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
Gerard Farrell | EurekAlert!
Oxygen can wake up dormant bacteria for antibiotic attacks
08.12.2016 | Penn State
NTU scientists build new ultrasound device using 3-D printing technology
07.12.2016 | Nanyang Technological University
In recent years, lasers with ultrashort pulses (USP) down to the femtosecond range have become established on an industrial scale. They could advance some applications with the much-lauded “cold ablation” – if that meant they would then achieve more throughput. A new generation of process engineering that will address this issue in particular will be discussed at the “4th UKP Workshop – Ultrafast Laser Technology” in April 2017.
Even back in the 1990s, scientists were comparing materials processing with nanosecond, picosecond and femtosesecond pulses. The result was surprising:...
Have you ever wondered how you see the world? Vision is about photons of light, which are packets of energy, interacting with the atoms or molecules in what...
A multi-institutional research collaboration has created a novel approach for fabricating three-dimensional micro-optics through the shape-defined formation of porous silicon (PSi), with broad impacts in integrated optoelectronics, imaging, and photovoltaics.
Working with colleagues at Stanford and The Dow Chemical Company, researchers at the University of Illinois at Urbana-Champaign fabricated 3-D birefringent...
In experiments with magnetic atoms conducted at extremely low temperatures, scientists have demonstrated a unique phase of matter: The atoms form a new type of quantum liquid or quantum droplet state. These so called quantum droplets may preserve their form in absence of external confinement because of quantum effects. The joint team of experimental physicists from Innsbruck and theoretical physicists from Hannover report on their findings in the journal Physical Review X.
“Our Quantum droplets are in the gas phase but they still drop like a rock,” explains experimental physicist Francesca Ferlaino when talking about the...
The Max Planck Institute for Physics (MPP) is opening up a new research field. A workshop from November 21 - 22, 2016 will mark the start of activities for an innovative axion experiment. Axions are still only purely hypothetical particles. Their detection could solve two fundamental problems in particle physics: What dark matter consists of and why it has not yet been possible to directly observe a CP violation for the strong interaction.
The “MADMAX” project is the MPP’s commitment to axion research. Axions are so far only a theoretical prediction and are difficult to detect: on the one hand,...
16.11.2016 | Event News
01.11.2016 | Event News
14.10.2016 | Event News
08.12.2016 | Life Sciences
08.12.2016 | Physics and Astronomy
08.12.2016 | Materials Sciences