Surgery: Tackling a Framework for Innovation

Photo: Operation

Researchers offer new framework to improve the safety and effectiveness of surgical procedures and implantable devices; © Yeulet

An international team of investigators co-led by Weill Cornell Medical College is offering a new framework for evidence-based surgery and device research, similar to the kind of risk and benefit analysis used in evidence-based medicine.

"Currently, there is no dynamic research framework to systematically detect devices and surgeries that don't offer any benefits to patients or may even be harmful," says co-lead investigator Doctor Art Sedrakyan.

Sedrakyan and his colleagues suggest ways that clinical trials, observational databases and registries can be used to provide quality assessment and surveillance of both surgery and the use of implanted medical devices.

"The failure to conduct methodologically rigorous studies has led to some devices/surgical interventions, such as metal-on-metal hip implants or robotic surgery, becoming popular without high quality supporting evidence," says Sedrakyan. He worked with a team of researchers from the United Kingdom, and United States Food and Drug Administration (FDA) who are part of the IDEAL (Idea, Development, Exploration, Assessment, Long-term follow-up) Collaboration. This group is working on ways to improve research in surgery and on medical devices as a way to spur surgical excellence, as well as innovation.

Regulatory agencies in a number of countries, and surgeons themselves, are now seeking ways to address the current lack of evidence-based research in surgery and device fields, Sedrakyan says.

"We have to recognize that not every surgical procedure that is offered is as safe and effective as we thought and so these techniques need to be evaluated," Sedrakyan says. "In addition, new innovative research methods need to be developed that are quite different than those used for the evaluation of pharmaceuticals."

Unlike the way drugs are tested, it isn't easy to conduct randomized clinical trials in surgery.

For example, if medical investigators want to know if an experimental cancer drug is more effective than an agent being used in the clinic, they test the new drug against the old one in a randomized clinical trial. Randomly assigned patients use the new drug or old drug.

However, when surgeons are trained to perform a specific kind of operation or have a preference for a particular technique they can't be easily asked to conduct an alternative surgery or apply a different technique so that new and old methods can be compared in a randomized clinical trial. On top of that, there is a variation in the choice of medical devices.; Source: Weill Cornell Medical College