MDedge Cardiology

Maintaining a slightly elevated CO₂ level (hypercapnia) for the first 24 hours in comatose patients who had been resuscitated after out-of-hospital cardiac arrest did not improve outcomes in a large randomized controlled trial.

The Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest (TAME) study showed that the intervention failed to improve neurologic or functional outcomes or quality of life at 6 months. However, the researchers also found that slightly elevated CO₂ levels were not associated with worse outcomes.

“I think these results show that our hypothesis – that raising CO₂ levels as applied in this trial may be beneficial for these patients – was not effective, even though previous work suggested that it would be,” co–lead investigator Alistair Nichol, MD, said in an interview.

“This was a rigorous trial; the intervention was well delivered, and the results are pretty clear. Unfortunately, we have proved a null hypothesis – that this approach doesn’t seem to work,” Dr. Nichol, who is professor of critical care medicine at University College Dublin, said.

“However, we did find that hypercapnia was safe. This is an important finding, as sometimes in very sick patients such as those who develop pneumonia, we have to drive the ventilator less hard to minimize injury to the lungs, and this can lead to higher CO₂ levels,” he added. “Our results show that this practice should not be harmful, which is reassuring.”

The TAME study was presented at the Critical Care Reviews 2023 Meeting (CCR23) held in Belfast, Northern Ireland.

It was simultaneously published online in the New England Journal of Medicine.

The researchers explain that after the return of spontaneous circulation, brain hypoperfusion may contribute to cerebral hypoxia, exacerbate brain damage, and lead to poor neurologic outcomes. The partial pressure of arterial carbon dioxide (PaCO₂) is the major physiologic regulator of cerebrovascular tone, and increasing CO₂ levels increases cerebral blood flow.

Two previous observational studies showed that exposure to hypercapnia was associated with an increase in the likelihood of being discharged home and better neurologic outcomes at 12 months, compared with hypocapnia or normocapnia.

In addition, a physiologic study showed that deliberate increases in PaCO₂ induced higher cerebral oxygen saturations, compared with normocapnia. A phase 2 randomized trial showed that hypercapnia significantly attenuated the release of neuron-specific enolase, a biomarker of brain injury, and also suggested better 6-month neurologic recovery with hypercapnia compared with normocapnia.

The current TAME trial was conducted to try to confirm these results in a larger, more definitive study.

For the trial, 1,700 adults with coma who had been resuscitated after out-of-hospital cardiac arrest were randomly assigned to receive either 24 hours of mild hypercapnia (target PaCO₂, 50-55 mm Hg) or normocapnia (target PaCO₂, 35-45 mm Hg).

The primary outcome – a favorable neurologic outcome, defined as a score of 5 or higher on the Glasgow Outcome Scale–Extended at 6 months – occurred in 43.5% in the mild hypercapnia group and in 44.6% in the normocapnia group (relative risk, 0.98; P = .76).

By 6 months, 48.2% of those in the mild hypercapnia group and 45.9% in the normocapnia group had died (relative risk with mild hypercapnia, 1.05; 95% confidence interval, 0.94-1.16). In the mild hypercapnia group, 53.4% had a poor functional outcome, defined as a Modified Rankin Scale score of 4-6, compared with 51.3% in the normocapnia group.

Health-related quality of life, as assessed by the EQ Visual Analogue Scale component of the EuroQol-5D-5L, was similar in the two groups.

In terms of safety, results showed that mild hypercapnia did not increase the incidence of prespecified adverse events.

The authors note that there is concern that mild hypercapnia may worsen cerebral edema and elevate intracranial pressure; however, elevated intracranial pressure is uncommon in the first 72 hours after the return of spontaneous circulation.

In the TAME trial, there was one case of cerebral edema in the hypercapnia group. “This is a very low rate and would be expected in a group this size, so this does not indicate a safety concern,” Dr. Nichol commented.

The researchers are planning further analyses of biological samples to look for possible prognostic markers.

“These out-of-hospital cardiac arrest patients are a very diverse group, and it may be possible that some patients could have benefited from hypercapnia while others may have been harmed,” Dr. Nichol noted.

“Raising CO₂ levels does improve overall delivery of oxygen to the brain, but this might not have occurred in the right areas. It may be possible that some patients benefited, and analysis of biological samples will help us look more closely at this.”

He added that other ongoing trials are investigating hypercapnia in patients with traumatic brain injury.

“These patients are managed differently and often have probes in their brain to measure the response to CO₂, so more of a precision medicine approach is possible,” he explained.

He also noted that the TAME study, which was conducted in conjunction with the TTM-2 study investigating hypothermia in out-of-hospital cardiac arrest patients, has established a network of ICU teams around the world, providing an infrastructure for further trials to be performed in this patient population in the future.

The TAME trial was funded by the National Health and Medical Research Council of Australia, the Health Research Board of Ireland, and the Health Research Council of New Zealand.

A version of this article originally appeared on Medscape.com.

Maintaining a slightly elevated CO₂ level (hypercapnia) for the first 24 hours in comatose patients who had been resuscitated after out-of-hospital cardiac arrest did not improve outcomes in a large randomized controlled trial.

The Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest (TAME) study showed that the intervention failed to improve neurologic or functional outcomes or quality of life at 6 months. However, the researchers also found that slightly elevated CO₂ levels were not associated with worse outcomes.

“I think these results show that our hypothesis – that raising CO₂ levels as applied in this trial may be beneficial for these patients – was not effective, even though previous work suggested that it would be,” co–lead investigator Alistair Nichol, MD, said in an interview.

“This was a rigorous trial; the intervention was well delivered, and the results are pretty clear. Unfortunately, we have proved a null hypothesis – that this approach doesn’t seem to work,” Dr. Nichol, who is professor of critical care medicine at University College Dublin, said.

“However, we did find that hypercapnia was safe. This is an important finding, as sometimes in very sick patients such as those who develop pneumonia, we have to drive the ventilator less hard to minimize injury to the lungs, and this can lead to higher CO₂ levels,” he added. “Our results show that this practice should not be harmful, which is reassuring.”

The TAME study was presented at the Critical Care Reviews 2023 Meeting (CCR23) held in Belfast, Northern Ireland.

It was simultaneously published online in the New England Journal of Medicine.

The researchers explain that after the return of spontaneous circulation, brain hypoperfusion may contribute to cerebral hypoxia, exacerbate brain damage, and lead to poor neurologic outcomes. The partial pressure of arterial carbon dioxide (PaCO₂) is the major physiologic regulator of cerebrovascular tone, and increasing CO₂ levels increases cerebral blood flow.

Two previous observational studies showed that exposure to hypercapnia was associated with an increase in the likelihood of being discharged home and better neurologic outcomes at 12 months, compared with hypocapnia or normocapnia.

In addition, a physiologic study showed that deliberate increases in PaCO₂ induced higher cerebral oxygen saturations, compared with normocapnia. A phase 2 randomized trial showed that hypercapnia significantly attenuated the release of neuron-specific enolase, a biomarker of brain injury, and also suggested better 6-month neurologic recovery with hypercapnia compared with normocapnia.

The current TAME trial was conducted to try to confirm these results in a larger, more definitive study.

For the trial, 1,700 adults with coma who had been resuscitated after out-of-hospital cardiac arrest were randomly assigned to receive either 24 hours of mild hypercapnia (target PaCO₂, 50-55 mm Hg) or normocapnia (target PaCO₂, 35-45 mm Hg).

The primary outcome – a favorable neurologic outcome, defined as a score of 5 or higher on the Glasgow Outcome Scale–Extended at 6 months – occurred in 43.5% in the mild hypercapnia group and in 44.6% in the normocapnia group (relative risk, 0.98; P = .76).

By 6 months, 48.2% of those in the mild hypercapnia group and 45.9% in the normocapnia group had died (relative risk with mild hypercapnia, 1.05; 95% confidence interval, 0.94-1.16). In the mild hypercapnia group, 53.4% had a poor functional outcome, defined as a Modified Rankin Scale score of 4-6, compared with 51.3% in the normocapnia group.

Health-related quality of life, as assessed by the EQ Visual Analogue Scale component of the EuroQol-5D-5L, was similar in the two groups.

In terms of safety, results showed that mild hypercapnia did not increase the incidence of prespecified adverse events.

The authors note that there is concern that mild hypercapnia may worsen cerebral edema and elevate intracranial pressure; however, elevated intracranial pressure is uncommon in the first 72 hours after the return of spontaneous circulation.

In the TAME trial, there was one case of cerebral edema in the hypercapnia group. “This is a very low rate and would be expected in a group this size, so this does not indicate a safety concern,” Dr. Nichol commented.

The researchers are planning further analyses of biological samples to look for possible prognostic markers.

“These out-of-hospital cardiac arrest patients are a very diverse group, and it may be possible that some patients could have benefited from hypercapnia while others may have been harmed,” Dr. Nichol noted.

“Raising CO₂ levels does improve overall delivery of oxygen to the brain, but this might not have occurred in the right areas. It may be possible that some patients benefited, and analysis of biological samples will help us look more closely at this.”

He added that other ongoing trials are investigating hypercapnia in patients with traumatic brain injury.

“These patients are managed differently and often have probes in their brain to measure the response to CO₂, so more of a precision medicine approach is possible,” he explained.

He also noted that the TAME study, which was conducted in conjunction with the TTM-2 study investigating hypothermia in out-of-hospital cardiac arrest patients, has established a network of ICU teams around the world, providing an infrastructure for further trials to be performed in this patient population in the future.

The TAME trial was funded by the National Health and Medical Research Council of Australia, the Health Research Board of Ireland, and the Health Research Council of New Zealand.

A version of this article originally appeared on Medscape.com.

Maintaining a slightly elevated CO₂ level (hypercapnia) for the first 24 hours in comatose patients who had been resuscitated after out-of-hospital cardiac arrest did not improve outcomes in a large randomized controlled trial.

The Targeted Therapeutic Mild Hypercapnia After Resuscitated Cardiac Arrest (TAME) study showed that the intervention failed to improve neurologic or functional outcomes or quality of life at 6 months. However, the researchers also found that slightly elevated CO₂ levels were not associated with worse outcomes.

“I think these results show that our hypothesis – that raising CO₂ levels as applied in this trial may be beneficial for these patients – was not effective, even though previous work suggested that it would be,” co–lead investigator Alistair Nichol, MD, said in an interview.

“This was a rigorous trial; the intervention was well delivered, and the results are pretty clear. Unfortunately, we have proved a null hypothesis – that this approach doesn’t seem to work,” Dr. Nichol, who is professor of critical care medicine at University College Dublin, said.

“However, we did find that hypercapnia was safe. This is an important finding, as sometimes in very sick patients such as those who develop pneumonia, we have to drive the ventilator less hard to minimize injury to the lungs, and this can lead to higher CO₂ levels,” he added. “Our results show that this practice should not be harmful, which is reassuring.”

The TAME study was presented at the Critical Care Reviews 2023 Meeting (CCR23) held in Belfast, Northern Ireland.

It was simultaneously published online in the New England Journal of Medicine.

The researchers explain that after the return of spontaneous circulation, brain hypoperfusion may contribute to cerebral hypoxia, exacerbate brain damage, and lead to poor neurologic outcomes. The partial pressure of arterial carbon dioxide (PaCO₂) is the major physiologic regulator of cerebrovascular tone, and increasing CO₂ levels increases cerebral blood flow.

Two previous observational studies showed that exposure to hypercapnia was associated with an increase in the likelihood of being discharged home and better neurologic outcomes at 12 months, compared with hypocapnia or normocapnia.

In addition, a physiologic study showed that deliberate increases in PaCO₂ induced higher cerebral oxygen saturations, compared with normocapnia. A phase 2 randomized trial showed that hypercapnia significantly attenuated the release of neuron-specific enolase, a biomarker of brain injury, and also suggested better 6-month neurologic recovery with hypercapnia compared with normocapnia.

The current TAME trial was conducted to try to confirm these results in a larger, more definitive study.

For the trial, 1,700 adults with coma who had been resuscitated after out-of-hospital cardiac arrest were randomly assigned to receive either 24 hours of mild hypercapnia (target PaCO₂, 50-55 mm Hg) or normocapnia (target PaCO₂, 35-45 mm Hg).

The primary outcome – a favorable neurologic outcome, defined as a score of 5 or higher on the Glasgow Outcome Scale–Extended at 6 months – occurred in 43.5% in the mild hypercapnia group and in 44.6% in the normocapnia group (relative risk, 0.98; P = .76).

By 6 months, 48.2% of those in the mild hypercapnia group and 45.9% in the normocapnia group had died (relative risk with mild hypercapnia, 1.05; 95% confidence interval, 0.94-1.16). In the mild hypercapnia group, 53.4% had a poor functional outcome, defined as a Modified Rankin Scale score of 4-6, compared with 51.3% in the normocapnia group.

Health-related quality of life, as assessed by the EQ Visual Analogue Scale component of the EuroQol-5D-5L, was similar in the two groups.

In terms of safety, results showed that mild hypercapnia did not increase the incidence of prespecified adverse events.

The authors note that there is concern that mild hypercapnia may worsen cerebral edema and elevate intracranial pressure; however, elevated intracranial pressure is uncommon in the first 72 hours after the return of spontaneous circulation.

In the TAME trial, there was one case of cerebral edema in the hypercapnia group. “This is a very low rate and would be expected in a group this size, so this does not indicate a safety concern,” Dr. Nichol commented.

The researchers are planning further analyses of biological samples to look for possible prognostic markers.

“These out-of-hospital cardiac arrest patients are a very diverse group, and it may be possible that some patients could have benefited from hypercapnia while others may have been harmed,” Dr. Nichol noted.

“Raising CO₂ levels does improve overall delivery of oxygen to the brain, but this might not have occurred in the right areas. It may be possible that some patients benefited, and analysis of biological samples will help us look more closely at this.”

He added that other ongoing trials are investigating hypercapnia in patients with traumatic brain injury.

“These patients are managed differently and often have probes in their brain to measure the response to CO₂, so more of a precision medicine approach is possible,” he explained.

He also noted that the TAME study, which was conducted in conjunction with the TTM-2 study investigating hypothermia in out-of-hospital cardiac arrest patients, has established a network of ICU teams around the world, providing an infrastructure for further trials to be performed in this patient population in the future.

The TAME trial was funded by the National Health and Medical Research Council of Australia, the Health Research Board of Ireland, and the Health Research Council of New Zealand.

A version of this article originally appeared on Medscape.com.

Given current driving restrictions after syncope, visits to the emergency department for syncope are not significantly associated with increased risk for a subsequent car crash, data suggest.

In a case-crossover study that examined health and driving data for about 3,000 drivers in British Columbia, researchers found similar rates of ED visits for syncope before the dates of car crashes (1.6%) and before control dates (1.2%).

“An emergency visit for syncope did not appear to increase the risk of subsequent traffic crash,” lead author John A. Staples, MD, MPH, clinical associate professor of general internal medicine at the University of British Columbia, Vancouver, said in an interview.

The findings were published online in the Canadian Journal of Cardiology.
 

Case-crossover study

Syncope prompts more than 1 million visits to EDs in the United States each year. About 9% of patients with syncope have recurrence within 1 year.

Some jurisdictions legally require clinicians to advise patients at higher risk for syncope recurrence to stop driving temporarily. But guidelines about when and whom to restrict are not standardized, said Dr. Staples.

“I came to this topic because I work as a physician in a hospital and, a few years ago, I advised a young woman who suffered a serious injury after she passed out while driving and crashed her car,” he added. “She wanted to know if she could drive again and when. I found out that there wasn’t much evidence that could guide my advice to her. That is what planted the seed that eventually grew into this study.”

The researchers examined driving data from the Insurance Corporation of British Columbia and detailed ED visit data from regional health authorities. They included licensed drivers who were diagnosed with syncope and collapse at an ED between 2010 and 2015 in their study. The researchers focused on eligible participants who were involved in a motor vehicle collision between August 2011 and December 2015.

For each patient, the date of the crash was used to establish three control dates without crashes. The control dates were 26 weeks, 52 weeks, and 78 weeks before the crash. The investigators compared the rate of emergency visit for syncope in the 28 days before the crash with the rate of emergency visit for syncope in the 28 days before each control date.

An emergency visit for syncope occurred in 47 of 3,026 precrash intervals and 112 of 9,078 control intervals. This result indicated that syncope was not significantly associated with subsequent crash (adjusted odds ratio, 1.27; P = .18).

In addition, there was no significant association between syncope and crash in subgroups considered to be at higher risk for adverse outcomes after syncope, such as patients older than 65 years and patients with cardiovascular disease or cardiac syncope.
 

Gaps in data

“It’s a complicated study design but one that’s helpful to understand the temporal relationship between syncope and crash,” said Dr. Staples. “If we had found that the syncope visit was more likely to occur in the 4 weeks before the crash than in earlier matched 4-week control periods, we would have concluded that syncope transiently increases crash risk.”

Dr. Staples emphasized that this was a real-world study and that some patients with syncope at higher risk for a car crash likely stopped driving. “This study doesn’t say there’s no relationship between syncope and subsequent crash, just that our current practices, including current driving restrictions, seem to do an acceptable job of preventing some crashes.”

Limitations of the study influence the interpretation of the results. For example, the data sources did not indicate how patients modified their driving, said Dr. Staples.

Also lacking is information about how physicians identified which patients were at heightened risk for another syncope episode and advised those patients not to drive. “Now would be a good time to start to think about what other studies are needed to better tailor driving restrictions for the right patient,” said Dr. Staples.
 

‘A messy situation’

In a comment, Deepak L. Bhatt, MD, MPH, professor of cardiovascular medicine at Icahn School of Medicine at Mount Sinai, New York, called the conclusions “well thought out.” He said the study addressed a common, often perplexing problem in a practical way. Dr. Bhatt was not involved in the research.

“This study is trying to address the issue of what to do with people who have had syncope or fainting and have had a car crash. In general, we don’t really know what to do with those people, but there’s a lot of concern for many reasons, for both the patient and the public. There are potential legal liabilities, and the whole thing, generally speaking, tends to be a messy situation. Usually, the default position physicians take is to be very cautious and conservative, and restrict driving,” said Dr. Bhatt.

The study is reassuring, he added. “The authors have contextualized this risk very nicely. Physicians worry a lot about patients who have had an episode of syncope while driving and restrict their patients’ driving, at least temporarily. But as a society, we are much more permissive about people who drive drunk or under the influence, or who drive without seat belts, or who speed, or text while driving. So, within that larger context, we are extremely worried about this one source of risk that is probably less than these other sources of risk.”

Most of the time, the cause of the syncope is benign, said Dr. Bhatt. “We rule out the bad things, like a heart attack or cardiac arrest, seizure, and arrhythmia. Afterwards, the risk from driving is relatively small.” The study results support current practices and suggest “that we probably don’t need to be excessive with our restrictions.

“There is going to be a wide variation in practice, with some physicians wanting to be more restrictive, but there is a lot of subjectivity in how these recommendations are acted on in real life. That’s why I think this study really should reassure physicians that it’s okay to use common sense and good medical judgment when giving advice on driving to their patients,” Dr. Bhatt concluded.

The study was supported by the Canadian Institutes of Health Research and the Heart and Stroke Foundation Canada. Dr. Staples and Dr. Bhatt reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Given current driving restrictions after syncope, visits to the emergency department for syncope are not significantly associated with increased risk for a subsequent car crash, data suggest.

In a case-crossover study that examined health and driving data for about 3,000 drivers in British Columbia, researchers found similar rates of ED visits for syncope before the dates of car crashes (1.6%) and before control dates (1.2%).

“An emergency visit for syncope did not appear to increase the risk of subsequent traffic crash,” lead author John A. Staples, MD, MPH, clinical associate professor of general internal medicine at the University of British Columbia, Vancouver, said in an interview.

The findings were published online in the Canadian Journal of Cardiology.
 

Case-crossover study

Syncope prompts more than 1 million visits to EDs in the United States each year. About 9% of patients with syncope have recurrence within 1 year.

Some jurisdictions legally require clinicians to advise patients at higher risk for syncope recurrence to stop driving temporarily. But guidelines about when and whom to restrict are not standardized, said Dr. Staples.

“I came to this topic because I work as a physician in a hospital and, a few years ago, I advised a young woman who suffered a serious injury after she passed out while driving and crashed her car,” he added. “She wanted to know if she could drive again and when. I found out that there wasn’t much evidence that could guide my advice to her. That is what planted the seed that eventually grew into this study.”

The researchers examined driving data from the Insurance Corporation of British Columbia and detailed ED visit data from regional health authorities. They included licensed drivers who were diagnosed with syncope and collapse at an ED between 2010 and 2015 in their study. The researchers focused on eligible participants who were involved in a motor vehicle collision between August 2011 and December 2015.

For each patient, the date of the crash was used to establish three control dates without crashes. The control dates were 26 weeks, 52 weeks, and 78 weeks before the crash. The investigators compared the rate of emergency visit for syncope in the 28 days before the crash with the rate of emergency visit for syncope in the 28 days before each control date.

An emergency visit for syncope occurred in 47 of 3,026 precrash intervals and 112 of 9,078 control intervals. This result indicated that syncope was not significantly associated with subsequent crash (adjusted odds ratio, 1.27; P = .18).

In addition, there was no significant association between syncope and crash in subgroups considered to be at higher risk for adverse outcomes after syncope, such as patients older than 65 years and patients with cardiovascular disease or cardiac syncope.
 

Gaps in data

“It’s a complicated study design but one that’s helpful to understand the temporal relationship between syncope and crash,” said Dr. Staples. “If we had found that the syncope visit was more likely to occur in the 4 weeks before the crash than in earlier matched 4-week control periods, we would have concluded that syncope transiently increases crash risk.”

Dr. Staples emphasized that this was a real-world study and that some patients with syncope at higher risk for a car crash likely stopped driving. “This study doesn’t say there’s no relationship between syncope and subsequent crash, just that our current practices, including current driving restrictions, seem to do an acceptable job of preventing some crashes.”

Limitations of the study influence the interpretation of the results. For example, the data sources did not indicate how patients modified their driving, said Dr. Staples.

Also lacking is information about how physicians identified which patients were at heightened risk for another syncope episode and advised those patients not to drive. “Now would be a good time to start to think about what other studies are needed to better tailor driving restrictions for the right patient,” said Dr. Staples.
 

‘A messy situation’

In a comment, Deepak L. Bhatt, MD, MPH, professor of cardiovascular medicine at Icahn School of Medicine at Mount Sinai, New York, called the conclusions “well thought out.” He said the study addressed a common, often perplexing problem in a practical way. Dr. Bhatt was not involved in the research.

“This study is trying to address the issue of what to do with people who have had syncope or fainting and have had a car crash. In general, we don’t really know what to do with those people, but there’s a lot of concern for many reasons, for both the patient and the public. There are potential legal liabilities, and the whole thing, generally speaking, tends to be a messy situation. Usually, the default position physicians take is to be very cautious and conservative, and restrict driving,” said Dr. Bhatt.

The study is reassuring, he added. “The authors have contextualized this risk very nicely. Physicians worry a lot about patients who have had an episode of syncope while driving and restrict their patients’ driving, at least temporarily. But as a society, we are much more permissive about people who drive drunk or under the influence, or who drive without seat belts, or who speed, or text while driving. So, within that larger context, we are extremely worried about this one source of risk that is probably less than these other sources of risk.”

Most of the time, the cause of the syncope is benign, said Dr. Bhatt. “We rule out the bad things, like a heart attack or cardiac arrest, seizure, and arrhythmia. Afterwards, the risk from driving is relatively small.” The study results support current practices and suggest “that we probably don’t need to be excessive with our restrictions.

“There is going to be a wide variation in practice, with some physicians wanting to be more restrictive, but there is a lot of subjectivity in how these recommendations are acted on in real life. That’s why I think this study really should reassure physicians that it’s okay to use common sense and good medical judgment when giving advice on driving to their patients,” Dr. Bhatt concluded.

The study was supported by the Canadian Institutes of Health Research and the Heart and Stroke Foundation Canada. Dr. Staples and Dr. Bhatt reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Given current driving restrictions after syncope, visits to the emergency department for syncope are not significantly associated with increased risk for a subsequent car crash, data suggest.

In a case-crossover study that examined health and driving data for about 3,000 drivers in British Columbia, researchers found similar rates of ED visits for syncope before the dates of car crashes (1.6%) and before control dates (1.2%).

“An emergency visit for syncope did not appear to increase the risk of subsequent traffic crash,” lead author John A. Staples, MD, MPH, clinical associate professor of general internal medicine at the University of British Columbia, Vancouver, said in an interview.

The findings were published online in the Canadian Journal of Cardiology.
 

Case-crossover study

Syncope prompts more than 1 million visits to EDs in the United States each year. About 9% of patients with syncope have recurrence within 1 year.

Some jurisdictions legally require clinicians to advise patients at higher risk for syncope recurrence to stop driving temporarily. But guidelines about when and whom to restrict are not standardized, said Dr. Staples.

“I came to this topic because I work as a physician in a hospital and, a few years ago, I advised a young woman who suffered a serious injury after she passed out while driving and crashed her car,” he added. “She wanted to know if she could drive again and when. I found out that there wasn’t much evidence that could guide my advice to her. That is what planted the seed that eventually grew into this study.”

The researchers examined driving data from the Insurance Corporation of British Columbia and detailed ED visit data from regional health authorities. They included licensed drivers who were diagnosed with syncope and collapse at an ED between 2010 and 2015 in their study. The researchers focused on eligible participants who were involved in a motor vehicle collision between August 2011 and December 2015.

For each patient, the date of the crash was used to establish three control dates without crashes. The control dates were 26 weeks, 52 weeks, and 78 weeks before the crash. The investigators compared the rate of emergency visit for syncope in the 28 days before the crash with the rate of emergency visit for syncope in the 28 days before each control date.

An emergency visit for syncope occurred in 47 of 3,026 precrash intervals and 112 of 9,078 control intervals. This result indicated that syncope was not significantly associated with subsequent crash (adjusted odds ratio, 1.27; P = .18).

In addition, there was no significant association between syncope and crash in subgroups considered to be at higher risk for adverse outcomes after syncope, such as patients older than 65 years and patients with cardiovascular disease or cardiac syncope.
 

Gaps in data

“It’s a complicated study design but one that’s helpful to understand the temporal relationship between syncope and crash,” said Dr. Staples. “If we had found that the syncope visit was more likely to occur in the 4 weeks before the crash than in earlier matched 4-week control periods, we would have concluded that syncope transiently increases crash risk.”

Dr. Staples emphasized that this was a real-world study and that some patients with syncope at higher risk for a car crash likely stopped driving. “This study doesn’t say there’s no relationship between syncope and subsequent crash, just that our current practices, including current driving restrictions, seem to do an acceptable job of preventing some crashes.”

Limitations of the study influence the interpretation of the results. For example, the data sources did not indicate how patients modified their driving, said Dr. Staples.

Also lacking is information about how physicians identified which patients were at heightened risk for another syncope episode and advised those patients not to drive. “Now would be a good time to start to think about what other studies are needed to better tailor driving restrictions for the right patient,” said Dr. Staples.
 

‘A messy situation’

In a comment, Deepak L. Bhatt, MD, MPH, professor of cardiovascular medicine at Icahn School of Medicine at Mount Sinai, New York, called the conclusions “well thought out.” He said the study addressed a common, often perplexing problem in a practical way. Dr. Bhatt was not involved in the research.

“This study is trying to address the issue of what to do with people who have had syncope or fainting and have had a car crash. In general, we don’t really know what to do with those people, but there’s a lot of concern for many reasons, for both the patient and the public. There are potential legal liabilities, and the whole thing, generally speaking, tends to be a messy situation. Usually, the default position physicians take is to be very cautious and conservative, and restrict driving,” said Dr. Bhatt.

The study is reassuring, he added. “The authors have contextualized this risk very nicely. Physicians worry a lot about patients who have had an episode of syncope while driving and restrict their patients’ driving, at least temporarily. But as a society, we are much more permissive about people who drive drunk or under the influence, or who drive without seat belts, or who speed, or text while driving. So, within that larger context, we are extremely worried about this one source of risk that is probably less than these other sources of risk.”

Most of the time, the cause of the syncope is benign, said Dr. Bhatt. “We rule out the bad things, like a heart attack or cardiac arrest, seizure, and arrhythmia. Afterwards, the risk from driving is relatively small.” The study results support current practices and suggest “that we probably don’t need to be excessive with our restrictions.

“There is going to be a wide variation in practice, with some physicians wanting to be more restrictive, but there is a lot of subjectivity in how these recommendations are acted on in real life. That’s why I think this study really should reassure physicians that it’s okay to use common sense and good medical judgment when giving advice on driving to their patients,” Dr. Bhatt concluded.

The study was supported by the Canadian Institutes of Health Research and the Heart and Stroke Foundation Canada. Dr. Staples and Dr. Bhatt reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

CHICAGO – Twice as many U.S. adults have obesity based on assessment of their fat volume by dual-energy X-ray absorptiometry (DEXA) scan compared with measurement of body mass index (BMI), a finding that highlights the shortcomings of BMI and adds to the growing case that BMI alone should not be the default gauge for obesity.

“BMI vastly underestimates true obesity,” Aayush Visaria, MD, said at the annual meeting of the Endocrine Society.

His findings highlight that “BMI should be supplemented with other measures of obesity” for the management of individual patients, with assessments that could include a bioelectrical impedance scale or waist circumference, said Dr. Visaria, a researcher at Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J.

Dr. Visaria cited a new policy issued by the American Medical Association a couple of days before his presentation, which advises that BMI “be used in conjunction with other valid measures of risk such as, but not limited to, measurements of visceral fat, body adiposity index, body composition, relative fat mass, waist circumference, and genetic/metabolic factors.”

“We’re at the start of the end of BMI,” Dr. Visaria declared during a press briefing at the meeting.

He said DEXA is not practical or cost-effective for obesity screening in routine practice. Therefore, he predicts that waist circumference, often expressed as waist-to-height ratio, will be measured more often, although he acknowledged that waist measurement can be difficult. However, better physician training on the measure should help it become the norm.

Another useful tool for obesity measurement he foresees quickly becoming widespread is bathroom scales that record both weight and body fat percentage using a small electric current to make a bioelectrical impedance measure of adiposity.

Bioimpedance scales will provide more standardized measurements than waist circumference and “revolutionize how we measure obesity,” Dr. Visaria predicted. They are “very accessible and cheap,” he noted, with many models sold for less than $100.
 

Obesity prevalence of 74%

The study by Dr. Visaria and colleagues used data from 9,784 U.S. adults aged 20-59 years (average age, 39 years) collected in several National Health and Nutrition Examination Surveys during 2011-2018. All these participants underwent DEXA assessment of their total body fat as well as a BMI calculation.

Using standard obesity cutoffs for both BMI and total body fat, Dr. Visaria found that DEXA rated 74% of participants as having obesity based on body fat compared with 36% based on BMI.

Among the 64% of the study group who were not obese by BMI, DEXA scans showed 53% of this subgroup did have obesity based on body fat content. Among those with a normal BMI, 43% had obesity by DEXA result.

Further analysis showed that when Dr. Visaria added waist circumference to BMI to enlarge the diagnostic net for obesity it cut the percentage of adults missed as having obesity by BMI alone nearly in half.

Additional analyses showed that the rate of missed diagnoses of obesity by BMI was most common only among people of Hispanic or Asian ethnicity, with both groups showing a 49% rate of obesity by DEXA among those with normal-range BMIs.

The rate of missed obesity diagnoses was highest among all women, with a 59% prevalence of obesity by DEXA among women with a normal-range BMI.

The study received no commercial funding. Dr. Visaria has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

CHICAGO – Twice as many U.S. adults have obesity based on assessment of their fat volume by dual-energy X-ray absorptiometry (DEXA) scan compared with measurement of body mass index (BMI), a finding that highlights the shortcomings of BMI and adds to the growing case that BMI alone should not be the default gauge for obesity.

“BMI vastly underestimates true obesity,” Aayush Visaria, MD, said at the annual meeting of the Endocrine Society.

His findings highlight that “BMI should be supplemented with other measures of obesity” for the management of individual patients, with assessments that could include a bioelectrical impedance scale or waist circumference, said Dr. Visaria, a researcher at Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J.

Dr. Visaria cited a new policy issued by the American Medical Association a couple of days before his presentation, which advises that BMI “be used in conjunction with other valid measures of risk such as, but not limited to, measurements of visceral fat, body adiposity index, body composition, relative fat mass, waist circumference, and genetic/metabolic factors.”

“We’re at the start of the end of BMI,” Dr. Visaria declared during a press briefing at the meeting.

He said DEXA is not practical or cost-effective for obesity screening in routine practice. Therefore, he predicts that waist circumference, often expressed as waist-to-height ratio, will be measured more often, although he acknowledged that waist measurement can be difficult. However, better physician training on the measure should help it become the norm.

Another useful tool for obesity measurement he foresees quickly becoming widespread is bathroom scales that record both weight and body fat percentage using a small electric current to make a bioelectrical impedance measure of adiposity.

Bioimpedance scales will provide more standardized measurements than waist circumference and “revolutionize how we measure obesity,” Dr. Visaria predicted. They are “very accessible and cheap,” he noted, with many models sold for less than $100.
 

Obesity prevalence of 74%

The study by Dr. Visaria and colleagues used data from 9,784 U.S. adults aged 20-59 years (average age, 39 years) collected in several National Health and Nutrition Examination Surveys during 2011-2018. All these participants underwent DEXA assessment of their total body fat as well as a BMI calculation.

Using standard obesity cutoffs for both BMI and total body fat, Dr. Visaria found that DEXA rated 74% of participants as having obesity based on body fat compared with 36% based on BMI.

Among the 64% of the study group who were not obese by BMI, DEXA scans showed 53% of this subgroup did have obesity based on body fat content. Among those with a normal BMI, 43% had obesity by DEXA result.

Further analysis showed that when Dr. Visaria added waist circumference to BMI to enlarge the diagnostic net for obesity it cut the percentage of adults missed as having obesity by BMI alone nearly in half.

Additional analyses showed that the rate of missed diagnoses of obesity by BMI was most common only among people of Hispanic or Asian ethnicity, with both groups showing a 49% rate of obesity by DEXA among those with normal-range BMIs.

The rate of missed obesity diagnoses was highest among all women, with a 59% prevalence of obesity by DEXA among women with a normal-range BMI.

The study received no commercial funding. Dr. Visaria has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

CHICAGO – Twice as many U.S. adults have obesity based on assessment of their fat volume by dual-energy X-ray absorptiometry (DEXA) scan compared with measurement of body mass index (BMI), a finding that highlights the shortcomings of BMI and adds to the growing case that BMI alone should not be the default gauge for obesity.

“BMI vastly underestimates true obesity,” Aayush Visaria, MD, said at the annual meeting of the Endocrine Society.

His findings highlight that “BMI should be supplemented with other measures of obesity” for the management of individual patients, with assessments that could include a bioelectrical impedance scale or waist circumference, said Dr. Visaria, a researcher at Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J.

Dr. Visaria cited a new policy issued by the American Medical Association a couple of days before his presentation, which advises that BMI “be used in conjunction with other valid measures of risk such as, but not limited to, measurements of visceral fat, body adiposity index, body composition, relative fat mass, waist circumference, and genetic/metabolic factors.”

“We’re at the start of the end of BMI,” Dr. Visaria declared during a press briefing at the meeting.

He said DEXA is not practical or cost-effective for obesity screening in routine practice. Therefore, he predicts that waist circumference, often expressed as waist-to-height ratio, will be measured more often, although he acknowledged that waist measurement can be difficult. However, better physician training on the measure should help it become the norm.

Another useful tool for obesity measurement he foresees quickly becoming widespread is bathroom scales that record both weight and body fat percentage using a small electric current to make a bioelectrical impedance measure of adiposity.

Bioimpedance scales will provide more standardized measurements than waist circumference and “revolutionize how we measure obesity,” Dr. Visaria predicted. They are “very accessible and cheap,” he noted, with many models sold for less than $100.
 

Obesity prevalence of 74%

The study by Dr. Visaria and colleagues used data from 9,784 U.S. adults aged 20-59 years (average age, 39 years) collected in several National Health and Nutrition Examination Surveys during 2011-2018. All these participants underwent DEXA assessment of their total body fat as well as a BMI calculation.

Using standard obesity cutoffs for both BMI and total body fat, Dr. Visaria found that DEXA rated 74% of participants as having obesity based on body fat compared with 36% based on BMI.

Among the 64% of the study group who were not obese by BMI, DEXA scans showed 53% of this subgroup did have obesity based on body fat content. Among those with a normal BMI, 43% had obesity by DEXA result.

Further analysis showed that when Dr. Visaria added waist circumference to BMI to enlarge the diagnostic net for obesity it cut the percentage of adults missed as having obesity by BMI alone nearly in half.

Additional analyses showed that the rate of missed diagnoses of obesity by BMI was most common only among people of Hispanic or Asian ethnicity, with both groups showing a 49% rate of obesity by DEXA among those with normal-range BMIs.

The rate of missed obesity diagnoses was highest among all women, with a 59% prevalence of obesity by DEXA among women with a normal-range BMI.

The study received no commercial funding. Dr. Visaria has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

Human Rights Watch, the nonprofit that for decades has called attention to the victims of war, famine, and political repression around the world, is taking aim at U.S. hospitals for pushing millions of American patients into debt.

In a new report, the group calls for stronger government action to protect Americans from aggressive billing and debt collection by nonprofit hospitals, which Human Rights Watch said are systematically undermining patients’ human rights.

“Given the high prevalence of hospital-related medical debt in the U.S., this system is clearly not working,” concludes the report, which draws extensively on an ongoing investigation of medical debt by KFF Health News and NPR.

The report continues: “The U.S. model of subsidizing privately operated hospitals with tax exemptions in the hope that they will increase the accessibility of hospital care for un- and underinsured patients allows for abusive medical billing and debt collection practices and undermines human rights, including the right to health.”

Nationwide, about 100 million people – or 41% of adults – have some form of health care debt, a KFF survey conducted for the KFF Health News–NPR project found. And while patient debt is being driven by a range of medical and dental bills, polls and studies suggest hospitals are a major contributor.

About a third of U.S. adults with health care debt owed money for hospitalization, KFF’s polling found. Close to half of those owed at least $5,000. About a quarter owed $10,000 or more.

The scale of this crisis – which is unparalleled among wealthy nations – compelled Human Rights Watch to release the new report, said researcher Matt McConnell, its author. “Historically, Human Rights Watch has been an organization that has focused on international human rights issues,” he said. “But on medical debt, the U.S. is a real outlier. What you see is a system that privileges a few but creates large barriers to people accessing basic health rights.”

Hospital industry officials defend their work, citing hospitals’ broader work to help the communities they serve. “As a field, hospitals provide more benefit to their communities than any other sector in health care,” Melinda Hatton, general counsel at the American Hospital Association, wrote in a response to the Human Right Watch report.

Federal law requires private, tax-exempt hospitals – which make up more than half the nation’s medical centers – to provide care at no cost or at a discount to low-income patients. But reporting by KFF Health News and others has found that many hospitals make this aid difficult for patients to get.

At the same time, thousands of medical centers – including many tax-exempt ones – engage in aggressive debt collection tactics to pursue patients, including garnishing patients’ wages, placing liens on their homes, or selling their debt to third-party debt collectors.

Overall, KFF Health News found that most of the nation’s approximately 5,100 hospitals serving the general public have policies to use legal action or other aggressive tactics against patients. And one in five will deny nonemergency care to people with outstanding debt.

“Medical debt is drowning many low-income and working families while hospitals continue to benefit from nonprofit tax status as they pursue families for medical debt,” said Marceline White, executive director of Economic Action Maryland. The advocacy group has helped enact tighter rules to ensure Maryland hospitals make financial assistance more easily accessible and to restrict hospitals from some aggressive debt collection tactics, such as placing liens on patients’ homes.

Similar efforts are underway in other states, including Colorado, New Mexico, New York, Oregon, and Washington. But many patient and consumer advocates say stronger federal action is needed to expand patient protections.

The Human Rights Watch report – titled “In Sheep’s Clothing: United States’ Poorly Regulated Nonprofit Hospitals Undermine Health Care Access” – lists more than a dozen recommendations. These include:

• Congress should pass legislation to ensure that hospitals provide at least the same amount of charity care as they receive in public subsidies.
• The IRS should set uniform national standards on patients’ eligibility for financial assistance at nonprofit hospitals. Currently, hospitals are free to set their own standards, resulting in widespread variation, which can confuse patients.
• The Consumer Financial Protection Bureau, a federal watchdog agency, should crack down on debt collectors that do not ensure that patients have been screened for financial assistance before being pursued.
• The federal Centers for Medicare & Medicaid Services, which administers the two mammoth public insurance programs, should penalize hospitals that do not provide adequate financial assistance to patients.

“Nonprofit hospitals are contributing to medical debt and engaging in abusive billing and debt collection practices,” Mr. McConnell said. “The reason this keeps happening is the absence of clear guidelines and the federal government’s inadequate enforcement of existing regulations.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.

Human Rights Watch, the nonprofit that for decades has called attention to the victims of war, famine, and political repression around the world, is taking aim at U.S. hospitals for pushing millions of American patients into debt.

In a new report, the group calls for stronger government action to protect Americans from aggressive billing and debt collection by nonprofit hospitals, which Human Rights Watch said are systematically undermining patients’ human rights.

“Given the high prevalence of hospital-related medical debt in the U.S., this system is clearly not working,” concludes the report, which draws extensively on an ongoing investigation of medical debt by KFF Health News and NPR.

The report continues: “The U.S. model of subsidizing privately operated hospitals with tax exemptions in the hope that they will increase the accessibility of hospital care for un- and underinsured patients allows for abusive medical billing and debt collection practices and undermines human rights, including the right to health.”

Nationwide, about 100 million people – or 41% of adults – have some form of health care debt, a KFF survey conducted for the KFF Health News–NPR project found. And while patient debt is being driven by a range of medical and dental bills, polls and studies suggest hospitals are a major contributor.

About a third of U.S. adults with health care debt owed money for hospitalization, KFF’s polling found. Close to half of those owed at least $5,000. About a quarter owed $10,000 or more.

The scale of this crisis – which is unparalleled among wealthy nations – compelled Human Rights Watch to release the new report, said researcher Matt McConnell, its author. “Historically, Human Rights Watch has been an organization that has focused on international human rights issues,” he said. “But on medical debt, the U.S. is a real outlier. What you see is a system that privileges a few but creates large barriers to people accessing basic health rights.”

Hospital industry officials defend their work, citing hospitals’ broader work to help the communities they serve. “As a field, hospitals provide more benefit to their communities than any other sector in health care,” Melinda Hatton, general counsel at the American Hospital Association, wrote in a response to the Human Right Watch report.

Federal law requires private, tax-exempt hospitals – which make up more than half the nation’s medical centers – to provide care at no cost or at a discount to low-income patients. But reporting by KFF Health News and others has found that many hospitals make this aid difficult for patients to get.

At the same time, thousands of medical centers – including many tax-exempt ones – engage in aggressive debt collection tactics to pursue patients, including garnishing patients’ wages, placing liens on their homes, or selling their debt to third-party debt collectors.

Overall, KFF Health News found that most of the nation’s approximately 5,100 hospitals serving the general public have policies to use legal action or other aggressive tactics against patients. And one in five will deny nonemergency care to people with outstanding debt.

“Medical debt is drowning many low-income and working families while hospitals continue to benefit from nonprofit tax status as they pursue families for medical debt,” said Marceline White, executive director of Economic Action Maryland. The advocacy group has helped enact tighter rules to ensure Maryland hospitals make financial assistance more easily accessible and to restrict hospitals from some aggressive debt collection tactics, such as placing liens on patients’ homes.

Similar efforts are underway in other states, including Colorado, New Mexico, New York, Oregon, and Washington. But many patient and consumer advocates say stronger federal action is needed to expand patient protections.

The Human Rights Watch report – titled “In Sheep’s Clothing: United States’ Poorly Regulated Nonprofit Hospitals Undermine Health Care Access” – lists more than a dozen recommendations. These include:

• Congress should pass legislation to ensure that hospitals provide at least the same amount of charity care as they receive in public subsidies.
• The IRS should set uniform national standards on patients’ eligibility for financial assistance at nonprofit hospitals. Currently, hospitals are free to set their own standards, resulting in widespread variation, which can confuse patients.
• The Consumer Financial Protection Bureau, a federal watchdog agency, should crack down on debt collectors that do not ensure that patients have been screened for financial assistance before being pursued.
• The federal Centers for Medicare & Medicaid Services, which administers the two mammoth public insurance programs, should penalize hospitals that do not provide adequate financial assistance to patients.

“Nonprofit hospitals are contributing to medical debt and engaging in abusive billing and debt collection practices,” Mr. McConnell said. “The reason this keeps happening is the absence of clear guidelines and the federal government’s inadequate enforcement of existing regulations.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.

Human Rights Watch, the nonprofit that for decades has called attention to the victims of war, famine, and political repression around the world, is taking aim at U.S. hospitals for pushing millions of American patients into debt.

In a new report, the group calls for stronger government action to protect Americans from aggressive billing and debt collection by nonprofit hospitals, which Human Rights Watch said are systematically undermining patients’ human rights.

“Given the high prevalence of hospital-related medical debt in the U.S., this system is clearly not working,” concludes the report, which draws extensively on an ongoing investigation of medical debt by KFF Health News and NPR.

The report continues: “The U.S. model of subsidizing privately operated hospitals with tax exemptions in the hope that they will increase the accessibility of hospital care for un- and underinsured patients allows for abusive medical billing and debt collection practices and undermines human rights, including the right to health.”

Nationwide, about 100 million people – or 41% of adults – have some form of health care debt, a KFF survey conducted for the KFF Health News–NPR project found. And while patient debt is being driven by a range of medical and dental bills, polls and studies suggest hospitals are a major contributor.

About a third of U.S. adults with health care debt owed money for hospitalization, KFF’s polling found. Close to half of those owed at least $5,000. About a quarter owed $10,000 or more.

The scale of this crisis – which is unparalleled among wealthy nations – compelled Human Rights Watch to release the new report, said researcher Matt McConnell, its author. “Historically, Human Rights Watch has been an organization that has focused on international human rights issues,” he said. “But on medical debt, the U.S. is a real outlier. What you see is a system that privileges a few but creates large barriers to people accessing basic health rights.”

Hospital industry officials defend their work, citing hospitals’ broader work to help the communities they serve. “As a field, hospitals provide more benefit to their communities than any other sector in health care,” Melinda Hatton, general counsel at the American Hospital Association, wrote in a response to the Human Right Watch report.

Federal law requires private, tax-exempt hospitals – which make up more than half the nation’s medical centers – to provide care at no cost or at a discount to low-income patients. But reporting by KFF Health News and others has found that many hospitals make this aid difficult for patients to get.

At the same time, thousands of medical centers – including many tax-exempt ones – engage in aggressive debt collection tactics to pursue patients, including garnishing patients’ wages, placing liens on their homes, or selling their debt to third-party debt collectors.

Overall, KFF Health News found that most of the nation’s approximately 5,100 hospitals serving the general public have policies to use legal action or other aggressive tactics against patients. And one in five will deny nonemergency care to people with outstanding debt.

“Medical debt is drowning many low-income and working families while hospitals continue to benefit from nonprofit tax status as they pursue families for medical debt,” said Marceline White, executive director of Economic Action Maryland. The advocacy group has helped enact tighter rules to ensure Maryland hospitals make financial assistance more easily accessible and to restrict hospitals from some aggressive debt collection tactics, such as placing liens on patients’ homes.

Similar efforts are underway in other states, including Colorado, New Mexico, New York, Oregon, and Washington. But many patient and consumer advocates say stronger federal action is needed to expand patient protections.

The Human Rights Watch report – titled “In Sheep’s Clothing: United States’ Poorly Regulated Nonprofit Hospitals Undermine Health Care Access” – lists more than a dozen recommendations. These include:

• Congress should pass legislation to ensure that hospitals provide at least the same amount of charity care as they receive in public subsidies.
• The IRS should set uniform national standards on patients’ eligibility for financial assistance at nonprofit hospitals. Currently, hospitals are free to set their own standards, resulting in widespread variation, which can confuse patients.
• The Consumer Financial Protection Bureau, a federal watchdog agency, should crack down on debt collectors that do not ensure that patients have been screened for financial assistance before being pursued.
• The federal Centers for Medicare & Medicaid Services, which administers the two mammoth public insurance programs, should penalize hospitals that do not provide adequate financial assistance to patients.

“Nonprofit hospitals are contributing to medical debt and engaging in abusive billing and debt collection practices,” Mr. McConnell said. “The reason this keeps happening is the absence of clear guidelines and the federal government’s inadequate enforcement of existing regulations.”

KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – the independent source for health policy research, polling, and journalism.

CHICAGO – Testosterone replacement therapy does not appear to raise the risk for adverse cardiac events among middle-aged and older men with hypogonadism at high risk for heart disease, long-awaited results from a major clinical trial show.

Among over 5,000 men aged 45-80 years randomized to daily transdermal testosterone gel or matching placebo gel for an average of 22 months, no increased risk was seen for a first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

There was also no increased risk for prostate cancer over the 33-month follow-up period. However, there were increases in rates of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group.

In terms of efficacy, testosterone therapy was associated with improved sexual function over two years of treatment and correction, or prevention, of anemia, but had no effect on progression to diabetes or glycemic parameters.

And, an unexpected finding was a significant and unexplained 43% increase in fractures with testosterone therapy.

The TRAVERSE study was mandated by the Food and Drug Administration in 2015 in response to concerns and conflicting data regarding the cardiovascular safety of testosterone replacement therapy in men. It was conducted by a consortium of five manufacturers of testosterone replacement products, led by AbbVie.

The results were presented during a symposium at the annual meeting of the Endocrine Society. The mandated safety data were published online in the New England Journal of Medicine. The efficacy outcomes, undertaken opportunistically due to the trial’s large sample size and relatively long followup time, will be published later this year.

Taken together, the TRAVERSE findings are expected to transform the risk–benefit discussions with patients about the use of testosterone therapy for hypogonadism, study coauthor Shalender Bhasin, MD, told this news organization.

“Testosterone deficiency doesn’t kill people as far as we know but it is really an important symptomatic condition that affects quality of life. Many middle-aged and older men seek assistance for these symptoms, so it’s an important condition and the treatment decisions are complicated,” said Dr. Bhasin, director of the research program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital in Boston.

These new data will be incorporated into future guidelines on testosterone therapy in men with hypoandrogenism, noted Dr. Bhasin, a coauthor of The Endocrine Society’s 2018 guidelines.
 

Findings apply only to men with bona fide testosterone deficiency

Asked to comment, endocrinologist Bradley D. Anawalt, MD, told this news organization that “the community of physicians who prescribe testosterone to men was waiting with bated breath” for the TRAVERSE results.

Safety reassuring, but some concerns will require more investigation

TRAVERSE was a multicenter, randomized, double-blind, placebo-controlled noninferiority trial that enrolled 5246 men aged 45-80 years. Participants had pre-existing or were at high risk of cardiovascular disease, reported symptoms of hypogonadism, and had two fasting testosterone levels < 300 ng/dL. They were randomly assigned to receive daily transdermal 1.62% testosterone gel or placebo gel.

The primary safety endpoint event (first adjudicated major adverse cardiac event) occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; P < .001 for noninferiority). Similar results were seen in sensitivity analyses.

Pulmonary embolism occurred in 0.9% of the testosterone group versus 0.5% of the placebo group, supporting current guidelines that testosterone should be used with caution in men who have had previous thromboembolic events, the authors note.

Prostate cancer occurred in 0.5% (n = 12) of patients in the testosterone group and 0.4% (n = 11) of patients in the placebo group, not a significant difference (P = .87).

There were, however, significant differences between the testosterone and placebo groups in terms of nonfatal arrhythmias warranting intervention (5.2% vs. 3.3%; P = .001), atrial fibrillation (3.5% vs. 2.4%; P = .02), and acute kidney injury (2.3% vs. 1.5%; P = .04).

“These adverse events were not expected,” the authors wrote.

Dr. Bhasin said that the team plans to investigate those cases further to look for possible risk factors, including whether COVID-19 played a role in these outcomes because the trial took place during the pandemic and some participants in both study groups contracted the virus.

Regarding acute kidney injury, Dr. Anawalt said: “I don’t know that I believe that ... It’s probably a statistical abnormality. It barely made ... significance.”
 

Finally, ‘real data on something we’ve been prescribing for decades’

Both Dr. Bhasin and Dr. Anawalt pointed out the deficiencies in the prior literature in terms of what has been known about testosterone’s effects. According to Dr. Bhasin, “In spite of all the folklore, there isn’t very much known about the efficacy of treatment beyond sexual function, and even there, the data are really limited. Most trials have been open-label and very small.”

He added that even among the few previous randomized clinical trials, only one, the TTrials series,  had an adequate number of participants and used robust measures to assess sexual function, but that study only lasted a year.

Indeed, Dr. Anawalt noted, “[TRAVERSE] and its father study, the TTrials, were the first systematic studies to look at large groups of men getting testosterone versus placebo. We’re now starting to get real data on something that we’ve been prescribing for decades.”

At the ENDO symposium, Dr. Bhasin presented data showing significant improvements with testosterone compared to placebo in overall sexual activity (P = .011), sexual symptoms (P < .001), and sexual desire over one year, and maintained over two years in TRAVERSE. All were assessed by validated questionnaires.

“They confirmed that there’s an improvement in sexual function and that it’s sustained. That’s important because there had been doubt about that ... and it sounds like it’s clinically significant,” Dr. Anawalt said.

Testosterone therapy was also associated with lower rates of anemia among men who were not anemic at baseline, and lower incidence of anemia in those who were anemic to begin with. However, the rate of progression from prediabetes to diabetes didn’t differ significantly, nor did testosterone therapy improve glycemic control or remission in men who had diabetes at baseline, Dr. Bhasin reported.
 

‘Big surprise’ and a mystery: Testosterone increased fracture risk

The fracture data were presented by Peter J. Snyder, MD, of the University of Pennsylvania, who earlier in the session had received an Endocrine Society award for his work in the testosterone field.

“No prior trial of testosterone treatment of hypogonadal men has been large enough or long enough to assess its effect on fractures ... until the TRAVERSE trial,” he said.

The hypothesis going in was that testosterone would decrease the fracture incidence, since prior data had suggested it improves many parameters of bone quality in elderly men and in those with severe hypogonadism.

Instead, there were 91 confirmed and adjudicated clinical fractures in the testosterone group versus 64 in the placebo group, giving a hazard ratio of 1.43 (P = .03). The risk was seen across fracture types, increasing the likelihood that this finding was, in fact, real, Dr. Snyder said.

“We could speculate about a possible mechanism, but because we did not expect these results, we did not design the trial to evaluate a possible mechanism,” Dr. Snyder noted.

Dr. Anawalt told this news organization that the fracture finding “was a big surprise. None of us would have expected that there would be an increase in fractures.”

Clinically, Dr. Anawalt said it suggests consideration of expanding the use of anti-osteoporotic medication such as bisphosphonates to men with low testosterone and elevated fracture risk for whom clinicians may have assumed that just giving them testosterone replacement might also protect their bones.

“This begs the question should we reorient the way we’re thinking about these men.”

The study was funded by AbbVie, Acerus Pharmaceuticals Corporation/Aytu Biosciences, Allergan Sales, Endo Pharmaceuticals, and Upsher-Smith Laboratories. Dr. Bhasin has disclosed grants to his institution from Function Promoting Therapies and Metro International Biotech, and owns stock in XYone. Dr. Anawalt has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This article was updated 6/19/23.

CHICAGO – Testosterone replacement therapy does not appear to raise the risk for adverse cardiac events among middle-aged and older men with hypogonadism at high risk for heart disease, long-awaited results from a major clinical trial show.

Among over 5,000 men aged 45-80 years randomized to daily transdermal testosterone gel or matching placebo gel for an average of 22 months, no increased risk was seen for a first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

There was also no increased risk for prostate cancer over the 33-month follow-up period. However, there were increases in rates of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group.

In terms of efficacy, testosterone therapy was associated with improved sexual function over two years of treatment and correction, or prevention, of anemia, but had no effect on progression to diabetes or glycemic parameters.

And, an unexpected finding was a significant and unexplained 43% increase in fractures with testosterone therapy.

The TRAVERSE study was mandated by the Food and Drug Administration in 2015 in response to concerns and conflicting data regarding the cardiovascular safety of testosterone replacement therapy in men. It was conducted by a consortium of five manufacturers of testosterone replacement products, led by AbbVie.

The results were presented during a symposium at the annual meeting of the Endocrine Society. The mandated safety data were published online in the New England Journal of Medicine. The efficacy outcomes, undertaken opportunistically due to the trial’s large sample size and relatively long followup time, will be published later this year.

Taken together, the TRAVERSE findings are expected to transform the risk–benefit discussions with patients about the use of testosterone therapy for hypogonadism, study coauthor Shalender Bhasin, MD, told this news organization.

“Testosterone deficiency doesn’t kill people as far as we know but it is really an important symptomatic condition that affects quality of life. Many middle-aged and older men seek assistance for these symptoms, so it’s an important condition and the treatment decisions are complicated,” said Dr. Bhasin, director of the research program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital in Boston.

These new data will be incorporated into future guidelines on testosterone therapy in men with hypoandrogenism, noted Dr. Bhasin, a coauthor of The Endocrine Society’s 2018 guidelines.
 

Findings apply only to men with bona fide testosterone deficiency

Asked to comment, endocrinologist Bradley D. Anawalt, MD, told this news organization that “the community of physicians who prescribe testosterone to men was waiting with bated breath” for the TRAVERSE results.

Safety reassuring, but some concerns will require more investigation

TRAVERSE was a multicenter, randomized, double-blind, placebo-controlled noninferiority trial that enrolled 5246 men aged 45-80 years. Participants had pre-existing or were at high risk of cardiovascular disease, reported symptoms of hypogonadism, and had two fasting testosterone levels < 300 ng/dL. They were randomly assigned to receive daily transdermal 1.62% testosterone gel or placebo gel.

The primary safety endpoint event (first adjudicated major adverse cardiac event) occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; P < .001 for noninferiority). Similar results were seen in sensitivity analyses.

Pulmonary embolism occurred in 0.9% of the testosterone group versus 0.5% of the placebo group, supporting current guidelines that testosterone should be used with caution in men who have had previous thromboembolic events, the authors note.

Prostate cancer occurred in 0.5% (n = 12) of patients in the testosterone group and 0.4% (n = 11) of patients in the placebo group, not a significant difference (P = .87).

There were, however, significant differences between the testosterone and placebo groups in terms of nonfatal arrhythmias warranting intervention (5.2% vs. 3.3%; P = .001), atrial fibrillation (3.5% vs. 2.4%; P = .02), and acute kidney injury (2.3% vs. 1.5%; P = .04).

“These adverse events were not expected,” the authors wrote.

Dr. Bhasin said that the team plans to investigate those cases further to look for possible risk factors, including whether COVID-19 played a role in these outcomes because the trial took place during the pandemic and some participants in both study groups contracted the virus.

Regarding acute kidney injury, Dr. Anawalt said: “I don’t know that I believe that ... It’s probably a statistical abnormality. It barely made ... significance.”
 

Finally, ‘real data on something we’ve been prescribing for decades’

Both Dr. Bhasin and Dr. Anawalt pointed out the deficiencies in the prior literature in terms of what has been known about testosterone’s effects. According to Dr. Bhasin, “In spite of all the folklore, there isn’t very much known about the efficacy of treatment beyond sexual function, and even there, the data are really limited. Most trials have been open-label and very small.”

He added that even among the few previous randomized clinical trials, only one, the TTrials series,  had an adequate number of participants and used robust measures to assess sexual function, but that study only lasted a year.

Indeed, Dr. Anawalt noted, “[TRAVERSE] and its father study, the TTrials, were the first systematic studies to look at large groups of men getting testosterone versus placebo. We’re now starting to get real data on something that we’ve been prescribing for decades.”

At the ENDO symposium, Dr. Bhasin presented data showing significant improvements with testosterone compared to placebo in overall sexual activity (P = .011), sexual symptoms (P < .001), and sexual desire over one year, and maintained over two years in TRAVERSE. All were assessed by validated questionnaires.

“They confirmed that there’s an improvement in sexual function and that it’s sustained. That’s important because there had been doubt about that ... and it sounds like it’s clinically significant,” Dr. Anawalt said.

Testosterone therapy was also associated with lower rates of anemia among men who were not anemic at baseline, and lower incidence of anemia in those who were anemic to begin with. However, the rate of progression from prediabetes to diabetes didn’t differ significantly, nor did testosterone therapy improve glycemic control or remission in men who had diabetes at baseline, Dr. Bhasin reported.
 

‘Big surprise’ and a mystery: Testosterone increased fracture risk

The fracture data were presented by Peter J. Snyder, MD, of the University of Pennsylvania, who earlier in the session had received an Endocrine Society award for his work in the testosterone field.

“No prior trial of testosterone treatment of hypogonadal men has been large enough or long enough to assess its effect on fractures ... until the TRAVERSE trial,” he said.

The hypothesis going in was that testosterone would decrease the fracture incidence, since prior data had suggested it improves many parameters of bone quality in elderly men and in those with severe hypogonadism.

Instead, there were 91 confirmed and adjudicated clinical fractures in the testosterone group versus 64 in the placebo group, giving a hazard ratio of 1.43 (P = .03). The risk was seen across fracture types, increasing the likelihood that this finding was, in fact, real, Dr. Snyder said.

“We could speculate about a possible mechanism, but because we did not expect these results, we did not design the trial to evaluate a possible mechanism,” Dr. Snyder noted.

Dr. Anawalt told this news organization that the fracture finding “was a big surprise. None of us would have expected that there would be an increase in fractures.”

Clinically, Dr. Anawalt said it suggests consideration of expanding the use of anti-osteoporotic medication such as bisphosphonates to men with low testosterone and elevated fracture risk for whom clinicians may have assumed that just giving them testosterone replacement might also protect their bones.

“This begs the question should we reorient the way we’re thinking about these men.”

The study was funded by AbbVie, Acerus Pharmaceuticals Corporation/Aytu Biosciences, Allergan Sales, Endo Pharmaceuticals, and Upsher-Smith Laboratories. Dr. Bhasin has disclosed grants to his institution from Function Promoting Therapies and Metro International Biotech, and owns stock in XYone. Dr. Anawalt has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This article was updated 6/19/23.

CHICAGO – Testosterone replacement therapy does not appear to raise the risk for adverse cardiac events among middle-aged and older men with hypogonadism at high risk for heart disease, long-awaited results from a major clinical trial show.

Among over 5,000 men aged 45-80 years randomized to daily transdermal testosterone gel or matching placebo gel for an average of 22 months, no increased risk was seen for a first occurrence of any component of a composite of death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke.

There was also no increased risk for prostate cancer over the 33-month follow-up period. However, there were increases in rates of atrial fibrillation, acute kidney injury, and pulmonary embolism in the testosterone group.

In terms of efficacy, testosterone therapy was associated with improved sexual function over two years of treatment and correction, or prevention, of anemia, but had no effect on progression to diabetes or glycemic parameters.

And, an unexpected finding was a significant and unexplained 43% increase in fractures with testosterone therapy.

The TRAVERSE study was mandated by the Food and Drug Administration in 2015 in response to concerns and conflicting data regarding the cardiovascular safety of testosterone replacement therapy in men. It was conducted by a consortium of five manufacturers of testosterone replacement products, led by AbbVie.

The results were presented during a symposium at the annual meeting of the Endocrine Society. The mandated safety data were published online in the New England Journal of Medicine. The efficacy outcomes, undertaken opportunistically due to the trial’s large sample size and relatively long followup time, will be published later this year.

Taken together, the TRAVERSE findings are expected to transform the risk–benefit discussions with patients about the use of testosterone therapy for hypogonadism, study coauthor Shalender Bhasin, MD, told this news organization.

“Testosterone deficiency doesn’t kill people as far as we know but it is really an important symptomatic condition that affects quality of life. Many middle-aged and older men seek assistance for these symptoms, so it’s an important condition and the treatment decisions are complicated,” said Dr. Bhasin, director of the research program in Men’s Health: Aging and Metabolism, at Brigham and Women’s Hospital in Boston.

These new data will be incorporated into future guidelines on testosterone therapy in men with hypoandrogenism, noted Dr. Bhasin, a coauthor of The Endocrine Society’s 2018 guidelines.
 

Findings apply only to men with bona fide testosterone deficiency

Asked to comment, endocrinologist Bradley D. Anawalt, MD, told this news organization that “the community of physicians who prescribe testosterone to men was waiting with bated breath” for the TRAVERSE results.

Safety reassuring, but some concerns will require more investigation

TRAVERSE was a multicenter, randomized, double-blind, placebo-controlled noninferiority trial that enrolled 5246 men aged 45-80 years. Participants had pre-existing or were at high risk of cardiovascular disease, reported symptoms of hypogonadism, and had two fasting testosterone levels < 300 ng/dL. They were randomly assigned to receive daily transdermal 1.62% testosterone gel or placebo gel.

The primary safety endpoint event (first adjudicated major adverse cardiac event) occurred in 182 patients (7.0%) in the testosterone group and in 190 patients (7.3%) in the placebo group (hazard ratio, 0.96; P < .001 for noninferiority). Similar results were seen in sensitivity analyses.

Pulmonary embolism occurred in 0.9% of the testosterone group versus 0.5% of the placebo group, supporting current guidelines that testosterone should be used with caution in men who have had previous thromboembolic events, the authors note.

Prostate cancer occurred in 0.5% (n = 12) of patients in the testosterone group and 0.4% (n = 11) of patients in the placebo group, not a significant difference (P = .87).

There were, however, significant differences between the testosterone and placebo groups in terms of nonfatal arrhythmias warranting intervention (5.2% vs. 3.3%; P = .001), atrial fibrillation (3.5% vs. 2.4%; P = .02), and acute kidney injury (2.3% vs. 1.5%; P = .04).

“These adverse events were not expected,” the authors wrote.

Dr. Bhasin said that the team plans to investigate those cases further to look for possible risk factors, including whether COVID-19 played a role in these outcomes because the trial took place during the pandemic and some participants in both study groups contracted the virus.

Regarding acute kidney injury, Dr. Anawalt said: “I don’t know that I believe that ... It’s probably a statistical abnormality. It barely made ... significance.”
 

Finally, ‘real data on something we’ve been prescribing for decades’

Both Dr. Bhasin and Dr. Anawalt pointed out the deficiencies in the prior literature in terms of what has been known about testosterone’s effects. According to Dr. Bhasin, “In spite of all the folklore, there isn’t very much known about the efficacy of treatment beyond sexual function, and even there, the data are really limited. Most trials have been open-label and very small.”

He added that even among the few previous randomized clinical trials, only one, the TTrials series,  had an adequate number of participants and used robust measures to assess sexual function, but that study only lasted a year.

Indeed, Dr. Anawalt noted, “[TRAVERSE] and its father study, the TTrials, were the first systematic studies to look at large groups of men getting testosterone versus placebo. We’re now starting to get real data on something that we’ve been prescribing for decades.”

At the ENDO symposium, Dr. Bhasin presented data showing significant improvements with testosterone compared to placebo in overall sexual activity (P = .011), sexual symptoms (P < .001), and sexual desire over one year, and maintained over two years in TRAVERSE. All were assessed by validated questionnaires.

“They confirmed that there’s an improvement in sexual function and that it’s sustained. That’s important because there had been doubt about that ... and it sounds like it’s clinically significant,” Dr. Anawalt said.

Testosterone therapy was also associated with lower rates of anemia among men who were not anemic at baseline, and lower incidence of anemia in those who were anemic to begin with. However, the rate of progression from prediabetes to diabetes didn’t differ significantly, nor did testosterone therapy improve glycemic control or remission in men who had diabetes at baseline, Dr. Bhasin reported.
 

‘Big surprise’ and a mystery: Testosterone increased fracture risk

The fracture data were presented by Peter J. Snyder, MD, of the University of Pennsylvania, who earlier in the session had received an Endocrine Society award for his work in the testosterone field.

“No prior trial of testosterone treatment of hypogonadal men has been large enough or long enough to assess its effect on fractures ... until the TRAVERSE trial,” he said.

The hypothesis going in was that testosterone would decrease the fracture incidence, since prior data had suggested it improves many parameters of bone quality in elderly men and in those with severe hypogonadism.

Instead, there were 91 confirmed and adjudicated clinical fractures in the testosterone group versus 64 in the placebo group, giving a hazard ratio of 1.43 (P = .03). The risk was seen across fracture types, increasing the likelihood that this finding was, in fact, real, Dr. Snyder said.

“We could speculate about a possible mechanism, but because we did not expect these results, we did not design the trial to evaluate a possible mechanism,” Dr. Snyder noted.

Dr. Anawalt told this news organization that the fracture finding “was a big surprise. None of us would have expected that there would be an increase in fractures.”

Clinically, Dr. Anawalt said it suggests consideration of expanding the use of anti-osteoporotic medication such as bisphosphonates to men with low testosterone and elevated fracture risk for whom clinicians may have assumed that just giving them testosterone replacement might also protect their bones.

“This begs the question should we reorient the way we’re thinking about these men.”

The study was funded by AbbVie, Acerus Pharmaceuticals Corporation/Aytu Biosciences, Allergan Sales, Endo Pharmaceuticals, and Upsher-Smith Laboratories. Dr. Bhasin has disclosed grants to his institution from Function Promoting Therapies and Metro International Biotech, and owns stock in XYone. Dr. Anawalt has reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

This article was updated 6/19/23.

In patients with persistent dyspnea following a pulmonary embolism, rehabilitation should be considered as a treatment option, according to findings from a randomized, controlled trial comparing usual care to a twice-weekly, 8-week physical exercise program.

The prevalence of persistent dyspnea, functional limitations, and reduced quality of life (QoL) after pulmonary embolism (PE) ranges from 30% to 50% in published studies. While the underlying mechanisms remain unclear and are likely multifactorial, Øyvind Jervan, MD, and colleagues reported, research suggests that deconditioning and psychological factors contribute substantially to post-PE impairment. Optimal management remains unknown. Symptom improvement following rehabilitation programs in chronic obstructive pulmonary disease and in cardiac diseases is well documented, however, but evidence in the post–pulmonary embolism setting is limited.

The investigators randomized adult patients 1:1 from two hospitals (Osfold Hospital and Akershus University Hospital) with PE identified via computed tomography pulmonary angiography 6-72 months prior to study inclusion to either a supervised outpatient exercise program or usual care. The once- or twice-weekly home-based program was tailored to each participant and included a 90-minute educational session on the cardiopulmonary system, diagnosis and treatment of PE and its possible long-term effects, the benefits of exercise and physical activity, and the management of breathlessness. Also during the intervention period, participants were given a simple home-based exercise program to be performed once or twice weekly. Differences between groups in the Incremental Shuttle Walk Test (ISWT), a standardized walking test that assesses exercise capacity, was the primary endpoint. Secondary endpoints included an endurance walk test (ESWT) and measures of symptoms and QoL.

Among 211 participants (median age 57 years; 56% men), the median time from diagnosis to inclusion was 10.3 months. Median baseline walking distance on the ISWT was 695 m with 21% achieving the 1,020-m maximum distance. At follow-up, a between-group difference of 53.0 m favored the rehabilitation group (89 evaluable subjects; 87 in usual care) (P = .0035). While subgroup analysis revealed a greater difference for those with shorter time from diagnosis (6-12 months vs. 12.1-72 months), the between-group differences were nonsignificant. Also, no ISWT differences between the intervention and control group were found for those with higher pulmonary embolism severity and dyspnea scores. The walk endurance test revealed no between-group differences.

Scores at follow-up on the Pulmonary Embolism-QoL questionnaire favored the rehabilitation group (mean difference –4%; P = .041), but there were no differences in generic QoL, dyspnea scores, or the ESWT.

“The present study adds to the growing evidence of the benefits of rehabilitation after PE,” the researchers stated. Although several recent studies have shown rehabilitation after PE results that were promising, the authors pointed out that most of these studies have been small or have lacked a control group, with great variations between them with respect to time, mode, and duration of intervention. In addition, the current study is the largest one addressing the effect of rehabilitation after PE to demonstrate in subjects with persistent dyspnea a positive effect on exercise capacity and QoL.

The researchers also commented that the small detected mean difference of 53 m in walking distance was lower than has been considered a worthwhile improvement by some, and its clinical relevance can be debated. Other studies, however, have used mean group differences of 40-62 m as clinically meaningful. The authors underscored also that the ISWT data were subject to a considerable ceiling effect which may underestimate the effect size.

Addressing study limitations, the researchers added that: “The rehabilitation program in the present study consisted mainly of exercise training. It is unknown whether the addition of occupational therapy, psychology, or dietary therapy would provide additional benefits for the participants. Most participants had mild symptoms, which may have limited the potential benefits of our rehabilitation program.”

The project was funded by Østfold Hospital Trust. Dr. Jervan reported no relevant conflicts of interest.

In patients with persistent dyspnea following a pulmonary embolism, rehabilitation should be considered as a treatment option, according to findings from a randomized, controlled trial comparing usual care to a twice-weekly, 8-week physical exercise program.

The prevalence of persistent dyspnea, functional limitations, and reduced quality of life (QoL) after pulmonary embolism (PE) ranges from 30% to 50% in published studies. While the underlying mechanisms remain unclear and are likely multifactorial, Øyvind Jervan, MD, and colleagues reported, research suggests that deconditioning and psychological factors contribute substantially to post-PE impairment. Optimal management remains unknown. Symptom improvement following rehabilitation programs in chronic obstructive pulmonary disease and in cardiac diseases is well documented, however, but evidence in the post–pulmonary embolism setting is limited.

The investigators randomized adult patients 1:1 from two hospitals (Osfold Hospital and Akershus University Hospital) with PE identified via computed tomography pulmonary angiography 6-72 months prior to study inclusion to either a supervised outpatient exercise program or usual care. The once- or twice-weekly home-based program was tailored to each participant and included a 90-minute educational session on the cardiopulmonary system, diagnosis and treatment of PE and its possible long-term effects, the benefits of exercise and physical activity, and the management of breathlessness. Also during the intervention period, participants were given a simple home-based exercise program to be performed once or twice weekly. Differences between groups in the Incremental Shuttle Walk Test (ISWT), a standardized walking test that assesses exercise capacity, was the primary endpoint. Secondary endpoints included an endurance walk test (ESWT) and measures of symptoms and QoL.

Among 211 participants (median age 57 years; 56% men), the median time from diagnosis to inclusion was 10.3 months. Median baseline walking distance on the ISWT was 695 m with 21% achieving the 1,020-m maximum distance. At follow-up, a between-group difference of 53.0 m favored the rehabilitation group (89 evaluable subjects; 87 in usual care) (P = .0035). While subgroup analysis revealed a greater difference for those with shorter time from diagnosis (6-12 months vs. 12.1-72 months), the between-group differences were nonsignificant. Also, no ISWT differences between the intervention and control group were found for those with higher pulmonary embolism severity and dyspnea scores. The walk endurance test revealed no between-group differences.

Scores at follow-up on the Pulmonary Embolism-QoL questionnaire favored the rehabilitation group (mean difference –4%; P = .041), but there were no differences in generic QoL, dyspnea scores, or the ESWT.

“The present study adds to the growing evidence of the benefits of rehabilitation after PE,” the researchers stated. Although several recent studies have shown rehabilitation after PE results that were promising, the authors pointed out that most of these studies have been small or have lacked a control group, with great variations between them with respect to time, mode, and duration of intervention. In addition, the current study is the largest one addressing the effect of rehabilitation after PE to demonstrate in subjects with persistent dyspnea a positive effect on exercise capacity and QoL.

The researchers also commented that the small detected mean difference of 53 m in walking distance was lower than has been considered a worthwhile improvement by some, and its clinical relevance can be debated. Other studies, however, have used mean group differences of 40-62 m as clinically meaningful. The authors underscored also that the ISWT data were subject to a considerable ceiling effect which may underestimate the effect size.

Addressing study limitations, the researchers added that: “The rehabilitation program in the present study consisted mainly of exercise training. It is unknown whether the addition of occupational therapy, psychology, or dietary therapy would provide additional benefits for the participants. Most participants had mild symptoms, which may have limited the potential benefits of our rehabilitation program.”

The project was funded by Østfold Hospital Trust. Dr. Jervan reported no relevant conflicts of interest.

In patients with persistent dyspnea following a pulmonary embolism, rehabilitation should be considered as a treatment option, according to findings from a randomized, controlled trial comparing usual care to a twice-weekly, 8-week physical exercise program.

The prevalence of persistent dyspnea, functional limitations, and reduced quality of life (QoL) after pulmonary embolism (PE) ranges from 30% to 50% in published studies. While the underlying mechanisms remain unclear and are likely multifactorial, Øyvind Jervan, MD, and colleagues reported, research suggests that deconditioning and psychological factors contribute substantially to post-PE impairment. Optimal management remains unknown. Symptom improvement following rehabilitation programs in chronic obstructive pulmonary disease and in cardiac diseases is well documented, however, but evidence in the post–pulmonary embolism setting is limited.

The investigators randomized adult patients 1:1 from two hospitals (Osfold Hospital and Akershus University Hospital) with PE identified via computed tomography pulmonary angiography 6-72 months prior to study inclusion to either a supervised outpatient exercise program or usual care. The once- or twice-weekly home-based program was tailored to each participant and included a 90-minute educational session on the cardiopulmonary system, diagnosis and treatment of PE and its possible long-term effects, the benefits of exercise and physical activity, and the management of breathlessness. Also during the intervention period, participants were given a simple home-based exercise program to be performed once or twice weekly. Differences between groups in the Incremental Shuttle Walk Test (ISWT), a standardized walking test that assesses exercise capacity, was the primary endpoint. Secondary endpoints included an endurance walk test (ESWT) and measures of symptoms and QoL.

Among 211 participants (median age 57 years; 56% men), the median time from diagnosis to inclusion was 10.3 months. Median baseline walking distance on the ISWT was 695 m with 21% achieving the 1,020-m maximum distance. At follow-up, a between-group difference of 53.0 m favored the rehabilitation group (89 evaluable subjects; 87 in usual care) (P = .0035). While subgroup analysis revealed a greater difference for those with shorter time from diagnosis (6-12 months vs. 12.1-72 months), the between-group differences were nonsignificant. Also, no ISWT differences between the intervention and control group were found for those with higher pulmonary embolism severity and dyspnea scores. The walk endurance test revealed no between-group differences.

Scores at follow-up on the Pulmonary Embolism-QoL questionnaire favored the rehabilitation group (mean difference –4%; P = .041), but there were no differences in generic QoL, dyspnea scores, or the ESWT.

“The present study adds to the growing evidence of the benefits of rehabilitation after PE,” the researchers stated. Although several recent studies have shown rehabilitation after PE results that were promising, the authors pointed out that most of these studies have been small or have lacked a control group, with great variations between them with respect to time, mode, and duration of intervention. In addition, the current study is the largest one addressing the effect of rehabilitation after PE to demonstrate in subjects with persistent dyspnea a positive effect on exercise capacity and QoL.

The researchers also commented that the small detected mean difference of 53 m in walking distance was lower than has been considered a worthwhile improvement by some, and its clinical relevance can be debated. Other studies, however, have used mean group differences of 40-62 m as clinically meaningful. The authors underscored also that the ISWT data were subject to a considerable ceiling effect which may underestimate the effect size.

Addressing study limitations, the researchers added that: “The rehabilitation program in the present study consisted mainly of exercise training. It is unknown whether the addition of occupational therapy, psychology, or dietary therapy would provide additional benefits for the participants. Most participants had mild symptoms, which may have limited the potential benefits of our rehabilitation program.”

The project was funded by Østfold Hospital Trust. Dr. Jervan reported no relevant conflicts of interest.

Baseline depression was significantly associated with recovered, incident, and persistent metabolic syndrome, based on data from more than 13,000 individuals.

Previous research has established a connection between metabolic syndrome and depression, but data on the increased risk for depressed individuals to develop metabolic syndrome (MetS) are lacking, wrote Lara Onofre Ferriani, PhD, of Federal University of Espírito Santo, Vitoria, Brazil, and colleagues.

“Individuals with MetS and depression have increased levels of inflammatory markers, and it is speculated that inflammation could mediate this comorbidity,” they said.

In a study published in the Journal of Psychiatric Research, the investigators reviewed data from 13,883 participants in the Brazilian Longitudinal Study of Adult Health; all were civil servants at universities in Brazil. The participants ranged from 35 to 74 years of age, with a mean age of 51.9 years; 54.3% were women; and 52.4% were white; the mean follow-up period was 3.8 years.

The primary outcome was the association between depression diagnosis and severity on components of MetS at baseline and over a 4-year period. Participants were classified by MetS trajectory as recovered, incident, or persistent, and classified by depression status as without depression or with a mild, moderate, or severe current depressive episode. Depression status was based on the Clinical Interview Schedule Revised. MetS components and diagnosis were based on the National Cholesterol Education Program Adult Treatment Panel III.

In a logistic regression analysis, baseline depression was positively associated with recovered, incident, and persistent MetS (odds ratios, 1.59, 1.45, and 1.70, respectively).

Depression at baseline also was significantly associated with separate components of MetS: large waist circumference, high triglycerides, low high-density lipoprotein cholesterol, and hyperglycemia, with odds ratios of 1.47, 1.23, 1.30, and 1.38, respectively.

Although not seen at baseline, a significant positive association between baseline depression and the presence of three or more MetS components was noted at follow-up, with a positive dose-response effect, the researchers wrote in their discussion.

Not all associations were statistically significant, but this was mainly because of the small number of cases of moderate and severe depression, they said. However, the magnitude of associations was greater in severe depression, when compared with moderate and mild, which suggests that the risk of MetS may be higher in this population, they added.

The study findings were limited by several factors including the possible misclassification of depression, inability to differentiate among depressive subtypes, and the potential lack of generalizability to other populations beyond Brazilian civil servants, the researchers noted.

However, the results were strengthened by the large sample size and support the role of depression as a risk factor for MetS, they said. More research is needed to determine a bidirectional relationship and to assess the trajectory of depression after MetS develops, but the findings “highlight the need to investigate and manage metabolic and cardiovascular alterations in the presence of depression in clinical settings,” they concluded.

The study was supported by the Brazilian Ministry of Health (Science and Technology Department) and the Brazilian Ministry of Science, Technology and Innovation FINEP and CNPq, and by the Coordenaçaõ de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). The researchers had no financial conflicts to disclose.
 

Baseline depression was significantly associated with recovered, incident, and persistent metabolic syndrome, based on data from more than 13,000 individuals.

Previous research has established a connection between metabolic syndrome and depression, but data on the increased risk for depressed individuals to develop metabolic syndrome (MetS) are lacking, wrote Lara Onofre Ferriani, PhD, of Federal University of Espírito Santo, Vitoria, Brazil, and colleagues.

“Individuals with MetS and depression have increased levels of inflammatory markers, and it is speculated that inflammation could mediate this comorbidity,” they said.

In a study published in the Journal of Psychiatric Research, the investigators reviewed data from 13,883 participants in the Brazilian Longitudinal Study of Adult Health; all were civil servants at universities in Brazil. The participants ranged from 35 to 74 years of age, with a mean age of 51.9 years; 54.3% were women; and 52.4% were white; the mean follow-up period was 3.8 years.

The primary outcome was the association between depression diagnosis and severity on components of MetS at baseline and over a 4-year period. Participants were classified by MetS trajectory as recovered, incident, or persistent, and classified by depression status as without depression or with a mild, moderate, or severe current depressive episode. Depression status was based on the Clinical Interview Schedule Revised. MetS components and diagnosis were based on the National Cholesterol Education Program Adult Treatment Panel III.

In a logistic regression analysis, baseline depression was positively associated with recovered, incident, and persistent MetS (odds ratios, 1.59, 1.45, and 1.70, respectively).

Depression at baseline also was significantly associated with separate components of MetS: large waist circumference, high triglycerides, low high-density lipoprotein cholesterol, and hyperglycemia, with odds ratios of 1.47, 1.23, 1.30, and 1.38, respectively.

Although not seen at baseline, a significant positive association between baseline depression and the presence of three or more MetS components was noted at follow-up, with a positive dose-response effect, the researchers wrote in their discussion.

Not all associations were statistically significant, but this was mainly because of the small number of cases of moderate and severe depression, they said. However, the magnitude of associations was greater in severe depression, when compared with moderate and mild, which suggests that the risk of MetS may be higher in this population, they added.

The study findings were limited by several factors including the possible misclassification of depression, inability to differentiate among depressive subtypes, and the potential lack of generalizability to other populations beyond Brazilian civil servants, the researchers noted.

However, the results were strengthened by the large sample size and support the role of depression as a risk factor for MetS, they said. More research is needed to determine a bidirectional relationship and to assess the trajectory of depression after MetS develops, but the findings “highlight the need to investigate and manage metabolic and cardiovascular alterations in the presence of depression in clinical settings,” they concluded.

The study was supported by the Brazilian Ministry of Health (Science and Technology Department) and the Brazilian Ministry of Science, Technology and Innovation FINEP and CNPq, and by the Coordenaçaõ de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). The researchers had no financial conflicts to disclose.
 

Baseline depression was significantly associated with recovered, incident, and persistent metabolic syndrome, based on data from more than 13,000 individuals.

Previous research has established a connection between metabolic syndrome and depression, but data on the increased risk for depressed individuals to develop metabolic syndrome (MetS) are lacking, wrote Lara Onofre Ferriani, PhD, of Federal University of Espírito Santo, Vitoria, Brazil, and colleagues.

“Individuals with MetS and depression have increased levels of inflammatory markers, and it is speculated that inflammation could mediate this comorbidity,” they said.

In a study published in the Journal of Psychiatric Research, the investigators reviewed data from 13,883 participants in the Brazilian Longitudinal Study of Adult Health; all were civil servants at universities in Brazil. The participants ranged from 35 to 74 years of age, with a mean age of 51.9 years; 54.3% were women; and 52.4% were white; the mean follow-up period was 3.8 years.

The primary outcome was the association between depression diagnosis and severity on components of MetS at baseline and over a 4-year period. Participants were classified by MetS trajectory as recovered, incident, or persistent, and classified by depression status as without depression or with a mild, moderate, or severe current depressive episode. Depression status was based on the Clinical Interview Schedule Revised. MetS components and diagnosis were based on the National Cholesterol Education Program Adult Treatment Panel III.

In a logistic regression analysis, baseline depression was positively associated with recovered, incident, and persistent MetS (odds ratios, 1.59, 1.45, and 1.70, respectively).

Depression at baseline also was significantly associated with separate components of MetS: large waist circumference, high triglycerides, low high-density lipoprotein cholesterol, and hyperglycemia, with odds ratios of 1.47, 1.23, 1.30, and 1.38, respectively.

Although not seen at baseline, a significant positive association between baseline depression and the presence of three or more MetS components was noted at follow-up, with a positive dose-response effect, the researchers wrote in their discussion.

Not all associations were statistically significant, but this was mainly because of the small number of cases of moderate and severe depression, they said. However, the magnitude of associations was greater in severe depression, when compared with moderate and mild, which suggests that the risk of MetS may be higher in this population, they added.

The study findings were limited by several factors including the possible misclassification of depression, inability to differentiate among depressive subtypes, and the potential lack of generalizability to other populations beyond Brazilian civil servants, the researchers noted.

However, the results were strengthened by the large sample size and support the role of depression as a risk factor for MetS, they said. More research is needed to determine a bidirectional relationship and to assess the trajectory of depression after MetS develops, but the findings “highlight the need to investigate and manage metabolic and cardiovascular alterations in the presence of depression in clinical settings,” they concluded.

The study was supported by the Brazilian Ministry of Health (Science and Technology Department) and the Brazilian Ministry of Science, Technology and Innovation FINEP and CNPq, and by the Coordenaçaõ de Aperfeiçoamento de Pessoal de Nível Superior – Brasil (CAPES). The researchers had no financial conflicts to disclose.
 

On Thanksgiving Day 2022, Kathy Stark watched as her husband of 35 years, Bobby Ray Stark, caught fire at a Nashville hospital. According to Clint Kelly, Kathy Stark’s attorney, the hospital staff was performing cardioversion to restore Bobby Ray’s heart rhythm when a spark ignited the oxygen and set the patient aflame.

Mr. Stark, 64, died of “a combination of cardiovascular disease and thermal burns,” according to a local news report. In May, Kathy Stark filed a malpractice lawsuit in U.S. District Court. Mr. Kelly hopes that the lawsuit will help improve patient safety. Meanwhile, Kathy Stark “goes to bed at night and sees her husband on fire,” Mr. Kelly says. A similar incident occurred last December in the operating room at Oregon Health & Science University, resulting in minor injuries to a patient.

Surgical fires happen rarely, but they can pose serious threats to patients and result in litigation against physicians and hospitals.
 

Underreported, but likely dropping

Reliable data on the incidence of surgical fires is lacking because incidents may go unreported over litigation fears, says Jeffrey Feldman, MD, MSE, anesthesiologist at Children’s Hospital of Philadelphia and chair of the Anesthesia Patient Safety Foundation’s Committee on Technology.

The Pennsylvania Patient Safety Authority has been tracking surgical fires for decades, however, and experts have used the agency’s data to extrapolate how often they occur in the United States.

In 2005, nationwide incidence was estimated to be somewhere in the neighborhood of 550-600 fires annually, says Barbara G. Malanga, acting director of health care incident investigation and technology consulting at ECRI (formerly the Emergency Care Research Institute). By 2011, that number appeared to have dropped to 200-240 incidents per year.

A similar analysis in 2018 found the incidence may now be as low as 88-105 a year. The drop is likely a result of increased awareness because of educational efforts on the part of the ECRI and the APSF, including a widely disseminated video on fire safety.

The decline of surgical fires “sounds great,” says Dr. Feldman, “except that it’s a 100% preventable complication, and they’re still happening.”
 

Accidents waiting to happen

How do these fires happen? It comes down to the ‘fire triangle’ often taught in grade school. Fire requires three things: an ignition source, fuel, and oxygen or an oxidizing agent. Ignition sources are plentiful in a surgical suite, including any of a variety of electrical devices commonly used in surgical procedures, including defibrillators. Gowns, gauze, drapes, sponges, oxygen masks, nasal cannulae, a patient’s hair or their clothing – all provide the necessary fuel.

But the key factor for surgical fire risk is the presence of high concentrations of oxygen.
 

Safety protocols

The best and most obvious way to mitigate risk is to reduce the amount of supplemental oxygen, explains Dr. Feldman.

“Many patients do not require a high concentration of oxygen during sedation,” he says.

When a patient does require a higher concentration for their safety, the APSF and ECRI recommend placing an endotracheal tube or supraglottic airway rather than using an oxygen mask or a nasal cannula. “You want to deliver the oxygen in such a way that high concentration doesn’t exist in the surgical field,” Dr. Feldman says. In cases where supplemental oxygen is necessary, ECRI and APSF recommend reducing the oxygen concentration to less than 30%.

In addition, safety protocols include giving flammable prep solutions time to dry before applying towels or drapes and beginning the procedure. These precautions to ensure the safety of patients take just a moment, says Chester H. Lake Jr, MD, MS, of the department of anesthesiology at the University of Mississippi Medical Center, Jackson.
 

Making fire safety part of the preop routine

These safety protocols are straightforward but not always observed, experts say. Part of the reason is a matter of culture. Both anesthesiologists and surgeons have absorbed the attitude that placing an airway escalates the procedure beyond what the patient needs, says Dr. Feldman. And indeed, according to a 2013 analysis of the American Society of Anesthesiologists closed claims database, 85% of surgical fires occur in outpatient settings where airways are less likely to be placed, and 81% of those claims were for procedures that used monitored anesthesia care.

In an article on prevention of surgical fires, Dr. Lake and colleagues recommend in-house education on preventing and responding to fires at least once a year. But it shouldn’t stop there. Because these fires – horrific as they are – are fairly rare, it’s important to maintain awareness. Making fire safety a regular part of the surgical “time-out” can help further reduce incidents, he says. ECRI and the APSF have teamed up to create a poster that can help surgical teams make fire safety a regular part of their routines.

Although the national decline in surgical fires is encouraging, the problem remains serious. “You can classify these incidents as low, but it’s not low if it happens to you or a family member,” says Dr. Lake. “One is too many.”

ECRI’s Ms. Malanga agrees. “I do like to emphasize that it’s rare,” she says. “But I’d like to see us reduce this until it’s zero.”

A version of this article originally appeared on Medscape.com.

On Thanksgiving Day 2022, Kathy Stark watched as her husband of 35 years, Bobby Ray Stark, caught fire at a Nashville hospital. According to Clint Kelly, Kathy Stark’s attorney, the hospital staff was performing cardioversion to restore Bobby Ray’s heart rhythm when a spark ignited the oxygen and set the patient aflame.

Mr. Stark, 64, died of “a combination of cardiovascular disease and thermal burns,” according to a local news report. In May, Kathy Stark filed a malpractice lawsuit in U.S. District Court. Mr. Kelly hopes that the lawsuit will help improve patient safety. Meanwhile, Kathy Stark “goes to bed at night and sees her husband on fire,” Mr. Kelly says. A similar incident occurred last December in the operating room at Oregon Health & Science University, resulting in minor injuries to a patient.

Surgical fires happen rarely, but they can pose serious threats to patients and result in litigation against physicians and hospitals.
 

Underreported, but likely dropping

Reliable data on the incidence of surgical fires is lacking because incidents may go unreported over litigation fears, says Jeffrey Feldman, MD, MSE, anesthesiologist at Children’s Hospital of Philadelphia and chair of the Anesthesia Patient Safety Foundation’s Committee on Technology.

The Pennsylvania Patient Safety Authority has been tracking surgical fires for decades, however, and experts have used the agency’s data to extrapolate how often they occur in the United States.

In 2005, nationwide incidence was estimated to be somewhere in the neighborhood of 550-600 fires annually, says Barbara G. Malanga, acting director of health care incident investigation and technology consulting at ECRI (formerly the Emergency Care Research Institute). By 2011, that number appeared to have dropped to 200-240 incidents per year.

A similar analysis in 2018 found the incidence may now be as low as 88-105 a year. The drop is likely a result of increased awareness because of educational efforts on the part of the ECRI and the APSF, including a widely disseminated video on fire safety.

The decline of surgical fires “sounds great,” says Dr. Feldman, “except that it’s a 100% preventable complication, and they’re still happening.”
 

Accidents waiting to happen

How do these fires happen? It comes down to the ‘fire triangle’ often taught in grade school. Fire requires three things: an ignition source, fuel, and oxygen or an oxidizing agent. Ignition sources are plentiful in a surgical suite, including any of a variety of electrical devices commonly used in surgical procedures, including defibrillators. Gowns, gauze, drapes, sponges, oxygen masks, nasal cannulae, a patient’s hair or their clothing – all provide the necessary fuel.

But the key factor for surgical fire risk is the presence of high concentrations of oxygen.
 

Safety protocols

The best and most obvious way to mitigate risk is to reduce the amount of supplemental oxygen, explains Dr. Feldman.

“Many patients do not require a high concentration of oxygen during sedation,” he says.

When a patient does require a higher concentration for their safety, the APSF and ECRI recommend placing an endotracheal tube or supraglottic airway rather than using an oxygen mask or a nasal cannula. “You want to deliver the oxygen in such a way that high concentration doesn’t exist in the surgical field,” Dr. Feldman says. In cases where supplemental oxygen is necessary, ECRI and APSF recommend reducing the oxygen concentration to less than 30%.

In addition, safety protocols include giving flammable prep solutions time to dry before applying towels or drapes and beginning the procedure. These precautions to ensure the safety of patients take just a moment, says Chester H. Lake Jr, MD, MS, of the department of anesthesiology at the University of Mississippi Medical Center, Jackson.
 

Making fire safety part of the preop routine

These safety protocols are straightforward but not always observed, experts say. Part of the reason is a matter of culture. Both anesthesiologists and surgeons have absorbed the attitude that placing an airway escalates the procedure beyond what the patient needs, says Dr. Feldman. And indeed, according to a 2013 analysis of the American Society of Anesthesiologists closed claims database, 85% of surgical fires occur in outpatient settings where airways are less likely to be placed, and 81% of those claims were for procedures that used monitored anesthesia care.

In an article on prevention of surgical fires, Dr. Lake and colleagues recommend in-house education on preventing and responding to fires at least once a year. But it shouldn’t stop there. Because these fires – horrific as they are – are fairly rare, it’s important to maintain awareness. Making fire safety a regular part of the surgical “time-out” can help further reduce incidents, he says. ECRI and the APSF have teamed up to create a poster that can help surgical teams make fire safety a regular part of their routines.

Although the national decline in surgical fires is encouraging, the problem remains serious. “You can classify these incidents as low, but it’s not low if it happens to you or a family member,” says Dr. Lake. “One is too many.”

ECRI’s Ms. Malanga agrees. “I do like to emphasize that it’s rare,” she says. “But I’d like to see us reduce this until it’s zero.”

A version of this article originally appeared on Medscape.com.

On Thanksgiving Day 2022, Kathy Stark watched as her husband of 35 years, Bobby Ray Stark, caught fire at a Nashville hospital. According to Clint Kelly, Kathy Stark’s attorney, the hospital staff was performing cardioversion to restore Bobby Ray’s heart rhythm when a spark ignited the oxygen and set the patient aflame.

Mr. Stark, 64, died of “a combination of cardiovascular disease and thermal burns,” according to a local news report. In May, Kathy Stark filed a malpractice lawsuit in U.S. District Court. Mr. Kelly hopes that the lawsuit will help improve patient safety. Meanwhile, Kathy Stark “goes to bed at night and sees her husband on fire,” Mr. Kelly says. A similar incident occurred last December in the operating room at Oregon Health & Science University, resulting in minor injuries to a patient.

Surgical fires happen rarely, but they can pose serious threats to patients and result in litigation against physicians and hospitals.
 

Underreported, but likely dropping

Reliable data on the incidence of surgical fires is lacking because incidents may go unreported over litigation fears, says Jeffrey Feldman, MD, MSE, anesthesiologist at Children’s Hospital of Philadelphia and chair of the Anesthesia Patient Safety Foundation’s Committee on Technology.

The Pennsylvania Patient Safety Authority has been tracking surgical fires for decades, however, and experts have used the agency’s data to extrapolate how often they occur in the United States.

In 2005, nationwide incidence was estimated to be somewhere in the neighborhood of 550-600 fires annually, says Barbara G. Malanga, acting director of health care incident investigation and technology consulting at ECRI (formerly the Emergency Care Research Institute). By 2011, that number appeared to have dropped to 200-240 incidents per year.

A similar analysis in 2018 found the incidence may now be as low as 88-105 a year. The drop is likely a result of increased awareness because of educational efforts on the part of the ECRI and the APSF, including a widely disseminated video on fire safety.

The decline of surgical fires “sounds great,” says Dr. Feldman, “except that it’s a 100% preventable complication, and they’re still happening.”
 

Accidents waiting to happen

How do these fires happen? It comes down to the ‘fire triangle’ often taught in grade school. Fire requires three things: an ignition source, fuel, and oxygen or an oxidizing agent. Ignition sources are plentiful in a surgical suite, including any of a variety of electrical devices commonly used in surgical procedures, including defibrillators. Gowns, gauze, drapes, sponges, oxygen masks, nasal cannulae, a patient’s hair or their clothing – all provide the necessary fuel.

But the key factor for surgical fire risk is the presence of high concentrations of oxygen.
 

Safety protocols

The best and most obvious way to mitigate risk is to reduce the amount of supplemental oxygen, explains Dr. Feldman.

“Many patients do not require a high concentration of oxygen during sedation,” he says.

When a patient does require a higher concentration for their safety, the APSF and ECRI recommend placing an endotracheal tube or supraglottic airway rather than using an oxygen mask or a nasal cannula. “You want to deliver the oxygen in such a way that high concentration doesn’t exist in the surgical field,” Dr. Feldman says. In cases where supplemental oxygen is necessary, ECRI and APSF recommend reducing the oxygen concentration to less than 30%.

In addition, safety protocols include giving flammable prep solutions time to dry before applying towels or drapes and beginning the procedure. These precautions to ensure the safety of patients take just a moment, says Chester H. Lake Jr, MD, MS, of the department of anesthesiology at the University of Mississippi Medical Center, Jackson.
 

Making fire safety part of the preop routine

These safety protocols are straightforward but not always observed, experts say. Part of the reason is a matter of culture. Both anesthesiologists and surgeons have absorbed the attitude that placing an airway escalates the procedure beyond what the patient needs, says Dr. Feldman. And indeed, according to a 2013 analysis of the American Society of Anesthesiologists closed claims database, 85% of surgical fires occur in outpatient settings where airways are less likely to be placed, and 81% of those claims were for procedures that used monitored anesthesia care.

In an article on prevention of surgical fires, Dr. Lake and colleagues recommend in-house education on preventing and responding to fires at least once a year. But it shouldn’t stop there. Because these fires – horrific as they are – are fairly rare, it’s important to maintain awareness. Making fire safety a regular part of the surgical “time-out” can help further reduce incidents, he says. ECRI and the APSF have teamed up to create a poster that can help surgical teams make fire safety a regular part of their routines.

Although the national decline in surgical fires is encouraging, the problem remains serious. “You can classify these incidents as low, but it’s not low if it happens to you or a family member,” says Dr. Lake. “One is too many.”

ECRI’s Ms. Malanga agrees. “I do like to emphasize that it’s rare,” she says. “But I’d like to see us reduce this until it’s zero.”

A version of this article originally appeared on Medscape.com.

Three big bumps on the weight-loss journey

The search for the Holy Grail. The destruction of the One Ring. The never-ending struggle to Lose Weight.

Like most legendary quests, weight loss is a journey, and we need support to help us achieve our goal. Maybe it’s gaining a new workout partner or finding a similarly-goaled Facebook Group. For a lot of people, it’s as simple as your friends and family. A recent study, however, suggests that the people closest to you may be your worst weight-loss enemies, and they might not even know it.

Spencer Davis/Unsplash

Researchers at the University of Surrey reviewed the literature on the positives and negatives of social support when it comes to weight loss and identified three types of negative effects: acts of sabotage, feeding behavior, and collusion.

Let’s start with the softest of intentions and work our way up. Collusion is the least negative. Friends and family may just go with the flow, even if it doesn’t agree with the goals of the person who’s trying to lose weight. It can even happen when health care professionals try to help their patients navigate or avoid obesity, ultimately killing with kindness, so to speak.

Next up, feeding behavior. Maybe you know someone whose love language is cooking. There are also people who share food because they don’t want to waste it or because they’re trying to be polite. They act out of the goodness of their hearts, but they’re putting up roadblocks to someone’s goals. These types of acts are usually one-sided, the researchers found. Remember, it’s okay to say, “No thanks.”

The last method, sabotage, is the most sinister. The saboteur may discourage others from eating healthy, undermine their efforts to be physically active, or take jabs at their confidence or self-esteem. Something as simple as criticizing someone for eating a salad or refusing to go on a walk with them can cause a setback.

“We need to explore this area further to develop interventions which could target family and friends and help them be more supportive in helping those they are close to lose weight,” said lead author Jane Odgen, PhD, of the University of Surrey, Guildford, England.

Like we said before, weight loss is a journey. The right support can only improve the odds of success.
 

Robots vs. mosquitoes

If there’s one thing robots are bad at, it’s giving solid mental health advice to people in crisis. If there’s one thing robots are very, very good at, it’s causing apocalypses. And joyous day for humanity, this time we’re not the ones being apocalypsed.

Yet.

Liu et al., 2023, PLOS Neglected Tropical Diseases, CC-BY 4.0

Taiwan has a big mosquito problem. Not only do the mosquitoes in Taiwan carry dengue – among other dangerous diseases – but they’ve urbanized. Not urbanized in the sense that they’ve acquired a taste for organic coffee and avocado toast (that would be the millennial mosquito, a separate but even more terrifying creature), but more that they’ve adapted to reproduce literally anywhere and everywhere. Taiwanese mosquitoes like to breed in roadside sewer ditches, and this is where our genocidal robot comes in.

To combat the new, dangerous form of street-savvy mosquito, researchers built a robot armed with both insecticide and high-temperature, high-pressure water jets and sent it into the sewers of Kaohsiung City. The robot’s goal was simple: Whenever it came across signs of heavy mosquito breeding – eggs, larvae, pupae, and so on – the robot went to work. Utilizing both its primary weapons, the robot scrubbed numerous breeding sites across the city clean.

The researchers could just sit back and wait to see how effective their robot was. In the immediate aftermath, at various monitoring sites placed alongside the ditches, adult mosquito density fell by two-thirds in areas targeted by the robot. That’s nothing to sniff at, and it does make sense. After all, mosquitoes are quite difficult to kill in their adult stage, why not target them when they’re young and basically immobile?

The researchers saw promise with their mosquito-killing robot, but we’ve noticed a rather large issue. Killing two-thirds of mosquitoes is fine, but the third that’s left will be very angry. Very angry indeed. After all, we’re targeting the mosquito equivalent of children. Let’s hope our mosquito Terminator managed to kill mosquito Sarah Connor, or we’re going to have a big problem on our hands a bit later down the line.
 

This is knot what you were expecting

Physicians who aren’t surgeons probably don’t realize it, but the big thing that’s been getting between the knot-tying specialists and perfect suturing technique all these years is a lack of physics. Don’t believe us? Well, maybe you’ll believe plastic surgeon Samia Guerid, MD, of Lausanne, Switzerland: “The lack of physics-based analysis has been a limitation.” Nuff said.

Alain Herzog / EPFL

That’s not enough for you, is it? Fine, we were warned.

Any surgical knot, Dr. Guerid and associates explained in a written statement, involves the “complex interplay” between six key factors: topology, geometry, elasticity, contact, friction, and polymer plasticity of the suturing filament. The strength of a suture “depends on the tension applied during the tying of the knot, [which] permanently deforms, or stretches the filament, creating a holding force.” Not enough tension and the knot comes undone, while too much snaps the filament.

For the experiment, Dr. Guerid tied a few dozen surgical knots, which were then scanned using x-ray micro–computed tomography to facilitate finite element modeling with a “3D continuum-level constitutive model for elastic-viscoplastic mechanical behavior” – no, we have no idea what that means, either – developed by the research team.

That model, and a great deal of math – so much math – allowed the researchers to define a threshold between loose and tight knots and uncover “relationships between knot strength and pretension, friction, and number of throws,” they said.

But what about the big question? The one about the ideal amount of tension? You may want to sit down. The answer to the ultimate question of the relationship between knot pretension and strength is … Did we mention that the team had its own mathematician? Their predictive model for safe knot-tying is … You’re not going to like this. The best way to teach safe knot-tying to both trainees and robots is … not ready yet.

The secret to targeting the knot tension sweet spot, for now, anyway, is still intuition gained from years of experience. Nobody ever said science was perfect … or easy … or quick.

Three big bumps on the weight-loss journey

The search for the Holy Grail. The destruction of the One Ring. The never-ending struggle to Lose Weight.

Like most legendary quests, weight loss is a journey, and we need support to help us achieve our goal. Maybe it’s gaining a new workout partner or finding a similarly-goaled Facebook Group. For a lot of people, it’s as simple as your friends and family. A recent study, however, suggests that the people closest to you may be your worst weight-loss enemies, and they might not even know it.

Spencer Davis/Unsplash

Researchers at the University of Surrey reviewed the literature on the positives and negatives of social support when it comes to weight loss and identified three types of negative effects: acts of sabotage, feeding behavior, and collusion.

Let’s start with the softest of intentions and work our way up. Collusion is the least negative. Friends and family may just go with the flow, even if it doesn’t agree with the goals of the person who’s trying to lose weight. It can even happen when health care professionals try to help their patients navigate or avoid obesity, ultimately killing with kindness, so to speak.

Next up, feeding behavior. Maybe you know someone whose love language is cooking. There are also people who share food because they don’t want to waste it or because they’re trying to be polite. They act out of the goodness of their hearts, but they’re putting up roadblocks to someone’s goals. These types of acts are usually one-sided, the researchers found. Remember, it’s okay to say, “No thanks.”

The last method, sabotage, is the most sinister. The saboteur may discourage others from eating healthy, undermine their efforts to be physically active, or take jabs at their confidence or self-esteem. Something as simple as criticizing someone for eating a salad or refusing to go on a walk with them can cause a setback.

“We need to explore this area further to develop interventions which could target family and friends and help them be more supportive in helping those they are close to lose weight,” said lead author Jane Odgen, PhD, of the University of Surrey, Guildford, England.

Like we said before, weight loss is a journey. The right support can only improve the odds of success.
 

Robots vs. mosquitoes

If there’s one thing robots are bad at, it’s giving solid mental health advice to people in crisis. If there’s one thing robots are very, very good at, it’s causing apocalypses. And joyous day for humanity, this time we’re not the ones being apocalypsed.

Yet.

Liu et al., 2023, PLOS Neglected Tropical Diseases, CC-BY 4.0

Taiwan has a big mosquito problem. Not only do the mosquitoes in Taiwan carry dengue – among other dangerous diseases – but they’ve urbanized. Not urbanized in the sense that they’ve acquired a taste for organic coffee and avocado toast (that would be the millennial mosquito, a separate but even more terrifying creature), but more that they’ve adapted to reproduce literally anywhere and everywhere. Taiwanese mosquitoes like to breed in roadside sewer ditches, and this is where our genocidal robot comes in.

To combat the new, dangerous form of street-savvy mosquito, researchers built a robot armed with both insecticide and high-temperature, high-pressure water jets and sent it into the sewers of Kaohsiung City. The robot’s goal was simple: Whenever it came across signs of heavy mosquito breeding – eggs, larvae, pupae, and so on – the robot went to work. Utilizing both its primary weapons, the robot scrubbed numerous breeding sites across the city clean.

The researchers could just sit back and wait to see how effective their robot was. In the immediate aftermath, at various monitoring sites placed alongside the ditches, adult mosquito density fell by two-thirds in areas targeted by the robot. That’s nothing to sniff at, and it does make sense. After all, mosquitoes are quite difficult to kill in their adult stage, why not target them when they’re young and basically immobile?

The researchers saw promise with their mosquito-killing robot, but we’ve noticed a rather large issue. Killing two-thirds of mosquitoes is fine, but the third that’s left will be very angry. Very angry indeed. After all, we’re targeting the mosquito equivalent of children. Let’s hope our mosquito Terminator managed to kill mosquito Sarah Connor, or we’re going to have a big problem on our hands a bit later down the line.
 

This is knot what you were expecting

Physicians who aren’t surgeons probably don’t realize it, but the big thing that’s been getting between the knot-tying specialists and perfect suturing technique all these years is a lack of physics. Don’t believe us? Well, maybe you’ll believe plastic surgeon Samia Guerid, MD, of Lausanne, Switzerland: “The lack of physics-based analysis has been a limitation.” Nuff said.

Alain Herzog / EPFL

That’s not enough for you, is it? Fine, we were warned.

Any surgical knot, Dr. Guerid and associates explained in a written statement, involves the “complex interplay” between six key factors: topology, geometry, elasticity, contact, friction, and polymer plasticity of the suturing filament. The strength of a suture “depends on the tension applied during the tying of the knot, [which] permanently deforms, or stretches the filament, creating a holding force.” Not enough tension and the knot comes undone, while too much snaps the filament.

For the experiment, Dr. Guerid tied a few dozen surgical knots, which were then scanned using x-ray micro–computed tomography to facilitate finite element modeling with a “3D continuum-level constitutive model for elastic-viscoplastic mechanical behavior” – no, we have no idea what that means, either – developed by the research team.

That model, and a great deal of math – so much math – allowed the researchers to define a threshold between loose and tight knots and uncover “relationships between knot strength and pretension, friction, and number of throws,” they said.

But what about the big question? The one about the ideal amount of tension? You may want to sit down. The answer to the ultimate question of the relationship between knot pretension and strength is … Did we mention that the team had its own mathematician? Their predictive model for safe knot-tying is … You’re not going to like this. The best way to teach safe knot-tying to both trainees and robots is … not ready yet.

The secret to targeting the knot tension sweet spot, for now, anyway, is still intuition gained from years of experience. Nobody ever said science was perfect … or easy … or quick.

Three big bumps on the weight-loss journey

The search for the Holy Grail. The destruction of the One Ring. The never-ending struggle to Lose Weight.

Like most legendary quests, weight loss is a journey, and we need support to help us achieve our goal. Maybe it’s gaining a new workout partner or finding a similarly-goaled Facebook Group. For a lot of people, it’s as simple as your friends and family. A recent study, however, suggests that the people closest to you may be your worst weight-loss enemies, and they might not even know it.

Spencer Davis/Unsplash

Researchers at the University of Surrey reviewed the literature on the positives and negatives of social support when it comes to weight loss and identified three types of negative effects: acts of sabotage, feeding behavior, and collusion.

Let’s start with the softest of intentions and work our way up. Collusion is the least negative. Friends and family may just go with the flow, even if it doesn’t agree with the goals of the person who’s trying to lose weight. It can even happen when health care professionals try to help their patients navigate or avoid obesity, ultimately killing with kindness, so to speak.

Next up, feeding behavior. Maybe you know someone whose love language is cooking. There are also people who share food because they don’t want to waste it or because they’re trying to be polite. They act out of the goodness of their hearts, but they’re putting up roadblocks to someone’s goals. These types of acts are usually one-sided, the researchers found. Remember, it’s okay to say, “No thanks.”

The last method, sabotage, is the most sinister. The saboteur may discourage others from eating healthy, undermine their efforts to be physically active, or take jabs at their confidence or self-esteem. Something as simple as criticizing someone for eating a salad or refusing to go on a walk with them can cause a setback.

“We need to explore this area further to develop interventions which could target family and friends and help them be more supportive in helping those they are close to lose weight,” said lead author Jane Odgen, PhD, of the University of Surrey, Guildford, England.

Like we said before, weight loss is a journey. The right support can only improve the odds of success.
 

Robots vs. mosquitoes

If there’s one thing robots are bad at, it’s giving solid mental health advice to people in crisis. If there’s one thing robots are very, very good at, it’s causing apocalypses. And joyous day for humanity, this time we’re not the ones being apocalypsed.

Yet.

Liu et al., 2023, PLOS Neglected Tropical Diseases, CC-BY 4.0

Taiwan has a big mosquito problem. Not only do the mosquitoes in Taiwan carry dengue – among other dangerous diseases – but they’ve urbanized. Not urbanized in the sense that they’ve acquired a taste for organic coffee and avocado toast (that would be the millennial mosquito, a separate but even more terrifying creature), but more that they’ve adapted to reproduce literally anywhere and everywhere. Taiwanese mosquitoes like to breed in roadside sewer ditches, and this is where our genocidal robot comes in.

To combat the new, dangerous form of street-savvy mosquito, researchers built a robot armed with both insecticide and high-temperature, high-pressure water jets and sent it into the sewers of Kaohsiung City. The robot’s goal was simple: Whenever it came across signs of heavy mosquito breeding – eggs, larvae, pupae, and so on – the robot went to work. Utilizing both its primary weapons, the robot scrubbed numerous breeding sites across the city clean.

The researchers could just sit back and wait to see how effective their robot was. In the immediate aftermath, at various monitoring sites placed alongside the ditches, adult mosquito density fell by two-thirds in areas targeted by the robot. That’s nothing to sniff at, and it does make sense. After all, mosquitoes are quite difficult to kill in their adult stage, why not target them when they’re young and basically immobile?

The researchers saw promise with their mosquito-killing robot, but we’ve noticed a rather large issue. Killing two-thirds of mosquitoes is fine, but the third that’s left will be very angry. Very angry indeed. After all, we’re targeting the mosquito equivalent of children. Let’s hope our mosquito Terminator managed to kill mosquito Sarah Connor, or we’re going to have a big problem on our hands a bit later down the line.
 

This is knot what you were expecting

Physicians who aren’t surgeons probably don’t realize it, but the big thing that’s been getting between the knot-tying specialists and perfect suturing technique all these years is a lack of physics. Don’t believe us? Well, maybe you’ll believe plastic surgeon Samia Guerid, MD, of Lausanne, Switzerland: “The lack of physics-based analysis has been a limitation.” Nuff said.

Alain Herzog / EPFL

That’s not enough for you, is it? Fine, we were warned.

Any surgical knot, Dr. Guerid and associates explained in a written statement, involves the “complex interplay” between six key factors: topology, geometry, elasticity, contact, friction, and polymer plasticity of the suturing filament. The strength of a suture “depends on the tension applied during the tying of the knot, [which] permanently deforms, or stretches the filament, creating a holding force.” Not enough tension and the knot comes undone, while too much snaps the filament.

For the experiment, Dr. Guerid tied a few dozen surgical knots, which were then scanned using x-ray micro–computed tomography to facilitate finite element modeling with a “3D continuum-level constitutive model for elastic-viscoplastic mechanical behavior” – no, we have no idea what that means, either – developed by the research team.

That model, and a great deal of math – so much math – allowed the researchers to define a threshold between loose and tight knots and uncover “relationships between knot strength and pretension, friction, and number of throws,” they said.

But what about the big question? The one about the ideal amount of tension? You may want to sit down. The answer to the ultimate question of the relationship between knot pretension and strength is … Did we mention that the team had its own mathematician? Their predictive model for safe knot-tying is … You’re not going to like this. The best way to teach safe knot-tying to both trainees and robots is … not ready yet.

The secret to targeting the knot tension sweet spot, for now, anyway, is still intuition gained from years of experience. Nobody ever said science was perfect … or easy … or quick.

A bill in the Maine legislature would have the medical malpractice statute of limitations clock start running when a patient discovers the negligence, which could be years after treatment took place. And other states could follow suit with similar bills. What danger does this pose for doctors?

As it stands, the time limit for patients to be able to bring a medical malpractice lawsuit varies by state. The bill that was introduced in Maine would enable patients to bring suits many years after treatment took place. For physicians, this extends their period of liability and could potentially increase the number of lawsuits against them.

“The theory behind a statute of limitations is that states want to provide a reasonable, but not indefinite, amount of time for someone to bring a case to court,” says Patrick T. O’Rourke, Esq., adjunct professor at University of Colorado School of Law, Boulder.

Without a statute of limitations, people could bring claims many years after the fact, which makes it harder to obtain and preserve evidence, Mr. O’Rourke says.

In most cases, it isn’t necessary for a patient to know the full extent of their injury or that their physician acted wrongfully or negligently for the statute of limitations to begin running.
 

Time of injury versus time of discovery

Most states’ laws dictate that the statute of limitations begins at a set time “after the cause of action accrues.” That means that the clock starts ticking from the date of the procedure, surgery, or treatment. In most states, that time is 2 or 3 years.

This can bar some patients from taking any action at all because the statute of limitations ran out. Because of these hurdles, the proposed bill in Maine would extend the statute of limitations.

Proponents of the bill say that patients would still have 3 years to file suit; it just changes when the clock starts. But opponents feel it could open the door to a limitless system in which people have an indefinite time to sue.

Many states already have discovery rules that extend the statute of limitations when the harm was not immediately obvious to the patient. The legal expectation is that patients who have significant pain or unexpected health conditions will seek medical treatment to investigate what’s wrong. Patients who don’t address the situation promptly are not protected by the discovery rule.

“It is the injured person’s obligation, once learning of the injury, to take action to protect their rights,” says Mr. O’Rourke.

Some states have also enacted other claims requirements in medical malpractice cases that are prerequisites for bringing lawsuits that have periods attached to them. For instance, in Florida, parties have 10 days to provide relevant medical records during the investigation period for a malpractice suit, and in Maine, before filing any malpractice action, a plaintiff must file a complaint with a prelitigation screening panel.
 

Medical malpractice statutes of limitations by state

Although each state has a basic statute of limitations, many states also include clauses for discovery rules. For example, in Vermont, in addition to the 3-year statute of limitations, a patient can pursue legal recourse “2 years from the date the injury is or reasonably should have been discovered, whichever occurs later, but not later than 7 years from the date of the incident.”

In some states, such as Virginia, special extensions apply in cases in which fraud, concealment, or intentional misrepresentation prevented discovery of the injury within the statute of limitations. And in most states, the statute of limitations is much longer for cases in which medical malpractice involves a child, usually at least until the child turns 18.
 

Statutes of limitations by state

1 Year: California, Kentucky, Louisiana, Ohio, Tennessee

2 Years: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, West Virginia, Wyoming

2.5 Years: New York

3 Years: Washington D.C., Maine, Maryland, Massachusetts, Montana, Nevada, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington, Wisconsin

4 Years: Minnesota
 

To protect yourself

Mr. O’Rourke says that if your state enacts a law that extends the statute of limitations for medical malpractice, there aren’t any proactive changes you need to make in terms of your day-to-day practice of medicine.

“Physicians should continue to provide care that is consistent with the standards of care for their specialty and ensure that the documentation accurately reflects the care they rendered,” he says.

Always be candid and up-front about a patient’s condition, Mr. O’Rourke says, especially if malpractice is on the table.

“If a physician misleads a patient about the nature or extent of an injury, that could prevent the statute of limitations from beginning to run,” he says. “Being open and honest about an injury doesn’t mean that a physician must admit any fault. The patient is owed timely, accurate, and candid information about their condition.”
 

Keep good records

If the statute of limitations increases, you’ll need to have access to the medical records for as long as the statute is in place, but this shouldn’t have an effect on your records keeping if you’re up to date with HIPAA compliance, says Mr. O’Rourke.

“I don’t think an extension of the statute should cause physicians to change their practices, particularly with the retention of medical records, which should be maintained consistently with HIPAA requirements irrespective of the limitations period in a particular state,” he adds.
 

Keep an eye on malpractice insurance rates

It’s possible that your malpractice insurance could go up as a result of laws that increase the statute of limitations. But Mr. O’Rourke thinks it likely won’t be a significant amount.

He says it’s “theoretically possible” that an increase in a limitations period could result in an increase in your malpractice insurance, since some claims that would otherwise have been barred because of time could then proceed, but the increase would be nominal.

“I would expect any increase to be fairly marginal because the majority of claims will already be accounted for on an actuarial basis,” he says. “I also don’t think that the extension of a limitations period would increase the award of damages in a particular case. The injuries should be the same under either limitations period, so the compensable loss should not increase.”

Anything that makes it easier for patients to recover should increase the cost of professional liability insurance, and vice versa, says Charles Silver, McDonald Endowed Chair in Civil Procedure at University of Texas at Austin School of Law and coauthor of “Medical Malpractice Litigation: How It Works – Why Tort Reform Hasn’t Helped.” But the long-term trend across the country is toward declining rates of liability and declining payouts on claims.

“The likelihood of being sued successfully by a former patient is low, as is the risk of having to pay out of pocket to settle a claim,” he says. In 2022, the number of adverse reports nationally was 38,938, and out of those, 10,807 resulted in a payout.

In his research on medical malpractice in Texas, Mr. Silver says physicians who carried $1 million in coverage essentially never faced any personal liability on medical malpractice claims. “[This means] that they never had to write a check to a victim,” he says. “Insurers provided all the money. I suspect that the same is true nationwide.”
 

Key takeaways

Ultimately, to protect yourself and your practice, you can do the following:

• Know the statute of limitations and discovery rules for your state.
• Review your coverage with your insurer to better understand your liability.
• Keep accurate records for as long as your statute requires.
• Notify your insurer or risk management department as soon as possible in the event of an adverse outcome with a patient, Mr. O’Rourke advises.

“The most important thing a physician can do to avoid being sued, even when negligent, is to treat patients with kindness and respect,” says Mr. Silver. “Patients don’t expect doctors to be perfect, and they rarely sue doctors they like.”

A version of this article first appeared on Medscape.com.

A bill in the Maine legislature would have the medical malpractice statute of limitations clock start running when a patient discovers the negligence, which could be years after treatment took place. And other states could follow suit with similar bills. What danger does this pose for doctors?

As it stands, the time limit for patients to be able to bring a medical malpractice lawsuit varies by state. The bill that was introduced in Maine would enable patients to bring suits many years after treatment took place. For physicians, this extends their period of liability and could potentially increase the number of lawsuits against them.

“The theory behind a statute of limitations is that states want to provide a reasonable, but not indefinite, amount of time for someone to bring a case to court,” says Patrick T. O’Rourke, Esq., adjunct professor at University of Colorado School of Law, Boulder.

Without a statute of limitations, people could bring claims many years after the fact, which makes it harder to obtain and preserve evidence, Mr. O’Rourke says.

In most cases, it isn’t necessary for a patient to know the full extent of their injury or that their physician acted wrongfully or negligently for the statute of limitations to begin running.
 

Time of injury versus time of discovery

Most states’ laws dictate that the statute of limitations begins at a set time “after the cause of action accrues.” That means that the clock starts ticking from the date of the procedure, surgery, or treatment. In most states, that time is 2 or 3 years.

This can bar some patients from taking any action at all because the statute of limitations ran out. Because of these hurdles, the proposed bill in Maine would extend the statute of limitations.

Proponents of the bill say that patients would still have 3 years to file suit; it just changes when the clock starts. But opponents feel it could open the door to a limitless system in which people have an indefinite time to sue.

Many states already have discovery rules that extend the statute of limitations when the harm was not immediately obvious to the patient. The legal expectation is that patients who have significant pain or unexpected health conditions will seek medical treatment to investigate what’s wrong. Patients who don’t address the situation promptly are not protected by the discovery rule.

“It is the injured person’s obligation, once learning of the injury, to take action to protect their rights,” says Mr. O’Rourke.

Some states have also enacted other claims requirements in medical malpractice cases that are prerequisites for bringing lawsuits that have periods attached to them. For instance, in Florida, parties have 10 days to provide relevant medical records during the investigation period for a malpractice suit, and in Maine, before filing any malpractice action, a plaintiff must file a complaint with a prelitigation screening panel.
 

Medical malpractice statutes of limitations by state

Although each state has a basic statute of limitations, many states also include clauses for discovery rules. For example, in Vermont, in addition to the 3-year statute of limitations, a patient can pursue legal recourse “2 years from the date the injury is or reasonably should have been discovered, whichever occurs later, but not later than 7 years from the date of the incident.”

In some states, such as Virginia, special extensions apply in cases in which fraud, concealment, or intentional misrepresentation prevented discovery of the injury within the statute of limitations. And in most states, the statute of limitations is much longer for cases in which medical malpractice involves a child, usually at least until the child turns 18.
 

Statutes of limitations by state

1 Year: California, Kentucky, Louisiana, Ohio, Tennessee

2 Years: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, West Virginia, Wyoming

2.5 Years: New York

3 Years: Washington D.C., Maine, Maryland, Massachusetts, Montana, Nevada, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington, Wisconsin

4 Years: Minnesota
 

To protect yourself

Mr. O’Rourke says that if your state enacts a law that extends the statute of limitations for medical malpractice, there aren’t any proactive changes you need to make in terms of your day-to-day practice of medicine.

“Physicians should continue to provide care that is consistent with the standards of care for their specialty and ensure that the documentation accurately reflects the care they rendered,” he says.

Always be candid and up-front about a patient’s condition, Mr. O’Rourke says, especially if malpractice is on the table.

“If a physician misleads a patient about the nature or extent of an injury, that could prevent the statute of limitations from beginning to run,” he says. “Being open and honest about an injury doesn’t mean that a physician must admit any fault. The patient is owed timely, accurate, and candid information about their condition.”
 

Keep good records

If the statute of limitations increases, you’ll need to have access to the medical records for as long as the statute is in place, but this shouldn’t have an effect on your records keeping if you’re up to date with HIPAA compliance, says Mr. O’Rourke.

“I don’t think an extension of the statute should cause physicians to change their practices, particularly with the retention of medical records, which should be maintained consistently with HIPAA requirements irrespective of the limitations period in a particular state,” he adds.
 

Keep an eye on malpractice insurance rates

It’s possible that your malpractice insurance could go up as a result of laws that increase the statute of limitations. But Mr. O’Rourke thinks it likely won’t be a significant amount.

He says it’s “theoretically possible” that an increase in a limitations period could result in an increase in your malpractice insurance, since some claims that would otherwise have been barred because of time could then proceed, but the increase would be nominal.

“I would expect any increase to be fairly marginal because the majority of claims will already be accounted for on an actuarial basis,” he says. “I also don’t think that the extension of a limitations period would increase the award of damages in a particular case. The injuries should be the same under either limitations period, so the compensable loss should not increase.”

Anything that makes it easier for patients to recover should increase the cost of professional liability insurance, and vice versa, says Charles Silver, McDonald Endowed Chair in Civil Procedure at University of Texas at Austin School of Law and coauthor of “Medical Malpractice Litigation: How It Works – Why Tort Reform Hasn’t Helped.” But the long-term trend across the country is toward declining rates of liability and declining payouts on claims.

“The likelihood of being sued successfully by a former patient is low, as is the risk of having to pay out of pocket to settle a claim,” he says. In 2022, the number of adverse reports nationally was 38,938, and out of those, 10,807 resulted in a payout.

In his research on medical malpractice in Texas, Mr. Silver says physicians who carried $1 million in coverage essentially never faced any personal liability on medical malpractice claims. “[This means] that they never had to write a check to a victim,” he says. “Insurers provided all the money. I suspect that the same is true nationwide.”
 

Key takeaways

Ultimately, to protect yourself and your practice, you can do the following:

• Know the statute of limitations and discovery rules for your state.
• Review your coverage with your insurer to better understand your liability.
• Keep accurate records for as long as your statute requires.
• Notify your insurer or risk management department as soon as possible in the event of an adverse outcome with a patient, Mr. O’Rourke advises.

“The most important thing a physician can do to avoid being sued, even when negligent, is to treat patients with kindness and respect,” says Mr. Silver. “Patients don’t expect doctors to be perfect, and they rarely sue doctors they like.”

A version of this article first appeared on Medscape.com.

A bill in the Maine legislature would have the medical malpractice statute of limitations clock start running when a patient discovers the negligence, which could be years after treatment took place. And other states could follow suit with similar bills. What danger does this pose for doctors?

As it stands, the time limit for patients to be able to bring a medical malpractice lawsuit varies by state. The bill that was introduced in Maine would enable patients to bring suits many years after treatment took place. For physicians, this extends their period of liability and could potentially increase the number of lawsuits against them.

“The theory behind a statute of limitations is that states want to provide a reasonable, but not indefinite, amount of time for someone to bring a case to court,” says Patrick T. O’Rourke, Esq., adjunct professor at University of Colorado School of Law, Boulder.

Without a statute of limitations, people could bring claims many years after the fact, which makes it harder to obtain and preserve evidence, Mr. O’Rourke says.

In most cases, it isn’t necessary for a patient to know the full extent of their injury or that their physician acted wrongfully or negligently for the statute of limitations to begin running.
 

Time of injury versus time of discovery

Most states’ laws dictate that the statute of limitations begins at a set time “after the cause of action accrues.” That means that the clock starts ticking from the date of the procedure, surgery, or treatment. In most states, that time is 2 or 3 years.

This can bar some patients from taking any action at all because the statute of limitations ran out. Because of these hurdles, the proposed bill in Maine would extend the statute of limitations.

Proponents of the bill say that patients would still have 3 years to file suit; it just changes when the clock starts. But opponents feel it could open the door to a limitless system in which people have an indefinite time to sue.

Many states already have discovery rules that extend the statute of limitations when the harm was not immediately obvious to the patient. The legal expectation is that patients who have significant pain or unexpected health conditions will seek medical treatment to investigate what’s wrong. Patients who don’t address the situation promptly are not protected by the discovery rule.

“It is the injured person’s obligation, once learning of the injury, to take action to protect their rights,” says Mr. O’Rourke.

Some states have also enacted other claims requirements in medical malpractice cases that are prerequisites for bringing lawsuits that have periods attached to them. For instance, in Florida, parties have 10 days to provide relevant medical records during the investigation period for a malpractice suit, and in Maine, before filing any malpractice action, a plaintiff must file a complaint with a prelitigation screening panel.
 

Medical malpractice statutes of limitations by state

Although each state has a basic statute of limitations, many states also include clauses for discovery rules. For example, in Vermont, in addition to the 3-year statute of limitations, a patient can pursue legal recourse “2 years from the date the injury is or reasonably should have been discovered, whichever occurs later, but not later than 7 years from the date of the incident.”

In some states, such as Virginia, special extensions apply in cases in which fraud, concealment, or intentional misrepresentation prevented discovery of the injury within the statute of limitations. And in most states, the statute of limitations is much longer for cases in which medical malpractice involves a child, usually at least until the child turns 18.
 

Statutes of limitations by state

1 Year: California, Kentucky, Louisiana, Ohio, Tennessee

2 Years: Alabama, Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Idaho, Illinois, Indiana, Iowa, Kansas, Michigan, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, North Dakota, Oklahoma, Oregon, Pennsylvania, South Dakota, Texas, Utah, Virginia, West Virginia, Wyoming

2.5 Years: New York

3 Years: Washington D.C., Maine, Maryland, Massachusetts, Montana, Nevada, New Mexico, North Carolina, Rhode Island, South Carolina, Vermont, Washington, Wisconsin

4 Years: Minnesota
 

To protect yourself

Mr. O’Rourke says that if your state enacts a law that extends the statute of limitations for medical malpractice, there aren’t any proactive changes you need to make in terms of your day-to-day practice of medicine.

“Physicians should continue to provide care that is consistent with the standards of care for their specialty and ensure that the documentation accurately reflects the care they rendered,” he says.

Always be candid and up-front about a patient’s condition, Mr. O’Rourke says, especially if malpractice is on the table.

“If a physician misleads a patient about the nature or extent of an injury, that could prevent the statute of limitations from beginning to run,” he says. “Being open and honest about an injury doesn’t mean that a physician must admit any fault. The patient is owed timely, accurate, and candid information about their condition.”
 

Keep good records

If the statute of limitations increases, you’ll need to have access to the medical records for as long as the statute is in place, but this shouldn’t have an effect on your records keeping if you’re up to date with HIPAA compliance, says Mr. O’Rourke.

“I don’t think an extension of the statute should cause physicians to change their practices, particularly with the retention of medical records, which should be maintained consistently with HIPAA requirements irrespective of the limitations period in a particular state,” he adds.
 

Keep an eye on malpractice insurance rates

It’s possible that your malpractice insurance could go up as a result of laws that increase the statute of limitations. But Mr. O’Rourke thinks it likely won’t be a significant amount.

He says it’s “theoretically possible” that an increase in a limitations period could result in an increase in your malpractice insurance, since some claims that would otherwise have been barred because of time could then proceed, but the increase would be nominal.

“I would expect any increase to be fairly marginal because the majority of claims will already be accounted for on an actuarial basis,” he says. “I also don’t think that the extension of a limitations period would increase the award of damages in a particular case. The injuries should be the same under either limitations period, so the compensable loss should not increase.”

Anything that makes it easier for patients to recover should increase the cost of professional liability insurance, and vice versa, says Charles Silver, McDonald Endowed Chair in Civil Procedure at University of Texas at Austin School of Law and coauthor of “Medical Malpractice Litigation: How It Works – Why Tort Reform Hasn’t Helped.” But the long-term trend across the country is toward declining rates of liability and declining payouts on claims.

“The likelihood of being sued successfully by a former patient is low, as is the risk of having to pay out of pocket to settle a claim,” he says. In 2022, the number of adverse reports nationally was 38,938, and out of those, 10,807 resulted in a payout.

In his research on medical malpractice in Texas, Mr. Silver says physicians who carried $1 million in coverage essentially never faced any personal liability on medical malpractice claims. “[This means] that they never had to write a check to a victim,” he says. “Insurers provided all the money. I suspect that the same is true nationwide.”
 

Key takeaways

Ultimately, to protect yourself and your practice, you can do the following:

• Know the statute of limitations and discovery rules for your state.
• Review your coverage with your insurer to better understand your liability.
• Keep accurate records for as long as your statute requires.
• Notify your insurer or risk management department as soon as possible in the event of an adverse outcome with a patient, Mr. O’Rourke advises.

“The most important thing a physician can do to avoid being sued, even when negligent, is to treat patients with kindness and respect,” says Mr. Silver. “Patients don’t expect doctors to be perfect, and they rarely sue doctors they like.”

A version of this article first appeared on Medscape.com.