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No benefit of EC/IC bypass versus meds in large-artery stroke
in the latest randomized trial comparing the two interventions.
However, subgroup analyses suggest a potential benefit of surgery for certain patients, such as those with MCA vs. ICA occlusion, mean transit time greater than 6 seconds, or regional blood flow of 0.8 or less.
“We were disappointed by the results,” Liqun Jiao, MD, of the National Center for Neurological Disorders in Beijing, told this news organization. “We were expecting to demonstrate a benefit from EC-IC bypass surgery over medical treatment alone in symptomatic patients with ICA or MCA occlusion and hemodynamic insufficiency, per our original hypothesis.”
Although the study showed improved efficacy and safety for the surgical procedure, he said, “The progress of medical treatment is even better.”
The study was published online in JAMA.
Subgroup analyses promising
Previous randomized clinical trials, including the EC/IC Bypass Study and the Carotid Occlusion Surgery Study (COSS), showed no benefit in stroke prevention for patients with atherosclerotic occlusion of the ICA or MCA.
However, in light of improvements over the years in surgical techniques and patient selection, the authors conducted the Carotid and Middle Cerebral Artery Occlusion Surgery Study (CMOSS), a multicenter, randomized, open-label trial comparing EC-IC bypass surgery plus medical therapy, consisting of antiplatelet therapy and control of stroke risk factors, with medical therapy alone in symptomatic patients with ICA or MCA occlusion and hemodynamic insufficiency, with refined patient and operator selection.
A total of 324 patients (median age, 52.7 years; 79% men) in 13 centers in China were included; 309 patients (95%) completed the study.
The primary outcome was a composite of stroke or death within 30 days or ipsilateral ischemic stroke beyond 30 days through 2 years after randomization.
Secondary outcomes included, among others, any stroke or death within 2 years and fatal stroke within 2 years.
No significant difference was found for the primary outcome between the surgical group (8.6%) and the medical group (12.3%).
The 30-day risk of stroke or death was 6.2% in the surgery group, versus 1.8% (3/163) for the medical group. The risk of ipsilateral ischemic stroke beyond 30 days through 2 years was 2%, versus 10.3% – nonsignificant differences.
Furthermore, none of the prespecified secondary endpoints showed a significant difference, including any stroke or death within 2 years (9.9% vs. 15.3%; hazard ratio, 0.69) and fatal stroke within 2 years (2% vs. none).
Despite the findings, “We are encouraged by the subgroup analysis and the trend of long-term outcomes,” Dr. Jiao said. “We will continue to finish 5-10 years of follow-up to see whether the benefit of bypass surgery can be identified.”
The team has also launched the CMOSS-2 trial with a refined study design based on the results of subgroup analysis of the CMOSS study.
CMOSS-2 is recruiting patients with symptomatic chronic occlusion of the MCA and severe hemodynamic insufficiency in 13 sites in China. The primary outcome is ischemic stroke in the territory of the target artery within 24 months after randomization.
Can’t exclude benefit
Thomas Jeerakathil, MD, a professor at the University of Alberta and Northern Stroke Lead, Cardiovascular and Stroke Strategic Clinical Network, Alberta Health Services, Edmonton, commented on the study for this news organization. Like the authors, he said, “I don’t consider this study to definitively exclude the benefit of EC/IC bypass. More studies are required.”
Dr. Jeerakathil would like to see a study of a higher-risk group based on both clinical and hemodynamic blood flow criteria. In the current study, he said, “The trial group overall may not have been at high enough stroke risk to justify the up-front risks of the EC-IC bypass procedure.”
In addition, “The analysis method of Cox proportional hazards regression for the primary outcome did not fit the data when the perioperative period was combined with the period beyond 30 days,” he noted. “The researchers were open about this and did pivot and included a post hoc relative risk-based analysis, but the validity of their primary analysis is questionable.”
Furthermore, the study was “somewhat underpowered with a relatively small sample size and had the potential to miss clinically significant differences between groups,” he said. “It would be good to see a longer follow-up period of at least 5 years added to this trial and used in future trials, rather than 2 years.”
“Lastly,” he said, “it’s difficult to ignore the reduction in recurrent stroke events over the 30-day to 2-year time period associated with EC-IC bypass (from 10.3% down to 2%). This reduction alone shows the procedure has some potential to prevent stroke and would argue for more trials.”
EC-IC could be considered for patients who have failed other medical therapies and have more substantial evidence of compromised blood flow to the brain than those in the CMOSS trial, he noted, as many of these patients have few other options. “In our center and many other centers, the approach to EC-IC bypass is probably much more selective than used in the trial.”
Dr. Jeerakathil concluded, “Clinicians should be cautious about offering the procedure to patients with just mildly delayed blood flow in the hemisphere affected by the occluded artery and those who have not yet failed maximal medical therapy.”
But Seemant Chaturvedi, MD, and J. Marc Simard, MD, PhD, both of the University of Maryland, Baltimore, are not as optimistic about the potential for EC-IC.
Writing in a related editorial, they conclude that the results with EC-IC bypass surgery in randomized trials “remain unimpressive. Until a better understanding of the unique hemodynamic features of the brain is achieved, it will be difficult for neurosurgeons to continue offering this procedure to patients with ICA or MCA occlusion. Intensive, multifaceted medical therapy remains the first-line treatment for [these] patients.”
The study was supported by a research grant from the National Health Commission of the People’s Republic of China. Dr. Jiao, Dr. Jeerakathil, Dr. Chaturvedi, and Dr. Simard reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
in the latest randomized trial comparing the two interventions.
However, subgroup analyses suggest a potential benefit of surgery for certain patients, such as those with MCA vs. ICA occlusion, mean transit time greater than 6 seconds, or regional blood flow of 0.8 or less.
“We were disappointed by the results,” Liqun Jiao, MD, of the National Center for Neurological Disorders in Beijing, told this news organization. “We were expecting to demonstrate a benefit from EC-IC bypass surgery over medical treatment alone in symptomatic patients with ICA or MCA occlusion and hemodynamic insufficiency, per our original hypothesis.”
Although the study showed improved efficacy and safety for the surgical procedure, he said, “The progress of medical treatment is even better.”
The study was published online in JAMA.
Subgroup analyses promising
Previous randomized clinical trials, including the EC/IC Bypass Study and the Carotid Occlusion Surgery Study (COSS), showed no benefit in stroke prevention for patients with atherosclerotic occlusion of the ICA or MCA.
However, in light of improvements over the years in surgical techniques and patient selection, the authors conducted the Carotid and Middle Cerebral Artery Occlusion Surgery Study (CMOSS), a multicenter, randomized, open-label trial comparing EC-IC bypass surgery plus medical therapy, consisting of antiplatelet therapy and control of stroke risk factors, with medical therapy alone in symptomatic patients with ICA or MCA occlusion and hemodynamic insufficiency, with refined patient and operator selection.
A total of 324 patients (median age, 52.7 years; 79% men) in 13 centers in China were included; 309 patients (95%) completed the study.
The primary outcome was a composite of stroke or death within 30 days or ipsilateral ischemic stroke beyond 30 days through 2 years after randomization.
Secondary outcomes included, among others, any stroke or death within 2 years and fatal stroke within 2 years.
No significant difference was found for the primary outcome between the surgical group (8.6%) and the medical group (12.3%).
The 30-day risk of stroke or death was 6.2% in the surgery group, versus 1.8% (3/163) for the medical group. The risk of ipsilateral ischemic stroke beyond 30 days through 2 years was 2%, versus 10.3% – nonsignificant differences.
Furthermore, none of the prespecified secondary endpoints showed a significant difference, including any stroke or death within 2 years (9.9% vs. 15.3%; hazard ratio, 0.69) and fatal stroke within 2 years (2% vs. none).
Despite the findings, “We are encouraged by the subgroup analysis and the trend of long-term outcomes,” Dr. Jiao said. “We will continue to finish 5-10 years of follow-up to see whether the benefit of bypass surgery can be identified.”
The team has also launched the CMOSS-2 trial with a refined study design based on the results of subgroup analysis of the CMOSS study.
CMOSS-2 is recruiting patients with symptomatic chronic occlusion of the MCA and severe hemodynamic insufficiency in 13 sites in China. The primary outcome is ischemic stroke in the territory of the target artery within 24 months after randomization.
Can’t exclude benefit
Thomas Jeerakathil, MD, a professor at the University of Alberta and Northern Stroke Lead, Cardiovascular and Stroke Strategic Clinical Network, Alberta Health Services, Edmonton, commented on the study for this news organization. Like the authors, he said, “I don’t consider this study to definitively exclude the benefit of EC/IC bypass. More studies are required.”
Dr. Jeerakathil would like to see a study of a higher-risk group based on both clinical and hemodynamic blood flow criteria. In the current study, he said, “The trial group overall may not have been at high enough stroke risk to justify the up-front risks of the EC-IC bypass procedure.”
In addition, “The analysis method of Cox proportional hazards regression for the primary outcome did not fit the data when the perioperative period was combined with the period beyond 30 days,” he noted. “The researchers were open about this and did pivot and included a post hoc relative risk-based analysis, but the validity of their primary analysis is questionable.”
Furthermore, the study was “somewhat underpowered with a relatively small sample size and had the potential to miss clinically significant differences between groups,” he said. “It would be good to see a longer follow-up period of at least 5 years added to this trial and used in future trials, rather than 2 years.”
“Lastly,” he said, “it’s difficult to ignore the reduction in recurrent stroke events over the 30-day to 2-year time period associated with EC-IC bypass (from 10.3% down to 2%). This reduction alone shows the procedure has some potential to prevent stroke and would argue for more trials.”
EC-IC could be considered for patients who have failed other medical therapies and have more substantial evidence of compromised blood flow to the brain than those in the CMOSS trial, he noted, as many of these patients have few other options. “In our center and many other centers, the approach to EC-IC bypass is probably much more selective than used in the trial.”
Dr. Jeerakathil concluded, “Clinicians should be cautious about offering the procedure to patients with just mildly delayed blood flow in the hemisphere affected by the occluded artery and those who have not yet failed maximal medical therapy.”
But Seemant Chaturvedi, MD, and J. Marc Simard, MD, PhD, both of the University of Maryland, Baltimore, are not as optimistic about the potential for EC-IC.
Writing in a related editorial, they conclude that the results with EC-IC bypass surgery in randomized trials “remain unimpressive. Until a better understanding of the unique hemodynamic features of the brain is achieved, it will be difficult for neurosurgeons to continue offering this procedure to patients with ICA or MCA occlusion. Intensive, multifaceted medical therapy remains the first-line treatment for [these] patients.”
The study was supported by a research grant from the National Health Commission of the People’s Republic of China. Dr. Jiao, Dr. Jeerakathil, Dr. Chaturvedi, and Dr. Simard reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
in the latest randomized trial comparing the two interventions.
However, subgroup analyses suggest a potential benefit of surgery for certain patients, such as those with MCA vs. ICA occlusion, mean transit time greater than 6 seconds, or regional blood flow of 0.8 or less.
“We were disappointed by the results,” Liqun Jiao, MD, of the National Center for Neurological Disorders in Beijing, told this news organization. “We were expecting to demonstrate a benefit from EC-IC bypass surgery over medical treatment alone in symptomatic patients with ICA or MCA occlusion and hemodynamic insufficiency, per our original hypothesis.”
Although the study showed improved efficacy and safety for the surgical procedure, he said, “The progress of medical treatment is even better.”
The study was published online in JAMA.
Subgroup analyses promising
Previous randomized clinical trials, including the EC/IC Bypass Study and the Carotid Occlusion Surgery Study (COSS), showed no benefit in stroke prevention for patients with atherosclerotic occlusion of the ICA or MCA.
However, in light of improvements over the years in surgical techniques and patient selection, the authors conducted the Carotid and Middle Cerebral Artery Occlusion Surgery Study (CMOSS), a multicenter, randomized, open-label trial comparing EC-IC bypass surgery plus medical therapy, consisting of antiplatelet therapy and control of stroke risk factors, with medical therapy alone in symptomatic patients with ICA or MCA occlusion and hemodynamic insufficiency, with refined patient and operator selection.
A total of 324 patients (median age, 52.7 years; 79% men) in 13 centers in China were included; 309 patients (95%) completed the study.
The primary outcome was a composite of stroke or death within 30 days or ipsilateral ischemic stroke beyond 30 days through 2 years after randomization.
Secondary outcomes included, among others, any stroke or death within 2 years and fatal stroke within 2 years.
No significant difference was found for the primary outcome between the surgical group (8.6%) and the medical group (12.3%).
The 30-day risk of stroke or death was 6.2% in the surgery group, versus 1.8% (3/163) for the medical group. The risk of ipsilateral ischemic stroke beyond 30 days through 2 years was 2%, versus 10.3% – nonsignificant differences.
Furthermore, none of the prespecified secondary endpoints showed a significant difference, including any stroke or death within 2 years (9.9% vs. 15.3%; hazard ratio, 0.69) and fatal stroke within 2 years (2% vs. none).
Despite the findings, “We are encouraged by the subgroup analysis and the trend of long-term outcomes,” Dr. Jiao said. “We will continue to finish 5-10 years of follow-up to see whether the benefit of bypass surgery can be identified.”
The team has also launched the CMOSS-2 trial with a refined study design based on the results of subgroup analysis of the CMOSS study.
CMOSS-2 is recruiting patients with symptomatic chronic occlusion of the MCA and severe hemodynamic insufficiency in 13 sites in China. The primary outcome is ischemic stroke in the territory of the target artery within 24 months after randomization.
Can’t exclude benefit
Thomas Jeerakathil, MD, a professor at the University of Alberta and Northern Stroke Lead, Cardiovascular and Stroke Strategic Clinical Network, Alberta Health Services, Edmonton, commented on the study for this news organization. Like the authors, he said, “I don’t consider this study to definitively exclude the benefit of EC/IC bypass. More studies are required.”
Dr. Jeerakathil would like to see a study of a higher-risk group based on both clinical and hemodynamic blood flow criteria. In the current study, he said, “The trial group overall may not have been at high enough stroke risk to justify the up-front risks of the EC-IC bypass procedure.”
In addition, “The analysis method of Cox proportional hazards regression for the primary outcome did not fit the data when the perioperative period was combined with the period beyond 30 days,” he noted. “The researchers were open about this and did pivot and included a post hoc relative risk-based analysis, but the validity of their primary analysis is questionable.”
Furthermore, the study was “somewhat underpowered with a relatively small sample size and had the potential to miss clinically significant differences between groups,” he said. “It would be good to see a longer follow-up period of at least 5 years added to this trial and used in future trials, rather than 2 years.”
“Lastly,” he said, “it’s difficult to ignore the reduction in recurrent stroke events over the 30-day to 2-year time period associated with EC-IC bypass (from 10.3% down to 2%). This reduction alone shows the procedure has some potential to prevent stroke and would argue for more trials.”
EC-IC could be considered for patients who have failed other medical therapies and have more substantial evidence of compromised blood flow to the brain than those in the CMOSS trial, he noted, as many of these patients have few other options. “In our center and many other centers, the approach to EC-IC bypass is probably much more selective than used in the trial.”
Dr. Jeerakathil concluded, “Clinicians should be cautious about offering the procedure to patients with just mildly delayed blood flow in the hemisphere affected by the occluded artery and those who have not yet failed maximal medical therapy.”
But Seemant Chaturvedi, MD, and J. Marc Simard, MD, PhD, both of the University of Maryland, Baltimore, are not as optimistic about the potential for EC-IC.
Writing in a related editorial, they conclude that the results with EC-IC bypass surgery in randomized trials “remain unimpressive. Until a better understanding of the unique hemodynamic features of the brain is achieved, it will be difficult for neurosurgeons to continue offering this procedure to patients with ICA or MCA occlusion. Intensive, multifaceted medical therapy remains the first-line treatment for [these] patients.”
The study was supported by a research grant from the National Health Commission of the People’s Republic of China. Dr. Jiao, Dr. Jeerakathil, Dr. Chaturvedi, and Dr. Simard reported no conflicts of interest.
A version of this article first appeared on Medscape.com.
FROM JAMA
One in five brain injury trials shows errors, signs of spin
LOS ANGELES –
“This is concerning result,” said general physician Lucas Piason F. Martins, MD, of the Bahiana School of Medicine and Public Health, Salvador, Brazil. “Many of these trials have been included in clinical guidelines and cited extensively in systematic reviews and meta-analyses, especially those related to hypothermia therapy.”
Dr. Martins presented the findings at the annual meeting of the American Association of Neurological Surgeons.
Defining spin
In recent years, medical researchers have sought to define and identify spin in medical literature. According to a 2017 report in PLOS Biology, “spin refers to reporting practices that distort the interpretation of results and mislead readers so that results are viewed in a more favorable light.”
Any spin can be dangerous, Dr. Martins said, because it “can potentially mislead readers and affect the interpretation of study results, which in turn can impact clinical decision-making.”
For the new report, a systematic review, Dr. Martins and colleagues examined 150 studies published in 18 top-ranked journals including the Journal of Neurotrauma (26%), the Journal of Neurosurgery (15%), Critical Care Medicine (9%), and the New England Journal of Medicine (8%).
Studies were published between 1960 and 2020. The review protocol was previously published in BMJ Open.
According to the report, most of the 32 studies with spin (75%) had a “focus on statistically significant results not based on primary outcome.”
For example, Dr. Martins said in an interview that the abstract for a study about drug treatment of brain contusions highlighted a secondary result instead of the main finding that the medication had no effect. Another study of treatment for severe closed head injuries focused on a subgroup outcome.
As Dr. Martins noted, it’s potentially problematic for studies to have several outcomes, measure outcomes in different ways, and have multiple time points without a predefined primary outcome. “A positive finding based on such strategies could potentially be explained by chance alone,” he said.
The researchers also reported that 65% of the studies with spin highlighted “the beneficial effect of the treatment despite statistically nonsignificant results” and that 9% had incorrect statistical analysis.
The findings are especially noteworthy because “the trials we analyzed were deemed to have the highest quality of methodology,” Dr. Martins said.
The researchers didn’t identify specific studies that they deemed to have spin, and they won’t do so, Dr. Martins said. The authors do plan to reveal which journals were most spin-heavy but only when these findings are published.
Were the study authors trying to mislead readers? Not necessarily. Researchers “may search for positive results to confirm their beliefs, although with good intentions,” Dr. Martins said, adding that the researchers found that “positive research tends to be more cited.”
They also reported that studies with smaller sample sizes were more likely to have spin (P = .04).
At 21%, the percentage of studies with spin was lower than that found in some previous reports that analyzed medical literature in other specialties.
A 2019 study of 93 randomized clinical studies in cardiology, for example, found spin in 57% of abstracts and 67% of full texts. The lower number in the new study may be due to its especially conservative definition of spin, Dr. Martins said.
Appropriate methodology
Cardiologist Richard Krasuski, MD, of Duke University Medical Center, Durham, N.C., who coauthored the 2019 study into spin in cardiology studies, told this news organization that the new analysis follows appropriate methodology and appears to be valid.
It makes sense, he said, that smaller studies had more spin: “It is much harder to show statistical significance in small studies and softer endpoints can be harder to predict. Small neutral trials are also much harder to publish in high-level journals. This all increases the tendency to spin the results so the reviewer and eventually the reader is more captivated.”
Why is there so much spin in medical research? “As an investigator, you always hope to positively impact patient health and outcomes, so there is a tendency to look at secondary analyses to have something good to emphasize,” he said. “This is an inherent trait in most of us, to find something good we can focus on. I do believe that much of this is subconscious and perhaps with noble intent.”
Dr. Krasuski said that he advises trainees to look at the methodology of studies, not just the abstract or discussion sections. “You don’t have to be a trained statistician to identify how well the findings match the author’s interpretation.
“Always try to identify what the primary outcome of the study was at the time of the design and whether the investigators achieved their objective. As a reviewer, my own personal experience in research into spin makes me more cognizant of its existence, and I generally require authors to reword and tone down their message if it is not supported by the data.”
What’s next? The investigators want to look for spin in the wider neurosurgery literature, Dr. Martins said, with an eye toward developing “practical strategies to assess spin and give pragmatic recommendations for good practice in clinical research.”
No study funding is reported. Dr. Martins has no disclosures, and several study authors reported funding from the UK National Institute for Health Research. Dr. Krasuski has no disclosures.
A version of this article first appeared on Medscape.com.
LOS ANGELES –
“This is concerning result,” said general physician Lucas Piason F. Martins, MD, of the Bahiana School of Medicine and Public Health, Salvador, Brazil. “Many of these trials have been included in clinical guidelines and cited extensively in systematic reviews and meta-analyses, especially those related to hypothermia therapy.”
Dr. Martins presented the findings at the annual meeting of the American Association of Neurological Surgeons.
Defining spin
In recent years, medical researchers have sought to define and identify spin in medical literature. According to a 2017 report in PLOS Biology, “spin refers to reporting practices that distort the interpretation of results and mislead readers so that results are viewed in a more favorable light.”
Any spin can be dangerous, Dr. Martins said, because it “can potentially mislead readers and affect the interpretation of study results, which in turn can impact clinical decision-making.”
For the new report, a systematic review, Dr. Martins and colleagues examined 150 studies published in 18 top-ranked journals including the Journal of Neurotrauma (26%), the Journal of Neurosurgery (15%), Critical Care Medicine (9%), and the New England Journal of Medicine (8%).
Studies were published between 1960 and 2020. The review protocol was previously published in BMJ Open.
According to the report, most of the 32 studies with spin (75%) had a “focus on statistically significant results not based on primary outcome.”
For example, Dr. Martins said in an interview that the abstract for a study about drug treatment of brain contusions highlighted a secondary result instead of the main finding that the medication had no effect. Another study of treatment for severe closed head injuries focused on a subgroup outcome.
As Dr. Martins noted, it’s potentially problematic for studies to have several outcomes, measure outcomes in different ways, and have multiple time points without a predefined primary outcome. “A positive finding based on such strategies could potentially be explained by chance alone,” he said.
The researchers also reported that 65% of the studies with spin highlighted “the beneficial effect of the treatment despite statistically nonsignificant results” and that 9% had incorrect statistical analysis.
The findings are especially noteworthy because “the trials we analyzed were deemed to have the highest quality of methodology,” Dr. Martins said.
The researchers didn’t identify specific studies that they deemed to have spin, and they won’t do so, Dr. Martins said. The authors do plan to reveal which journals were most spin-heavy but only when these findings are published.
Were the study authors trying to mislead readers? Not necessarily. Researchers “may search for positive results to confirm their beliefs, although with good intentions,” Dr. Martins said, adding that the researchers found that “positive research tends to be more cited.”
They also reported that studies with smaller sample sizes were more likely to have spin (P = .04).
At 21%, the percentage of studies with spin was lower than that found in some previous reports that analyzed medical literature in other specialties.
A 2019 study of 93 randomized clinical studies in cardiology, for example, found spin in 57% of abstracts and 67% of full texts. The lower number in the new study may be due to its especially conservative definition of spin, Dr. Martins said.
Appropriate methodology
Cardiologist Richard Krasuski, MD, of Duke University Medical Center, Durham, N.C., who coauthored the 2019 study into spin in cardiology studies, told this news organization that the new analysis follows appropriate methodology and appears to be valid.
It makes sense, he said, that smaller studies had more spin: “It is much harder to show statistical significance in small studies and softer endpoints can be harder to predict. Small neutral trials are also much harder to publish in high-level journals. This all increases the tendency to spin the results so the reviewer and eventually the reader is more captivated.”
Why is there so much spin in medical research? “As an investigator, you always hope to positively impact patient health and outcomes, so there is a tendency to look at secondary analyses to have something good to emphasize,” he said. “This is an inherent trait in most of us, to find something good we can focus on. I do believe that much of this is subconscious and perhaps with noble intent.”
Dr. Krasuski said that he advises trainees to look at the methodology of studies, not just the abstract or discussion sections. “You don’t have to be a trained statistician to identify how well the findings match the author’s interpretation.
“Always try to identify what the primary outcome of the study was at the time of the design and whether the investigators achieved their objective. As a reviewer, my own personal experience in research into spin makes me more cognizant of its existence, and I generally require authors to reword and tone down their message if it is not supported by the data.”
What’s next? The investigators want to look for spin in the wider neurosurgery literature, Dr. Martins said, with an eye toward developing “practical strategies to assess spin and give pragmatic recommendations for good practice in clinical research.”
No study funding is reported. Dr. Martins has no disclosures, and several study authors reported funding from the UK National Institute for Health Research. Dr. Krasuski has no disclosures.
A version of this article first appeared on Medscape.com.
LOS ANGELES –
“This is concerning result,” said general physician Lucas Piason F. Martins, MD, of the Bahiana School of Medicine and Public Health, Salvador, Brazil. “Many of these trials have been included in clinical guidelines and cited extensively in systematic reviews and meta-analyses, especially those related to hypothermia therapy.”
Dr. Martins presented the findings at the annual meeting of the American Association of Neurological Surgeons.
Defining spin
In recent years, medical researchers have sought to define and identify spin in medical literature. According to a 2017 report in PLOS Biology, “spin refers to reporting practices that distort the interpretation of results and mislead readers so that results are viewed in a more favorable light.”
Any spin can be dangerous, Dr. Martins said, because it “can potentially mislead readers and affect the interpretation of study results, which in turn can impact clinical decision-making.”
For the new report, a systematic review, Dr. Martins and colleagues examined 150 studies published in 18 top-ranked journals including the Journal of Neurotrauma (26%), the Journal of Neurosurgery (15%), Critical Care Medicine (9%), and the New England Journal of Medicine (8%).
Studies were published between 1960 and 2020. The review protocol was previously published in BMJ Open.
According to the report, most of the 32 studies with spin (75%) had a “focus on statistically significant results not based on primary outcome.”
For example, Dr. Martins said in an interview that the abstract for a study about drug treatment of brain contusions highlighted a secondary result instead of the main finding that the medication had no effect. Another study of treatment for severe closed head injuries focused on a subgroup outcome.
As Dr. Martins noted, it’s potentially problematic for studies to have several outcomes, measure outcomes in different ways, and have multiple time points without a predefined primary outcome. “A positive finding based on such strategies could potentially be explained by chance alone,” he said.
The researchers also reported that 65% of the studies with spin highlighted “the beneficial effect of the treatment despite statistically nonsignificant results” and that 9% had incorrect statistical analysis.
The findings are especially noteworthy because “the trials we analyzed were deemed to have the highest quality of methodology,” Dr. Martins said.
The researchers didn’t identify specific studies that they deemed to have spin, and they won’t do so, Dr. Martins said. The authors do plan to reveal which journals were most spin-heavy but only when these findings are published.
Were the study authors trying to mislead readers? Not necessarily. Researchers “may search for positive results to confirm their beliefs, although with good intentions,” Dr. Martins said, adding that the researchers found that “positive research tends to be more cited.”
They also reported that studies with smaller sample sizes were more likely to have spin (P = .04).
At 21%, the percentage of studies with spin was lower than that found in some previous reports that analyzed medical literature in other specialties.
A 2019 study of 93 randomized clinical studies in cardiology, for example, found spin in 57% of abstracts and 67% of full texts. The lower number in the new study may be due to its especially conservative definition of spin, Dr. Martins said.
Appropriate methodology
Cardiologist Richard Krasuski, MD, of Duke University Medical Center, Durham, N.C., who coauthored the 2019 study into spin in cardiology studies, told this news organization that the new analysis follows appropriate methodology and appears to be valid.
It makes sense, he said, that smaller studies had more spin: “It is much harder to show statistical significance in small studies and softer endpoints can be harder to predict. Small neutral trials are also much harder to publish in high-level journals. This all increases the tendency to spin the results so the reviewer and eventually the reader is more captivated.”
Why is there so much spin in medical research? “As an investigator, you always hope to positively impact patient health and outcomes, so there is a tendency to look at secondary analyses to have something good to emphasize,” he said. “This is an inherent trait in most of us, to find something good we can focus on. I do believe that much of this is subconscious and perhaps with noble intent.”
Dr. Krasuski said that he advises trainees to look at the methodology of studies, not just the abstract or discussion sections. “You don’t have to be a trained statistician to identify how well the findings match the author’s interpretation.
“Always try to identify what the primary outcome of the study was at the time of the design and whether the investigators achieved their objective. As a reviewer, my own personal experience in research into spin makes me more cognizant of its existence, and I generally require authors to reword and tone down their message if it is not supported by the data.”
What’s next? The investigators want to look for spin in the wider neurosurgery literature, Dr. Martins said, with an eye toward developing “practical strategies to assess spin and give pragmatic recommendations for good practice in clinical research.”
No study funding is reported. Dr. Martins has no disclosures, and several study authors reported funding from the UK National Institute for Health Research. Dr. Krasuski has no disclosures.
A version of this article first appeared on Medscape.com.
FROM AANS 2023
FDA breakthrough designation for spinal cord stimulation device
The U.S. Food and Drug Administration has granted breakthrough device designation to the Avantis spinal cord stimulation system (Reach Neuro), which has been shown in early testing to restore arm and hand movement in patients with post-stroke upper limb paresis.
“We are excited about the FDA’s recognition of our technology’s potential to change the lives of millions of people living with disability,” Marc Powell, PhD, CEO, and co-founder of Reach Neuro, said in a company news release.
“The breakthrough device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system,” Dr. Powell added.
Results of the first-in-human study of the system were published in Nature Medicine.
Investigators percutaneously implanted two linear leads in the dorsolateral epidural space targeting neural circuits that control arm and hand muscles in two chronic post-stroke patients.
In both patients, continuous stimulation of the targeted neural circuits led to significant and immediate improvement in arm and hand strength and dexterity. This enabled the patients to perform movements that they couldn’t perform without spinal cord stimulation.
The process also enabled fine motor skills, such as opening a lock and using utensils to eat independently – tasks that one patient had not been able to do for 9 years.
“Having the stimulation working and being able to move my arm/hand again after 9 years was one of the most surreal experiences of my life – it was as if my brain was in control of my arm again. This technology gave me such immense hope that one day I will regain a sense of independence again,” study participant Heather Rendulic said in the news release.
Surprisingly, some improvements were retained up to 1 month after the study, even without stimulation. No serious adverse events were reported.
Nearly three-quarters of patients with stroke experience lasting deficits in motor control of their arm and hand as a result of permanent damage to the brain’s ability to send signals to muscles.
The early results with the Avantis system provide “promising, albeit preliminary, evidence that spinal cord stimulation could be an assistive as well as a restorative approach for upper-limb recovery after stroke,” the study team said in Nature Medicine.
Reach Neuro was founded in 2021 as a spinout company of the University of Pittsburgh and Carnegie Mellon University, also in Pittsburgh, where the technology is currently being tested in a clinical trial funded by the National Institutes of Health.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has granted breakthrough device designation to the Avantis spinal cord stimulation system (Reach Neuro), which has been shown in early testing to restore arm and hand movement in patients with post-stroke upper limb paresis.
“We are excited about the FDA’s recognition of our technology’s potential to change the lives of millions of people living with disability,” Marc Powell, PhD, CEO, and co-founder of Reach Neuro, said in a company news release.
“The breakthrough device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system,” Dr. Powell added.
Results of the first-in-human study of the system were published in Nature Medicine.
Investigators percutaneously implanted two linear leads in the dorsolateral epidural space targeting neural circuits that control arm and hand muscles in two chronic post-stroke patients.
In both patients, continuous stimulation of the targeted neural circuits led to significant and immediate improvement in arm and hand strength and dexterity. This enabled the patients to perform movements that they couldn’t perform without spinal cord stimulation.
The process also enabled fine motor skills, such as opening a lock and using utensils to eat independently – tasks that one patient had not been able to do for 9 years.
“Having the stimulation working and being able to move my arm/hand again after 9 years was one of the most surreal experiences of my life – it was as if my brain was in control of my arm again. This technology gave me such immense hope that one day I will regain a sense of independence again,” study participant Heather Rendulic said in the news release.
Surprisingly, some improvements were retained up to 1 month after the study, even without stimulation. No serious adverse events were reported.
Nearly three-quarters of patients with stroke experience lasting deficits in motor control of their arm and hand as a result of permanent damage to the brain’s ability to send signals to muscles.
The early results with the Avantis system provide “promising, albeit preliminary, evidence that spinal cord stimulation could be an assistive as well as a restorative approach for upper-limb recovery after stroke,” the study team said in Nature Medicine.
Reach Neuro was founded in 2021 as a spinout company of the University of Pittsburgh and Carnegie Mellon University, also in Pittsburgh, where the technology is currently being tested in a clinical trial funded by the National Institutes of Health.
A version of this article first appeared on Medscape.com.
The U.S. Food and Drug Administration has granted breakthrough device designation to the Avantis spinal cord stimulation system (Reach Neuro), which has been shown in early testing to restore arm and hand movement in patients with post-stroke upper limb paresis.
“We are excited about the FDA’s recognition of our technology’s potential to change the lives of millions of people living with disability,” Marc Powell, PhD, CEO, and co-founder of Reach Neuro, said in a company news release.
“The breakthrough device designation is an incredible opportunity to work closely with FDA experts to expedite the clinical translation of the Avantis system,” Dr. Powell added.
Results of the first-in-human study of the system were published in Nature Medicine.
Investigators percutaneously implanted two linear leads in the dorsolateral epidural space targeting neural circuits that control arm and hand muscles in two chronic post-stroke patients.
In both patients, continuous stimulation of the targeted neural circuits led to significant and immediate improvement in arm and hand strength and dexterity. This enabled the patients to perform movements that they couldn’t perform without spinal cord stimulation.
The process also enabled fine motor skills, such as opening a lock and using utensils to eat independently – tasks that one patient had not been able to do for 9 years.
“Having the stimulation working and being able to move my arm/hand again after 9 years was one of the most surreal experiences of my life – it was as if my brain was in control of my arm again. This technology gave me such immense hope that one day I will regain a sense of independence again,” study participant Heather Rendulic said in the news release.
Surprisingly, some improvements were retained up to 1 month after the study, even without stimulation. No serious adverse events were reported.
Nearly three-quarters of patients with stroke experience lasting deficits in motor control of their arm and hand as a result of permanent damage to the brain’s ability to send signals to muscles.
The early results with the Avantis system provide “promising, albeit preliminary, evidence that spinal cord stimulation could be an assistive as well as a restorative approach for upper-limb recovery after stroke,” the study team said in Nature Medicine.
Reach Neuro was founded in 2021 as a spinout company of the University of Pittsburgh and Carnegie Mellon University, also in Pittsburgh, where the technology is currently being tested in a clinical trial funded by the National Institutes of Health.
A version of this article first appeared on Medscape.com.
Spinal cord stimulation may help diabetic neuropathy
according to research that released early, prior to its presentation at the annual meeting of the American Academy of Neurology.
The data represents the longest follow-up available for spinal cord stimulation at a frequency higher than the 60 Hz initially approved for diabetic neuropathy by the Food and Drug Administration, according to lead author Erika A. Petersen, MD, a professor of neurosurgery and the residency program director at the University of Arkansas for Medical Sciences, Little Rock.
“You would expect that somebody who continues to have diabetes for 24 months and has neuropathy would have worse neuropathy after 2 years, and what we’re seeing is that people were stable or better in terms of their nerve function at 2 years,” Dr. Petersen said in an interview. “So that’s really revolutionary.”
Encouraging preliminary findings
The findings are “promising and preliminary,” John D. Markman, MD, a professor in neurology and neurosurgery, vice chair for clinical research, and director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, said in an interview. Dr. Markman, who was not involved in this study, said that, though the results are encouraging, it’s “less clear how much of [the pain improvement] is due to what we would consider to be on-target, pain-relieving benefit from stimulation versus other factors like expectation.” The crossover rate and amount of reduction in pain intensity are promising, but “I think that excitement is weighed against the fact that this is an open-label study.”
An underused treatment
Although spinal cord stimulation has been around since the late 1960s, its use only picked up steam in the 2000s, when it became more frequently used to treat chronic nerve damage related to neuropathic pain syndromes, Dr. Petersen explained. The FDA approved the treatment’s new indication for diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown benefits from spinal cord stimulation at 60 Hz, but some patients are uncomfortable with the vibration or tingling feelings the devices can cause at that frequency.
“They describe creepy crawlies or ants crawling over the feet, or pins and needles, and painful sensitivity,” Dr. Petersen said. “You create a vibration feeling in the same zone where they already have those feelings of buzzing and pain and vibration, and it’s sometimes actually even more uncomfortable and less satisfying to them in terms of relief” with the spinal cord stimulation at 60 Hz, she said, “so there’s a lot of attrition in terms of who will actually use it.”
At 10 kHz, however, “people don’t feel any vibration or tingling associated with it; it just jams the signal of the pain,” she said. The difference between the frequencies is like that between “a lifeguard whistle and a dog whistle.”
Testing high-frequency stimulation
The new findings included the 24-month follow-up data from a randomized controlled trial that assessed the effectiveness of high-frequency spinal cord stimulation for painful diabetic neuropathy. The original 216 participants enrolled in the trial had diabetic neuropathy symptoms for at least 12 months and either could no not tolerate or did not respond to medications. Enrollment criteria also included lower-limb pain intensity of at least 5 on a 0-10 visual analogy scale and hemoglobin A1c of no more than 10%.
For the first 6 months of the trial – before crossover was offered – participants were randomly assigned to receive either 10 kHz of spinal cord stimulation along with conventional medical management or to receive conventional medical management alone. The 6-month data from 187 patients, as reported in April 2021 in JAMA Neurology, revealed that 79% of those receiving spinal cord stimulation experienced at least 50% improved pain relief without worsening of their baseline neurologic deficits, compared with only 5% of those receiving only conventional treatments.
Average pain levels increased 2% in the control participants compared with a decrease of 76% in those with the spinal cord stimulation devices. In addition, 62% of the patients receiving spinal cord stimulation demonstration neurologic improvement in reflexes, strength, movement and sensation, compared with 3% of those in the control group. The study’s findings led the FDA to approve the device using 10 kHz.
At 6 months, 93% of control patients crossed over to receiving spinal cord stimulation while none with the devices opted to stop their spinal cord stimulation. The 12-month data revealed that 85% of those receiving spinal cord stimulation experienced at least 50% pain relief, with the average pain relief at 74%. Patients also reported statistically significant improved quality of life as well as less interference with sleep, mood, and daily activities from pain.
Two years after baseline, patients’ pain relief was maintained with average 80% improvement, and 66% of patients showed neurologic improvement since baseline. Though no patients had devices removed because of ineffectiveness, five patients’ devices were removed because of infection while infections in three other patients resolved.
“Being able to offer something that is not a pharmaceutical, without the side effects, that shows an even longer durability to that response is a really important finding at this point,” Dr. Petersen said.
Surgical considerations
Among the estimated 37 million Americans with type 1 or 2 diabetes, approximately one quarter of them experience some level of painful diabetic neuropathy, but medication and other medical management strategies are not always adequate in treating their pain. After a 1-week trial of spinal cord stimulation, the devices are implanted under the skin and rechargeable through the skin for up to 10 years, after which they can be replaced.
An appropriate candidate for spinal cord stimulation would be someone for whom existing non-invasive pain relief options, including medications, are ineffective or intolerable, Dr. Petersen and Dr. Markman both said. An adequate trial of medication is not “one size fits all” and will vary by each patient, added Dr. Markman, who is also interested in whether this study’s participants were able to have a reduction in use of pain relief medications.
“I think there’s a significant number of patients out there who can benefit from this, so I think that’s why it’s promising and exciting,” Dr. Markman said. “I do think it’s important to see if this actually allows them to be on less medication or whether stimulation turns out to be another treatment in addition to their baseline treatments.” The challenge is identifying “which patients are most likely to be benefiting from this and which are most likely to be harmed.”
Aside from infection from implantation, other possible risks include pain at the battery site and, in rare cases, a need for reoperation because of migration of the leads, he said.
Improvement in symptom severity and quality of life
After the wound from the implant has completely healed, Dr. Petersen said patients using the devices do not have any activity restrictions outside of magnetic interference, such as MRIs. “I’ve had people go back-country kayaking, scuba diving, fishing with their grandkids, all sorts of all sorts of things. If patients need to go through a scanner of any kind, they should ask whether it’s safe for pacemakers since these devices are like a “pacemaker for pain.
“I had a patient bring solar chargers with him so that he could recharge his battery in the backwoods while kayaking because that’s the level of improvement in pain that he got – from barely being able to walk down the hall to feeling comfortable being off the grid and active again,” Dr. Petersen said. “Those kinds of improvements in quality of life are massive.”
The study findings may also suggest that spinal cord stimulation can benefit a broader population of patients experiencing neuropathic pain, Dr. Markman said.
“There’s an extraordinary unmet need for treatments for neuropathy, and one important question here is the extent to which diabetic peripheral neuropathy and the response that we’re seeing here is a proxy for a broader effect across many neuropathies that are caused by other conditions other than diabetes,” Dr. Markman said. “There’s a lot of reason to think that this will be helpful not just for diabetes-related neuropathic pain, but for other types of neuropathic pain that have similar clinical presentations or clinical symptom patterns to diabetic peripheral neuropathy.”
The study was funded by Nevro, who manufactures the devices. Dr. Petersen and Dr. Markman both reported consulting with, receiving support from, holding stock options with, and serving on the data safety monitoring boards and advisory boards of numerous pharmaceutical companies.
according to research that released early, prior to its presentation at the annual meeting of the American Academy of Neurology.
The data represents the longest follow-up available for spinal cord stimulation at a frequency higher than the 60 Hz initially approved for diabetic neuropathy by the Food and Drug Administration, according to lead author Erika A. Petersen, MD, a professor of neurosurgery and the residency program director at the University of Arkansas for Medical Sciences, Little Rock.
“You would expect that somebody who continues to have diabetes for 24 months and has neuropathy would have worse neuropathy after 2 years, and what we’re seeing is that people were stable or better in terms of their nerve function at 2 years,” Dr. Petersen said in an interview. “So that’s really revolutionary.”
Encouraging preliminary findings
The findings are “promising and preliminary,” John D. Markman, MD, a professor in neurology and neurosurgery, vice chair for clinical research, and director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, said in an interview. Dr. Markman, who was not involved in this study, said that, though the results are encouraging, it’s “less clear how much of [the pain improvement] is due to what we would consider to be on-target, pain-relieving benefit from stimulation versus other factors like expectation.” The crossover rate and amount of reduction in pain intensity are promising, but “I think that excitement is weighed against the fact that this is an open-label study.”
An underused treatment
Although spinal cord stimulation has been around since the late 1960s, its use only picked up steam in the 2000s, when it became more frequently used to treat chronic nerve damage related to neuropathic pain syndromes, Dr. Petersen explained. The FDA approved the treatment’s new indication for diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown benefits from spinal cord stimulation at 60 Hz, but some patients are uncomfortable with the vibration or tingling feelings the devices can cause at that frequency.
“They describe creepy crawlies or ants crawling over the feet, or pins and needles, and painful sensitivity,” Dr. Petersen said. “You create a vibration feeling in the same zone where they already have those feelings of buzzing and pain and vibration, and it’s sometimes actually even more uncomfortable and less satisfying to them in terms of relief” with the spinal cord stimulation at 60 Hz, she said, “so there’s a lot of attrition in terms of who will actually use it.”
At 10 kHz, however, “people don’t feel any vibration or tingling associated with it; it just jams the signal of the pain,” she said. The difference between the frequencies is like that between “a lifeguard whistle and a dog whistle.”
Testing high-frequency stimulation
The new findings included the 24-month follow-up data from a randomized controlled trial that assessed the effectiveness of high-frequency spinal cord stimulation for painful diabetic neuropathy. The original 216 participants enrolled in the trial had diabetic neuropathy symptoms for at least 12 months and either could no not tolerate or did not respond to medications. Enrollment criteria also included lower-limb pain intensity of at least 5 on a 0-10 visual analogy scale and hemoglobin A1c of no more than 10%.
For the first 6 months of the trial – before crossover was offered – participants were randomly assigned to receive either 10 kHz of spinal cord stimulation along with conventional medical management or to receive conventional medical management alone. The 6-month data from 187 patients, as reported in April 2021 in JAMA Neurology, revealed that 79% of those receiving spinal cord stimulation experienced at least 50% improved pain relief without worsening of their baseline neurologic deficits, compared with only 5% of those receiving only conventional treatments.
Average pain levels increased 2% in the control participants compared with a decrease of 76% in those with the spinal cord stimulation devices. In addition, 62% of the patients receiving spinal cord stimulation demonstration neurologic improvement in reflexes, strength, movement and sensation, compared with 3% of those in the control group. The study’s findings led the FDA to approve the device using 10 kHz.
At 6 months, 93% of control patients crossed over to receiving spinal cord stimulation while none with the devices opted to stop their spinal cord stimulation. The 12-month data revealed that 85% of those receiving spinal cord stimulation experienced at least 50% pain relief, with the average pain relief at 74%. Patients also reported statistically significant improved quality of life as well as less interference with sleep, mood, and daily activities from pain.
Two years after baseline, patients’ pain relief was maintained with average 80% improvement, and 66% of patients showed neurologic improvement since baseline. Though no patients had devices removed because of ineffectiveness, five patients’ devices were removed because of infection while infections in three other patients resolved.
“Being able to offer something that is not a pharmaceutical, without the side effects, that shows an even longer durability to that response is a really important finding at this point,” Dr. Petersen said.
Surgical considerations
Among the estimated 37 million Americans with type 1 or 2 diabetes, approximately one quarter of them experience some level of painful diabetic neuropathy, but medication and other medical management strategies are not always adequate in treating their pain. After a 1-week trial of spinal cord stimulation, the devices are implanted under the skin and rechargeable through the skin for up to 10 years, after which they can be replaced.
An appropriate candidate for spinal cord stimulation would be someone for whom existing non-invasive pain relief options, including medications, are ineffective or intolerable, Dr. Petersen and Dr. Markman both said. An adequate trial of medication is not “one size fits all” and will vary by each patient, added Dr. Markman, who is also interested in whether this study’s participants were able to have a reduction in use of pain relief medications.
“I think there’s a significant number of patients out there who can benefit from this, so I think that’s why it’s promising and exciting,” Dr. Markman said. “I do think it’s important to see if this actually allows them to be on less medication or whether stimulation turns out to be another treatment in addition to their baseline treatments.” The challenge is identifying “which patients are most likely to be benefiting from this and which are most likely to be harmed.”
Aside from infection from implantation, other possible risks include pain at the battery site and, in rare cases, a need for reoperation because of migration of the leads, he said.
Improvement in symptom severity and quality of life
After the wound from the implant has completely healed, Dr. Petersen said patients using the devices do not have any activity restrictions outside of magnetic interference, such as MRIs. “I’ve had people go back-country kayaking, scuba diving, fishing with their grandkids, all sorts of all sorts of things. If patients need to go through a scanner of any kind, they should ask whether it’s safe for pacemakers since these devices are like a “pacemaker for pain.
“I had a patient bring solar chargers with him so that he could recharge his battery in the backwoods while kayaking because that’s the level of improvement in pain that he got – from barely being able to walk down the hall to feeling comfortable being off the grid and active again,” Dr. Petersen said. “Those kinds of improvements in quality of life are massive.”
The study findings may also suggest that spinal cord stimulation can benefit a broader population of patients experiencing neuropathic pain, Dr. Markman said.
“There’s an extraordinary unmet need for treatments for neuropathy, and one important question here is the extent to which diabetic peripheral neuropathy and the response that we’re seeing here is a proxy for a broader effect across many neuropathies that are caused by other conditions other than diabetes,” Dr. Markman said. “There’s a lot of reason to think that this will be helpful not just for diabetes-related neuropathic pain, but for other types of neuropathic pain that have similar clinical presentations or clinical symptom patterns to diabetic peripheral neuropathy.”
The study was funded by Nevro, who manufactures the devices. Dr. Petersen and Dr. Markman both reported consulting with, receiving support from, holding stock options with, and serving on the data safety monitoring boards and advisory boards of numerous pharmaceutical companies.
according to research that released early, prior to its presentation at the annual meeting of the American Academy of Neurology.
The data represents the longest follow-up available for spinal cord stimulation at a frequency higher than the 60 Hz initially approved for diabetic neuropathy by the Food and Drug Administration, according to lead author Erika A. Petersen, MD, a professor of neurosurgery and the residency program director at the University of Arkansas for Medical Sciences, Little Rock.
“You would expect that somebody who continues to have diabetes for 24 months and has neuropathy would have worse neuropathy after 2 years, and what we’re seeing is that people were stable or better in terms of their nerve function at 2 years,” Dr. Petersen said in an interview. “So that’s really revolutionary.”
Encouraging preliminary findings
The findings are “promising and preliminary,” John D. Markman, MD, a professor in neurology and neurosurgery, vice chair for clinical research, and director of the Translational Pain Research Program at the University of Rochester (N.Y.) Medical Center, said in an interview. Dr. Markman, who was not involved in this study, said that, though the results are encouraging, it’s “less clear how much of [the pain improvement] is due to what we would consider to be on-target, pain-relieving benefit from stimulation versus other factors like expectation.” The crossover rate and amount of reduction in pain intensity are promising, but “I think that excitement is weighed against the fact that this is an open-label study.”
An underused treatment
Although spinal cord stimulation has been around since the late 1960s, its use only picked up steam in the 2000s, when it became more frequently used to treat chronic nerve damage related to neuropathic pain syndromes, Dr. Petersen explained. The FDA approved the treatment’s new indication for diabetic neuropathy in 2015, and data from Abbott and Medtronic have shown benefits from spinal cord stimulation at 60 Hz, but some patients are uncomfortable with the vibration or tingling feelings the devices can cause at that frequency.
“They describe creepy crawlies or ants crawling over the feet, or pins and needles, and painful sensitivity,” Dr. Petersen said. “You create a vibration feeling in the same zone where they already have those feelings of buzzing and pain and vibration, and it’s sometimes actually even more uncomfortable and less satisfying to them in terms of relief” with the spinal cord stimulation at 60 Hz, she said, “so there’s a lot of attrition in terms of who will actually use it.”
At 10 kHz, however, “people don’t feel any vibration or tingling associated with it; it just jams the signal of the pain,” she said. The difference between the frequencies is like that between “a lifeguard whistle and a dog whistle.”
Testing high-frequency stimulation
The new findings included the 24-month follow-up data from a randomized controlled trial that assessed the effectiveness of high-frequency spinal cord stimulation for painful diabetic neuropathy. The original 216 participants enrolled in the trial had diabetic neuropathy symptoms for at least 12 months and either could no not tolerate or did not respond to medications. Enrollment criteria also included lower-limb pain intensity of at least 5 on a 0-10 visual analogy scale and hemoglobin A1c of no more than 10%.
For the first 6 months of the trial – before crossover was offered – participants were randomly assigned to receive either 10 kHz of spinal cord stimulation along with conventional medical management or to receive conventional medical management alone. The 6-month data from 187 patients, as reported in April 2021 in JAMA Neurology, revealed that 79% of those receiving spinal cord stimulation experienced at least 50% improved pain relief without worsening of their baseline neurologic deficits, compared with only 5% of those receiving only conventional treatments.
Average pain levels increased 2% in the control participants compared with a decrease of 76% in those with the spinal cord stimulation devices. In addition, 62% of the patients receiving spinal cord stimulation demonstration neurologic improvement in reflexes, strength, movement and sensation, compared with 3% of those in the control group. The study’s findings led the FDA to approve the device using 10 kHz.
At 6 months, 93% of control patients crossed over to receiving spinal cord stimulation while none with the devices opted to stop their spinal cord stimulation. The 12-month data revealed that 85% of those receiving spinal cord stimulation experienced at least 50% pain relief, with the average pain relief at 74%. Patients also reported statistically significant improved quality of life as well as less interference with sleep, mood, and daily activities from pain.
Two years after baseline, patients’ pain relief was maintained with average 80% improvement, and 66% of patients showed neurologic improvement since baseline. Though no patients had devices removed because of ineffectiveness, five patients’ devices were removed because of infection while infections in three other patients resolved.
“Being able to offer something that is not a pharmaceutical, without the side effects, that shows an even longer durability to that response is a really important finding at this point,” Dr. Petersen said.
Surgical considerations
Among the estimated 37 million Americans with type 1 or 2 diabetes, approximately one quarter of them experience some level of painful diabetic neuropathy, but medication and other medical management strategies are not always adequate in treating their pain. After a 1-week trial of spinal cord stimulation, the devices are implanted under the skin and rechargeable through the skin for up to 10 years, after which they can be replaced.
An appropriate candidate for spinal cord stimulation would be someone for whom existing non-invasive pain relief options, including medications, are ineffective or intolerable, Dr. Petersen and Dr. Markman both said. An adequate trial of medication is not “one size fits all” and will vary by each patient, added Dr. Markman, who is also interested in whether this study’s participants were able to have a reduction in use of pain relief medications.
“I think there’s a significant number of patients out there who can benefit from this, so I think that’s why it’s promising and exciting,” Dr. Markman said. “I do think it’s important to see if this actually allows them to be on less medication or whether stimulation turns out to be another treatment in addition to their baseline treatments.” The challenge is identifying “which patients are most likely to be benefiting from this and which are most likely to be harmed.”
Aside from infection from implantation, other possible risks include pain at the battery site and, in rare cases, a need for reoperation because of migration of the leads, he said.
Improvement in symptom severity and quality of life
After the wound from the implant has completely healed, Dr. Petersen said patients using the devices do not have any activity restrictions outside of magnetic interference, such as MRIs. “I’ve had people go back-country kayaking, scuba diving, fishing with their grandkids, all sorts of all sorts of things. If patients need to go through a scanner of any kind, they should ask whether it’s safe for pacemakers since these devices are like a “pacemaker for pain.
“I had a patient bring solar chargers with him so that he could recharge his battery in the backwoods while kayaking because that’s the level of improvement in pain that he got – from barely being able to walk down the hall to feeling comfortable being off the grid and active again,” Dr. Petersen said. “Those kinds of improvements in quality of life are massive.”
The study findings may also suggest that spinal cord stimulation can benefit a broader population of patients experiencing neuropathic pain, Dr. Markman said.
“There’s an extraordinary unmet need for treatments for neuropathy, and one important question here is the extent to which diabetic peripheral neuropathy and the response that we’re seeing here is a proxy for a broader effect across many neuropathies that are caused by other conditions other than diabetes,” Dr. Markman said. “There’s a lot of reason to think that this will be helpful not just for diabetes-related neuropathic pain, but for other types of neuropathic pain that have similar clinical presentations or clinical symptom patterns to diabetic peripheral neuropathy.”
The study was funded by Nevro, who manufactures the devices. Dr. Petersen and Dr. Markman both reported consulting with, receiving support from, holding stock options with, and serving on the data safety monitoring boards and advisory boards of numerous pharmaceutical companies.
FROM AAN 2023
Four PTSD blood biomarkers identified
“More accurate means of predicting or screening for PTSD could help to overcome the disorder by identifying individuals at high risk of developing PTSD and providing them with early intervention or prevention strategies,” said study investigator Stacy-Ann Miller, MS.
She also noted that the biomarkers could be used to monitor treatment for PTSD, identify subtypes of PTSD, and lead to a new understanding of the mechanisms underlying PTSD.
The findings were presented at Discover BMB, the annual meeting of the American Society for Biochemistry and Molecular Biology.
Toward better clinical assessment
The findings originated from research conducted by the Department of Defense–initiated PTSD Systems Biology Consortium. The consortium’s goals include developing a reproducible panel of blood-based biomarkers with high sensitivity and specificity for PTSD diagnosis and is made up of about 45 researchers, led by Marti Jett, PhD, Charles Marmar, MD, and Francis J. Doyle III, PhD.
The researchers analyzed blood samples from 1,000 active-duty Army personnel from the 101st Airborne at Fort Campbell, Ky. Participants were assessed before and after deployment to Afghanistan in February 2014 and are referred to as the Fort Campbell Cohort (FCC). Participants’ age ranged from 25 to 30 and approximately 6% were female.
Investigators collected blood samples from the service members and looked for four biomarkers: glycolytic ratio, arginine, serotonin, and glutamate. The team then divided the participants into four groups – those with PTSD (PTSD Checklist score above 30), those who were subthreshold for PTSD (PTSD Checklist score 15-30), those who had high resilience, and those who had low levels of resilience.
The resilience groups were determined based on answers to the Generalized Anxiety Disorder Questionnaire, Patient Health Questionnaire, Pittsburgh Sleep Quality Index, Intensive Combat Exposure (DRRI-D), the number of deployments, whether they had moderate or severe traumatic brain injury, and scores on the Alcohol Use Disorders Identification Test.
Those who scored in the high range at current or prior time points or who were PTSD/subthreshold at prior time points were placed in the low resilience group.
Ms. Miller noted that those in the PTSD group had more severe symptoms than those in the PTSD subthreshold group based on the longitudinal clinical assessment at 3-6 months, 5 years, and longer post deployment. The low resilience group had a much higher rate of PTSD post deployment than the high resilience group.
Investigators found participants with PTSD or subthreshold PTSD had significantly higher glycolic ratios and lower arginine than those with high resilience. They also found that those with PTSD had significantly lower serotonin and higher glutamate levels versus those with high resilience. These associations were independent of factors such as sex, age, body mass index, smoking, and caffeine consumption.
Ms. Miller said that the study results require further validation by the consortium’s labs and third-party labs.
“We are also interested in determining the most appropriate time to screen soldiers for PTSD, as it has been noted that the time period where we see the most psychological issues is around 2-3 months post return from deployment and when the soldier is preparing for their next assignment, perhaps a next deployment,” she said.
She added that previous studies have identified several promising biomarkers of PTSD. “However, like much of the research data, the study sample was comprised mainly of combat-exposed males. With more women serving on the front lines, the military faces new challenges in how combat affects females in the military,” including sex-specific biomarkers that will improve clinical assessment for female soldiers.
Eventually, the team would also like to be able to apply their research to the civilian population experiencing PTSD.
“Our research is anticipated to be useful in helping the medical provider select appropriate therapeutic interventions,” Ms. Miller said.
A version of this article first appeared on Medscape.com.
“More accurate means of predicting or screening for PTSD could help to overcome the disorder by identifying individuals at high risk of developing PTSD and providing them with early intervention or prevention strategies,” said study investigator Stacy-Ann Miller, MS.
She also noted that the biomarkers could be used to monitor treatment for PTSD, identify subtypes of PTSD, and lead to a new understanding of the mechanisms underlying PTSD.
The findings were presented at Discover BMB, the annual meeting of the American Society for Biochemistry and Molecular Biology.
Toward better clinical assessment
The findings originated from research conducted by the Department of Defense–initiated PTSD Systems Biology Consortium. The consortium’s goals include developing a reproducible panel of blood-based biomarkers with high sensitivity and specificity for PTSD diagnosis and is made up of about 45 researchers, led by Marti Jett, PhD, Charles Marmar, MD, and Francis J. Doyle III, PhD.
The researchers analyzed blood samples from 1,000 active-duty Army personnel from the 101st Airborne at Fort Campbell, Ky. Participants were assessed before and after deployment to Afghanistan in February 2014 and are referred to as the Fort Campbell Cohort (FCC). Participants’ age ranged from 25 to 30 and approximately 6% were female.
Investigators collected blood samples from the service members and looked for four biomarkers: glycolytic ratio, arginine, serotonin, and glutamate. The team then divided the participants into four groups – those with PTSD (PTSD Checklist score above 30), those who were subthreshold for PTSD (PTSD Checklist score 15-30), those who had high resilience, and those who had low levels of resilience.
The resilience groups were determined based on answers to the Generalized Anxiety Disorder Questionnaire, Patient Health Questionnaire, Pittsburgh Sleep Quality Index, Intensive Combat Exposure (DRRI-D), the number of deployments, whether they had moderate or severe traumatic brain injury, and scores on the Alcohol Use Disorders Identification Test.
Those who scored in the high range at current or prior time points or who were PTSD/subthreshold at prior time points were placed in the low resilience group.
Ms. Miller noted that those in the PTSD group had more severe symptoms than those in the PTSD subthreshold group based on the longitudinal clinical assessment at 3-6 months, 5 years, and longer post deployment. The low resilience group had a much higher rate of PTSD post deployment than the high resilience group.
Investigators found participants with PTSD or subthreshold PTSD had significantly higher glycolic ratios and lower arginine than those with high resilience. They also found that those with PTSD had significantly lower serotonin and higher glutamate levels versus those with high resilience. These associations were independent of factors such as sex, age, body mass index, smoking, and caffeine consumption.
Ms. Miller said that the study results require further validation by the consortium’s labs and third-party labs.
“We are also interested in determining the most appropriate time to screen soldiers for PTSD, as it has been noted that the time period where we see the most psychological issues is around 2-3 months post return from deployment and when the soldier is preparing for their next assignment, perhaps a next deployment,” she said.
She added that previous studies have identified several promising biomarkers of PTSD. “However, like much of the research data, the study sample was comprised mainly of combat-exposed males. With more women serving on the front lines, the military faces new challenges in how combat affects females in the military,” including sex-specific biomarkers that will improve clinical assessment for female soldiers.
Eventually, the team would also like to be able to apply their research to the civilian population experiencing PTSD.
“Our research is anticipated to be useful in helping the medical provider select appropriate therapeutic interventions,” Ms. Miller said.
A version of this article first appeared on Medscape.com.
“More accurate means of predicting or screening for PTSD could help to overcome the disorder by identifying individuals at high risk of developing PTSD and providing them with early intervention or prevention strategies,” said study investigator Stacy-Ann Miller, MS.
She also noted that the biomarkers could be used to monitor treatment for PTSD, identify subtypes of PTSD, and lead to a new understanding of the mechanisms underlying PTSD.
The findings were presented at Discover BMB, the annual meeting of the American Society for Biochemistry and Molecular Biology.
Toward better clinical assessment
The findings originated from research conducted by the Department of Defense–initiated PTSD Systems Biology Consortium. The consortium’s goals include developing a reproducible panel of blood-based biomarkers with high sensitivity and specificity for PTSD diagnosis and is made up of about 45 researchers, led by Marti Jett, PhD, Charles Marmar, MD, and Francis J. Doyle III, PhD.
The researchers analyzed blood samples from 1,000 active-duty Army personnel from the 101st Airborne at Fort Campbell, Ky. Participants were assessed before and after deployment to Afghanistan in February 2014 and are referred to as the Fort Campbell Cohort (FCC). Participants’ age ranged from 25 to 30 and approximately 6% were female.
Investigators collected blood samples from the service members and looked for four biomarkers: glycolytic ratio, arginine, serotonin, and glutamate. The team then divided the participants into four groups – those with PTSD (PTSD Checklist score above 30), those who were subthreshold for PTSD (PTSD Checklist score 15-30), those who had high resilience, and those who had low levels of resilience.
The resilience groups were determined based on answers to the Generalized Anxiety Disorder Questionnaire, Patient Health Questionnaire, Pittsburgh Sleep Quality Index, Intensive Combat Exposure (DRRI-D), the number of deployments, whether they had moderate or severe traumatic brain injury, and scores on the Alcohol Use Disorders Identification Test.
Those who scored in the high range at current or prior time points or who were PTSD/subthreshold at prior time points were placed in the low resilience group.
Ms. Miller noted that those in the PTSD group had more severe symptoms than those in the PTSD subthreshold group based on the longitudinal clinical assessment at 3-6 months, 5 years, and longer post deployment. The low resilience group had a much higher rate of PTSD post deployment than the high resilience group.
Investigators found participants with PTSD or subthreshold PTSD had significantly higher glycolic ratios and lower arginine than those with high resilience. They also found that those with PTSD had significantly lower serotonin and higher glutamate levels versus those with high resilience. These associations were independent of factors such as sex, age, body mass index, smoking, and caffeine consumption.
Ms. Miller said that the study results require further validation by the consortium’s labs and third-party labs.
“We are also interested in determining the most appropriate time to screen soldiers for PTSD, as it has been noted that the time period where we see the most psychological issues is around 2-3 months post return from deployment and when the soldier is preparing for their next assignment, perhaps a next deployment,” she said.
She added that previous studies have identified several promising biomarkers of PTSD. “However, like much of the research data, the study sample was comprised mainly of combat-exposed males. With more women serving on the front lines, the military faces new challenges in how combat affects females in the military,” including sex-specific biomarkers that will improve clinical assessment for female soldiers.
Eventually, the team would also like to be able to apply their research to the civilian population experiencing PTSD.
“Our research is anticipated to be useful in helping the medical provider select appropriate therapeutic interventions,” Ms. Miller said.
A version of this article first appeared on Medscape.com.
FROM DISCOVER BMB
Blood biomarkers predict TBI disability and mortality
, new research suggests.
In new data from the TRACK-TBI study group, high levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) proteins found in glial cells and neurons, respectively, correlated with death and severe injury. Investigators note that measuring these biomarkers may give a more accurate assessment of a patient’s prognosis following TBI.
This study is the “first report of the accuracy of a blood test that can be obtained rapidly on the day of injury to predict neurological recovery at 6 months after injury,” lead author Frederick Korley, MD, PhD, associate professor of emergency medicine at the University of Michigan, Ann Arbor, said in a news release.
The findings were published online in the Lancet Neurology.
Added value
The researchers measured GFAP and UCH-L1 in blood samples taken from 1,696 patients with TBI on the day of their injury, and they assessed patient recovery 6 months later.
The markers were measured using the i-STAT TBI Plasma test (Abbott Labs). The test was approved in 2021 by the U.S. Food and Drug Administration to determine which patients with mild TBI should undergo computed tomography scans.
About two-thirds of the study population were men, and the average age was 39 years. All patients were evaluated at Level I trauma centers for injuries caused primarily by traffic accidents or falls.
Six months following injury, 7% of the patients had died and 14% had an unfavorable outcome, ranging from vegetative state to severe disability requiring daily support. In addition, 67% had incomplete recovery, ranging from moderate disabilities requiring assistance outside of the home to minor disabling neurological or psychological deficits.
Day-of-injury GFAP and UCH-L1 levels had a high probability of predicting death (87% for GFAP and 89% for UCH-L1) and severe disability (86% for both GFAP and UCH-L1) at 6 months, the investigators reported.
The biomarkers were less accurate in predicting incomplete recovery (62% for GFAP and 61% for UCH-L1).
The researchers also assessed the added value of combining the blood biomarkers to current TBI prognostic models that take into account variables such as age, motor score, pupil reactivity, and CT characteristics.
In patients with a Glasgow Coma Scale (GCS) score of 3-12, adding GFAP and UCH-L1 alone or combined to each of the three International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) models significantly increased their accuracy for predicting death (range, 90%-94%) and unfavorable outcome (range, 83%-89%).
In patients with milder TBI (GCS score, 13-15), adding GFAP and UCH-L1 to the UPFRONT prognostic model modestly increased accuracy for predicting incomplete recovery (69%).
‘Important’ findings
Commenting on the study, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University, St. Louis, said this “critical” study shows that these biomarkers can “predict key outcomes,” including mortality and severe disability. “Thus, in conjunction with clinical evaluations and related data such as neuroimaging, these tests may warrant translation to broader clinical practice, particularly in acute settings,” said Dr. Raji, who was not involved in the research.
Also weighing in, Heidi Fusco, MD, assistant director of the traumatic brain injury program at NYU Langone Rusk Rehabilitation, said the findings are “important.”
“Prognosis after brain injury often is based on the initial presentation, ongoing clinical exams, and neuroimaging; and the addition of biomarkers would contribute to creating a more objective prognostic model,” Dr. Fusco said.
She noted “it’s unclear” whether clinical hospital laboratories would be able to accommodate this type of laboratory drawing.
“It is imperative that clinicians still use the patient history [and] clinical and radiological exam when making clinical decisions for a patient and not just lab values. It would be best to incorporate the GFAP and UCH-L1 into a preexisting prognostic model,” Dr. Fusco said.
The study was funded by the U.S. National Institutes of Health, the National Institute of Neurologic Disorders and Stroke, the U.S. Department of Defense, One Mind, and U.S. Army Medical Research and Development Command. Dr. Korley reported having previously consulted for Abbott Laboratories and has received research funding from Abbott Laboratories, which makes the assays used in the study. Dr. Raji is a consultant for Brainreader ApS and Neurevolution. Dr. Fusco has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In new data from the TRACK-TBI study group, high levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) proteins found in glial cells and neurons, respectively, correlated with death and severe injury. Investigators note that measuring these biomarkers may give a more accurate assessment of a patient’s prognosis following TBI.
This study is the “first report of the accuracy of a blood test that can be obtained rapidly on the day of injury to predict neurological recovery at 6 months after injury,” lead author Frederick Korley, MD, PhD, associate professor of emergency medicine at the University of Michigan, Ann Arbor, said in a news release.
The findings were published online in the Lancet Neurology.
Added value
The researchers measured GFAP and UCH-L1 in blood samples taken from 1,696 patients with TBI on the day of their injury, and they assessed patient recovery 6 months later.
The markers were measured using the i-STAT TBI Plasma test (Abbott Labs). The test was approved in 2021 by the U.S. Food and Drug Administration to determine which patients with mild TBI should undergo computed tomography scans.
About two-thirds of the study population were men, and the average age was 39 years. All patients were evaluated at Level I trauma centers for injuries caused primarily by traffic accidents or falls.
Six months following injury, 7% of the patients had died and 14% had an unfavorable outcome, ranging from vegetative state to severe disability requiring daily support. In addition, 67% had incomplete recovery, ranging from moderate disabilities requiring assistance outside of the home to minor disabling neurological or psychological deficits.
Day-of-injury GFAP and UCH-L1 levels had a high probability of predicting death (87% for GFAP and 89% for UCH-L1) and severe disability (86% for both GFAP and UCH-L1) at 6 months, the investigators reported.
The biomarkers were less accurate in predicting incomplete recovery (62% for GFAP and 61% for UCH-L1).
The researchers also assessed the added value of combining the blood biomarkers to current TBI prognostic models that take into account variables such as age, motor score, pupil reactivity, and CT characteristics.
In patients with a Glasgow Coma Scale (GCS) score of 3-12, adding GFAP and UCH-L1 alone or combined to each of the three International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) models significantly increased their accuracy for predicting death (range, 90%-94%) and unfavorable outcome (range, 83%-89%).
In patients with milder TBI (GCS score, 13-15), adding GFAP and UCH-L1 to the UPFRONT prognostic model modestly increased accuracy for predicting incomplete recovery (69%).
‘Important’ findings
Commenting on the study, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University, St. Louis, said this “critical” study shows that these biomarkers can “predict key outcomes,” including mortality and severe disability. “Thus, in conjunction with clinical evaluations and related data such as neuroimaging, these tests may warrant translation to broader clinical practice, particularly in acute settings,” said Dr. Raji, who was not involved in the research.
Also weighing in, Heidi Fusco, MD, assistant director of the traumatic brain injury program at NYU Langone Rusk Rehabilitation, said the findings are “important.”
“Prognosis after brain injury often is based on the initial presentation, ongoing clinical exams, and neuroimaging; and the addition of biomarkers would contribute to creating a more objective prognostic model,” Dr. Fusco said.
She noted “it’s unclear” whether clinical hospital laboratories would be able to accommodate this type of laboratory drawing.
“It is imperative that clinicians still use the patient history [and] clinical and radiological exam when making clinical decisions for a patient and not just lab values. It would be best to incorporate the GFAP and UCH-L1 into a preexisting prognostic model,” Dr. Fusco said.
The study was funded by the U.S. National Institutes of Health, the National Institute of Neurologic Disorders and Stroke, the U.S. Department of Defense, One Mind, and U.S. Army Medical Research and Development Command. Dr. Korley reported having previously consulted for Abbott Laboratories and has received research funding from Abbott Laboratories, which makes the assays used in the study. Dr. Raji is a consultant for Brainreader ApS and Neurevolution. Dr. Fusco has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new research suggests.
In new data from the TRACK-TBI study group, high levels of glial fibrillary acidic protein (GFAP) and ubiquitin carboxy-terminal hydrolase L1 (UCH-L1) proteins found in glial cells and neurons, respectively, correlated with death and severe injury. Investigators note that measuring these biomarkers may give a more accurate assessment of a patient’s prognosis following TBI.
This study is the “first report of the accuracy of a blood test that can be obtained rapidly on the day of injury to predict neurological recovery at 6 months after injury,” lead author Frederick Korley, MD, PhD, associate professor of emergency medicine at the University of Michigan, Ann Arbor, said in a news release.
The findings were published online in the Lancet Neurology.
Added value
The researchers measured GFAP and UCH-L1 in blood samples taken from 1,696 patients with TBI on the day of their injury, and they assessed patient recovery 6 months later.
The markers were measured using the i-STAT TBI Plasma test (Abbott Labs). The test was approved in 2021 by the U.S. Food and Drug Administration to determine which patients with mild TBI should undergo computed tomography scans.
About two-thirds of the study population were men, and the average age was 39 years. All patients were evaluated at Level I trauma centers for injuries caused primarily by traffic accidents or falls.
Six months following injury, 7% of the patients had died and 14% had an unfavorable outcome, ranging from vegetative state to severe disability requiring daily support. In addition, 67% had incomplete recovery, ranging from moderate disabilities requiring assistance outside of the home to minor disabling neurological or psychological deficits.
Day-of-injury GFAP and UCH-L1 levels had a high probability of predicting death (87% for GFAP and 89% for UCH-L1) and severe disability (86% for both GFAP and UCH-L1) at 6 months, the investigators reported.
The biomarkers were less accurate in predicting incomplete recovery (62% for GFAP and 61% for UCH-L1).
The researchers also assessed the added value of combining the blood biomarkers to current TBI prognostic models that take into account variables such as age, motor score, pupil reactivity, and CT characteristics.
In patients with a Glasgow Coma Scale (GCS) score of 3-12, adding GFAP and UCH-L1 alone or combined to each of the three International Mission for Prognosis and Analysis of Clinical Trials in TBI (IMPACT) models significantly increased their accuracy for predicting death (range, 90%-94%) and unfavorable outcome (range, 83%-89%).
In patients with milder TBI (GCS score, 13-15), adding GFAP and UCH-L1 to the UPFRONT prognostic model modestly increased accuracy for predicting incomplete recovery (69%).
‘Important’ findings
Commenting on the study, Cyrus A. Raji, MD, PhD, assistant professor of radiology and neurology, Washington University, St. Louis, said this “critical” study shows that these biomarkers can “predict key outcomes,” including mortality and severe disability. “Thus, in conjunction with clinical evaluations and related data such as neuroimaging, these tests may warrant translation to broader clinical practice, particularly in acute settings,” said Dr. Raji, who was not involved in the research.
Also weighing in, Heidi Fusco, MD, assistant director of the traumatic brain injury program at NYU Langone Rusk Rehabilitation, said the findings are “important.”
“Prognosis after brain injury often is based on the initial presentation, ongoing clinical exams, and neuroimaging; and the addition of biomarkers would contribute to creating a more objective prognostic model,” Dr. Fusco said.
She noted “it’s unclear” whether clinical hospital laboratories would be able to accommodate this type of laboratory drawing.
“It is imperative that clinicians still use the patient history [and] clinical and radiological exam when making clinical decisions for a patient and not just lab values. It would be best to incorporate the GFAP and UCH-L1 into a preexisting prognostic model,” Dr. Fusco said.
The study was funded by the U.S. National Institutes of Health, the National Institute of Neurologic Disorders and Stroke, the U.S. Department of Defense, One Mind, and U.S. Army Medical Research and Development Command. Dr. Korley reported having previously consulted for Abbott Laboratories and has received research funding from Abbott Laboratories, which makes the assays used in the study. Dr. Raji is a consultant for Brainreader ApS and Neurevolution. Dr. Fusco has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE LANCET NEUROLOGY
Incomplete recovery common 6 months after mild TBI
, new data from the TRACK-TBI study shows.
“Seeing that more than half of the GCS [Glasgow Coma Score] 15, CT-negative TBI cohort in our study were not back to their preinjury baseline at 6 months was surprising and impacts the millions of Americans who suffer from concussions annually,” said lead author Debbie Madhok, MD, with department of emergency medicine, University of California, San Francisco.
“These results highlight the importance of improving care pathways for concussion, particularly from the emergency department,” Dr. Madhok said.
The findings were published online in JAMA Network Open.
The short- and long-term outcomes in the large group of patients who come into the ED with TBI, a GCS of 15, and without acute intracranial traumatic injury (defined as a negative head CT scan) remain poorly understood, the investigators noted. To investigate further, they evaluated outcomes at 2 weeks and 6 months in 991 of these patients (mean age, 38 years; 64% men) from the TRACK-TBI study.
Among the 751 (76%) participants followed up at 2 weeks after the injury, only 204 (27%) had functional recovery – with a Glasgow Outcome Scale-Extended (GOS-E) score of 8. The remaining 547 (73%) had incomplete recovery (GOS-E scores < 8).
Among the 659 patients (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery.
Most patients who failed to recover completely reported they had not returned to their preinjury life (88%). They described trouble returning to social activities outside the home and disruptions in family relationships and friendships.
The researchers noted that the study population had a high rate of preinjury psychiatric comorbidities, and these patients were more likely to have incomplete recovery than those without psychiatric comorbidities. This aligns with results from previous studies, they added.
The investigators also noted that patients with mild TBI without acute intracranial trauma are typically managed by ED personnel.
“These findings highlight the importance of ED clinicians being aware of the risk of incomplete recovery for patients with a mild TBI (that is, GCS score of 15 and negative head CT scan) and providing accurate education and timely referral information before ED discharge,” they wrote.
The study was funded by grants from the National Foundation of Emergency Medicine, the National Institute of Neurological Disorders and Stroke, and the U.S. Department of Defense Traumatic Brain Injury Endpoints Development Initiative. Dr. Madhok has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new data from the TRACK-TBI study shows.
“Seeing that more than half of the GCS [Glasgow Coma Score] 15, CT-negative TBI cohort in our study were not back to their preinjury baseline at 6 months was surprising and impacts the millions of Americans who suffer from concussions annually,” said lead author Debbie Madhok, MD, with department of emergency medicine, University of California, San Francisco.
“These results highlight the importance of improving care pathways for concussion, particularly from the emergency department,” Dr. Madhok said.
The findings were published online in JAMA Network Open.
The short- and long-term outcomes in the large group of patients who come into the ED with TBI, a GCS of 15, and without acute intracranial traumatic injury (defined as a negative head CT scan) remain poorly understood, the investigators noted. To investigate further, they evaluated outcomes at 2 weeks and 6 months in 991 of these patients (mean age, 38 years; 64% men) from the TRACK-TBI study.
Among the 751 (76%) participants followed up at 2 weeks after the injury, only 204 (27%) had functional recovery – with a Glasgow Outcome Scale-Extended (GOS-E) score of 8. The remaining 547 (73%) had incomplete recovery (GOS-E scores < 8).
Among the 659 patients (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery.
Most patients who failed to recover completely reported they had not returned to their preinjury life (88%). They described trouble returning to social activities outside the home and disruptions in family relationships and friendships.
The researchers noted that the study population had a high rate of preinjury psychiatric comorbidities, and these patients were more likely to have incomplete recovery than those without psychiatric comorbidities. This aligns with results from previous studies, they added.
The investigators also noted that patients with mild TBI without acute intracranial trauma are typically managed by ED personnel.
“These findings highlight the importance of ED clinicians being aware of the risk of incomplete recovery for patients with a mild TBI (that is, GCS score of 15 and negative head CT scan) and providing accurate education and timely referral information before ED discharge,” they wrote.
The study was funded by grants from the National Foundation of Emergency Medicine, the National Institute of Neurological Disorders and Stroke, and the U.S. Department of Defense Traumatic Brain Injury Endpoints Development Initiative. Dr. Madhok has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, new data from the TRACK-TBI study shows.
“Seeing that more than half of the GCS [Glasgow Coma Score] 15, CT-negative TBI cohort in our study were not back to their preinjury baseline at 6 months was surprising and impacts the millions of Americans who suffer from concussions annually,” said lead author Debbie Madhok, MD, with department of emergency medicine, University of California, San Francisco.
“These results highlight the importance of improving care pathways for concussion, particularly from the emergency department,” Dr. Madhok said.
The findings were published online in JAMA Network Open.
The short- and long-term outcomes in the large group of patients who come into the ED with TBI, a GCS of 15, and without acute intracranial traumatic injury (defined as a negative head CT scan) remain poorly understood, the investigators noted. To investigate further, they evaluated outcomes at 2 weeks and 6 months in 991 of these patients (mean age, 38 years; 64% men) from the TRACK-TBI study.
Among the 751 (76%) participants followed up at 2 weeks after the injury, only 204 (27%) had functional recovery – with a Glasgow Outcome Scale-Extended (GOS-E) score of 8. The remaining 547 (73%) had incomplete recovery (GOS-E scores < 8).
Among the 659 patients (66%) followed up at 6 months after the injury, 287 (44%) had functional recovery and 372 (56%) had incomplete recovery.
Most patients who failed to recover completely reported they had not returned to their preinjury life (88%). They described trouble returning to social activities outside the home and disruptions in family relationships and friendships.
The researchers noted that the study population had a high rate of preinjury psychiatric comorbidities, and these patients were more likely to have incomplete recovery than those without psychiatric comorbidities. This aligns with results from previous studies, they added.
The investigators also noted that patients with mild TBI without acute intracranial trauma are typically managed by ED personnel.
“These findings highlight the importance of ED clinicians being aware of the risk of incomplete recovery for patients with a mild TBI (that is, GCS score of 15 and negative head CT scan) and providing accurate education and timely referral information before ED discharge,” they wrote.
The study was funded by grants from the National Foundation of Emergency Medicine, the National Institute of Neurological Disorders and Stroke, and the U.S. Department of Defense Traumatic Brain Injury Endpoints Development Initiative. Dr. Madhok has reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Doc fails to order crucial tests; paralyzed patient wins $17 million; more
according to a report by WOWK13 News, a local CBS affiliate in Huntington and Charleston, W. Va., among other news outlets.
On or about June 4, 2017, Michael Rodgers sustained injuries while riding his motorcycle. Admitted to Charleston Area Medical Center’s (CAMC’s) Level I trauma center, he initially showed no neurologic impairment and was able to feel and move all his extremities. A subsequent CT scan revealed, though, that he had incurred a T5 Chance fracture, as his later complaint states.
On June 6, a neurosurgeon affiliated with CAMC, John Orphanos, MD, instructed Mr. Rodgers to wear a back brace for 6 to 8 weeks. Later that day, though, Dr. Orphanos changed his course of treatment and recommended that Mr. Rodgers undergo surgery to treat his injuries. Despite his new recommendation, the neurosurgeon/spine specialist didn’t order a presurgical MRI of his patient’s thoracic spine. Typically, such a scan would have been used to determine any existing or potential spinal cord problems and any soft-tissue problems in the area of the fracture.
Not having such information, Dr. Orphanos was unaware that his patient had “an abundance of epidural fat, cord compression, cord edema, spinal abnormality, and spinal cord injury,” the complaint states. The neurosurgeon’s operative plan, therefore, included neither decompression of the spinal column nor use of neurophysiologic intraoperative monitoring, which is used to gauge, in real time during procedures, both how fast and how strongly a patient’s nerves are carrying signals.
Late on June 6, Dr. Orphanos performed a surgery to fuse his patient’s vertebrae from the T2 to the T6 region. Following the procedure, however, Mr. Rodgers experienced a complete loss of motor function and sensation in his lower extremities. A postoperative MRI proved inconclusive because of certain distorting effects of hardware implanted during the original surgery. Had a CT myelogram been ordered, it would have yielded a more accurate picture, the plaintiff alleged in his complaint.
Mr. Rodgers underwent a second surgery, during which Dr. Orphanos performed a T5 laminectomy. The patient’s loss of motor function and sensation persisted, however. He has been experiencing T5-level paraplegia ever since, with complete loss of control of his legs, bowel, and bladder.
In his complaint, Mr. Rodgers alleged that Dr. Orphanos had repeatedly deviated from the standard of care. Among other things, the plaintiff claimed, Dr. Orphanos had failed in both of his surgeries to order the proper preop and postop testing, thereby jeopardizing the outcomes of each procedure. This gross negligence and recklessness, the plaintiff argued, led directly to his permanent and disabling injuries.
Late last month, a West Virginia jury agreed that Dr. Orphanos was at fault and awarded Mr. Rodgers $17 million in damages.
Commented one of the pair of attorneys representing Mr. Rodgers: “We are very grateful to the jury, who saw through the attempts to rationalize the defendant’s conduct and delivered a jury verdict that will take care of Mr. Rodgers and provide the services he will need.”
Provider-to-provider disputes not time sensitive, state high court says
Early last month, Indiana’s high court ruled that the state’s med-mal statute of limitations doesn’t apply to disputes between providers, as a story in Radiology Business and other news sites reports.
The legal wrangling dates to April 2011. At that time, Joseph Shaughnessy underwent two CT scans at a Franciscan Alliance hospital, part of a healthcare system run by Franciscan Health. Outside radiologists from Lake Imaging read the scans, but they allegedly failed to note bleeding on the right side of the patient’s brain. Mr. Shaughnessy subsequently died, and his family filed suit against Franciscan, on the assumption that the radiologists were employees.
In 2015, the plaintiffs and Franciscan reached a $187,000 settlement, but Franciscan claimed it wasn’t liable for the payment, citing a clause in its prior agreement with Lake Imaging that protected it. But Lake Imaging sought to dismiss the Franciscan claim, arguing that the hospital system had failed to bring its suit within the state’s 2-year med-mal statute of limitations.
In its review of the case, the Indiana Supreme Court dismissed this argument: “(T)here is nothing in the [Medical Malpractice Act] to suggest that it extends beyond the physician-patient relationship to encompass commercial contracts between healthcare providers.”
In other words, while Indiana law places a 2-year limit on patients suing a hospital, doctor, or other healthcare professional, it places no such limit on contractually bound providers who take steps to sue each other.
As part of its unanimous decision, the high court also sent a claim by Lake Imaging against its insurance provider back to the trial court. The claim asks the insurance carrier — and not Lake Imaging — to assume responsibility for the settlement between Mr. Shaughnessy and Franciscan Alliance.
There was no word at press time as to when further legal proceedings would take place.
Paralyzed patient seeks millions
An Oregon man who was left paralyzed after undergoing surgery to address issues in his leg and foot has filed a large claim against both the hospital and surgical group involved in the procedure, details a story first reported by the Associated Press and picked up by other news outlets, including Fox12 Oregon.
On January 8, 2020, the man underwent brain surgery to address numbness in his left foot and a “vague” pain in his left leg. During the procedure, he experienced a dural tear, which the lead surgeon and his team addressed.
The following day, the man’s condition deteriorated, and he complained of severe pain, according to his lawsuit. Two days after his initial procedure, another surgeon performed a second procedure “to drain fluid and relieve pressure” on the patient’s brain. Nevertheless, the patient neither recovered sensation in his lower extremities nor use of his legs.
His claim against the facility and surgical practice asks for $43.5 million in damages for his injuries. For its part, the hospital expressed “deep compassion” for the patient and his family while making it clear that it believes its “caregivers provided excellent care.”
A version of this article first appeared on Medscape.com.
according to a report by WOWK13 News, a local CBS affiliate in Huntington and Charleston, W. Va., among other news outlets.
On or about June 4, 2017, Michael Rodgers sustained injuries while riding his motorcycle. Admitted to Charleston Area Medical Center’s (CAMC’s) Level I trauma center, he initially showed no neurologic impairment and was able to feel and move all his extremities. A subsequent CT scan revealed, though, that he had incurred a T5 Chance fracture, as his later complaint states.
On June 6, a neurosurgeon affiliated with CAMC, John Orphanos, MD, instructed Mr. Rodgers to wear a back brace for 6 to 8 weeks. Later that day, though, Dr. Orphanos changed his course of treatment and recommended that Mr. Rodgers undergo surgery to treat his injuries. Despite his new recommendation, the neurosurgeon/spine specialist didn’t order a presurgical MRI of his patient’s thoracic spine. Typically, such a scan would have been used to determine any existing or potential spinal cord problems and any soft-tissue problems in the area of the fracture.
Not having such information, Dr. Orphanos was unaware that his patient had “an abundance of epidural fat, cord compression, cord edema, spinal abnormality, and spinal cord injury,” the complaint states. The neurosurgeon’s operative plan, therefore, included neither decompression of the spinal column nor use of neurophysiologic intraoperative monitoring, which is used to gauge, in real time during procedures, both how fast and how strongly a patient’s nerves are carrying signals.
Late on June 6, Dr. Orphanos performed a surgery to fuse his patient’s vertebrae from the T2 to the T6 region. Following the procedure, however, Mr. Rodgers experienced a complete loss of motor function and sensation in his lower extremities. A postoperative MRI proved inconclusive because of certain distorting effects of hardware implanted during the original surgery. Had a CT myelogram been ordered, it would have yielded a more accurate picture, the plaintiff alleged in his complaint.
Mr. Rodgers underwent a second surgery, during which Dr. Orphanos performed a T5 laminectomy. The patient’s loss of motor function and sensation persisted, however. He has been experiencing T5-level paraplegia ever since, with complete loss of control of his legs, bowel, and bladder.
In his complaint, Mr. Rodgers alleged that Dr. Orphanos had repeatedly deviated from the standard of care. Among other things, the plaintiff claimed, Dr. Orphanos had failed in both of his surgeries to order the proper preop and postop testing, thereby jeopardizing the outcomes of each procedure. This gross negligence and recklessness, the plaintiff argued, led directly to his permanent and disabling injuries.
Late last month, a West Virginia jury agreed that Dr. Orphanos was at fault and awarded Mr. Rodgers $17 million in damages.
Commented one of the pair of attorneys representing Mr. Rodgers: “We are very grateful to the jury, who saw through the attempts to rationalize the defendant’s conduct and delivered a jury verdict that will take care of Mr. Rodgers and provide the services he will need.”
Provider-to-provider disputes not time sensitive, state high court says
Early last month, Indiana’s high court ruled that the state’s med-mal statute of limitations doesn’t apply to disputes between providers, as a story in Radiology Business and other news sites reports.
The legal wrangling dates to April 2011. At that time, Joseph Shaughnessy underwent two CT scans at a Franciscan Alliance hospital, part of a healthcare system run by Franciscan Health. Outside radiologists from Lake Imaging read the scans, but they allegedly failed to note bleeding on the right side of the patient’s brain. Mr. Shaughnessy subsequently died, and his family filed suit against Franciscan, on the assumption that the radiologists were employees.
In 2015, the plaintiffs and Franciscan reached a $187,000 settlement, but Franciscan claimed it wasn’t liable for the payment, citing a clause in its prior agreement with Lake Imaging that protected it. But Lake Imaging sought to dismiss the Franciscan claim, arguing that the hospital system had failed to bring its suit within the state’s 2-year med-mal statute of limitations.
In its review of the case, the Indiana Supreme Court dismissed this argument: “(T)here is nothing in the [Medical Malpractice Act] to suggest that it extends beyond the physician-patient relationship to encompass commercial contracts between healthcare providers.”
In other words, while Indiana law places a 2-year limit on patients suing a hospital, doctor, or other healthcare professional, it places no such limit on contractually bound providers who take steps to sue each other.
As part of its unanimous decision, the high court also sent a claim by Lake Imaging against its insurance provider back to the trial court. The claim asks the insurance carrier — and not Lake Imaging — to assume responsibility for the settlement between Mr. Shaughnessy and Franciscan Alliance.
There was no word at press time as to when further legal proceedings would take place.
Paralyzed patient seeks millions
An Oregon man who was left paralyzed after undergoing surgery to address issues in his leg and foot has filed a large claim against both the hospital and surgical group involved in the procedure, details a story first reported by the Associated Press and picked up by other news outlets, including Fox12 Oregon.
On January 8, 2020, the man underwent brain surgery to address numbness in his left foot and a “vague” pain in his left leg. During the procedure, he experienced a dural tear, which the lead surgeon and his team addressed.
The following day, the man’s condition deteriorated, and he complained of severe pain, according to his lawsuit. Two days after his initial procedure, another surgeon performed a second procedure “to drain fluid and relieve pressure” on the patient’s brain. Nevertheless, the patient neither recovered sensation in his lower extremities nor use of his legs.
His claim against the facility and surgical practice asks for $43.5 million in damages for his injuries. For its part, the hospital expressed “deep compassion” for the patient and his family while making it clear that it believes its “caregivers provided excellent care.”
A version of this article first appeared on Medscape.com.
according to a report by WOWK13 News, a local CBS affiliate in Huntington and Charleston, W. Va., among other news outlets.
On or about June 4, 2017, Michael Rodgers sustained injuries while riding his motorcycle. Admitted to Charleston Area Medical Center’s (CAMC’s) Level I trauma center, he initially showed no neurologic impairment and was able to feel and move all his extremities. A subsequent CT scan revealed, though, that he had incurred a T5 Chance fracture, as his later complaint states.
On June 6, a neurosurgeon affiliated with CAMC, John Orphanos, MD, instructed Mr. Rodgers to wear a back brace for 6 to 8 weeks. Later that day, though, Dr. Orphanos changed his course of treatment and recommended that Mr. Rodgers undergo surgery to treat his injuries. Despite his new recommendation, the neurosurgeon/spine specialist didn’t order a presurgical MRI of his patient’s thoracic spine. Typically, such a scan would have been used to determine any existing or potential spinal cord problems and any soft-tissue problems in the area of the fracture.
Not having such information, Dr. Orphanos was unaware that his patient had “an abundance of epidural fat, cord compression, cord edema, spinal abnormality, and spinal cord injury,” the complaint states. The neurosurgeon’s operative plan, therefore, included neither decompression of the spinal column nor use of neurophysiologic intraoperative monitoring, which is used to gauge, in real time during procedures, both how fast and how strongly a patient’s nerves are carrying signals.
Late on June 6, Dr. Orphanos performed a surgery to fuse his patient’s vertebrae from the T2 to the T6 region. Following the procedure, however, Mr. Rodgers experienced a complete loss of motor function and sensation in his lower extremities. A postoperative MRI proved inconclusive because of certain distorting effects of hardware implanted during the original surgery. Had a CT myelogram been ordered, it would have yielded a more accurate picture, the plaintiff alleged in his complaint.
Mr. Rodgers underwent a second surgery, during which Dr. Orphanos performed a T5 laminectomy. The patient’s loss of motor function and sensation persisted, however. He has been experiencing T5-level paraplegia ever since, with complete loss of control of his legs, bowel, and bladder.
In his complaint, Mr. Rodgers alleged that Dr. Orphanos had repeatedly deviated from the standard of care. Among other things, the plaintiff claimed, Dr. Orphanos had failed in both of his surgeries to order the proper preop and postop testing, thereby jeopardizing the outcomes of each procedure. This gross negligence and recklessness, the plaintiff argued, led directly to his permanent and disabling injuries.
Late last month, a West Virginia jury agreed that Dr. Orphanos was at fault and awarded Mr. Rodgers $17 million in damages.
Commented one of the pair of attorneys representing Mr. Rodgers: “We are very grateful to the jury, who saw through the attempts to rationalize the defendant’s conduct and delivered a jury verdict that will take care of Mr. Rodgers and provide the services he will need.”
Provider-to-provider disputes not time sensitive, state high court says
Early last month, Indiana’s high court ruled that the state’s med-mal statute of limitations doesn’t apply to disputes between providers, as a story in Radiology Business and other news sites reports.
The legal wrangling dates to April 2011. At that time, Joseph Shaughnessy underwent two CT scans at a Franciscan Alliance hospital, part of a healthcare system run by Franciscan Health. Outside radiologists from Lake Imaging read the scans, but they allegedly failed to note bleeding on the right side of the patient’s brain. Mr. Shaughnessy subsequently died, and his family filed suit against Franciscan, on the assumption that the radiologists were employees.
In 2015, the plaintiffs and Franciscan reached a $187,000 settlement, but Franciscan claimed it wasn’t liable for the payment, citing a clause in its prior agreement with Lake Imaging that protected it. But Lake Imaging sought to dismiss the Franciscan claim, arguing that the hospital system had failed to bring its suit within the state’s 2-year med-mal statute of limitations.
In its review of the case, the Indiana Supreme Court dismissed this argument: “(T)here is nothing in the [Medical Malpractice Act] to suggest that it extends beyond the physician-patient relationship to encompass commercial contracts between healthcare providers.”
In other words, while Indiana law places a 2-year limit on patients suing a hospital, doctor, or other healthcare professional, it places no such limit on contractually bound providers who take steps to sue each other.
As part of its unanimous decision, the high court also sent a claim by Lake Imaging against its insurance provider back to the trial court. The claim asks the insurance carrier — and not Lake Imaging — to assume responsibility for the settlement between Mr. Shaughnessy and Franciscan Alliance.
There was no word at press time as to when further legal proceedings would take place.
Paralyzed patient seeks millions
An Oregon man who was left paralyzed after undergoing surgery to address issues in his leg and foot has filed a large claim against both the hospital and surgical group involved in the procedure, details a story first reported by the Associated Press and picked up by other news outlets, including Fox12 Oregon.
On January 8, 2020, the man underwent brain surgery to address numbness in his left foot and a “vague” pain in his left leg. During the procedure, he experienced a dural tear, which the lead surgeon and his team addressed.
The following day, the man’s condition deteriorated, and he complained of severe pain, according to his lawsuit. Two days after his initial procedure, another surgeon performed a second procedure “to drain fluid and relieve pressure” on the patient’s brain. Nevertheless, the patient neither recovered sensation in his lower extremities nor use of his legs.
His claim against the facility and surgical practice asks for $43.5 million in damages for his injuries. For its part, the hospital expressed “deep compassion” for the patient and his family while making it clear that it believes its “caregivers provided excellent care.”
A version of this article first appeared on Medscape.com.
Brain implant is a potential life-changer for paralyzed patients
, results of a small, first-in-human study show.
A potential life changer for patients with amyotrophic lateral sclerosis (ALS), the minimally invasive device enables patients to carry out important activities of daily living.
“Our participants are able to use the device to perform tasks like sending email, texting loved ones and caregivers, browsing the web, and doing personal finances such as online banking,” study investigator Douglas J. Weber, PhD, professor of mechanical engineering and neuroscience, Carnegie Mellon University, Pittsburgh, told a press briefing.
The technology allowed one patient to write a book (due out later this year) and another patient to maintain communication despite losing his ability to speak, said the study’s lead investigator, Bruce Campbell, MBBS, PhD, professor of neurology, Royal Melbourne Hospital, University of Melbourne.
“In addition to providing patients with communicative capabilities not possible as a result of their disease, it is our goal to enable patients to be more independently involved in their care going forward, by enabling effective and faster communication directly with their caregiver and physician,” said Dr. Campbell.
The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
Minimally invasive
ALS, also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. Patients with ALS eventually lose the ability to control muscle movement, often leading to total paralysis.
“Extending the period in which patients are able to communicate with loved ones and caregivers could provide a very meaningful benefit to patients with ALS,” said Dr. Weber.
Brain-computer interfaces measure and translate brain signals, with some functioning as motor neuro-prostheses. These devices provide direct communication between the brain and an external device by recording and decoding signals from the precentral gyrus as the result of movement intention.
“The technology has potential to empower the more than five million people in the U.S. who are severely paralyzed to once again perform important activities of daily living independently,” said Dr. Weber.
Until now, motor neuro-prostheses required surgery to remove a portion of the skull and place electrodes on to the brain. However, the new minimally invasive motor neuro-prostheses reach the brain by vascular access, dispensing with the need for a craniotomy.
“The brain-computer interface device used in our study is unique in that it does not require invasive open surgery to implant,” said Dr. Weber. “Instead this is an endovascular brain-computer interface.”
Using a catheter, surgeons feed the BCI through one of two jugular veins in the neck. They position an array of 16 sensors or electrodes on a stent-like scaffold that deploys against the walls of the superior sagittal sinus.
No adverse events
Describing the device, Dr. Weber said the electrodes or sensing elements are tiny and the body of the stent, which serves as a scaffold to support the electrodes, resembles a standard endovascular stent.
“It’s very small at the time of delivery because it’s held within the body of a catheter, but then when deployed it expands to contact the wall of the vein.”
The device transmits brain signals from the motor cortex to an electronics unit, located in a subcutaneous pocket that decodes movement signals. The machine-learning decoder is programmed as follows: When a trainer asked participants to attempt certain movements, like tapping their foot or extending their knee, the decoder analyzes nerve cell signals from those movement attempts. The decoder is able to translate movement signals into computer navigation.
The study included four patients with ALS who were paralyzed because of the disease and were trained to use the device.
A key safety endpoint was device-related serious adverse events resulting in death or increased disability during the post-implant evaluation period. Results showed all four participants successfully completed the 12-month follow-up with no serious adverse events.
Researchers also assessed target vessel patency and incidence of device migration at 3 and 12 months. Postoperative imaging showed that in all participants, the blood vessel that held the implanted device remained open and stayed in place.
Addressing the potential for blood clots, Dr. Weber said that so far there has been no sign of clotting or vascular occlusion.
“The device itself integrates well into the walls of the blood vessel over time,” he said. “Within the acute period after implantation, there’s time where the device is exposed to the blood stream, but once it becomes encapsulated and fully integrated into the blood vessel wall, the risks of thrombosis diminish.”
Greater independence
Researchers also recorded signal fidelity and stability over 12 months and use of the brain-computer interface to perform routine tasks. All participants learned to use the motor neuro-prostheses with eye tracking for computer use. Eye tracking technology helps a computer determine what a person is looking at.
Using the system, patients were able to complete tasks without help. These included text messaging and managing finances. “Since the device is fully implanted and easy for patients to use, they can use the technology independently and in their own home,” said Dr. Weber.
Although the study started with patients with ALS, those paralyzed from other causes, such as an upper spinal cord injury or brain-stem stroke could also benefit from this technology, Dr. Weber said. In addition, the technology could be expanded to broaden brain communication capabilities potentially to include robotic limbs, he said.
There’s even the potential to use this minimally invasive brain interface technology to deliver therapies like deep brain stimulation, which Dr. Weber noted is a growing field. “It’s [the] early days, but it’s a very exciting new direction for brain interface technology,” he said.
Researchers are now recruiting patients for the first U.S.-based feasibility trial of the device that will be funded by the NIH, said Dr. Weber. A limitation of the research was the study’s small size.
Advancing the field
Reached for a comment, Kevin C. Davis, an MD and PhD student in the department of biomedical engineering, University of Miami Miller School of Medicine, said this new work moves the field forward in an important way.
Dr. Davis and colleagues have shown the effectiveness of another technology used to overcome paralysis – a small portable system that facilitates hand grasp of a patient with a spinal cord injury. He reported on this DBS-based BCI system at the American Association of Neurological Surgeons (AANS) 2021 Annual Meeting.
Developing effective brain-computer interfaces, and motor neural prosthetics that avoid surgery, as the team did in this new study, is “worth exploring,” said Dr. Davis.
However, although the device used in this new study avoids cranial surgery, “sole vascular access may limit the device’s ability to reach other areas of the brain more suitable for upper-limb motor prosthetics,” he said.
“Determining how much function such a device could provide to individuals with locked-in syndrome or paralysis will be important in determining its viability as an eventual clinical tool for patients.”
The study was supported by Synchron, the maker of the device, the U.S. Defense Advanced Research Projects Agency, the Office of Naval Research, the National Health and Medical Research Council of Australia, the Australian Federal Government Foundation, and the Motor Neuron Disease Research Institute of Australia.
A version of this article first appeared on Medscape.com.
, results of a small, first-in-human study show.
A potential life changer for patients with amyotrophic lateral sclerosis (ALS), the minimally invasive device enables patients to carry out important activities of daily living.
“Our participants are able to use the device to perform tasks like sending email, texting loved ones and caregivers, browsing the web, and doing personal finances such as online banking,” study investigator Douglas J. Weber, PhD, professor of mechanical engineering and neuroscience, Carnegie Mellon University, Pittsburgh, told a press briefing.
The technology allowed one patient to write a book (due out later this year) and another patient to maintain communication despite losing his ability to speak, said the study’s lead investigator, Bruce Campbell, MBBS, PhD, professor of neurology, Royal Melbourne Hospital, University of Melbourne.
“In addition to providing patients with communicative capabilities not possible as a result of their disease, it is our goal to enable patients to be more independently involved in their care going forward, by enabling effective and faster communication directly with their caregiver and physician,” said Dr. Campbell.
The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
Minimally invasive
ALS, also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. Patients with ALS eventually lose the ability to control muscle movement, often leading to total paralysis.
“Extending the period in which patients are able to communicate with loved ones and caregivers could provide a very meaningful benefit to patients with ALS,” said Dr. Weber.
Brain-computer interfaces measure and translate brain signals, with some functioning as motor neuro-prostheses. These devices provide direct communication between the brain and an external device by recording and decoding signals from the precentral gyrus as the result of movement intention.
“The technology has potential to empower the more than five million people in the U.S. who are severely paralyzed to once again perform important activities of daily living independently,” said Dr. Weber.
Until now, motor neuro-prostheses required surgery to remove a portion of the skull and place electrodes on to the brain. However, the new minimally invasive motor neuro-prostheses reach the brain by vascular access, dispensing with the need for a craniotomy.
“The brain-computer interface device used in our study is unique in that it does not require invasive open surgery to implant,” said Dr. Weber. “Instead this is an endovascular brain-computer interface.”
Using a catheter, surgeons feed the BCI through one of two jugular veins in the neck. They position an array of 16 sensors or electrodes on a stent-like scaffold that deploys against the walls of the superior sagittal sinus.
No adverse events
Describing the device, Dr. Weber said the electrodes or sensing elements are tiny and the body of the stent, which serves as a scaffold to support the electrodes, resembles a standard endovascular stent.
“It’s very small at the time of delivery because it’s held within the body of a catheter, but then when deployed it expands to contact the wall of the vein.”
The device transmits brain signals from the motor cortex to an electronics unit, located in a subcutaneous pocket that decodes movement signals. The machine-learning decoder is programmed as follows: When a trainer asked participants to attempt certain movements, like tapping their foot or extending their knee, the decoder analyzes nerve cell signals from those movement attempts. The decoder is able to translate movement signals into computer navigation.
The study included four patients with ALS who were paralyzed because of the disease and were trained to use the device.
A key safety endpoint was device-related serious adverse events resulting in death or increased disability during the post-implant evaluation period. Results showed all four participants successfully completed the 12-month follow-up with no serious adverse events.
Researchers also assessed target vessel patency and incidence of device migration at 3 and 12 months. Postoperative imaging showed that in all participants, the blood vessel that held the implanted device remained open and stayed in place.
Addressing the potential for blood clots, Dr. Weber said that so far there has been no sign of clotting or vascular occlusion.
“The device itself integrates well into the walls of the blood vessel over time,” he said. “Within the acute period after implantation, there’s time where the device is exposed to the blood stream, but once it becomes encapsulated and fully integrated into the blood vessel wall, the risks of thrombosis diminish.”
Greater independence
Researchers also recorded signal fidelity and stability over 12 months and use of the brain-computer interface to perform routine tasks. All participants learned to use the motor neuro-prostheses with eye tracking for computer use. Eye tracking technology helps a computer determine what a person is looking at.
Using the system, patients were able to complete tasks without help. These included text messaging and managing finances. “Since the device is fully implanted and easy for patients to use, they can use the technology independently and in their own home,” said Dr. Weber.
Although the study started with patients with ALS, those paralyzed from other causes, such as an upper spinal cord injury or brain-stem stroke could also benefit from this technology, Dr. Weber said. In addition, the technology could be expanded to broaden brain communication capabilities potentially to include robotic limbs, he said.
There’s even the potential to use this minimally invasive brain interface technology to deliver therapies like deep brain stimulation, which Dr. Weber noted is a growing field. “It’s [the] early days, but it’s a very exciting new direction for brain interface technology,” he said.
Researchers are now recruiting patients for the first U.S.-based feasibility trial of the device that will be funded by the NIH, said Dr. Weber. A limitation of the research was the study’s small size.
Advancing the field
Reached for a comment, Kevin C. Davis, an MD and PhD student in the department of biomedical engineering, University of Miami Miller School of Medicine, said this new work moves the field forward in an important way.
Dr. Davis and colleagues have shown the effectiveness of another technology used to overcome paralysis – a small portable system that facilitates hand grasp of a patient with a spinal cord injury. He reported on this DBS-based BCI system at the American Association of Neurological Surgeons (AANS) 2021 Annual Meeting.
Developing effective brain-computer interfaces, and motor neural prosthetics that avoid surgery, as the team did in this new study, is “worth exploring,” said Dr. Davis.
However, although the device used in this new study avoids cranial surgery, “sole vascular access may limit the device’s ability to reach other areas of the brain more suitable for upper-limb motor prosthetics,” he said.
“Determining how much function such a device could provide to individuals with locked-in syndrome or paralysis will be important in determining its viability as an eventual clinical tool for patients.”
The study was supported by Synchron, the maker of the device, the U.S. Defense Advanced Research Projects Agency, the Office of Naval Research, the National Health and Medical Research Council of Australia, the Australian Federal Government Foundation, and the Motor Neuron Disease Research Institute of Australia.
A version of this article first appeared on Medscape.com.
, results of a small, first-in-human study show.
A potential life changer for patients with amyotrophic lateral sclerosis (ALS), the minimally invasive device enables patients to carry out important activities of daily living.
“Our participants are able to use the device to perform tasks like sending email, texting loved ones and caregivers, browsing the web, and doing personal finances such as online banking,” study investigator Douglas J. Weber, PhD, professor of mechanical engineering and neuroscience, Carnegie Mellon University, Pittsburgh, told a press briefing.
The technology allowed one patient to write a book (due out later this year) and another patient to maintain communication despite losing his ability to speak, said the study’s lead investigator, Bruce Campbell, MBBS, PhD, professor of neurology, Royal Melbourne Hospital, University of Melbourne.
“In addition to providing patients with communicative capabilities not possible as a result of their disease, it is our goal to enable patients to be more independently involved in their care going forward, by enabling effective and faster communication directly with their caregiver and physician,” said Dr. Campbell.
The findings were presented at the 2022 annual meeting of the American Academy of Neurology.
Minimally invasive
ALS, also known as Lou Gehrig’s disease, is a progressive neurodegenerative disease that affects nerve cells in the brain and spinal cord. Patients with ALS eventually lose the ability to control muscle movement, often leading to total paralysis.
“Extending the period in which patients are able to communicate with loved ones and caregivers could provide a very meaningful benefit to patients with ALS,” said Dr. Weber.
Brain-computer interfaces measure and translate brain signals, with some functioning as motor neuro-prostheses. These devices provide direct communication between the brain and an external device by recording and decoding signals from the precentral gyrus as the result of movement intention.
“The technology has potential to empower the more than five million people in the U.S. who are severely paralyzed to once again perform important activities of daily living independently,” said Dr. Weber.
Until now, motor neuro-prostheses required surgery to remove a portion of the skull and place electrodes on to the brain. However, the new minimally invasive motor neuro-prostheses reach the brain by vascular access, dispensing with the need for a craniotomy.
“The brain-computer interface device used in our study is unique in that it does not require invasive open surgery to implant,” said Dr. Weber. “Instead this is an endovascular brain-computer interface.”
Using a catheter, surgeons feed the BCI through one of two jugular veins in the neck. They position an array of 16 sensors or electrodes on a stent-like scaffold that deploys against the walls of the superior sagittal sinus.
No adverse events
Describing the device, Dr. Weber said the electrodes or sensing elements are tiny and the body of the stent, which serves as a scaffold to support the electrodes, resembles a standard endovascular stent.
“It’s very small at the time of delivery because it’s held within the body of a catheter, but then when deployed it expands to contact the wall of the vein.”
The device transmits brain signals from the motor cortex to an electronics unit, located in a subcutaneous pocket that decodes movement signals. The machine-learning decoder is programmed as follows: When a trainer asked participants to attempt certain movements, like tapping their foot or extending their knee, the decoder analyzes nerve cell signals from those movement attempts. The decoder is able to translate movement signals into computer navigation.
The study included four patients with ALS who were paralyzed because of the disease and were trained to use the device.
A key safety endpoint was device-related serious adverse events resulting in death or increased disability during the post-implant evaluation period. Results showed all four participants successfully completed the 12-month follow-up with no serious adverse events.
Researchers also assessed target vessel patency and incidence of device migration at 3 and 12 months. Postoperative imaging showed that in all participants, the blood vessel that held the implanted device remained open and stayed in place.
Addressing the potential for blood clots, Dr. Weber said that so far there has been no sign of clotting or vascular occlusion.
“The device itself integrates well into the walls of the blood vessel over time,” he said. “Within the acute period after implantation, there’s time where the device is exposed to the blood stream, but once it becomes encapsulated and fully integrated into the blood vessel wall, the risks of thrombosis diminish.”
Greater independence
Researchers also recorded signal fidelity and stability over 12 months and use of the brain-computer interface to perform routine tasks. All participants learned to use the motor neuro-prostheses with eye tracking for computer use. Eye tracking technology helps a computer determine what a person is looking at.
Using the system, patients were able to complete tasks without help. These included text messaging and managing finances. “Since the device is fully implanted and easy for patients to use, they can use the technology independently and in their own home,” said Dr. Weber.
Although the study started with patients with ALS, those paralyzed from other causes, such as an upper spinal cord injury or brain-stem stroke could also benefit from this technology, Dr. Weber said. In addition, the technology could be expanded to broaden brain communication capabilities potentially to include robotic limbs, he said.
There’s even the potential to use this minimally invasive brain interface technology to deliver therapies like deep brain stimulation, which Dr. Weber noted is a growing field. “It’s [the] early days, but it’s a very exciting new direction for brain interface technology,” he said.
Researchers are now recruiting patients for the first U.S.-based feasibility trial of the device that will be funded by the NIH, said Dr. Weber. A limitation of the research was the study’s small size.
Advancing the field
Reached for a comment, Kevin C. Davis, an MD and PhD student in the department of biomedical engineering, University of Miami Miller School of Medicine, said this new work moves the field forward in an important way.
Dr. Davis and colleagues have shown the effectiveness of another technology used to overcome paralysis – a small portable system that facilitates hand grasp of a patient with a spinal cord injury. He reported on this DBS-based BCI system at the American Association of Neurological Surgeons (AANS) 2021 Annual Meeting.
Developing effective brain-computer interfaces, and motor neural prosthetics that avoid surgery, as the team did in this new study, is “worth exploring,” said Dr. Davis.
However, although the device used in this new study avoids cranial surgery, “sole vascular access may limit the device’s ability to reach other areas of the brain more suitable for upper-limb motor prosthetics,” he said.
“Determining how much function such a device could provide to individuals with locked-in syndrome or paralysis will be important in determining its viability as an eventual clinical tool for patients.”
The study was supported by Synchron, the maker of the device, the U.S. Defense Advanced Research Projects Agency, the Office of Naval Research, the National Health and Medical Research Council of Australia, the Australian Federal Government Foundation, and the Motor Neuron Disease Research Institute of Australia.
A version of this article first appeared on Medscape.com.
FROM AAN 2022
Performance anxiety highly common among surgeons
a new study of surgeons in the United Kingdom shows.
“Performance anxiety or stage fright is a widely recognized problem in music and sports, and there are many similarities between these arenas and the operating theater,” first author Robert Miller, MRCS, of the Surgical Psychology and Performance Group and the department of plastic and reconstructive surgery at St. George’s Hospital NHS Trust, London, said in an interview. “We were aware of it anecdotally in a surgical context, but for one reason or another, perhaps professional pride and fear of negative perception, this is rarely openly discussed amongst surgeons.”
In the cross-sectional study, published in Annals of Surgery, Dr. Miller and colleagues surveyed surgeons in all specialties working in the United Kingdom who had at least 1 year of postgraduate surgical training.
Of a total of 631 responses received, 523 (83%) were included in the analysis. The median age of those who responded was 41.2 years, and the mean duration of surgical experience was 15.3 years (range, 1-52 years). Among them, 62% were men, and 52% were of consultant/attending grade.
All of the respondents – 100% – said they believed that performance anxiety affected surgeons, 87% reported having experienced it themselves, and 65% said they felt that performance anxiety had an effect on their surgical performance.
Both male and female surgeons who reported experiencing performance anxiety had significantly worse mental well-being, as assessed using the Short Warwick Edinburgh Mental Wellbeing Scale, compared with those who did not have performance anxiety (P < .0001 for men and P < .001 for women).
Overall, however, male surgeons had significantly better mental well-being, compared with female surgeons (P = .003), yet both genders had significantly lower mental well-being scores compared with U.K. population norms (P = .0019 for men and P = .0001 for women).
The gender differences are “clearly an important topic, which is likely multifactorial,” Dr. Miller told this news organization. “The gender well-being gap requires more in-depth research, and qualitative work involving female surgeons is critical.”
Surgical perfectionism was significantly more common among respondents who did have performance anxiety in comparison with those who did not (P < .0001).
“Although perfectionism may be a beneficial trait in surgery, our findings from hierarchical multiple regression analysis also indicate that perfectionism, [as well as] sex and experience, may drive surgical performance anxiety and help predict those experiencing [the anxiety],” the authors noted.
Performing in presence of colleagues a key trigger
By far, the leading trigger that was identified as prompting surgeon performance anxiety was the presence – and scrutiny – of colleagues within the parent specialty. This was reported by 151 respondents. Other triggers were having to perform on highly complex or high-risk cases (66 responses) and a lack of experience (30 responses).
Next to planning and preparation, opening up and talking about the anxiety and shedding light on the issue was seen as a leading strategy to help with the problem, but very few respondents reported openly sharing their struggles. Only 9% reported that they had shared it openly; 27% said they had confided in someone, and 47% did not respond to the question.
“I wish we talked about it more and shared our insecurities,” one respondent lamented. “Most of my colleagues pretend they are living gods.”
Only about 45% of respondents reported a specific technique for overcoming their anxiety. In addition to being open about the problem, other techniques included self-care, such as exercise; and distraction outside of work to get perspective; relaxation techniques such as deep or controlled breathing; music; mindfulness; and positive self-statements.
About 9% said they had received psychological counseling for performance anxiety, and only 3% reported using medication for the problem.
Anxiety a positive factor?
Surprisingly, 70% of respondents reported feeling that surgical performance anxiety could have a positive impact on surgical performance, which the authors noted is consistent with some theories.
“This may be explained by the traditional bell-curve relationship between arousal and performance, which describes a dose-dependent relationship between performance and arousal until a ‘tipping point,’ after which performance declines,” the authors explained. “A heightened awareness secondary to anxiety may be beneficial, but at high doses, anxiety can negatively affect attentional control and cause somatic symptoms.”
They noted that “the challenge would be to reap the benefits of low-level stimulation without incurring possible adverse effects.”
Dr. Miller said that, in determining whether selection bias had a role in the results, a detailed analysis showed that “our respondents were not skewed to those with only high levels of trait anxiety.
“We also had a good spread of consultants versus trainees [about half and half], and different specialties, so we feel this is likely to be a representative sample,” he told this news organization.
That being said, the results underscore the need for increased awareness – and open discussion – of the issue of surgical performance anxiety.
“Within other professions, particularly the performing arts and sports, performance psychology is becoming an integral part of training and development,” Dr. Miller said. “We feel surgeons should be supported in a similar manner.
“Surgical performance anxiety is normal for surgeons at all levels and not something to be ashamed about,” Dr. Miller added. “Talk about it, acknowledge it, and be supportive to your colleagues.”
Many keep it to themselves in ‘prevailing culture of stoicism’
Commenting on the study, Carter C. Lebares, MD, an associate professor of surgery and director of the Center for Mindfulness in Surgery, department of surgery, University of California, San Francisco, said she was not surprised to see the high rates of performance anxiety among surgeons.
“As surgeons, no matter how hard we train or how thoroughly we prepare our intellectual understanding or the patient, the disease process, and the operation, there may be surprises, unforeseen challenges, or off days,” Dr. Lebares said.
“And whatever we encounter, we are managing these things directly under the scrutiny of others – people who can affect our reputation, operating privileges, and mental health. So, I am not surprised this is a prevalent and widely recognized issue.”
Dr. Lebares noted that the reluctance to share the anxiety is part of a “challenging and recognized conundrum in both medicine and surgery and is a matter of the prevailing culture of stoicism.
“We often are called to shoulder tremendous weight intraoperatively (having perseverance, self-confidence, or sustained focus), and in owning the weight of complications (which eventually we all will have),” she said.
“So, we do need to be strong and not complain, [but] we also need to be able to set that aside [when appropriate] and ask for help or allow others to shoulder the weight for a while, and this is not [yet] a common part of surgical culture.”
Dr. Lebares added that randomized, controlled trials have shown benefits of mindfulness interventions on burnout and anxiety.
“We have observed positive effects on mental noise, self-perception, conflict resolution, and resilience in surgical residents trained in mindfulness-based cognitive skills,” she said. “[Residents] report applying these skills in the OR, in their home lives, and in how they approach their training/education.”
The authors disclosed no relevant financial relationships. Dr. Lebares has developed mindfulness-based cognitive skills training for surgeons but receives no financial compensation for the activities.
A version of this article first appeared on Medscape.com.
a new study of surgeons in the United Kingdom shows.
“Performance anxiety or stage fright is a widely recognized problem in music and sports, and there are many similarities between these arenas and the operating theater,” first author Robert Miller, MRCS, of the Surgical Psychology and Performance Group and the department of plastic and reconstructive surgery at St. George’s Hospital NHS Trust, London, said in an interview. “We were aware of it anecdotally in a surgical context, but for one reason or another, perhaps professional pride and fear of negative perception, this is rarely openly discussed amongst surgeons.”
In the cross-sectional study, published in Annals of Surgery, Dr. Miller and colleagues surveyed surgeons in all specialties working in the United Kingdom who had at least 1 year of postgraduate surgical training.
Of a total of 631 responses received, 523 (83%) were included in the analysis. The median age of those who responded was 41.2 years, and the mean duration of surgical experience was 15.3 years (range, 1-52 years). Among them, 62% were men, and 52% were of consultant/attending grade.
All of the respondents – 100% – said they believed that performance anxiety affected surgeons, 87% reported having experienced it themselves, and 65% said they felt that performance anxiety had an effect on their surgical performance.
Both male and female surgeons who reported experiencing performance anxiety had significantly worse mental well-being, as assessed using the Short Warwick Edinburgh Mental Wellbeing Scale, compared with those who did not have performance anxiety (P < .0001 for men and P < .001 for women).
Overall, however, male surgeons had significantly better mental well-being, compared with female surgeons (P = .003), yet both genders had significantly lower mental well-being scores compared with U.K. population norms (P = .0019 for men and P = .0001 for women).
The gender differences are “clearly an important topic, which is likely multifactorial,” Dr. Miller told this news organization. “The gender well-being gap requires more in-depth research, and qualitative work involving female surgeons is critical.”
Surgical perfectionism was significantly more common among respondents who did have performance anxiety in comparison with those who did not (P < .0001).
“Although perfectionism may be a beneficial trait in surgery, our findings from hierarchical multiple regression analysis also indicate that perfectionism, [as well as] sex and experience, may drive surgical performance anxiety and help predict those experiencing [the anxiety],” the authors noted.
Performing in presence of colleagues a key trigger
By far, the leading trigger that was identified as prompting surgeon performance anxiety was the presence – and scrutiny – of colleagues within the parent specialty. This was reported by 151 respondents. Other triggers were having to perform on highly complex or high-risk cases (66 responses) and a lack of experience (30 responses).
Next to planning and preparation, opening up and talking about the anxiety and shedding light on the issue was seen as a leading strategy to help with the problem, but very few respondents reported openly sharing their struggles. Only 9% reported that they had shared it openly; 27% said they had confided in someone, and 47% did not respond to the question.
“I wish we talked about it more and shared our insecurities,” one respondent lamented. “Most of my colleagues pretend they are living gods.”
Only about 45% of respondents reported a specific technique for overcoming their anxiety. In addition to being open about the problem, other techniques included self-care, such as exercise; and distraction outside of work to get perspective; relaxation techniques such as deep or controlled breathing; music; mindfulness; and positive self-statements.
About 9% said they had received psychological counseling for performance anxiety, and only 3% reported using medication for the problem.
Anxiety a positive factor?
Surprisingly, 70% of respondents reported feeling that surgical performance anxiety could have a positive impact on surgical performance, which the authors noted is consistent with some theories.
“This may be explained by the traditional bell-curve relationship between arousal and performance, which describes a dose-dependent relationship between performance and arousal until a ‘tipping point,’ after which performance declines,” the authors explained. “A heightened awareness secondary to anxiety may be beneficial, but at high doses, anxiety can negatively affect attentional control and cause somatic symptoms.”
They noted that “the challenge would be to reap the benefits of low-level stimulation without incurring possible adverse effects.”
Dr. Miller said that, in determining whether selection bias had a role in the results, a detailed analysis showed that “our respondents were not skewed to those with only high levels of trait anxiety.
“We also had a good spread of consultants versus trainees [about half and half], and different specialties, so we feel this is likely to be a representative sample,” he told this news organization.
That being said, the results underscore the need for increased awareness – and open discussion – of the issue of surgical performance anxiety.
“Within other professions, particularly the performing arts and sports, performance psychology is becoming an integral part of training and development,” Dr. Miller said. “We feel surgeons should be supported in a similar manner.
“Surgical performance anxiety is normal for surgeons at all levels and not something to be ashamed about,” Dr. Miller added. “Talk about it, acknowledge it, and be supportive to your colleagues.”
Many keep it to themselves in ‘prevailing culture of stoicism’
Commenting on the study, Carter C. Lebares, MD, an associate professor of surgery and director of the Center for Mindfulness in Surgery, department of surgery, University of California, San Francisco, said she was not surprised to see the high rates of performance anxiety among surgeons.
“As surgeons, no matter how hard we train or how thoroughly we prepare our intellectual understanding or the patient, the disease process, and the operation, there may be surprises, unforeseen challenges, or off days,” Dr. Lebares said.
“And whatever we encounter, we are managing these things directly under the scrutiny of others – people who can affect our reputation, operating privileges, and mental health. So, I am not surprised this is a prevalent and widely recognized issue.”
Dr. Lebares noted that the reluctance to share the anxiety is part of a “challenging and recognized conundrum in both medicine and surgery and is a matter of the prevailing culture of stoicism.
“We often are called to shoulder tremendous weight intraoperatively (having perseverance, self-confidence, or sustained focus), and in owning the weight of complications (which eventually we all will have),” she said.
“So, we do need to be strong and not complain, [but] we also need to be able to set that aside [when appropriate] and ask for help or allow others to shoulder the weight for a while, and this is not [yet] a common part of surgical culture.”
Dr. Lebares added that randomized, controlled trials have shown benefits of mindfulness interventions on burnout and anxiety.
“We have observed positive effects on mental noise, self-perception, conflict resolution, and resilience in surgical residents trained in mindfulness-based cognitive skills,” she said. “[Residents] report applying these skills in the OR, in their home lives, and in how they approach their training/education.”
The authors disclosed no relevant financial relationships. Dr. Lebares has developed mindfulness-based cognitive skills training for surgeons but receives no financial compensation for the activities.
A version of this article first appeared on Medscape.com.
a new study of surgeons in the United Kingdom shows.
“Performance anxiety or stage fright is a widely recognized problem in music and sports, and there are many similarities between these arenas and the operating theater,” first author Robert Miller, MRCS, of the Surgical Psychology and Performance Group and the department of plastic and reconstructive surgery at St. George’s Hospital NHS Trust, London, said in an interview. “We were aware of it anecdotally in a surgical context, but for one reason or another, perhaps professional pride and fear of negative perception, this is rarely openly discussed amongst surgeons.”
In the cross-sectional study, published in Annals of Surgery, Dr. Miller and colleagues surveyed surgeons in all specialties working in the United Kingdom who had at least 1 year of postgraduate surgical training.
Of a total of 631 responses received, 523 (83%) were included in the analysis. The median age of those who responded was 41.2 years, and the mean duration of surgical experience was 15.3 years (range, 1-52 years). Among them, 62% were men, and 52% were of consultant/attending grade.
All of the respondents – 100% – said they believed that performance anxiety affected surgeons, 87% reported having experienced it themselves, and 65% said they felt that performance anxiety had an effect on their surgical performance.
Both male and female surgeons who reported experiencing performance anxiety had significantly worse mental well-being, as assessed using the Short Warwick Edinburgh Mental Wellbeing Scale, compared with those who did not have performance anxiety (P < .0001 for men and P < .001 for women).
Overall, however, male surgeons had significantly better mental well-being, compared with female surgeons (P = .003), yet both genders had significantly lower mental well-being scores compared with U.K. population norms (P = .0019 for men and P = .0001 for women).
The gender differences are “clearly an important topic, which is likely multifactorial,” Dr. Miller told this news organization. “The gender well-being gap requires more in-depth research, and qualitative work involving female surgeons is critical.”
Surgical perfectionism was significantly more common among respondents who did have performance anxiety in comparison with those who did not (P < .0001).
“Although perfectionism may be a beneficial trait in surgery, our findings from hierarchical multiple regression analysis also indicate that perfectionism, [as well as] sex and experience, may drive surgical performance anxiety and help predict those experiencing [the anxiety],” the authors noted.
Performing in presence of colleagues a key trigger
By far, the leading trigger that was identified as prompting surgeon performance anxiety was the presence – and scrutiny – of colleagues within the parent specialty. This was reported by 151 respondents. Other triggers were having to perform on highly complex or high-risk cases (66 responses) and a lack of experience (30 responses).
Next to planning and preparation, opening up and talking about the anxiety and shedding light on the issue was seen as a leading strategy to help with the problem, but very few respondents reported openly sharing their struggles. Only 9% reported that they had shared it openly; 27% said they had confided in someone, and 47% did not respond to the question.
“I wish we talked about it more and shared our insecurities,” one respondent lamented. “Most of my colleagues pretend they are living gods.”
Only about 45% of respondents reported a specific technique for overcoming their anxiety. In addition to being open about the problem, other techniques included self-care, such as exercise; and distraction outside of work to get perspective; relaxation techniques such as deep or controlled breathing; music; mindfulness; and positive self-statements.
About 9% said they had received psychological counseling for performance anxiety, and only 3% reported using medication for the problem.
Anxiety a positive factor?
Surprisingly, 70% of respondents reported feeling that surgical performance anxiety could have a positive impact on surgical performance, which the authors noted is consistent with some theories.
“This may be explained by the traditional bell-curve relationship between arousal and performance, which describes a dose-dependent relationship between performance and arousal until a ‘tipping point,’ after which performance declines,” the authors explained. “A heightened awareness secondary to anxiety may be beneficial, but at high doses, anxiety can negatively affect attentional control and cause somatic symptoms.”
They noted that “the challenge would be to reap the benefits of low-level stimulation without incurring possible adverse effects.”
Dr. Miller said that, in determining whether selection bias had a role in the results, a detailed analysis showed that “our respondents were not skewed to those with only high levels of trait anxiety.
“We also had a good spread of consultants versus trainees [about half and half], and different specialties, so we feel this is likely to be a representative sample,” he told this news organization.
That being said, the results underscore the need for increased awareness – and open discussion – of the issue of surgical performance anxiety.
“Within other professions, particularly the performing arts and sports, performance psychology is becoming an integral part of training and development,” Dr. Miller said. “We feel surgeons should be supported in a similar manner.
“Surgical performance anxiety is normal for surgeons at all levels and not something to be ashamed about,” Dr. Miller added. “Talk about it, acknowledge it, and be supportive to your colleagues.”
Many keep it to themselves in ‘prevailing culture of stoicism’
Commenting on the study, Carter C. Lebares, MD, an associate professor of surgery and director of the Center for Mindfulness in Surgery, department of surgery, University of California, San Francisco, said she was not surprised to see the high rates of performance anxiety among surgeons.
“As surgeons, no matter how hard we train or how thoroughly we prepare our intellectual understanding or the patient, the disease process, and the operation, there may be surprises, unforeseen challenges, or off days,” Dr. Lebares said.
“And whatever we encounter, we are managing these things directly under the scrutiny of others – people who can affect our reputation, operating privileges, and mental health. So, I am not surprised this is a prevalent and widely recognized issue.”
Dr. Lebares noted that the reluctance to share the anxiety is part of a “challenging and recognized conundrum in both medicine and surgery and is a matter of the prevailing culture of stoicism.
“We often are called to shoulder tremendous weight intraoperatively (having perseverance, self-confidence, or sustained focus), and in owning the weight of complications (which eventually we all will have),” she said.
“So, we do need to be strong and not complain, [but] we also need to be able to set that aside [when appropriate] and ask for help or allow others to shoulder the weight for a while, and this is not [yet] a common part of surgical culture.”
Dr. Lebares added that randomized, controlled trials have shown benefits of mindfulness interventions on burnout and anxiety.
“We have observed positive effects on mental noise, self-perception, conflict resolution, and resilience in surgical residents trained in mindfulness-based cognitive skills,” she said. “[Residents] report applying these skills in the OR, in their home lives, and in how they approach their training/education.”
The authors disclosed no relevant financial relationships. Dr. Lebares has developed mindfulness-based cognitive skills training for surgeons but receives no financial compensation for the activities.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF SURGERY