NEW ORLEANS – The increased use of digital screens for school during the COVID-19 pandemic may be causing convergence insufficiency in children, researchers say.

Although the long-term implications for current schoolchildren are not clear, convergence insufficiency sometimes persists for a lifetime, said Kammi Gunton, MD, interim chief of pediatric ophthalmology and strabismus at Wills Eye Hospital, Philadelphia.

“It’s important, if we use digital technology for education, that we are aware that it might contribute to increased eye symptoms in children,” Dr. Gunton told this news organization.

Dr. Gunton’s colleague, Jordan Hamburger, an MD candidate at Sidney Kimmel Medical College, Philadelphia, presented the finding at the American Academy of Ophthalmology 2021 Annual Meeting.

Convergence insufficiency is an impairment of binocularity. Symptoms include headaches while reading, words that seem to move around the page, blurriness, diplopia, and eye fatigue. It can be treated with exercise, prism glasses, or, rarely, surgery.

“We have some kids who improve with either time or maturity, then we have other patients who suffer from it for their entire lives,” Dr. Gunton said.

Previous research has linked the use of digital screens to convergence insufficiency, so when many schools shifted to distance learning for the pandemic, Dr. Gunton and her colleagues wanted to see whether it would have this effect on the students’ eyes.

They surveyed 110 healthy schoolchildren and adolescent students regarding eye symptoms before and after a day of virtual school. The mean age of the participants was 14 years (range, 10-17 years). The participants spent an average of 6.96 hours per day in virtual school. Forty-one percent also attended school in person part time. These students filled out the survey on days when they were in virtual school.

The participants answered questions on the Convergence Insufficiency Symptom Survey (CISS). The survey consists of 15 questions about eye complaints. On each question, the students rated symptoms from 0 to 4, with 4 indicating a severe symptom.

The average sum of the CISS scores rose from 5.17 before school to 9.82 after school, a statistically significant change (P < .001). Sixty-one percent of the participants reported an increase in convergence insufficiency symptoms.

Seventeen percent scored a total of at least 16, which is the threshold score considered suggestive of convergence insufficiency.

The researchers also found that, on average, the more hours each student spent in virtual school, the higher their CISS scores.

This makes sense, because reading requires convergence, Dr. Gunton said. The same problem might occur in traditional school if the students were looking at books all day instead of focusing on objects at various distances in their classrooms, such as the teacher or the whiteboard. “So, in the past, if you read a book, maybe you wouldn’t read for several hours, but now we’re asking children during virtual learning to stay on a device with the camera on,” she said.

Previous research has shown that people blink less when reading or using electronic devices, probably because of their increased concentration. This might explain symptoms such as burning and itching. Fifty-three percent of the students reported an increase in asthenopia symptoms.

The researchers would have liked to have compared the students in virtual school to a matched group of students in traditional school. However, almost all students were enrolled in virtual school when the study was conducted, making such a control difficult.

Although previous research has related virtual learning to myopia, as reported by this news organization, this study did not investigate myopia, and the researchers do not believe that convergence insufficiency causes myopia or vice versa.

Parents can help prevent convergence insufficiency during school by reminding their children to take breaks, Dr. Gunton said. She recommends the 20/20/20 rule: After 20 minutes of work that involves looking at objects nearby, students should take a 20-second break and look at something 20 feet away.

“I also think the take-home message is for parents to ask students if they’re having symptoms,” she said, “and if they hear complaints while kids are on the computers, to have them see an eye doctor and have an evaluation.”

Stephen Lipsky, MD, who wasn’t involved in the study, said he is seeing more cases of eye strain at Children’s Healthcare of Atlanta, where he is a consulting ophthalmologist.

“The study is very valuable in that it shines a light on the fact that these children do have symptoms, such as asthenopia or convergence insufficiency,” he told this news organization. “But I’m optimistic that with a return to more traditional learning, we will return the more traditional incidence of these problems.”

Dr. Gunton and Dr. Lipsky have disclosed no relevant financial relationships.

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

NEW ORLEANS – The increased use of digital screens for school during the COVID-19 pandemic may be causing convergence insufficiency in children, researchers say.

Although the long-term implications for current schoolchildren are not clear, convergence insufficiency sometimes persists for a lifetime, said Kammi Gunton, MD, interim chief of pediatric ophthalmology and strabismus at Wills Eye Hospital, Philadelphia.

“It’s important, if we use digital technology for education, that we are aware that it might contribute to increased eye symptoms in children,” Dr. Gunton told this news organization.

Dr. Gunton’s colleague, Jordan Hamburger, an MD candidate at Sidney Kimmel Medical College, Philadelphia, presented the finding at the American Academy of Ophthalmology 2021 Annual Meeting.

Convergence insufficiency is an impairment of binocularity. Symptoms include headaches while reading, words that seem to move around the page, blurriness, diplopia, and eye fatigue. It can be treated with exercise, prism glasses, or, rarely, surgery.

“We have some kids who improve with either time or maturity, then we have other patients who suffer from it for their entire lives,” Dr. Gunton said.

Previous research has linked the use of digital screens to convergence insufficiency, so when many schools shifted to distance learning for the pandemic, Dr. Gunton and her colleagues wanted to see whether it would have this effect on the students’ eyes.

They surveyed 110 healthy schoolchildren and adolescent students regarding eye symptoms before and after a day of virtual school. The mean age of the participants was 14 years (range, 10-17 years). The participants spent an average of 6.96 hours per day in virtual school. Forty-one percent also attended school in person part time. These students filled out the survey on days when they were in virtual school.

The participants answered questions on the Convergence Insufficiency Symptom Survey (CISS). The survey consists of 15 questions about eye complaints. On each question, the students rated symptoms from 0 to 4, with 4 indicating a severe symptom.

The average sum of the CISS scores rose from 5.17 before school to 9.82 after school, a statistically significant change (P < .001). Sixty-one percent of the participants reported an increase in convergence insufficiency symptoms.

Seventeen percent scored a total of at least 16, which is the threshold score considered suggestive of convergence insufficiency.

The researchers also found that, on average, the more hours each student spent in virtual school, the higher their CISS scores.

This makes sense, because reading requires convergence, Dr. Gunton said. The same problem might occur in traditional school if the students were looking at books all day instead of focusing on objects at various distances in their classrooms, such as the teacher or the whiteboard. “So, in the past, if you read a book, maybe you wouldn’t read for several hours, but now we’re asking children during virtual learning to stay on a device with the camera on,” she said.

Previous research has shown that people blink less when reading or using electronic devices, probably because of their increased concentration. This might explain symptoms such as burning and itching. Fifty-three percent of the students reported an increase in asthenopia symptoms.

The researchers would have liked to have compared the students in virtual school to a matched group of students in traditional school. However, almost all students were enrolled in virtual school when the study was conducted, making such a control difficult.

Although previous research has related virtual learning to myopia, as reported by this news organization, this study did not investigate myopia, and the researchers do not believe that convergence insufficiency causes myopia or vice versa.

Parents can help prevent convergence insufficiency during school by reminding their children to take breaks, Dr. Gunton said. She recommends the 20/20/20 rule: After 20 minutes of work that involves looking at objects nearby, students should take a 20-second break and look at something 20 feet away.

“I also think the take-home message is for parents to ask students if they’re having symptoms,” she said, “and if they hear complaints while kids are on the computers, to have them see an eye doctor and have an evaluation.”

Stephen Lipsky, MD, who wasn’t involved in the study, said he is seeing more cases of eye strain at Children’s Healthcare of Atlanta, where he is a consulting ophthalmologist.

“The study is very valuable in that it shines a light on the fact that these children do have symptoms, such as asthenopia or convergence insufficiency,” he told this news organization. “But I’m optimistic that with a return to more traditional learning, we will return the more traditional incidence of these problems.”

Dr. Gunton and Dr. Lipsky have disclosed no relevant financial relationships.

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

NEW ORLEANS – The increased use of digital screens for school during the COVID-19 pandemic may be causing convergence insufficiency in children, researchers say.

Although the long-term implications for current schoolchildren are not clear, convergence insufficiency sometimes persists for a lifetime, said Kammi Gunton, MD, interim chief of pediatric ophthalmology and strabismus at Wills Eye Hospital, Philadelphia.

“It’s important, if we use digital technology for education, that we are aware that it might contribute to increased eye symptoms in children,” Dr. Gunton told this news organization.

Dr. Gunton’s colleague, Jordan Hamburger, an MD candidate at Sidney Kimmel Medical College, Philadelphia, presented the finding at the American Academy of Ophthalmology 2021 Annual Meeting.

Convergence insufficiency is an impairment of binocularity. Symptoms include headaches while reading, words that seem to move around the page, blurriness, diplopia, and eye fatigue. It can be treated with exercise, prism glasses, or, rarely, surgery.

“We have some kids who improve with either time or maturity, then we have other patients who suffer from it for their entire lives,” Dr. Gunton said.

Previous research has linked the use of digital screens to convergence insufficiency, so when many schools shifted to distance learning for the pandemic, Dr. Gunton and her colleagues wanted to see whether it would have this effect on the students’ eyes.

They surveyed 110 healthy schoolchildren and adolescent students regarding eye symptoms before and after a day of virtual school. The mean age of the participants was 14 years (range, 10-17 years). The participants spent an average of 6.96 hours per day in virtual school. Forty-one percent also attended school in person part time. These students filled out the survey on days when they were in virtual school.

The participants answered questions on the Convergence Insufficiency Symptom Survey (CISS). The survey consists of 15 questions about eye complaints. On each question, the students rated symptoms from 0 to 4, with 4 indicating a severe symptom.

The average sum of the CISS scores rose from 5.17 before school to 9.82 after school, a statistically significant change (P < .001). Sixty-one percent of the participants reported an increase in convergence insufficiency symptoms.

Seventeen percent scored a total of at least 16, which is the threshold score considered suggestive of convergence insufficiency.

The researchers also found that, on average, the more hours each student spent in virtual school, the higher their CISS scores.

This makes sense, because reading requires convergence, Dr. Gunton said. The same problem might occur in traditional school if the students were looking at books all day instead of focusing on objects at various distances in their classrooms, such as the teacher or the whiteboard. “So, in the past, if you read a book, maybe you wouldn’t read for several hours, but now we’re asking children during virtual learning to stay on a device with the camera on,” she said.

Previous research has shown that people blink less when reading or using electronic devices, probably because of their increased concentration. This might explain symptoms such as burning and itching. Fifty-three percent of the students reported an increase in asthenopia symptoms.

The researchers would have liked to have compared the students in virtual school to a matched group of students in traditional school. However, almost all students were enrolled in virtual school when the study was conducted, making such a control difficult.

Although previous research has related virtual learning to myopia, as reported by this news organization, this study did not investigate myopia, and the researchers do not believe that convergence insufficiency causes myopia or vice versa.

Parents can help prevent convergence insufficiency during school by reminding their children to take breaks, Dr. Gunton said. She recommends the 20/20/20 rule: After 20 minutes of work that involves looking at objects nearby, students should take a 20-second break and look at something 20 feet away.

“I also think the take-home message is for parents to ask students if they’re having symptoms,” she said, “and if they hear complaints while kids are on the computers, to have them see an eye doctor and have an evaluation.”

Stephen Lipsky, MD, who wasn’t involved in the study, said he is seeing more cases of eye strain at Children’s Healthcare of Atlanta, where he is a consulting ophthalmologist.

“The study is very valuable in that it shines a light on the fact that these children do have symptoms, such as asthenopia or convergence insufficiency,” he told this news organization. “But I’m optimistic that with a return to more traditional learning, we will return the more traditional incidence of these problems.”

Dr. Gunton and Dr. Lipsky have disclosed no relevant financial relationships.

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

The sodium-glucose transporter 2 inhibitors, relative newcomers among first-line agents for chronic heart failure (HF), could well attain the same go-to status in patients hospitalized with acute HF if the EMPULSE trial has anything to say about it.

Of the study’s 530 such patients, those started on daily empagliflozin (Jardiance) soon after they were stabilized, compared with a control group, were less likely to die or be rehospitalized for HF over the next 3 months.

Also, “we saw an improvement in quality of life, we saw a greater reduction in body weight, and we didn’t see any safety concerns in this very vulnerable and sick patient population,” Adriaan A. Voors, MD, University Medical Center Groningen (the Netherlands), said when presenting the trial at the American Heart Association scientific sessions.

Patients assigned to empagliflozin had a 36% greater likelihood of showing a benefit as reflected in the treatment’s win ratio when opposed by placebo, an emerging way to express outcomes in cardiovascular clinical trials. The SGLT2 inhibitor’s win ratio for the primary endpoint was 1.36 (95% confidence interval, 1.09-1.68, P = .0054), Dr. Voors reported. The outcome consisted of death, number of HF events, time to first HF event, and 90-day change in quality of life scores.

There is reluctance in practice to start patients that early after decompensation on drugs used in chronic HF, Dr. Voors said in an interview. Empagliflozin in the trial was initiated in the stabilized setting an average of 3 days after hospital admission, he said. The trial should reassure physicians that the drug “is not only safe to start early in hospital, but it’s also beneficial to start early in hospital.”

EMPULSE, combined with support from other recent trials, “should be clinical practice changing, with early in-hospital initiation of SGLT2 inhibitors in patients hospitalized with HF being the expectation, along with clear recognition that delaying SGLT2 inhibitor initiation may expose patients to unnecessary harms and delays in improved health status,” Gregg C. Fonarow, MD, University of California Los Angeles Medical Center, told this news organization.

“For patients with HF, irrespective of ejection fraction, early in-hospital initiation of SGLT2 inhibitors – once stabilized and in the absence of contraindications – should be considered a new standard of care,” said Fonarow, who was not part of EMPULSE.

The trial also lends new weight to the strategy of “simultaneous or rapid-sequence initiation” of the so-called four pillars of guideline-directed medical therapy of HF with reduced ejection fraction in patients hospitalized with HFrEF, once they are stabilized, Dr. Fonarow said. The four-pronged approach, he noted, consists of sacubitril/valsartan (Entresto), a beta-blocker, a mineralocorticoid receptor antagonist (MRA), and an SGLT2 inhibitor.

Indeed, the new findings “fill an important gap and are clearly practice changing,” agreed Nancy K. Sweitzer, MD, PhD, University of Arizona Sarver Heart Center, Tucson, as an invited discussant following Dr. Voors’ presentation. “Few therapies have been shown to impact the course of those hospitalized with acute decompensated heart failure.”

Of note in the trial, Dr. Sweitzer continued, patients were started on empagliflozin regardless of any drug therapy they might already be on for chronic HF. “Because patients in the EMPULSE trial could be enrolled with a new diagnosis of heart failure, they were, by definition, not all on chronic guideline-directed heart failure therapy. Nevertheless, such patients benefited equally from the study intervention,” she said.

“This is crucial, as it tells us these drugs have immediate and important effects and should not be withheld while other drug classes are initiated and optimized.”

EMPULSE entered patients hospitalized for acute HF, which could be de novo or a decompensation of chronic HF, without regard to ejection fraction or whether they had diabetes, and who were clinically stable after at least one dose of loop diuretics. Their ejection fractions averaged 35% and exceeded 40% in about one-third of the total cohort.

At 90 days in the win ratio analysis, the 265 patients assigned to empagliflozin 10 mg once daily were the “winners”; that is, they were more likely to show a clinical benefit about 54% of the time in paired match-ups of patient outcomes, compared with about 40% for the 265 in the control group. The match-ups were a tie 6.4% of the time.

The empagliflozin group also benefited significantly for the endpoint of death from any cause or first HF event, with a hazard ratio of 0.65 (95% CI, 0.43-0.99; P = .042). They also were less likely to experience acute renal failure (7.7% vs. 12.1% for the control group) or serious adverse events (32.3% vs. 43.6%), Dr. Voors reported.

Tempting as it might be, the findings can’t necessarily be generalized to other SGLT2 inhibitors without an evidence base. But as Dr. Voors observed, several ongoing trials are exploring dapagliflozin (Farxiga) in a similar clinical setting.

They include DICTATE-AHF in patients with diabetes admitted with acute HF, and DAPA ACT HF-TIMI 68, which is entering patients stabilized during hospitalization with acute decompensated HFrEF. The trials are scheduled for completion in 2022 and 2023, respectively.

EMPULSE was supported by the Boehringer Ingelheim–Eli Lilly Diabetes Alliance. Dr. Voors disclosed research support and consulting for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Merck, Myokardia, Novo Nordisk, Novartis, and Roche Diagnostics. Dr. Sweitzer disclosed honoraria from Acorda and Myokardia, and reported receiving research support from Novartis and Merck. Dr. Fonarow cited honoraria from Abbott, Amgen, Janssen, Medtronic, Bayer, Merck, AstraZeneca, Cytokinetics, and Novartis.

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

The sodium-glucose transporter 2 inhibitors, relative newcomers among first-line agents for chronic heart failure (HF), could well attain the same go-to status in patients hospitalized with acute HF if the EMPULSE trial has anything to say about it.

Of the study’s 530 such patients, those started on daily empagliflozin (Jardiance) soon after they were stabilized, compared with a control group, were less likely to die or be rehospitalized for HF over the next 3 months.

Also, “we saw an improvement in quality of life, we saw a greater reduction in body weight, and we didn’t see any safety concerns in this very vulnerable and sick patient population,” Adriaan A. Voors, MD, University Medical Center Groningen (the Netherlands), said when presenting the trial at the American Heart Association scientific sessions.

Patients assigned to empagliflozin had a 36% greater likelihood of showing a benefit as reflected in the treatment’s win ratio when opposed by placebo, an emerging way to express outcomes in cardiovascular clinical trials. The SGLT2 inhibitor’s win ratio for the primary endpoint was 1.36 (95% confidence interval, 1.09-1.68, P = .0054), Dr. Voors reported. The outcome consisted of death, number of HF events, time to first HF event, and 90-day change in quality of life scores.

There is reluctance in practice to start patients that early after decompensation on drugs used in chronic HF, Dr. Voors said in an interview. Empagliflozin in the trial was initiated in the stabilized setting an average of 3 days after hospital admission, he said. The trial should reassure physicians that the drug “is not only safe to start early in hospital, but it’s also beneficial to start early in hospital.”

EMPULSE, combined with support from other recent trials, “should be clinical practice changing, with early in-hospital initiation of SGLT2 inhibitors in patients hospitalized with HF being the expectation, along with clear recognition that delaying SGLT2 inhibitor initiation may expose patients to unnecessary harms and delays in improved health status,” Gregg C. Fonarow, MD, University of California Los Angeles Medical Center, told this news organization.

“For patients with HF, irrespective of ejection fraction, early in-hospital initiation of SGLT2 inhibitors – once stabilized and in the absence of contraindications – should be considered a new standard of care,” said Fonarow, who was not part of EMPULSE.

The trial also lends new weight to the strategy of “simultaneous or rapid-sequence initiation” of the so-called four pillars of guideline-directed medical therapy of HF with reduced ejection fraction in patients hospitalized with HFrEF, once they are stabilized, Dr. Fonarow said. The four-pronged approach, he noted, consists of sacubitril/valsartan (Entresto), a beta-blocker, a mineralocorticoid receptor antagonist (MRA), and an SGLT2 inhibitor.

Indeed, the new findings “fill an important gap and are clearly practice changing,” agreed Nancy K. Sweitzer, MD, PhD, University of Arizona Sarver Heart Center, Tucson, as an invited discussant following Dr. Voors’ presentation. “Few therapies have been shown to impact the course of those hospitalized with acute decompensated heart failure.”

Of note in the trial, Dr. Sweitzer continued, patients were started on empagliflozin regardless of any drug therapy they might already be on for chronic HF. “Because patients in the EMPULSE trial could be enrolled with a new diagnosis of heart failure, they were, by definition, not all on chronic guideline-directed heart failure therapy. Nevertheless, such patients benefited equally from the study intervention,” she said.

“This is crucial, as it tells us these drugs have immediate and important effects and should not be withheld while other drug classes are initiated and optimized.”

EMPULSE entered patients hospitalized for acute HF, which could be de novo or a decompensation of chronic HF, without regard to ejection fraction or whether they had diabetes, and who were clinically stable after at least one dose of loop diuretics. Their ejection fractions averaged 35% and exceeded 40% in about one-third of the total cohort.

At 90 days in the win ratio analysis, the 265 patients assigned to empagliflozin 10 mg once daily were the “winners”; that is, they were more likely to show a clinical benefit about 54% of the time in paired match-ups of patient outcomes, compared with about 40% for the 265 in the control group. The match-ups were a tie 6.4% of the time.

The empagliflozin group also benefited significantly for the endpoint of death from any cause or first HF event, with a hazard ratio of 0.65 (95% CI, 0.43-0.99; P = .042). They also were less likely to experience acute renal failure (7.7% vs. 12.1% for the control group) or serious adverse events (32.3% vs. 43.6%), Dr. Voors reported.

Tempting as it might be, the findings can’t necessarily be generalized to other SGLT2 inhibitors without an evidence base. But as Dr. Voors observed, several ongoing trials are exploring dapagliflozin (Farxiga) in a similar clinical setting.

They include DICTATE-AHF in patients with diabetes admitted with acute HF, and DAPA ACT HF-TIMI 68, which is entering patients stabilized during hospitalization with acute decompensated HFrEF. The trials are scheduled for completion in 2022 and 2023, respectively.

EMPULSE was supported by the Boehringer Ingelheim–Eli Lilly Diabetes Alliance. Dr. Voors disclosed research support and consulting for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Merck, Myokardia, Novo Nordisk, Novartis, and Roche Diagnostics. Dr. Sweitzer disclosed honoraria from Acorda and Myokardia, and reported receiving research support from Novartis and Merck. Dr. Fonarow cited honoraria from Abbott, Amgen, Janssen, Medtronic, Bayer, Merck, AstraZeneca, Cytokinetics, and Novartis.

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

The sodium-glucose transporter 2 inhibitors, relative newcomers among first-line agents for chronic heart failure (HF), could well attain the same go-to status in patients hospitalized with acute HF if the EMPULSE trial has anything to say about it.

Of the study’s 530 such patients, those started on daily empagliflozin (Jardiance) soon after they were stabilized, compared with a control group, were less likely to die or be rehospitalized for HF over the next 3 months.

Also, “we saw an improvement in quality of life, we saw a greater reduction in body weight, and we didn’t see any safety concerns in this very vulnerable and sick patient population,” Adriaan A. Voors, MD, University Medical Center Groningen (the Netherlands), said when presenting the trial at the American Heart Association scientific sessions.

Patients assigned to empagliflozin had a 36% greater likelihood of showing a benefit as reflected in the treatment’s win ratio when opposed by placebo, an emerging way to express outcomes in cardiovascular clinical trials. The SGLT2 inhibitor’s win ratio for the primary endpoint was 1.36 (95% confidence interval, 1.09-1.68, P = .0054), Dr. Voors reported. The outcome consisted of death, number of HF events, time to first HF event, and 90-day change in quality of life scores.

There is reluctance in practice to start patients that early after decompensation on drugs used in chronic HF, Dr. Voors said in an interview. Empagliflozin in the trial was initiated in the stabilized setting an average of 3 days after hospital admission, he said. The trial should reassure physicians that the drug “is not only safe to start early in hospital, but it’s also beneficial to start early in hospital.”

EMPULSE, combined with support from other recent trials, “should be clinical practice changing, with early in-hospital initiation of SGLT2 inhibitors in patients hospitalized with HF being the expectation, along with clear recognition that delaying SGLT2 inhibitor initiation may expose patients to unnecessary harms and delays in improved health status,” Gregg C. Fonarow, MD, University of California Los Angeles Medical Center, told this news organization.

“For patients with HF, irrespective of ejection fraction, early in-hospital initiation of SGLT2 inhibitors – once stabilized and in the absence of contraindications – should be considered a new standard of care,” said Fonarow, who was not part of EMPULSE.

The trial also lends new weight to the strategy of “simultaneous or rapid-sequence initiation” of the so-called four pillars of guideline-directed medical therapy of HF with reduced ejection fraction in patients hospitalized with HFrEF, once they are stabilized, Dr. Fonarow said. The four-pronged approach, he noted, consists of sacubitril/valsartan (Entresto), a beta-blocker, a mineralocorticoid receptor antagonist (MRA), and an SGLT2 inhibitor.

Indeed, the new findings “fill an important gap and are clearly practice changing,” agreed Nancy K. Sweitzer, MD, PhD, University of Arizona Sarver Heart Center, Tucson, as an invited discussant following Dr. Voors’ presentation. “Few therapies have been shown to impact the course of those hospitalized with acute decompensated heart failure.”

Of note in the trial, Dr. Sweitzer continued, patients were started on empagliflozin regardless of any drug therapy they might already be on for chronic HF. “Because patients in the EMPULSE trial could be enrolled with a new diagnosis of heart failure, they were, by definition, not all on chronic guideline-directed heart failure therapy. Nevertheless, such patients benefited equally from the study intervention,” she said.

“This is crucial, as it tells us these drugs have immediate and important effects and should not be withheld while other drug classes are initiated and optimized.”

EMPULSE entered patients hospitalized for acute HF, which could be de novo or a decompensation of chronic HF, without regard to ejection fraction or whether they had diabetes, and who were clinically stable after at least one dose of loop diuretics. Their ejection fractions averaged 35% and exceeded 40% in about one-third of the total cohort.

At 90 days in the win ratio analysis, the 265 patients assigned to empagliflozin 10 mg once daily were the “winners”; that is, they were more likely to show a clinical benefit about 54% of the time in paired match-ups of patient outcomes, compared with about 40% for the 265 in the control group. The match-ups were a tie 6.4% of the time.

The empagliflozin group also benefited significantly for the endpoint of death from any cause or first HF event, with a hazard ratio of 0.65 (95% CI, 0.43-0.99; P = .042). They also were less likely to experience acute renal failure (7.7% vs. 12.1% for the control group) or serious adverse events (32.3% vs. 43.6%), Dr. Voors reported.

Tempting as it might be, the findings can’t necessarily be generalized to other SGLT2 inhibitors without an evidence base. But as Dr. Voors observed, several ongoing trials are exploring dapagliflozin (Farxiga) in a similar clinical setting.

They include DICTATE-AHF in patients with diabetes admitted with acute HF, and DAPA ACT HF-TIMI 68, which is entering patients stabilized during hospitalization with acute decompensated HFrEF. The trials are scheduled for completion in 2022 and 2023, respectively.

EMPULSE was supported by the Boehringer Ingelheim–Eli Lilly Diabetes Alliance. Dr. Voors disclosed research support and consulting for Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Cytokinetics, Merck, Myokardia, Novo Nordisk, Novartis, and Roche Diagnostics. Dr. Sweitzer disclosed honoraria from Acorda and Myokardia, and reported receiving research support from Novartis and Merck. Dr. Fonarow cited honoraria from Abbott, Amgen, Janssen, Medtronic, Bayer, Merck, AstraZeneca, Cytokinetics, and Novartis.

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

For the first time, new data show that risk for breast cancer recurrence extends past 30 years.

The data come from a Danish study involving 20,315 women who were treated for early operable breast cancer between 1987 and 2004, all of whom were disease-free at 10 years.

Further follow-up showed that 2,595 women had a breast cancer recurrence more than 10 years after their primary diagnosis.

The cumulative incidence of recurrence was 8.5% at 15 years; 12.5% at 20 years; 15.2% at 25 years, and 16.6% at 32 years.

Recurrence risk was greatest early in the study period.

Women who had primary tumors larger than 20 mm, lymph node-positive disease, and estrogen receptor-positive tumors were at higher risk for late recurrence.

“Such patients may warrant extended surveillance, more aggressive treatment, or new therapy approaches,” said the investigators, led by Rikke Pedersen, MD, a PhD candidate in epidemiology at Aarhus University Hospital, Denmark.

“Our observed high cumulative incidence of late breast cancer recurrence is a concern given the increasing prevalence of long-term survivors.” Among other things, a new model to better select women for prolonged surveillance is needed, they said.

The new findings were published online Nov. 8 in the Journal of the National Cancer Institute (NCI).

This study confirms previous investigations, but it is the first to report that breast cancer can recur more than 30 years after diagnosis, note the authors of an accompanying editorial, Serban Negoita, MD, DrPH, and Esmeralda Ramirez-Peña, PhD, MPH, both from the National Cancer Institute.

The caveat is that treatment has evolved considerably since the women in the study were diagnosed, so the prognostic value of the findings with current treatment regimens is uncertain, they note. Some studies haven’t found a recurrence benefit for aggressive upfront treatment, but those studies had shorter follow-ups.

Research into the issue is “increasingly important” to guide clinical management and counsel women who are living longer after their primary diagnosis, they comment.  
 

Further details from the study

Data for the study came from the Danish Breast Cancer Group clinical database and other national databases. The researchers focused on women who were disease-free at 10 years after their primary diagnosis, which was stage I or II disease. Median age was 55 years.

Cumulative incidence for breast cancer recurrence was highest for grade 1 tumors with four or more positive lymph nodes (37.9% 10-25 years after the primary diagnosis) and was lowest for patients with grade 3 disease and no involved lymph nodes (7.5%).

The finding of higher recurrence incidence with lower grade tumors goes against some previous reports, the researchers commented. It may be that some tumors considered lower risk decades ago, and treated accordingly, would be considered higher risk in more recent times.

The cumulative incidence of late recurrence was also higher in younger patients and those treated with breast-conserving surgery instead of mastectomy, the team reported.

Adjusted hazard ratios followed the incidence trends, with higher hazards of recurrence for women diagnosed before age 40 as well as those who had breast-conserving surgery, four or more positive lymph nodes, and primary tumors 20 mm or more across.

The work was funded by the Danish Cancer Society and Aarhus University. Lead author Dr. Pedersen reports no disclosures, but coauthors report ties to Amgen, Novo Nordisk, Roche, and other companies. The editorialists have disclosed no relevant financial relationships.

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

For the first time, new data show that risk for breast cancer recurrence extends past 30 years.

The data come from a Danish study involving 20,315 women who were treated for early operable breast cancer between 1987 and 2004, all of whom were disease-free at 10 years.

Further follow-up showed that 2,595 women had a breast cancer recurrence more than 10 years after their primary diagnosis.

The cumulative incidence of recurrence was 8.5% at 15 years; 12.5% at 20 years; 15.2% at 25 years, and 16.6% at 32 years.

Recurrence risk was greatest early in the study period.

Women who had primary tumors larger than 20 mm, lymph node-positive disease, and estrogen receptor-positive tumors were at higher risk for late recurrence.

“Such patients may warrant extended surveillance, more aggressive treatment, or new therapy approaches,” said the investigators, led by Rikke Pedersen, MD, a PhD candidate in epidemiology at Aarhus University Hospital, Denmark.

“Our observed high cumulative incidence of late breast cancer recurrence is a concern given the increasing prevalence of long-term survivors.” Among other things, a new model to better select women for prolonged surveillance is needed, they said.

The new findings were published online Nov. 8 in the Journal of the National Cancer Institute (NCI).

This study confirms previous investigations, but it is the first to report that breast cancer can recur more than 30 years after diagnosis, note the authors of an accompanying editorial, Serban Negoita, MD, DrPH, and Esmeralda Ramirez-Peña, PhD, MPH, both from the National Cancer Institute.

The caveat is that treatment has evolved considerably since the women in the study were diagnosed, so the prognostic value of the findings with current treatment regimens is uncertain, they note. Some studies haven’t found a recurrence benefit for aggressive upfront treatment, but those studies had shorter follow-ups.

Research into the issue is “increasingly important” to guide clinical management and counsel women who are living longer after their primary diagnosis, they comment.  
 

Further details from the study

Data for the study came from the Danish Breast Cancer Group clinical database and other national databases. The researchers focused on women who were disease-free at 10 years after their primary diagnosis, which was stage I or II disease. Median age was 55 years.

Cumulative incidence for breast cancer recurrence was highest for grade 1 tumors with four or more positive lymph nodes (37.9% 10-25 years after the primary diagnosis) and was lowest for patients with grade 3 disease and no involved lymph nodes (7.5%).

The finding of higher recurrence incidence with lower grade tumors goes against some previous reports, the researchers commented. It may be that some tumors considered lower risk decades ago, and treated accordingly, would be considered higher risk in more recent times.

The cumulative incidence of late recurrence was also higher in younger patients and those treated with breast-conserving surgery instead of mastectomy, the team reported.

Adjusted hazard ratios followed the incidence trends, with higher hazards of recurrence for women diagnosed before age 40 as well as those who had breast-conserving surgery, four or more positive lymph nodes, and primary tumors 20 mm or more across.

The work was funded by the Danish Cancer Society and Aarhus University. Lead author Dr. Pedersen reports no disclosures, but coauthors report ties to Amgen, Novo Nordisk, Roche, and other companies. The editorialists have disclosed no relevant financial relationships.

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

For the first time, new data show that risk for breast cancer recurrence extends past 30 years.

The data come from a Danish study involving 20,315 women who were treated for early operable breast cancer between 1987 and 2004, all of whom were disease-free at 10 years.

Further follow-up showed that 2,595 women had a breast cancer recurrence more than 10 years after their primary diagnosis.

The cumulative incidence of recurrence was 8.5% at 15 years; 12.5% at 20 years; 15.2% at 25 years, and 16.6% at 32 years.

Recurrence risk was greatest early in the study period.

Women who had primary tumors larger than 20 mm, lymph node-positive disease, and estrogen receptor-positive tumors were at higher risk for late recurrence.

“Such patients may warrant extended surveillance, more aggressive treatment, or new therapy approaches,” said the investigators, led by Rikke Pedersen, MD, a PhD candidate in epidemiology at Aarhus University Hospital, Denmark.

“Our observed high cumulative incidence of late breast cancer recurrence is a concern given the increasing prevalence of long-term survivors.” Among other things, a new model to better select women for prolonged surveillance is needed, they said.

The new findings were published online Nov. 8 in the Journal of the National Cancer Institute (NCI).

This study confirms previous investigations, but it is the first to report that breast cancer can recur more than 30 years after diagnosis, note the authors of an accompanying editorial, Serban Negoita, MD, DrPH, and Esmeralda Ramirez-Peña, PhD, MPH, both from the National Cancer Institute.

The caveat is that treatment has evolved considerably since the women in the study were diagnosed, so the prognostic value of the findings with current treatment regimens is uncertain, they note. Some studies haven’t found a recurrence benefit for aggressive upfront treatment, but those studies had shorter follow-ups.

Research into the issue is “increasingly important” to guide clinical management and counsel women who are living longer after their primary diagnosis, they comment.  
 

Further details from the study

Data for the study came from the Danish Breast Cancer Group clinical database and other national databases. The researchers focused on women who were disease-free at 10 years after their primary diagnosis, which was stage I or II disease. Median age was 55 years.

Cumulative incidence for breast cancer recurrence was highest for grade 1 tumors with four or more positive lymph nodes (37.9% 10-25 years after the primary diagnosis) and was lowest for patients with grade 3 disease and no involved lymph nodes (7.5%).

The finding of higher recurrence incidence with lower grade tumors goes against some previous reports, the researchers commented. It may be that some tumors considered lower risk decades ago, and treated accordingly, would be considered higher risk in more recent times.

The cumulative incidence of late recurrence was also higher in younger patients and those treated with breast-conserving surgery instead of mastectomy, the team reported.

Adjusted hazard ratios followed the incidence trends, with higher hazards of recurrence for women diagnosed before age 40 as well as those who had breast-conserving surgery, four or more positive lymph nodes, and primary tumors 20 mm or more across.

The work was funded by the Danish Cancer Society and Aarhus University. Lead author Dr. Pedersen reports no disclosures, but coauthors report ties to Amgen, Novo Nordisk, Roche, and other companies. The editorialists have disclosed no relevant financial relationships.

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

The SARS-CoV-2 pandemic has given added impetus for metagenomic testing using nanopore sequencing to progress from a research tool to routine clinical application. A study led by researchers from Guy’s and St. Thomas’ NHS Foundation Trust has shown the potential for clinical metagenomics to become a same-day test for identifying secondary infection in ventilated ICU patients. Getting results in hours rather than days would help to ensure rapid treatment with the correct antibiotic, minimize unnecessary prescriptions, and thus reduce the growing menace of antimicrobial resistance.

‘SARS-CoV-2 has put considerable strain on ICUs’

The researchers point out that the setting of an intensive care unit involves frequent staff-patient contact that imparts a risk of secondary or nosocomial infection. In addition, invasive ventilation may introduce organisms into the lungs and lead to ventilator-acquired pneumonia. This carries a high mortality and is responsible for up to 70% of antimicrobial prescribing, with current guidelines requiring empiric antibiotics pending culture results, which typically takes 2-4 days.

Many of these infection problems worsened during SARS-CoV-2. Expanded critical care capacity raised the risk of nosocomial infections, with attendant increased antimicrobial prescriptions and the threat of antimicrobial resistance. In addition, treatment of COVID-19 patients with steroid therapy potentially exacerbates bacterial or fungal infections.

The researchers, from the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, in collaboration with the Quadram Institute in Norwich, Oxford Nanopore Technologies, and Viapath, the U.K.’s largest independent pathology service provider, noted that the pandemic thus reinforced “a need for rapid comprehensive diagnostics to improve antimicrobial stewardship and help prevent emergence and transmission of multi-drug-resistant organisms.”

“As soon as the pandemic started, our scientists realized there would be a benefit to sequencing genomes of all bacteria and fungi causing infection in COVID-19 patients while on ICU,” said Professor Jonathan Edgeworth, who led the research team.

“Within a few weeks we showed it can diagnose secondary infection, target antibiotic treatment, and detect outbreaks much earlier than current technologies – all from a single sample.”
 

Proof-of-concept study

The team performed a proof-of-concept study of nanopore metagenomics sequencing – a type of DNA sequencing that allows direct rapid unbiased detection of all organisms present in a clinical sample – on 43 surplus respiratory samples from 34 intubated COVID-19 patients with suspected secondary bacterial or fungal pneumonia. Patients were drawn from seven ICUs at St. Thomas’ Hospital, London over a 9-week period between April 11 and June 15 2020, during the first wave of COVID-19.

Their median age was 52, 70% were male, 47% White, and 44% Black or minority ethnicities. Median length of stay was 32 days and mortality 24%. Samples sent for metagenomic analysis and culture included 10 bronchoalveolar lavages, 6 tracheal aspirates, and 27 non-direct bronchoalveolar lavages.

The study, published in Genome Medicine, showed that an 8-hour metagenomics workflow was 92% sensitive (95% CI, 75% to 99%) and 82% specific (95% CI, 57% to 96%) for bacterial identification, based on culture-positive and culture-negative samples, respectively.

The main Gram-negative bacteria identified were Klebsiella spp. (53%), Citrobacter spp. (15%), and E coli (9%). The main Gram-positive bacteria were S aureus (9%), C striatum (24%) and Enterococcus spp. (12%). In addition, C albicans, other Candida spp. and Aspergillus spp. were cultured from 38%, 15%, and 9% of patients, respectively.

In every case, the initial antibiotics prescribed according to prevailing guideline recommendations would have been modified by metagenomic sequencing demonstrating the presence or absence of β-lactam-resistant genes carried by Enterobacterales.

Next day results of sequencing also detected Aspergillus fumigatus in four samples, with results 100% concordant with quantitative PCR for both the four positive and 39 negative samples. It identified two multi-drug–resistant outbreaks, one involving K pneumoniae ST307 affecting four patients and one a C striatum outbreak involving 14 patients across three ICUs.

Thus, a single sample can provide enough genetic sequence data to compare pathogen genomes with a database and accurately identify patients carrying the same strain, enabling early detection of outbreaks. This is the first time this combined benefit of a single test has been demonstrated, the team say.

Gordon Sanghera, CEO of Oxford Nanopore commented that “rapidly characterizing co-infections for precision prescribing is a vital next step for both COVID-19 patients and respiratory disease in general.”

Dr. Andrew Page of the Quadram Institute said: “We have been working on metagenomics technology for the last 7 years. It is great to see it applied to patient care during the COVID-19 pandemic.”

He said in an interview: “The pandemic has accelerated the transition from using sequencing purely in research labs to using it in the clinic to rapidly provide clinicians with information they can use to improve outcomes for patients.”
 

Potential to inform antimicrobial prescribing and infection control

“Clinical metagenomic testing provides accurate pathogen detection and antibiotic resistance prediction in a same-day laboratory workflow, with assembled genomes available the next day for genomic surveillance,” the researchers say.

The technology “could fundamentally change the multi-disciplinary team approach to managing ICU infections.” It has the potential to improve initial targeted antimicrobial treatment and infection control decisions, as well as help rapidly detect unsuspected outbreaks of multi-drug–resistant pathogens.

Professor Edgeworth told this news organization that since the study, “secondary bacterial and fungal infections have increased, perhaps due to immunomodulatory treatments or just the length of time patients spend on ICU recovering from COVID-19. This makes rapid diagnosis even more important to ensure patients get more targeted antibiotics earlier, rather than relying on generic guidelines.”

The team “are planning to move respiratory metagenomics into pilot service under our Trust’s quality improvement framework,” he revealed. This will enable them to gather data on patient benefits.  

“We also need to see how clinicians use these tests to improve antibiotic treatment, to stop antibiotics when not needed or to identify outbreaks earlier, and then how that translates into tangible benefits for individual patients and the wider NHS.”

He predicts that the technique will revolutionize the approach to prevention and treatment of serious infection in ICUs, and it is now planned to offer it as a clinical service for COVID-19 and influenza patients during the coming winter.

In addition, he said: “It can be equally applied to other samples such as tissue fluids and biopsies, including those removed at operation. It therefore has potential to impact on diagnostics for many clinical services, particularly if the progress is maintained at the current pace.”

This article first appeared on Medscape UK/Univadis.

The SARS-CoV-2 pandemic has given added impetus for metagenomic testing using nanopore sequencing to progress from a research tool to routine clinical application. A study led by researchers from Guy’s and St. Thomas’ NHS Foundation Trust has shown the potential for clinical metagenomics to become a same-day test for identifying secondary infection in ventilated ICU patients. Getting results in hours rather than days would help to ensure rapid treatment with the correct antibiotic, minimize unnecessary prescriptions, and thus reduce the growing menace of antimicrobial resistance.

‘SARS-CoV-2 has put considerable strain on ICUs’

The researchers point out that the setting of an intensive care unit involves frequent staff-patient contact that imparts a risk of secondary or nosocomial infection. In addition, invasive ventilation may introduce organisms into the lungs and lead to ventilator-acquired pneumonia. This carries a high mortality and is responsible for up to 70% of antimicrobial prescribing, with current guidelines requiring empiric antibiotics pending culture results, which typically takes 2-4 days.

Many of these infection problems worsened during SARS-CoV-2. Expanded critical care capacity raised the risk of nosocomial infections, with attendant increased antimicrobial prescriptions and the threat of antimicrobial resistance. In addition, treatment of COVID-19 patients with steroid therapy potentially exacerbates bacterial or fungal infections.

The researchers, from the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, in collaboration with the Quadram Institute in Norwich, Oxford Nanopore Technologies, and Viapath, the U.K.’s largest independent pathology service provider, noted that the pandemic thus reinforced “a need for rapid comprehensive diagnostics to improve antimicrobial stewardship and help prevent emergence and transmission of multi-drug-resistant organisms.”

“As soon as the pandemic started, our scientists realized there would be a benefit to sequencing genomes of all bacteria and fungi causing infection in COVID-19 patients while on ICU,” said Professor Jonathan Edgeworth, who led the research team.

“Within a few weeks we showed it can diagnose secondary infection, target antibiotic treatment, and detect outbreaks much earlier than current technologies – all from a single sample.”
 

Proof-of-concept study

The team performed a proof-of-concept study of nanopore metagenomics sequencing – a type of DNA sequencing that allows direct rapid unbiased detection of all organisms present in a clinical sample – on 43 surplus respiratory samples from 34 intubated COVID-19 patients with suspected secondary bacterial or fungal pneumonia. Patients were drawn from seven ICUs at St. Thomas’ Hospital, London over a 9-week period between April 11 and June 15 2020, during the first wave of COVID-19.

Their median age was 52, 70% were male, 47% White, and 44% Black or minority ethnicities. Median length of stay was 32 days and mortality 24%. Samples sent for metagenomic analysis and culture included 10 bronchoalveolar lavages, 6 tracheal aspirates, and 27 non-direct bronchoalveolar lavages.

The study, published in Genome Medicine, showed that an 8-hour metagenomics workflow was 92% sensitive (95% CI, 75% to 99%) and 82% specific (95% CI, 57% to 96%) for bacterial identification, based on culture-positive and culture-negative samples, respectively.

The main Gram-negative bacteria identified were Klebsiella spp. (53%), Citrobacter spp. (15%), and E coli (9%). The main Gram-positive bacteria were S aureus (9%), C striatum (24%) and Enterococcus spp. (12%). In addition, C albicans, other Candida spp. and Aspergillus spp. were cultured from 38%, 15%, and 9% of patients, respectively.

In every case, the initial antibiotics prescribed according to prevailing guideline recommendations would have been modified by metagenomic sequencing demonstrating the presence or absence of β-lactam-resistant genes carried by Enterobacterales.

Next day results of sequencing also detected Aspergillus fumigatus in four samples, with results 100% concordant with quantitative PCR for both the four positive and 39 negative samples. It identified two multi-drug–resistant outbreaks, one involving K pneumoniae ST307 affecting four patients and one a C striatum outbreak involving 14 patients across three ICUs.

Thus, a single sample can provide enough genetic sequence data to compare pathogen genomes with a database and accurately identify patients carrying the same strain, enabling early detection of outbreaks. This is the first time this combined benefit of a single test has been demonstrated, the team say.

Gordon Sanghera, CEO of Oxford Nanopore commented that “rapidly characterizing co-infections for precision prescribing is a vital next step for both COVID-19 patients and respiratory disease in general.”

Dr. Andrew Page of the Quadram Institute said: “We have been working on metagenomics technology for the last 7 years. It is great to see it applied to patient care during the COVID-19 pandemic.”

He said in an interview: “The pandemic has accelerated the transition from using sequencing purely in research labs to using it in the clinic to rapidly provide clinicians with information they can use to improve outcomes for patients.”
 

Potential to inform antimicrobial prescribing and infection control

“Clinical metagenomic testing provides accurate pathogen detection and antibiotic resistance prediction in a same-day laboratory workflow, with assembled genomes available the next day for genomic surveillance,” the researchers say.

The technology “could fundamentally change the multi-disciplinary team approach to managing ICU infections.” It has the potential to improve initial targeted antimicrobial treatment and infection control decisions, as well as help rapidly detect unsuspected outbreaks of multi-drug–resistant pathogens.

Professor Edgeworth told this news organization that since the study, “secondary bacterial and fungal infections have increased, perhaps due to immunomodulatory treatments or just the length of time patients spend on ICU recovering from COVID-19. This makes rapid diagnosis even more important to ensure patients get more targeted antibiotics earlier, rather than relying on generic guidelines.”

The team “are planning to move respiratory metagenomics into pilot service under our Trust’s quality improvement framework,” he revealed. This will enable them to gather data on patient benefits.  

“We also need to see how clinicians use these tests to improve antibiotic treatment, to stop antibiotics when not needed or to identify outbreaks earlier, and then how that translates into tangible benefits for individual patients and the wider NHS.”

He predicts that the technique will revolutionize the approach to prevention and treatment of serious infection in ICUs, and it is now planned to offer it as a clinical service for COVID-19 and influenza patients during the coming winter.

In addition, he said: “It can be equally applied to other samples such as tissue fluids and biopsies, including those removed at operation. It therefore has potential to impact on diagnostics for many clinical services, particularly if the progress is maintained at the current pace.”

This article first appeared on Medscape UK/Univadis.

The SARS-CoV-2 pandemic has given added impetus for metagenomic testing using nanopore sequencing to progress from a research tool to routine clinical application. A study led by researchers from Guy’s and St. Thomas’ NHS Foundation Trust has shown the potential for clinical metagenomics to become a same-day test for identifying secondary infection in ventilated ICU patients. Getting results in hours rather than days would help to ensure rapid treatment with the correct antibiotic, minimize unnecessary prescriptions, and thus reduce the growing menace of antimicrobial resistance.

‘SARS-CoV-2 has put considerable strain on ICUs’

The researchers point out that the setting of an intensive care unit involves frequent staff-patient contact that imparts a risk of secondary or nosocomial infection. In addition, invasive ventilation may introduce organisms into the lungs and lead to ventilator-acquired pneumonia. This carries a high mortality and is responsible for up to 70% of antimicrobial prescribing, with current guidelines requiring empiric antibiotics pending culture results, which typically takes 2-4 days.

Many of these infection problems worsened during SARS-CoV-2. Expanded critical care capacity raised the risk of nosocomial infections, with attendant increased antimicrobial prescriptions and the threat of antimicrobial resistance. In addition, treatment of COVID-19 patients with steroid therapy potentially exacerbates bacterial or fungal infections.

The researchers, from the National Institute for Health Research (NIHR) Biomedical Research Centre at Guy’s and St. Thomas’ NHS Foundation Trust and King’s College London, in collaboration with the Quadram Institute in Norwich, Oxford Nanopore Technologies, and Viapath, the U.K.’s largest independent pathology service provider, noted that the pandemic thus reinforced “a need for rapid comprehensive diagnostics to improve antimicrobial stewardship and help prevent emergence and transmission of multi-drug-resistant organisms.”

“As soon as the pandemic started, our scientists realized there would be a benefit to sequencing genomes of all bacteria and fungi causing infection in COVID-19 patients while on ICU,” said Professor Jonathan Edgeworth, who led the research team.

“Within a few weeks we showed it can diagnose secondary infection, target antibiotic treatment, and detect outbreaks much earlier than current technologies – all from a single sample.”
 

Proof-of-concept study

The team performed a proof-of-concept study of nanopore metagenomics sequencing – a type of DNA sequencing that allows direct rapid unbiased detection of all organisms present in a clinical sample – on 43 surplus respiratory samples from 34 intubated COVID-19 patients with suspected secondary bacterial or fungal pneumonia. Patients were drawn from seven ICUs at St. Thomas’ Hospital, London over a 9-week period between April 11 and June 15 2020, during the first wave of COVID-19.

Their median age was 52, 70% were male, 47% White, and 44% Black or minority ethnicities. Median length of stay was 32 days and mortality 24%. Samples sent for metagenomic analysis and culture included 10 bronchoalveolar lavages, 6 tracheal aspirates, and 27 non-direct bronchoalveolar lavages.

The study, published in Genome Medicine, showed that an 8-hour metagenomics workflow was 92% sensitive (95% CI, 75% to 99%) and 82% specific (95% CI, 57% to 96%) for bacterial identification, based on culture-positive and culture-negative samples, respectively.

The main Gram-negative bacteria identified were Klebsiella spp. (53%), Citrobacter spp. (15%), and E coli (9%). The main Gram-positive bacteria were S aureus (9%), C striatum (24%) and Enterococcus spp. (12%). In addition, C albicans, other Candida spp. and Aspergillus spp. were cultured from 38%, 15%, and 9% of patients, respectively.

In every case, the initial antibiotics prescribed according to prevailing guideline recommendations would have been modified by metagenomic sequencing demonstrating the presence or absence of β-lactam-resistant genes carried by Enterobacterales.

Next day results of sequencing also detected Aspergillus fumigatus in four samples, with results 100% concordant with quantitative PCR for both the four positive and 39 negative samples. It identified two multi-drug–resistant outbreaks, one involving K pneumoniae ST307 affecting four patients and one a C striatum outbreak involving 14 patients across three ICUs.

Thus, a single sample can provide enough genetic sequence data to compare pathogen genomes with a database and accurately identify patients carrying the same strain, enabling early detection of outbreaks. This is the first time this combined benefit of a single test has been demonstrated, the team say.

Gordon Sanghera, CEO of Oxford Nanopore commented that “rapidly characterizing co-infections for precision prescribing is a vital next step for both COVID-19 patients and respiratory disease in general.”

Dr. Andrew Page of the Quadram Institute said: “We have been working on metagenomics technology for the last 7 years. It is great to see it applied to patient care during the COVID-19 pandemic.”

He said in an interview: “The pandemic has accelerated the transition from using sequencing purely in research labs to using it in the clinic to rapidly provide clinicians with information they can use to improve outcomes for patients.”
 

Potential to inform antimicrobial prescribing and infection control

“Clinical metagenomic testing provides accurate pathogen detection and antibiotic resistance prediction in a same-day laboratory workflow, with assembled genomes available the next day for genomic surveillance,” the researchers say.

The technology “could fundamentally change the multi-disciplinary team approach to managing ICU infections.” It has the potential to improve initial targeted antimicrobial treatment and infection control decisions, as well as help rapidly detect unsuspected outbreaks of multi-drug–resistant pathogens.

Professor Edgeworth told this news organization that since the study, “secondary bacterial and fungal infections have increased, perhaps due to immunomodulatory treatments or just the length of time patients spend on ICU recovering from COVID-19. This makes rapid diagnosis even more important to ensure patients get more targeted antibiotics earlier, rather than relying on generic guidelines.”

The team “are planning to move respiratory metagenomics into pilot service under our Trust’s quality improvement framework,” he revealed. This will enable them to gather data on patient benefits.  

“We also need to see how clinicians use these tests to improve antibiotic treatment, to stop antibiotics when not needed or to identify outbreaks earlier, and then how that translates into tangible benefits for individual patients and the wider NHS.”

He predicts that the technique will revolutionize the approach to prevention and treatment of serious infection in ICUs, and it is now planned to offer it as a clinical service for COVID-19 and influenza patients during the coming winter.

In addition, he said: “It can be equally applied to other samples such as tissue fluids and biopsies, including those removed at operation. It therefore has potential to impact on diagnostics for many clinical services, particularly if the progress is maintained at the current pace.”

This article first appeared on Medscape UK/Univadis.

LAS VEGAS – Although endoscopic resection of T1 esophageal adenocarcinoma (EAC) is associated with excellent overall survival, recurrence can occur years later, emphasizing the need for long-term surveillance, according to investigators.

Recurrence was about twice as common among patients lacking complete remission of intestinal metaplasia (CRIM) upon follow-up, reported lead author Kevin Song, MD, of the Mayo Clinic, Scottsdale, Ariz., and colleagues.

“Endoscopic resection of early-stage EAC has gained acceptance in recent years,” Dr. Song said during his presentation at the annual meeting of the American College of Gastroenterology. “While studies have demonstrated promising outcomes for short-term remission and recurrence, little is known about long-term recurrence and EAC-related mortality beyond 5 years.”

To address this knowledge gap, Dr. Song and colleagues reviewed data from 98 patients who had undergone endoscopic resection of T1 EAC at four tertiary academic centers with follow-up of at least 5 years. CRIM was defined by negative biopsies from the tubular esophagus and the gastroesophageal junction at one posttreatment surveillance endoscopy. Early recurrence was defined by a 2-year limit.

After a median follow-up of 8.76 years, 93 out of 98 patients (95%) experienced remission, while 82 patients (84%) demonstrated CRIM. Fourteen patients (14%) had recurrence of EAC, among whom eight (57%) had early recurrence at a median of 0.75 years (interquartile range, 0.43-0.80 years), while the other six (43%) had late recurrence at a median of 7.7 years (IQR, 5.20-8.77 years). Among the 93 patients entering remission, five (5.38%) had recurrence after 5 years.

CRIM was associated with a significantly lower rate of recurrence (11% vs. 46%; P = .01), generating an odds ratio of 6.55 (95% confidence interval, 1.71-26.71). Patients with CRIM also had later recurrence, at a median of 5.20 years, compared with 0.81 years for patients without CRIM. Moreover, the overall EAC-related mortality rate was 6.45%.

Dr. Song noted excellent overall survival and concluded his presentation by emphasizing the predictive value of CRIM and the need for long-term surveillance.

“CRIM should be considered the most significant endpoint for endotherapy of T1 EAC,” he said. “Surveillance is important even when early recurrence is not observed.”

Rishindra M. Reddy, MD, professor of thoracic surgery at the University of Michigan Health, Ann Arbor, agreed “100%” with Dr. Song and colleagues’ conclusion about the need for long-term surveillance.

“We struggle, in our patient population, to get people to do regular surveillance,” he said. “I think you have to have patients who have regular access to their gastroenterologist or surgeons and are willing to come in every 3 months to 6 months for surveillance endoscopies as well as CT scans.”

Dr. Reddy recommended that endoscopic resection of EAC be handled at high-volume centers.

“This really needs to be done in a multidisciplinary setting where you have both experienced endoscopists and thoracic surgeons and/or surgical oncologists who do esophagectomies to make these decisions about optimal treatment,” he said, “as well as pathologists who are more experienced in what to look for in terms of depth or lateral margins.”

The present work is a “great first study,” Dr. Reddy said. He suggested that larger real-world trials are needed to confirm findings and compare outcomes between tumor subtypes.

“I think for T1a tumors, there’s a good consensus on endoscopic mucosal resection,” he said. “I think T1b is an area where we would suggest more often doing surgery… and there’s even some nuance at a T1a level about the depth. It would be helpful to understand the risks of recurrence after [resecting] different levels of T1 tumors.”

The investigators disclosed relationships with CDX, Interpace, Lucid, and others. Dr. Reddy disclosed no relevant conflicts of interest.

LAS VEGAS – Although endoscopic resection of T1 esophageal adenocarcinoma (EAC) is associated with excellent overall survival, recurrence can occur years later, emphasizing the need for long-term surveillance, according to investigators.

Recurrence was about twice as common among patients lacking complete remission of intestinal metaplasia (CRIM) upon follow-up, reported lead author Kevin Song, MD, of the Mayo Clinic, Scottsdale, Ariz., and colleagues.

“Endoscopic resection of early-stage EAC has gained acceptance in recent years,” Dr. Song said during his presentation at the annual meeting of the American College of Gastroenterology. “While studies have demonstrated promising outcomes for short-term remission and recurrence, little is known about long-term recurrence and EAC-related mortality beyond 5 years.”

To address this knowledge gap, Dr. Song and colleagues reviewed data from 98 patients who had undergone endoscopic resection of T1 EAC at four tertiary academic centers with follow-up of at least 5 years. CRIM was defined by negative biopsies from the tubular esophagus and the gastroesophageal junction at one posttreatment surveillance endoscopy. Early recurrence was defined by a 2-year limit.

After a median follow-up of 8.76 years, 93 out of 98 patients (95%) experienced remission, while 82 patients (84%) demonstrated CRIM. Fourteen patients (14%) had recurrence of EAC, among whom eight (57%) had early recurrence at a median of 0.75 years (interquartile range, 0.43-0.80 years), while the other six (43%) had late recurrence at a median of 7.7 years (IQR, 5.20-8.77 years). Among the 93 patients entering remission, five (5.38%) had recurrence after 5 years.

CRIM was associated with a significantly lower rate of recurrence (11% vs. 46%; P = .01), generating an odds ratio of 6.55 (95% confidence interval, 1.71-26.71). Patients with CRIM also had later recurrence, at a median of 5.20 years, compared with 0.81 years for patients without CRIM. Moreover, the overall EAC-related mortality rate was 6.45%.

Dr. Song noted excellent overall survival and concluded his presentation by emphasizing the predictive value of CRIM and the need for long-term surveillance.

“CRIM should be considered the most significant endpoint for endotherapy of T1 EAC,” he said. “Surveillance is important even when early recurrence is not observed.”

Rishindra M. Reddy, MD, professor of thoracic surgery at the University of Michigan Health, Ann Arbor, agreed “100%” with Dr. Song and colleagues’ conclusion about the need for long-term surveillance.

“We struggle, in our patient population, to get people to do regular surveillance,” he said. “I think you have to have patients who have regular access to their gastroenterologist or surgeons and are willing to come in every 3 months to 6 months for surveillance endoscopies as well as CT scans.”

Dr. Reddy recommended that endoscopic resection of EAC be handled at high-volume centers.

“This really needs to be done in a multidisciplinary setting where you have both experienced endoscopists and thoracic surgeons and/or surgical oncologists who do esophagectomies to make these decisions about optimal treatment,” he said, “as well as pathologists who are more experienced in what to look for in terms of depth or lateral margins.”

The present work is a “great first study,” Dr. Reddy said. He suggested that larger real-world trials are needed to confirm findings and compare outcomes between tumor subtypes.

“I think for T1a tumors, there’s a good consensus on endoscopic mucosal resection,” he said. “I think T1b is an area where we would suggest more often doing surgery… and there’s even some nuance at a T1a level about the depth. It would be helpful to understand the risks of recurrence after [resecting] different levels of T1 tumors.”

The investigators disclosed relationships with CDX, Interpace, Lucid, and others. Dr. Reddy disclosed no relevant conflicts of interest.

LAS VEGAS – Although endoscopic resection of T1 esophageal adenocarcinoma (EAC) is associated with excellent overall survival, recurrence can occur years later, emphasizing the need for long-term surveillance, according to investigators.

Recurrence was about twice as common among patients lacking complete remission of intestinal metaplasia (CRIM) upon follow-up, reported lead author Kevin Song, MD, of the Mayo Clinic, Scottsdale, Ariz., and colleagues.

“Endoscopic resection of early-stage EAC has gained acceptance in recent years,” Dr. Song said during his presentation at the annual meeting of the American College of Gastroenterology. “While studies have demonstrated promising outcomes for short-term remission and recurrence, little is known about long-term recurrence and EAC-related mortality beyond 5 years.”

To address this knowledge gap, Dr. Song and colleagues reviewed data from 98 patients who had undergone endoscopic resection of T1 EAC at four tertiary academic centers with follow-up of at least 5 years. CRIM was defined by negative biopsies from the tubular esophagus and the gastroesophageal junction at one posttreatment surveillance endoscopy. Early recurrence was defined by a 2-year limit.

After a median follow-up of 8.76 years, 93 out of 98 patients (95%) experienced remission, while 82 patients (84%) demonstrated CRIM. Fourteen patients (14%) had recurrence of EAC, among whom eight (57%) had early recurrence at a median of 0.75 years (interquartile range, 0.43-0.80 years), while the other six (43%) had late recurrence at a median of 7.7 years (IQR, 5.20-8.77 years). Among the 93 patients entering remission, five (5.38%) had recurrence after 5 years.

CRIM was associated with a significantly lower rate of recurrence (11% vs. 46%; P = .01), generating an odds ratio of 6.55 (95% confidence interval, 1.71-26.71). Patients with CRIM also had later recurrence, at a median of 5.20 years, compared with 0.81 years for patients without CRIM. Moreover, the overall EAC-related mortality rate was 6.45%.

Dr. Song noted excellent overall survival and concluded his presentation by emphasizing the predictive value of CRIM and the need for long-term surveillance.

“CRIM should be considered the most significant endpoint for endotherapy of T1 EAC,” he said. “Surveillance is important even when early recurrence is not observed.”

Rishindra M. Reddy, MD, professor of thoracic surgery at the University of Michigan Health, Ann Arbor, agreed “100%” with Dr. Song and colleagues’ conclusion about the need for long-term surveillance.

“We struggle, in our patient population, to get people to do regular surveillance,” he said. “I think you have to have patients who have regular access to their gastroenterologist or surgeons and are willing to come in every 3 months to 6 months for surveillance endoscopies as well as CT scans.”

Dr. Reddy recommended that endoscopic resection of EAC be handled at high-volume centers.

“This really needs to be done in a multidisciplinary setting where you have both experienced endoscopists and thoracic surgeons and/or surgical oncologists who do esophagectomies to make these decisions about optimal treatment,” he said, “as well as pathologists who are more experienced in what to look for in terms of depth or lateral margins.”

The present work is a “great first study,” Dr. Reddy said. He suggested that larger real-world trials are needed to confirm findings and compare outcomes between tumor subtypes.

“I think for T1a tumors, there’s a good consensus on endoscopic mucosal resection,” he said. “I think T1b is an area where we would suggest more often doing surgery… and there’s even some nuance at a T1a level about the depth. It would be helpful to understand the risks of recurrence after [resecting] different levels of T1 tumors.”

The investigators disclosed relationships with CDX, Interpace, Lucid, and others. Dr. Reddy disclosed no relevant conflicts of interest.

As I sit down to write this article, I cannot help but reflect on the significance of today and the upcoming week – Transgender Awareness Week. While it may seem that the transgender community has made great strides in political, social, and health care forums, this week serves as a cold and grave reality check for members of the community and its allies. We still have a long way to go.

This annual tradition began in 1998 in response to the murder of a transgender woman, Rita Hester. Now Transgender Awareness Week, which occurs from Nov. 13th through the 19th is a week dedicated to help raise awareness and improve visibility of transgender people and the issues they face.¹ The week culminates on Nov. 20 with The Transgender Day of Remembrance (TDOR). The day is an annual observance to honor the memory of the transgender people who lost their lives to acts of antitransgender violence during that year.¹

Unfortunately, 2021 marks the worst year in recent history for transgender violence and anti-LGBT legislation. Over this past year, 375 transgender people were killed – 96% of whom were black and migrant trans women of color and over half (58%) of whom were sex workers.² What is even more shocking is that one in four of these victims were murdered in their own homes.² Compared with 2015, which previously held the title of “worst year,” 250 anti-LGBT bills have been introduced in state legislatures in 2021; 17 of which have been already enacted into law.³ The recently passed laws involve antitrans sports bans, religious refusal, anti-LGBTQ education, antitrans medical care, antitrans birth certificates, and an anti–all comers bill.³ In evaluating the 250 anti-LGBT bills introduced into state legislatures, at least 35 of these would prohibit transgender youth from accessing gender-affirming medical care and an additional 43 bills would allow people to deny or not provide services (including all medical care) by asserting religious freedom.³ The current bills exhibit a flagrant disregard for current best practices, which have demonstrated the benefits of gender-affirming medical care. Furthermore, they can increase the already high death toll for transgender patients by allowing providers and institutions to deny care to patients seeking services unrelated to their gender identity or sexual orientation.

Even if providers are not directly prescribing hormone therapy or performing gender-affirming procedures, all providers have encountered and will treat an LGBTQ patient at some point during their career. It is necessary for all obstetrician-gynecologists to be aware of the systemic damages and threats that LGBTQ patients face, as well as pending legislation that can significantly affect and harm patient care. As a result, we need to screen these patients for depression and history of self-harm, and to assess social support, as well as challenge legislation that can negatively affect LGBTQ care. The American College of Obstetricians and Gynecologists has not only issued formal statements condemning discrimination on the basis of gender identity and sexual orientation, but also advocates for inclusive, thoughtful, and affirming care for transgender individuals.⁴ In a time when our patients may not feel as though they can advocate for themselves, we as providers must use our voices and medical knowledge to enact these changes to encourage equitable and safe health care for all.
 

Dr. Brandt is an an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Transgender awareness month 2021. Fenway Health. 2021 Nov 1.

2. Wareham J. 375 transgender people murdered in 2021 – ‘Deadliest year’ since records began. Forbes. 2021 Nov 11..

3. Ronan R. 2021 officially becomes worst year in recent history for LGBTQ state legislative attacks as unprecedented number of states enact record-shattering number of anti-LGBTQ measures into law. Human Rights Campaign Press Release. 2021 May 7..

4. Practice Guideline. Health care for transgender and gender diverse individuals: ACOG Committee Opinion, No. 823. American College of Obstetricians and Gynecologists.

As I sit down to write this article, I cannot help but reflect on the significance of today and the upcoming week – Transgender Awareness Week. While it may seem that the transgender community has made great strides in political, social, and health care forums, this week serves as a cold and grave reality check for members of the community and its allies. We still have a long way to go.

This annual tradition began in 1998 in response to the murder of a transgender woman, Rita Hester. Now Transgender Awareness Week, which occurs from Nov. 13th through the 19th is a week dedicated to help raise awareness and improve visibility of transgender people and the issues they face.¹ The week culminates on Nov. 20 with The Transgender Day of Remembrance (TDOR). The day is an annual observance to honor the memory of the transgender people who lost their lives to acts of antitransgender violence during that year.¹

Unfortunately, 2021 marks the worst year in recent history for transgender violence and anti-LGBT legislation. Over this past year, 375 transgender people were killed – 96% of whom were black and migrant trans women of color and over half (58%) of whom were sex workers.² What is even more shocking is that one in four of these victims were murdered in their own homes.² Compared with 2015, which previously held the title of “worst year,” 250 anti-LGBT bills have been introduced in state legislatures in 2021; 17 of which have been already enacted into law.³ The recently passed laws involve antitrans sports bans, religious refusal, anti-LGBTQ education, antitrans medical care, antitrans birth certificates, and an anti–all comers bill.³ In evaluating the 250 anti-LGBT bills introduced into state legislatures, at least 35 of these would prohibit transgender youth from accessing gender-affirming medical care and an additional 43 bills would allow people to deny or not provide services (including all medical care) by asserting religious freedom.³ The current bills exhibit a flagrant disregard for current best practices, which have demonstrated the benefits of gender-affirming medical care. Furthermore, they can increase the already high death toll for transgender patients by allowing providers and institutions to deny care to patients seeking services unrelated to their gender identity or sexual orientation.

Even if providers are not directly prescribing hormone therapy or performing gender-affirming procedures, all providers have encountered and will treat an LGBTQ patient at some point during their career. It is necessary for all obstetrician-gynecologists to be aware of the systemic damages and threats that LGBTQ patients face, as well as pending legislation that can significantly affect and harm patient care. As a result, we need to screen these patients for depression and history of self-harm, and to assess social support, as well as challenge legislation that can negatively affect LGBTQ care. The American College of Obstetricians and Gynecologists has not only issued formal statements condemning discrimination on the basis of gender identity and sexual orientation, but also advocates for inclusive, thoughtful, and affirming care for transgender individuals.⁴ In a time when our patients may not feel as though they can advocate for themselves, we as providers must use our voices and medical knowledge to enact these changes to encourage equitable and safe health care for all.
 

Dr. Brandt is an an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Transgender awareness month 2021. Fenway Health. 2021 Nov 1.

2. Wareham J. 375 transgender people murdered in 2021 – ‘Deadliest year’ since records began. Forbes. 2021 Nov 11..

3. Ronan R. 2021 officially becomes worst year in recent history for LGBTQ state legislative attacks as unprecedented number of states enact record-shattering number of anti-LGBTQ measures into law. Human Rights Campaign Press Release. 2021 May 7..

4. Practice Guideline. Health care for transgender and gender diverse individuals: ACOG Committee Opinion, No. 823. American College of Obstetricians and Gynecologists.

As I sit down to write this article, I cannot help but reflect on the significance of today and the upcoming week – Transgender Awareness Week. While it may seem that the transgender community has made great strides in political, social, and health care forums, this week serves as a cold and grave reality check for members of the community and its allies. We still have a long way to go.

This annual tradition began in 1998 in response to the murder of a transgender woman, Rita Hester. Now Transgender Awareness Week, which occurs from Nov. 13th through the 19th is a week dedicated to help raise awareness and improve visibility of transgender people and the issues they face.¹ The week culminates on Nov. 20 with The Transgender Day of Remembrance (TDOR). The day is an annual observance to honor the memory of the transgender people who lost their lives to acts of antitransgender violence during that year.¹

Unfortunately, 2021 marks the worst year in recent history for transgender violence and anti-LGBT legislation. Over this past year, 375 transgender people were killed – 96% of whom were black and migrant trans women of color and over half (58%) of whom were sex workers.² What is even more shocking is that one in four of these victims were murdered in their own homes.² Compared with 2015, which previously held the title of “worst year,” 250 anti-LGBT bills have been introduced in state legislatures in 2021; 17 of which have been already enacted into law.³ The recently passed laws involve antitrans sports bans, religious refusal, anti-LGBTQ education, antitrans medical care, antitrans birth certificates, and an anti–all comers bill.³ In evaluating the 250 anti-LGBT bills introduced into state legislatures, at least 35 of these would prohibit transgender youth from accessing gender-affirming medical care and an additional 43 bills would allow people to deny or not provide services (including all medical care) by asserting religious freedom.³ The current bills exhibit a flagrant disregard for current best practices, which have demonstrated the benefits of gender-affirming medical care. Furthermore, they can increase the already high death toll for transgender patients by allowing providers and institutions to deny care to patients seeking services unrelated to their gender identity or sexual orientation.

Even if providers are not directly prescribing hormone therapy or performing gender-affirming procedures, all providers have encountered and will treat an LGBTQ patient at some point during their career. It is necessary for all obstetrician-gynecologists to be aware of the systemic damages and threats that LGBTQ patients face, as well as pending legislation that can significantly affect and harm patient care. As a result, we need to screen these patients for depression and history of self-harm, and to assess social support, as well as challenge legislation that can negatively affect LGBTQ care. The American College of Obstetricians and Gynecologists has not only issued formal statements condemning discrimination on the basis of gender identity and sexual orientation, but also advocates for inclusive, thoughtful, and affirming care for transgender individuals.⁴ In a time when our patients may not feel as though they can advocate for themselves, we as providers must use our voices and medical knowledge to enact these changes to encourage equitable and safe health care for all.
 

Dr. Brandt is an an ob.gyn. and fellowship-trained gender-affirming surgeon in West Reading, Pa.

References

1. Transgender awareness month 2021. Fenway Health. 2021 Nov 1.

2. Wareham J. 375 transgender people murdered in 2021 – ‘Deadliest year’ since records began. Forbes. 2021 Nov 11..

3. Ronan R. 2021 officially becomes worst year in recent history for LGBTQ state legislative attacks as unprecedented number of states enact record-shattering number of anti-LGBTQ measures into law. Human Rights Campaign Press Release. 2021 May 7..

4. Practice Guideline. Health care for transgender and gender diverse individuals: ACOG Committee Opinion, No. 823. American College of Obstetricians and Gynecologists.

Treatment with endoscopic submucosal dissection (ESD) is associated with higher rates of complete remission of dysplasia at 2 years compared with cap-assisted endoscopic mucosal resection (cEMR) in patients with Barrett’s esophagus with dysplasia or early-stage intramucosal esophageal adenocarcinoma (EAC), according to study findings.

Despite the seeming advantage of ESD over cEMR, the study found similar rates of complete remission of intestinal metaplasia (CRIM) between the treatment groups at 2 years.

The study authors explained that ESD, a recent development in endoscopic resection, allows for en bloc resection of larger lesions in dysplastic Barrett’s and EAC and features less diagnostic uncertainty compared with cEMR. Findings from the study highlight the importance of this newer technique but also emphasize the utility of both treatments. “In expert hands both sets of procedures appear to be safe and well tolerated,” wrote study authors Don Codipilly, MD, of the Mayo Clinic in Rochester, Minn., and colleagues in Clinical Gastroenterology and Hepatology.

Given the lack of comparative data on the long-term outcomes of cEMR versus ESD in patients with neoplasia associated with Barrett’s esophagus, Dr. Codipilly and colleagues examined histologic outcomes in a prospectively maintained database of 537 patients who underwent endoscopic eradication therapy for Barrett’s esophagus or EAC at the Mayo Clinic between 2006 and 2020. Only patients who had undergone either cEMR (n = 456) or ESD (n = 81) followed by endoscopic ablation were included in the analysis.

The primary endpoint of the study was the rate and time to complete remission of dysplasia (CRD), which was defined by the absence of dysplasia on biopsy from the gastroesophageal junction and tubular esophagus during ≥1 surveillance endoscopy. Researchers also examined the rates of complications, such as clinically significant intraprocedural or post-procedural bleeding that required hospitalization, perforation, receipt of red blood cells within 30 days of the initial procedure, and stricture formation that required dilation within 120 days of the index procedure.

Patients in the ESD group had a longer mean length of resected specimens (23.9 vs. 10.9 mm; P <.01) as well as higher rates of en bloc (97.5% vs. 41.9%; P <.01) and R0 resection (58% vs. 20.2%; P <.01). Patients were generally balanced on other basic baseline demographics, including age, sex distribution, and smoking status.

Over a median 11.2-year follow-up period, a total of 420 patients in the cEMR group achieved CRD. In the ESD group, 48 patients achieved CRD over a median 1.4-year follow-up period. The 2-year cumulative probability of CRD was lower in patients who received cEMR versus those who received ESD (75.8% vs. 85.6%, respectively). In a univariate analysis, the odds of achieving CRD were lower in cEMR versus ESD (hazard ratio, 0.41; 95% CI, 0.31-0.54; P <.01).

According to multivariate analysis, 2 independent predictors of CRD included ESD (hazard ratio, 2.38; P <.01) and shorter Barrett’s segment length (HR, 1.11; P <.01).

The investigators also assessed whether advancements made in cEMR technique have contributed to the findings in an analysis of patients who underwent cEMR (n = 48) with ESD (n = 80) from 2015 to 2019. In this analysis, the researchers found that the odds of CRD were lower than that of ESD (HR, 0.67; 95% CI, 0.45-0.99). Additionally, higher odds of achieving CRD in the cEMR group were observed in years between 2013 and 2019 (n = 129) compared with years 2006 and 2012 (n = 112) (HR, 2.09; 95% CI, 1.59-2.75; P <.01).

Demographic and clinical variables were incorporated into a Cox proportional hazard model to identify factors associated with decreased odds of CRD. This analysis found that decreased odds of CRD were associated with longer Barrett’s esophagus segment length (HR, 0.90; P <.01) and treatment with cEMR versus ESD (HR, 0.42; P <.01).

Over median follow-up periods of 7.8 years in the cEMR group and 1.1 years in the ESD group, approximately 78.5% and 40.7% of patients, respectively, achieved CRIM. While those in the ESD group achieved CRIM earlier, the cumulative probabilities of CRIM were similar by 2 years (59.3% vs. 50.6%; HR, 0.74; 95% CI, 0.52-1.07; P =.11). Shorter Barrett’s esophagus segment was the only independent predictor of CRIM (HR, 1.16; P <.01).

The researchers noted that the study population may have included patients with more severe disease than that in the general population, which may limit the generalizability of the findings. Additionally, the lack of a randomized design was cited as an additional study limitation.

In spite of their findings, the researchers explained that “continued monitoring for additional outcomes such as recurrence are required for further elucidation of the optimal role of these procedures in the management of” neoplasia associated with Barrett’s esophagus.”

The study was funded by the National Cancer Institute and the Freeman Foundation. The researchers reported no conflicts of interest with any pharmaceutical companies.

Treatment with endoscopic submucosal dissection (ESD) is associated with higher rates of complete remission of dysplasia at 2 years compared with cap-assisted endoscopic mucosal resection (cEMR) in patients with Barrett’s esophagus with dysplasia or early-stage intramucosal esophageal adenocarcinoma (EAC), according to study findings.

Despite the seeming advantage of ESD over cEMR, the study found similar rates of complete remission of intestinal metaplasia (CRIM) between the treatment groups at 2 years.

The study authors explained that ESD, a recent development in endoscopic resection, allows for en bloc resection of larger lesions in dysplastic Barrett’s and EAC and features less diagnostic uncertainty compared with cEMR. Findings from the study highlight the importance of this newer technique but also emphasize the utility of both treatments. “In expert hands both sets of procedures appear to be safe and well tolerated,” wrote study authors Don Codipilly, MD, of the Mayo Clinic in Rochester, Minn., and colleagues in Clinical Gastroenterology and Hepatology.

Given the lack of comparative data on the long-term outcomes of cEMR versus ESD in patients with neoplasia associated with Barrett’s esophagus, Dr. Codipilly and colleagues examined histologic outcomes in a prospectively maintained database of 537 patients who underwent endoscopic eradication therapy for Barrett’s esophagus or EAC at the Mayo Clinic between 2006 and 2020. Only patients who had undergone either cEMR (n = 456) or ESD (n = 81) followed by endoscopic ablation were included in the analysis.

The primary endpoint of the study was the rate and time to complete remission of dysplasia (CRD), which was defined by the absence of dysplasia on biopsy from the gastroesophageal junction and tubular esophagus during ≥1 surveillance endoscopy. Researchers also examined the rates of complications, such as clinically significant intraprocedural or post-procedural bleeding that required hospitalization, perforation, receipt of red blood cells within 30 days of the initial procedure, and stricture formation that required dilation within 120 days of the index procedure.

Patients in the ESD group had a longer mean length of resected specimens (23.9 vs. 10.9 mm; P <.01) as well as higher rates of en bloc (97.5% vs. 41.9%; P <.01) and R0 resection (58% vs. 20.2%; P <.01). Patients were generally balanced on other basic baseline demographics, including age, sex distribution, and smoking status.

Over a median 11.2-year follow-up period, a total of 420 patients in the cEMR group achieved CRD. In the ESD group, 48 patients achieved CRD over a median 1.4-year follow-up period. The 2-year cumulative probability of CRD was lower in patients who received cEMR versus those who received ESD (75.8% vs. 85.6%, respectively). In a univariate analysis, the odds of achieving CRD were lower in cEMR versus ESD (hazard ratio, 0.41; 95% CI, 0.31-0.54; P <.01).

According to multivariate analysis, 2 independent predictors of CRD included ESD (hazard ratio, 2.38; P <.01) and shorter Barrett’s segment length (HR, 1.11; P <.01).

The investigators also assessed whether advancements made in cEMR technique have contributed to the findings in an analysis of patients who underwent cEMR (n = 48) with ESD (n = 80) from 2015 to 2019. In this analysis, the researchers found that the odds of CRD were lower than that of ESD (HR, 0.67; 95% CI, 0.45-0.99). Additionally, higher odds of achieving CRD in the cEMR group were observed in years between 2013 and 2019 (n = 129) compared with years 2006 and 2012 (n = 112) (HR, 2.09; 95% CI, 1.59-2.75; P <.01).

Demographic and clinical variables were incorporated into a Cox proportional hazard model to identify factors associated with decreased odds of CRD. This analysis found that decreased odds of CRD were associated with longer Barrett’s esophagus segment length (HR, 0.90; P <.01) and treatment with cEMR versus ESD (HR, 0.42; P <.01).

Over median follow-up periods of 7.8 years in the cEMR group and 1.1 years in the ESD group, approximately 78.5% and 40.7% of patients, respectively, achieved CRIM. While those in the ESD group achieved CRIM earlier, the cumulative probabilities of CRIM were similar by 2 years (59.3% vs. 50.6%; HR, 0.74; 95% CI, 0.52-1.07; P =.11). Shorter Barrett’s esophagus segment was the only independent predictor of CRIM (HR, 1.16; P <.01).

The researchers noted that the study population may have included patients with more severe disease than that in the general population, which may limit the generalizability of the findings. Additionally, the lack of a randomized design was cited as an additional study limitation.

In spite of their findings, the researchers explained that “continued monitoring for additional outcomes such as recurrence are required for further elucidation of the optimal role of these procedures in the management of” neoplasia associated with Barrett’s esophagus.”

The study was funded by the National Cancer Institute and the Freeman Foundation. The researchers reported no conflicts of interest with any pharmaceutical companies.

Treatment with endoscopic submucosal dissection (ESD) is associated with higher rates of complete remission of dysplasia at 2 years compared with cap-assisted endoscopic mucosal resection (cEMR) in patients with Barrett’s esophagus with dysplasia or early-stage intramucosal esophageal adenocarcinoma (EAC), according to study findings.

Despite the seeming advantage of ESD over cEMR, the study found similar rates of complete remission of intestinal metaplasia (CRIM) between the treatment groups at 2 years.

The study authors explained that ESD, a recent development in endoscopic resection, allows for en bloc resection of larger lesions in dysplastic Barrett’s and EAC and features less diagnostic uncertainty compared with cEMR. Findings from the study highlight the importance of this newer technique but also emphasize the utility of both treatments. “In expert hands both sets of procedures appear to be safe and well tolerated,” wrote study authors Don Codipilly, MD, of the Mayo Clinic in Rochester, Minn., and colleagues in Clinical Gastroenterology and Hepatology.

Given the lack of comparative data on the long-term outcomes of cEMR versus ESD in patients with neoplasia associated with Barrett’s esophagus, Dr. Codipilly and colleagues examined histologic outcomes in a prospectively maintained database of 537 patients who underwent endoscopic eradication therapy for Barrett’s esophagus or EAC at the Mayo Clinic between 2006 and 2020. Only patients who had undergone either cEMR (n = 456) or ESD (n = 81) followed by endoscopic ablation were included in the analysis.

The primary endpoint of the study was the rate and time to complete remission of dysplasia (CRD), which was defined by the absence of dysplasia on biopsy from the gastroesophageal junction and tubular esophagus during ≥1 surveillance endoscopy. Researchers also examined the rates of complications, such as clinically significant intraprocedural or post-procedural bleeding that required hospitalization, perforation, receipt of red blood cells within 30 days of the initial procedure, and stricture formation that required dilation within 120 days of the index procedure.

Patients in the ESD group had a longer mean length of resected specimens (23.9 vs. 10.9 mm; P <.01) as well as higher rates of en bloc (97.5% vs. 41.9%; P <.01) and R0 resection (58% vs. 20.2%; P <.01). Patients were generally balanced on other basic baseline demographics, including age, sex distribution, and smoking status.

Over a median 11.2-year follow-up period, a total of 420 patients in the cEMR group achieved CRD. In the ESD group, 48 patients achieved CRD over a median 1.4-year follow-up period. The 2-year cumulative probability of CRD was lower in patients who received cEMR versus those who received ESD (75.8% vs. 85.6%, respectively). In a univariate analysis, the odds of achieving CRD were lower in cEMR versus ESD (hazard ratio, 0.41; 95% CI, 0.31-0.54; P <.01).

According to multivariate analysis, 2 independent predictors of CRD included ESD (hazard ratio, 2.38; P <.01) and shorter Barrett’s segment length (HR, 1.11; P <.01).

The investigators also assessed whether advancements made in cEMR technique have contributed to the findings in an analysis of patients who underwent cEMR (n = 48) with ESD (n = 80) from 2015 to 2019. In this analysis, the researchers found that the odds of CRD were lower than that of ESD (HR, 0.67; 95% CI, 0.45-0.99). Additionally, higher odds of achieving CRD in the cEMR group were observed in years between 2013 and 2019 (n = 129) compared with years 2006 and 2012 (n = 112) (HR, 2.09; 95% CI, 1.59-2.75; P <.01).

Demographic and clinical variables were incorporated into a Cox proportional hazard model to identify factors associated with decreased odds of CRD. This analysis found that decreased odds of CRD were associated with longer Barrett’s esophagus segment length (HR, 0.90; P <.01) and treatment with cEMR versus ESD (HR, 0.42; P <.01).

Over median follow-up periods of 7.8 years in the cEMR group and 1.1 years in the ESD group, approximately 78.5% and 40.7% of patients, respectively, achieved CRIM. While those in the ESD group achieved CRIM earlier, the cumulative probabilities of CRIM were similar by 2 years (59.3% vs. 50.6%; HR, 0.74; 95% CI, 0.52-1.07; P =.11). Shorter Barrett’s esophagus segment was the only independent predictor of CRIM (HR, 1.16; P <.01).

The researchers noted that the study population may have included patients with more severe disease than that in the general population, which may limit the generalizability of the findings. Additionally, the lack of a randomized design was cited as an additional study limitation.

In spite of their findings, the researchers explained that “continued monitoring for additional outcomes such as recurrence are required for further elucidation of the optimal role of these procedures in the management of” neoplasia associated with Barrett’s esophagus.”

The study was funded by the National Cancer Institute and the Freeman Foundation. The researchers reported no conflicts of interest with any pharmaceutical companies.

While often linked to deleterious outcomes in certain disease states, the hepatocyte-produced inflammatory marker C-reactive protein (CRP) may be a checkpoint that protects against acetaminophen-induced acute liver injury, according to research findings.

Based on the study findings, researchers believe long-term suppression of CRP function or expression may increase an individual’s susceptibility to acetaminophen-induced liver injury. In contrast, CRP “could be exploited as a promising therapeutic approach to treat hepatotoxicity caused by drug overdose” wrote study authors Hai-Yun Li, MD, of the Xi’an Jiaotong University in Shaanxi, China, and colleagues in Cellular and Molecular Gastroenterology and Hepatology.

According to Dr. Li and colleagues, a major cause of acute liver failure is acetaminophen-induced liver injury, but despite this risk, very few treatment options for this condition exist. The only approved treatment for this complication is N-acetyl cysteine (NAC).

Although CRP represents a marker for inflammation following tissue injury, a study from 2020 and one from 2018 suggest the protein regulates complement activation and may modulate responses of immune cells. The authors of the current study noted that few studies have explored what roles complement activation and modulated immune cell responses via CRP play in acetaminophen-induced acute liver injury.

To further elucidate the role of CRP in this setting, Dr. Li and researchers assessed the mechanisms of CRP action both in vitro as well as in CRP mice with Fcy receptor 2B knockout. The researchers suggested CRP may modulate immune cell responses via these receptors. Additionally, the investigators assessed CRP action in mice with C3 knockout, given previous studies suggesting C3 knockout may alleviate acetaminophen-induced liver injury in mice. The researchers also investigated hepatic expression of CRP mutants that were defective in complement interaction. Finally, the researchers sought to understand the therapeutic potential of the inflammatory marker by performing intraperitoneal administration of human CRP at 2 or 6 hours after induction of acetaminophen-induced acute liver injury in wild-type mice.

Injection of 300 mg/kg acetaminophen over 24 hours led to overt liver injury in wild-type mice, which was characterized by increased levels of circulating alanine transaminase (ALT) and aspartate transaminase (AST) as well as massive necrosis of hepatocytes. The researchers noted that these manifestations were exacerbated significantly in the CRP knockout mice.

The intravenous administration of human CRP in the mice with the drug-induced liver injury rescued defects caused by mouse CRP knockout. Additionally, human CRP administration alleviated acetaminophen-induced acute liver injury in the wild-type mice. The researchers wrote that these findings demonstrate that endogenous and human CRP “are both protective,” at least in mouse models of acetaminophen-induced liver injury.

In a second experiment, the researchers examined the mechanisms involved in CRP protection in early phases of drug-induced liver injury. Based on the experiment, the researchers found that the knockout of an inhibitory Fcy receptor mediating the anti-inflammatory activities of CRP demonstrated only “marginal effects” on the protection of the protein in acetaminophen-induced liver injury. Overall, the investigators suggested that the inflammatory marker does not likely act via the cellular Fcy receptor 2B to inhibit early phases of acetaminophen-induced hepatocyte injury. Rather, the investigators explained that CRP may act via factor H, which is recruited by CRP in regulating complement activation, to inhibit overactivation of complement on injured hepatocytes. Ultimately, the researchers explained, this results in suppression of the late phase amplification of inflammation that is mediated by neutrophils’ C3a-dependent actions.

Finally, the researchers found that intraperitoneal administration of human CRP at 2.5 mg/kg in wild-type mice at 2 hours following induction of acetaminophen-induced liver injury led to “markedly reduced liver injury,” with an efficacy that was similar to that of 500 mg/kg N-acetylcysteine, the only available treatment approved for acetaminophen-induced liver injury.

The researchers noted that N-acetylcysteine is only effective during the early phases of the acetaminophen-induced liver injury and loses effectiveness at 6 hours following injury. In contrast, human CRP in this study was still highly effective at this time point. “Given that people can tolerate high levels of circulating CRP, the administration of this protein might be a promising option to treat [acetaminophen-induced liver injury] with minimal side effects,” the researchers wrote.

The study was funded by the National Natural Science Foundation of China. The researchers reported no conflicts of interest with any pharmaceutical companies.

This article was updated on Sep. 20, 2022.

While often linked to deleterious outcomes in certain disease states, the hepatocyte-produced inflammatory marker C-reactive protein (CRP) may be a checkpoint that protects against acetaminophen-induced acute liver injury, according to research findings.

Based on the study findings, researchers believe long-term suppression of CRP function or expression may increase an individual’s susceptibility to acetaminophen-induced liver injury. In contrast, CRP “could be exploited as a promising therapeutic approach to treat hepatotoxicity caused by drug overdose” wrote study authors Hai-Yun Li, MD, of the Xi’an Jiaotong University in Shaanxi, China, and colleagues in Cellular and Molecular Gastroenterology and Hepatology.

According to Dr. Li and colleagues, a major cause of acute liver failure is acetaminophen-induced liver injury, but despite this risk, very few treatment options for this condition exist. The only approved treatment for this complication is N-acetyl cysteine (NAC).

Although CRP represents a marker for inflammation following tissue injury, a study from 2020 and one from 2018 suggest the protein regulates complement activation and may modulate responses of immune cells. The authors of the current study noted that few studies have explored what roles complement activation and modulated immune cell responses via CRP play in acetaminophen-induced acute liver injury.

To further elucidate the role of CRP in this setting, Dr. Li and researchers assessed the mechanisms of CRP action both in vitro as well as in CRP mice with Fcy receptor 2B knockout. The researchers suggested CRP may modulate immune cell responses via these receptors. Additionally, the investigators assessed CRP action in mice with C3 knockout, given previous studies suggesting C3 knockout may alleviate acetaminophen-induced liver injury in mice. The researchers also investigated hepatic expression of CRP mutants that were defective in complement interaction. Finally, the researchers sought to understand the therapeutic potential of the inflammatory marker by performing intraperitoneal administration of human CRP at 2 or 6 hours after induction of acetaminophen-induced acute liver injury in wild-type mice.

Injection of 300 mg/kg acetaminophen over 24 hours led to overt liver injury in wild-type mice, which was characterized by increased levels of circulating alanine transaminase (ALT) and aspartate transaminase (AST) as well as massive necrosis of hepatocytes. The researchers noted that these manifestations were exacerbated significantly in the CRP knockout mice.

The intravenous administration of human CRP in the mice with the drug-induced liver injury rescued defects caused by mouse CRP knockout. Additionally, human CRP administration alleviated acetaminophen-induced acute liver injury in the wild-type mice. The researchers wrote that these findings demonstrate that endogenous and human CRP “are both protective,” at least in mouse models of acetaminophen-induced liver injury.

In a second experiment, the researchers examined the mechanisms involved in CRP protection in early phases of drug-induced liver injury. Based on the experiment, the researchers found that the knockout of an inhibitory Fcy receptor mediating the anti-inflammatory activities of CRP demonstrated only “marginal effects” on the protection of the protein in acetaminophen-induced liver injury. Overall, the investigators suggested that the inflammatory marker does not likely act via the cellular Fcy receptor 2B to inhibit early phases of acetaminophen-induced hepatocyte injury. Rather, the investigators explained that CRP may act via factor H, which is recruited by CRP in regulating complement activation, to inhibit overactivation of complement on injured hepatocytes. Ultimately, the researchers explained, this results in suppression of the late phase amplification of inflammation that is mediated by neutrophils’ C3a-dependent actions.

Finally, the researchers found that intraperitoneal administration of human CRP at 2.5 mg/kg in wild-type mice at 2 hours following induction of acetaminophen-induced liver injury led to “markedly reduced liver injury,” with an efficacy that was similar to that of 500 mg/kg N-acetylcysteine, the only available treatment approved for acetaminophen-induced liver injury.

The researchers noted that N-acetylcysteine is only effective during the early phases of the acetaminophen-induced liver injury and loses effectiveness at 6 hours following injury. In contrast, human CRP in this study was still highly effective at this time point. “Given that people can tolerate high levels of circulating CRP, the administration of this protein might be a promising option to treat [acetaminophen-induced liver injury] with minimal side effects,” the researchers wrote.

The study was funded by the National Natural Science Foundation of China. The researchers reported no conflicts of interest with any pharmaceutical companies.

This article was updated on Sep. 20, 2022.

While often linked to deleterious outcomes in certain disease states, the hepatocyte-produced inflammatory marker C-reactive protein (CRP) may be a checkpoint that protects against acetaminophen-induced acute liver injury, according to research findings.

Based on the study findings, researchers believe long-term suppression of CRP function or expression may increase an individual’s susceptibility to acetaminophen-induced liver injury. In contrast, CRP “could be exploited as a promising therapeutic approach to treat hepatotoxicity caused by drug overdose” wrote study authors Hai-Yun Li, MD, of the Xi’an Jiaotong University in Shaanxi, China, and colleagues in Cellular and Molecular Gastroenterology and Hepatology.

According to Dr. Li and colleagues, a major cause of acute liver failure is acetaminophen-induced liver injury, but despite this risk, very few treatment options for this condition exist. The only approved treatment for this complication is N-acetyl cysteine (NAC).

Although CRP represents a marker for inflammation following tissue injury, a study from 2020 and one from 2018 suggest the protein regulates complement activation and may modulate responses of immune cells. The authors of the current study noted that few studies have explored what roles complement activation and modulated immune cell responses via CRP play in acetaminophen-induced acute liver injury.

To further elucidate the role of CRP in this setting, Dr. Li and researchers assessed the mechanisms of CRP action both in vitro as well as in CRP mice with Fcy receptor 2B knockout. The researchers suggested CRP may modulate immune cell responses via these receptors. Additionally, the investigators assessed CRP action in mice with C3 knockout, given previous studies suggesting C3 knockout may alleviate acetaminophen-induced liver injury in mice. The researchers also investigated hepatic expression of CRP mutants that were defective in complement interaction. Finally, the researchers sought to understand the therapeutic potential of the inflammatory marker by performing intraperitoneal administration of human CRP at 2 or 6 hours after induction of acetaminophen-induced acute liver injury in wild-type mice.

Injection of 300 mg/kg acetaminophen over 24 hours led to overt liver injury in wild-type mice, which was characterized by increased levels of circulating alanine transaminase (ALT) and aspartate transaminase (AST) as well as massive necrosis of hepatocytes. The researchers noted that these manifestations were exacerbated significantly in the CRP knockout mice.

The intravenous administration of human CRP in the mice with the drug-induced liver injury rescued defects caused by mouse CRP knockout. Additionally, human CRP administration alleviated acetaminophen-induced acute liver injury in the wild-type mice. The researchers wrote that these findings demonstrate that endogenous and human CRP “are both protective,” at least in mouse models of acetaminophen-induced liver injury.

In a second experiment, the researchers examined the mechanisms involved in CRP protection in early phases of drug-induced liver injury. Based on the experiment, the researchers found that the knockout of an inhibitory Fcy receptor mediating the anti-inflammatory activities of CRP demonstrated only “marginal effects” on the protection of the protein in acetaminophen-induced liver injury. Overall, the investigators suggested that the inflammatory marker does not likely act via the cellular Fcy receptor 2B to inhibit early phases of acetaminophen-induced hepatocyte injury. Rather, the investigators explained that CRP may act via factor H, which is recruited by CRP in regulating complement activation, to inhibit overactivation of complement on injured hepatocytes. Ultimately, the researchers explained, this results in suppression of the late phase amplification of inflammation that is mediated by neutrophils’ C3a-dependent actions.

Finally, the researchers found that intraperitoneal administration of human CRP at 2.5 mg/kg in wild-type mice at 2 hours following induction of acetaminophen-induced liver injury led to “markedly reduced liver injury,” with an efficacy that was similar to that of 500 mg/kg N-acetylcysteine, the only available treatment approved for acetaminophen-induced liver injury.

The researchers noted that N-acetylcysteine is only effective during the early phases of the acetaminophen-induced liver injury and loses effectiveness at 6 hours following injury. In contrast, human CRP in this study was still highly effective at this time point. “Given that people can tolerate high levels of circulating CRP, the administration of this protein might be a promising option to treat [acetaminophen-induced liver injury] with minimal side effects,” the researchers wrote.

The study was funded by the National Natural Science Foundation of China. The researchers reported no conflicts of interest with any pharmaceutical companies.

This article was updated on Sep. 20, 2022.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

On this occasion of writing our last of a decade of tech columns, we want to take the time to emphasize that our collective excitement about medical technology should never eclipse the reason for which it is created: to facilitate high-quality care.

Indeed, science and technology provide opportunities to improve outcomes in ways not even imagined 100 years ago, yet we must acknowledge that technology also threatens to erect barriers between us and our patients. We can be easily tempted to confuse new care delivery tools with the actual care itself.

Courtesy Dr. Christopher Notte

Threats to the physician-patient relationship

Medical history provides many examples of how our zeal to innovate can have untoward consequences to the physician-patient relationship.

In the late 1800s, for example, to convey a sense of science, purity of intent, and trust, the medical community began wearing white coats. Those white coats have been discussed as creating emotional distance between physicians and their patients.¹

Even when we in the medical community are slow and reluctant to change, the external forces propelling us forward often seem unstoppable; kinetic aspirations to innovate electronic information systems and new applications seem suddenly to revolutionize care delivery when we least expect it. The rapidity of change in technology can sometimes be dizzying but can at the same time can occur so swiftly we don’t even notice it.

After René Laennec invented the stethoscope in the early 1800s, clinicians no longer needed to physically lean in and place an ear directly onto patients to hear their hearts beating. This created a distance from patients that was still lamented 50 years later, when a professor of medicine is reported to have said, “he that hath ears to hear, let him use his ears and not a stethoscope.” Still, while the stethoscope has literally distanced us from patients, it is such an important tool that we no longer think about this distancing. We have adapted over time to remain close to our patients, to sincerely listen to their thoughts and reassure them that we hear them without the need to feel our ears on their chests.

Francis Peabody, the eminent Harvard physician, wrote an essay in 1927 titled, “The Care of the Patient.” At the end of the first paragraph, he states: “The most common criticism made at present by older practitioners is that young graduates ... are too “scientific” and do not know how to take care of patients.” He goes on to say that “one of the essential qualities of the clinician is interest in humanity, for the secret of the care of the patient is in caring for the patient.”²

We agree with Dr. Peabody. As we embrace science and technology that can change health outcomes, our patients’ needs to feel understood and cared for will not diminish. Instead, that need will continue to be an important aspect of our struggle and joy in providing holistic, humane, competent care into the future.

Twenty-first century physicians have access to an ever-growing trove of data, yet our ability to truly know our patients seems somehow less accessible. Home health devices have begun to provide a flow of information about parameters, ranging from continuous glucose readings to home blood pressures, weights, and inspiratory flow readings. These data can provide much more accurate insight into patients than what we can glean from one point in time during an office visit. Yet we need to remember that behind the data are people with dreams and desires, not just table entries in an electronic health record.

In 1923, the German philosopher Martin Buber published the book for which he is best known, “I and Thou.” In that book, Mr. Buber says that there are two ways we can approach relationships: “I-Thou” or “I-It.” In I-It relationships, we view the other person as an “it” to be used to accomplish a purpose, or to be experienced without his or her full involvement. In an I-Thou relationship, we appreciate the other people for all their complexity, in their full humanness. We must consciously remind ourselves amid the rush of technology that there are real people behind those data. We must acknowledge and approach each person as a unique individual who has dreams, goals, fears, and wishes that may be different from ours but to which we can still relate.

‘From the Beating End of the Stethoscope’

John Ciardi, an American poet, said the following in a poem titled, “Lines From the Beating End of the Stethoscope”:

I speak, as I say, the patient’s point of view.

But, given time, doctors are patients, too.

And there’s our bond: beyond anatomy,

Or in it, through it, to the mystery

Medicine takes the pulse of and lets go

Forever unexplained. It’s art, we know,

Not science at the heart. Doctor be whole,

I won’t insist the patient is a soul,

But he’s a something, possibly laughable,

Or possibly sublime, but not quite graphable.

Not quite containable on a bed chart.

Where science touches man it turns to art.³

This poem is a reminder of the subtle needs of patients during their encounters with doctors, especially around many of the most important decisions and events in their lives. Patients’ needs are varied, complex, difficult to discern, and not able to be fully explained or understood through math and science.

Einstein warned us that the modern age would be characterized by a perfection of means and a confusion of goals.⁴ As clinicians, we should strive to clarify and align our goals with those of our patients, providing care that is real, compassionate, and personal, not just an optimized means to achieve standardized metrics. While technology can assist us in this pursuit, we’ll need be careful that our enchantment with innovation does not cloud our actual goal: truly caring for our patients.
 

Dr. Notte is a family physician and chief medical officer of Abington (Pa.) Hospital–Jefferson Health. Dr. Skolnik is professor of family and community medicine at Sidney Kimmel Medical College, Philadelphia, and associate director of the family medicine residency program at Abington Hospital–Jefferson Health. They have no conflicts related to the content of this piece.

References

1. Jones VA. The white coat: Why not follow suit? JAMA. 1999;281(5):478. doi: 10.1001/jama.281.5.478-JMS0203-5-1

2. Peabody, Francis (1927). “The care of the patient.” JAMA. 88(12):877-82. doi: 10.1001/jama.1927.02680380001001.

3. Ciardi, John. Lines from the Beating End of the Stethoscope. Saturday Review, Nov. 18, 1968.

4. Albert Einstein, Out of My Later Years, 1950.

A new survey of U.S. patients with breast cancer found that 42% were using cannabis, primarily to relieve side effects associated with treatment, such as pain, anxiety, nausea, and insomnia.

Most (75%) of the patients who reported using cannabis said it was extremely helpful or very helpful in alleviating symptoms.

The authors warn of potential safety concerns with cannabis, especially with the use of unregulated products.

In addition, the survey found that physicians were not highly regarded as a source of information about cannabis use. Only 39% of patients said that they discussed cannabis with their physicians; 28% reported feeling uncomfortable when broaching the topic. Only 4% indicated that physicians were the most helpful source of information about cannabis.

The survey involved 612 patients with breast cancer. The results were published online Oct. 12 in Cancer.

“Our study highlights an important opportunity for providers to initiate informed conversations about medical cannabis with their patients, as the evidence shows that many are using medical cannabis without our knowledge or guidance,” said lead author Marisa Weiss, MD, of Breastcancer.org and the Lankenau Medical Center, near Philadelphia. “Not knowing whether or not our cancer patients are using cannabis is a major blind spot in our ability to provide optimal care,” she said.

Cannabis in one form or another has been legalized in many states across America, and even in states where it hasn’t been legalized, people are using it.

“Even though many states have relaxed their laws on cannabis, it remains a Schedule I drug on the federal level and is essentially still considered illegal,” commented Donald I. Abrams, MD, professor of medicine at the University of California, San Francisco, and an integrative oncologist at the UCSF Osher Center for Integrative Medicine. “This is why many physicians are uncomfortable discussing it with patients,” he said.

“Cannabis use isn’t taught in medical school, and until that changes, I don’t know how physicians are going to be advisers for this,” said Dr. Abrams, who was approached by this news organization for comment.

This “is a really nice study in that it looks at a large group of breast cancer patients from the community ... It’s not from a single institution [such as this previous study] and so a more representative mix,” Dr. Abrams said.

However, he also commented that the article had a “scent of ‘reefer madness’” about it, given its emphasis on potential harms and safety concerns.

“It’s interesting how alcohol is considered mainstream but cannabis has been demonized,” he said. “Especially for women with breast cancer, it’s so clear that alcohol is related to the development of postmenopausal breast cancer. As a recreational intervention, cannabis in my mind appears to be much safer for women for relaxation.”

“The one thing I worry about are patients who take highly concentrated CBD [cannabidiol] oil, as it can block the metabolism of prescription drugs and allow them to build up in the blood,” Dr. Abrams said. “I advise people against using these products.”
 

Cannabis to relieve symptoms

Previous studies have noted widespread use of cannabis among patients with cancer. For example, a large study from Israel that included nearly 3,000 participants found that cannabis use improved a variety of cancer-related symptoms, including nausea and vomiting, sleep disorders, pain, anxiety, and depression. Among those with cancer who survived to 6 months and who finished the study protocol, 60% achieved “treatment success.” Of note, at 6 months, 36% of patients had stopped taking opioids, and for 9.9%, the dose of opioids had decreased.

In the current study, dubbed the Coala-T-Cannabis study, the investigators approached U.S. members of the Breastcancer.org and Healthline.com communities who self-reported that they had been diagnosed with breast cancer within the past 5 years; 612 surveys were completed.

Half of all respondents said they had looked for information on medical cannabis, but most were unsatisfied with the information that they had received. Only 6% were extremely satisfied; 25% were very satisfied with the information.

Most patients (39%) did not discuss cannabis use with their physicians. Of those who did, 28% reported feeling uncomfortable discussing the topic. Only 4% of survey respondents indicated that physicians were the most helpful source of cannabis information.

Regarding which source of information was most helpful, 22% said websites, 18% said family members or friends, 12% said staffers and pharmacists in dispensaries, and 7% said other patients with breast cancer.

Forty-two percent of the survey respondents said they used cannabis for medical purposes and for relief of symptoms, which included pain (78%), insomnia (70%), anxiety (57%), stress (51%), and nausea/vomiting (46%).

In addition, 49% believed that medical cannabis could be used to treat the cancer itself.

A fair number were also using cannabis for recreational purposes. Of those who used cannabis, only 23% reported that they used it for medical purposes only.

Participants used cannabis in a variety of forms. The most popular form of consumption was as edibles (70%), followed by liquids/tinctures (65%), smoking (51%), topicals (46%), and vape pens (45%). Participants reported using an average of 3.7 different products.
 

Safety concerns?

The authors caution about the use of cannabis while receiving anticancer therapies because such use “raises important efficacy and safety concerns.”

“Many chemotherapy agents as well as cannabinoids are metabolized in the liver’s p450 cytochrome system,” Dr. Weiss and colleagues note, and the mechanism by which cannabinoids interact with particular CYP450 isoenzymes “has the potential to alter the metabolism of other medications and lead to adverse side effects.”

They also question the safety of some of the cannabis products that are being used. Participants reported receiving cannabis from a variety of sources, which included state-regulated dispensaries, “dealers,” and family/friends.

Three-quarters of respondents believed that cannabis was better than “chemicals” and that the benefits outweighed the risks. But many of the products used are unregulated, the authors point out.

“Providers should communicate clearly about the health and safety concerns associated with certain cannabis products and methods of delivery,” they conclude. “Without these measures, patients may make these decisions without qualified medical guidance, obtain poor-quality cannabis products, and consume them through potentially hazardous delivery methods during various types of cancer therapies.”

The study was supported by research grants from Ananda Health/Ecofibre and the Dr. Philip Reeves Legacy Fund. Several coauthors reported relationships with industry, as noted in the article. Dr. Abrams owns stock in Cannformatics and Lumen; he has received honorarium from Clever Leaves and Maui Grown Therapies and speaker honorarium from GW Pharmaceuticals.

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

A new survey of U.S. patients with breast cancer found that 42% were using cannabis, primarily to relieve side effects associated with treatment, such as pain, anxiety, nausea, and insomnia.

Most (75%) of the patients who reported using cannabis said it was extremely helpful or very helpful in alleviating symptoms.

The authors warn of potential safety concerns with cannabis, especially with the use of unregulated products.

In addition, the survey found that physicians were not highly regarded as a source of information about cannabis use. Only 39% of patients said that they discussed cannabis with their physicians; 28% reported feeling uncomfortable when broaching the topic. Only 4% indicated that physicians were the most helpful source of information about cannabis.

The survey involved 612 patients with breast cancer. The results were published online Oct. 12 in Cancer.

“Our study highlights an important opportunity for providers to initiate informed conversations about medical cannabis with their patients, as the evidence shows that many are using medical cannabis without our knowledge or guidance,” said lead author Marisa Weiss, MD, of Breastcancer.org and the Lankenau Medical Center, near Philadelphia. “Not knowing whether or not our cancer patients are using cannabis is a major blind spot in our ability to provide optimal care,” she said.

Cannabis in one form or another has been legalized in many states across America, and even in states where it hasn’t been legalized, people are using it.

“Even though many states have relaxed their laws on cannabis, it remains a Schedule I drug on the federal level and is essentially still considered illegal,” commented Donald I. Abrams, MD, professor of medicine at the University of California, San Francisco, and an integrative oncologist at the UCSF Osher Center for Integrative Medicine. “This is why many physicians are uncomfortable discussing it with patients,” he said.

“Cannabis use isn’t taught in medical school, and until that changes, I don’t know how physicians are going to be advisers for this,” said Dr. Abrams, who was approached by this news organization for comment.

This “is a really nice study in that it looks at a large group of breast cancer patients from the community ... It’s not from a single institution [such as this previous study] and so a more representative mix,” Dr. Abrams said.

However, he also commented that the article had a “scent of ‘reefer madness’” about it, given its emphasis on potential harms and safety concerns.

“It’s interesting how alcohol is considered mainstream but cannabis has been demonized,” he said. “Especially for women with breast cancer, it’s so clear that alcohol is related to the development of postmenopausal breast cancer. As a recreational intervention, cannabis in my mind appears to be much safer for women for relaxation.”

“The one thing I worry about are patients who take highly concentrated CBD [cannabidiol] oil, as it can block the metabolism of prescription drugs and allow them to build up in the blood,” Dr. Abrams said. “I advise people against using these products.”
 

Cannabis to relieve symptoms

Previous studies have noted widespread use of cannabis among patients with cancer. For example, a large study from Israel that included nearly 3,000 participants found that cannabis use improved a variety of cancer-related symptoms, including nausea and vomiting, sleep disorders, pain, anxiety, and depression. Among those with cancer who survived to 6 months and who finished the study protocol, 60% achieved “treatment success.” Of note, at 6 months, 36% of patients had stopped taking opioids, and for 9.9%, the dose of opioids had decreased.

In the current study, dubbed the Coala-T-Cannabis study, the investigators approached U.S. members of the Breastcancer.org and Healthline.com communities who self-reported that they had been diagnosed with breast cancer within the past 5 years; 612 surveys were completed.

Half of all respondents said they had looked for information on medical cannabis, but most were unsatisfied with the information that they had received. Only 6% were extremely satisfied; 25% were very satisfied with the information.

Most patients (39%) did not discuss cannabis use with their physicians. Of those who did, 28% reported feeling uncomfortable discussing the topic. Only 4% of survey respondents indicated that physicians were the most helpful source of cannabis information.

Regarding which source of information was most helpful, 22% said websites, 18% said family members or friends, 12% said staffers and pharmacists in dispensaries, and 7% said other patients with breast cancer.

Forty-two percent of the survey respondents said they used cannabis for medical purposes and for relief of symptoms, which included pain (78%), insomnia (70%), anxiety (57%), stress (51%), and nausea/vomiting (46%).

In addition, 49% believed that medical cannabis could be used to treat the cancer itself.

A fair number were also using cannabis for recreational purposes. Of those who used cannabis, only 23% reported that they used it for medical purposes only.

Participants used cannabis in a variety of forms. The most popular form of consumption was as edibles (70%), followed by liquids/tinctures (65%), smoking (51%), topicals (46%), and vape pens (45%). Participants reported using an average of 3.7 different products.
 

Safety concerns?

The authors caution about the use of cannabis while receiving anticancer therapies because such use “raises important efficacy and safety concerns.”

“Many chemotherapy agents as well as cannabinoids are metabolized in the liver’s p450 cytochrome system,” Dr. Weiss and colleagues note, and the mechanism by which cannabinoids interact with particular CYP450 isoenzymes “has the potential to alter the metabolism of other medications and lead to adverse side effects.”

They also question the safety of some of the cannabis products that are being used. Participants reported receiving cannabis from a variety of sources, which included state-regulated dispensaries, “dealers,” and family/friends.

Three-quarters of respondents believed that cannabis was better than “chemicals” and that the benefits outweighed the risks. But many of the products used are unregulated, the authors point out.

“Providers should communicate clearly about the health and safety concerns associated with certain cannabis products and methods of delivery,” they conclude. “Without these measures, patients may make these decisions without qualified medical guidance, obtain poor-quality cannabis products, and consume them through potentially hazardous delivery methods during various types of cancer therapies.”

The study was supported by research grants from Ananda Health/Ecofibre and the Dr. Philip Reeves Legacy Fund. Several coauthors reported relationships with industry, as noted in the article. Dr. Abrams owns stock in Cannformatics and Lumen; he has received honorarium from Clever Leaves and Maui Grown Therapies and speaker honorarium from GW Pharmaceuticals.

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

A new survey of U.S. patients with breast cancer found that 42% were using cannabis, primarily to relieve side effects associated with treatment, such as pain, anxiety, nausea, and insomnia.

Most (75%) of the patients who reported using cannabis said it was extremely helpful or very helpful in alleviating symptoms.

The authors warn of potential safety concerns with cannabis, especially with the use of unregulated products.

In addition, the survey found that physicians were not highly regarded as a source of information about cannabis use. Only 39% of patients said that they discussed cannabis with their physicians; 28% reported feeling uncomfortable when broaching the topic. Only 4% indicated that physicians were the most helpful source of information about cannabis.

The survey involved 612 patients with breast cancer. The results were published online Oct. 12 in Cancer.

“Our study highlights an important opportunity for providers to initiate informed conversations about medical cannabis with their patients, as the evidence shows that many are using medical cannabis without our knowledge or guidance,” said lead author Marisa Weiss, MD, of Breastcancer.org and the Lankenau Medical Center, near Philadelphia. “Not knowing whether or not our cancer patients are using cannabis is a major blind spot in our ability to provide optimal care,” she said.

Cannabis in one form or another has been legalized in many states across America, and even in states where it hasn’t been legalized, people are using it.

“Even though many states have relaxed their laws on cannabis, it remains a Schedule I drug on the federal level and is essentially still considered illegal,” commented Donald I. Abrams, MD, professor of medicine at the University of California, San Francisco, and an integrative oncologist at the UCSF Osher Center for Integrative Medicine. “This is why many physicians are uncomfortable discussing it with patients,” he said.

“Cannabis use isn’t taught in medical school, and until that changes, I don’t know how physicians are going to be advisers for this,” said Dr. Abrams, who was approached by this news organization for comment.

This “is a really nice study in that it looks at a large group of breast cancer patients from the community ... It’s not from a single institution [such as this previous study] and so a more representative mix,” Dr. Abrams said.

However, he also commented that the article had a “scent of ‘reefer madness’” about it, given its emphasis on potential harms and safety concerns.

“It’s interesting how alcohol is considered mainstream but cannabis has been demonized,” he said. “Especially for women with breast cancer, it’s so clear that alcohol is related to the development of postmenopausal breast cancer. As a recreational intervention, cannabis in my mind appears to be much safer for women for relaxation.”

“The one thing I worry about are patients who take highly concentrated CBD [cannabidiol] oil, as it can block the metabolism of prescription drugs and allow them to build up in the blood,” Dr. Abrams said. “I advise people against using these products.”
 

Cannabis to relieve symptoms

Previous studies have noted widespread use of cannabis among patients with cancer. For example, a large study from Israel that included nearly 3,000 participants found that cannabis use improved a variety of cancer-related symptoms, including nausea and vomiting, sleep disorders, pain, anxiety, and depression. Among those with cancer who survived to 6 months and who finished the study protocol, 60% achieved “treatment success.” Of note, at 6 months, 36% of patients had stopped taking opioids, and for 9.9%, the dose of opioids had decreased.

In the current study, dubbed the Coala-T-Cannabis study, the investigators approached U.S. members of the Breastcancer.org and Healthline.com communities who self-reported that they had been diagnosed with breast cancer within the past 5 years; 612 surveys were completed.

Half of all respondents said they had looked for information on medical cannabis, but most were unsatisfied with the information that they had received. Only 6% were extremely satisfied; 25% were very satisfied with the information.

Most patients (39%) did not discuss cannabis use with their physicians. Of those who did, 28% reported feeling uncomfortable discussing the topic. Only 4% of survey respondents indicated that physicians were the most helpful source of cannabis information.

Regarding which source of information was most helpful, 22% said websites, 18% said family members or friends, 12% said staffers and pharmacists in dispensaries, and 7% said other patients with breast cancer.

Forty-two percent of the survey respondents said they used cannabis for medical purposes and for relief of symptoms, which included pain (78%), insomnia (70%), anxiety (57%), stress (51%), and nausea/vomiting (46%).

In addition, 49% believed that medical cannabis could be used to treat the cancer itself.

A fair number were also using cannabis for recreational purposes. Of those who used cannabis, only 23% reported that they used it for medical purposes only.

Participants used cannabis in a variety of forms. The most popular form of consumption was as edibles (70%), followed by liquids/tinctures (65%), smoking (51%), topicals (46%), and vape pens (45%). Participants reported using an average of 3.7 different products.
 

Safety concerns?

The authors caution about the use of cannabis while receiving anticancer therapies because such use “raises important efficacy and safety concerns.”

“Many chemotherapy agents as well as cannabinoids are metabolized in the liver’s p450 cytochrome system,” Dr. Weiss and colleagues note, and the mechanism by which cannabinoids interact with particular CYP450 isoenzymes “has the potential to alter the metabolism of other medications and lead to adverse side effects.”

They also question the safety of some of the cannabis products that are being used. Participants reported receiving cannabis from a variety of sources, which included state-regulated dispensaries, “dealers,” and family/friends.

Three-quarters of respondents believed that cannabis was better than “chemicals” and that the benefits outweighed the risks. But many of the products used are unregulated, the authors point out.

“Providers should communicate clearly about the health and safety concerns associated with certain cannabis products and methods of delivery,” they conclude. “Without these measures, patients may make these decisions without qualified medical guidance, obtain poor-quality cannabis products, and consume them through potentially hazardous delivery methods during various types of cancer therapies.”

The study was supported by research grants from Ananda Health/Ecofibre and the Dr. Philip Reeves Legacy Fund. Several coauthors reported relationships with industry, as noted in the article. Dr. Abrams owns stock in Cannformatics and Lumen; he has received honorarium from Clever Leaves and Maui Grown Therapies and speaker honorarium from GW Pharmaceuticals.

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