative received $4.5 million to compare the outcomes of three bariatric weight loss procedures: Roux-en-y gastric bypass, adjustable gastric banding, and sleeve gastrectomy. The focus will be on three outcomes, weight loss, rates of remission and relapse of diabetes, and the risk of major adverse events. It should be noted the use of recently approved, less invasive weight loss balloon threatens to replace bariatric surgery as main non-medicated approach to weight loss.
PCORI also funded studies about integrating behavioral health and primary care, integrated versus referral care for complex psychiatric disorders, and childhood obesity.