Live case demonstrations at meetings provide unique medical education

They also raise ethical, regulatory concerns.

The live broadcasting of surgical procedures to medical meetings continues to provide cardiologists with essential real-time training and education, but has also generated some ethical and regulatory questions.

Although the technology that allows live broadcasts to stream into medical meetings is relatively modern, the concept of live case demonstrations is as old as medical education itself, according to David R. Holmes III, MD, a professor of medicine at the Mayo Clinic in Rochester, Minn. and a member of the Cardiology Today Editorial Board.

“If you look back 150 years ago in places like Johns Hopkins or the Mayo Clinic in Rochester, operations used to be performed on the first story and the live audience filed in on the second story and watched the operation proceeding,” Holmes said. “This is not new — it has been around for 150 years since medicine first started, where we in fact learned by interacting and watching somebody else do it. We should never lose sight of that.”

David R. Holmes III, MD, says live case demonstrations have played a vital role in medical education. Photo by: Amanda Durhman, Design Partners of Stiehm & Durhman

But the broadcast of live case demonstrations may also create ethical considerations for both operators and patients, such as patient consent, operator competency and skill, patient privacy and voluntariness as well as the role of institutional review boards.

Ethical considerations

Charles R. Mackay, PhD, an ethicist at Washington Hospital Center in Washington, D.C., described some of the possible ethical issues that physicians in particular should consider when doing a live case demonstration, with paramount importance placed on oversight.

“It is important to know the aim of the demonstration because very often it is to attract patients or to boast about the prominence of the surgeon or the advantages of the hospital,” Mackay recently said during a discussion at the Cardiovascular Research Technologies 2009 meeting. “We live in a competitive society, and those motives should be present and should not be squelched, but unless teaching is the principal aim and focus, we can lose sight and can get into areas of conflict of interest.”

Another area of ethical concern, according to Mackay, is determining who is in charge of the procedure. “To some extent, the Association for Continuing Medical Education accredits the programs, but it does not really vet the programs,” Mackay said. “So who is in charge? Who selects what is going to happen? Which procedures will be used? Is the procedure done because some individual wants to demonstrate institutional or surgical benefits to the public? We do not know, and there is no way of vetting all of this.”

Regulatory perspective

Regulations governing broadcasted, live case demonstrations have generally been less restrictive in Europe than in the United States, according to Horst Sievert, MD, associate professor of internal medicine and cardiology at the University of Frankfurt in Germany.

“Live transmissions are not regulated in Europe; they are not regulated by the government, by insurance or really any other authority,” Sievert said. “Needless to mention is that live cases still have to be performed according to the rules and regulations, which apply to all kinds of medical treatment.”

Sievert said that although it is important to adhere to normal procedural guidelines that are already in place for medical treatments, the tendency to overregulate is also a potential problem.

“A priority is to fight overregulation because it always slows down progress, which is not in the interest of the patient,” Sievert said.

Regulation in the United States is more extensive than in Europe, but according to Bram D. Zuckerman, MD, director of the division of cardiac devices at the Center for Devices and Radiological Health at the FDA, there remains a paucity of literature and data on the safety of using the live case method for educational instruction.

“It is remarkable how little literature there is on this topic, even though we have a great tradition in medicine of teaching by live case demonstration,” Zuckerman said. “It is welcome to hear that the main professional cardiology societies, including the Heart Rhythm Society, are working diligently on resolving this problem.”

Zuckerman also questioned whether operators who need to interact with a panel and audience during a live case are always using their best medical judgment in choosing treatment options and whether they are swayed by the real-time scenario and a desire to impress their peers.

Zuckerman also outlined the extent of the regulatory authority of the FDA in the area of live case demonstrations which, although narrow, still prevents some investigational and unapproved devices from being used in live case demonstrations within the United States.

“We only have regulatory authority in the United States to determine whether an unapproved medical device in an investigational device exemption can be shown in a live case demonstration,” Zuckerman said. “FDA does not have regulatory authority on live case demonstrations broadcast from Europe to a U.S. audience, even if an unapproved medical device is being used. From a regulatory perspective, FDA is looking at a small piece of the current landscape but we are also looking at this problem from a broader public health perspective.”

Charles Simonton, MD, a former interventional cardiologist and divisional vice president of medical affairs as well as chief medical officer of Abbott Vascular, pointed out that live case demonstrations are crucial not only for introducing new medical technologies to practitioners and trainees but also in helping the operators improve their effectiveness and skill.

“You cannot learn these procedures in textbooks, and direct training usually ends after the interventional fellowship in terms of the hands-on training,” Simonton said. “The methods of learning new procedures following training are pretty limited, and we have only recently had simulators come into play in training.” – by Eric Raible

For more information:

• Holmes D, Sievert H, Mackay C, Simonton C, Zuckerman B. Should live cases be broadcast to meetings? Regulation in education and training. Module V. Presented at: Cardiovascular Research Technologies; March 4-6, 2009; Washington.

There are both good and bad aspects to live demonstrations. As Dr. Holmes said, these have been with us for several years as important teaching venues. My concerns include the ethical issues raised by Dr. Mackay, as well as several others. For example, would a medical decision be made for the benefit of the audience, rather than for what is in the best interest of the patient? I could envision the scenario where a patient gets into trouble during the procedure, which would ordinarily call for aborting it, but the procedure continues because of the audience. There are also educational concerns. For example, there is a lot of “down time” in performing routine parts of a procedure possessing little educational value that would ordinarily be edited out of a teaching tape. I agree with Dr. Zuckerman that this is a worthy topic for Heart Rhythm Society discussion and guidance.

– Douglas Zipes, MD

Cardiology Today Section Editor