Surgical Innovation Framework May Improve Patient Outcomes

Laurie Barclay, MD

June 21, 2013

A new research framework for surgical innovation should help improve the safety and effectiveness of surgical procedures and implantable devices, according to a report from the Idea, Development, Exploration, Assessment, Long-term follow-up (IDEAL) Collaboration, published online June 18 in the BMJ.

"If the IDEAL framework were widely implemented, the clinical implications would be considerably better evidence for surgical devices and surgical procedures," Philipp Dahm, MD, MHSc, professor of urology, University of Florida, Gainesville, told Medscape Medical News when asked for independent comment. "It would align evidentiary standards for medical treatments (drugs) and surgical treatments/devices and result in safer patient care."

The new framework for evidence-based surgery and device research is similar to the risk–benefit analysis presently underlying evidence-based medicine. The US Food and Drug Administration, regulatory agencies from other countries, and surgeons themselves are now attempting to address the lack of evidence-based research in surgery and device fields.

"Historically, the focus of government-funded research has been on pharmaceuticals and often not surgical/device interventions, which has been limited as a consequence," co–lead investigator Art Sedrakyan, MD, PhD, from Weill Cornell Medical College in New York City, said in a college news release. "Drugs have certainly dominated the agenda."

Proposed methodological strategies, such as analysis of observational data already collected within registries, would allow investigators to compare the safety and efficacy of different surgical techniques and devices. The report also suggests standards for performing clinical trials regarding surgical procedures and implantable devices.

"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," Dr. Sedrakyan said in the release.

"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."

Key Features of the Proposed Framework

  • The evaluation and long-term study stages require rigorous examination of surgical innovations, including comprehensive outcome assessment.

  • Large, multicenter, randomized trials and long-term observational studies of surgical interventions should be designed with consideration of the complexity of surgery and variation in practice.

  • Key issues for surgical trial design are specifying the interventions and those who will deliver them and are determining the potential effect of patient and surgeon preferences.

  • Long-term assessments of procedures and devices are essential, as well as development of data collection and surveillance methodology. For long-term surveillance of procedures, large, preferably national patient registries are best.

Pros and Cons of the Proposed Framework

"This is the first formal framework for surgical innovation," said Dr. Dahm, who is also coordinating editor, Cochrane Prostatic Diseases and Urological Cancers Group. "But it represents a major overhaul of the approval system for surgical devices and procedures, which will require time and resources to implement."

In terms of additional research, Dr. Dahm recommends specific funding opportunities for IDEAL-based research, widespread journal endorsement of IDEAL principles, and pilot research projects using IDEAL.

"[N]ew innovative research methods need to be developed that are quite different than those used for the evaluation of pharmaceuticals," Dr. Sedrakyan concluded in the release.

"Our framework can potentially be used by agencies to guide regulatory science related to implantable devices. We can look at the performance of surgery and devices by recognizing the unique aspects of specific types of surgery and by developing robust new methods."

The US Food and Drug Administration supported Dr. Sedrakyan's research. Other sources of funding for this study include the National Institute for Health Research, Johnson & Johnson, Medtronic, and Zimmer. One coauthor reports receiving financial support from the National Institute for Health Research’s Health Technology Assessment programme, Johnson & Johnson, Medtronic, and Zimmer. Dr. Dahm is a member of the IDEAL Collaboration but was not involved in this study or publication and has no relevant financial disclosures.

BMJ. Published online June 18, 2013. Full text


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