Conference Coverage

An alarming increase in both esophageal cancer (EC) and the primary precursor lesion for esophageal adenocarcinoma known as Barrett’s esophagus (BE) has been observed among middle-aged adults over the past 5 years, and it’s not because of better or more frequent screening, warn the authors of a new study from Florida.

“We found that the [prevalence of] esophageal cancer and Barrett’s esophagus may have in fact plateaued in the elderly, but there is a concerning increase in their prevalence in middle-aged adults despite the fact that there has been no increase in the use of endoscopy in this population,” Bashar Qumseya, MD, MPH, associate professor of medicine and chief of endoscopy, University of Florida, Gainesville, told a press briefing.

“This should be of great concern to physicians and to patients, and it is our suggestion that maybe we should consider screening middle-aged patients or even those at younger ages for both conditions,” he added.

The study was highlighted during a press briefing in advance of the annual Digestive Disease Week® (DDW).
 

Research network

The analysis was carried out using electronic health records from the OneFlorida Clinical Data Research Network, a database that covers over 40% of residents living in Florida. The researchers identified patients who had been diagnosed with EC or BE between 2012 and 2019. “The primary outcome of interest was the adjusted prevalence of EC and BE in the population,” they stated.

The cohort was categorized by age: those aged 18-44 years (young); those aged 45-64 years (middle-aged), and those older than 65 (elderly). The number of patients included in the database varied by year and ranged from 4,238,884 to 5,411,838 patients per year, the investigators noted. Interestingly, in the most recent year, 2019, more women, at over 57%, were diagnosed with EC than were men.

Over the study interval, the prevalence of EC remained stable among the elderly but nearly doubled among middle-aged patients, from a rate of 49 per 100,000 in 2012 to a rate of 94 per 100,000 in 2019.

Similarly, there was a 50% increase in BE over the same study interval, from 304 per 100,000 in 2012 to 466 per 100,000 in 2019, again in the middle-aged group. The increase in the prevalence of BE was highest in those aged 51-60 years, followed by those aged 61-70 years and then by those aged 41-50.

Data from the same cohort also indicated that the great majority of patients with multiple risk factors for EC or BE – obesity, diet, and gastroesophageal reflux disease – had never undergone endoscopy, “so we can definitely do better,” Dr. Qumseya said. One simple way to “do better” is to offer patients an endoscopy when they undergo their first colonoscopy at the recommended age of 45 years.

“I am not in a position to make the guidelines,”Dr. Qumseya commented. “But we do [already] have guidelines that suggest that patients with multiple risk factors [for EC and BE] be screened, and since we know from our data that this is not happening, I believe that if a patient has multiple risk factors, they should have at least one screening endoscopy at the time of colonoscopy. Otherwise, we are missing a good opportunity to do so, and personally, I think this is something that we should be considering.”

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

An alarming increase in both esophageal cancer (EC) and the primary precursor lesion for esophageal adenocarcinoma known as Barrett’s esophagus (BE) has been observed among middle-aged adults over the past 5 years, and it’s not because of better or more frequent screening, warn the authors of a new study from Florida.

“We found that the [prevalence of] esophageal cancer and Barrett’s esophagus may have in fact plateaued in the elderly, but there is a concerning increase in their prevalence in middle-aged adults despite the fact that there has been no increase in the use of endoscopy in this population,” Bashar Qumseya, MD, MPH, associate professor of medicine and chief of endoscopy, University of Florida, Gainesville, told a press briefing.

“This should be of great concern to physicians and to patients, and it is our suggestion that maybe we should consider screening middle-aged patients or even those at younger ages for both conditions,” he added.

The study was highlighted during a press briefing in advance of the annual Digestive Disease Week® (DDW).
 

Research network

The analysis was carried out using electronic health records from the OneFlorida Clinical Data Research Network, a database that covers over 40% of residents living in Florida. The researchers identified patients who had been diagnosed with EC or BE between 2012 and 2019. “The primary outcome of interest was the adjusted prevalence of EC and BE in the population,” they stated.

The cohort was categorized by age: those aged 18-44 years (young); those aged 45-64 years (middle-aged), and those older than 65 (elderly). The number of patients included in the database varied by year and ranged from 4,238,884 to 5,411,838 patients per year, the investigators noted. Interestingly, in the most recent year, 2019, more women, at over 57%, were diagnosed with EC than were men.

Over the study interval, the prevalence of EC remained stable among the elderly but nearly doubled among middle-aged patients, from a rate of 49 per 100,000 in 2012 to a rate of 94 per 100,000 in 2019.

Similarly, there was a 50% increase in BE over the same study interval, from 304 per 100,000 in 2012 to 466 per 100,000 in 2019, again in the middle-aged group. The increase in the prevalence of BE was highest in those aged 51-60 years, followed by those aged 61-70 years and then by those aged 41-50.

Data from the same cohort also indicated that the great majority of patients with multiple risk factors for EC or BE – obesity, diet, and gastroesophageal reflux disease – had never undergone endoscopy, “so we can definitely do better,” Dr. Qumseya said. One simple way to “do better” is to offer patients an endoscopy when they undergo their first colonoscopy at the recommended age of 45 years.

“I am not in a position to make the guidelines,”Dr. Qumseya commented. “But we do [already] have guidelines that suggest that patients with multiple risk factors [for EC and BE] be screened, and since we know from our data that this is not happening, I believe that if a patient has multiple risk factors, they should have at least one screening endoscopy at the time of colonoscopy. Otherwise, we are missing a good opportunity to do so, and personally, I think this is something that we should be considering.”

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

An alarming increase in both esophageal cancer (EC) and the primary precursor lesion for esophageal adenocarcinoma known as Barrett’s esophagus (BE) has been observed among middle-aged adults over the past 5 years, and it’s not because of better or more frequent screening, warn the authors of a new study from Florida.

“We found that the [prevalence of] esophageal cancer and Barrett’s esophagus may have in fact plateaued in the elderly, but there is a concerning increase in their prevalence in middle-aged adults despite the fact that there has been no increase in the use of endoscopy in this population,” Bashar Qumseya, MD, MPH, associate professor of medicine and chief of endoscopy, University of Florida, Gainesville, told a press briefing.

“This should be of great concern to physicians and to patients, and it is our suggestion that maybe we should consider screening middle-aged patients or even those at younger ages for both conditions,” he added.

The study was highlighted during a press briefing in advance of the annual Digestive Disease Week® (DDW).
 

Research network

The analysis was carried out using electronic health records from the OneFlorida Clinical Data Research Network, a database that covers over 40% of residents living in Florida. The researchers identified patients who had been diagnosed with EC or BE between 2012 and 2019. “The primary outcome of interest was the adjusted prevalence of EC and BE in the population,” they stated.

The cohort was categorized by age: those aged 18-44 years (young); those aged 45-64 years (middle-aged), and those older than 65 (elderly). The number of patients included in the database varied by year and ranged from 4,238,884 to 5,411,838 patients per year, the investigators noted. Interestingly, in the most recent year, 2019, more women, at over 57%, were diagnosed with EC than were men.

Over the study interval, the prevalence of EC remained stable among the elderly but nearly doubled among middle-aged patients, from a rate of 49 per 100,000 in 2012 to a rate of 94 per 100,000 in 2019.

Similarly, there was a 50% increase in BE over the same study interval, from 304 per 100,000 in 2012 to 466 per 100,000 in 2019, again in the middle-aged group. The increase in the prevalence of BE was highest in those aged 51-60 years, followed by those aged 61-70 years and then by those aged 41-50.

Data from the same cohort also indicated that the great majority of patients with multiple risk factors for EC or BE – obesity, diet, and gastroesophageal reflux disease – had never undergone endoscopy, “so we can definitely do better,” Dr. Qumseya said. One simple way to “do better” is to offer patients an endoscopy when they undergo their first colonoscopy at the recommended age of 45 years.

“I am not in a position to make the guidelines,”Dr. Qumseya commented. “But we do [already] have guidelines that suggest that patients with multiple risk factors [for EC and BE] be screened, and since we know from our data that this is not happening, I believe that if a patient has multiple risk factors, they should have at least one screening endoscopy at the time of colonoscopy. Otherwise, we are missing a good opportunity to do so, and personally, I think this is something that we should be considering.”

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

Patients who have paclitaxel-coated stents and balloons have survival and outcomes comparable to those who have a bare-metal stent or percutaneous transluminal angioplasty, according to updated results from a large study of almost 170,000 Medicare beneficiaries.

The SAFE-PAD study analyzed Medicare claims data of 168,533 patients, including 70,584 who were treated with drug-coated devices (DCD), from April 2015 through 2018.

Notably, Eric A. Secemsky, MD, MSc, said in an interview, that included more than 32,000 patients with more than 5 years of follow-up. He presented the results at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.

“What we’re seeing now with this study is that paclitaxel-coated devices [PCDs] have the same long-term survival compared to those treated with non–drug-coated devices (NDCDs),” said Dr. Secemsky, director of vascular intervention at Beth Israel Deaconess Medical Center in Boston. “I think this is another important piece and some of the longest-term data in this size population to demonstrate the long-term safety of PCD, and hopefully it will help us get back to normal practice that has been halted now for over 3 years.”

That was a reference to the 2018 meta-analysis by Konstantinos Katsanos, MD, PhD, of Patras University in Greece, and colleagues, which showed an increased risk of death after PCD placements. That study threw a wet blanket of sorts on PCD use, Dr. Secemsky said.

The median follow-up for SAFE-PAD (formally called the Safety Assessment of Femoropopliteal Endovascular treatment with Paclitaxel-coated Devices) was 3.5 years, with the longest follow-up, 6.3 years. The weighted cumulative incidence of mortality at 6.3 years was 63.6% with NDCDs and 62.5% with DCDs (hazard ratio, 0.98; 95% confidence interval, 0.96-0.99; P < .0001). A subgroup analysis found no link between DCDs and increased death in low-risk patients, low-comorbid patients, inpatient or outpatient treatment, patients without critical limb ischemia, or patients treated with stents or balloon angioplasty alone.

“This report and the length of follow-up is one more piece that has continued to demonstrate safety with PCDs,” Dr. Secemsky said. He added that these results fall in line with smaller studies that failed to show a link between DCDs and long-term mortality, notably the SWEDEPAD randomized study of 2,289 patients evaluated through 4 years, and a subanalysis of 4,000 patients in VOYAGER-PAD through 42 months of follow-up.

“So we’ve really shown through these data sets and others that we can’t replicate any harms that we’ve seen in that Katsanos meta-analysis, and it suggests that there was some bias in that meta-analysis.”

Strengths of the study are its size and the way it followed the patients longitudinally, Sahil A. Parikh, MD, director of endovascular services at Columbia University Vagelos College of Physicians and Surgeons in New York, said in an interview.

With regard to its limitations, Dr. Parikh said, “On the other hand, it’s a claims database which doesn’t have the granularity about the patients’ specific procedural factors,” he said. “There are gaps that might further inform the value of lack thereof of the drug-coated device, but certainly at the topline, which is the hard endpoint of mortality, you can read quite a lot and you can assume that with such large numbers, the signal-to-noise ratio would be sufficiently sensitive that you get a real signal.”

With these updated SAFE-PAD results along with other studies, Dr. Parikh said, “If one weighs the risk benefit of  cardiac lesion revascularization regarding requiring a repeat procedure vs. the risk of mortality from paclitaxel, if there is such a thing, I think most physicians have come back and the pendulum has swung back considering it reasonable to use paclitaxel products.”

That’s a message that will resonate with patients reluctant to return to the hospital since the COVID-19 outbreak, he said. “If you can tell them we can avoid a repeat trip to the hospital, they’re all for it,” Dr. Parikh said.

The study results were published simultaneously with Dr. Secemsky’s presentation. Funding for SAFE-PAD came from a multi-industry consortium consisting of BD, Boston Scientific, Cook Medical, Medtronic and Philips, which wasn’t involved in the study design or analysis.

Dr. Secemsky disclosed relationships with Abbott, BD, Bayer, Boston Scientific, Cook Medical, CSI, Endovascular Engineering, Inari, Janssen, Medtronic, Philips, and Venture Med. Dr. Parikh disclosed relationships with TriReme Medical, Boston Scientific, Heartflow, Cordis, Janssen, Terumo, Canon, Shockwave, Abiomed, Abbott, Cardiovascular Systems, Inari and Surmodics.

Patients who have paclitaxel-coated stents and balloons have survival and outcomes comparable to those who have a bare-metal stent or percutaneous transluminal angioplasty, according to updated results from a large study of almost 170,000 Medicare beneficiaries.

The SAFE-PAD study analyzed Medicare claims data of 168,533 patients, including 70,584 who were treated with drug-coated devices (DCD), from April 2015 through 2018.

Notably, Eric A. Secemsky, MD, MSc, said in an interview, that included more than 32,000 patients with more than 5 years of follow-up. He presented the results at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.

“What we’re seeing now with this study is that paclitaxel-coated devices [PCDs] have the same long-term survival compared to those treated with non–drug-coated devices (NDCDs),” said Dr. Secemsky, director of vascular intervention at Beth Israel Deaconess Medical Center in Boston. “I think this is another important piece and some of the longest-term data in this size population to demonstrate the long-term safety of PCD, and hopefully it will help us get back to normal practice that has been halted now for over 3 years.”

That was a reference to the 2018 meta-analysis by Konstantinos Katsanos, MD, PhD, of Patras University in Greece, and colleagues, which showed an increased risk of death after PCD placements. That study threw a wet blanket of sorts on PCD use, Dr. Secemsky said.

The median follow-up for SAFE-PAD (formally called the Safety Assessment of Femoropopliteal Endovascular treatment with Paclitaxel-coated Devices) was 3.5 years, with the longest follow-up, 6.3 years. The weighted cumulative incidence of mortality at 6.3 years was 63.6% with NDCDs and 62.5% with DCDs (hazard ratio, 0.98; 95% confidence interval, 0.96-0.99; P < .0001). A subgroup analysis found no link between DCDs and increased death in low-risk patients, low-comorbid patients, inpatient or outpatient treatment, patients without critical limb ischemia, or patients treated with stents or balloon angioplasty alone.

“This report and the length of follow-up is one more piece that has continued to demonstrate safety with PCDs,” Dr. Secemsky said. He added that these results fall in line with smaller studies that failed to show a link between DCDs and long-term mortality, notably the SWEDEPAD randomized study of 2,289 patients evaluated through 4 years, and a subanalysis of 4,000 patients in VOYAGER-PAD through 42 months of follow-up.

“So we’ve really shown through these data sets and others that we can’t replicate any harms that we’ve seen in that Katsanos meta-analysis, and it suggests that there was some bias in that meta-analysis.”

Strengths of the study are its size and the way it followed the patients longitudinally, Sahil A. Parikh, MD, director of endovascular services at Columbia University Vagelos College of Physicians and Surgeons in New York, said in an interview.

With regard to its limitations, Dr. Parikh said, “On the other hand, it’s a claims database which doesn’t have the granularity about the patients’ specific procedural factors,” he said. “There are gaps that might further inform the value of lack thereof of the drug-coated device, but certainly at the topline, which is the hard endpoint of mortality, you can read quite a lot and you can assume that with such large numbers, the signal-to-noise ratio would be sufficiently sensitive that you get a real signal.”

With these updated SAFE-PAD results along with other studies, Dr. Parikh said, “If one weighs the risk benefit of  cardiac lesion revascularization regarding requiring a repeat procedure vs. the risk of mortality from paclitaxel, if there is such a thing, I think most physicians have come back and the pendulum has swung back considering it reasonable to use paclitaxel products.”

That’s a message that will resonate with patients reluctant to return to the hospital since the COVID-19 outbreak, he said. “If you can tell them we can avoid a repeat trip to the hospital, they’re all for it,” Dr. Parikh said.

The study results were published simultaneously with Dr. Secemsky’s presentation. Funding for SAFE-PAD came from a multi-industry consortium consisting of BD, Boston Scientific, Cook Medical, Medtronic and Philips, which wasn’t involved in the study design or analysis.

Dr. Secemsky disclosed relationships with Abbott, BD, Bayer, Boston Scientific, Cook Medical, CSI, Endovascular Engineering, Inari, Janssen, Medtronic, Philips, and Venture Med. Dr. Parikh disclosed relationships with TriReme Medical, Boston Scientific, Heartflow, Cordis, Janssen, Terumo, Canon, Shockwave, Abiomed, Abbott, Cardiovascular Systems, Inari and Surmodics.

Patients who have paclitaxel-coated stents and balloons have survival and outcomes comparable to those who have a bare-metal stent or percutaneous transluminal angioplasty, according to updated results from a large study of almost 170,000 Medicare beneficiaries.

The SAFE-PAD study analyzed Medicare claims data of 168,533 patients, including 70,584 who were treated with drug-coated devices (DCD), from April 2015 through 2018.

Notably, Eric A. Secemsky, MD, MSc, said in an interview, that included more than 32,000 patients with more than 5 years of follow-up. He presented the results at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.

“What we’re seeing now with this study is that paclitaxel-coated devices [PCDs] have the same long-term survival compared to those treated with non–drug-coated devices (NDCDs),” said Dr. Secemsky, director of vascular intervention at Beth Israel Deaconess Medical Center in Boston. “I think this is another important piece and some of the longest-term data in this size population to demonstrate the long-term safety of PCD, and hopefully it will help us get back to normal practice that has been halted now for over 3 years.”

That was a reference to the 2018 meta-analysis by Konstantinos Katsanos, MD, PhD, of Patras University in Greece, and colleagues, which showed an increased risk of death after PCD placements. That study threw a wet blanket of sorts on PCD use, Dr. Secemsky said.

The median follow-up for SAFE-PAD (formally called the Safety Assessment of Femoropopliteal Endovascular treatment with Paclitaxel-coated Devices) was 3.5 years, with the longest follow-up, 6.3 years. The weighted cumulative incidence of mortality at 6.3 years was 63.6% with NDCDs and 62.5% with DCDs (hazard ratio, 0.98; 95% confidence interval, 0.96-0.99; P < .0001). A subgroup analysis found no link between DCDs and increased death in low-risk patients, low-comorbid patients, inpatient or outpatient treatment, patients without critical limb ischemia, or patients treated with stents or balloon angioplasty alone.

“This report and the length of follow-up is one more piece that has continued to demonstrate safety with PCDs,” Dr. Secemsky said. He added that these results fall in line with smaller studies that failed to show a link between DCDs and long-term mortality, notably the SWEDEPAD randomized study of 2,289 patients evaluated through 4 years, and a subanalysis of 4,000 patients in VOYAGER-PAD through 42 months of follow-up.

“So we’ve really shown through these data sets and others that we can’t replicate any harms that we’ve seen in that Katsanos meta-analysis, and it suggests that there was some bias in that meta-analysis.”

Strengths of the study are its size and the way it followed the patients longitudinally, Sahil A. Parikh, MD, director of endovascular services at Columbia University Vagelos College of Physicians and Surgeons in New York, said in an interview.

With regard to its limitations, Dr. Parikh said, “On the other hand, it’s a claims database which doesn’t have the granularity about the patients’ specific procedural factors,” he said. “There are gaps that might further inform the value of lack thereof of the drug-coated device, but certainly at the topline, which is the hard endpoint of mortality, you can read quite a lot and you can assume that with such large numbers, the signal-to-noise ratio would be sufficiently sensitive that you get a real signal.”

With these updated SAFE-PAD results along with other studies, Dr. Parikh said, “If one weighs the risk benefit of  cardiac lesion revascularization regarding requiring a repeat procedure vs. the risk of mortality from paclitaxel, if there is such a thing, I think most physicians have come back and the pendulum has swung back considering it reasonable to use paclitaxel products.”

That’s a message that will resonate with patients reluctant to return to the hospital since the COVID-19 outbreak, he said. “If you can tell them we can avoid a repeat trip to the hospital, they’re all for it,” Dr. Parikh said.

The study results were published simultaneously with Dr. Secemsky’s presentation. Funding for SAFE-PAD came from a multi-industry consortium consisting of BD, Boston Scientific, Cook Medical, Medtronic and Philips, which wasn’t involved in the study design or analysis.

Dr. Secemsky disclosed relationships with Abbott, BD, Bayer, Boston Scientific, Cook Medical, CSI, Endovascular Engineering, Inari, Janssen, Medtronic, Philips, and Venture Med. Dr. Parikh disclosed relationships with TriReme Medical, Boston Scientific, Heartflow, Cordis, Janssen, Terumo, Canon, Shockwave, Abiomed, Abbott, Cardiovascular Systems, Inari and Surmodics.

NEW ORLEANS – The patient, a 60-year-old woman who’d just tried to kill herself by overdosing on gabapentin, felt the need to make a confession. As she told a resident psychiatrist late one night at a Philadelphia crisis response center, she’d just murdered two people and buried them in her backyard. More details kept coming, including who was dead and where their bodies were.

It didn’t take long for the attending physician’s phone to ring as the resident sought guidance. This wasn’t a typical “duty to warn” case since there was no one to warn of a threat of violence. But then what kind of case was it? As Meghan Musselman, MD, and colleagues noted in a report presented at the annual meeting of the American Psychiatric Association, the law and medical ethics didn’t present a clear-cut solution to whether the patient’s claim should be reported to the authorities.

“This was much more of a gray zone case than we typically see,” said Dr. Musselman, of the department of psychiatry at Temple University in Philadelphia, in an interview. “If someone is threatening to harm someone, most states have statutes about what to do in that situation. The same doesn’t really exist for when the crime has already happened.”

Even so, might the existing “duty to warn/protect” laws be helpful as a guide to what to do? Maybe, but it’s complicated. The laws, which address the waiving of therapist-patient confidentiality when violence is threatened, are widely variable. Some don’t specifically cover psychiatrists, according to the National Conference of State Legislatures. Some simply allow – but don’t require – certain mental-health professionals to take action regarding threats of violence without getting in trouble themselves.

There are no duty to warn/protect laws in Nevada, North Dakota, North Carolina, and Maine. Pennsylvania requires “mental-health professionals” to act when there’s a “clear and immediate danger to others or to society.”

In an interview, Columbia University, New York, psychiatrist and medical law/ethics specialist Paul S. Appelbaum, MD, said that “with the exception of situations like child abuse or elder abuse, for which psychiatrists are mandatory reporters, psychiatrists generally have the same responsibilities for reporting crimes as other citizens.”

He added that there is a crime in English common law known as “misprision” that refers to failing to report a felony. “A few states still have misprision statutes, but courts have tended to interpret them to require an affirmative act to conceal a crime, not just failure to report,” he said. “Unless the patient’s confession indicates a continuing threat to other people – e.g., a serial rapist or murderer – there is probably no obligation to report a previous crime.”

In this case, Dr. Musselman said, the physicians thought they might be able to waive confidentiality because it was possible that the alleged murder victims were still alive and in need of help.

However, the patient ultimately took the decision out of the hands of the psychiatrists and agreed to confess to the police. There’s a happy ending: The patient later recanted the story, Dr. Musselman said, and there was no follow-up by the authorities.

What should psychiatrists do in a similar situation? Besides the law, Dr. Musselman said, it’s important to consider medical ethics, confidentiality, and the greater good. “Doctors may have to ask themselves: Would I rather be sued because I’m breaking confidentiality or potentially play a part in someone’s suffering?”

She recommended reaching out to attorneys for legal guidance. “There’s a saying in forensic psychiatry by [Harvard University psychiatrist] Thomas Gutheil: Never worry alone.”

Dr. Applebaum agreed, and added: “Psychiatrists should consider the credibility of the patient’s confession: Could it represent a delusion? Is it being proffered as a way of manipulating the therapist? What is the extent to which, if valid, it indicates an ongoing threat to others? Is the patient is willing to contact the police and admit to the crime or authorize the psychiatrist to do so? Only in the case of a credible confession, an ongoing threat, and a patient unwilling to contact the police themselves should the psychiatrist seriously consider breaching confidentiality to report.”

No study funding or disclosures were reported.

NEW ORLEANS – The patient, a 60-year-old woman who’d just tried to kill herself by overdosing on gabapentin, felt the need to make a confession. As she told a resident psychiatrist late one night at a Philadelphia crisis response center, she’d just murdered two people and buried them in her backyard. More details kept coming, including who was dead and where their bodies were.

It didn’t take long for the attending physician’s phone to ring as the resident sought guidance. This wasn’t a typical “duty to warn” case since there was no one to warn of a threat of violence. But then what kind of case was it? As Meghan Musselman, MD, and colleagues noted in a report presented at the annual meeting of the American Psychiatric Association, the law and medical ethics didn’t present a clear-cut solution to whether the patient’s claim should be reported to the authorities.

“This was much more of a gray zone case than we typically see,” said Dr. Musselman, of the department of psychiatry at Temple University in Philadelphia, in an interview. “If someone is threatening to harm someone, most states have statutes about what to do in that situation. The same doesn’t really exist for when the crime has already happened.”

Even so, might the existing “duty to warn/protect” laws be helpful as a guide to what to do? Maybe, but it’s complicated. The laws, which address the waiving of therapist-patient confidentiality when violence is threatened, are widely variable. Some don’t specifically cover psychiatrists, according to the National Conference of State Legislatures. Some simply allow – but don’t require – certain mental-health professionals to take action regarding threats of violence without getting in trouble themselves.

There are no duty to warn/protect laws in Nevada, North Dakota, North Carolina, and Maine. Pennsylvania requires “mental-health professionals” to act when there’s a “clear and immediate danger to others or to society.”

In an interview, Columbia University, New York, psychiatrist and medical law/ethics specialist Paul S. Appelbaum, MD, said that “with the exception of situations like child abuse or elder abuse, for which psychiatrists are mandatory reporters, psychiatrists generally have the same responsibilities for reporting crimes as other citizens.”

He added that there is a crime in English common law known as “misprision” that refers to failing to report a felony. “A few states still have misprision statutes, but courts have tended to interpret them to require an affirmative act to conceal a crime, not just failure to report,” he said. “Unless the patient’s confession indicates a continuing threat to other people – e.g., a serial rapist or murderer – there is probably no obligation to report a previous crime.”

In this case, Dr. Musselman said, the physicians thought they might be able to waive confidentiality because it was possible that the alleged murder victims were still alive and in need of help.

However, the patient ultimately took the decision out of the hands of the psychiatrists and agreed to confess to the police. There’s a happy ending: The patient later recanted the story, Dr. Musselman said, and there was no follow-up by the authorities.

What should psychiatrists do in a similar situation? Besides the law, Dr. Musselman said, it’s important to consider medical ethics, confidentiality, and the greater good. “Doctors may have to ask themselves: Would I rather be sued because I’m breaking confidentiality or potentially play a part in someone’s suffering?”

She recommended reaching out to attorneys for legal guidance. “There’s a saying in forensic psychiatry by [Harvard University psychiatrist] Thomas Gutheil: Never worry alone.”

Dr. Applebaum agreed, and added: “Psychiatrists should consider the credibility of the patient’s confession: Could it represent a delusion? Is it being proffered as a way of manipulating the therapist? What is the extent to which, if valid, it indicates an ongoing threat to others? Is the patient is willing to contact the police and admit to the crime or authorize the psychiatrist to do so? Only in the case of a credible confession, an ongoing threat, and a patient unwilling to contact the police themselves should the psychiatrist seriously consider breaching confidentiality to report.”

No study funding or disclosures were reported.

NEW ORLEANS – The patient, a 60-year-old woman who’d just tried to kill herself by overdosing on gabapentin, felt the need to make a confession. As she told a resident psychiatrist late one night at a Philadelphia crisis response center, she’d just murdered two people and buried them in her backyard. More details kept coming, including who was dead and where their bodies were.

It didn’t take long for the attending physician’s phone to ring as the resident sought guidance. This wasn’t a typical “duty to warn” case since there was no one to warn of a threat of violence. But then what kind of case was it? As Meghan Musselman, MD, and colleagues noted in a report presented at the annual meeting of the American Psychiatric Association, the law and medical ethics didn’t present a clear-cut solution to whether the patient’s claim should be reported to the authorities.

“This was much more of a gray zone case than we typically see,” said Dr. Musselman, of the department of psychiatry at Temple University in Philadelphia, in an interview. “If someone is threatening to harm someone, most states have statutes about what to do in that situation. The same doesn’t really exist for when the crime has already happened.”

Even so, might the existing “duty to warn/protect” laws be helpful as a guide to what to do? Maybe, but it’s complicated. The laws, which address the waiving of therapist-patient confidentiality when violence is threatened, are widely variable. Some don’t specifically cover psychiatrists, according to the National Conference of State Legislatures. Some simply allow – but don’t require – certain mental-health professionals to take action regarding threats of violence without getting in trouble themselves.

There are no duty to warn/protect laws in Nevada, North Dakota, North Carolina, and Maine. Pennsylvania requires “mental-health professionals” to act when there’s a “clear and immediate danger to others or to society.”

In an interview, Columbia University, New York, psychiatrist and medical law/ethics specialist Paul S. Appelbaum, MD, said that “with the exception of situations like child abuse or elder abuse, for which psychiatrists are mandatory reporters, psychiatrists generally have the same responsibilities for reporting crimes as other citizens.”

He added that there is a crime in English common law known as “misprision” that refers to failing to report a felony. “A few states still have misprision statutes, but courts have tended to interpret them to require an affirmative act to conceal a crime, not just failure to report,” he said. “Unless the patient’s confession indicates a continuing threat to other people – e.g., a serial rapist or murderer – there is probably no obligation to report a previous crime.”

In this case, Dr. Musselman said, the physicians thought they might be able to waive confidentiality because it was possible that the alleged murder victims were still alive and in need of help.

However, the patient ultimately took the decision out of the hands of the psychiatrists and agreed to confess to the police. There’s a happy ending: The patient later recanted the story, Dr. Musselman said, and there was no follow-up by the authorities.

What should psychiatrists do in a similar situation? Besides the law, Dr. Musselman said, it’s important to consider medical ethics, confidentiality, and the greater good. “Doctors may have to ask themselves: Would I rather be sued because I’m breaking confidentiality or potentially play a part in someone’s suffering?”

She recommended reaching out to attorneys for legal guidance. “There’s a saying in forensic psychiatry by [Harvard University psychiatrist] Thomas Gutheil: Never worry alone.”

Dr. Applebaum agreed, and added: “Psychiatrists should consider the credibility of the patient’s confession: Could it represent a delusion? Is it being proffered as a way of manipulating the therapist? What is the extent to which, if valid, it indicates an ongoing threat to others? Is the patient is willing to contact the police and admit to the crime or authorize the psychiatrist to do so? Only in the case of a credible confession, an ongoing threat, and a patient unwilling to contact the police themselves should the psychiatrist seriously consider breaching confidentiality to report.”

No study funding or disclosures were reported.

The first prospective study to evaluate the accuracy of a blood test for people being screened for colorectal cancer (CRC) revealed a high sensitivity and specificity.

At 90% specificity, the blood assay (Guardant Health) was 100% sensitive for detecting CRC. At 95% specificity, sensitivity was 88%.

The blood assay detects circulating tumor DNA from cancer in the bloodstream, which is then analyzed for multiple factors, including cancer genetics and methylation.

Lead author Paloma Peinado, MD, a medical oncologist at HM Hospitales, Madrid, and colleagues, called the results similar to those seen with noninvasive, stool-based testing, noting that the “sensitivity and specificity of the blood-based test reached clinically significant thresholds.”

“The reported performance, combined with a more acceptable mode of testing, suggests that this blood-based test may be a viable CRC screening option,” they added.

The study was presented at Digestive Disease Week^® (DDW) 2022, held virtually and in San Diego.

Dr. Peinado and colleagues studied 557 people who agreed to have blood drawn at the time of their colonoscopy. They enrolled participants at four hospitals in Spain.

One-third of participants (33%) who sought CRC screening were at average risk. Of the remainder, 49% were symptomatic, 11% had a positive family history of CRC, 6% had a positive stool-based test result, and 1% presented for colonoscopy for other reasons.

The prospective observational study included people age 45-84 years. The median age of participants was 55 years, and just over half (52%) were women.

The prevalence rate of colorectal adenocarcinoma was 2.6%. Eight patients had stage I cancer, three had stage II cancer, two had stage III cancer, and two had stage IV cancer.

The study was designed to follow patients for 1 year after screening. To date, 14% of participants have reached this point.

Not a general population screening study

“We definitely we need more studies like this,” said Barbara H. Jung, MD, chair of the department of medicine at the University of Washington, Seattle, when asked to comment on the study.

“We need to find other ways to detect colorectal cancer early, to enhance the screening, and to broaden it to a larger population who may not be amenable to the other techniques.”

Dr. Jung added a caveat that the study population included people at a higher risk for CRC. Therefore, she said, it was a screening study but not a general population, average-risk screening study.

However, she said, “that does not mean that this could not be optimized in the future.”  

Ideally, we need tests for every application, including people who are asymptomatic, Dr. Jung said.

Dr. Peinado reports no relevant financial relationships. Some of the study authors are employees of Guardant Health. Dr. Jung reports no relevant financial relationships.

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

The first prospective study to evaluate the accuracy of a blood test for people being screened for colorectal cancer (CRC) revealed a high sensitivity and specificity.

At 90% specificity, the blood assay (Guardant Health) was 100% sensitive for detecting CRC. At 95% specificity, sensitivity was 88%.

The blood assay detects circulating tumor DNA from cancer in the bloodstream, which is then analyzed for multiple factors, including cancer genetics and methylation.

Lead author Paloma Peinado, MD, a medical oncologist at HM Hospitales, Madrid, and colleagues, called the results similar to those seen with noninvasive, stool-based testing, noting that the “sensitivity and specificity of the blood-based test reached clinically significant thresholds.”

“The reported performance, combined with a more acceptable mode of testing, suggests that this blood-based test may be a viable CRC screening option,” they added.

The study was presented at Digestive Disease Week^® (DDW) 2022, held virtually and in San Diego.

Dr. Peinado and colleagues studied 557 people who agreed to have blood drawn at the time of their colonoscopy. They enrolled participants at four hospitals in Spain.

One-third of participants (33%) who sought CRC screening were at average risk. Of the remainder, 49% were symptomatic, 11% had a positive family history of CRC, 6% had a positive stool-based test result, and 1% presented for colonoscopy for other reasons.

The prospective observational study included people age 45-84 years. The median age of participants was 55 years, and just over half (52%) were women.

The prevalence rate of colorectal adenocarcinoma was 2.6%. Eight patients had stage I cancer, three had stage II cancer, two had stage III cancer, and two had stage IV cancer.

The study was designed to follow patients for 1 year after screening. To date, 14% of participants have reached this point.

Not a general population screening study

“We definitely we need more studies like this,” said Barbara H. Jung, MD, chair of the department of medicine at the University of Washington, Seattle, when asked to comment on the study.

“We need to find other ways to detect colorectal cancer early, to enhance the screening, and to broaden it to a larger population who may not be amenable to the other techniques.”

Dr. Jung added a caveat that the study population included people at a higher risk for CRC. Therefore, she said, it was a screening study but not a general population, average-risk screening study.

However, she said, “that does not mean that this could not be optimized in the future.”  

Ideally, we need tests for every application, including people who are asymptomatic, Dr. Jung said.

Dr. Peinado reports no relevant financial relationships. Some of the study authors are employees of Guardant Health. Dr. Jung reports no relevant financial relationships.

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

The first prospective study to evaluate the accuracy of a blood test for people being screened for colorectal cancer (CRC) revealed a high sensitivity and specificity.

At 90% specificity, the blood assay (Guardant Health) was 100% sensitive for detecting CRC. At 95% specificity, sensitivity was 88%.

The blood assay detects circulating tumor DNA from cancer in the bloodstream, which is then analyzed for multiple factors, including cancer genetics and methylation.

Lead author Paloma Peinado, MD, a medical oncologist at HM Hospitales, Madrid, and colleagues, called the results similar to those seen with noninvasive, stool-based testing, noting that the “sensitivity and specificity of the blood-based test reached clinically significant thresholds.”

“The reported performance, combined with a more acceptable mode of testing, suggests that this blood-based test may be a viable CRC screening option,” they added.

The study was presented at Digestive Disease Week^® (DDW) 2022, held virtually and in San Diego.

Dr. Peinado and colleagues studied 557 people who agreed to have blood drawn at the time of their colonoscopy. They enrolled participants at four hospitals in Spain.

One-third of participants (33%) who sought CRC screening were at average risk. Of the remainder, 49% were symptomatic, 11% had a positive family history of CRC, 6% had a positive stool-based test result, and 1% presented for colonoscopy for other reasons.

The prospective observational study included people age 45-84 years. The median age of participants was 55 years, and just over half (52%) were women.

The prevalence rate of colorectal adenocarcinoma was 2.6%. Eight patients had stage I cancer, three had stage II cancer, two had stage III cancer, and two had stage IV cancer.

The study was designed to follow patients for 1 year after screening. To date, 14% of participants have reached this point.

Not a general population screening study

“We definitely we need more studies like this,” said Barbara H. Jung, MD, chair of the department of medicine at the University of Washington, Seattle, when asked to comment on the study.

“We need to find other ways to detect colorectal cancer early, to enhance the screening, and to broaden it to a larger population who may not be amenable to the other techniques.”

Dr. Jung added a caveat that the study population included people at a higher risk for CRC. Therefore, she said, it was a screening study but not a general population, average-risk screening study.

However, she said, “that does not mean that this could not be optimized in the future.”  

Ideally, we need tests for every application, including people who are asymptomatic, Dr. Jung said.

Dr. Peinado reports no relevant financial relationships. Some of the study authors are employees of Guardant Health. Dr. Jung reports no relevant financial relationships.

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

NEW ORLEANS – With 2 years of COVID-19 in the rearview mirror, anxiety among U.S. adults has turned instead toward global events, results from the annual Healthy Minds Poll from the American Psychiatric Association show.

“It’s not surprising that recent events, such as the war in Ukraine, racially motivated mass shootings, or the impacts of climate change, are weighing heavily on Americans’ minds,” APA president Vivian Pender, MD, said in a news release. 

“COVID-19 in a way has taken a back seat, but the pandemic and its mental health effects are very much still with us. It’s important that we are cognizant of that and continue to work to ensure people who need psychiatric care, whether the causes are tied to the pandemic or to other issues, can access it,” Dr. Pender added.

Results from the 2022’s poll were released May 22 during the annual meeting of the APA.
 

Record low COVID anxiety

The poll was conducted by Morning Consult between April 23-24 and included 2,210 adult participants.

Results showed that anxiety about COVID is at its recorded lowest, with 50% of respondents indicating they are anxious about the pandemic. This was down from 65% in 2021 and from 75% in 2020.

Instead, nearly three-quarters (73%) of adults are somewhat or extremely anxious about current events happening around the world, 64% are anxious about keeping themselves or their families safe, and 60% worry about their health in general.

Overall, about one-third (32%) reported being more anxious now than in 2021, 46% reported no change in their anxiety level, and 18% were less anxious.

About one-quarter (26%) have spoken with a mental health care professional in the past few years, which is down from 34% in 2021. In addition, Hispanic (36%) and Black (35%) adults were more likely to have reached out for help than White (25%) adults.

Despite the U.S. Surgeon General’s recent advisory on the mental health crisis among children, the poll results also showed that Americans are less concerned about their children’s mental health than in 2021. A total of 41% of parents expressed concern about this topic, which was down from 53% in 2021.

Still, 40% of parents said their children had received help from a mental health professional since the pandemic hit. Of that group, 36% sought help before the pandemic, whereas half said the pandemic had caused mental health issues for their children.

“While the overall level of concern has dropped, still 4 in 10 parents are worried about how their children are doing, and a third are having issues with access to care,” Saul Levin, MD, CEO and medical director of the APA, said in the release.

“This is unacceptable and as a nation, we need to invest in the kind of systems that will ensure any parent who’s worried about their child has access to lifesaving treatment,” Dr. Levin added.
 

Workplace mental health

In addition, the poll showed employees often have a tough time getting mental health support from employers, or are hesitant to ask for help.

“What’s troubling about the results of this poll is that, even as the pandemic has continued and its mental health effects wear on, fewer employees are reporting that they have access to mental health services,” Dr. Pender said. 

“Workplaces need to ensure that they are paying attention to what their employees need, particularly now, and moving away from mental health benefits isn’t the right move,” she added.

About half (48%) of those polled said they can discuss mental health openly and honestly with their supervisor, down from 56% in 2021 and 62% in 2020.

Only about half (52%) said they feel comfortable using mental health services with their current employer, compared with 64% in 2021 and 67% in 2020.

In addition, fewer workers felt their employer is offering sufficient mental health resources and benefits. In 2022, 53% of workers thought resources and benefits were adequate, which was down from 65% in 2021 and 68% in 2020.

“It’s quite concerning to see that fewer people feel comfortable discussing mental health with a supervisor, at a time when people experiencing symptoms of anxiety, depression, and other conditions are on the rise and impact nearly every aspect of work, including productivity, performance, retention, and overall health care costs,” said Darcy Gruttadaro, JD, director of the APA Foundation’s Center for Workplace Mental Health.

“As rates of these conditions rise, we should see more employees knowing about available workplace mental health resources, not less,” Ms. Gruttadaro said.
 

Strong bipartisan support 

Perhaps unexpectedly, the poll shows strong support among Democrats, Republicans, and Independents for three APA-backed approaches to improve timely access to mental health care and treatment.

Specifically, about three-quarters of those polled supported making it easier to see a mental health professional via telehealth, allowing patients to receive mental health care through a primary care provider, and funding mental health care professionals to work in rural or urban communities that are traditionally underserved.

“We’re in a moment when mental health is a big part of the national conversation, and clearly political party doesn’t matter as much on this issue,” Dr. Pender noted. 

“It’s a rare thing in Washington these days to see such a resounding endorsement, but there is strong support for these practical workable solutions that mean more access to mental health care,” she said.

“What you see in this poll is agreement: It’s hard to access mental [health care] but we do have great solutions that could work across party lines,” Dr. Levin added.

“Many policy makers, in the administration and in Congress, are already putting these ideas into action, and they should feel encouraged that the public wants to see Congress act on them,” he said.

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

NEW ORLEANS – With 2 years of COVID-19 in the rearview mirror, anxiety among U.S. adults has turned instead toward global events, results from the annual Healthy Minds Poll from the American Psychiatric Association show.

“It’s not surprising that recent events, such as the war in Ukraine, racially motivated mass shootings, or the impacts of climate change, are weighing heavily on Americans’ minds,” APA president Vivian Pender, MD, said in a news release. 

“COVID-19 in a way has taken a back seat, but the pandemic and its mental health effects are very much still with us. It’s important that we are cognizant of that and continue to work to ensure people who need psychiatric care, whether the causes are tied to the pandemic or to other issues, can access it,” Dr. Pender added.

Results from the 2022’s poll were released May 22 during the annual meeting of the APA.
 

Record low COVID anxiety

The poll was conducted by Morning Consult between April 23-24 and included 2,210 adult participants.

Results showed that anxiety about COVID is at its recorded lowest, with 50% of respondents indicating they are anxious about the pandemic. This was down from 65% in 2021 and from 75% in 2020.

Instead, nearly three-quarters (73%) of adults are somewhat or extremely anxious about current events happening around the world, 64% are anxious about keeping themselves or their families safe, and 60% worry about their health in general.

Overall, about one-third (32%) reported being more anxious now than in 2021, 46% reported no change in their anxiety level, and 18% were less anxious.

About one-quarter (26%) have spoken with a mental health care professional in the past few years, which is down from 34% in 2021. In addition, Hispanic (36%) and Black (35%) adults were more likely to have reached out for help than White (25%) adults.

Despite the U.S. Surgeon General’s recent advisory on the mental health crisis among children, the poll results also showed that Americans are less concerned about their children’s mental health than in 2021. A total of 41% of parents expressed concern about this topic, which was down from 53% in 2021.

Still, 40% of parents said their children had received help from a mental health professional since the pandemic hit. Of that group, 36% sought help before the pandemic, whereas half said the pandemic had caused mental health issues for their children.

“While the overall level of concern has dropped, still 4 in 10 parents are worried about how their children are doing, and a third are having issues with access to care,” Saul Levin, MD, CEO and medical director of the APA, said in the release.

“This is unacceptable and as a nation, we need to invest in the kind of systems that will ensure any parent who’s worried about their child has access to lifesaving treatment,” Dr. Levin added.
 

Workplace mental health

In addition, the poll showed employees often have a tough time getting mental health support from employers, or are hesitant to ask for help.

“What’s troubling about the results of this poll is that, even as the pandemic has continued and its mental health effects wear on, fewer employees are reporting that they have access to mental health services,” Dr. Pender said. 

“Workplaces need to ensure that they are paying attention to what their employees need, particularly now, and moving away from mental health benefits isn’t the right move,” she added.

About half (48%) of those polled said they can discuss mental health openly and honestly with their supervisor, down from 56% in 2021 and 62% in 2020.

Only about half (52%) said they feel comfortable using mental health services with their current employer, compared with 64% in 2021 and 67% in 2020.

In addition, fewer workers felt their employer is offering sufficient mental health resources and benefits. In 2022, 53% of workers thought resources and benefits were adequate, which was down from 65% in 2021 and 68% in 2020.

“It’s quite concerning to see that fewer people feel comfortable discussing mental health with a supervisor, at a time when people experiencing symptoms of anxiety, depression, and other conditions are on the rise and impact nearly every aspect of work, including productivity, performance, retention, and overall health care costs,” said Darcy Gruttadaro, JD, director of the APA Foundation’s Center for Workplace Mental Health.

“As rates of these conditions rise, we should see more employees knowing about available workplace mental health resources, not less,” Ms. Gruttadaro said.
 

Strong bipartisan support 

Perhaps unexpectedly, the poll shows strong support among Democrats, Republicans, and Independents for three APA-backed approaches to improve timely access to mental health care and treatment.

Specifically, about three-quarters of those polled supported making it easier to see a mental health professional via telehealth, allowing patients to receive mental health care through a primary care provider, and funding mental health care professionals to work in rural or urban communities that are traditionally underserved.

“We’re in a moment when mental health is a big part of the national conversation, and clearly political party doesn’t matter as much on this issue,” Dr. Pender noted. 

“It’s a rare thing in Washington these days to see such a resounding endorsement, but there is strong support for these practical workable solutions that mean more access to mental health care,” she said.

“What you see in this poll is agreement: It’s hard to access mental [health care] but we do have great solutions that could work across party lines,” Dr. Levin added.

“Many policy makers, in the administration and in Congress, are already putting these ideas into action, and they should feel encouraged that the public wants to see Congress act on them,” he said.

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

NEW ORLEANS – With 2 years of COVID-19 in the rearview mirror, anxiety among U.S. adults has turned instead toward global events, results from the annual Healthy Minds Poll from the American Psychiatric Association show.

“It’s not surprising that recent events, such as the war in Ukraine, racially motivated mass shootings, or the impacts of climate change, are weighing heavily on Americans’ minds,” APA president Vivian Pender, MD, said in a news release. 

“COVID-19 in a way has taken a back seat, but the pandemic and its mental health effects are very much still with us. It’s important that we are cognizant of that and continue to work to ensure people who need psychiatric care, whether the causes are tied to the pandemic or to other issues, can access it,” Dr. Pender added.

Results from the 2022’s poll were released May 22 during the annual meeting of the APA.
 

Record low COVID anxiety

The poll was conducted by Morning Consult between April 23-24 and included 2,210 adult participants.

Results showed that anxiety about COVID is at its recorded lowest, with 50% of respondents indicating they are anxious about the pandemic. This was down from 65% in 2021 and from 75% in 2020.

Instead, nearly three-quarters (73%) of adults are somewhat or extremely anxious about current events happening around the world, 64% are anxious about keeping themselves or their families safe, and 60% worry about their health in general.

Overall, about one-third (32%) reported being more anxious now than in 2021, 46% reported no change in their anxiety level, and 18% were less anxious.

About one-quarter (26%) have spoken with a mental health care professional in the past few years, which is down from 34% in 2021. In addition, Hispanic (36%) and Black (35%) adults were more likely to have reached out for help than White (25%) adults.

Despite the U.S. Surgeon General’s recent advisory on the mental health crisis among children, the poll results also showed that Americans are less concerned about their children’s mental health than in 2021. A total of 41% of parents expressed concern about this topic, which was down from 53% in 2021.

Still, 40% of parents said their children had received help from a mental health professional since the pandemic hit. Of that group, 36% sought help before the pandemic, whereas half said the pandemic had caused mental health issues for their children.

“While the overall level of concern has dropped, still 4 in 10 parents are worried about how their children are doing, and a third are having issues with access to care,” Saul Levin, MD, CEO and medical director of the APA, said in the release.

“This is unacceptable and as a nation, we need to invest in the kind of systems that will ensure any parent who’s worried about their child has access to lifesaving treatment,” Dr. Levin added.
 

Workplace mental health

In addition, the poll showed employees often have a tough time getting mental health support from employers, or are hesitant to ask for help.

“What’s troubling about the results of this poll is that, even as the pandemic has continued and its mental health effects wear on, fewer employees are reporting that they have access to mental health services,” Dr. Pender said. 

“Workplaces need to ensure that they are paying attention to what their employees need, particularly now, and moving away from mental health benefits isn’t the right move,” she added.

About half (48%) of those polled said they can discuss mental health openly and honestly with their supervisor, down from 56% in 2021 and 62% in 2020.

Only about half (52%) said they feel comfortable using mental health services with their current employer, compared with 64% in 2021 and 67% in 2020.

In addition, fewer workers felt their employer is offering sufficient mental health resources and benefits. In 2022, 53% of workers thought resources and benefits were adequate, which was down from 65% in 2021 and 68% in 2020.

“It’s quite concerning to see that fewer people feel comfortable discussing mental health with a supervisor, at a time when people experiencing symptoms of anxiety, depression, and other conditions are on the rise and impact nearly every aspect of work, including productivity, performance, retention, and overall health care costs,” said Darcy Gruttadaro, JD, director of the APA Foundation’s Center for Workplace Mental Health.

“As rates of these conditions rise, we should see more employees knowing about available workplace mental health resources, not less,” Ms. Gruttadaro said.
 

Strong bipartisan support 

Perhaps unexpectedly, the poll shows strong support among Democrats, Republicans, and Independents for three APA-backed approaches to improve timely access to mental health care and treatment.

Specifically, about three-quarters of those polled supported making it easier to see a mental health professional via telehealth, allowing patients to receive mental health care through a primary care provider, and funding mental health care professionals to work in rural or urban communities that are traditionally underserved.

“We’re in a moment when mental health is a big part of the national conversation, and clearly political party doesn’t matter as much on this issue,” Dr. Pender noted. 

“It’s a rare thing in Washington these days to see such a resounding endorsement, but there is strong support for these practical workable solutions that mean more access to mental health care,” she said.

“What you see in this poll is agreement: It’s hard to access mental [health care] but we do have great solutions that could work across party lines,” Dr. Levin added.

“Many policy makers, in the administration and in Congress, are already putting these ideas into action, and they should feel encouraged that the public wants to see Congress act on them,” he said.

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

SAN DIEGO – When the Food and Drug Administration gave the nod to a first-in-class tissue removal device in July of 2021, clearance was limited to the treatment of moderate to severe wrinkles in the mid to lower face.

But once the device – Ellacor– becomes available in late 2022, potential applications are likely to be wide-ranging, Jill S. Waibel, MD, a dermatologist with the Miami Dermatology and Laser Institute, predicted at the annual conference of the American Society for Laser Medicine and Surgery. “I’m using it in my practice more for laxity and jowls,” she said. Eventually, “I think it’s going to be preventative for 30- to 50-year-olds but that hasn’t been studied. I think it’s going to have a pre- and postrhytidectomy role, so I think the plastic surgeons are going to love this in their practice.”

Developed by Cytrellis, and based on research conducted by William G. Austen Jr., MD, chief of plastic and reconstructive surgery at Massachusetts General Hospital (MGH), Boston, and R. Rox Anderson, MD, director of the Wellman Center for Photomedicine at MGH, the company’s scientific founders, the device uses hollow needles contained in a handpiece to create thousands of microexcisions to physically remove small cores of skin – a process known as microcoring. Dr. Austin and Dr. Anderson were the senior authors, respectively, of seminal trials of the device in swine, published in 2013 and 2015.

This can result in immediate physical hole closures (mechanical closure), which may lead to skin tightening.

“We’re removing dermis and epidermis,” said Dr. Waibel, who noted that the technology has been studied mostly for skin laxity and rhytids. “There are no other devices that are doing this.”

The immediate closure of tiny holes in the skin results in a quantitative and directional reduction in the treated area of skin, she said, which leads to wrinkle improvement, tightening, and smoothing of lax skin. The device contains three 22-guage needles that are less than 500 micrometers in diameter. “Based on optical coherence tomography work we did, these channels of treated skin stay open for about 1.5 minutes,” she added, noting that the tunable depth of the device ranges from 0 to 4 mm. “I tend to treat only with the 4-mm depth,” said Dr. Waibel, who is subsection chief of dermatology at Baptist Hospital of Miami.

The device features a disposable tip that can remove up to 24,000 cores of skin, and the amount of skin removed in a treated area can be 1%, 3%, 5%, 7%, and 8%. “The more cores you do, the more wrinkle improvement we saw in pivotal trials,” she said. “A minimal core count of 12,000 per treatment is recommended for the mid and lower face. Interestingly, higher core counts do not result in more patient downtime.” In her office, she said that the treatment takes about 20 minutes. Recommended postoperative care involves application of petrolatum or Aquaphor over the treated area for 24 hours, or until the holes have closed. “There is very low postoperative downtime,” she noted.

According to pivotal clinical data from Cytrellis on 51 patients treated with Ellacor, patients experienced a mean 1.3-grade improvement on the Lemperle Rating Scale, 86% said that they were satisfied with the procedure, and investigators rated their Global Aesthetic Improvement as 90%.

To date, Dr. Waibel and her colleagues in Miami have treated 102 patients with Ellacor, mostly for wrinkles and skin laxity. In these patients, the minimal downtime experienced was 3.8 days, 75% of patients did not miss any work, and 46% did not miss any social activities. The worst part for patients is the preprocedure numbing, she said. “We do lidocaine injections. Some people do nerve blocks. Once you do the lidocaine injection, the average pain is about 0.36 on a scale of 1-10 during treatment and 0 for all subsequent time points.”

At the meeting, she presented a set of before and after photos that showed improvement of moderate facial wrinkles in a female patient 90 days after one treatment with Ellacor, which removed about 5% of skin in the area of the jowls. “It’s pretty incredible,” Dr. Waibel remarked.

“I don’t have anything in my practice that can help with that kind of laxity other than sending them to a plastic surgeon, and I have about 80 devices.”

Images courtesy Dr. Jill S. Waibel

At the 2019 meeting of the American Society for Dermatologic Surgery, Dr. Waibel and Roy G. Geronemus, MD, director of the Laser & Skin Surgery Center of New York, presented a small pilot study on the successful use of Ellacor for acne scars and striae. Dr. Waibel said that she and her colleagues in Miami have been using the device to treat skin laxity in several anatomical areas, including the neck, nose, inner thigh, above the knee, elbow, and the axillary region. They have used the device to treat tattoos, rhytidectomy scars, abdominal striae, acne and surgical scars, and idiopathic guttate hypomelanosis, she added.

“We do a lot of combinations with other devices on the same day, and I think this list will increase over the next few years,” she said. “Probably my favorite use in the past 5 months has been doing microcoring and, separated by a month, doing resurfacing.”

Clinical trials of Ellacor were conducted in patients with types I-IV skin, but she has treated several patients with types V-VI skin “with absolutely no safety issues,” which includes treatment of epidermal nevi.

Which variables are the most important for patient selection and procedural success remain unclear, she continued, including patient age, elastic recoil, body mass index, history of a prior procedure (such as radiofrequency or ultrasound), the amount of laxity and rhytids, and overall health, which have not been studied, Dr. Waibel said.

“We have patients that don’t have the same response as others. For the modest improvement seen in some patients, is that their elastic recoil or are we choosing the wrong patients? Do they need more treatments? We are also still learning about the ideal treatment for scars and other indications.”

The device is expected to launch in fourth quarter of 2022.

Dr. Waibel disclosed that she is an advisory board member for Cytrellis. She has conducted clinical trials for and is a consultant to many pharmaceutical and device companies.

SAN DIEGO – When the Food and Drug Administration gave the nod to a first-in-class tissue removal device in July of 2021, clearance was limited to the treatment of moderate to severe wrinkles in the mid to lower face.

But once the device – Ellacor– becomes available in late 2022, potential applications are likely to be wide-ranging, Jill S. Waibel, MD, a dermatologist with the Miami Dermatology and Laser Institute, predicted at the annual conference of the American Society for Laser Medicine and Surgery. “I’m using it in my practice more for laxity and jowls,” she said. Eventually, “I think it’s going to be preventative for 30- to 50-year-olds but that hasn’t been studied. I think it’s going to have a pre- and postrhytidectomy role, so I think the plastic surgeons are going to love this in their practice.”

Developed by Cytrellis, and based on research conducted by William G. Austen Jr., MD, chief of plastic and reconstructive surgery at Massachusetts General Hospital (MGH), Boston, and R. Rox Anderson, MD, director of the Wellman Center for Photomedicine at MGH, the company’s scientific founders, the device uses hollow needles contained in a handpiece to create thousands of microexcisions to physically remove small cores of skin – a process known as microcoring. Dr. Austin and Dr. Anderson were the senior authors, respectively, of seminal trials of the device in swine, published in 2013 and 2015.

This can result in immediate physical hole closures (mechanical closure), which may lead to skin tightening.

“We’re removing dermis and epidermis,” said Dr. Waibel, who noted that the technology has been studied mostly for skin laxity and rhytids. “There are no other devices that are doing this.”

The immediate closure of tiny holes in the skin results in a quantitative and directional reduction in the treated area of skin, she said, which leads to wrinkle improvement, tightening, and smoothing of lax skin. The device contains three 22-guage needles that are less than 500 micrometers in diameter. “Based on optical coherence tomography work we did, these channels of treated skin stay open for about 1.5 minutes,” she added, noting that the tunable depth of the device ranges from 0 to 4 mm. “I tend to treat only with the 4-mm depth,” said Dr. Waibel, who is subsection chief of dermatology at Baptist Hospital of Miami.

The device features a disposable tip that can remove up to 24,000 cores of skin, and the amount of skin removed in a treated area can be 1%, 3%, 5%, 7%, and 8%. “The more cores you do, the more wrinkle improvement we saw in pivotal trials,” she said. “A minimal core count of 12,000 per treatment is recommended for the mid and lower face. Interestingly, higher core counts do not result in more patient downtime.” In her office, she said that the treatment takes about 20 minutes. Recommended postoperative care involves application of petrolatum or Aquaphor over the treated area for 24 hours, or until the holes have closed. “There is very low postoperative downtime,” she noted.

According to pivotal clinical data from Cytrellis on 51 patients treated with Ellacor, patients experienced a mean 1.3-grade improvement on the Lemperle Rating Scale, 86% said that they were satisfied with the procedure, and investigators rated their Global Aesthetic Improvement as 90%.

To date, Dr. Waibel and her colleagues in Miami have treated 102 patients with Ellacor, mostly for wrinkles and skin laxity. In these patients, the minimal downtime experienced was 3.8 days, 75% of patients did not miss any work, and 46% did not miss any social activities. The worst part for patients is the preprocedure numbing, she said. “We do lidocaine injections. Some people do nerve blocks. Once you do the lidocaine injection, the average pain is about 0.36 on a scale of 1-10 during treatment and 0 for all subsequent time points.”

At the meeting, she presented a set of before and after photos that showed improvement of moderate facial wrinkles in a female patient 90 days after one treatment with Ellacor, which removed about 5% of skin in the area of the jowls. “It’s pretty incredible,” Dr. Waibel remarked.

“I don’t have anything in my practice that can help with that kind of laxity other than sending them to a plastic surgeon, and I have about 80 devices.”

Images courtesy Dr. Jill S. Waibel

At the 2019 meeting of the American Society for Dermatologic Surgery, Dr. Waibel and Roy G. Geronemus, MD, director of the Laser & Skin Surgery Center of New York, presented a small pilot study on the successful use of Ellacor for acne scars and striae. Dr. Waibel said that she and her colleagues in Miami have been using the device to treat skin laxity in several anatomical areas, including the neck, nose, inner thigh, above the knee, elbow, and the axillary region. They have used the device to treat tattoos, rhytidectomy scars, abdominal striae, acne and surgical scars, and idiopathic guttate hypomelanosis, she added.

“We do a lot of combinations with other devices on the same day, and I think this list will increase over the next few years,” she said. “Probably my favorite use in the past 5 months has been doing microcoring and, separated by a month, doing resurfacing.”

Clinical trials of Ellacor were conducted in patients with types I-IV skin, but she has treated several patients with types V-VI skin “with absolutely no safety issues,” which includes treatment of epidermal nevi.

Which variables are the most important for patient selection and procedural success remain unclear, she continued, including patient age, elastic recoil, body mass index, history of a prior procedure (such as radiofrequency or ultrasound), the amount of laxity and rhytids, and overall health, which have not been studied, Dr. Waibel said.

“We have patients that don’t have the same response as others. For the modest improvement seen in some patients, is that their elastic recoil or are we choosing the wrong patients? Do they need more treatments? We are also still learning about the ideal treatment for scars and other indications.”

The device is expected to launch in fourth quarter of 2022.

Dr. Waibel disclosed that she is an advisory board member for Cytrellis. She has conducted clinical trials for and is a consultant to many pharmaceutical and device companies.

SAN DIEGO – When the Food and Drug Administration gave the nod to a first-in-class tissue removal device in July of 2021, clearance was limited to the treatment of moderate to severe wrinkles in the mid to lower face.

But once the device – Ellacor– becomes available in late 2022, potential applications are likely to be wide-ranging, Jill S. Waibel, MD, a dermatologist with the Miami Dermatology and Laser Institute, predicted at the annual conference of the American Society for Laser Medicine and Surgery. “I’m using it in my practice more for laxity and jowls,” she said. Eventually, “I think it’s going to be preventative for 30- to 50-year-olds but that hasn’t been studied. I think it’s going to have a pre- and postrhytidectomy role, so I think the plastic surgeons are going to love this in their practice.”

Developed by Cytrellis, and based on research conducted by William G. Austen Jr., MD, chief of plastic and reconstructive surgery at Massachusetts General Hospital (MGH), Boston, and R. Rox Anderson, MD, director of the Wellman Center for Photomedicine at MGH, the company’s scientific founders, the device uses hollow needles contained in a handpiece to create thousands of microexcisions to physically remove small cores of skin – a process known as microcoring. Dr. Austin and Dr. Anderson were the senior authors, respectively, of seminal trials of the device in swine, published in 2013 and 2015.

This can result in immediate physical hole closures (mechanical closure), which may lead to skin tightening.

“We’re removing dermis and epidermis,” said Dr. Waibel, who noted that the technology has been studied mostly for skin laxity and rhytids. “There are no other devices that are doing this.”

The immediate closure of tiny holes in the skin results in a quantitative and directional reduction in the treated area of skin, she said, which leads to wrinkle improvement, tightening, and smoothing of lax skin. The device contains three 22-guage needles that are less than 500 micrometers in diameter. “Based on optical coherence tomography work we did, these channels of treated skin stay open for about 1.5 minutes,” she added, noting that the tunable depth of the device ranges from 0 to 4 mm. “I tend to treat only with the 4-mm depth,” said Dr. Waibel, who is subsection chief of dermatology at Baptist Hospital of Miami.

The device features a disposable tip that can remove up to 24,000 cores of skin, and the amount of skin removed in a treated area can be 1%, 3%, 5%, 7%, and 8%. “The more cores you do, the more wrinkle improvement we saw in pivotal trials,” she said. “A minimal core count of 12,000 per treatment is recommended for the mid and lower face. Interestingly, higher core counts do not result in more patient downtime.” In her office, she said that the treatment takes about 20 minutes. Recommended postoperative care involves application of petrolatum or Aquaphor over the treated area for 24 hours, or until the holes have closed. “There is very low postoperative downtime,” she noted.

According to pivotal clinical data from Cytrellis on 51 patients treated with Ellacor, patients experienced a mean 1.3-grade improvement on the Lemperle Rating Scale, 86% said that they were satisfied with the procedure, and investigators rated their Global Aesthetic Improvement as 90%.

To date, Dr. Waibel and her colleagues in Miami have treated 102 patients with Ellacor, mostly for wrinkles and skin laxity. In these patients, the minimal downtime experienced was 3.8 days, 75% of patients did not miss any work, and 46% did not miss any social activities. The worst part for patients is the preprocedure numbing, she said. “We do lidocaine injections. Some people do nerve blocks. Once you do the lidocaine injection, the average pain is about 0.36 on a scale of 1-10 during treatment and 0 for all subsequent time points.”

At the meeting, she presented a set of before and after photos that showed improvement of moderate facial wrinkles in a female patient 90 days after one treatment with Ellacor, which removed about 5% of skin in the area of the jowls. “It’s pretty incredible,” Dr. Waibel remarked.

“I don’t have anything in my practice that can help with that kind of laxity other than sending them to a plastic surgeon, and I have about 80 devices.”

Images courtesy Dr. Jill S. Waibel

At the 2019 meeting of the American Society for Dermatologic Surgery, Dr. Waibel and Roy G. Geronemus, MD, director of the Laser & Skin Surgery Center of New York, presented a small pilot study on the successful use of Ellacor for acne scars and striae. Dr. Waibel said that she and her colleagues in Miami have been using the device to treat skin laxity in several anatomical areas, including the neck, nose, inner thigh, above the knee, elbow, and the axillary region. They have used the device to treat tattoos, rhytidectomy scars, abdominal striae, acne and surgical scars, and idiopathic guttate hypomelanosis, she added.

“We do a lot of combinations with other devices on the same day, and I think this list will increase over the next few years,” she said. “Probably my favorite use in the past 5 months has been doing microcoring and, separated by a month, doing resurfacing.”

Clinical trials of Ellacor were conducted in patients with types I-IV skin, but she has treated several patients with types V-VI skin “with absolutely no safety issues,” which includes treatment of epidermal nevi.

Which variables are the most important for patient selection and procedural success remain unclear, she continued, including patient age, elastic recoil, body mass index, history of a prior procedure (such as radiofrequency or ultrasound), the amount of laxity and rhytids, and overall health, which have not been studied, Dr. Waibel said.

“We have patients that don’t have the same response as others. For the modest improvement seen in some patients, is that their elastic recoil or are we choosing the wrong patients? Do they need more treatments? We are also still learning about the ideal treatment for scars and other indications.”

The device is expected to launch in fourth quarter of 2022.

Dr. Waibel disclosed that she is an advisory board member for Cytrellis. She has conducted clinical trials for and is a consultant to many pharmaceutical and device companies.

SAN DIEGO – An analysis of a large, international cohort suggests that treatment with protease-inhibitor (PI)–based direct-acting antivirals (DAAs) may be safe for patients with hepatitis C virus (HCV) with cirrhosis and early-stage liver decompensation.

The study relied on data from the REAL-C registry, including 935 patients treated with oral DAAs at 27 centers in the U.S., Europe, and Asia Pacific countries. The researchers compared efficacy and tolerability outcomes from PI-based and non PI-based DAA regimens in patients deemed to have decompensated HCV cirrhosis.

The findings were encouraging. “It is something important because currently we are short of treatments for decompensated HCV patients. If the tolerability is similar, we perhaps should not withhold [PI] treatment for these patients that sometimes need them the most,” said Yu Jun Wong, MD, who presented the study at the annual Digestive Disease Week^® (DDW). Dr. Wong is a second-year consultant at Changchi General Hospital in Singapore.

“I think it was a very interesting study and something that needed to be done. It was encouraging that patients who did have some level of decompensated cirrhosis did not worsen compared to those who were on a non PI-based therapy,” said Meena Bansal, MD, who comoderated the session where the research was presented.

However, the study was limited by some uncertainty around the definition of decompensation among the study participants. During the Q&A session, audience members questioned whether patients categorized as decompensated were truly decompensated at the time of treatment initiation. Dr. Bansal noted, for example, that a patient might experience a variceal bleed in the context of heavy alcohol consumption, and therefore be considered decompensated, but might stop drinking afterward with a reduction in portal hypertension and recovery of liver function. “So it would be important to know if they were still decompensated at the time they initiated therapy. If that was the case, then these results are more promising,” said Dr. Bansal.

Despite these limitations, the study is good news. “If you do not have access to non-PI based therapy, you might feel a little bit more secure starting a PI-based therapy, particularly the second generation PI-based therapies, if they’re at least on the earlier side of that decompensation scale. But it’s still unclear in true decompensated Child’s B or C whether or not PI-based therapy would have the same results,” said Dr. Bansal.

Dr. Wong acknowledged the limitation that the study doesn’t apply to more severely decompensated patients. “Whether it remains safe in patients with higher Child-Pugh scores is hard to extrapolate at this point of time. We still need to look further into the data,” said Dr. Wong.

Still, the results offer hope to physicians and patients who might find themselves in difficult circumstances. “If you’re resource limited, and you don’t even have access to transplant, these findings suggest that early decompensated patients may benefit from PI-based therapy. If I say to the patient, there’s a chance this could make you worse, but there’s a chance this could make you better, [this is an option] as long as the patient is aware of the possible outcomes,” said Dr. Bansal.

The study included patients with a history of ascites, variceal bleeding, jaundice, or hepatic encephalopathy 6 months before treatment with DAA, or baseline measures of Child-Turcotte-Pugh (CTP) score ≥7 or Model of End-Stage Liver Disease (MELD) score >10. The analysis included data between 2014 and 2021.

The mean age was 64, and 59.6% of participants were male. Overall, 70.8% had genotype 1, and 32% were treatment experienced. In total, 45.2% were treated with PI-based DAAs.

The PI cohort was older (64.6 versus 62.7; P = .01), and more likely to have genotype 1 (87.2% versus 56.3%; P < .001) and chronic renal disease (64.0% vs. 53.9%; P = .001).

The two groups had similar rates of sustained virologic response at 12 and 24 weeks, as well as similar rates of significant improvement or significant worsening, suggesting similar tolerability. There was a lower frequency of liver decompensation in the PI group at 12 weeks (4.4% vs. 7.9%; P = .04) and a trend at 24 weeks (8.8% versus 12.6%; P = .08).

Another limitation of the study is the potential for bias due to its retrospective nature.

Dr. Wong has been an invited speaker for AbbVie and Gilead. Dr. Bansal has no relevant financial disclosures.

SAN DIEGO – An analysis of a large, international cohort suggests that treatment with protease-inhibitor (PI)–based direct-acting antivirals (DAAs) may be safe for patients with hepatitis C virus (HCV) with cirrhosis and early-stage liver decompensation.

The study relied on data from the REAL-C registry, including 935 patients treated with oral DAAs at 27 centers in the U.S., Europe, and Asia Pacific countries. The researchers compared efficacy and tolerability outcomes from PI-based and non PI-based DAA regimens in patients deemed to have decompensated HCV cirrhosis.

The findings were encouraging. “It is something important because currently we are short of treatments for decompensated HCV patients. If the tolerability is similar, we perhaps should not withhold [PI] treatment for these patients that sometimes need them the most,” said Yu Jun Wong, MD, who presented the study at the annual Digestive Disease Week^® (DDW). Dr. Wong is a second-year consultant at Changchi General Hospital in Singapore.

“I think it was a very interesting study and something that needed to be done. It was encouraging that patients who did have some level of decompensated cirrhosis did not worsen compared to those who were on a non PI-based therapy,” said Meena Bansal, MD, who comoderated the session where the research was presented.

However, the study was limited by some uncertainty around the definition of decompensation among the study participants. During the Q&A session, audience members questioned whether patients categorized as decompensated were truly decompensated at the time of treatment initiation. Dr. Bansal noted, for example, that a patient might experience a variceal bleed in the context of heavy alcohol consumption, and therefore be considered decompensated, but might stop drinking afterward with a reduction in portal hypertension and recovery of liver function. “So it would be important to know if they were still decompensated at the time they initiated therapy. If that was the case, then these results are more promising,” said Dr. Bansal.

Despite these limitations, the study is good news. “If you do not have access to non-PI based therapy, you might feel a little bit more secure starting a PI-based therapy, particularly the second generation PI-based therapies, if they’re at least on the earlier side of that decompensation scale. But it’s still unclear in true decompensated Child’s B or C whether or not PI-based therapy would have the same results,” said Dr. Bansal.

Dr. Wong acknowledged the limitation that the study doesn’t apply to more severely decompensated patients. “Whether it remains safe in patients with higher Child-Pugh scores is hard to extrapolate at this point of time. We still need to look further into the data,” said Dr. Wong.

Still, the results offer hope to physicians and patients who might find themselves in difficult circumstances. “If you’re resource limited, and you don’t even have access to transplant, these findings suggest that early decompensated patients may benefit from PI-based therapy. If I say to the patient, there’s a chance this could make you worse, but there’s a chance this could make you better, [this is an option] as long as the patient is aware of the possible outcomes,” said Dr. Bansal.

The study included patients with a history of ascites, variceal bleeding, jaundice, or hepatic encephalopathy 6 months before treatment with DAA, or baseline measures of Child-Turcotte-Pugh (CTP) score ≥7 or Model of End-Stage Liver Disease (MELD) score >10. The analysis included data between 2014 and 2021.

The mean age was 64, and 59.6% of participants were male. Overall, 70.8% had genotype 1, and 32% were treatment experienced. In total, 45.2% were treated with PI-based DAAs.

The PI cohort was older (64.6 versus 62.7; P = .01), and more likely to have genotype 1 (87.2% versus 56.3%; P < .001) and chronic renal disease (64.0% vs. 53.9%; P = .001).

The two groups had similar rates of sustained virologic response at 12 and 24 weeks, as well as similar rates of significant improvement or significant worsening, suggesting similar tolerability. There was a lower frequency of liver decompensation in the PI group at 12 weeks (4.4% vs. 7.9%; P = .04) and a trend at 24 weeks (8.8% versus 12.6%; P = .08).

Another limitation of the study is the potential for bias due to its retrospective nature.

Dr. Wong has been an invited speaker for AbbVie and Gilead. Dr. Bansal has no relevant financial disclosures.

SAN DIEGO – An analysis of a large, international cohort suggests that treatment with protease-inhibitor (PI)–based direct-acting antivirals (DAAs) may be safe for patients with hepatitis C virus (HCV) with cirrhosis and early-stage liver decompensation.

The study relied on data from the REAL-C registry, including 935 patients treated with oral DAAs at 27 centers in the U.S., Europe, and Asia Pacific countries. The researchers compared efficacy and tolerability outcomes from PI-based and non PI-based DAA regimens in patients deemed to have decompensated HCV cirrhosis.

The findings were encouraging. “It is something important because currently we are short of treatments for decompensated HCV patients. If the tolerability is similar, we perhaps should not withhold [PI] treatment for these patients that sometimes need them the most,” said Yu Jun Wong, MD, who presented the study at the annual Digestive Disease Week^® (DDW). Dr. Wong is a second-year consultant at Changchi General Hospital in Singapore.

“I think it was a very interesting study and something that needed to be done. It was encouraging that patients who did have some level of decompensated cirrhosis did not worsen compared to those who were on a non PI-based therapy,” said Meena Bansal, MD, who comoderated the session where the research was presented.

However, the study was limited by some uncertainty around the definition of decompensation among the study participants. During the Q&A session, audience members questioned whether patients categorized as decompensated were truly decompensated at the time of treatment initiation. Dr. Bansal noted, for example, that a patient might experience a variceal bleed in the context of heavy alcohol consumption, and therefore be considered decompensated, but might stop drinking afterward with a reduction in portal hypertension and recovery of liver function. “So it would be important to know if they were still decompensated at the time they initiated therapy. If that was the case, then these results are more promising,” said Dr. Bansal.

Despite these limitations, the study is good news. “If you do not have access to non-PI based therapy, you might feel a little bit more secure starting a PI-based therapy, particularly the second generation PI-based therapies, if they’re at least on the earlier side of that decompensation scale. But it’s still unclear in true decompensated Child’s B or C whether or not PI-based therapy would have the same results,” said Dr. Bansal.

Dr. Wong acknowledged the limitation that the study doesn’t apply to more severely decompensated patients. “Whether it remains safe in patients with higher Child-Pugh scores is hard to extrapolate at this point of time. We still need to look further into the data,” said Dr. Wong.

Still, the results offer hope to physicians and patients who might find themselves in difficult circumstances. “If you’re resource limited, and you don’t even have access to transplant, these findings suggest that early decompensated patients may benefit from PI-based therapy. If I say to the patient, there’s a chance this could make you worse, but there’s a chance this could make you better, [this is an option] as long as the patient is aware of the possible outcomes,” said Dr. Bansal.

The study included patients with a history of ascites, variceal bleeding, jaundice, or hepatic encephalopathy 6 months before treatment with DAA, or baseline measures of Child-Turcotte-Pugh (CTP) score ≥7 or Model of End-Stage Liver Disease (MELD) score >10. The analysis included data between 2014 and 2021.

The mean age was 64, and 59.6% of participants were male. Overall, 70.8% had genotype 1, and 32% were treatment experienced. In total, 45.2% were treated with PI-based DAAs.

The PI cohort was older (64.6 versus 62.7; P = .01), and more likely to have genotype 1 (87.2% versus 56.3%; P < .001) and chronic renal disease (64.0% vs. 53.9%; P = .001).

The two groups had similar rates of sustained virologic response at 12 and 24 weeks, as well as similar rates of significant improvement or significant worsening, suggesting similar tolerability. There was a lower frequency of liver decompensation in the PI group at 12 weeks (4.4% vs. 7.9%; P = .04) and a trend at 24 weeks (8.8% versus 12.6%; P = .08).

Another limitation of the study is the potential for bias due to its retrospective nature.

Dr. Wong has been an invited speaker for AbbVie and Gilead. Dr. Bansal has no relevant financial disclosures.

SAN DIEGO – A novel combination of eight human commensal bacteria has shown efficacy in preventing recurrent Clostridioides difficile infections in high-risk populations. The cocktail of bacterial strains (VE303), produced under tightly-controlled conditions, is delivered in powdered form over a period of 14 days.

The approach, sponsored by Vedanta Biosciences, is one of several efforts to use carefully defined microbial populations instead of fecal microbiota transplantation (FMT) to treat or prevent C. diff infections.

The key issue is that not all of the bacteria found in FMTs are needed to provide a therapeutic effect, according to Thomas Louie, MD, professor of medicine at the University of Calgary (Alta.). “You don’t need all the bugs. You don’t need raw [stool]. You can take only the good parts,” said Dr. Louie, who presented the results of the phase 2 study at the annual Digestive Disease Week^® (DDW). In fact, FMT carries the risk of infection of pathogenic bacteria.

The strains found in VE303 were consistently identified in patients’ microbiota following successful FMTs, though they were absent before the transplant. Animal and human studies then showed that the microbes could repopulate microbiota.

Among 78 patients included in the efficacy analysis of the study, after 8 weeks, 13.8% of the VE303 group experienced a recurrent C. diff infection, versus 45.5% of the placebo group, amounting to more than an 80% reduction in risk (odds ratio, 0.192; P = .0077). Adverse events were mild and similar across both groups, with no treatment-related serious adverse events reported.

The same session included a post hoc analysis of a phase 3 study sponsored by Seres Therapeutics, which showed that the company’s oral product SER-109, composed of purified Firmicutes spores, reduced the risk of recurrent C. diff infection after 8 weeks compared to placebo (12.4% versus 39.8%; P < .001).

The new analysis examined short-, medium-, and branch-chained fatty acids in patient stools. After just 1 week of treatment, there was an increase in the short-chain fatty acid butyrate and medium-chain fatty acids valerate and hexanoate. They continued to be higher in weeks 2 and 8 in the treatment arm. The results suggest that increased fatty acid production might boost clinical outcomes, according to Kevin Litcofsky of Seres, who presented the results.

Both approaches have potential, according to Melinda Engevik, PhD, who comoderated the session where the study was presented. “I think that they’re both interesting ideas. The spores [from Seres], I think, are going to be better at passing through the stomach and a little bit more resistant, but then they have to germinate and engraft, whereas if you give the lyophilized bacteria [from Vedanta], you might lose some more, but they’re already primed and ready to go. So I think they’re both very different approaches, but the data from both seem to support that they worked and probably in different ways,” said Dr. Engevik, assistant professor at the Medical University of South Carolina, Charleston.

“Patients that have recurrent [C. diff], they are desperate to be able to break the cycle of recurrence. I think that they’ve shown a lot of safety with this, which is an issue for FMT. Both of the talks seemed like there is a path moving forward to help those patients. I was encouraged,” said Dr. Engevik.

Comoderator Anoop Kumar, PhD, assistant professor of gastroenterology and hepatology at University of Illinois, Chicago, agreed and noted the advantage of such treatments over FMT during the COVID-19 pandemic, which has disrupted FMT delivery.

Previous studies have looked at probiotics, but results so far have been mixed, said Dr. Engevik. She suspects these two approaches, containing more bacterial strains, are likely to have better success. “I think you really have to have a complex gut microbiota community, at least minimally complex, to be able to get the effects. I think it’s the wave of the future,” she said.

Dr. Engevik also suggested that the benefits might not stop at C. diff. She highlighted research in other gastrointestinal diseases such as inflammatory bowel disease, and even efforts underway to enhance responses to checkpoint inhibitors in the treatment of cancer. “Gut microbes are master regulators, so they have these wide-reaching effects. I think that a lot of human health will be started to be targeted by looking at the gut microbiota,” she said.

Dr. Louie also highlighted the potential for more applications. “C. diff is low-hanging fruit. I think these bugs will have some usefulness for [irritable bowel syndrome]. I’ve transplanted some patients with IBS and it seemed to work. I haven’t had time to design and do an IBS trial, but the future is these bugs.”

Dr. Louie also participated in the Seres study. He has been on the advisory board for Vedanta, Seres, Finch Therapeutics, and Artugen Therapeutics. Dr. Engevik and Dr. Kumar have no relevant financial disclosures.

SAN DIEGO – A novel combination of eight human commensal bacteria has shown efficacy in preventing recurrent Clostridioides difficile infections in high-risk populations. The cocktail of bacterial strains (VE303), produced under tightly-controlled conditions, is delivered in powdered form over a period of 14 days.

The approach, sponsored by Vedanta Biosciences, is one of several efforts to use carefully defined microbial populations instead of fecal microbiota transplantation (FMT) to treat or prevent C. diff infections.

The key issue is that not all of the bacteria found in FMTs are needed to provide a therapeutic effect, according to Thomas Louie, MD, professor of medicine at the University of Calgary (Alta.). “You don’t need all the bugs. You don’t need raw [stool]. You can take only the good parts,” said Dr. Louie, who presented the results of the phase 2 study at the annual Digestive Disease Week^® (DDW). In fact, FMT carries the risk of infection of pathogenic bacteria.

The strains found in VE303 were consistently identified in patients’ microbiota following successful FMTs, though they were absent before the transplant. Animal and human studies then showed that the microbes could repopulate microbiota.

Among 78 patients included in the efficacy analysis of the study, after 8 weeks, 13.8% of the VE303 group experienced a recurrent C. diff infection, versus 45.5% of the placebo group, amounting to more than an 80% reduction in risk (odds ratio, 0.192; P = .0077). Adverse events were mild and similar across both groups, with no treatment-related serious adverse events reported.

The same session included a post hoc analysis of a phase 3 study sponsored by Seres Therapeutics, which showed that the company’s oral product SER-109, composed of purified Firmicutes spores, reduced the risk of recurrent C. diff infection after 8 weeks compared to placebo (12.4% versus 39.8%; P < .001).

The new analysis examined short-, medium-, and branch-chained fatty acids in patient stools. After just 1 week of treatment, there was an increase in the short-chain fatty acid butyrate and medium-chain fatty acids valerate and hexanoate. They continued to be higher in weeks 2 and 8 in the treatment arm. The results suggest that increased fatty acid production might boost clinical outcomes, according to Kevin Litcofsky of Seres, who presented the results.

Both approaches have potential, according to Melinda Engevik, PhD, who comoderated the session where the study was presented. “I think that they’re both interesting ideas. The spores [from Seres], I think, are going to be better at passing through the stomach and a little bit more resistant, but then they have to germinate and engraft, whereas if you give the lyophilized bacteria [from Vedanta], you might lose some more, but they’re already primed and ready to go. So I think they’re both very different approaches, but the data from both seem to support that they worked and probably in different ways,” said Dr. Engevik, assistant professor at the Medical University of South Carolina, Charleston.

“Patients that have recurrent [C. diff], they are desperate to be able to break the cycle of recurrence. I think that they’ve shown a lot of safety with this, which is an issue for FMT. Both of the talks seemed like there is a path moving forward to help those patients. I was encouraged,” said Dr. Engevik.

Comoderator Anoop Kumar, PhD, assistant professor of gastroenterology and hepatology at University of Illinois, Chicago, agreed and noted the advantage of such treatments over FMT during the COVID-19 pandemic, which has disrupted FMT delivery.

Previous studies have looked at probiotics, but results so far have been mixed, said Dr. Engevik. She suspects these two approaches, containing more bacterial strains, are likely to have better success. “I think you really have to have a complex gut microbiota community, at least minimally complex, to be able to get the effects. I think it’s the wave of the future,” she said.

Dr. Engevik also suggested that the benefits might not stop at C. diff. She highlighted research in other gastrointestinal diseases such as inflammatory bowel disease, and even efforts underway to enhance responses to checkpoint inhibitors in the treatment of cancer. “Gut microbes are master regulators, so they have these wide-reaching effects. I think that a lot of human health will be started to be targeted by looking at the gut microbiota,” she said.

Dr. Louie also highlighted the potential for more applications. “C. diff is low-hanging fruit. I think these bugs will have some usefulness for [irritable bowel syndrome]. I’ve transplanted some patients with IBS and it seemed to work. I haven’t had time to design and do an IBS trial, but the future is these bugs.”

Dr. Louie also participated in the Seres study. He has been on the advisory board for Vedanta, Seres, Finch Therapeutics, and Artugen Therapeutics. Dr. Engevik and Dr. Kumar have no relevant financial disclosures.

SAN DIEGO – A novel combination of eight human commensal bacteria has shown efficacy in preventing recurrent Clostridioides difficile infections in high-risk populations. The cocktail of bacterial strains (VE303), produced under tightly-controlled conditions, is delivered in powdered form over a period of 14 days.

The approach, sponsored by Vedanta Biosciences, is one of several efforts to use carefully defined microbial populations instead of fecal microbiota transplantation (FMT) to treat or prevent C. diff infections.

The key issue is that not all of the bacteria found in FMTs are needed to provide a therapeutic effect, according to Thomas Louie, MD, professor of medicine at the University of Calgary (Alta.). “You don’t need all the bugs. You don’t need raw [stool]. You can take only the good parts,” said Dr. Louie, who presented the results of the phase 2 study at the annual Digestive Disease Week^® (DDW). In fact, FMT carries the risk of infection of pathogenic bacteria.

The strains found in VE303 were consistently identified in patients’ microbiota following successful FMTs, though they were absent before the transplant. Animal and human studies then showed that the microbes could repopulate microbiota.

Among 78 patients included in the efficacy analysis of the study, after 8 weeks, 13.8% of the VE303 group experienced a recurrent C. diff infection, versus 45.5% of the placebo group, amounting to more than an 80% reduction in risk (odds ratio, 0.192; P = .0077). Adverse events were mild and similar across both groups, with no treatment-related serious adverse events reported.

The same session included a post hoc analysis of a phase 3 study sponsored by Seres Therapeutics, which showed that the company’s oral product SER-109, composed of purified Firmicutes spores, reduced the risk of recurrent C. diff infection after 8 weeks compared to placebo (12.4% versus 39.8%; P < .001).

The new analysis examined short-, medium-, and branch-chained fatty acids in patient stools. After just 1 week of treatment, there was an increase in the short-chain fatty acid butyrate and medium-chain fatty acids valerate and hexanoate. They continued to be higher in weeks 2 and 8 in the treatment arm. The results suggest that increased fatty acid production might boost clinical outcomes, according to Kevin Litcofsky of Seres, who presented the results.

Both approaches have potential, according to Melinda Engevik, PhD, who comoderated the session where the study was presented. “I think that they’re both interesting ideas. The spores [from Seres], I think, are going to be better at passing through the stomach and a little bit more resistant, but then they have to germinate and engraft, whereas if you give the lyophilized bacteria [from Vedanta], you might lose some more, but they’re already primed and ready to go. So I think they’re both very different approaches, but the data from both seem to support that they worked and probably in different ways,” said Dr. Engevik, assistant professor at the Medical University of South Carolina, Charleston.

“Patients that have recurrent [C. diff], they are desperate to be able to break the cycle of recurrence. I think that they’ve shown a lot of safety with this, which is an issue for FMT. Both of the talks seemed like there is a path moving forward to help those patients. I was encouraged,” said Dr. Engevik.

Comoderator Anoop Kumar, PhD, assistant professor of gastroenterology and hepatology at University of Illinois, Chicago, agreed and noted the advantage of such treatments over FMT during the COVID-19 pandemic, which has disrupted FMT delivery.

Previous studies have looked at probiotics, but results so far have been mixed, said Dr. Engevik. She suspects these two approaches, containing more bacterial strains, are likely to have better success. “I think you really have to have a complex gut microbiota community, at least minimally complex, to be able to get the effects. I think it’s the wave of the future,” she said.

Dr. Engevik also suggested that the benefits might not stop at C. diff. She highlighted research in other gastrointestinal diseases such as inflammatory bowel disease, and even efforts underway to enhance responses to checkpoint inhibitors in the treatment of cancer. “Gut microbes are master regulators, so they have these wide-reaching effects. I think that a lot of human health will be started to be targeted by looking at the gut microbiota,” she said.

Dr. Louie also highlighted the potential for more applications. “C. diff is low-hanging fruit. I think these bugs will have some usefulness for [irritable bowel syndrome]. I’ve transplanted some patients with IBS and it seemed to work. I haven’t had time to design and do an IBS trial, but the future is these bugs.”

Dr. Louie also participated in the Seres study. He has been on the advisory board for Vedanta, Seres, Finch Therapeutics, and Artugen Therapeutics. Dr. Engevik and Dr. Kumar have no relevant financial disclosures.

SAN DIEGO – Treating people with alcoholic hepatitis for alcohol abuse may reduce their risk of hospital readmission, researchers reported.

In a retrospective analysis of nationwide data, 7.83% of those patients who received psychotherapy, counseling, or drug treatment for alcohol abuse were readmitted within 30 days, versus 11.67% of those who did not receive these kinds of treatment.

The finding lends support to the argument that hospitals should invest more in the treatments, despite the complexities involved.

“It takes a multidisciplinary approach, starting from the physician or the health care provider along with the pharmacists, the behavioral health specialists, or a psychiatrist or psychologist, along with case management as well,” said Harleen Chela, MD, a third-year resident at the University of Missouri in Columbia. She presented the findings at the annual Digestive Disease Week^® (DDW).

The researchers started with the premise that patients with alcoholic hepatitis can prevent the condition from worsening by abstaining from alcohol. To see whether interventions aimed at encouraging that abstention could prevent readmissions, Dr. Chela and colleagues analyzed data on readmissions for the first 11 months of the year 2018.

They included patients who were at least 18 years of age and who had a nonelective admission with a principal diagnosis of alcohol abuse.

Using procedure codes, they compared those patients given psychotherapy (including cognitive behavioral therapy), formal inpatient counseling, and drug treatment for alcohol abuse to those who didn’t. Then they counted how many patients were readmitted within 30 days.

They found records of 45,617 patients admitted for alcoholic hepatitis of whom 1,552 received treatment for alcohol abuse and 44,065 did not.

They did not find any significant difference between the two groups in demographics, income, or insurance status.

Adjusting for such factors, the researchers found that people who received alcohol abuse treatment were 64% as likely to be readmitted as were those who did not (hazard ratio, 0.64; 95% confidence interval, 0.46-0.91; P = 0.01).

If alcohol abuse treatment is so effective, why isn’t it routine? “It’s not always feasible to implement this, on the inpatient side, because it takes more than a day or two just to get some of these things put in place,” Dr. Chela told this news organization.

They did find that people were more likely to get treatment for alcohol abuse if they were admitted to a hospital in a big city rather than a small town and if their hospital was owned by private investors rather than by a not-for-profit organization or the government.

“Larger hospitals and private sector institutions have more access to resources and money to have those kinds of systems in place for the patients,” said Dr. Chela.

She became interested in the issue at her hospital when she noticed that patients with alcoholic hepatitis were not getting behavioral counseling. “The inpatient load in the behavioral health side is so much that they don’t have time for these kinds of consults,” she said. “That’s one of the challenges: A shortage of behavioral specialists like psychiatrists.”

And hospitals tend to focus on treating conditions that threaten their patients’ lives in the short term. “Someone who has a heart attack or a gastrointestinal bleed – there’s more focus on resources for those kinds of patients,” she said.

Virginia Commonwealth University in Richmond provides alcohol abuse treatment to patients with alcoholic hepatitis partly using telehealth, said Richard Sterling, MD, MSc, chief of hepatology, who was not involved in the study. “For people who live too far away, don’t have transportation, or have other health disparities, we now have technology and mechanisms to keep them engaged in care,” he told this news organization. “We’re doing a lot of Zoom visits.”

Dr. Chela and colleagues also found that those who got alcohol abuse treatment were less likely to be discharged to a skilled nursing facility or to home health. The data couldn’t give the researchers a definitive reason for this, but Dr. Chela speculated that the patients who received treatment for alcohol abuse stayed longer in the hospital and may have been in better shape when they were discharged.

The U.S. health care system doesn’t necessarily provide incentives to keep patients healthy, Dr. Sterling said. “Hospital systems make money off of filling beds, and providing a lot of inpatient care and hospital days,” he said. “That may be not necessarily congruent with a health system that is supposed to provide health for these covered lives.”

Neither Dr. Chela nor Dr. Sterling reported any relevant financial relationships.

SAN DIEGO – Treating people with alcoholic hepatitis for alcohol abuse may reduce their risk of hospital readmission, researchers reported.

In a retrospective analysis of nationwide data, 7.83% of those patients who received psychotherapy, counseling, or drug treatment for alcohol abuse were readmitted within 30 days, versus 11.67% of those who did not receive these kinds of treatment.

The finding lends support to the argument that hospitals should invest more in the treatments, despite the complexities involved.

“It takes a multidisciplinary approach, starting from the physician or the health care provider along with the pharmacists, the behavioral health specialists, or a psychiatrist or psychologist, along with case management as well,” said Harleen Chela, MD, a third-year resident at the University of Missouri in Columbia. She presented the findings at the annual Digestive Disease Week^® (DDW).

The researchers started with the premise that patients with alcoholic hepatitis can prevent the condition from worsening by abstaining from alcohol. To see whether interventions aimed at encouraging that abstention could prevent readmissions, Dr. Chela and colleagues analyzed data on readmissions for the first 11 months of the year 2018.

They included patients who were at least 18 years of age and who had a nonelective admission with a principal diagnosis of alcohol abuse.

Using procedure codes, they compared those patients given psychotherapy (including cognitive behavioral therapy), formal inpatient counseling, and drug treatment for alcohol abuse to those who didn’t. Then they counted how many patients were readmitted within 30 days.

They found records of 45,617 patients admitted for alcoholic hepatitis of whom 1,552 received treatment for alcohol abuse and 44,065 did not.

They did not find any significant difference between the two groups in demographics, income, or insurance status.

Adjusting for such factors, the researchers found that people who received alcohol abuse treatment were 64% as likely to be readmitted as were those who did not (hazard ratio, 0.64; 95% confidence interval, 0.46-0.91; P = 0.01).

If alcohol abuse treatment is so effective, why isn’t it routine? “It’s not always feasible to implement this, on the inpatient side, because it takes more than a day or two just to get some of these things put in place,” Dr. Chela told this news organization.

They did find that people were more likely to get treatment for alcohol abuse if they were admitted to a hospital in a big city rather than a small town and if their hospital was owned by private investors rather than by a not-for-profit organization or the government.

“Larger hospitals and private sector institutions have more access to resources and money to have those kinds of systems in place for the patients,” said Dr. Chela.

She became interested in the issue at her hospital when she noticed that patients with alcoholic hepatitis were not getting behavioral counseling. “The inpatient load in the behavioral health side is so much that they don’t have time for these kinds of consults,” she said. “That’s one of the challenges: A shortage of behavioral specialists like psychiatrists.”

And hospitals tend to focus on treating conditions that threaten their patients’ lives in the short term. “Someone who has a heart attack or a gastrointestinal bleed – there’s more focus on resources for those kinds of patients,” she said.

Virginia Commonwealth University in Richmond provides alcohol abuse treatment to patients with alcoholic hepatitis partly using telehealth, said Richard Sterling, MD, MSc, chief of hepatology, who was not involved in the study. “For people who live too far away, don’t have transportation, or have other health disparities, we now have technology and mechanisms to keep them engaged in care,” he told this news organization. “We’re doing a lot of Zoom visits.”

Dr. Chela and colleagues also found that those who got alcohol abuse treatment were less likely to be discharged to a skilled nursing facility or to home health. The data couldn’t give the researchers a definitive reason for this, but Dr. Chela speculated that the patients who received treatment for alcohol abuse stayed longer in the hospital and may have been in better shape when they were discharged.

The U.S. health care system doesn’t necessarily provide incentives to keep patients healthy, Dr. Sterling said. “Hospital systems make money off of filling beds, and providing a lot of inpatient care and hospital days,” he said. “That may be not necessarily congruent with a health system that is supposed to provide health for these covered lives.”

Neither Dr. Chela nor Dr. Sterling reported any relevant financial relationships.

SAN DIEGO – Treating people with alcoholic hepatitis for alcohol abuse may reduce their risk of hospital readmission, researchers reported.

In a retrospective analysis of nationwide data, 7.83% of those patients who received psychotherapy, counseling, or drug treatment for alcohol abuse were readmitted within 30 days, versus 11.67% of those who did not receive these kinds of treatment.

The finding lends support to the argument that hospitals should invest more in the treatments, despite the complexities involved.

“It takes a multidisciplinary approach, starting from the physician or the health care provider along with the pharmacists, the behavioral health specialists, or a psychiatrist or psychologist, along with case management as well,” said Harleen Chela, MD, a third-year resident at the University of Missouri in Columbia. She presented the findings at the annual Digestive Disease Week^® (DDW).

The researchers started with the premise that patients with alcoholic hepatitis can prevent the condition from worsening by abstaining from alcohol. To see whether interventions aimed at encouraging that abstention could prevent readmissions, Dr. Chela and colleagues analyzed data on readmissions for the first 11 months of the year 2018.

They included patients who were at least 18 years of age and who had a nonelective admission with a principal diagnosis of alcohol abuse.

Using procedure codes, they compared those patients given psychotherapy (including cognitive behavioral therapy), formal inpatient counseling, and drug treatment for alcohol abuse to those who didn’t. Then they counted how many patients were readmitted within 30 days.

They found records of 45,617 patients admitted for alcoholic hepatitis of whom 1,552 received treatment for alcohol abuse and 44,065 did not.

They did not find any significant difference between the two groups in demographics, income, or insurance status.

Adjusting for such factors, the researchers found that people who received alcohol abuse treatment were 64% as likely to be readmitted as were those who did not (hazard ratio, 0.64; 95% confidence interval, 0.46-0.91; P = 0.01).

If alcohol abuse treatment is so effective, why isn’t it routine? “It’s not always feasible to implement this, on the inpatient side, because it takes more than a day or two just to get some of these things put in place,” Dr. Chela told this news organization.

They did find that people were more likely to get treatment for alcohol abuse if they were admitted to a hospital in a big city rather than a small town and if their hospital was owned by private investors rather than by a not-for-profit organization or the government.

“Larger hospitals and private sector institutions have more access to resources and money to have those kinds of systems in place for the patients,” said Dr. Chela.

She became interested in the issue at her hospital when she noticed that patients with alcoholic hepatitis were not getting behavioral counseling. “The inpatient load in the behavioral health side is so much that they don’t have time for these kinds of consults,” she said. “That’s one of the challenges: A shortage of behavioral specialists like psychiatrists.”

And hospitals tend to focus on treating conditions that threaten their patients’ lives in the short term. “Someone who has a heart attack or a gastrointestinal bleed – there’s more focus on resources for those kinds of patients,” she said.

Virginia Commonwealth University in Richmond provides alcohol abuse treatment to patients with alcoholic hepatitis partly using telehealth, said Richard Sterling, MD, MSc, chief of hepatology, who was not involved in the study. “For people who live too far away, don’t have transportation, or have other health disparities, we now have technology and mechanisms to keep them engaged in care,” he told this news organization. “We’re doing a lot of Zoom visits.”

Dr. Chela and colleagues also found that those who got alcohol abuse treatment were less likely to be discharged to a skilled nursing facility or to home health. The data couldn’t give the researchers a definitive reason for this, but Dr. Chela speculated that the patients who received treatment for alcohol abuse stayed longer in the hospital and may have been in better shape when they were discharged.

The U.S. health care system doesn’t necessarily provide incentives to keep patients healthy, Dr. Sterling said. “Hospital systems make money off of filling beds, and providing a lot of inpatient care and hospital days,” he said. “That may be not necessarily congruent with a health system that is supposed to provide health for these covered lives.”

Neither Dr. Chela nor Dr. Sterling reported any relevant financial relationships.

SAN FRANCISCO – Along with first responders, health care workers in pulmonary and critical care have borne the brunt of the COVID-19 pandemic, and it’s not surprising that a large proportion have suffered from burnout, a syndrome characterized by chronic workplace stress, emotional exhaustion, cynicism about the job, and a reduced sense of personal accomplishment.

“Prior to the pandemic, 50% of providers reported burnout, and that, of course, has been exacerbated, with recent surveys showing up to 80% of health care workers reporting burnout,” said Sangeeta Joshi, MD, of the division of pulmonary, allergy, and critical care medicine at Duke University in Durham, N.C.

In a randomized clinical trial, Dr. Joshi and colleagues showed that transcendental meditation (TM) can significantly improve burnout symptoms of emotional exhaustion, anxiety, and insomnia compared with other interventions, albeit without significant improvement in acute psychological distress.

Dr. Joshi reported the results of the trial at the American Thoracic Society’s international conference.
 

Mind-body intervention

TM, popularized in the 1960s by the Beatles and their guru, Maharishi Mahesh Yogi, is a nonpharmacologic mind-body intervention that has been shown to reduce sympathetic arousal and to promote a state of relaxation, Dr. Joshi said.

Although the mechanism of action is not fully understood, proposed explanations for its efficacy include increased alpha coherence, as seen on electroencephalography, and increases in blood flow to the prefrontal cortex, as visualized on functional MRI.

TM has been shown to be effective for reducing symptoms of posttraumatic stress disorder in veterans and for reducing stress and burnout symptoms in teachers, Dr. Joshi noted.
 

Randomized trial

To see whether TM could make a difference for health care providers, Dr. Joshi and colleagues screened candidates for burnout with the single-item Columbia–Suicide Severity Rating Scale and digital autonomic reactivity, a measure of the depth of physiologic stimulus.

Their study included 80 eligible participants, who were randomly assigned to receive either TM or treatment as usual.

The participants who received the intervention were assigned to attend four TM instruction sessions over 4 consecutive days, followed by four virtual follow-up sessions over the 3-month period. The investigators hypothesized that these participants would have significant improvements in symptoms of burnout over baseline compared with those assigned to standard treatments. Participants who underwent the intervention were encouraged to perform TM at home for 20 minutes twice each day.

Participants were evaluated at baseline and at 3-month follow-up with the Brief Symptom Inventory–18 (BSI), the Maslach Burnout Inventory (MBI), the Patient Health Questionnaire–9 (PHQ-9), the Generalized Anxiety Disorder–7, the Insomnia Severity Index (ISI), and the Connor Davidson Resilience Scale (CD-RISC)–25.

At baseline, 70% of all participants reported a history of visiting a psychiatrist or other mental health worker, and 91% reported onset of a mental health condition. Only 30% reported that they had had a mental health condition that resolved with treatment.

At 3 months, there were significant improvements over baseline in the TM group compared with the treatment-as-usual group for the MBI emotional exhaustion item (P = .005), insomnia (P = .029), and anxiety (P = .010). There was trend toward significance on the PHQ-9 (P = .057), but no significant difference in the Global Severity Index (the total score of BSI items).

There were improvements in both study arms in both the MBI professional accomplishment item and in the CD-RISC scale, but the between-group differences were not significant.

The results show that “TM is a feasible, efficacious intervention in health care workers, especially during a pandemic,” Dr. Joshi said.

Future studies of TM in this setting should expand the number of participants and recruitment sites so as to have the necessary power to detect statistically significant changes in the numerical scales, she said.
 

Integrating TM into employee wellness

“These results are really encouraging,” said Seppo Rinne, MD, PhD, assistant professor of medicine at Boston University, who comoderated the oral abstract session in which the data were presented but was not involved in the study.

Commenting on the fact that TM is not more widely offered as part of a package of services for treating employees with symptoms of burnout, he noted that “in the burnout literature, we have a tendency to dichotomize these individual vs. organizational interventions, and the reality is that they are probably more integrated, and it’s not really helpful for us to think about these as totally separate.

“We need organizational interventions that support individual wellness,” he said.

The trial was sponsored by Duke University. Dr. Joshi and Dr. Rinne reported no relevant financial relationships.

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

SAN FRANCISCO – Along with first responders, health care workers in pulmonary and critical care have borne the brunt of the COVID-19 pandemic, and it’s not surprising that a large proportion have suffered from burnout, a syndrome characterized by chronic workplace stress, emotional exhaustion, cynicism about the job, and a reduced sense of personal accomplishment.

“Prior to the pandemic, 50% of providers reported burnout, and that, of course, has been exacerbated, with recent surveys showing up to 80% of health care workers reporting burnout,” said Sangeeta Joshi, MD, of the division of pulmonary, allergy, and critical care medicine at Duke University in Durham, N.C.

In a randomized clinical trial, Dr. Joshi and colleagues showed that transcendental meditation (TM) can significantly improve burnout symptoms of emotional exhaustion, anxiety, and insomnia compared with other interventions, albeit without significant improvement in acute psychological distress.

Dr. Joshi reported the results of the trial at the American Thoracic Society’s international conference.
 

Mind-body intervention

TM, popularized in the 1960s by the Beatles and their guru, Maharishi Mahesh Yogi, is a nonpharmacologic mind-body intervention that has been shown to reduce sympathetic arousal and to promote a state of relaxation, Dr. Joshi said.

Although the mechanism of action is not fully understood, proposed explanations for its efficacy include increased alpha coherence, as seen on electroencephalography, and increases in blood flow to the prefrontal cortex, as visualized on functional MRI.

TM has been shown to be effective for reducing symptoms of posttraumatic stress disorder in veterans and for reducing stress and burnout symptoms in teachers, Dr. Joshi noted.
 

Randomized trial

To see whether TM could make a difference for health care providers, Dr. Joshi and colleagues screened candidates for burnout with the single-item Columbia–Suicide Severity Rating Scale and digital autonomic reactivity, a measure of the depth of physiologic stimulus.

Their study included 80 eligible participants, who were randomly assigned to receive either TM or treatment as usual.

The participants who received the intervention were assigned to attend four TM instruction sessions over 4 consecutive days, followed by four virtual follow-up sessions over the 3-month period. The investigators hypothesized that these participants would have significant improvements in symptoms of burnout over baseline compared with those assigned to standard treatments. Participants who underwent the intervention were encouraged to perform TM at home for 20 minutes twice each day.

Participants were evaluated at baseline and at 3-month follow-up with the Brief Symptom Inventory–18 (BSI), the Maslach Burnout Inventory (MBI), the Patient Health Questionnaire–9 (PHQ-9), the Generalized Anxiety Disorder–7, the Insomnia Severity Index (ISI), and the Connor Davidson Resilience Scale (CD-RISC)–25.

At baseline, 70% of all participants reported a history of visiting a psychiatrist or other mental health worker, and 91% reported onset of a mental health condition. Only 30% reported that they had had a mental health condition that resolved with treatment.

At 3 months, there were significant improvements over baseline in the TM group compared with the treatment-as-usual group for the MBI emotional exhaustion item (P = .005), insomnia (P = .029), and anxiety (P = .010). There was trend toward significance on the PHQ-9 (P = .057), but no significant difference in the Global Severity Index (the total score of BSI items).

There were improvements in both study arms in both the MBI professional accomplishment item and in the CD-RISC scale, but the between-group differences were not significant.

The results show that “TM is a feasible, efficacious intervention in health care workers, especially during a pandemic,” Dr. Joshi said.

Future studies of TM in this setting should expand the number of participants and recruitment sites so as to have the necessary power to detect statistically significant changes in the numerical scales, she said.
 

Integrating TM into employee wellness

“These results are really encouraging,” said Seppo Rinne, MD, PhD, assistant professor of medicine at Boston University, who comoderated the oral abstract session in which the data were presented but was not involved in the study.

Commenting on the fact that TM is not more widely offered as part of a package of services for treating employees with symptoms of burnout, he noted that “in the burnout literature, we have a tendency to dichotomize these individual vs. organizational interventions, and the reality is that they are probably more integrated, and it’s not really helpful for us to think about these as totally separate.

“We need organizational interventions that support individual wellness,” he said.

The trial was sponsored by Duke University. Dr. Joshi and Dr. Rinne reported no relevant financial relationships.

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

SAN FRANCISCO – Along with first responders, health care workers in pulmonary and critical care have borne the brunt of the COVID-19 pandemic, and it’s not surprising that a large proportion have suffered from burnout, a syndrome characterized by chronic workplace stress, emotional exhaustion, cynicism about the job, and a reduced sense of personal accomplishment.

“Prior to the pandemic, 50% of providers reported burnout, and that, of course, has been exacerbated, with recent surveys showing up to 80% of health care workers reporting burnout,” said Sangeeta Joshi, MD, of the division of pulmonary, allergy, and critical care medicine at Duke University in Durham, N.C.

In a randomized clinical trial, Dr. Joshi and colleagues showed that transcendental meditation (TM) can significantly improve burnout symptoms of emotional exhaustion, anxiety, and insomnia compared with other interventions, albeit without significant improvement in acute psychological distress.

Dr. Joshi reported the results of the trial at the American Thoracic Society’s international conference.
 

Mind-body intervention

TM, popularized in the 1960s by the Beatles and their guru, Maharishi Mahesh Yogi, is a nonpharmacologic mind-body intervention that has been shown to reduce sympathetic arousal and to promote a state of relaxation, Dr. Joshi said.

Although the mechanism of action is not fully understood, proposed explanations for its efficacy include increased alpha coherence, as seen on electroencephalography, and increases in blood flow to the prefrontal cortex, as visualized on functional MRI.

TM has been shown to be effective for reducing symptoms of posttraumatic stress disorder in veterans and for reducing stress and burnout symptoms in teachers, Dr. Joshi noted.
 

Randomized trial

To see whether TM could make a difference for health care providers, Dr. Joshi and colleagues screened candidates for burnout with the single-item Columbia–Suicide Severity Rating Scale and digital autonomic reactivity, a measure of the depth of physiologic stimulus.

Their study included 80 eligible participants, who were randomly assigned to receive either TM or treatment as usual.

The participants who received the intervention were assigned to attend four TM instruction sessions over 4 consecutive days, followed by four virtual follow-up sessions over the 3-month period. The investigators hypothesized that these participants would have significant improvements in symptoms of burnout over baseline compared with those assigned to standard treatments. Participants who underwent the intervention were encouraged to perform TM at home for 20 minutes twice each day.

Participants were evaluated at baseline and at 3-month follow-up with the Brief Symptom Inventory–18 (BSI), the Maslach Burnout Inventory (MBI), the Patient Health Questionnaire–9 (PHQ-9), the Generalized Anxiety Disorder–7, the Insomnia Severity Index (ISI), and the Connor Davidson Resilience Scale (CD-RISC)–25.

At baseline, 70% of all participants reported a history of visiting a psychiatrist or other mental health worker, and 91% reported onset of a mental health condition. Only 30% reported that they had had a mental health condition that resolved with treatment.

At 3 months, there were significant improvements over baseline in the TM group compared with the treatment-as-usual group for the MBI emotional exhaustion item (P = .005), insomnia (P = .029), and anxiety (P = .010). There was trend toward significance on the PHQ-9 (P = .057), but no significant difference in the Global Severity Index (the total score of BSI items).

There were improvements in both study arms in both the MBI professional accomplishment item and in the CD-RISC scale, but the between-group differences were not significant.

The results show that “TM is a feasible, efficacious intervention in health care workers, especially during a pandemic,” Dr. Joshi said.

Future studies of TM in this setting should expand the number of participants and recruitment sites so as to have the necessary power to detect statistically significant changes in the numerical scales, she said.
 

Integrating TM into employee wellness

“These results are really encouraging,” said Seppo Rinne, MD, PhD, assistant professor of medicine at Boston University, who comoderated the oral abstract session in which the data were presented but was not involved in the study.

Commenting on the fact that TM is not more widely offered as part of a package of services for treating employees with symptoms of burnout, he noted that “in the burnout literature, we have a tendency to dichotomize these individual vs. organizational interventions, and the reality is that they are probably more integrated, and it’s not really helpful for us to think about these as totally separate.

“We need organizational interventions that support individual wellness,” he said.

The trial was sponsored by Duke University. Dr. Joshi and Dr. Rinne reported no relevant financial relationships.

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