Forum for Science, Industry and Business

Sponsored by:     3M 
Search our Site:

 

Tackling a framework for surgical innovation

19.06.2013
Researchers offer new framework to improve the safety and effectiveness of surgical procedures and implantable devices

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 Dr. Art Sedrakyan of Weill Cornell Medical College.

In the June 18 issue of the British Medical Journal (BMJ), Dr. 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 Dr. Sedrakyan, associate professor of public health and cardiothoracic surgery at Weill Cornell. Dr. Sedrakyan worked with a team of researchers from the United Kingdom, and U.S. 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.

At Weill Cornell Medical College, Dr. Sedrakyan leads the Medical Device Epidemiology Network's Science and Infrastructure Center, one of two FDA-funded centers in the country that evaluates medical devices, especially implantable devices. He is the vice-chair of the IDEAL Collaboration advancing device evaluation and, prior to joining Weill Cornell, has worked on post-market surveillance and modernization surveillance at the FDA.

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, Dr. 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," Dr. Sedrakyan says. "In addition, new innovative research methods need to be developed that are quite different than those used for the evaluation of pharmaceuticals."

Research in Surgery

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.

"Historically, the focus of government-funded research has been on pharmaceuticals and often not surgical/device interventions, which has been limited as a consequence. Drugs have certainly dominated the agenda," says Dr. Sedrakyan.

But in their new study, researchers point out that there are methodological ways to use available data that will allow a researcher to compare the safety and effectiveness of different surgical techniques and devices. One method, highlighted in the study, involves the right way to scrutinize observational data that has already been collected within registries or other observational data sources. The study also suggests ways that clinical trials can be conducted in surgery and in the field of implantable devices.

"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," says Dr. Sedrakyan.

Researchers contributing to the study include Dr. Jonathan Cook, the corresponding author, from the University of Aberdeen, UK; Dr. Peter McCulloch and Dr. David J. Beard from the University of Oxford, UK; Dr. Jane M. Blazeby, from the University of Bristol, UK; and Dr. Danica Marinac-Dabic from the U.S. FDA.

Dr. Sedrakyan's research is funded by the FDA. Other sources of funding for this study include the National Institute for Health Research in the UK, Health Technology Assessment programme in the UK, Johnson & Johnson, Medtronic and Zimmer (all unrestricted grants) to support an IDEAL workshop.

Weill Cornell Medical College

Weill Cornell Medical College, Cornell University's medical school located in New York City, is committed to excellence in research, teaching, patient care and the advancement of the art and science of medicine, locally, nationally and globally. Physicians and scientists of Weill Cornell Medical College are engaged in cutting-edge research from bench to bedside, aimed at unlocking mysteries of the human body in health and sickness and toward developing new treatments and prevention strategies. In its commitment to global health and education, Weill Cornell has a strong presence in places such as Qatar, Tanzania, Haiti, Brazil, Austria and Turkey. Through the historic Weill Cornell Medical College in Qatar, the Medical College is the first in the U.S. to offer its M.D. degree overseas. Weill Cornell is the birthplace of many medical advances -- including the development of the Pap test for cervical cancer, the synthesis of penicillin, the first successful embryo-biopsy pregnancy and birth in the U.S., the first clinical trial of gene therapy for Parkinson's disease, and most recently, the world's first successful use of deep brain stimulation to treat a minimally conscious brain-injured patient. Weill Cornell Medical College is affiliated with NewYork-Presbyterian Hospital, where its faculty provides comprehensive patient care at NewYork-Presbyterian Hospital/Weill Cornell Medical Center. The Medical College is also affiliated with the Methodist Hospital in Houston. For more information, visit weill.cornell.edu.
Office of External Affairs
Weill Cornell Medical College
tel: 646.317.7401
email: pr@med.cornell.edu

Gerard Farrell | EurekAlert!
Further information:
http://weill.cornell.edu

More articles from Health and Medicine:

nachricht New High-Performance Center Translational Medical Engineering
26.04.2017 | Fraunhofer ITEM

nachricht A promising target for kidney fibrosis
21.04.2017 | Brigham and Women's Hospital

All articles from Health and Medicine >>>

The most recent press releases about innovation >>>

Die letzten 5 Focus-News des innovations-reports im Überblick:

Im Focus: Making lightweight construction suitable for series production

More and more automobile companies are focusing on body parts made of carbon fiber reinforced plastics (CFRP). However, manufacturing and repair costs must be further reduced in order to make CFRP more economical in use. Together with the Volkswagen AG and five other partners in the project HolQueSt 3D, the Laser Zentrum Hannover e.V. (LZH) has developed laser processes for the automatic trimming, drilling and repair of three-dimensional components.

Automated manufacturing processes are the basis for ultimately establishing the series production of CFRP components. In the project HolQueSt 3D, the LZH has...

Im Focus: Wonder material? Novel nanotube structure strengthens thin films for flexible electronics

Reflecting the structure of composites found in nature and the ancient world, researchers at the University of Illinois at Urbana-Champaign have synthesized thin carbon nanotube (CNT) textiles that exhibit both high electrical conductivity and a level of toughness that is about fifty times higher than copper films, currently used in electronics.

"The structural robustness of thin metal films has significant importance for the reliable operation of smart skin and flexible electronics including...

Im Focus: Deep inside Galaxy M87

The nearby, giant radio galaxy M87 hosts a supermassive black hole (BH) and is well-known for its bright jet dominating the spectrum over ten orders of magnitude in frequency. Due to its proximity, jet prominence, and the large black hole mass, M87 is the best laboratory for investigating the formation, acceleration, and collimation of relativistic jets. A research team led by Silke Britzen from the Max Planck Institute for Radio Astronomy in Bonn, Germany, has found strong indication for turbulent processes connecting the accretion disk and the jet of that galaxy providing insights into the longstanding problem of the origin of astrophysical jets.

Supermassive black holes form some of the most enigmatic phenomena in astrophysics. Their enormous energy output is supposed to be generated by the...

Im Focus: A Quantum Low Pass for Photons

Physicists in Garching observe novel quantum effect that limits the number of emitted photons.

The probability to find a certain number of photons inside a laser pulse usually corresponds to a classical distribution of independent events, the so-called...

Im Focus: Microprocessors based on a layer of just three atoms

Microprocessors based on atomically thin materials hold the promise of the evolution of traditional processors as well as new applications in the field of flexible electronics. Now, a TU Wien research team led by Thomas Müller has made a breakthrough in this field as part of an ongoing research project.

Two-dimensional materials, or 2D materials for short, are extremely versatile, although – or often more precisely because – they are made up of just one or a...

All Focus news of the innovation-report >>>

Anzeige

Anzeige

Event News

Expert meeting “Health Business Connect” will connect international medical technology companies

20.04.2017 | Event News

Wenn der Computer das Gehirn austrickst

18.04.2017 | Event News

7th International Conference on Crystalline Silicon Photovoltaics in Freiburg on April 3-5, 2017

03.04.2017 | Event News

 
Latest News

Scientist invents way to trigger artificial photosynthesis to clean air

26.04.2017 | Materials Sciences

Ammonium nitrogen input increases the synthesis of anticarcinogenic compounds in broccoli

26.04.2017 | Agricultural and Forestry Science

SwRI-led team discovers lull in Mars' giant impact history

26.04.2017 | Physics and Astronomy

VideoLinks
B2B-VideoLinks
More VideoLinks >>>