“If your purpose is to minimize the impact on the patient, implant a pacemaker.”
In presenting the results of a 115-patient trial comparing implantable cardiac monitors with pacing therapy, Dr. Robert Sheldon of the University of Calgary said the choice is clear.
“If your purpose is to minimize the impact on the patient, put in a pacemaker,” Sheldon said. “What we found was actually a striking difference between the two arms. The patients who got pacemakers had fewer [negative] outcomes, by a lot – about ⅔ fewer outcomes.”
Sheldon’s study was designed using nine of the 10 criteria for pragmatic trial design, he noted, aiming to speed the transfer of knowledge from clinical to daily preactice.
“In pragmatic trials, you basically have broad incluscion criteria – you try to exclude as few people as possible,” he explained. “You basically randomize the patients and let the different centers do pretty much what they want, and then collect the data.”