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BOSTON – Unforeseen complications and steep learning curves represent the downside of new devices and new procedures, but there are some strategies to minimize these risks, according to experts outlining three such approaches during a session on quality outcomes at the 2017 AGA Tech Summit.
One approach involves a reorientation in skill acquisition in health care delivery. Another involves novel strategies to identify problems with new devices more rapidly. The third involves an ongoing evolution in mentoring clinicians through telecommunication.
Mastering new skills
The strategy described for equipping clinicians with the skills to produce uniform, reproducible outcomes is a technique referred to as simulation-based mastery learning, explained E. Matthew Ritter, MD, vice chairman for education and program director of the general surgery residency program at Walter Reed National Military Medical Center’s Uniformed Services University, Bethesda, Md. The technique is based on the goal of eliciting a “specific level of performance without regard to a time-based approach that is the typical standard in learning processes.”
“More and more evidence is available that performing something a lot of times does not necessarily correlate with performing something well,” Dr. Ritter said. He proposed that direct measurements of skill acquisition address this problem.
“My work has been primarily in laparoscopic surgery, but this approach is not specialty-specific,” Dr. Ritter said in an interview, explaining that the approach focuses on breaking down clinical procedures into tasks for which mastery can be objectively defined. The mastery learning for any one task is complete when performance criteria are met rather than after any specific number of repetitions.
“There is substantial evidence that this approach improves skill acquisition and improves outcome,” Dr. Ritter reported.
Identifying problems more quickly
To reduce the risks and complications of new devices, various strategies for postmarketing surveillance are being pursued simultaneously, according to Dana Telem, MD, MPH, director of the Michigan Comprehensive Hernia Program and an associate professor of surgery at the University of Michigan, Ann Arbor. As has been demonstrated repeatedly, the premarket testing and regulatory approval process does not rule out risk of unforeseen complications, including serious risks that may ultimately lead to the technology being discarded.
One approach has been the increasing use of registries so that constant capture of patient data allows isolated but recurring events to become rapidly identifiable, but Dr. Telem said that the value of these registries can be increased “by encouraging and empowering patients to report issues when they occur” to improve capture of adverse events.
As an example of a strategy to more rapidly drill down to the cause of complications, Dr. Telem reported on an effort to encourage creation of unique device identifiers for a given device. As devices are commonly updated and modified, the serial number may be useful when trying to determine whether the issue can be linked to a specific design change. More importantly, these numbers would be identifiable in billing data and potentially linked to registries to improve real time identification of adverse event patterns.
“The problem with adding new layers of premarketing regulation is the risk of stifling innovation, but we have not done a great job of postmarketing surveillance, and I think the focus now being placed on better strategies will greatly improve patient safety,” Dr. Telem reported.
Adding more layers of review and testing prior to approval of a new technology does not necessarily identify all risks, because not all complications are foreseeable, Dr. Telem explained.
“The long-term monitoring of new devices and technologies is mission critical if we really hope to safely innovate in the future.” Dr. Telem said.
Improving learning through telementoring
Employing avenues of telecommunication to better mentor clinicians acquiring new skills was the third example of an innovative area of improving quality assurance. A large focus of the presentation by Christopher Schlachta, MD, professor of surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont., was on telementoring. He explained that this concept is not new, but it is becoming increasingly sophisticated, and there is a growing body of objective evidence that it is effective.
The Internet expands the possibilities. Remote screens can accommodate multiple images, including, in the case of surgical procedures, the surgical field and situational cameras that provide one or more views of the surgical team as they proceed. For laparoscopy, the information being fed to the mentor is often even more comprehensive.
“So much of what we do now is computer assisted, so the chip on the end of scope, for example, is capturing images digitally. These data can be transmitted and translated into images essentially simultaneously for the operator and a mentor who could be hundreds of miles away,” Dr. Schlachta reported.
There are now “plenty of studies that telementoring is effective in a variety of different surgical procedures,” Dr. Schlachta added. While the data confirming the value of telementoring for teaching skills in endoscopic procedures are fewer, Dr. Schlachta predicted this will soon change. He noted that the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recently created a telementoring task force.
Reviewing several do-it-yourself and proprietary systems that have been developed for telemonitoring, Dr. Schlachta acknowledged that is it not always clear who should pay for this form of learning. He noted that there is potential value for mentees, hospitals wishing to expand services, and health systems attempting to improve quality outcomes. So far, industry has been the primary source of funds.
“For a company introducing a new technology, there is a risk that the technology will fail rapidly if there are bad results in the early going, making it valuable for industry to invest in these telementoring programs,” Dr. Schlacta explained.
“There are related technologies, such as those involving the use of tablets, that are also likely to contribute to the ongoing evolution in how procedural skills are taught and validated. I think these will accelerate and improve learning with the very important potential of better patient outcomes,” Dr. Schlachta reported.
BOSTON – Unforeseen complications and steep learning curves represent the downside of new devices and new procedures, but there are some strategies to minimize these risks, according to experts outlining three such approaches during a session on quality outcomes at the 2017 AGA Tech Summit.
One approach involves a reorientation in skill acquisition in health care delivery. Another involves novel strategies to identify problems with new devices more rapidly. The third involves an ongoing evolution in mentoring clinicians through telecommunication.
Mastering new skills
The strategy described for equipping clinicians with the skills to produce uniform, reproducible outcomes is a technique referred to as simulation-based mastery learning, explained E. Matthew Ritter, MD, vice chairman for education and program director of the general surgery residency program at Walter Reed National Military Medical Center’s Uniformed Services University, Bethesda, Md. The technique is based on the goal of eliciting a “specific level of performance without regard to a time-based approach that is the typical standard in learning processes.”
“More and more evidence is available that performing something a lot of times does not necessarily correlate with performing something well,” Dr. Ritter said. He proposed that direct measurements of skill acquisition address this problem.
“My work has been primarily in laparoscopic surgery, but this approach is not specialty-specific,” Dr. Ritter said in an interview, explaining that the approach focuses on breaking down clinical procedures into tasks for which mastery can be objectively defined. The mastery learning for any one task is complete when performance criteria are met rather than after any specific number of repetitions.
“There is substantial evidence that this approach improves skill acquisition and improves outcome,” Dr. Ritter reported.
Identifying problems more quickly
To reduce the risks and complications of new devices, various strategies for postmarketing surveillance are being pursued simultaneously, according to Dana Telem, MD, MPH, director of the Michigan Comprehensive Hernia Program and an associate professor of surgery at the University of Michigan, Ann Arbor. As has been demonstrated repeatedly, the premarket testing and regulatory approval process does not rule out risk of unforeseen complications, including serious risks that may ultimately lead to the technology being discarded.
One approach has been the increasing use of registries so that constant capture of patient data allows isolated but recurring events to become rapidly identifiable, but Dr. Telem said that the value of these registries can be increased “by encouraging and empowering patients to report issues when they occur” to improve capture of adverse events.
As an example of a strategy to more rapidly drill down to the cause of complications, Dr. Telem reported on an effort to encourage creation of unique device identifiers for a given device. As devices are commonly updated and modified, the serial number may be useful when trying to determine whether the issue can be linked to a specific design change. More importantly, these numbers would be identifiable in billing data and potentially linked to registries to improve real time identification of adverse event patterns.
“The problem with adding new layers of premarketing regulation is the risk of stifling innovation, but we have not done a great job of postmarketing surveillance, and I think the focus now being placed on better strategies will greatly improve patient safety,” Dr. Telem reported.
Adding more layers of review and testing prior to approval of a new technology does not necessarily identify all risks, because not all complications are foreseeable, Dr. Telem explained.
“The long-term monitoring of new devices and technologies is mission critical if we really hope to safely innovate in the future.” Dr. Telem said.
Improving learning through telementoring
Employing avenues of telecommunication to better mentor clinicians acquiring new skills was the third example of an innovative area of improving quality assurance. A large focus of the presentation by Christopher Schlachta, MD, professor of surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont., was on telementoring. He explained that this concept is not new, but it is becoming increasingly sophisticated, and there is a growing body of objective evidence that it is effective.
The Internet expands the possibilities. Remote screens can accommodate multiple images, including, in the case of surgical procedures, the surgical field and situational cameras that provide one or more views of the surgical team as they proceed. For laparoscopy, the information being fed to the mentor is often even more comprehensive.
“So much of what we do now is computer assisted, so the chip on the end of scope, for example, is capturing images digitally. These data can be transmitted and translated into images essentially simultaneously for the operator and a mentor who could be hundreds of miles away,” Dr. Schlachta reported.
There are now “plenty of studies that telementoring is effective in a variety of different surgical procedures,” Dr. Schlachta added. While the data confirming the value of telementoring for teaching skills in endoscopic procedures are fewer, Dr. Schlachta predicted this will soon change. He noted that the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recently created a telementoring task force.
Reviewing several do-it-yourself and proprietary systems that have been developed for telemonitoring, Dr. Schlachta acknowledged that is it not always clear who should pay for this form of learning. He noted that there is potential value for mentees, hospitals wishing to expand services, and health systems attempting to improve quality outcomes. So far, industry has been the primary source of funds.
“For a company introducing a new technology, there is a risk that the technology will fail rapidly if there are bad results in the early going, making it valuable for industry to invest in these telementoring programs,” Dr. Schlacta explained.
“There are related technologies, such as those involving the use of tablets, that are also likely to contribute to the ongoing evolution in how procedural skills are taught and validated. I think these will accelerate and improve learning with the very important potential of better patient outcomes,” Dr. Schlachta reported.
BOSTON – Unforeseen complications and steep learning curves represent the downside of new devices and new procedures, but there are some strategies to minimize these risks, according to experts outlining three such approaches during a session on quality outcomes at the 2017 AGA Tech Summit.
One approach involves a reorientation in skill acquisition in health care delivery. Another involves novel strategies to identify problems with new devices more rapidly. The third involves an ongoing evolution in mentoring clinicians through telecommunication.
Mastering new skills
The strategy described for equipping clinicians with the skills to produce uniform, reproducible outcomes is a technique referred to as simulation-based mastery learning, explained E. Matthew Ritter, MD, vice chairman for education and program director of the general surgery residency program at Walter Reed National Military Medical Center’s Uniformed Services University, Bethesda, Md. The technique is based on the goal of eliciting a “specific level of performance without regard to a time-based approach that is the typical standard in learning processes.”
“More and more evidence is available that performing something a lot of times does not necessarily correlate with performing something well,” Dr. Ritter said. He proposed that direct measurements of skill acquisition address this problem.
“My work has been primarily in laparoscopic surgery, but this approach is not specialty-specific,” Dr. Ritter said in an interview, explaining that the approach focuses on breaking down clinical procedures into tasks for which mastery can be objectively defined. The mastery learning for any one task is complete when performance criteria are met rather than after any specific number of repetitions.
“There is substantial evidence that this approach improves skill acquisition and improves outcome,” Dr. Ritter reported.
Identifying problems more quickly
To reduce the risks and complications of new devices, various strategies for postmarketing surveillance are being pursued simultaneously, according to Dana Telem, MD, MPH, director of the Michigan Comprehensive Hernia Program and an associate professor of surgery at the University of Michigan, Ann Arbor. As has been demonstrated repeatedly, the premarket testing and regulatory approval process does not rule out risk of unforeseen complications, including serious risks that may ultimately lead to the technology being discarded.
One approach has been the increasing use of registries so that constant capture of patient data allows isolated but recurring events to become rapidly identifiable, but Dr. Telem said that the value of these registries can be increased “by encouraging and empowering patients to report issues when they occur” to improve capture of adverse events.
As an example of a strategy to more rapidly drill down to the cause of complications, Dr. Telem reported on an effort to encourage creation of unique device identifiers for a given device. As devices are commonly updated and modified, the serial number may be useful when trying to determine whether the issue can be linked to a specific design change. More importantly, these numbers would be identifiable in billing data and potentially linked to registries to improve real time identification of adverse event patterns.
“The problem with adding new layers of premarketing regulation is the risk of stifling innovation, but we have not done a great job of postmarketing surveillance, and I think the focus now being placed on better strategies will greatly improve patient safety,” Dr. Telem reported.
Adding more layers of review and testing prior to approval of a new technology does not necessarily identify all risks, because not all complications are foreseeable, Dr. Telem explained.
“The long-term monitoring of new devices and technologies is mission critical if we really hope to safely innovate in the future.” Dr. Telem said.
Improving learning through telementoring
Employing avenues of telecommunication to better mentor clinicians acquiring new skills was the third example of an innovative area of improving quality assurance. A large focus of the presentation by Christopher Schlachta, MD, professor of surgery, Schulich School of Medicine and Dentistry, Western University, London, Ont., was on telementoring. He explained that this concept is not new, but it is becoming increasingly sophisticated, and there is a growing body of objective evidence that it is effective.
The Internet expands the possibilities. Remote screens can accommodate multiple images, including, in the case of surgical procedures, the surgical field and situational cameras that provide one or more views of the surgical team as they proceed. For laparoscopy, the information being fed to the mentor is often even more comprehensive.
“So much of what we do now is computer assisted, so the chip on the end of scope, for example, is capturing images digitally. These data can be transmitted and translated into images essentially simultaneously for the operator and a mentor who could be hundreds of miles away,” Dr. Schlachta reported.
There are now “plenty of studies that telementoring is effective in a variety of different surgical procedures,” Dr. Schlachta added. While the data confirming the value of telementoring for teaching skills in endoscopic procedures are fewer, Dr. Schlachta predicted this will soon change. He noted that the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) recently created a telementoring task force.
Reviewing several do-it-yourself and proprietary systems that have been developed for telemonitoring, Dr. Schlachta acknowledged that is it not always clear who should pay for this form of learning. He noted that there is potential value for mentees, hospitals wishing to expand services, and health systems attempting to improve quality outcomes. So far, industry has been the primary source of funds.
“For a company introducing a new technology, there is a risk that the technology will fail rapidly if there are bad results in the early going, making it valuable for industry to invest in these telementoring programs,” Dr. Schlacta explained.
“There are related technologies, such as those involving the use of tablets, that are also likely to contribute to the ongoing evolution in how procedural skills are taught and validated. I think these will accelerate and improve learning with the very important potential of better patient outcomes,” Dr. Schlachta reported.
FROM THE 2017 AGA TECH SUMMIT