Metformin has a modest favorable effect on body mass index z score and insulin resistance in children and adolescents with obesity, compared with placebo, according to a systematic review of trial data.

moodboard/thinkstockphotos

“The available evidence is of varying quality,” however, and the drug increases the likelihood of gastrointestinal adverse effects, reported Reem Masarwa, PharmD, PhD, and colleagues in Pediatrics. “Nonetheless, metformin may be considered for use as a pharmacologic therapy in this pediatric population because of its modest efficacy, availability, cost, and safety profile.”

The Food and Drug Administration has approved metformin for the treatment of type 2 diabetes in children and adolescents. Doctors have used the drug off label for weight loss in children with obesity, but this use “remains controversial,” the review authors said.

To assess the efficacy and safety of metformin plus lifestyle interventions compared with placebo plus lifestyle interventions in children and adolescents with obesity, Dr. Masarwa, with the Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, and the department of epidemiology, biostatistics, and occupational health, McGill University, Montreal, and colleagues systematically reviewed data from randomized controlled trials (RCTs). Their review was published online in Pediatrics.

The investigators focused on studies that examined outcomes such as body mass index, BMI z score, insulin resistance, and gastrointestinal adverse effects. They excluded studies of children with type 2 diabetes.

The researchers included 24 RCTs in their review. The studies included 1,623 children and adolescents who received metformin (861 participants) or placebo (762 participants). Indications included uncomplicated obesity in 10 studies, obesity with insulin resistance in 9 studies, prediabetes in 3 studies, and nonalcoholic fatty liver disease in 2 studies. One of the trials did not incorporate a lifestyle cointervention.

Participants ranged in age from 4 years to 19 years, and trial durations ranged from 2 months to 2 years. The total daily dose of metformin ranged from 500 mg to 2,000 mg.

In 14 RCTs that reported BMI, metformin generally decreased BMI (range of mean changes: –2.70 to 1.30), compared with placebo (range of mean changes: –1.12 to 1.90), although three trials suggested that metformin increased BMI. The average difference in the treatment effect between the metformin and placebo groups ranged from –2.72 to 0.70. “Importantly, the authors of many RCTs reported variable treatment effects, preventing definitive conclusions from being drawn from individual trials,” Dr. Masarwa and coauthors wrote.

In seven RCTs that reported BMI z score, metformin consistently decreased BMI z score (range of mean changes: –0.37 to –0.03), compared with placebo (range of mean changes: –0.22 to 0.15). The mean difference in the treatment effect between treatment groups ranged from –0.15 to –0.07. The largest decrease occurred in patients with nonalcoholic fatty liver disease.

The rate of gastrointestinal adverse events nearly doubled with metformin treatment, relative to placebo (rate range: 2%-74% for metformin vs. 0%-42% for placebo).

Metformin adherence rates ranged from 60% to 90%, and lifestyle cointerventions varied substantially across the trials, the researchers noted. The clinical significance and long-term effects of metformin treatment in this population “remain uncertain,” they said.
 

Off-label use may not be ideal

“Ideally, children with obesity should be entered into a clinical trial rather than placed on an off-label medication,” Vandana Raman, MD, and Carol M. Foster, MD, said in a related commentary. Still, treatment with metformin may be reasonable in certain cases, said Dr. Raman and Dr. Foster of the division of endocrinology in the department of pediatrics at the University of Utah in Salt Lake City. “Metformin is a low-cost option and may provide modest clinical benefit for weight loss with minimal side effects. If lifestyle modification has been pursued but has achieved minimal weight loss, it may be reasonable to try an agent such as metformin as adjunctive therapy,” they said.

Lifestyle modification therapy – including nutritional changes, physical activity, and behavior modification – has been the “mainstay of management” for patients with obesity, and this approach underpins successful weight loss, they said. But durable weight loss with lifestyle modification may be challenging, and pharmacologic treatments “are attractive options before proceeding to bariatric surgery,” they said.

For younger patients, FDA-approved medications for obesity include orlistat and liraglutide for patients aged 12 years and older, and phentermine for patients aged 16 years and older.

“Orlistat has been associated with modest BMI reduction but may cause intolerable gastrointestinal side effects and possible fat-soluble vitamin deficiency,” they said. “Phentermine is approved for short-term therapy only and may increase heart rate and blood pressure and cause irritability and insomnia.”

Liraglutide, which was approved for the treatment of pediatric obesity in December 2020, reduced BMI in a trial that included adolescents with obesity. About 43% of the participants who received liraglutide, compared with 18% who received placebo, had a 5% reduction in BMI. In addition, 26% and 8%, respectively, had a 10% reduction in BMI. The use of liraglutide “is limited by the need for daily subcutaneous injections and high frequency of gastrointestinal side effects and high cost,” however, the commentary authors noted.

In addition, the FDA has approved setmelanotide for children older than 6 years with obesity caused by three rare genetic conditions.

Some small studies have suggested that topiramate may lead to meaningful weight loss in children, but the medication has been associated with cognitive dysfunction, they said.
 

Considering surgery

“This is an important review of the efficacy of metformin as a tool for weight loss in children with obesity,” said Suzanne C. Boulter, MD, adjunct professor emeritus of pediatrics and community and family medicine at the Geisel School of Medicine at Dartmouth in Hanover, N.H. “Results showed modest decreases in BMI z scores compared to placebo but there were a significant percentage of GI side effects and dropouts from the trials.”

“Tools other than lifestyle changes are needed to address” pediatric obesity, Dr. Boulter said. “Another tool is gastric bypass which is now a recommended intervention in selected clinical sites for adolescents 14 years of age and older with BMIs greater than 35.”

Dr. Boulter highlighted a recent study in Pediatrics that examined data from more than 200 adolescents who underwent bariatric surgery. The researchers found that outcomes were similar for older and younger patients.

“It would be interesting to pediatricians in practice to see a comparison study between metformin and bariatric surgery long-term results,” Dr. Boulter added.

Dr. Masarwa and coauthors received support from the Quebec Foundation for Health Research and the Canadian Institutes of Health Research Drug Safety and Effectiveness Cross-Disciplinary Training Program. One coauthor also is supported by an award from McGill University.

The authors of the systematic review and the accompanying commentary had no relevant financial disclosures. Dr. Boulter is a member of the editorial advisory board for Pediatric News and had no relevant financial disclosures.

[email protected]

Metformin has a modest favorable effect on body mass index z score and insulin resistance in children and adolescents with obesity, compared with placebo, according to a systematic review of trial data.

moodboard/thinkstockphotos

“The available evidence is of varying quality,” however, and the drug increases the likelihood of gastrointestinal adverse effects, reported Reem Masarwa, PharmD, PhD, and colleagues in Pediatrics. “Nonetheless, metformin may be considered for use as a pharmacologic therapy in this pediatric population because of its modest efficacy, availability, cost, and safety profile.”

The Food and Drug Administration has approved metformin for the treatment of type 2 diabetes in children and adolescents. Doctors have used the drug off label for weight loss in children with obesity, but this use “remains controversial,” the review authors said.

To assess the efficacy and safety of metformin plus lifestyle interventions compared with placebo plus lifestyle interventions in children and adolescents with obesity, Dr. Masarwa, with the Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, and the department of epidemiology, biostatistics, and occupational health, McGill University, Montreal, and colleagues systematically reviewed data from randomized controlled trials (RCTs). Their review was published online in Pediatrics.

The investigators focused on studies that examined outcomes such as body mass index, BMI z score, insulin resistance, and gastrointestinal adverse effects. They excluded studies of children with type 2 diabetes.

The researchers included 24 RCTs in their review. The studies included 1,623 children and adolescents who received metformin (861 participants) or placebo (762 participants). Indications included uncomplicated obesity in 10 studies, obesity with insulin resistance in 9 studies, prediabetes in 3 studies, and nonalcoholic fatty liver disease in 2 studies. One of the trials did not incorporate a lifestyle cointervention.

Participants ranged in age from 4 years to 19 years, and trial durations ranged from 2 months to 2 years. The total daily dose of metformin ranged from 500 mg to 2,000 mg.

In 14 RCTs that reported BMI, metformin generally decreased BMI (range of mean changes: –2.70 to 1.30), compared with placebo (range of mean changes: –1.12 to 1.90), although three trials suggested that metformin increased BMI. The average difference in the treatment effect between the metformin and placebo groups ranged from –2.72 to 0.70. “Importantly, the authors of many RCTs reported variable treatment effects, preventing definitive conclusions from being drawn from individual trials,” Dr. Masarwa and coauthors wrote.

In seven RCTs that reported BMI z score, metformin consistently decreased BMI z score (range of mean changes: –0.37 to –0.03), compared with placebo (range of mean changes: –0.22 to 0.15). The mean difference in the treatment effect between treatment groups ranged from –0.15 to –0.07. The largest decrease occurred in patients with nonalcoholic fatty liver disease.

The rate of gastrointestinal adverse events nearly doubled with metformin treatment, relative to placebo (rate range: 2%-74% for metformin vs. 0%-42% for placebo).

Metformin adherence rates ranged from 60% to 90%, and lifestyle cointerventions varied substantially across the trials, the researchers noted. The clinical significance and long-term effects of metformin treatment in this population “remain uncertain,” they said.
 

Off-label use may not be ideal

“Ideally, children with obesity should be entered into a clinical trial rather than placed on an off-label medication,” Vandana Raman, MD, and Carol M. Foster, MD, said in a related commentary. Still, treatment with metformin may be reasonable in certain cases, said Dr. Raman and Dr. Foster of the division of endocrinology in the department of pediatrics at the University of Utah in Salt Lake City. “Metformin is a low-cost option and may provide modest clinical benefit for weight loss with minimal side effects. If lifestyle modification has been pursued but has achieved minimal weight loss, it may be reasonable to try an agent such as metformin as adjunctive therapy,” they said.

Lifestyle modification therapy – including nutritional changes, physical activity, and behavior modification – has been the “mainstay of management” for patients with obesity, and this approach underpins successful weight loss, they said. But durable weight loss with lifestyle modification may be challenging, and pharmacologic treatments “are attractive options before proceeding to bariatric surgery,” they said.

For younger patients, FDA-approved medications for obesity include orlistat and liraglutide for patients aged 12 years and older, and phentermine for patients aged 16 years and older.

“Orlistat has been associated with modest BMI reduction but may cause intolerable gastrointestinal side effects and possible fat-soluble vitamin deficiency,” they said. “Phentermine is approved for short-term therapy only and may increase heart rate and blood pressure and cause irritability and insomnia.”

Liraglutide, which was approved for the treatment of pediatric obesity in December 2020, reduced BMI in a trial that included adolescents with obesity. About 43% of the participants who received liraglutide, compared with 18% who received placebo, had a 5% reduction in BMI. In addition, 26% and 8%, respectively, had a 10% reduction in BMI. The use of liraglutide “is limited by the need for daily subcutaneous injections and high frequency of gastrointestinal side effects and high cost,” however, the commentary authors noted.

In addition, the FDA has approved setmelanotide for children older than 6 years with obesity caused by three rare genetic conditions.

Some small studies have suggested that topiramate may lead to meaningful weight loss in children, but the medication has been associated with cognitive dysfunction, they said.
 

Considering surgery

“This is an important review of the efficacy of metformin as a tool for weight loss in children with obesity,” said Suzanne C. Boulter, MD, adjunct professor emeritus of pediatrics and community and family medicine at the Geisel School of Medicine at Dartmouth in Hanover, N.H. “Results showed modest decreases in BMI z scores compared to placebo but there were a significant percentage of GI side effects and dropouts from the trials.”

“Tools other than lifestyle changes are needed to address” pediatric obesity, Dr. Boulter said. “Another tool is gastric bypass which is now a recommended intervention in selected clinical sites for adolescents 14 years of age and older with BMIs greater than 35.”

Dr. Boulter highlighted a recent study in Pediatrics that examined data from more than 200 adolescents who underwent bariatric surgery. The researchers found that outcomes were similar for older and younger patients.

“It would be interesting to pediatricians in practice to see a comparison study between metformin and bariatric surgery long-term results,” Dr. Boulter added.

Dr. Masarwa and coauthors received support from the Quebec Foundation for Health Research and the Canadian Institutes of Health Research Drug Safety and Effectiveness Cross-Disciplinary Training Program. One coauthor also is supported by an award from McGill University.

The authors of the systematic review and the accompanying commentary had no relevant financial disclosures. Dr. Boulter is a member of the editorial advisory board for Pediatric News and had no relevant financial disclosures.

[email protected]

Metformin has a modest favorable effect on body mass index z score and insulin resistance in children and adolescents with obesity, compared with placebo, according to a systematic review of trial data.

moodboard/thinkstockphotos

“The available evidence is of varying quality,” however, and the drug increases the likelihood of gastrointestinal adverse effects, reported Reem Masarwa, PharmD, PhD, and colleagues in Pediatrics. “Nonetheless, metformin may be considered for use as a pharmacologic therapy in this pediatric population because of its modest efficacy, availability, cost, and safety profile.”

The Food and Drug Administration has approved metformin for the treatment of type 2 diabetes in children and adolescents. Doctors have used the drug off label for weight loss in children with obesity, but this use “remains controversial,” the review authors said.

To assess the efficacy and safety of metformin plus lifestyle interventions compared with placebo plus lifestyle interventions in children and adolescents with obesity, Dr. Masarwa, with the Center for Clinical Epidemiology, Lady Davis Institute, Jewish General Hospital, and the department of epidemiology, biostatistics, and occupational health, McGill University, Montreal, and colleagues systematically reviewed data from randomized controlled trials (RCTs). Their review was published online in Pediatrics.

The investigators focused on studies that examined outcomes such as body mass index, BMI z score, insulin resistance, and gastrointestinal adverse effects. They excluded studies of children with type 2 diabetes.

The researchers included 24 RCTs in their review. The studies included 1,623 children and adolescents who received metformin (861 participants) or placebo (762 participants). Indications included uncomplicated obesity in 10 studies, obesity with insulin resistance in 9 studies, prediabetes in 3 studies, and nonalcoholic fatty liver disease in 2 studies. One of the trials did not incorporate a lifestyle cointervention.

Participants ranged in age from 4 years to 19 years, and trial durations ranged from 2 months to 2 years. The total daily dose of metformin ranged from 500 mg to 2,000 mg.

In 14 RCTs that reported BMI, metformin generally decreased BMI (range of mean changes: –2.70 to 1.30), compared with placebo (range of mean changes: –1.12 to 1.90), although three trials suggested that metformin increased BMI. The average difference in the treatment effect between the metformin and placebo groups ranged from –2.72 to 0.70. “Importantly, the authors of many RCTs reported variable treatment effects, preventing definitive conclusions from being drawn from individual trials,” Dr. Masarwa and coauthors wrote.

In seven RCTs that reported BMI z score, metformin consistently decreased BMI z score (range of mean changes: –0.37 to –0.03), compared with placebo (range of mean changes: –0.22 to 0.15). The mean difference in the treatment effect between treatment groups ranged from –0.15 to –0.07. The largest decrease occurred in patients with nonalcoholic fatty liver disease.

The rate of gastrointestinal adverse events nearly doubled with metformin treatment, relative to placebo (rate range: 2%-74% for metformin vs. 0%-42% for placebo).

Metformin adherence rates ranged from 60% to 90%, and lifestyle cointerventions varied substantially across the trials, the researchers noted. The clinical significance and long-term effects of metformin treatment in this population “remain uncertain,” they said.
 

Off-label use may not be ideal

“Ideally, children with obesity should be entered into a clinical trial rather than placed on an off-label medication,” Vandana Raman, MD, and Carol M. Foster, MD, said in a related commentary. Still, treatment with metformin may be reasonable in certain cases, said Dr. Raman and Dr. Foster of the division of endocrinology in the department of pediatrics at the University of Utah in Salt Lake City. “Metformin is a low-cost option and may provide modest clinical benefit for weight loss with minimal side effects. If lifestyle modification has been pursued but has achieved minimal weight loss, it may be reasonable to try an agent such as metformin as adjunctive therapy,” they said.

Lifestyle modification therapy – including nutritional changes, physical activity, and behavior modification – has been the “mainstay of management” for patients with obesity, and this approach underpins successful weight loss, they said. But durable weight loss with lifestyle modification may be challenging, and pharmacologic treatments “are attractive options before proceeding to bariatric surgery,” they said.

For younger patients, FDA-approved medications for obesity include orlistat and liraglutide for patients aged 12 years and older, and phentermine for patients aged 16 years and older.

“Orlistat has been associated with modest BMI reduction but may cause intolerable gastrointestinal side effects and possible fat-soluble vitamin deficiency,” they said. “Phentermine is approved for short-term therapy only and may increase heart rate and blood pressure and cause irritability and insomnia.”

Liraglutide, which was approved for the treatment of pediatric obesity in December 2020, reduced BMI in a trial that included adolescents with obesity. About 43% of the participants who received liraglutide, compared with 18% who received placebo, had a 5% reduction in BMI. In addition, 26% and 8%, respectively, had a 10% reduction in BMI. The use of liraglutide “is limited by the need for daily subcutaneous injections and high frequency of gastrointestinal side effects and high cost,” however, the commentary authors noted.

In addition, the FDA has approved setmelanotide for children older than 6 years with obesity caused by three rare genetic conditions.

Some small studies have suggested that topiramate may lead to meaningful weight loss in children, but the medication has been associated with cognitive dysfunction, they said.
 

Considering surgery

“This is an important review of the efficacy of metformin as a tool for weight loss in children with obesity,” said Suzanne C. Boulter, MD, adjunct professor emeritus of pediatrics and community and family medicine at the Geisel School of Medicine at Dartmouth in Hanover, N.H. “Results showed modest decreases in BMI z scores compared to placebo but there were a significant percentage of GI side effects and dropouts from the trials.”

“Tools other than lifestyle changes are needed to address” pediatric obesity, Dr. Boulter said. “Another tool is gastric bypass which is now a recommended intervention in selected clinical sites for adolescents 14 years of age and older with BMIs greater than 35.”

Dr. Boulter highlighted a recent study in Pediatrics that examined data from more than 200 adolescents who underwent bariatric surgery. The researchers found that outcomes were similar for older and younger patients.

“It would be interesting to pediatricians in practice to see a comparison study between metformin and bariatric surgery long-term results,” Dr. Boulter added.

Dr. Masarwa and coauthors received support from the Quebec Foundation for Health Research and the Canadian Institutes of Health Research Drug Safety and Effectiveness Cross-Disciplinary Training Program. One coauthor also is supported by an award from McGill University.

The authors of the systematic review and the accompanying commentary had no relevant financial disclosures. Dr. Boulter is a member of the editorial advisory board for Pediatric News and had no relevant financial disclosures.

[email protected]

Shared decision-making is an integral step in lung cancer screening with low-dose CT (LDCT) in high-risk patients, but a cross-sectional study at two academic medical centers in Texas has found wide variability in the quality of shared decision-making encounters and that nearly a third of patients reported being conflicted about their decisions to pursue screening.

Lead author Shawn P.E. Nishi, MD, associate professor in the division of pulmonary critical care and sleep medicine, department of internal medicine, of the University of Texas Medical Branch, Galveston, noted two striking findings of the study, published in Chest: that physicians rarely used decision aids according to Centers for Medicare & Medicaid Services direction, and that a “considerable imbalance” exists in the way physicians present management choices to patients. “As physicians, we want to focus on the positive,” she said, “but in shared decision-making (SDM) there needs to be a better balance between presentation and understanding of the risks and the benefits of lung cancer screening (LCS).”

Since 2015, CMS has reimbursed for LCS counseling and an shared decision-making visit before a patient has the screening.

The study analyzed self-reported survey results of 266 patients who had been through SDM at UTMB Galveston and MD Anderson Cancer Center in Houston in 2017. They completed patient surveys the following year. The study population was 87% White, 38% had a family history of lung cancer, and 39% were current smokers. The mean pack-year history was 40.4 years.

A high percentage – 86.6% – said they were satisfied with the level in which they were involved in their screening decision. Patients reported that their doctors talked to them about the benefits of LCS far more frequently than the potential harms, 68.3% to 20.8%. And 12.5% said they understood that an abnormal scan was likely to result in a negative finding. Only 30.7% said they’d received educational materials about LCS during the screening process.

A year after completing the SDM process, their knowledge of LCS was variable at best; on average, they answered 41.4% of the questions correctly, and almost one-third (31%) indicated that screening, rather than quitting smoking, was the best way reduce their lung cancer risk.

The study noted that, for patients who derive a small benefit from LCS, the absolute risk reduction is only 0.3%, which may not be enough to offset the potential harms of LDCT.

“The LCS exam itself is a simple noninvasive procedure; you get a scan and go about your day once it’s read,” Dr. Nishi said. “However there is a high false-positive rate, and the question really becomes that, as you start to work up those false positives and even true positives, however small, there is a risk associated with every procedure or evaluation thereafter. So the shared decision-making process is really there to ensure that patients value finding their lung cancer early if they do have it versus the potential harms down the line.”

However, as this study points out, there aren’t many parameters for what SDM entails. “It’s more than just an information exchange back and forth,” Dr. Nishi said. “It’s about having good-quality communication between the provider and patients so that the right decision can ultimately be made for each patient. It takes a very dedicated person that can commit the time and expertise to it. I don’t think that it should be taken lightly.”

As Dr. Nishi and colleagues pointed out in their study, SDM incorporates three essential elements: recognizing and acknowledging that a decision has to be made, knowing and understanding the best available evidence, and incorporating the patient’s own values and preferences in the decision.

CMS outlines specific components of SDM. It includes, beyond a discussion of the potential benefits and harms and use of a decision aid, education on the need for adherence to annual screening, and counseling on either stopping smoking or continued abstinence.

For physicians, dedicating the time and energy SDM needs can be a challenge, Dr. Nishi noted, “Health care doesn’t have a lot of support to perform shared decision-making,” she said. “In a very busy practice it’s very hard to make sure you have a good process where you can sit down and take all the time you need with a patient to open up a dialog about the risks and benefits.”

After they completed the screening process, 33.6% of patients said they had some conflicting feelings about their decision. Non-White patients were about four times more likely than White patients to feel conflicted about their choices (odds ratio, 4.31; 95% confidence interval, 1.36-13.70), as were former smokers, compared with current smokers (OR, 1.93; 95% CI, 1.04-3.55).

Future studies of SDM in LCS should focus on outcomes, said Dr. Nishi. “Hopefully then we can focus on those things that benefit patients the most.”

Abbie Begnaud, MD, FCCP, a pulmonologist at the University of Minnesota, Minneapolis, said this study confirmed what other studies found about shortcomings of SDM, with one difference. “We already knew we were not doing a great job at shared decision-making,” she said. “To me, the difference in this study is that most of the patients were pretty satisfied with their degree of involvement.”

She noted the low percentage of patients who understood that abnormal scans may be noncancerous. “This is one area that I think is an important place for us to improve,” Dr. Begnaud said.

The findings about non-White patients and former smokers are also telling, Dr. Begnaud said. “This highlights that we need to pay close attention to these two groups – people who have traditionally, historically been marginalized in medical care – and provide them the support they need to make a decision.”

Dr. Nishi and colleagues have no relevant disclosures. The study was supported by the Cancer Prevention and Research Institute of Texas and received grants from the National Cancer Institute and the University of Texas MD Anderson Cancer Center Duncan Family Institute for Cancer Prevention and Risk Assessment. Dr. Begnaud has no relevant relationships to disclose.

Shared decision-making is an integral step in lung cancer screening with low-dose CT (LDCT) in high-risk patients, but a cross-sectional study at two academic medical centers in Texas has found wide variability in the quality of shared decision-making encounters and that nearly a third of patients reported being conflicted about their decisions to pursue screening.

Lead author Shawn P.E. Nishi, MD, associate professor in the division of pulmonary critical care and sleep medicine, department of internal medicine, of the University of Texas Medical Branch, Galveston, noted two striking findings of the study, published in Chest: that physicians rarely used decision aids according to Centers for Medicare & Medicaid Services direction, and that a “considerable imbalance” exists in the way physicians present management choices to patients. “As physicians, we want to focus on the positive,” she said, “but in shared decision-making (SDM) there needs to be a better balance between presentation and understanding of the risks and the benefits of lung cancer screening (LCS).”

Since 2015, CMS has reimbursed for LCS counseling and an shared decision-making visit before a patient has the screening.

The study analyzed self-reported survey results of 266 patients who had been through SDM at UTMB Galveston and MD Anderson Cancer Center in Houston in 2017. They completed patient surveys the following year. The study population was 87% White, 38% had a family history of lung cancer, and 39% were current smokers. The mean pack-year history was 40.4 years.

A high percentage – 86.6% – said they were satisfied with the level in which they were involved in their screening decision. Patients reported that their doctors talked to them about the benefits of LCS far more frequently than the potential harms, 68.3% to 20.8%. And 12.5% said they understood that an abnormal scan was likely to result in a negative finding. Only 30.7% said they’d received educational materials about LCS during the screening process.

A year after completing the SDM process, their knowledge of LCS was variable at best; on average, they answered 41.4% of the questions correctly, and almost one-third (31%) indicated that screening, rather than quitting smoking, was the best way reduce their lung cancer risk.

The study noted that, for patients who derive a small benefit from LCS, the absolute risk reduction is only 0.3%, which may not be enough to offset the potential harms of LDCT.

“The LCS exam itself is a simple noninvasive procedure; you get a scan and go about your day once it’s read,” Dr. Nishi said. “However there is a high false-positive rate, and the question really becomes that, as you start to work up those false positives and even true positives, however small, there is a risk associated with every procedure or evaluation thereafter. So the shared decision-making process is really there to ensure that patients value finding their lung cancer early if they do have it versus the potential harms down the line.”

However, as this study points out, there aren’t many parameters for what SDM entails. “It’s more than just an information exchange back and forth,” Dr. Nishi said. “It’s about having good-quality communication between the provider and patients so that the right decision can ultimately be made for each patient. It takes a very dedicated person that can commit the time and expertise to it. I don’t think that it should be taken lightly.”

As Dr. Nishi and colleagues pointed out in their study, SDM incorporates three essential elements: recognizing and acknowledging that a decision has to be made, knowing and understanding the best available evidence, and incorporating the patient’s own values and preferences in the decision.

CMS outlines specific components of SDM. It includes, beyond a discussion of the potential benefits and harms and use of a decision aid, education on the need for adherence to annual screening, and counseling on either stopping smoking or continued abstinence.

For physicians, dedicating the time and energy SDM needs can be a challenge, Dr. Nishi noted, “Health care doesn’t have a lot of support to perform shared decision-making,” she said. “In a very busy practice it’s very hard to make sure you have a good process where you can sit down and take all the time you need with a patient to open up a dialog about the risks and benefits.”

After they completed the screening process, 33.6% of patients said they had some conflicting feelings about their decision. Non-White patients were about four times more likely than White patients to feel conflicted about their choices (odds ratio, 4.31; 95% confidence interval, 1.36-13.70), as were former smokers, compared with current smokers (OR, 1.93; 95% CI, 1.04-3.55).

Future studies of SDM in LCS should focus on outcomes, said Dr. Nishi. “Hopefully then we can focus on those things that benefit patients the most.”

Abbie Begnaud, MD, FCCP, a pulmonologist at the University of Minnesota, Minneapolis, said this study confirmed what other studies found about shortcomings of SDM, with one difference. “We already knew we were not doing a great job at shared decision-making,” she said. “To me, the difference in this study is that most of the patients were pretty satisfied with their degree of involvement.”

She noted the low percentage of patients who understood that abnormal scans may be noncancerous. “This is one area that I think is an important place for us to improve,” Dr. Begnaud said.

The findings about non-White patients and former smokers are also telling, Dr. Begnaud said. “This highlights that we need to pay close attention to these two groups – people who have traditionally, historically been marginalized in medical care – and provide them the support they need to make a decision.”

Dr. Nishi and colleagues have no relevant disclosures. The study was supported by the Cancer Prevention and Research Institute of Texas and received grants from the National Cancer Institute and the University of Texas MD Anderson Cancer Center Duncan Family Institute for Cancer Prevention and Risk Assessment. Dr. Begnaud has no relevant relationships to disclose.

Shared decision-making is an integral step in lung cancer screening with low-dose CT (LDCT) in high-risk patients, but a cross-sectional study at two academic medical centers in Texas has found wide variability in the quality of shared decision-making encounters and that nearly a third of patients reported being conflicted about their decisions to pursue screening.

Lead author Shawn P.E. Nishi, MD, associate professor in the division of pulmonary critical care and sleep medicine, department of internal medicine, of the University of Texas Medical Branch, Galveston, noted two striking findings of the study, published in Chest: that physicians rarely used decision aids according to Centers for Medicare & Medicaid Services direction, and that a “considerable imbalance” exists in the way physicians present management choices to patients. “As physicians, we want to focus on the positive,” she said, “but in shared decision-making (SDM) there needs to be a better balance between presentation and understanding of the risks and the benefits of lung cancer screening (LCS).”

Since 2015, CMS has reimbursed for LCS counseling and an shared decision-making visit before a patient has the screening.

The study analyzed self-reported survey results of 266 patients who had been through SDM at UTMB Galveston and MD Anderson Cancer Center in Houston in 2017. They completed patient surveys the following year. The study population was 87% White, 38% had a family history of lung cancer, and 39% were current smokers. The mean pack-year history was 40.4 years.

A high percentage – 86.6% – said they were satisfied with the level in which they were involved in their screening decision. Patients reported that their doctors talked to them about the benefits of LCS far more frequently than the potential harms, 68.3% to 20.8%. And 12.5% said they understood that an abnormal scan was likely to result in a negative finding. Only 30.7% said they’d received educational materials about LCS during the screening process.

A year after completing the SDM process, their knowledge of LCS was variable at best; on average, they answered 41.4% of the questions correctly, and almost one-third (31%) indicated that screening, rather than quitting smoking, was the best way reduce their lung cancer risk.

The study noted that, for patients who derive a small benefit from LCS, the absolute risk reduction is only 0.3%, which may not be enough to offset the potential harms of LDCT.

“The LCS exam itself is a simple noninvasive procedure; you get a scan and go about your day once it’s read,” Dr. Nishi said. “However there is a high false-positive rate, and the question really becomes that, as you start to work up those false positives and even true positives, however small, there is a risk associated with every procedure or evaluation thereafter. So the shared decision-making process is really there to ensure that patients value finding their lung cancer early if they do have it versus the potential harms down the line.”

However, as this study points out, there aren’t many parameters for what SDM entails. “It’s more than just an information exchange back and forth,” Dr. Nishi said. “It’s about having good-quality communication between the provider and patients so that the right decision can ultimately be made for each patient. It takes a very dedicated person that can commit the time and expertise to it. I don’t think that it should be taken lightly.”

As Dr. Nishi and colleagues pointed out in their study, SDM incorporates three essential elements: recognizing and acknowledging that a decision has to be made, knowing and understanding the best available evidence, and incorporating the patient’s own values and preferences in the decision.

CMS outlines specific components of SDM. It includes, beyond a discussion of the potential benefits and harms and use of a decision aid, education on the need for adherence to annual screening, and counseling on either stopping smoking or continued abstinence.

For physicians, dedicating the time and energy SDM needs can be a challenge, Dr. Nishi noted, “Health care doesn’t have a lot of support to perform shared decision-making,” she said. “In a very busy practice it’s very hard to make sure you have a good process where you can sit down and take all the time you need with a patient to open up a dialog about the risks and benefits.”

After they completed the screening process, 33.6% of patients said they had some conflicting feelings about their decision. Non-White patients were about four times more likely than White patients to feel conflicted about their choices (odds ratio, 4.31; 95% confidence interval, 1.36-13.70), as were former smokers, compared with current smokers (OR, 1.93; 95% CI, 1.04-3.55).

Future studies of SDM in LCS should focus on outcomes, said Dr. Nishi. “Hopefully then we can focus on those things that benefit patients the most.”

Abbie Begnaud, MD, FCCP, a pulmonologist at the University of Minnesota, Minneapolis, said this study confirmed what other studies found about shortcomings of SDM, with one difference. “We already knew we were not doing a great job at shared decision-making,” she said. “To me, the difference in this study is that most of the patients were pretty satisfied with their degree of involvement.”

She noted the low percentage of patients who understood that abnormal scans may be noncancerous. “This is one area that I think is an important place for us to improve,” Dr. Begnaud said.

The findings about non-White patients and former smokers are also telling, Dr. Begnaud said. “This highlights that we need to pay close attention to these two groups – people who have traditionally, historically been marginalized in medical care – and provide them the support they need to make a decision.”

Dr. Nishi and colleagues have no relevant disclosures. The study was supported by the Cancer Prevention and Research Institute of Texas and received grants from the National Cancer Institute and the University of Texas MD Anderson Cancer Center Duncan Family Institute for Cancer Prevention and Risk Assessment. Dr. Begnaud has no relevant relationships to disclose.

A study of post–COVID-19 patients in the United Kingdom who developed severe lung inflammation after they left the hospital may provide greater clarity on which patients are most likely to have persistent lung dysfunction.

In addition to pinpointing those most at risk, the findings showed that conventional corticosteroid treatment is highly effective in improving lung function and reducing symptoms.

Researchers from Guy’s and St. Thomas’ National Health Foundation Trust in London reported that a small percentage of patients – 4.8%, or 35 of 837 patients in the study – had severe persistent interstitial lung disease (ILD), mostly organizing pneumonia, 4 weeks after discharge. Of these patients, 30 received steroid treatment, all of whom showed improvement in lung function.

Lead author Katherine Jane Myall, MRCP, and colleagues wrote that the most common radiologic finding in acute COVID-19 is bilateral ground-glass opacification, and findings of organizing pneumonia are common. However, no reports exist of the role of inflammatory infiltrates during recovery from COVID-19 or of the effectiveness of treatments for persistent ILD. “The long-term respiratory morbidity remains unclear,” Dr. Myall and colleagues wrote.

The study findings are significant because they quantify the degree of lung disease that patients have after COVID-19, said Sachin Gupta, MD, FCCP, a pulmonologist and critical care specialist at Alameda Health System in Oakland, Calif. He added that the disease course and presentation followed the pattern of organizing pneumonia in some patients, and traditional corticosteroid therapy seemed to resolve symptoms and improve lung function.

“This is a really important piece to get out there because it describes what a lot of us are worried about in patients with post-COVID lung disease and about what type of lung disease they have. It offers a potential treatment,” he said.

Dr. Myall and colleagues noted that even a “relatively small proportion” of patients with persistent, severe ILD – as reported in this study – pose “a significant disease burden.” They added: “Prompt therapy may avoid potentially permanent fibrosis and functional impairment.”

The single-center, prospective, observational study followed discharged patients with telephone calls 4 weeks after discharge to determine their status. At that point, 39% of the study cohort (n = 325) reported ongoing symptoms.

The patients had outpatient examinations at 6 weeks post discharge, at which time 42.9% (n = 138) had no signs or symptoms of persistent disease; 33.8% (n = 110) had symptoms but no radiologic findings and received referrals to other departments; and 24% (n = 77) were referred to the post-COVID lung disease multidisciplinary team. A total of 59 were diagnosed with persistent post-COVID interstitial change, 35 of whom had organizing pneumonia, hence the rationale for using steroids in this group, Dr. Myall and colleagues stated.

The 30 patients treated with corticosteroids received a maximum initial dose of 0.5 mg/kg prednisolone, which was rapidly weaned over 3 weeks. Some patients received lower doses depending on their comorbidities.

Treatment resulted in an average relative increase in transfer factor of 31.6% (P < .001) and forced vital capacity of 9.6% (P = .014), along with significant improvement in symptoms and x-ray signs.

The study identified some key characteristics of the patients who had persistent post–COVID-19 inflammatory ILD. They were mostly male (71.5%) and overweight with an average body mass index of 28.3, but only 26% were obese. Most had at least one comorbidity, with the most common being diabetes and asthma (22.9%). Their average hospital stay was 16.9 days, 82.9% required oxygen, 55% were in the ICU, and 46% needed invasive mechanical ventilation.

The patients most vulnerable to ILD and organizing pneumonia were the “sicker” of the whole cohort, Dr. Gupta said. “In one sense, it’s reassuring that this is not just happening in anyone; this is happening in patients who had the worst course and were hospitalized in the ICU for the most part.”

The study shows that identifying these patients early on and initiating steroid therapy could avoid persistent lung injury and scarring, Dr. Gupta said.

The London researchers noted that theirs wasn’t a radiologic study, so CT scans weren’t formally scored before and after treatment. They also acknowledged vagueness about imaging and clinical findings representing “nothing other than slow ongoing recovery.”

Patients with post–COVID-19 ILD will require ongoing follow-up to better understand the disease course, Dr. Myall and colleagues stated, although they predicted organizing pneumonia is unlikely to recur once it resolves.

Dr. Myall and coauthors had no relevant relationships to disclose. Dr. Gupta disclosed he is also an employee and shareholder at Genentech.

A study of post–COVID-19 patients in the United Kingdom who developed severe lung inflammation after they left the hospital may provide greater clarity on which patients are most likely to have persistent lung dysfunction.

In addition to pinpointing those most at risk, the findings showed that conventional corticosteroid treatment is highly effective in improving lung function and reducing symptoms.

Researchers from Guy’s and St. Thomas’ National Health Foundation Trust in London reported that a small percentage of patients – 4.8%, or 35 of 837 patients in the study – had severe persistent interstitial lung disease (ILD), mostly organizing pneumonia, 4 weeks after discharge. Of these patients, 30 received steroid treatment, all of whom showed improvement in lung function.

Lead author Katherine Jane Myall, MRCP, and colleagues wrote that the most common radiologic finding in acute COVID-19 is bilateral ground-glass opacification, and findings of organizing pneumonia are common. However, no reports exist of the role of inflammatory infiltrates during recovery from COVID-19 or of the effectiveness of treatments for persistent ILD. “The long-term respiratory morbidity remains unclear,” Dr. Myall and colleagues wrote.

The study findings are significant because they quantify the degree of lung disease that patients have after COVID-19, said Sachin Gupta, MD, FCCP, a pulmonologist and critical care specialist at Alameda Health System in Oakland, Calif. He added that the disease course and presentation followed the pattern of organizing pneumonia in some patients, and traditional corticosteroid therapy seemed to resolve symptoms and improve lung function.

“This is a really important piece to get out there because it describes what a lot of us are worried about in patients with post-COVID lung disease and about what type of lung disease they have. It offers a potential treatment,” he said.

Dr. Myall and colleagues noted that even a “relatively small proportion” of patients with persistent, severe ILD – as reported in this study – pose “a significant disease burden.” They added: “Prompt therapy may avoid potentially permanent fibrosis and functional impairment.”

The single-center, prospective, observational study followed discharged patients with telephone calls 4 weeks after discharge to determine their status. At that point, 39% of the study cohort (n = 325) reported ongoing symptoms.

The patients had outpatient examinations at 6 weeks post discharge, at which time 42.9% (n = 138) had no signs or symptoms of persistent disease; 33.8% (n = 110) had symptoms but no radiologic findings and received referrals to other departments; and 24% (n = 77) were referred to the post-COVID lung disease multidisciplinary team. A total of 59 were diagnosed with persistent post-COVID interstitial change, 35 of whom had organizing pneumonia, hence the rationale for using steroids in this group, Dr. Myall and colleagues stated.

The 30 patients treated with corticosteroids received a maximum initial dose of 0.5 mg/kg prednisolone, which was rapidly weaned over 3 weeks. Some patients received lower doses depending on their comorbidities.

Treatment resulted in an average relative increase in transfer factor of 31.6% (P < .001) and forced vital capacity of 9.6% (P = .014), along with significant improvement in symptoms and x-ray signs.

The study identified some key characteristics of the patients who had persistent post–COVID-19 inflammatory ILD. They were mostly male (71.5%) and overweight with an average body mass index of 28.3, but only 26% were obese. Most had at least one comorbidity, with the most common being diabetes and asthma (22.9%). Their average hospital stay was 16.9 days, 82.9% required oxygen, 55% were in the ICU, and 46% needed invasive mechanical ventilation.

The patients most vulnerable to ILD and organizing pneumonia were the “sicker” of the whole cohort, Dr. Gupta said. “In one sense, it’s reassuring that this is not just happening in anyone; this is happening in patients who had the worst course and were hospitalized in the ICU for the most part.”

The study shows that identifying these patients early on and initiating steroid therapy could avoid persistent lung injury and scarring, Dr. Gupta said.

The London researchers noted that theirs wasn’t a radiologic study, so CT scans weren’t formally scored before and after treatment. They also acknowledged vagueness about imaging and clinical findings representing “nothing other than slow ongoing recovery.”

Patients with post–COVID-19 ILD will require ongoing follow-up to better understand the disease course, Dr. Myall and colleagues stated, although they predicted organizing pneumonia is unlikely to recur once it resolves.

Dr. Myall and coauthors had no relevant relationships to disclose. Dr. Gupta disclosed he is also an employee and shareholder at Genentech.

A study of post–COVID-19 patients in the United Kingdom who developed severe lung inflammation after they left the hospital may provide greater clarity on which patients are most likely to have persistent lung dysfunction.

In addition to pinpointing those most at risk, the findings showed that conventional corticosteroid treatment is highly effective in improving lung function and reducing symptoms.

Researchers from Guy’s and St. Thomas’ National Health Foundation Trust in London reported that a small percentage of patients – 4.8%, or 35 of 837 patients in the study – had severe persistent interstitial lung disease (ILD), mostly organizing pneumonia, 4 weeks after discharge. Of these patients, 30 received steroid treatment, all of whom showed improvement in lung function.

Lead author Katherine Jane Myall, MRCP, and colleagues wrote that the most common radiologic finding in acute COVID-19 is bilateral ground-glass opacification, and findings of organizing pneumonia are common. However, no reports exist of the role of inflammatory infiltrates during recovery from COVID-19 or of the effectiveness of treatments for persistent ILD. “The long-term respiratory morbidity remains unclear,” Dr. Myall and colleagues wrote.

The study findings are significant because they quantify the degree of lung disease that patients have after COVID-19, said Sachin Gupta, MD, FCCP, a pulmonologist and critical care specialist at Alameda Health System in Oakland, Calif. He added that the disease course and presentation followed the pattern of organizing pneumonia in some patients, and traditional corticosteroid therapy seemed to resolve symptoms and improve lung function.

“This is a really important piece to get out there because it describes what a lot of us are worried about in patients with post-COVID lung disease and about what type of lung disease they have. It offers a potential treatment,” he said.

Dr. Myall and colleagues noted that even a “relatively small proportion” of patients with persistent, severe ILD – as reported in this study – pose “a significant disease burden.” They added: “Prompt therapy may avoid potentially permanent fibrosis and functional impairment.”

The single-center, prospective, observational study followed discharged patients with telephone calls 4 weeks after discharge to determine their status. At that point, 39% of the study cohort (n = 325) reported ongoing symptoms.

The patients had outpatient examinations at 6 weeks post discharge, at which time 42.9% (n = 138) had no signs or symptoms of persistent disease; 33.8% (n = 110) had symptoms but no radiologic findings and received referrals to other departments; and 24% (n = 77) were referred to the post-COVID lung disease multidisciplinary team. A total of 59 were diagnosed with persistent post-COVID interstitial change, 35 of whom had organizing pneumonia, hence the rationale for using steroids in this group, Dr. Myall and colleagues stated.

The 30 patients treated with corticosteroids received a maximum initial dose of 0.5 mg/kg prednisolone, which was rapidly weaned over 3 weeks. Some patients received lower doses depending on their comorbidities.

Treatment resulted in an average relative increase in transfer factor of 31.6% (P < .001) and forced vital capacity of 9.6% (P = .014), along with significant improvement in symptoms and x-ray signs.

The study identified some key characteristics of the patients who had persistent post–COVID-19 inflammatory ILD. They were mostly male (71.5%) and overweight with an average body mass index of 28.3, but only 26% were obese. Most had at least one comorbidity, with the most common being diabetes and asthma (22.9%). Their average hospital stay was 16.9 days, 82.9% required oxygen, 55% were in the ICU, and 46% needed invasive mechanical ventilation.

The patients most vulnerable to ILD and organizing pneumonia were the “sicker” of the whole cohort, Dr. Gupta said. “In one sense, it’s reassuring that this is not just happening in anyone; this is happening in patients who had the worst course and were hospitalized in the ICU for the most part.”

The study shows that identifying these patients early on and initiating steroid therapy could avoid persistent lung injury and scarring, Dr. Gupta said.

The London researchers noted that theirs wasn’t a radiologic study, so CT scans weren’t formally scored before and after treatment. They also acknowledged vagueness about imaging and clinical findings representing “nothing other than slow ongoing recovery.”

Patients with post–COVID-19 ILD will require ongoing follow-up to better understand the disease course, Dr. Myall and colleagues stated, although they predicted organizing pneumonia is unlikely to recur once it resolves.

Dr. Myall and coauthors had no relevant relationships to disclose. Dr. Gupta disclosed he is also an employee and shareholder at Genentech.

When patients relay their fantasies during psychotherapy sessions, those visions are often rooted in frustration or wish fulfillment, according to Jessica Ferranti, MD.

“[Sigmund] Freud talked about how our fantasy life is invested with large amounts of energy and interest and conveys a true essence of our personality – a truth about what we’re thinking and who we are,” Dr. Ferranti, a forensic psychiatrist in the division of psychiatry and the law at the University of California, Davis, said during an annual psychopharmacology update held by the Nevada Psychiatric Association.

“Fantasy life is one of the most important conveyances of information that we can get from our patients, whether in the general office or in the forensic realm – if we can access it, which is difficult, because fantasies are often intensely personal. They fall into the category of very high resistance topics with many patients.”

Psychiatrists routinely ask about violent thoughts and homicidal ideation, but violent fantasies – especially those that are sexually violent in nature – can be a warning sign of future danger. Dr. Ferranti defined violent fantasies as those depicting the use of physical force with the intent to injure another person or destroy property.

“This would be an individual who fantasizes about sadistically raping a woman, for instance,” said Dr. Ferranti, who directs the UC Davis Workplace Safety and Psychiatric Assessment Clinic. “That is an ominous and psychopathological sign in terms of the preoccupation with that kind of violent crime.”

Aggression, on the other hand, “is a very broad spectrum, with actions like assertion, interpersonal confrontation, or verbal expressions that are angry or hostile, but that do not necessarily lead to violence.”

Dr. Ferranti acknowledged that today’s rushed clinical environment makes it challenging for psychiatrists and psychologists to get patients to share detailed fantasies they may be harboring.

“It’s very difficult to get to deeper material with patients, unless potentially you have more intensive therapy going on, like a psychotherapeutic relationship where you see the patient frequently, an intensive treatment, [or] perhaps an inpatient hospitalization or a partial day program.” The key is that “the patient gets comfortable with relaying more of the truth about what they’re experiencing,” she said. “In some cases, this occurs during the forensic evaluation, because we have the luxury to do very lengthy evaluations. Under the stress of being with another person in the room for many hours, oftentimes the patient will disclose things eventually.

“I’ve been a forensic psychiatrist for the better part of 12 years, and I can tell you after hundreds of evaluations I’ve never had a person not speak. That’s a good thing, because a principle of the work we do, or talk therapy even, is that the things that we can put into words, we are less likely to act out. When we lose symbolism, the ability to represent things in our mind and speak about them, we are at greater risk of collapsing into the real and acting on the things we think about.”

Statutory reporting duties vary from state to state. In California, mandatory reporting duties include child abuse, elder abuse, abuse or neglect of developmentally disabled individuals, domestic violence, and victims of a gunshot wound. “Failing to report any of these crimes is a misdemeanor in California,” she said. “With all these statutory reporting duties, we have no legal obligation to inform the patient of the report. Under California law, patients do not have the right to refuse the report. These are reports we make in our best judgment, whether the patient is happy about that or not.”

What happens if your patient confesses to a past crime? “There’s no legal duty to report this,” Dr. Ferranti said. “The general rule is, unless there’s a current person who’s at risk, it would be violating confidentiality to report. This includes murder, bank robbery, and sexual assault. In addition, you cannot admit a patient to an inpatient setting to help them avoid arrest, even if you think the act in question was due to symptoms of a mental disorder, disease, or defect. You can actually be charged with aiding and abetting a criminal.”

In the 1976 landmark case Tarasoff v. the Regents of the University of California, the California Supreme Court ruled that psychiatrists and other therapists have a duty to do what is reasonably necessary to protect third parties if a patient presents a serious risk of violence to another person.

“Reasonable steps may include warning the third party, notifying police, detaining and hospitalizing the patient, intensifying the treatment to a higher level of care or more frequent outpatient appointments, removing weapons, and changing the medication therapy,” Dr. Ferranti said. “The more you can do of these, the better.”

She also discussed the concept of foreseeability, which she defined as the reasonable anticipation that harm or injury is likely to result from an act or omission to act.

“This is the malpractice standard for negligence,” she said. “In other words, was it foreseeable by a reasonable psychiatrist that this person was going to hurt someone else or themselves?” Another landmark case, Jablonski Pahls v. the United States broadened the reporting obligations of psychiatrists. In this 1983 case, the U.S. Court of Appeals 9th Circuit ruled that mental health professionals have to do more than warn foreseeable victims of an imminent danger of potential harm; they must involuntarily hospitalize the dangerous individual and consult that person’s prior records.

There is no sure-fire way to predict when an individual’s underlying violent fantasies are likely to be acted on, but Dr. Ferranti mentioned several behaviors that should raise alarm. One is a heightened physiological arousal when the person discusses the fantasy, such as rapid heartbeat, sweating; or physical posturing, such as clenching their fists or pounding their hands on an object as they tell you about it. You also want to determine the persistence of the fantasy.

“Can the patient think about it?” she asked. “Can they retain the ability to symbolize and separate themselves from necessarily doing whatever it is they think about?” You also want to determine the individual’s propensity for externalizing behaviors. “Here we’re talking about cluster B personality group patients – antisocial, narcissistic, and borderline patients who by virtue of their aggressivity titer and difficulties with anger, have a higher propensity for acting out and acting violently.”

Then there’s the concept of foreseeability. “Ask yourself, how likely is it that this could actually happen, based on the known risk factors and what you know about the patient?” Dr. Ferranti said. “Past history of violence is also very important. What people have done once before, they’re likely to do again.”

A good violence risk assessment can help you mitigate the potential for one of your patients to carry out harm to self or to others. Key risk factors include psychopathy, past violence, substance abuse, specific person/entity threatened, a history of impulsivity, unemployment, military history, gun possession, and the presence of paranoid and/or persecutory ideation or delusions.

“Know your specific state statutes and case law,” Dr. Ferranti concluded. “Delaying Tarasoff notification may indicate no need to violate confidentiality. If you think it’s warranted, do it without delay. Documentation is important when you’re consulting with therapists back and forth. You also want to attempt to obtain prior records and release only information that is required in a case of violence toward others. The details of the therapy or diagnosis are likely not relevant.”

Dr. Ferranti reported having no disclosures.

[email protected]

When patients relay their fantasies during psychotherapy sessions, those visions are often rooted in frustration or wish fulfillment, according to Jessica Ferranti, MD.

“[Sigmund] Freud talked about how our fantasy life is invested with large amounts of energy and interest and conveys a true essence of our personality – a truth about what we’re thinking and who we are,” Dr. Ferranti, a forensic psychiatrist in the division of psychiatry and the law at the University of California, Davis, said during an annual psychopharmacology update held by the Nevada Psychiatric Association.

“Fantasy life is one of the most important conveyances of information that we can get from our patients, whether in the general office or in the forensic realm – if we can access it, which is difficult, because fantasies are often intensely personal. They fall into the category of very high resistance topics with many patients.”

Psychiatrists routinely ask about violent thoughts and homicidal ideation, but violent fantasies – especially those that are sexually violent in nature – can be a warning sign of future danger. Dr. Ferranti defined violent fantasies as those depicting the use of physical force with the intent to injure another person or destroy property.

“This would be an individual who fantasizes about sadistically raping a woman, for instance,” said Dr. Ferranti, who directs the UC Davis Workplace Safety and Psychiatric Assessment Clinic. “That is an ominous and psychopathological sign in terms of the preoccupation with that kind of violent crime.”

Aggression, on the other hand, “is a very broad spectrum, with actions like assertion, interpersonal confrontation, or verbal expressions that are angry or hostile, but that do not necessarily lead to violence.”

Dr. Ferranti acknowledged that today’s rushed clinical environment makes it challenging for psychiatrists and psychologists to get patients to share detailed fantasies they may be harboring.

“It’s very difficult to get to deeper material with patients, unless potentially you have more intensive therapy going on, like a psychotherapeutic relationship where you see the patient frequently, an intensive treatment, [or] perhaps an inpatient hospitalization or a partial day program.” The key is that “the patient gets comfortable with relaying more of the truth about what they’re experiencing,” she said. “In some cases, this occurs during the forensic evaluation, because we have the luxury to do very lengthy evaluations. Under the stress of being with another person in the room for many hours, oftentimes the patient will disclose things eventually.

“I’ve been a forensic psychiatrist for the better part of 12 years, and I can tell you after hundreds of evaluations I’ve never had a person not speak. That’s a good thing, because a principle of the work we do, or talk therapy even, is that the things that we can put into words, we are less likely to act out. When we lose symbolism, the ability to represent things in our mind and speak about them, we are at greater risk of collapsing into the real and acting on the things we think about.”

Statutory reporting duties vary from state to state. In California, mandatory reporting duties include child abuse, elder abuse, abuse or neglect of developmentally disabled individuals, domestic violence, and victims of a gunshot wound. “Failing to report any of these crimes is a misdemeanor in California,” she said. “With all these statutory reporting duties, we have no legal obligation to inform the patient of the report. Under California law, patients do not have the right to refuse the report. These are reports we make in our best judgment, whether the patient is happy about that or not.”

What happens if your patient confesses to a past crime? “There’s no legal duty to report this,” Dr. Ferranti said. “The general rule is, unless there’s a current person who’s at risk, it would be violating confidentiality to report. This includes murder, bank robbery, and sexual assault. In addition, you cannot admit a patient to an inpatient setting to help them avoid arrest, even if you think the act in question was due to symptoms of a mental disorder, disease, or defect. You can actually be charged with aiding and abetting a criminal.”

In the 1976 landmark case Tarasoff v. the Regents of the University of California, the California Supreme Court ruled that psychiatrists and other therapists have a duty to do what is reasonably necessary to protect third parties if a patient presents a serious risk of violence to another person.

“Reasonable steps may include warning the third party, notifying police, detaining and hospitalizing the patient, intensifying the treatment to a higher level of care or more frequent outpatient appointments, removing weapons, and changing the medication therapy,” Dr. Ferranti said. “The more you can do of these, the better.”

She also discussed the concept of foreseeability, which she defined as the reasonable anticipation that harm or injury is likely to result from an act or omission to act.

“This is the malpractice standard for negligence,” she said. “In other words, was it foreseeable by a reasonable psychiatrist that this person was going to hurt someone else or themselves?” Another landmark case, Jablonski Pahls v. the United States broadened the reporting obligations of psychiatrists. In this 1983 case, the U.S. Court of Appeals 9th Circuit ruled that mental health professionals have to do more than warn foreseeable victims of an imminent danger of potential harm; they must involuntarily hospitalize the dangerous individual and consult that person’s prior records.

There is no sure-fire way to predict when an individual’s underlying violent fantasies are likely to be acted on, but Dr. Ferranti mentioned several behaviors that should raise alarm. One is a heightened physiological arousal when the person discusses the fantasy, such as rapid heartbeat, sweating; or physical posturing, such as clenching their fists or pounding their hands on an object as they tell you about it. You also want to determine the persistence of the fantasy.

“Can the patient think about it?” she asked. “Can they retain the ability to symbolize and separate themselves from necessarily doing whatever it is they think about?” You also want to determine the individual’s propensity for externalizing behaviors. “Here we’re talking about cluster B personality group patients – antisocial, narcissistic, and borderline patients who by virtue of their aggressivity titer and difficulties with anger, have a higher propensity for acting out and acting violently.”

Then there’s the concept of foreseeability. “Ask yourself, how likely is it that this could actually happen, based on the known risk factors and what you know about the patient?” Dr. Ferranti said. “Past history of violence is also very important. What people have done once before, they’re likely to do again.”

A good violence risk assessment can help you mitigate the potential for one of your patients to carry out harm to self or to others. Key risk factors include psychopathy, past violence, substance abuse, specific person/entity threatened, a history of impulsivity, unemployment, military history, gun possession, and the presence of paranoid and/or persecutory ideation or delusions.

“Know your specific state statutes and case law,” Dr. Ferranti concluded. “Delaying Tarasoff notification may indicate no need to violate confidentiality. If you think it’s warranted, do it without delay. Documentation is important when you’re consulting with therapists back and forth. You also want to attempt to obtain prior records and release only information that is required in a case of violence toward others. The details of the therapy or diagnosis are likely not relevant.”

Dr. Ferranti reported having no disclosures.

[email protected]

When patients relay their fantasies during psychotherapy sessions, those visions are often rooted in frustration or wish fulfillment, according to Jessica Ferranti, MD.

“[Sigmund] Freud talked about how our fantasy life is invested with large amounts of energy and interest and conveys a true essence of our personality – a truth about what we’re thinking and who we are,” Dr. Ferranti, a forensic psychiatrist in the division of psychiatry and the law at the University of California, Davis, said during an annual psychopharmacology update held by the Nevada Psychiatric Association.

“Fantasy life is one of the most important conveyances of information that we can get from our patients, whether in the general office or in the forensic realm – if we can access it, which is difficult, because fantasies are often intensely personal. They fall into the category of very high resistance topics with many patients.”

Psychiatrists routinely ask about violent thoughts and homicidal ideation, but violent fantasies – especially those that are sexually violent in nature – can be a warning sign of future danger. Dr. Ferranti defined violent fantasies as those depicting the use of physical force with the intent to injure another person or destroy property.

“This would be an individual who fantasizes about sadistically raping a woman, for instance,” said Dr. Ferranti, who directs the UC Davis Workplace Safety and Psychiatric Assessment Clinic. “That is an ominous and psychopathological sign in terms of the preoccupation with that kind of violent crime.”

Aggression, on the other hand, “is a very broad spectrum, with actions like assertion, interpersonal confrontation, or verbal expressions that are angry or hostile, but that do not necessarily lead to violence.”

Dr. Ferranti acknowledged that today’s rushed clinical environment makes it challenging for psychiatrists and psychologists to get patients to share detailed fantasies they may be harboring.

“It’s very difficult to get to deeper material with patients, unless potentially you have more intensive therapy going on, like a psychotherapeutic relationship where you see the patient frequently, an intensive treatment, [or] perhaps an inpatient hospitalization or a partial day program.” The key is that “the patient gets comfortable with relaying more of the truth about what they’re experiencing,” she said. “In some cases, this occurs during the forensic evaluation, because we have the luxury to do very lengthy evaluations. Under the stress of being with another person in the room for many hours, oftentimes the patient will disclose things eventually.

“I’ve been a forensic psychiatrist for the better part of 12 years, and I can tell you after hundreds of evaluations I’ve never had a person not speak. That’s a good thing, because a principle of the work we do, or talk therapy even, is that the things that we can put into words, we are less likely to act out. When we lose symbolism, the ability to represent things in our mind and speak about them, we are at greater risk of collapsing into the real and acting on the things we think about.”

Statutory reporting duties vary from state to state. In California, mandatory reporting duties include child abuse, elder abuse, abuse or neglect of developmentally disabled individuals, domestic violence, and victims of a gunshot wound. “Failing to report any of these crimes is a misdemeanor in California,” she said. “With all these statutory reporting duties, we have no legal obligation to inform the patient of the report. Under California law, patients do not have the right to refuse the report. These are reports we make in our best judgment, whether the patient is happy about that or not.”

What happens if your patient confesses to a past crime? “There’s no legal duty to report this,” Dr. Ferranti said. “The general rule is, unless there’s a current person who’s at risk, it would be violating confidentiality to report. This includes murder, bank robbery, and sexual assault. In addition, you cannot admit a patient to an inpatient setting to help them avoid arrest, even if you think the act in question was due to symptoms of a mental disorder, disease, or defect. You can actually be charged with aiding and abetting a criminal.”

In the 1976 landmark case Tarasoff v. the Regents of the University of California, the California Supreme Court ruled that psychiatrists and other therapists have a duty to do what is reasonably necessary to protect third parties if a patient presents a serious risk of violence to another person.

“Reasonable steps may include warning the third party, notifying police, detaining and hospitalizing the patient, intensifying the treatment to a higher level of care or more frequent outpatient appointments, removing weapons, and changing the medication therapy,” Dr. Ferranti said. “The more you can do of these, the better.”

She also discussed the concept of foreseeability, which she defined as the reasonable anticipation that harm or injury is likely to result from an act or omission to act.

“This is the malpractice standard for negligence,” she said. “In other words, was it foreseeable by a reasonable psychiatrist that this person was going to hurt someone else or themselves?” Another landmark case, Jablonski Pahls v. the United States broadened the reporting obligations of psychiatrists. In this 1983 case, the U.S. Court of Appeals 9th Circuit ruled that mental health professionals have to do more than warn foreseeable victims of an imminent danger of potential harm; they must involuntarily hospitalize the dangerous individual and consult that person’s prior records.

There is no sure-fire way to predict when an individual’s underlying violent fantasies are likely to be acted on, but Dr. Ferranti mentioned several behaviors that should raise alarm. One is a heightened physiological arousal when the person discusses the fantasy, such as rapid heartbeat, sweating; or physical posturing, such as clenching their fists or pounding their hands on an object as they tell you about it. You also want to determine the persistence of the fantasy.

“Can the patient think about it?” she asked. “Can they retain the ability to symbolize and separate themselves from necessarily doing whatever it is they think about?” You also want to determine the individual’s propensity for externalizing behaviors. “Here we’re talking about cluster B personality group patients – antisocial, narcissistic, and borderline patients who by virtue of their aggressivity titer and difficulties with anger, have a higher propensity for acting out and acting violently.”

Then there’s the concept of foreseeability. “Ask yourself, how likely is it that this could actually happen, based on the known risk factors and what you know about the patient?” Dr. Ferranti said. “Past history of violence is also very important. What people have done once before, they’re likely to do again.”

A good violence risk assessment can help you mitigate the potential for one of your patients to carry out harm to self or to others. Key risk factors include psychopathy, past violence, substance abuse, specific person/entity threatened, a history of impulsivity, unemployment, military history, gun possession, and the presence of paranoid and/or persecutory ideation or delusions.

“Know your specific state statutes and case law,” Dr. Ferranti concluded. “Delaying Tarasoff notification may indicate no need to violate confidentiality. If you think it’s warranted, do it without delay. Documentation is important when you’re consulting with therapists back and forth. You also want to attempt to obtain prior records and release only information that is required in a case of violence toward others. The details of the therapy or diagnosis are likely not relevant.”

Dr. Ferranti reported having no disclosures.

[email protected]

The American Society for Dermatologic Surgery Association and the department of dermatology at Northwestern University, Chicago, have launched the Cutaneous Procedures Adverse Events Reporting (CAPER) registry.

CAPER is a voluntary reporting system designed to collect reports of patients’ adverse events encountered during dermatologic surgery procedures, both cosmetic and those related to skin cancer. The goals of the CAPER registry are to provide safety monitoring, identify practice and/or education gaps associated with adverse events, and identify potential adverse event risk factors.

“CAPER is a registry overseen by a group of board-certified dermatologists, clinicians, and researchers with more than 20 years of experience in patient care and physician advocacy who are committed to improving safety outcomes,” according to an ASDSA press release. “The collaboration between Northwestern University and ASDSA will ensure that CAPER becomes the common place for dermatologic surgeons and their staff to report adverse events from devices, drugs or biologics.”

The launch of the database is important because it fills a gap in adverse event reporting, Murad Alam, MD, professor of dermatology and chief of cutaneous and aesthetic surgery in the department of dermatology at Northwestern University, said in an interview.

There has been no central registry specifically for reporting adverse events associated with dermatologic surgical procedures, including cosmetic and injectable treatments, he said. “While minimally invasive cosmetic and skin procedures have been proven to be exceedingly safe, this registry will provide an early warning system to identify any problems that do occur, so these can be addressed promptly. This registry will allow dermatologists, patients, and industry scientists to work together to further improve the safety of dermatologic procedures,” added Dr. Alam, the past ASDSA president, and current chair of the ASDSA’s Federal Affairs Work Group.

In addition, “recent reports of the possible interaction between some filler injections and certain COVID vaccines confirms the timeliness of redoubling our emphasis on safety. Dermatologists have always been at the forefront of maximizing the patient experience while minimizing risk; this registry is further evidence of that ongoing commitment,” he emphasized.

The CAPER database will gather information on a variety of dermatologic and cosmetic procedures, including those involving topicals and injectables (such as botulinum toxin, fillers, and chemical peels), devices (such as lasers and microneedling devices), cellular-based therapies (such as platelet-rich plasma and stem cell treatments), and surgical treatments (such as liposuction and hair transplantation), Dr. Alam said.

“Novel procedures, and those yet to be devised, as long as they relate to skin surgery or cosmetic improvement, will also be able to be reported. We encourage the reporting of all associated adverse events, even if it is not clear what caused the event. No dermatologic or cosmetic procedures will be excluded from reporting,” he added.

The purpose of the CAPER registry is “to help patients, physicians, and industry work collaboratively to ensure the highest levels of patient safety,” Dr. Alam continued. Data entered into the registry will be deidentified and will remain confidential, and as data on particular topics accumulate, the data “may be analyzed to better understand the patient experience and, secondly, to develop strategies to further improve safety,” he noted.

“One unique element of this registry is that it is focused on dermatologic and cosmetic procedures,” Dr. Alam added. “As a result, those managing and analyzing the data collected will be attuned to the particular concerns associated with such procedures and the patients receiving them.”

For more information and to report dermatologic surgery-related adverse events, go to caper.net.

The American Society for Dermatologic Surgery Association and the department of dermatology at Northwestern University, Chicago, have launched the Cutaneous Procedures Adverse Events Reporting (CAPER) registry.

CAPER is a voluntary reporting system designed to collect reports of patients’ adverse events encountered during dermatologic surgery procedures, both cosmetic and those related to skin cancer. The goals of the CAPER registry are to provide safety monitoring, identify practice and/or education gaps associated with adverse events, and identify potential adverse event risk factors.

“CAPER is a registry overseen by a group of board-certified dermatologists, clinicians, and researchers with more than 20 years of experience in patient care and physician advocacy who are committed to improving safety outcomes,” according to an ASDSA press release. “The collaboration between Northwestern University and ASDSA will ensure that CAPER becomes the common place for dermatologic surgeons and their staff to report adverse events from devices, drugs or biologics.”

The launch of the database is important because it fills a gap in adverse event reporting, Murad Alam, MD, professor of dermatology and chief of cutaneous and aesthetic surgery in the department of dermatology at Northwestern University, said in an interview.

There has been no central registry specifically for reporting adverse events associated with dermatologic surgical procedures, including cosmetic and injectable treatments, he said. “While minimally invasive cosmetic and skin procedures have been proven to be exceedingly safe, this registry will provide an early warning system to identify any problems that do occur, so these can be addressed promptly. This registry will allow dermatologists, patients, and industry scientists to work together to further improve the safety of dermatologic procedures,” added Dr. Alam, the past ASDSA president, and current chair of the ASDSA’s Federal Affairs Work Group.

In addition, “recent reports of the possible interaction between some filler injections and certain COVID vaccines confirms the timeliness of redoubling our emphasis on safety. Dermatologists have always been at the forefront of maximizing the patient experience while minimizing risk; this registry is further evidence of that ongoing commitment,” he emphasized.

The CAPER database will gather information on a variety of dermatologic and cosmetic procedures, including those involving topicals and injectables (such as botulinum toxin, fillers, and chemical peels), devices (such as lasers and microneedling devices), cellular-based therapies (such as platelet-rich plasma and stem cell treatments), and surgical treatments (such as liposuction and hair transplantation), Dr. Alam said.

“Novel procedures, and those yet to be devised, as long as they relate to skin surgery or cosmetic improvement, will also be able to be reported. We encourage the reporting of all associated adverse events, even if it is not clear what caused the event. No dermatologic or cosmetic procedures will be excluded from reporting,” he added.

The purpose of the CAPER registry is “to help patients, physicians, and industry work collaboratively to ensure the highest levels of patient safety,” Dr. Alam continued. Data entered into the registry will be deidentified and will remain confidential, and as data on particular topics accumulate, the data “may be analyzed to better understand the patient experience and, secondly, to develop strategies to further improve safety,” he noted.

“One unique element of this registry is that it is focused on dermatologic and cosmetic procedures,” Dr. Alam added. “As a result, those managing and analyzing the data collected will be attuned to the particular concerns associated with such procedures and the patients receiving them.”

For more information and to report dermatologic surgery-related adverse events, go to caper.net.

The American Society for Dermatologic Surgery Association and the department of dermatology at Northwestern University, Chicago, have launched the Cutaneous Procedures Adverse Events Reporting (CAPER) registry.

CAPER is a voluntary reporting system designed to collect reports of patients’ adverse events encountered during dermatologic surgery procedures, both cosmetic and those related to skin cancer. The goals of the CAPER registry are to provide safety monitoring, identify practice and/or education gaps associated with adverse events, and identify potential adverse event risk factors.

“CAPER is a registry overseen by a group of board-certified dermatologists, clinicians, and researchers with more than 20 years of experience in patient care and physician advocacy who are committed to improving safety outcomes,” according to an ASDSA press release. “The collaboration between Northwestern University and ASDSA will ensure that CAPER becomes the common place for dermatologic surgeons and their staff to report adverse events from devices, drugs or biologics.”

The launch of the database is important because it fills a gap in adverse event reporting, Murad Alam, MD, professor of dermatology and chief of cutaneous and aesthetic surgery in the department of dermatology at Northwestern University, said in an interview.

There has been no central registry specifically for reporting adverse events associated with dermatologic surgical procedures, including cosmetic and injectable treatments, he said. “While minimally invasive cosmetic and skin procedures have been proven to be exceedingly safe, this registry will provide an early warning system to identify any problems that do occur, so these can be addressed promptly. This registry will allow dermatologists, patients, and industry scientists to work together to further improve the safety of dermatologic procedures,” added Dr. Alam, the past ASDSA president, and current chair of the ASDSA’s Federal Affairs Work Group.

In addition, “recent reports of the possible interaction between some filler injections and certain COVID vaccines confirms the timeliness of redoubling our emphasis on safety. Dermatologists have always been at the forefront of maximizing the patient experience while minimizing risk; this registry is further evidence of that ongoing commitment,” he emphasized.

The CAPER database will gather information on a variety of dermatologic and cosmetic procedures, including those involving topicals and injectables (such as botulinum toxin, fillers, and chemical peels), devices (such as lasers and microneedling devices), cellular-based therapies (such as platelet-rich plasma and stem cell treatments), and surgical treatments (such as liposuction and hair transplantation), Dr. Alam said.

“Novel procedures, and those yet to be devised, as long as they relate to skin surgery or cosmetic improvement, will also be able to be reported. We encourage the reporting of all associated adverse events, even if it is not clear what caused the event. No dermatologic or cosmetic procedures will be excluded from reporting,” he added.

The purpose of the CAPER registry is “to help patients, physicians, and industry work collaboratively to ensure the highest levels of patient safety,” Dr. Alam continued. Data entered into the registry will be deidentified and will remain confidential, and as data on particular topics accumulate, the data “may be analyzed to better understand the patient experience and, secondly, to develop strategies to further improve safety,” he noted.

“One unique element of this registry is that it is focused on dermatologic and cosmetic procedures,” Dr. Alam added. “As a result, those managing and analyzing the data collected will be attuned to the particular concerns associated with such procedures and the patients receiving them.”

For more information and to report dermatologic surgery-related adverse events, go to caper.net.

Clinicians who manage patients with cirrhosis should incorporate palliative care “irrespective of transplant candidacy,” according to a clinical practice update from the American Gastroenterological Association.

“[T]his care should be based on needs assessment instead of prognosis alone, delivered concurrently with curative or life-prolonging treatments, and tailored to the stage of disease,” wrote Puneeta Tandon, MD, of University of Alberta in Edmonton, Alta., and associates. Their report is in Clinical Gastroenterology and Hepatology.

Cirrhosis has a median survival ranging from 2 years for decompensated disease to 12 years for compensated disease, according to one systemic review. Moreover, even compensated cirrhosis incurs “a high burden of physical and psychological symptoms,” which increases as cirrhosis progresses, the update authors noted.

According to another review, there is established evidence outside cirrhosis that palliative care – including comprehensive symptom management, advance care planning, and timely referrals to specialty palliative care and hospice support – has the potential to significantly improve quality of life, end-of-life care, health care costs, coordination among providers, and caregiver outcomes.

However, the update authors noted that there remain few guidelines or guidance statements regarding palliative care in cirrhosis. Hence, the clinical practice update reviews 10 best practices to help clinicians fill this gap.

Providers “from any specialty, within any healthcare setting” can help provide palliative care for patients with cirrhosis, the experts emphasized. This is, in part, because of the growing population with cirrhosis being met with a limited number of palliative care specialists; dealing with this reality can be helped by inviting other providers to learn about and engage in palliative care.

Another best practice statement addressed assessing symptoms “within physical, psychological, social, and spiritual domains related to [patients’] liver disease, its treatment, and prognosis.” This approach is needed because of the complex effects that a life-threatening illness and its symptoms can have on many variables, including loss of independence/identity, financial stress, and impact on personal relationships. A systematic review of symptom prevalence in end-stage liver disease revealed a complex milieu, including pain, muscle cramps, sexual dysfunction, insomnia, and anxiety.

High-quality communication is important in palliative care, including discussion of prognosis and goals of care. Providers specializing in gastroenterology/hepatology should reevaluate prognosis and clarify prognosis and goals of care with patients and caregivers during routine visits and sentinel events, such as new complications, a hospital or intensive care admission, and when transplant eligibility is determined. However, prognostication in cirrhosis can be challenging, the experts noted. The update authors also acknowledged that, while more research is needed to inform practice regarding communicating with patients with serious illness about palliative care and goals of care, there are courses and resources meant to help improve those skills, including those provided by Vital Talk, Respecting Choices, and the Serious Illness Conversation Guide.

Cirrhosis “has physical, mental, and financial consequences” for caregivers, especially when patients have decompensated disease. To support caregivers, clinicians can routinely evaluate their burdens and needs. Tools such as the Caregiver Strain Index are useful and can be administered by ancillary staff. Clinicians also can reach out to primary care and palliative care providers to identify local resources for caregiver support.

“Because lack of time is one of the major barriers to administering palliative care, healthcare providers should consider how they can optimize efficiencies in palliative care delivery,” the experts wrote. Examples include identifying local billing codes, arranging for ancillary staff to screen patients on their palliative care needs, and setting up multidisciplinary teams that work together to deliver palliative care. If access to specialty palliative care is limited, providers can collaborate with local specialist teams to set “clear triggers and pathways for referral.”

Finally, hospice referrals are often delayed for patients with cirrhosis. “Find out your local referral criteria for hospice and what would be required to refer a cirrhosis patient there,” the experts advised. “Healthcare providers caring for patients with cirrhosis should provide timely referral to hospice for patients who have comfort-oriented goals and prognosis of 6 months or less.”

The authors of the clinical practice update received no funding support. They reported having no relevant conflicts of interest.

Clinicians who manage patients with cirrhosis should incorporate palliative care “irrespective of transplant candidacy,” according to a clinical practice update from the American Gastroenterological Association.

“[T]his care should be based on needs assessment instead of prognosis alone, delivered concurrently with curative or life-prolonging treatments, and tailored to the stage of disease,” wrote Puneeta Tandon, MD, of University of Alberta in Edmonton, Alta., and associates. Their report is in Clinical Gastroenterology and Hepatology.

Cirrhosis has a median survival ranging from 2 years for decompensated disease to 12 years for compensated disease, according to one systemic review. Moreover, even compensated cirrhosis incurs “a high burden of physical and psychological symptoms,” which increases as cirrhosis progresses, the update authors noted.

According to another review, there is established evidence outside cirrhosis that palliative care – including comprehensive symptom management, advance care planning, and timely referrals to specialty palliative care and hospice support – has the potential to significantly improve quality of life, end-of-life care, health care costs, coordination among providers, and caregiver outcomes.

However, the update authors noted that there remain few guidelines or guidance statements regarding palliative care in cirrhosis. Hence, the clinical practice update reviews 10 best practices to help clinicians fill this gap.

Providers “from any specialty, within any healthcare setting” can help provide palliative care for patients with cirrhosis, the experts emphasized. This is, in part, because of the growing population with cirrhosis being met with a limited number of palliative care specialists; dealing with this reality can be helped by inviting other providers to learn about and engage in palliative care.

Another best practice statement addressed assessing symptoms “within physical, psychological, social, and spiritual domains related to [patients’] liver disease, its treatment, and prognosis.” This approach is needed because of the complex effects that a life-threatening illness and its symptoms can have on many variables, including loss of independence/identity, financial stress, and impact on personal relationships. A systematic review of symptom prevalence in end-stage liver disease revealed a complex milieu, including pain, muscle cramps, sexual dysfunction, insomnia, and anxiety.

High-quality communication is important in palliative care, including discussion of prognosis and goals of care. Providers specializing in gastroenterology/hepatology should reevaluate prognosis and clarify prognosis and goals of care with patients and caregivers during routine visits and sentinel events, such as new complications, a hospital or intensive care admission, and when transplant eligibility is determined. However, prognostication in cirrhosis can be challenging, the experts noted. The update authors also acknowledged that, while more research is needed to inform practice regarding communicating with patients with serious illness about palliative care and goals of care, there are courses and resources meant to help improve those skills, including those provided by Vital Talk, Respecting Choices, and the Serious Illness Conversation Guide.

Cirrhosis “has physical, mental, and financial consequences” for caregivers, especially when patients have decompensated disease. To support caregivers, clinicians can routinely evaluate their burdens and needs. Tools such as the Caregiver Strain Index are useful and can be administered by ancillary staff. Clinicians also can reach out to primary care and palliative care providers to identify local resources for caregiver support.

“Because lack of time is one of the major barriers to administering palliative care, healthcare providers should consider how they can optimize efficiencies in palliative care delivery,” the experts wrote. Examples include identifying local billing codes, arranging for ancillary staff to screen patients on their palliative care needs, and setting up multidisciplinary teams that work together to deliver palliative care. If access to specialty palliative care is limited, providers can collaborate with local specialist teams to set “clear triggers and pathways for referral.”

Finally, hospice referrals are often delayed for patients with cirrhosis. “Find out your local referral criteria for hospice and what would be required to refer a cirrhosis patient there,” the experts advised. “Healthcare providers caring for patients with cirrhosis should provide timely referral to hospice for patients who have comfort-oriented goals and prognosis of 6 months or less.”

The authors of the clinical practice update received no funding support. They reported having no relevant conflicts of interest.

Clinicians who manage patients with cirrhosis should incorporate palliative care “irrespective of transplant candidacy,” according to a clinical practice update from the American Gastroenterological Association.

“[T]his care should be based on needs assessment instead of prognosis alone, delivered concurrently with curative or life-prolonging treatments, and tailored to the stage of disease,” wrote Puneeta Tandon, MD, of University of Alberta in Edmonton, Alta., and associates. Their report is in Clinical Gastroenterology and Hepatology.

Cirrhosis has a median survival ranging from 2 years for decompensated disease to 12 years for compensated disease, according to one systemic review. Moreover, even compensated cirrhosis incurs “a high burden of physical and psychological symptoms,” which increases as cirrhosis progresses, the update authors noted.

According to another review, there is established evidence outside cirrhosis that palliative care – including comprehensive symptom management, advance care planning, and timely referrals to specialty palliative care and hospice support – has the potential to significantly improve quality of life, end-of-life care, health care costs, coordination among providers, and caregiver outcomes.

However, the update authors noted that there remain few guidelines or guidance statements regarding palliative care in cirrhosis. Hence, the clinical practice update reviews 10 best practices to help clinicians fill this gap.

Providers “from any specialty, within any healthcare setting” can help provide palliative care for patients with cirrhosis, the experts emphasized. This is, in part, because of the growing population with cirrhosis being met with a limited number of palliative care specialists; dealing with this reality can be helped by inviting other providers to learn about and engage in palliative care.

Another best practice statement addressed assessing symptoms “within physical, psychological, social, and spiritual domains related to [patients’] liver disease, its treatment, and prognosis.” This approach is needed because of the complex effects that a life-threatening illness and its symptoms can have on many variables, including loss of independence/identity, financial stress, and impact on personal relationships. A systematic review of symptom prevalence in end-stage liver disease revealed a complex milieu, including pain, muscle cramps, sexual dysfunction, insomnia, and anxiety.

High-quality communication is important in palliative care, including discussion of prognosis and goals of care. Providers specializing in gastroenterology/hepatology should reevaluate prognosis and clarify prognosis and goals of care with patients and caregivers during routine visits and sentinel events, such as new complications, a hospital or intensive care admission, and when transplant eligibility is determined. However, prognostication in cirrhosis can be challenging, the experts noted. The update authors also acknowledged that, while more research is needed to inform practice regarding communicating with patients with serious illness about palliative care and goals of care, there are courses and resources meant to help improve those skills, including those provided by Vital Talk, Respecting Choices, and the Serious Illness Conversation Guide.

Cirrhosis “has physical, mental, and financial consequences” for caregivers, especially when patients have decompensated disease. To support caregivers, clinicians can routinely evaluate their burdens and needs. Tools such as the Caregiver Strain Index are useful and can be administered by ancillary staff. Clinicians also can reach out to primary care and palliative care providers to identify local resources for caregiver support.

“Because lack of time is one of the major barriers to administering palliative care, healthcare providers should consider how they can optimize efficiencies in palliative care delivery,” the experts wrote. Examples include identifying local billing codes, arranging for ancillary staff to screen patients on their palliative care needs, and setting up multidisciplinary teams that work together to deliver palliative care. If access to specialty palliative care is limited, providers can collaborate with local specialist teams to set “clear triggers and pathways for referral.”

Finally, hospice referrals are often delayed for patients with cirrhosis. “Find out your local referral criteria for hospice and what would be required to refer a cirrhosis patient there,” the experts advised. “Healthcare providers caring for patients with cirrhosis should provide timely referral to hospice for patients who have comfort-oriented goals and prognosis of 6 months or less.”

The authors of the clinical practice update received no funding support. They reported having no relevant conflicts of interest.

New guidelines from the American Society of Hematology “strongly recommend” using no thromboprophylaxis over using parenteral thromboprophylaxis in ambulatory patients receiving cancer chemotherapy who have low venous thromboembolism (VTE) risk, and using no thromboprophylaxis over oral thromboprophylaxis with vitamin K antagonists in those at any VTE risk level.

The evidence-based guidelines for the prevention and treatment of VTE in patient with cancer, published online in Blood Advances, also include a “conditional recommendation” for using either thromboprophylaxis with the direct oral anticoagulants (DOACs) apixaban or rivaroxaban or using no thromboprophylaxis in ambulatory patients with intermediate risk and using the DOACs over no thromboprophylaxis in those with high VTE risk.

The purpose of the guidelines, which also address VTE prophylaxis in hospitalized patients with cancer and the use of anticoagulation for VTE treatment in patients with cancer, is to provide clinical decision support for shared decision-making by patients and clinicians, Gary H. Lyman, MD, of Fred Hutchinson Cancer Research Center, Seattle and Marc Carrier, MD, of the University of Ottawa, and their colleagues from the multidisciplinary guidelines panel explained.

“The recommendations take into consideration the strength of the evidence, risks of mortality, VTE, and bleeding, as well as quality of life, acceptability, and cost considerations,” they wrote, noting that VTE is a common complication in patients with cancer, who are at markedly increased risk for morbidity and mortality from VTE.
 

Levels of evidence

The panel members relied on updated and original systematic evidence reviews. Conditional recommendations, as opposed to strong recommendations, are defined by the panel as “suggestions,” and all 33 recommendations that make up the guidelines include a statement on the strength of the relevant evidence.

For example, the thromboprophylaxis recommendations for low, intermediate, and high VTE risk are made based on “moderate certainty in the evidence of effects,” and the recommendation for no thromboprophylaxis over oral thromboprophylaxis with vitamin K antagonists is a strong recommendation based on “very low certainty in the evidence of benefits, but high certainty about the harms.”

The guidelines panel also strongly recommends, based on moderate certainty in the evidence of effects, using low-molecular-weight heparin over unfractionated heparin for the initial treatment of VTE in patients with cancer, and suggests, based on “very low certainty in the evidence of effects,” using LMWH over fondaparinux in this setting.

In addition to primary prophylaxis in ambulatory and hospitalized patients and initial VTE treatment, they also address primary prophylaxis for patients with cancer who have a central venous catheter, VTE treatment in surgical patients with cancer, short-term VTE treatment, and long-term VTE treatment.

For example, the guidelines panel conditionally recommends:

• Not using parenteral or oral thromboprophylaxis in patients with cancer and a central venous catheter
• Using LMWH or fondaparinux for surgical patients with cancer
• Using DOACS for the short-term treatment of VTE, and LMWH or DOACs for the long-term treatment of VTE in patients with cancer.

The perils of VTE

VTE in patients with cancer can interfere with treatment, increase mortality risk, and increase costs, the authors noted, adding that VTE can also adversely affect cancer patients’ quality of life.

“Some have even reported the experience of VTE to be more upsetting than that of the cancer,” they wrote. “More than 50% of thrombotic events occur within 3 months of the cancer diagnosis, a time when most cancer treatments will be underway. Patients, who are still coming to terms with a recent cancer diagnosis, often view the occurrence of VTE as a further threat to life, confirmation of the severity of their condition, and a poor prognostic sign.”

Therefore, the new guidelines aim to reduce VTE frequency, risk of bleeding complications, morbidity, and costs, thereby improving quality of life and the patient experience, the authors said, noting that three other recent guidelines on VTEs in patients with cancer have been published: the 2019 American Society of Clinical Oncology guidelines, the 2019 International Initiative on Thrombosis and Cancer guidelines, and the 2020 National Comprehensive Cancer Network guidelines.

The ASH guidelines are similar in many ways to the other guidelines, but differ in some ways, as well. An example is the timing of initiation of pharmacological thromboprophylaxis in patients undergoing cancer-related major abdominal surgery. The ASCO and ITAC guidelines advise starting thromboprophylaxis preoperatively, whereas the ASH guidelines recommend initiating thromboprophylaxis postoperatively, citing “the limited advantages to initiating thromboprophylaxis preoperatively, in addition to the potential bleeding and logistical considerations associated with neuraxial anesthesia.”

These differences highlight a lack of data in that setting and the need for additional studies, the authors said.
 

ASH vs. ASCO

James Douketis, MD, a practicing clinician and professor of medicine at McMaster University, Hamilton, Ont., highlighted another difference between the ASH and ASCO guidelines.

“For the treatment of [cancer-associated thrombosis], ASCO gives a strong recommendation to use LMWH or DOACs (with some caveats), which is easy to follow. ASH, on the other hand, suggests LMWH or a DOAC for the first 7-10 days, DOACs for the first 3-6 months, and back to LMWH or DOACs after 6 months,” he said in an interview.

The recommendation is “very evidence based but ambiguous and not helpful for the practicing clinician,” added Dr. Douketis, who helped develop the ITAC guidelines, but was not part of the ASH or ASCO guideline panels.

ASCO also provides a clear recommendation for giving VTE prophylaxis for 4 weeks after cancer surgery in patients with high VTE risk, whereas ASH gives “a somewhat vague recommendation” for thromboprophylaxis after hospital discharge.

The guidelines are “pretty well aligned” with respect to recommendations on VTE prophylaxis in medical cancer patients receiving chemotherapy, and although the “extremely academic” ASH guidelines were developed by “a superb team using the same evidence and excellent methodology,” they are interpreted in slightly different ways and fall short when it comes to being clinician friendly, Dr. Douketis said.

“At the end of day, for practicing clinicians, the ASH guidelines don’t provide a message that’s easy to digest,” he added.

ASH has, however, provided a resource page that includes tools and information for implementing the guidelines in clinical practice, and will maintain the guidelines “through surveillance for new evidence, ongoing review by experts, and regular revisions,” the authors said.

[email protected]

New guidelines from the American Society of Hematology “strongly recommend” using no thromboprophylaxis over using parenteral thromboprophylaxis in ambulatory patients receiving cancer chemotherapy who have low venous thromboembolism (VTE) risk, and using no thromboprophylaxis over oral thromboprophylaxis with vitamin K antagonists in those at any VTE risk level.

The evidence-based guidelines for the prevention and treatment of VTE in patient with cancer, published online in Blood Advances, also include a “conditional recommendation” for using either thromboprophylaxis with the direct oral anticoagulants (DOACs) apixaban or rivaroxaban or using no thromboprophylaxis in ambulatory patients with intermediate risk and using the DOACs over no thromboprophylaxis in those with high VTE risk.

The purpose of the guidelines, which also address VTE prophylaxis in hospitalized patients with cancer and the use of anticoagulation for VTE treatment in patients with cancer, is to provide clinical decision support for shared decision-making by patients and clinicians, Gary H. Lyman, MD, of Fred Hutchinson Cancer Research Center, Seattle and Marc Carrier, MD, of the University of Ottawa, and their colleagues from the multidisciplinary guidelines panel explained.

“The recommendations take into consideration the strength of the evidence, risks of mortality, VTE, and bleeding, as well as quality of life, acceptability, and cost considerations,” they wrote, noting that VTE is a common complication in patients with cancer, who are at markedly increased risk for morbidity and mortality from VTE.
 

Levels of evidence

The panel members relied on updated and original systematic evidence reviews. Conditional recommendations, as opposed to strong recommendations, are defined by the panel as “suggestions,” and all 33 recommendations that make up the guidelines include a statement on the strength of the relevant evidence.

For example, the thromboprophylaxis recommendations for low, intermediate, and high VTE risk are made based on “moderate certainty in the evidence of effects,” and the recommendation for no thromboprophylaxis over oral thromboprophylaxis with vitamin K antagonists is a strong recommendation based on “very low certainty in the evidence of benefits, but high certainty about the harms.”

The guidelines panel also strongly recommends, based on moderate certainty in the evidence of effects, using low-molecular-weight heparin over unfractionated heparin for the initial treatment of VTE in patients with cancer, and suggests, based on “very low certainty in the evidence of effects,” using LMWH over fondaparinux in this setting.

In addition to primary prophylaxis in ambulatory and hospitalized patients and initial VTE treatment, they also address primary prophylaxis for patients with cancer who have a central venous catheter, VTE treatment in surgical patients with cancer, short-term VTE treatment, and long-term VTE treatment.

For example, the guidelines panel conditionally recommends:

• Not using parenteral or oral thromboprophylaxis in patients with cancer and a central venous catheter
• Using LMWH or fondaparinux for surgical patients with cancer
• Using DOACS for the short-term treatment of VTE, and LMWH or DOACs for the long-term treatment of VTE in patients with cancer.

The perils of VTE

VTE in patients with cancer can interfere with treatment, increase mortality risk, and increase costs, the authors noted, adding that VTE can also adversely affect cancer patients’ quality of life.

“Some have even reported the experience of VTE to be more upsetting than that of the cancer,” they wrote. “More than 50% of thrombotic events occur within 3 months of the cancer diagnosis, a time when most cancer treatments will be underway. Patients, who are still coming to terms with a recent cancer diagnosis, often view the occurrence of VTE as a further threat to life, confirmation of the severity of their condition, and a poor prognostic sign.”

Therefore, the new guidelines aim to reduce VTE frequency, risk of bleeding complications, morbidity, and costs, thereby improving quality of life and the patient experience, the authors said, noting that three other recent guidelines on VTEs in patients with cancer have been published: the 2019 American Society of Clinical Oncology guidelines, the 2019 International Initiative on Thrombosis and Cancer guidelines, and the 2020 National Comprehensive Cancer Network guidelines.

The ASH guidelines are similar in many ways to the other guidelines, but differ in some ways, as well. An example is the timing of initiation of pharmacological thromboprophylaxis in patients undergoing cancer-related major abdominal surgery. The ASCO and ITAC guidelines advise starting thromboprophylaxis preoperatively, whereas the ASH guidelines recommend initiating thromboprophylaxis postoperatively, citing “the limited advantages to initiating thromboprophylaxis preoperatively, in addition to the potential bleeding and logistical considerations associated with neuraxial anesthesia.”

These differences highlight a lack of data in that setting and the need for additional studies, the authors said.
 

ASH vs. ASCO

James Douketis, MD, a practicing clinician and professor of medicine at McMaster University, Hamilton, Ont., highlighted another difference between the ASH and ASCO guidelines.

“For the treatment of [cancer-associated thrombosis], ASCO gives a strong recommendation to use LMWH or DOACs (with some caveats), which is easy to follow. ASH, on the other hand, suggests LMWH or a DOAC for the first 7-10 days, DOACs for the first 3-6 months, and back to LMWH or DOACs after 6 months,” he said in an interview.

The recommendation is “very evidence based but ambiguous and not helpful for the practicing clinician,” added Dr. Douketis, who helped develop the ITAC guidelines, but was not part of the ASH or ASCO guideline panels.

ASCO also provides a clear recommendation for giving VTE prophylaxis for 4 weeks after cancer surgery in patients with high VTE risk, whereas ASH gives “a somewhat vague recommendation” for thromboprophylaxis after hospital discharge.

The guidelines are “pretty well aligned” with respect to recommendations on VTE prophylaxis in medical cancer patients receiving chemotherapy, and although the “extremely academic” ASH guidelines were developed by “a superb team using the same evidence and excellent methodology,” they are interpreted in slightly different ways and fall short when it comes to being clinician friendly, Dr. Douketis said.

“At the end of day, for practicing clinicians, the ASH guidelines don’t provide a message that’s easy to digest,” he added.

ASH has, however, provided a resource page that includes tools and information for implementing the guidelines in clinical practice, and will maintain the guidelines “through surveillance for new evidence, ongoing review by experts, and regular revisions,” the authors said.

[email protected]

New guidelines from the American Society of Hematology “strongly recommend” using no thromboprophylaxis over using parenteral thromboprophylaxis in ambulatory patients receiving cancer chemotherapy who have low venous thromboembolism (VTE) risk, and using no thromboprophylaxis over oral thromboprophylaxis with vitamin K antagonists in those at any VTE risk level.

The evidence-based guidelines for the prevention and treatment of VTE in patient with cancer, published online in Blood Advances, also include a “conditional recommendation” for using either thromboprophylaxis with the direct oral anticoagulants (DOACs) apixaban or rivaroxaban or using no thromboprophylaxis in ambulatory patients with intermediate risk and using the DOACs over no thromboprophylaxis in those with high VTE risk.

The purpose of the guidelines, which also address VTE prophylaxis in hospitalized patients with cancer and the use of anticoagulation for VTE treatment in patients with cancer, is to provide clinical decision support for shared decision-making by patients and clinicians, Gary H. Lyman, MD, of Fred Hutchinson Cancer Research Center, Seattle and Marc Carrier, MD, of the University of Ottawa, and their colleagues from the multidisciplinary guidelines panel explained.

“The recommendations take into consideration the strength of the evidence, risks of mortality, VTE, and bleeding, as well as quality of life, acceptability, and cost considerations,” they wrote, noting that VTE is a common complication in patients with cancer, who are at markedly increased risk for morbidity and mortality from VTE.
 

Levels of evidence

The panel members relied on updated and original systematic evidence reviews. Conditional recommendations, as opposed to strong recommendations, are defined by the panel as “suggestions,” and all 33 recommendations that make up the guidelines include a statement on the strength of the relevant evidence.

For example, the thromboprophylaxis recommendations for low, intermediate, and high VTE risk are made based on “moderate certainty in the evidence of effects,” and the recommendation for no thromboprophylaxis over oral thromboprophylaxis with vitamin K antagonists is a strong recommendation based on “very low certainty in the evidence of benefits, but high certainty about the harms.”

The guidelines panel also strongly recommends, based on moderate certainty in the evidence of effects, using low-molecular-weight heparin over unfractionated heparin for the initial treatment of VTE in patients with cancer, and suggests, based on “very low certainty in the evidence of effects,” using LMWH over fondaparinux in this setting.

In addition to primary prophylaxis in ambulatory and hospitalized patients and initial VTE treatment, they also address primary prophylaxis for patients with cancer who have a central venous catheter, VTE treatment in surgical patients with cancer, short-term VTE treatment, and long-term VTE treatment.

For example, the guidelines panel conditionally recommends:

• Not using parenteral or oral thromboprophylaxis in patients with cancer and a central venous catheter
• Using LMWH or fondaparinux for surgical patients with cancer
• Using DOACS for the short-term treatment of VTE, and LMWH or DOACs for the long-term treatment of VTE in patients with cancer.

The perils of VTE

VTE in patients with cancer can interfere with treatment, increase mortality risk, and increase costs, the authors noted, adding that VTE can also adversely affect cancer patients’ quality of life.

“Some have even reported the experience of VTE to be more upsetting than that of the cancer,” they wrote. “More than 50% of thrombotic events occur within 3 months of the cancer diagnosis, a time when most cancer treatments will be underway. Patients, who are still coming to terms with a recent cancer diagnosis, often view the occurrence of VTE as a further threat to life, confirmation of the severity of their condition, and a poor prognostic sign.”

Therefore, the new guidelines aim to reduce VTE frequency, risk of bleeding complications, morbidity, and costs, thereby improving quality of life and the patient experience, the authors said, noting that three other recent guidelines on VTEs in patients with cancer have been published: the 2019 American Society of Clinical Oncology guidelines, the 2019 International Initiative on Thrombosis and Cancer guidelines, and the 2020 National Comprehensive Cancer Network guidelines.

The ASH guidelines are similar in many ways to the other guidelines, but differ in some ways, as well. An example is the timing of initiation of pharmacological thromboprophylaxis in patients undergoing cancer-related major abdominal surgery. The ASCO and ITAC guidelines advise starting thromboprophylaxis preoperatively, whereas the ASH guidelines recommend initiating thromboprophylaxis postoperatively, citing “the limited advantages to initiating thromboprophylaxis preoperatively, in addition to the potential bleeding and logistical considerations associated with neuraxial anesthesia.”

These differences highlight a lack of data in that setting and the need for additional studies, the authors said.
 

ASH vs. ASCO

James Douketis, MD, a practicing clinician and professor of medicine at McMaster University, Hamilton, Ont., highlighted another difference between the ASH and ASCO guidelines.

“For the treatment of [cancer-associated thrombosis], ASCO gives a strong recommendation to use LMWH or DOACs (with some caveats), which is easy to follow. ASH, on the other hand, suggests LMWH or a DOAC for the first 7-10 days, DOACs for the first 3-6 months, and back to LMWH or DOACs after 6 months,” he said in an interview.

The recommendation is “very evidence based but ambiguous and not helpful for the practicing clinician,” added Dr. Douketis, who helped develop the ITAC guidelines, but was not part of the ASH or ASCO guideline panels.

ASCO also provides a clear recommendation for giving VTE prophylaxis for 4 weeks after cancer surgery in patients with high VTE risk, whereas ASH gives “a somewhat vague recommendation” for thromboprophylaxis after hospital discharge.

The guidelines are “pretty well aligned” with respect to recommendations on VTE prophylaxis in medical cancer patients receiving chemotherapy, and although the “extremely academic” ASH guidelines were developed by “a superb team using the same evidence and excellent methodology,” they are interpreted in slightly different ways and fall short when it comes to being clinician friendly, Dr. Douketis said.

“At the end of day, for practicing clinicians, the ASH guidelines don’t provide a message that’s easy to digest,” he added.

ASH has, however, provided a resource page that includes tools and information for implementing the guidelines in clinical practice, and will maintain the guidelines “through surveillance for new evidence, ongoing review by experts, and regular revisions,” the authors said.

[email protected]

A 16-year-old patient sits in front of you and says, “I think I’m transgender.”

Origovisualis/Getty Images

What do you do?

Whether you are an endocrinologist, family physician, pediatrician, or emergency physician, it’s probably a situation for which medical school education did not sufficiently prepare you. What you know is that you want to do your best to guide your patient and offer every resource necessary for a healthy and happy life. The good news is that your patient trusted you enough to disclose this information to you.

Sadly, this isn’t always the case. About 23% of transgender adults responding to the 2015 U.S. Transgender Survey put off necessary health care because they fear being mistreated or disrespected. Nearly one-third (31%) of survey respondents reported that none of their health care providers knew they were transgender.

Now that your patient feels comfortable enough with you to share this information, you must make sure you do everything in your power to continue to earn your patient’s trust.
 

Language matters

First, make sure that you are respectful with your terminology. Ask the patient for their name, pronouns, and gender identity. For example: “My name is Dr. Pine, and my pronouns are she/her. What are your pronouns? How do you describe your gender identity?” Each person may have terminology that is specific to their own experience, so allowing people to use their own language is the most respectful method.

People may identify as male, female, transwoman, transman, gender fluid, nonbinary, agender, neutrois, pangender, two-spirit, or other options not listed here. Physicians can be supportive by ensuring that their paperwork or electronic medical systems are sensitive to the needs of the transgender community. Having an option for the patient’s chosen name is courteous to all patients, regardless of gender identity; not everyone uses their legal name in everyday conversation.

Paperwork and electronic medical systems should ask for gender identity and sex assigned at birth, allow write-in options for issues of gender and sexual orientation, and ask for an anatomical inventory or organ inventory so that cancer screening can be conducted for the appropriate body parts.
 

Questions to ask

Ask patients about their gender journey: How long have they felt this way? How did they come to understand themselves and their gender? When did they start to disclose their experience with others? With pediatric patients, I ask if they have discussed this with their parents/guardians, and if they would like to have that conversation together.

Ask how you can support the patient on their journey. Are they interested in therapy, puberty blockers, hormones, or surgery? People may seek therapy for help coping with internalized transphobia, family rejection, or stigma. They may also want information or support with accessing hormones or surgery. In addition to individual therapy, there are numerous support groups for children, individuals, parents/guardians, and partners, such as PFLAG.org and Genderspectrum.org.

If you are the right kind of doctor and ready to prescribe, you can begin counseling. If not, you should know how to find local resources. The World Professional Association for Transgender Health has a directory of providers, and there are other resources listed below.
 

What does gender transitioning entail?

There are many components to gender transition. Some transitions may consist primarily of a social transition, with people using a different name, pronouns, and external expression, such as hairstyle and clothing. For others, there may be a medical component.

Mental health care is also an important component of gender transition for children, adolescents, adults, and family members. Mental health concerns are significantly greater in transgender and gender-nonconforming people, with higher rates of depression, anxiety, suicidal ideation, self-harm, substance abuse, eating disorders, and neurodiversity on the autism spectrum. In a study of more than 6,400 transgender people in the United States, 41% reported attempting suicide – a rate 25 times higher than that of the general population. Numerous studies show that hormonal treatment decreases depression, suicidal ideation, and anxiety, and also improves quality of life.

One common misperception, especially when working with children, is that youth transition involves a “sex change” (an outdated term) or any type of surgery. In reality, the main intervention before puberty is psychological support and social transition. The use of a chosen name at school, home, work, and with friends was shown to be associated with lower depression, suicidal ideation, and suicidal behavior. Another study demonstrated that children supported in their identities have mental health similar to that of cisgender siblings and peers.

When puberty approaches, if there is distress around natal pubertal development, then gonadotropin-releasing hormone agonists or “puberty blockers” may be used to temporarily pause the pubertal process, but only after Tanner stage II-III is reached. These medications have been safely used for decades for patients with central precocious puberty. Access to puberty-blocking medication in adolescence (when desired) has been associated with lower rates of suicidal ideation in adulthood and can truly be a lifesaving intervention.

When teens are older, they may choose to take gender-affirming hormone therapy to go through the puberty that is concordant with their affirmed gender. Adults who decide to transition medically may decide to take hormone therapy and may have gender-confirmation surgery, if desired, to align the body with their gender identity and alleviate gender dysphoria. Overall, access to medical care and hormone therapy have been shown to decrease depression, anxiety, and suicidality, and improve quality of life.
 

Sexuality and fertility

It is important to understand that sexuality is separate from gender identity, and that attraction and sexual activity cannot be assumed. Take a sensitive romantic and sexual history from your patient to get the information necessary to counsel patients about safe relationships and sexual practices. It is important not to make assumptions; a patient who is asexual may still be having sex, and a transgender man may be having receptive vaginal intercourse and may need information about contraception and family planning.

Also, be careful about using clinical language. Some people may want to use anatomical terms, but others may be uncomfortable or triggered by them. For instance, a transgender man may use “chest” for breasts, or “genital canal,” and “junk,” “dick,” or “front hole” for the vagina. Ask patients what terms they prefer to use.

It is also important to consider the impact that medical and surgical interventions may have on fertility, especially when discussing the topic with children and adolescents who may not have spent much time thinking about family planning. Be careful not to make assumptions about plans for parenthood, and remember that there are many paths to becoming a parent.
 

What does the patient need right now?

When I was a fourth-year medical student on my outpatient child psychiatry rotation, a 5-year-old child assigned male at birth was guarded and frightened of me until their mother said: “It’s okay, Dr. Elyse likes girl things too,” at which point the child became animated and happy while chatting with me about Barbie dolls. My patient had already endured teasing about gender nonconformity, starting in kindergarten; it was unclear to my patient whether I would be a safe person or a bully.

The mother was kind and affirming, but she also wanted answers. Would her child grow up to be a gay man? Or a transgender woman? Would her child be able to live freely, or would they always be quiet around others, scared of what people might say? Would her child be safe?

We can’t predict the future, but as doctors, we want to use all of our knowledge and tools to help our patients live healthy lives. In this case, it meant helping the mother know how to support her child’s identity, how to advocate for a safe school and community, where to connect with other gender-creative children, and how to tolerate ambiguity and celebrate the child she has, not the child she expected.

We know that people with higher support and higher self-esteem can have greater resilience and greater success. This family may need medical resources for puberty blockers, hormone therapy, and even surgery someday, but reassurance is what was needed in the moment. When your patient comes out to you, they are trusting you. It is your obligation and privilege as a medical professional to help them begin a journey to an authentic life.

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

A 16-year-old patient sits in front of you and says, “I think I’m transgender.”

Origovisualis/Getty Images

What do you do?

Whether you are an endocrinologist, family physician, pediatrician, or emergency physician, it’s probably a situation for which medical school education did not sufficiently prepare you. What you know is that you want to do your best to guide your patient and offer every resource necessary for a healthy and happy life. The good news is that your patient trusted you enough to disclose this information to you.

Sadly, this isn’t always the case. About 23% of transgender adults responding to the 2015 U.S. Transgender Survey put off necessary health care because they fear being mistreated or disrespected. Nearly one-third (31%) of survey respondents reported that none of their health care providers knew they were transgender.

Now that your patient feels comfortable enough with you to share this information, you must make sure you do everything in your power to continue to earn your patient’s trust.
 

Language matters

First, make sure that you are respectful with your terminology. Ask the patient for their name, pronouns, and gender identity. For example: “My name is Dr. Pine, and my pronouns are she/her. What are your pronouns? How do you describe your gender identity?” Each person may have terminology that is specific to their own experience, so allowing people to use their own language is the most respectful method.

People may identify as male, female, transwoman, transman, gender fluid, nonbinary, agender, neutrois, pangender, two-spirit, or other options not listed here. Physicians can be supportive by ensuring that their paperwork or electronic medical systems are sensitive to the needs of the transgender community. Having an option for the patient’s chosen name is courteous to all patients, regardless of gender identity; not everyone uses their legal name in everyday conversation.

Paperwork and electronic medical systems should ask for gender identity and sex assigned at birth, allow write-in options for issues of gender and sexual orientation, and ask for an anatomical inventory or organ inventory so that cancer screening can be conducted for the appropriate body parts.
 

Questions to ask

Ask patients about their gender journey: How long have they felt this way? How did they come to understand themselves and their gender? When did they start to disclose their experience with others? With pediatric patients, I ask if they have discussed this with their parents/guardians, and if they would like to have that conversation together.

Ask how you can support the patient on their journey. Are they interested in therapy, puberty blockers, hormones, or surgery? People may seek therapy for help coping with internalized transphobia, family rejection, or stigma. They may also want information or support with accessing hormones or surgery. In addition to individual therapy, there are numerous support groups for children, individuals, parents/guardians, and partners, such as PFLAG.org and Genderspectrum.org.

If you are the right kind of doctor and ready to prescribe, you can begin counseling. If not, you should know how to find local resources. The World Professional Association for Transgender Health has a directory of providers, and there are other resources listed below.
 

What does gender transitioning entail?

There are many components to gender transition. Some transitions may consist primarily of a social transition, with people using a different name, pronouns, and external expression, such as hairstyle and clothing. For others, there may be a medical component.

Mental health care is also an important component of gender transition for children, adolescents, adults, and family members. Mental health concerns are significantly greater in transgender and gender-nonconforming people, with higher rates of depression, anxiety, suicidal ideation, self-harm, substance abuse, eating disorders, and neurodiversity on the autism spectrum. In a study of more than 6,400 transgender people in the United States, 41% reported attempting suicide – a rate 25 times higher than that of the general population. Numerous studies show that hormonal treatment decreases depression, suicidal ideation, and anxiety, and also improves quality of life.

One common misperception, especially when working with children, is that youth transition involves a “sex change” (an outdated term) or any type of surgery. In reality, the main intervention before puberty is psychological support and social transition. The use of a chosen name at school, home, work, and with friends was shown to be associated with lower depression, suicidal ideation, and suicidal behavior. Another study demonstrated that children supported in their identities have mental health similar to that of cisgender siblings and peers.

When puberty approaches, if there is distress around natal pubertal development, then gonadotropin-releasing hormone agonists or “puberty blockers” may be used to temporarily pause the pubertal process, but only after Tanner stage II-III is reached. These medications have been safely used for decades for patients with central precocious puberty. Access to puberty-blocking medication in adolescence (when desired) has been associated with lower rates of suicidal ideation in adulthood and can truly be a lifesaving intervention.

When teens are older, they may choose to take gender-affirming hormone therapy to go through the puberty that is concordant with their affirmed gender. Adults who decide to transition medically may decide to take hormone therapy and may have gender-confirmation surgery, if desired, to align the body with their gender identity and alleviate gender dysphoria. Overall, access to medical care and hormone therapy have been shown to decrease depression, anxiety, and suicidality, and improve quality of life.
 

Sexuality and fertility

It is important to understand that sexuality is separate from gender identity, and that attraction and sexual activity cannot be assumed. Take a sensitive romantic and sexual history from your patient to get the information necessary to counsel patients about safe relationships and sexual practices. It is important not to make assumptions; a patient who is asexual may still be having sex, and a transgender man may be having receptive vaginal intercourse and may need information about contraception and family planning.

Also, be careful about using clinical language. Some people may want to use anatomical terms, but others may be uncomfortable or triggered by them. For instance, a transgender man may use “chest” for breasts, or “genital canal,” and “junk,” “dick,” or “front hole” for the vagina. Ask patients what terms they prefer to use.

It is also important to consider the impact that medical and surgical interventions may have on fertility, especially when discussing the topic with children and adolescents who may not have spent much time thinking about family planning. Be careful not to make assumptions about plans for parenthood, and remember that there are many paths to becoming a parent.
 

What does the patient need right now?

When I was a fourth-year medical student on my outpatient child psychiatry rotation, a 5-year-old child assigned male at birth was guarded and frightened of me until their mother said: “It’s okay, Dr. Elyse likes girl things too,” at which point the child became animated and happy while chatting with me about Barbie dolls. My patient had already endured teasing about gender nonconformity, starting in kindergarten; it was unclear to my patient whether I would be a safe person or a bully.

The mother was kind and affirming, but she also wanted answers. Would her child grow up to be a gay man? Or a transgender woman? Would her child be able to live freely, or would they always be quiet around others, scared of what people might say? Would her child be safe?

We can’t predict the future, but as doctors, we want to use all of our knowledge and tools to help our patients live healthy lives. In this case, it meant helping the mother know how to support her child’s identity, how to advocate for a safe school and community, where to connect with other gender-creative children, and how to tolerate ambiguity and celebrate the child she has, not the child she expected.

We know that people with higher support and higher self-esteem can have greater resilience and greater success. This family may need medical resources for puberty blockers, hormone therapy, and even surgery someday, but reassurance is what was needed in the moment. When your patient comes out to you, they are trusting you. It is your obligation and privilege as a medical professional to help them begin a journey to an authentic life.

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

A 16-year-old patient sits in front of you and says, “I think I’m transgender.”

Origovisualis/Getty Images

What do you do?

Whether you are an endocrinologist, family physician, pediatrician, or emergency physician, it’s probably a situation for which medical school education did not sufficiently prepare you. What you know is that you want to do your best to guide your patient and offer every resource necessary for a healthy and happy life. The good news is that your patient trusted you enough to disclose this information to you.

Sadly, this isn’t always the case. About 23% of transgender adults responding to the 2015 U.S. Transgender Survey put off necessary health care because they fear being mistreated or disrespected. Nearly one-third (31%) of survey respondents reported that none of their health care providers knew they were transgender.

Now that your patient feels comfortable enough with you to share this information, you must make sure you do everything in your power to continue to earn your patient’s trust.
 

Language matters

First, make sure that you are respectful with your terminology. Ask the patient for their name, pronouns, and gender identity. For example: “My name is Dr. Pine, and my pronouns are she/her. What are your pronouns? How do you describe your gender identity?” Each person may have terminology that is specific to their own experience, so allowing people to use their own language is the most respectful method.

People may identify as male, female, transwoman, transman, gender fluid, nonbinary, agender, neutrois, pangender, two-spirit, or other options not listed here. Physicians can be supportive by ensuring that their paperwork or electronic medical systems are sensitive to the needs of the transgender community. Having an option for the patient’s chosen name is courteous to all patients, regardless of gender identity; not everyone uses their legal name in everyday conversation.

Paperwork and electronic medical systems should ask for gender identity and sex assigned at birth, allow write-in options for issues of gender and sexual orientation, and ask for an anatomical inventory or organ inventory so that cancer screening can be conducted for the appropriate body parts.
 

Questions to ask

Ask patients about their gender journey: How long have they felt this way? How did they come to understand themselves and their gender? When did they start to disclose their experience with others? With pediatric patients, I ask if they have discussed this with their parents/guardians, and if they would like to have that conversation together.

Ask how you can support the patient on their journey. Are they interested in therapy, puberty blockers, hormones, or surgery? People may seek therapy for help coping with internalized transphobia, family rejection, or stigma. They may also want information or support with accessing hormones or surgery. In addition to individual therapy, there are numerous support groups for children, individuals, parents/guardians, and partners, such as PFLAG.org and Genderspectrum.org.

If you are the right kind of doctor and ready to prescribe, you can begin counseling. If not, you should know how to find local resources. The World Professional Association for Transgender Health has a directory of providers, and there are other resources listed below.
 

What does gender transitioning entail?

There are many components to gender transition. Some transitions may consist primarily of a social transition, with people using a different name, pronouns, and external expression, such as hairstyle and clothing. For others, there may be a medical component.

Mental health care is also an important component of gender transition for children, adolescents, adults, and family members. Mental health concerns are significantly greater in transgender and gender-nonconforming people, with higher rates of depression, anxiety, suicidal ideation, self-harm, substance abuse, eating disorders, and neurodiversity on the autism spectrum. In a study of more than 6,400 transgender people in the United States, 41% reported attempting suicide – a rate 25 times higher than that of the general population. Numerous studies show that hormonal treatment decreases depression, suicidal ideation, and anxiety, and also improves quality of life.

One common misperception, especially when working with children, is that youth transition involves a “sex change” (an outdated term) or any type of surgery. In reality, the main intervention before puberty is psychological support and social transition. The use of a chosen name at school, home, work, and with friends was shown to be associated with lower depression, suicidal ideation, and suicidal behavior. Another study demonstrated that children supported in their identities have mental health similar to that of cisgender siblings and peers.

When puberty approaches, if there is distress around natal pubertal development, then gonadotropin-releasing hormone agonists or “puberty blockers” may be used to temporarily pause the pubertal process, but only after Tanner stage II-III is reached. These medications have been safely used for decades for patients with central precocious puberty. Access to puberty-blocking medication in adolescence (when desired) has been associated with lower rates of suicidal ideation in adulthood and can truly be a lifesaving intervention.

When teens are older, they may choose to take gender-affirming hormone therapy to go through the puberty that is concordant with their affirmed gender. Adults who decide to transition medically may decide to take hormone therapy and may have gender-confirmation surgery, if desired, to align the body with their gender identity and alleviate gender dysphoria. Overall, access to medical care and hormone therapy have been shown to decrease depression, anxiety, and suicidality, and improve quality of life.
 

Sexuality and fertility

It is important to understand that sexuality is separate from gender identity, and that attraction and sexual activity cannot be assumed. Take a sensitive romantic and sexual history from your patient to get the information necessary to counsel patients about safe relationships and sexual practices. It is important not to make assumptions; a patient who is asexual may still be having sex, and a transgender man may be having receptive vaginal intercourse and may need information about contraception and family planning.

Also, be careful about using clinical language. Some people may want to use anatomical terms, but others may be uncomfortable or triggered by them. For instance, a transgender man may use “chest” for breasts, or “genital canal,” and “junk,” “dick,” or “front hole” for the vagina. Ask patients what terms they prefer to use.

It is also important to consider the impact that medical and surgical interventions may have on fertility, especially when discussing the topic with children and adolescents who may not have spent much time thinking about family planning. Be careful not to make assumptions about plans for parenthood, and remember that there are many paths to becoming a parent.
 

What does the patient need right now?

When I was a fourth-year medical student on my outpatient child psychiatry rotation, a 5-year-old child assigned male at birth was guarded and frightened of me until their mother said: “It’s okay, Dr. Elyse likes girl things too,” at which point the child became animated and happy while chatting with me about Barbie dolls. My patient had already endured teasing about gender nonconformity, starting in kindergarten; it was unclear to my patient whether I would be a safe person or a bully.

The mother was kind and affirming, but she also wanted answers. Would her child grow up to be a gay man? Or a transgender woman? Would her child be able to live freely, or would they always be quiet around others, scared of what people might say? Would her child be safe?

We can’t predict the future, but as doctors, we want to use all of our knowledge and tools to help our patients live healthy lives. In this case, it meant helping the mother know how to support her child’s identity, how to advocate for a safe school and community, where to connect with other gender-creative children, and how to tolerate ambiguity and celebrate the child she has, not the child she expected.

We know that people with higher support and higher self-esteem can have greater resilience and greater success. This family may need medical resources for puberty blockers, hormone therapy, and even surgery someday, but reassurance is what was needed in the moment. When your patient comes out to you, they are trusting you. It is your obligation and privilege as a medical professional to help them begin a journey to an authentic life.

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

Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.

“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.

H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”

A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.

Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).

Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.

Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.

Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.

“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.

H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”

A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.

Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).

Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.

Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.

Antimicrobial resistance is the most common cause of treatment-refractory Helicobacter pylori infection, but before switching antibiotics, clinicians should screen for factors such as treatment nonadherence or inadequate suppression of gastric acid, according to a clinical practice update from the American Gastroenterological Association.

“Inadequate acid suppression is associated with H. pylori eradication failure. The use of high-dose and more potent PPIs, PPIs not metabolized by CYP2C19, or potassium-competitive acid blockers, if available, should be considered in cases of refractory H. pylori infection,” wrote Shailja C. Shah, MD, MPH, of Vanderbilt University Medical Center in Nashville, Tenn., and coauthors Prasad G. Iyer, MD, and Steven F. Moss, MD. . Their report is in Gastroenterology.

H. pylori infection is the most common cause of gastric cancer. Although eradication is widely recommended, it can be challenging because of strain diversity, rising antimicrobial resistance, a dearth of recent head-to-head clinical trials, and sparse epidemiologic and sensitivity data, the experts noted. For this reason, before selecting an eradication regimen, it is vital to thoroughly review a patient’s history of antibiotics – for example, any prior macrolide or fluoroquinolone exposure should preclude the use of clarithromycin- or levofloxacin-based regimens “given the high likelihood of resistance,” the experts wrote. They also advised that clinicians should avoid levofloxacin unless the H. pylori strain is known to be sensitive to it or if population rates of levofloxacin resistance rates are known to be less than 15%. However, amoxicillin, tetracycline, and rifabutin resistance are rare, and these agents “can be considered for subsequent therapies in refractory H. pylori infection.”

A longer antimicrobial regimen (such as 14 vs. 7 days) is more likely to eradicate H. pylori. If first-line bismuth quadruple therapy (such as a PPI plus bismuth, metronidazole, and tetracycline) fails, then second-line options include another bismuth-containing quadruple-agent regimen, or triple therapy with rifabutin or levofloxacin plus high-dose dual PPI therapy and amoxicillin. If patient history contains “penicillin allergy” but does not list anaphylaxis, then penicillin allergy testing can help determine if amoxicillin-based regimens are an option. The authors also note that, when used, amoxicillin should be dosed at 2 g/day in divided doses three to four times per day in order to avoid low trough levels because this might be associated with H. pylori eradication failure. For metronidazole, regardless of in vitro resistance, eradication is more likely if patients receive 1.5-2 g/day, in divided doses, with concomitant bismuth.

Treatment nonadherence contributes to refractory H. pylori infection and may be caused by the complexity of the treatment regimen, high pill burden, and side effects. To improve adherence, the experts advised counseling patients on the rationale for the treatment regimen, the dosing instructions, the importance of completing the full course of therapy, and providing anticipatory guidance regarding common side effects. If a patient adheres to second-line treatment and it still fails, then susceptibility testing is advised before starting another regimen. Depending on the results, options may include levofloxacin-based quadruple therapy, another round of bismuth-based quadruple therapy, a PPI plus amoxicillin and rifabutin, or high-dose PPI therapy plus high-dose amoxicillin (2-3 g/day divided across three to four doses).

Other considerations include how to approach patients and caregivers, particularly the elderly and other vulnerable patients, with shared decision-making to help them weigh the potential benefits of continuing to try to eradicate H. pylori against the risk of possible adverse effects and the “inconvenience of repeated exposure to antibiotics and high-dose acid suppression,” the experts wrote. They also advised tracking rates of eradication success and relevant demographic and clinical data, including patients’ antibiotic history. Publicly sharing aggregated, deidentified results can help other local clinicians select eradication regimens. Finally, the use of probiotics and other adjunctive therapies “should be considered experimental” since these have no clear benefit for treating refractory H. pylori infection.

Dr. Shah was funded by an AGA Research Scholar Award and a Veterans Affairs Career Development Award. She reported having no conflicts of interest. Dr. Iyer and Dr. Moss disclosed ties to Exact Sciences, Pentax Medical, Redhill Biopharma, Phathom, American Molecular Laboratories, and Takeda.

One dose of the novel agent, REGN1908-1909 (Regeneron Pharmaceuticals) resulted in a rapid and durable reduction in cat-allergen-induced bronchoconstriction in cat-allergic subjects with mild asthma.

vladans/iStock/Getty Images Plus

The finding, from a phase 2 randomized placebo-controlled study, is good news for the millions of people who are plagued by cat allergies, the investigators say.

The study, which was sponsored by Regeneron, was presented in a late breaking oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

“REGN1908-1909 contains antibodies against Fel d 1, the major cat allergen, and here we show that it quickly and lastingly reduces acute bronchoconstriction in people with cat allergy,” lead author Frederic J. de Blay, MD, Strasbourg University Hospital, France, said in an interview.

Dr. de Blay admitted he is “quite excited” about the results.

“This study was performed in an environmental exposure chamber, and we clearly demonstrate that these antibodies decrease the asthmatic response to cat allergen within 8 days, and that these effects last 3 months. I never saw that in my life. I was a little bit skeptical at first, so to obtain such robust results after just 8 days, after just one injection, I was very surprised,” he said.

Dr. de Blay and his team screened potential participants to make sure they were cat allergic by exposing them to cat allergen for up to 2 hours while they were in the environmental exposure chamber. To be eligible for the study, participants had to show an early asthmatic response (EAR), defined as a reduction in forced expiratory volume in 1 second (FEV₁₎ of at least 20% from baseline.

The participants were then randomized to receive either single-dose REGN1908-1909, 600 mg, subcutaneously (n = 29 patients) or placebo (n = 27 patients) prior to cat-allergen exposure in the controlled environmental chamber.

Dr. de Blay developed the chamber used in the study: the ALYATEC environmental exposure chamber.

“The chamber is 60 meters square, or 150 cubic meters, and can accommodate 20 patients. We are able to nebulize cat allergen, mice allergen, or whatever we wish to study so we can standardize the exposure. We can control the particle size and the amount so we know the exact amount of allergen that the patient has been exposed to,” he explained.

To test the efficacy of REGN1908-1909 in reducing acute bronchoconstriction, or EAR, the researchers measured FEV₁ at baseline, and on days 8, 29, 57, and 85 in both groups. During each exposure, measurements were taken every 10 minutes for periods that lasted up to 4 hours.

They found that the probability of remaining in the chamber with no asthmatic response was substantially elevated in the group treated with REGN1908-1909.

Compared with placebo, REGN1908-1909 significantly increased the median time to EAR, from 51 minutes at baseline to more than 4 hours on day 8, (hazard ratio [HR], 0.36; P < .0083), day 29 (HR, 0.24; P < .0001), day 57 (HR, 0.45; P = .0222), and day 85 (HR, 0.27; P = .0003).

The FEV₁ area under the curve (AUC) was also better with REGN1908-1909 than with placebo at day 8 (15.2% vs. 1.6%; P < .001). And a single dose reduced skin-test reactivity to cat allergen at 1 week, which persisted for up to 4 months.

In addition, participants who received REGN1908-1909 were able to tolerate a threefold higher amount of the cat allergen than those who received placebo (P = .003).

“We initially gave 40 nanograms of cat allergen, and then 8 days later they were able to stay longer in the chamber and inhale more of the allergen, to almost triple the amount they had originally been given. That 40 nanograms is very close to real world exposure,” Dr. de Blay noted.

Regeneron plans to start a phase 3 trial soon, he reported.
 

Promising results

“The study is well designed and shows a reduction in drop of FEV₁ in response to cat allergen provocation and a decreased AUC in cat SPT response over 4 months,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, said in an interview.

“These are very promising results, which show that REGN1908-1909 can be a novel treatment for cat-induced asthma, which is often the only sensitization patients have. And they love their cats – one-third of the U.S. population has a cat and one-third has a dog, and 50% have both,” noted Dr. Bernstein, who was not involved with the study.

“This novel study used our scientific knowledge of the cat allergen itself to design a targeted antibody-based treatment that demonstrates significant benefit even after the first shot,” added Edwin H. Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill.

“This strategy has the potential to revolutionize not only our treatment of common environmental allergies but also other allergic diseases with well-described triggers, such as food and drug allergy,” Dr. Kim, who was not part of the study, said in an interview.

Dr. de Blay reported a financial relationship with Regeneron Pharmaceuticals, which sponsored the study. Dr. Bernstein and Dr. Kim have disclosed no relevant financial relationships.

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

One dose of the novel agent, REGN1908-1909 (Regeneron Pharmaceuticals) resulted in a rapid and durable reduction in cat-allergen-induced bronchoconstriction in cat-allergic subjects with mild asthma.

vladans/iStock/Getty Images Plus

The finding, from a phase 2 randomized placebo-controlled study, is good news for the millions of people who are plagued by cat allergies, the investigators say.

The study, which was sponsored by Regeneron, was presented in a late breaking oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

“REGN1908-1909 contains antibodies against Fel d 1, the major cat allergen, and here we show that it quickly and lastingly reduces acute bronchoconstriction in people with cat allergy,” lead author Frederic J. de Blay, MD, Strasbourg University Hospital, France, said in an interview.

Dr. de Blay admitted he is “quite excited” about the results.

“This study was performed in an environmental exposure chamber, and we clearly demonstrate that these antibodies decrease the asthmatic response to cat allergen within 8 days, and that these effects last 3 months. I never saw that in my life. I was a little bit skeptical at first, so to obtain such robust results after just 8 days, after just one injection, I was very surprised,” he said.

Dr. de Blay and his team screened potential participants to make sure they were cat allergic by exposing them to cat allergen for up to 2 hours while they were in the environmental exposure chamber. To be eligible for the study, participants had to show an early asthmatic response (EAR), defined as a reduction in forced expiratory volume in 1 second (FEV₁₎ of at least 20% from baseline.

The participants were then randomized to receive either single-dose REGN1908-1909, 600 mg, subcutaneously (n = 29 patients) or placebo (n = 27 patients) prior to cat-allergen exposure in the controlled environmental chamber.

Dr. de Blay developed the chamber used in the study: the ALYATEC environmental exposure chamber.

“The chamber is 60 meters square, or 150 cubic meters, and can accommodate 20 patients. We are able to nebulize cat allergen, mice allergen, or whatever we wish to study so we can standardize the exposure. We can control the particle size and the amount so we know the exact amount of allergen that the patient has been exposed to,” he explained.

To test the efficacy of REGN1908-1909 in reducing acute bronchoconstriction, or EAR, the researchers measured FEV₁ at baseline, and on days 8, 29, 57, and 85 in both groups. During each exposure, measurements were taken every 10 minutes for periods that lasted up to 4 hours.

They found that the probability of remaining in the chamber with no asthmatic response was substantially elevated in the group treated with REGN1908-1909.

Compared with placebo, REGN1908-1909 significantly increased the median time to EAR, from 51 minutes at baseline to more than 4 hours on day 8, (hazard ratio [HR], 0.36; P < .0083), day 29 (HR, 0.24; P < .0001), day 57 (HR, 0.45; P = .0222), and day 85 (HR, 0.27; P = .0003).

The FEV₁ area under the curve (AUC) was also better with REGN1908-1909 than with placebo at day 8 (15.2% vs. 1.6%; P < .001). And a single dose reduced skin-test reactivity to cat allergen at 1 week, which persisted for up to 4 months.

In addition, participants who received REGN1908-1909 were able to tolerate a threefold higher amount of the cat allergen than those who received placebo (P = .003).

“We initially gave 40 nanograms of cat allergen, and then 8 days later they were able to stay longer in the chamber and inhale more of the allergen, to almost triple the amount they had originally been given. That 40 nanograms is very close to real world exposure,” Dr. de Blay noted.

Regeneron plans to start a phase 3 trial soon, he reported.
 

Promising results

“The study is well designed and shows a reduction in drop of FEV₁ in response to cat allergen provocation and a decreased AUC in cat SPT response over 4 months,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, said in an interview.

“These are very promising results, which show that REGN1908-1909 can be a novel treatment for cat-induced asthma, which is often the only sensitization patients have. And they love their cats – one-third of the U.S. population has a cat and one-third has a dog, and 50% have both,” noted Dr. Bernstein, who was not involved with the study.

“This novel study used our scientific knowledge of the cat allergen itself to design a targeted antibody-based treatment that demonstrates significant benefit even after the first shot,” added Edwin H. Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill.

“This strategy has the potential to revolutionize not only our treatment of common environmental allergies but also other allergic diseases with well-described triggers, such as food and drug allergy,” Dr. Kim, who was not part of the study, said in an interview.

Dr. de Blay reported a financial relationship with Regeneron Pharmaceuticals, which sponsored the study. Dr. Bernstein and Dr. Kim have disclosed no relevant financial relationships.

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

One dose of the novel agent, REGN1908-1909 (Regeneron Pharmaceuticals) resulted in a rapid and durable reduction in cat-allergen-induced bronchoconstriction in cat-allergic subjects with mild asthma.

vladans/iStock/Getty Images Plus

The finding, from a phase 2 randomized placebo-controlled study, is good news for the millions of people who are plagued by cat allergies, the investigators say.

The study, which was sponsored by Regeneron, was presented in a late breaking oral abstract session at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year.

“REGN1908-1909 contains antibodies against Fel d 1, the major cat allergen, and here we show that it quickly and lastingly reduces acute bronchoconstriction in people with cat allergy,” lead author Frederic J. de Blay, MD, Strasbourg University Hospital, France, said in an interview.

Dr. de Blay admitted he is “quite excited” about the results.

“This study was performed in an environmental exposure chamber, and we clearly demonstrate that these antibodies decrease the asthmatic response to cat allergen within 8 days, and that these effects last 3 months. I never saw that in my life. I was a little bit skeptical at first, so to obtain such robust results after just 8 days, after just one injection, I was very surprised,” he said.

Dr. de Blay and his team screened potential participants to make sure they were cat allergic by exposing them to cat allergen for up to 2 hours while they were in the environmental exposure chamber. To be eligible for the study, participants had to show an early asthmatic response (EAR), defined as a reduction in forced expiratory volume in 1 second (FEV₁₎ of at least 20% from baseline.

The participants were then randomized to receive either single-dose REGN1908-1909, 600 mg, subcutaneously (n = 29 patients) or placebo (n = 27 patients) prior to cat-allergen exposure in the controlled environmental chamber.

Dr. de Blay developed the chamber used in the study: the ALYATEC environmental exposure chamber.

“The chamber is 60 meters square, or 150 cubic meters, and can accommodate 20 patients. We are able to nebulize cat allergen, mice allergen, or whatever we wish to study so we can standardize the exposure. We can control the particle size and the amount so we know the exact amount of allergen that the patient has been exposed to,” he explained.

To test the efficacy of REGN1908-1909 in reducing acute bronchoconstriction, or EAR, the researchers measured FEV₁ at baseline, and on days 8, 29, 57, and 85 in both groups. During each exposure, measurements were taken every 10 minutes for periods that lasted up to 4 hours.

They found that the probability of remaining in the chamber with no asthmatic response was substantially elevated in the group treated with REGN1908-1909.

Compared with placebo, REGN1908-1909 significantly increased the median time to EAR, from 51 minutes at baseline to more than 4 hours on day 8, (hazard ratio [HR], 0.36; P < .0083), day 29 (HR, 0.24; P < .0001), day 57 (HR, 0.45; P = .0222), and day 85 (HR, 0.27; P = .0003).

The FEV₁ area under the curve (AUC) was also better with REGN1908-1909 than with placebo at day 8 (15.2% vs. 1.6%; P < .001). And a single dose reduced skin-test reactivity to cat allergen at 1 week, which persisted for up to 4 months.

In addition, participants who received REGN1908-1909 were able to tolerate a threefold higher amount of the cat allergen than those who received placebo (P = .003).

“We initially gave 40 nanograms of cat allergen, and then 8 days later they were able to stay longer in the chamber and inhale more of the allergen, to almost triple the amount they had originally been given. That 40 nanograms is very close to real world exposure,” Dr. de Blay noted.

Regeneron plans to start a phase 3 trial soon, he reported.
 

Promising results

“The study is well designed and shows a reduction in drop of FEV₁ in response to cat allergen provocation and a decreased AUC in cat SPT response over 4 months,” Jonathan A. Bernstein, MD, professor of medicine at the University of Cincinnati, said in an interview.

“These are very promising results, which show that REGN1908-1909 can be a novel treatment for cat-induced asthma, which is often the only sensitization patients have. And they love their cats – one-third of the U.S. population has a cat and one-third has a dog, and 50% have both,” noted Dr. Bernstein, who was not involved with the study.

“This novel study used our scientific knowledge of the cat allergen itself to design a targeted antibody-based treatment that demonstrates significant benefit even after the first shot,” added Edwin H. Kim, MD, director of the UNC Food Allergy Initiative at the University of North Carolina at Chapel Hill.

“This strategy has the potential to revolutionize not only our treatment of common environmental allergies but also other allergic diseases with well-described triggers, such as food and drug allergy,” Dr. Kim, who was not part of the study, said in an interview.

Dr. de Blay reported a financial relationship with Regeneron Pharmaceuticals, which sponsored the study. Dr. Bernstein and Dr. Kim have disclosed no relevant financial relationships.

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