Guidelines

Unexplained diarrhea may be the most reliable symptom of small intestinal bacterial overgrowth (SIBO) in at-risk patients, according to a new clinical practice update from the American Gastroenterological Association.

“In those predisposed to SIBO due to anatomical, pathological, pharmacological or other changes that promote stasis or recirculation of colonic contents and/or impaired resistance to bacteria, SIBO will lead to diarrhea and can progress to a full-blown malabsorption syndrome” marked by steatorrhea and vitamin deficiencies, wrote Eamonn M.M. Quigley, MD, of Houston Methodist Hospital and Weill Cornell Medical College in Houston together with his fellow experts in Gastroenterology. But malabsorption is uncommon in patients whose SIBO is not caused by structural abnormalities, and gastrointestinal symptoms are “weakly predictive at best” if patients lack clear risk factors for SIBO, the experts cautioned.

The growing availability of breath testing has fueled diagnoses of SIBO, which the lay press often implicates in various disorders even though SIBO has no clear clinical or laboratory definition. Recent progress in techniques to measure bacterial populations and their metabolic products “should provide much needed clarity,” but for now, a SIBO diagnosis simply means that a patient’s presenting symptoms or laboratory findings are attributed to bacterial changes in the small intestine, the experts wrote.

Detecting SIBO also remains challenging. Most patients have normal results on routine laboratory tests, and there is not enough evidence to support testing for inflammatory markers such as fecal calprotectin. Patients with SIBO may have increased folate levels because of bacterial production of folic acid. Vitamin B₁₂ and other nutrient deficiencies also occur but are less common. The preferred diagnostic method is culture of a duodenal aspirate, and recent research supports a cutoff value of greater than 10³ CFUs of coliform bacteria per mL. Breath testing is less invasive but “more complex than simply measuring hydrogen,” the experts stressed. Methane-producing microorganisms (methanogens) suppress hydrogen on a breath test (fortunately, standard breath tests measure methane). Furthermore, a positive methane breath test also has been linked to constipation-predominant irritable bowel syndrome (IBS). Recent studies also suggest that lactulose breath testing is more sensitive than glucose for identifying SIBO in patients with IBS.

Antibiotic therapy is the treatment mainstay but remains largely empiric. The goal is to improve SIBO symptoms, not eradicate bacteria from the small intestine. Ideally, the antimicrobial regimen should cover both aerobic and anaerobic bacteria, but clinicians should be mindful of the risks of chronic broad-spectrum antibiotic exposure. In studies, a single 7- to 10-day antibiotic course improved symptoms in approximately 45%-90% of patients with SIBO (rates of breath test response were lower). For patients with IBS and SIBO, rifaximin (which is poorly absorbed) produced encouraging results in two phase 3 studies, but most patients did not receive breath testing, the experts noted. Patients with recurrent SIBO symptoms may need multiple courses of antibiotics with specific regimens rotated to help prevent resistance. “Decisions on management should be individualized and also [should factor in] such risks as diarrhea, Clostridiodes difficile infection, intolerance, and cost,” the experts wrote. “It is not necessary to repeat diagnostic tests for SIBO following antibiotic therapy [if] gastrointestinal symptoms respond.”

Dr. Quigley disclosed financial ties to 4D Pharma, Alimentary Health, Allergan, Biocodex, Biomerica, Ironwood, Salix, Takeda, Vibrant, and Zealand. He also disclosed patents with and equity in Alimentary Health. Both of his coauthors also disclosed ties to various pharmaceutical companies.

SOURCE: Quigley EMM et al. Gastroenterology. 2020 Jun 1. doi: 10.1053/j.gastro.2020.06.090.
 

Unexplained diarrhea may be the most reliable symptom of small intestinal bacterial overgrowth (SIBO) in at-risk patients, according to a new clinical practice update from the American Gastroenterological Association.

“In those predisposed to SIBO due to anatomical, pathological, pharmacological or other changes that promote stasis or recirculation of colonic contents and/or impaired resistance to bacteria, SIBO will lead to diarrhea and can progress to a full-blown malabsorption syndrome” marked by steatorrhea and vitamin deficiencies, wrote Eamonn M.M. Quigley, MD, of Houston Methodist Hospital and Weill Cornell Medical College in Houston together with his fellow experts in Gastroenterology. But malabsorption is uncommon in patients whose SIBO is not caused by structural abnormalities, and gastrointestinal symptoms are “weakly predictive at best” if patients lack clear risk factors for SIBO, the experts cautioned.

The growing availability of breath testing has fueled diagnoses of SIBO, which the lay press often implicates in various disorders even though SIBO has no clear clinical or laboratory definition. Recent progress in techniques to measure bacterial populations and their metabolic products “should provide much needed clarity,” but for now, a SIBO diagnosis simply means that a patient’s presenting symptoms or laboratory findings are attributed to bacterial changes in the small intestine, the experts wrote.

Detecting SIBO also remains challenging. Most patients have normal results on routine laboratory tests, and there is not enough evidence to support testing for inflammatory markers such as fecal calprotectin. Patients with SIBO may have increased folate levels because of bacterial production of folic acid. Vitamin B₁₂ and other nutrient deficiencies also occur but are less common. The preferred diagnostic method is culture of a duodenal aspirate, and recent research supports a cutoff value of greater than 10³ CFUs of coliform bacteria per mL. Breath testing is less invasive but “more complex than simply measuring hydrogen,” the experts stressed. Methane-producing microorganisms (methanogens) suppress hydrogen on a breath test (fortunately, standard breath tests measure methane). Furthermore, a positive methane breath test also has been linked to constipation-predominant irritable bowel syndrome (IBS). Recent studies also suggest that lactulose breath testing is more sensitive than glucose for identifying SIBO in patients with IBS.

Antibiotic therapy is the treatment mainstay but remains largely empiric. The goal is to improve SIBO symptoms, not eradicate bacteria from the small intestine. Ideally, the antimicrobial regimen should cover both aerobic and anaerobic bacteria, but clinicians should be mindful of the risks of chronic broad-spectrum antibiotic exposure. In studies, a single 7- to 10-day antibiotic course improved symptoms in approximately 45%-90% of patients with SIBO (rates of breath test response were lower). For patients with IBS and SIBO, rifaximin (which is poorly absorbed) produced encouraging results in two phase 3 studies, but most patients did not receive breath testing, the experts noted. Patients with recurrent SIBO symptoms may need multiple courses of antibiotics with specific regimens rotated to help prevent resistance. “Decisions on management should be individualized and also [should factor in] such risks as diarrhea, Clostridiodes difficile infection, intolerance, and cost,” the experts wrote. “It is not necessary to repeat diagnostic tests for SIBO following antibiotic therapy [if] gastrointestinal symptoms respond.”

Dr. Quigley disclosed financial ties to 4D Pharma, Alimentary Health, Allergan, Biocodex, Biomerica, Ironwood, Salix, Takeda, Vibrant, and Zealand. He also disclosed patents with and equity in Alimentary Health. Both of his coauthors also disclosed ties to various pharmaceutical companies.

SOURCE: Quigley EMM et al. Gastroenterology. 2020 Jun 1. doi: 10.1053/j.gastro.2020.06.090.
 

Unexplained diarrhea may be the most reliable symptom of small intestinal bacterial overgrowth (SIBO) in at-risk patients, according to a new clinical practice update from the American Gastroenterological Association.

“In those predisposed to SIBO due to anatomical, pathological, pharmacological or other changes that promote stasis or recirculation of colonic contents and/or impaired resistance to bacteria, SIBO will lead to diarrhea and can progress to a full-blown malabsorption syndrome” marked by steatorrhea and vitamin deficiencies, wrote Eamonn M.M. Quigley, MD, of Houston Methodist Hospital and Weill Cornell Medical College in Houston together with his fellow experts in Gastroenterology. But malabsorption is uncommon in patients whose SIBO is not caused by structural abnormalities, and gastrointestinal symptoms are “weakly predictive at best” if patients lack clear risk factors for SIBO, the experts cautioned.

The growing availability of breath testing has fueled diagnoses of SIBO, which the lay press often implicates in various disorders even though SIBO has no clear clinical or laboratory definition. Recent progress in techniques to measure bacterial populations and their metabolic products “should provide much needed clarity,” but for now, a SIBO diagnosis simply means that a patient’s presenting symptoms or laboratory findings are attributed to bacterial changes in the small intestine, the experts wrote.

Detecting SIBO also remains challenging. Most patients have normal results on routine laboratory tests, and there is not enough evidence to support testing for inflammatory markers such as fecal calprotectin. Patients with SIBO may have increased folate levels because of bacterial production of folic acid. Vitamin B₁₂ and other nutrient deficiencies also occur but are less common. The preferred diagnostic method is culture of a duodenal aspirate, and recent research supports a cutoff value of greater than 10³ CFUs of coliform bacteria per mL. Breath testing is less invasive but “more complex than simply measuring hydrogen,” the experts stressed. Methane-producing microorganisms (methanogens) suppress hydrogen on a breath test (fortunately, standard breath tests measure methane). Furthermore, a positive methane breath test also has been linked to constipation-predominant irritable bowel syndrome (IBS). Recent studies also suggest that lactulose breath testing is more sensitive than glucose for identifying SIBO in patients with IBS.

Antibiotic therapy is the treatment mainstay but remains largely empiric. The goal is to improve SIBO symptoms, not eradicate bacteria from the small intestine. Ideally, the antimicrobial regimen should cover both aerobic and anaerobic bacteria, but clinicians should be mindful of the risks of chronic broad-spectrum antibiotic exposure. In studies, a single 7- to 10-day antibiotic course improved symptoms in approximately 45%-90% of patients with SIBO (rates of breath test response were lower). For patients with IBS and SIBO, rifaximin (which is poorly absorbed) produced encouraging results in two phase 3 studies, but most patients did not receive breath testing, the experts noted. Patients with recurrent SIBO symptoms may need multiple courses of antibiotics with specific regimens rotated to help prevent resistance. “Decisions on management should be individualized and also [should factor in] such risks as diarrhea, Clostridiodes difficile infection, intolerance, and cost,” the experts wrote. “It is not necessary to repeat diagnostic tests for SIBO following antibiotic therapy [if] gastrointestinal symptoms respond.”

Dr. Quigley disclosed financial ties to 4D Pharma, Alimentary Health, Allergan, Biocodex, Biomerica, Ironwood, Salix, Takeda, Vibrant, and Zealand. He also disclosed patents with and equity in Alimentary Health. Both of his coauthors also disclosed ties to various pharmaceutical companies.

SOURCE: Quigley EMM et al. Gastroenterology. 2020 Jun 1. doi: 10.1053/j.gastro.2020.06.090.
 

The rising incidence of colorectal cancer in adults younger than 50 years heightens the need to evaluate the colon and rectum of any patient, regardless of age, who presents with symptoms such as rectal bleeding, weight loss, abdominal pain, iron-deficiency anemia, or changes in bowel habits, according to a new American Gastroenterological Association clinical practice update.

In addition to receiving cancer staging or being referred to an oncologist, newly diagnosed patients should be counseled about both germline genetic testing and fertility preservation, wrote Lisa A. Boardman, MD, of Mayo Clinic in Rochester, Minn., with associates in Clinical Gastroenterology and Hepatology. “Clinicians should present the role of fertility preservation prior to [administering] cancer-directed therapy, including surgery, pelvic radiation, or chemotherapy.”

It remains unclear why the incidence of young adult–onset colorectal cancer is rising, but the trend is not limited to the United States. Implicated risk factors include inflammatory bowel disease, prior irradiation, harboring a pathogenic germline mutation for a known hereditary cancer syndrome, and having a first- or second-degree relative with colorectal cancer. Indeed, the odds of developing young adult–onset disease are nearly 4 times higher if a parent has colorectal cancer and nearly 12 times higher if a sibling is affected.

For newly diagnosed young adults, it is important to collect a family cancer history but vital, regardless of history, to discuss targeted or multiplex germline mutation testing. Detecting hereditary colorectal cancer syndromes is crucial because their nature informs surgical options for treatment. “Roughly one in five young adult–onset colorectal cancers will be caused by a germline mutation, and among those with a detectable hereditary condition, half of those patients with young adult–onset colorectal cancer will have Lynch syndrome,” the experts noted. For these patients (who have mutations involving MSH2, EPCAM, MLH1, MSH6, and PMS2), ileorectostomy (IRA) for colorectal cancer should be considered.

For patients with the classic subtype of familial adenomatous polyposis, ileal pouch anal anastomosis is recommended after the polyp burden can no longer be managed endoscopically, although initial IRA with subsequent conversion to IPAA is an option for women of child-bearing age, according to the clinical practice update. Patients with the attenuated subtype of familial adenomatous polyposis should consider IRA or colectomy if colorectal cancer develops or if the polyp burden exceeds endoscopic control. In contrast, colectomy is the only type of surgery recommended for patients with serrated polyposis syndrome requiring surgical treatment.

Finally, clinicians should offer only screening for hereditary cancer syndromes if young adults cancer have been diagnosed with a hereditary colorectal cancer syndrome. “For patients with sporadic young adult–onset colorectal cancer, extracolonic screening and colorectal cancer surveillance intervals are the same as for patients with older adult–onset colorectal cancer,” the experts wrote. For young patients without an apparent underlying genetic syndrome, molecular studies may eventually help tailor treatment options, “but at this point, more extensive surgery or more aggressive chemotherapy cannot be recommended. As cancer treatments evolve to use patient tumor specific therapeutics, our management of patients with young adult–onset colorectal cancer will improve.”

Dr. Boardman and associates reported having no relevant conflicts of interest.

SOURCE: Boardman LA et al. Clin Gastroenterol Hepatol. 2020 Jun 7. doi: 10.1016/j.cgh.2020.05.058.
 

The rising incidence of colorectal cancer in adults younger than 50 years heightens the need to evaluate the colon and rectum of any patient, regardless of age, who presents with symptoms such as rectal bleeding, weight loss, abdominal pain, iron-deficiency anemia, or changes in bowel habits, according to a new American Gastroenterological Association clinical practice update.

In addition to receiving cancer staging or being referred to an oncologist, newly diagnosed patients should be counseled about both germline genetic testing and fertility preservation, wrote Lisa A. Boardman, MD, of Mayo Clinic in Rochester, Minn., with associates in Clinical Gastroenterology and Hepatology. “Clinicians should present the role of fertility preservation prior to [administering] cancer-directed therapy, including surgery, pelvic radiation, or chemotherapy.”

It remains unclear why the incidence of young adult–onset colorectal cancer is rising, but the trend is not limited to the United States. Implicated risk factors include inflammatory bowel disease, prior irradiation, harboring a pathogenic germline mutation for a known hereditary cancer syndrome, and having a first- or second-degree relative with colorectal cancer. Indeed, the odds of developing young adult–onset disease are nearly 4 times higher if a parent has colorectal cancer and nearly 12 times higher if a sibling is affected.

For newly diagnosed young adults, it is important to collect a family cancer history but vital, regardless of history, to discuss targeted or multiplex germline mutation testing. Detecting hereditary colorectal cancer syndromes is crucial because their nature informs surgical options for treatment. “Roughly one in five young adult–onset colorectal cancers will be caused by a germline mutation, and among those with a detectable hereditary condition, half of those patients with young adult–onset colorectal cancer will have Lynch syndrome,” the experts noted. For these patients (who have mutations involving MSH2, EPCAM, MLH1, MSH6, and PMS2), ileorectostomy (IRA) for colorectal cancer should be considered.

For patients with the classic subtype of familial adenomatous polyposis, ileal pouch anal anastomosis is recommended after the polyp burden can no longer be managed endoscopically, although initial IRA with subsequent conversion to IPAA is an option for women of child-bearing age, according to the clinical practice update. Patients with the attenuated subtype of familial adenomatous polyposis should consider IRA or colectomy if colorectal cancer develops or if the polyp burden exceeds endoscopic control. In contrast, colectomy is the only type of surgery recommended for patients with serrated polyposis syndrome requiring surgical treatment.

Finally, clinicians should offer only screening for hereditary cancer syndromes if young adults cancer have been diagnosed with a hereditary colorectal cancer syndrome. “For patients with sporadic young adult–onset colorectal cancer, extracolonic screening and colorectal cancer surveillance intervals are the same as for patients with older adult–onset colorectal cancer,” the experts wrote. For young patients without an apparent underlying genetic syndrome, molecular studies may eventually help tailor treatment options, “but at this point, more extensive surgery or more aggressive chemotherapy cannot be recommended. As cancer treatments evolve to use patient tumor specific therapeutics, our management of patients with young adult–onset colorectal cancer will improve.”

Dr. Boardman and associates reported having no relevant conflicts of interest.

SOURCE: Boardman LA et al. Clin Gastroenterol Hepatol. 2020 Jun 7. doi: 10.1016/j.cgh.2020.05.058.
 

The rising incidence of colorectal cancer in adults younger than 50 years heightens the need to evaluate the colon and rectum of any patient, regardless of age, who presents with symptoms such as rectal bleeding, weight loss, abdominal pain, iron-deficiency anemia, or changes in bowel habits, according to a new American Gastroenterological Association clinical practice update.

In addition to receiving cancer staging or being referred to an oncologist, newly diagnosed patients should be counseled about both germline genetic testing and fertility preservation, wrote Lisa A. Boardman, MD, of Mayo Clinic in Rochester, Minn., with associates in Clinical Gastroenterology and Hepatology. “Clinicians should present the role of fertility preservation prior to [administering] cancer-directed therapy, including surgery, pelvic radiation, or chemotherapy.”

It remains unclear why the incidence of young adult–onset colorectal cancer is rising, but the trend is not limited to the United States. Implicated risk factors include inflammatory bowel disease, prior irradiation, harboring a pathogenic germline mutation for a known hereditary cancer syndrome, and having a first- or second-degree relative with colorectal cancer. Indeed, the odds of developing young adult–onset disease are nearly 4 times higher if a parent has colorectal cancer and nearly 12 times higher if a sibling is affected.

For newly diagnosed young adults, it is important to collect a family cancer history but vital, regardless of history, to discuss targeted or multiplex germline mutation testing. Detecting hereditary colorectal cancer syndromes is crucial because their nature informs surgical options for treatment. “Roughly one in five young adult–onset colorectal cancers will be caused by a germline mutation, and among those with a detectable hereditary condition, half of those patients with young adult–onset colorectal cancer will have Lynch syndrome,” the experts noted. For these patients (who have mutations involving MSH2, EPCAM, MLH1, MSH6, and PMS2), ileorectostomy (IRA) for colorectal cancer should be considered.

For patients with the classic subtype of familial adenomatous polyposis, ileal pouch anal anastomosis is recommended after the polyp burden can no longer be managed endoscopically, although initial IRA with subsequent conversion to IPAA is an option for women of child-bearing age, according to the clinical practice update. Patients with the attenuated subtype of familial adenomatous polyposis should consider IRA or colectomy if colorectal cancer develops or if the polyp burden exceeds endoscopic control. In contrast, colectomy is the only type of surgery recommended for patients with serrated polyposis syndrome requiring surgical treatment.

Finally, clinicians should offer only screening for hereditary cancer syndromes if young adults cancer have been diagnosed with a hereditary colorectal cancer syndrome. “For patients with sporadic young adult–onset colorectal cancer, extracolonic screening and colorectal cancer surveillance intervals are the same as for patients with older adult–onset colorectal cancer,” the experts wrote. For young patients without an apparent underlying genetic syndrome, molecular studies may eventually help tailor treatment options, “but at this point, more extensive surgery or more aggressive chemotherapy cannot be recommended. As cancer treatments evolve to use patient tumor specific therapeutics, our management of patients with young adult–onset colorectal cancer will improve.”

Dr. Boardman and associates reported having no relevant conflicts of interest.

SOURCE: Boardman LA et al. Clin Gastroenterol Hepatol. 2020 Jun 7. doi: 10.1016/j.cgh.2020.05.058.
 

For patients with gastroesophageal reflux disease (GERD), endoscopic and minimally invasive surgical techniques may be viable alternatives to proton pump inhibitor (PPI) therapy, according to investigators.

Still, their exact role in the treatment process remains undetermined, reported Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues.

“The frequent incomplete response to PPI therapy, in addition to recent studies suggesting chronic complications with PPI therapy, have fueled discussion of alternative strategies for treating patients with GERD,” the investigators wrote in Gastroenterology. “For a substantial number of patients and providers with the above concerns who are unwilling to pursue the traditional surgical gastric fundoplication, endoscopic or less invasive surgical strategies have gained some traction.”

Dr. Vaezi and colleagues noted that they conducted the scoping review with intentions of being more descriptive than prescriptive.

“Our goal is not to recommend the utility of any of the discussed techniques in specific clinical scenarios,” they wrote. “Rather, it is to summarize the currently available evidence and identify where more research may be helpful.”

Across 22 randomized, controlled trials and observational studies, objective and symptomatic improvement varied between modalities. Measured outcomes also varied; most studies reported symptoms, health-related quality of life, and PPI use; fewer studies (but still a majority) reported intraesophageal acid exposure and/or lower esophageal sphincter (LES) pressure. Conclusions drawn by Dr. Vaezi and colleagues are summarized below.
 

Magnetic sphincter augmentation of the LES

In multiple trials, magnetic sphincter augmentation demonstrated a “high degree of efficacy” in the short or midterm, and a favorable safety profile. Dr. Vaezi and colleagues highlighted significant improvements in disease-related quality of life, with “a substantial proportion” of patients achieving normalization or at least 50% improvement in acid exposure. While some patients required esophageal dilation after the procedure, this was not needed any more frequently than after surgical fundoplication.

Radiofrequency ablation

Across five trials, radiofrequency ablation, which involves delivery of energy to the LES and gastric cardia, improved GERD-related quality of life, and reduced, but did not normalize, acid exposure. The technique lessened short-term need for PPIs, but long-term relief was not observed. Compared with observational studies, efficacy signals were weaker in randomized, controlled trials. The procedure was generally safe.

Surgical implantation of LES pacemaker

Limited data were available for LES sphincter stimulation among patients with GERD, and the most recent study, involving a comparison of device placement with or without stimulation, was terminated early. Still, available data suggest that the technique is generally well tolerated, with reduced need for PPIs, improved symptoms, and lessened acid exposure. Dr. Vaezi and colleagues noted that the manufacturing company, EndoStim, is in receivership, putting U.S. availability in question.

Full-thickness fundoplication

Endoscopic full-thickness fundoplication was associated with improvement of symptoms and quality of life, and a favorable safety profile. Although the procedure generally reduced PPI use, most patients still needed PPIs long-term. Reflux improved after the procedure, but not to the same degree as laparoscopic plication.

Transoral incisionless fundoplication

Based on a number of studies, including five randomized, controlled trials, transoral incisionless fundoplication appears safe and effective, with reduced need for PPIs up to 5 years. According to Dr. Vaezi and colleagues, variable results across studies are likely explained by variations in the technique over time and heterogeneous patient populations. Recent studies in which the “TIF 2.0 technique” has been performed on patients with hiatal hernias less than 2 cm have met objective efficacy outcomes.

Incisionless fundoplication with magnetic ultrasonic surgical endostapler

The magnetic ultrasonic surgical endostapler, which allows for incisionless fundoplication, had more limited data. Only two studies have been conducted, and neither had sham-controlled nor comparative-trial data. Furthermore, multiple safety signals have been encountered, with “substantial” complication rates and serious adverse events that were “noticeable and concerning,” according to Dr. Vaezi and colleagues.

Concluding their discussion, the investigators suggested that some endoscopic and minimally invasive approaches to GERD are “promising” alternatives to PPI therapy.

“However, their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially the durability of their effect, are understood,” they wrote.

The investigators reported no conflicts of interest.

SOURCE: Vaezi MF et al. Gastroenterology. 2020 Jul 1. doi: 10.1053/j.gastro.2020.05.097.

For patients with gastroesophageal reflux disease (GERD), endoscopic and minimally invasive surgical techniques may be viable alternatives to proton pump inhibitor (PPI) therapy, according to investigators.

Still, their exact role in the treatment process remains undetermined, reported Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues.

“The frequent incomplete response to PPI therapy, in addition to recent studies suggesting chronic complications with PPI therapy, have fueled discussion of alternative strategies for treating patients with GERD,” the investigators wrote in Gastroenterology. “For a substantial number of patients and providers with the above concerns who are unwilling to pursue the traditional surgical gastric fundoplication, endoscopic or less invasive surgical strategies have gained some traction.”

Dr. Vaezi and colleagues noted that they conducted the scoping review with intentions of being more descriptive than prescriptive.

“Our goal is not to recommend the utility of any of the discussed techniques in specific clinical scenarios,” they wrote. “Rather, it is to summarize the currently available evidence and identify where more research may be helpful.”

Across 22 randomized, controlled trials and observational studies, objective and symptomatic improvement varied between modalities. Measured outcomes also varied; most studies reported symptoms, health-related quality of life, and PPI use; fewer studies (but still a majority) reported intraesophageal acid exposure and/or lower esophageal sphincter (LES) pressure. Conclusions drawn by Dr. Vaezi and colleagues are summarized below.
 

Magnetic sphincter augmentation of the LES

In multiple trials, magnetic sphincter augmentation demonstrated a “high degree of efficacy” in the short or midterm, and a favorable safety profile. Dr. Vaezi and colleagues highlighted significant improvements in disease-related quality of life, with “a substantial proportion” of patients achieving normalization or at least 50% improvement in acid exposure. While some patients required esophageal dilation after the procedure, this was not needed any more frequently than after surgical fundoplication.

Radiofrequency ablation

Across five trials, radiofrequency ablation, which involves delivery of energy to the LES and gastric cardia, improved GERD-related quality of life, and reduced, but did not normalize, acid exposure. The technique lessened short-term need for PPIs, but long-term relief was not observed. Compared with observational studies, efficacy signals were weaker in randomized, controlled trials. The procedure was generally safe.

Surgical implantation of LES pacemaker

Limited data were available for LES sphincter stimulation among patients with GERD, and the most recent study, involving a comparison of device placement with or without stimulation, was terminated early. Still, available data suggest that the technique is generally well tolerated, with reduced need for PPIs, improved symptoms, and lessened acid exposure. Dr. Vaezi and colleagues noted that the manufacturing company, EndoStim, is in receivership, putting U.S. availability in question.

Full-thickness fundoplication

Endoscopic full-thickness fundoplication was associated with improvement of symptoms and quality of life, and a favorable safety profile. Although the procedure generally reduced PPI use, most patients still needed PPIs long-term. Reflux improved after the procedure, but not to the same degree as laparoscopic plication.

Transoral incisionless fundoplication

Based on a number of studies, including five randomized, controlled trials, transoral incisionless fundoplication appears safe and effective, with reduced need for PPIs up to 5 years. According to Dr. Vaezi and colleagues, variable results across studies are likely explained by variations in the technique over time and heterogeneous patient populations. Recent studies in which the “TIF 2.0 technique” has been performed on patients with hiatal hernias less than 2 cm have met objective efficacy outcomes.

Incisionless fundoplication with magnetic ultrasonic surgical endostapler

The magnetic ultrasonic surgical endostapler, which allows for incisionless fundoplication, had more limited data. Only two studies have been conducted, and neither had sham-controlled nor comparative-trial data. Furthermore, multiple safety signals have been encountered, with “substantial” complication rates and serious adverse events that were “noticeable and concerning,” according to Dr. Vaezi and colleagues.

Concluding their discussion, the investigators suggested that some endoscopic and minimally invasive approaches to GERD are “promising” alternatives to PPI therapy.

“However, their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially the durability of their effect, are understood,” they wrote.

The investigators reported no conflicts of interest.

SOURCE: Vaezi MF et al. Gastroenterology. 2020 Jul 1. doi: 10.1053/j.gastro.2020.05.097.

For patients with gastroesophageal reflux disease (GERD), endoscopic and minimally invasive surgical techniques may be viable alternatives to proton pump inhibitor (PPI) therapy, according to investigators.

Still, their exact role in the treatment process remains undetermined, reported Michael F. Vaezi, MD, PhD, of Vanderbilt University Medical Center in Nashville, Tenn., and colleagues.

“The frequent incomplete response to PPI therapy, in addition to recent studies suggesting chronic complications with PPI therapy, have fueled discussion of alternative strategies for treating patients with GERD,” the investigators wrote in Gastroenterology. “For a substantial number of patients and providers with the above concerns who are unwilling to pursue the traditional surgical gastric fundoplication, endoscopic or less invasive surgical strategies have gained some traction.”

Dr. Vaezi and colleagues noted that they conducted the scoping review with intentions of being more descriptive than prescriptive.

“Our goal is not to recommend the utility of any of the discussed techniques in specific clinical scenarios,” they wrote. “Rather, it is to summarize the currently available evidence and identify where more research may be helpful.”

Across 22 randomized, controlled trials and observational studies, objective and symptomatic improvement varied between modalities. Measured outcomes also varied; most studies reported symptoms, health-related quality of life, and PPI use; fewer studies (but still a majority) reported intraesophageal acid exposure and/or lower esophageal sphincter (LES) pressure. Conclusions drawn by Dr. Vaezi and colleagues are summarized below.
 

Magnetic sphincter augmentation of the LES

In multiple trials, magnetic sphincter augmentation demonstrated a “high degree of efficacy” in the short or midterm, and a favorable safety profile. Dr. Vaezi and colleagues highlighted significant improvements in disease-related quality of life, with “a substantial proportion” of patients achieving normalization or at least 50% improvement in acid exposure. While some patients required esophageal dilation after the procedure, this was not needed any more frequently than after surgical fundoplication.

Radiofrequency ablation

Across five trials, radiofrequency ablation, which involves delivery of energy to the LES and gastric cardia, improved GERD-related quality of life, and reduced, but did not normalize, acid exposure. The technique lessened short-term need for PPIs, but long-term relief was not observed. Compared with observational studies, efficacy signals were weaker in randomized, controlled trials. The procedure was generally safe.

Surgical implantation of LES pacemaker

Limited data were available for LES sphincter stimulation among patients with GERD, and the most recent study, involving a comparison of device placement with or without stimulation, was terminated early. Still, available data suggest that the technique is generally well tolerated, with reduced need for PPIs, improved symptoms, and lessened acid exposure. Dr. Vaezi and colleagues noted that the manufacturing company, EndoStim, is in receivership, putting U.S. availability in question.

Full-thickness fundoplication

Endoscopic full-thickness fundoplication was associated with improvement of symptoms and quality of life, and a favorable safety profile. Although the procedure generally reduced PPI use, most patients still needed PPIs long-term. Reflux improved after the procedure, but not to the same degree as laparoscopic plication.

Transoral incisionless fundoplication

Based on a number of studies, including five randomized, controlled trials, transoral incisionless fundoplication appears safe and effective, with reduced need for PPIs up to 5 years. According to Dr. Vaezi and colleagues, variable results across studies are likely explained by variations in the technique over time and heterogeneous patient populations. Recent studies in which the “TIF 2.0 technique” has been performed on patients with hiatal hernias less than 2 cm have met objective efficacy outcomes.

Incisionless fundoplication with magnetic ultrasonic surgical endostapler

The magnetic ultrasonic surgical endostapler, which allows for incisionless fundoplication, had more limited data. Only two studies have been conducted, and neither had sham-controlled nor comparative-trial data. Furthermore, multiple safety signals have been encountered, with “substantial” complication rates and serious adverse events that were “noticeable and concerning,” according to Dr. Vaezi and colleagues.

Concluding their discussion, the investigators suggested that some endoscopic and minimally invasive approaches to GERD are “promising” alternatives to PPI therapy.

“However, their place in the treatment algorithm for GERD will be better defined when important clinical parameters, especially the durability of their effect, are understood,” they wrote.

The investigators reported no conflicts of interest.

SOURCE: Vaezi MF et al. Gastroenterology. 2020 Jul 1. doi: 10.1053/j.gastro.2020.05.097.

The American Psychiatric Association has released a new evidence-based practice guideline for the treatment of schizophrenia.

The guideline focuses on assessment and treatment planning, which are integral to patient-centered care, and includes recommendations regarding pharmacotherapy, with particular focus on clozapine, as well as previously recommended and new psychosocial interventions.

“Our intention was to make recommendations to treat the whole person and take into account their family and other significant people in their lives,” George Keepers, MD, chair of the guideline writing group, said in an interview.
 

‘State-of-the-art methodology’

Dr. Keepers, professor of psychiatry at Oregon Health and Science University, Portland, explained the rigorous process that informs the current guideline, which was “based not solely on expert consensus but was preceded by an evidence-based review of the literature that was then discussed, digested, and distilled into specific recommendations.”

Many current recommendations are “similar to previous recommendations, but there are a few important differences,” he said.

Two experts in schizophrenia who were not involved in guideline authorship praised it for its usefulness and methodology.

Philip D. Harvey, PhD, Leonard M. Miller Professor of Psychiatry and Behavioral Sciences, University of Miami, said in an interview that the guideline “clarified the typical treatment algorithm from first episode to treatment resistance [which is] very clearly laid out for the first time.”

Christoph Correll, MD, professor of psychiatry and molecular medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y., said in an interview that the guideline “followed state-of-the-art methodology.”
 

First steps

The guideline recommends beginning with assessment of the patient and determination of the treatment plan.

Patients should be “treated with an antipsychotic medication and monitored for effectiveness and side effects.” Even after the patient’s symptoms have improved, antipsychotic treatment should continue.

For patients whose symptoms have improved, treatment should continue with the same antipsychotic and should not be switched.

“The problem we’re addressing in this recommendation is that patients are often treated with an effective medication and then forced, by circumstances or their insurance company, to switch to another that may not be effective for them, resulting in unnecessary relapses of the illness,” said Dr. Keepers.

“All we can do is recommend appropriate treatment and hope that the decision makers of the insurance companies will heed these recommendations and do what’s in the best interest of the patient,” he said.

“The guideline called out that antipsychotics that are effective and tolerated should be continued, without specifying a duration of treatment, thereby indicating indirectly that there is no clear end of the recommendation for ongoing maintenance treatment in individuals with schizophrenia,” said Dr. Correll.
 

Clozapine underutilized

The guideline highlights the role of clozapine and recommends its use for patients with treatment-resistant schizophrenia and those at risk for suicide. Clozapine is also recommended for patients at “substantial” risk for aggressive behavior, regardless of other treatments.

“Clozapine is underutilized for treatment of schizophrenia in the U.S. and a number of other countries, but it is a really important treatment for patients who don’t respond to other antipsychotic agents,” said Dr. Keepers.

“With this recommendation, we hope that more patients will wind up receiving the medication and benefiting from it,” he added.

In addition, patients should receive treatment with a long-acting injectable antipsychotic “if they prefer such treatment or if they have a history of poor or uncertain adherence” (level of evidence, 2B).

The guideline authors “are recommending long-acting injectable medications for people who want them, not just people with poor prior adherence, which is a critical step,” said Dr. Harvey, director of the division of psychology at the University of Miami.
 

Managing antipsychotic side effects

The guideline offers recommendations for patients experiencing antipsychotic-induced side effects. 

VMAT2s, which represent a “class of drugs that have become available since the last schizophrenia guidelines, are effective in tardive dyskinesia. It is important that patients with tardive dyskinesia have access to these drugs because they do work,” Dr. Keepers said.
 

Adequate funding needed

Recommended psychosocial interventions include treatment in a specialty care program for patients with schizophrenia who are experiencing a first episode of psychosis, use of cognitive-behavioral therapy for psychosis, psychoeducation, and supported employment services (2B).

“We reviewed very good data showing that patients who receive these services are more likely to be able to be employed and less likely to be rehospitalized or have a relapse,” Dr. Keepers observed.

In addition, patients with schizophrenia should receive assertive community treatment interventions if there is a “history of poor engagement with services leading to frequent relapse or social disruption.”

Family interventions are recommended for patients who have ongoing contact with their families (2B), and patients should also receive interventions “aimed at developing self-management skills and enhancing person-oriented recovery.” They should receive cognitive remediation, social skills training, and supportive psychotherapy.

Dr. Keepers pointed to “major barriers” to providing some of these psychosocial treatments. “They are beyond the scope of someone in an individual private practice situation, so they need to be delivered within the context of treatment programs that are either publicly or privately based,” he said.

“Psychiatrists can and do work closely with community and mental health centers, psychologists, and social workers who can provide these kinds of treatments,” but “many [treatments] require specialized skills and training before they can be offered, and there is a shortage of personnel to deliver them,” he noted.

“Both the national and state governments have not provided adequate funding for treatment of individuals with this condition [schizophrenia],” he added.

Dr. Keepers reports no relevant financial relationships. The other authors’ disclosures are listed in the original article. Dr. Harvey reports no relevant financial relationships. Dr. Correll disclosed ties to Acadia, Alkermes, Allergan, Angelini, Axsome, Gedeon Richter, Gerson Lehrman Group, Indivior, IntraCellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, Medscape, Merck, Mylan, Neurocrine, Noven, Otsuka, Pfizer, Recordati, Rovi, Servier, Sumitomo Dainippon, Sunovion, Supernus, Takeda, and Teva. He has received grant support from Janssen and Takeda. He is also a stock option holder of LB Pharma.
 

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

The American Psychiatric Association has released a new evidence-based practice guideline for the treatment of schizophrenia.

The guideline focuses on assessment and treatment planning, which are integral to patient-centered care, and includes recommendations regarding pharmacotherapy, with particular focus on clozapine, as well as previously recommended and new psychosocial interventions.

“Our intention was to make recommendations to treat the whole person and take into account their family and other significant people in their lives,” George Keepers, MD, chair of the guideline writing group, said in an interview.
 

‘State-of-the-art methodology’

Dr. Keepers, professor of psychiatry at Oregon Health and Science University, Portland, explained the rigorous process that informs the current guideline, which was “based not solely on expert consensus but was preceded by an evidence-based review of the literature that was then discussed, digested, and distilled into specific recommendations.”

Many current recommendations are “similar to previous recommendations, but there are a few important differences,” he said.

Two experts in schizophrenia who were not involved in guideline authorship praised it for its usefulness and methodology.

Philip D. Harvey, PhD, Leonard M. Miller Professor of Psychiatry and Behavioral Sciences, University of Miami, said in an interview that the guideline “clarified the typical treatment algorithm from first episode to treatment resistance [which is] very clearly laid out for the first time.”

Christoph Correll, MD, professor of psychiatry and molecular medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y., said in an interview that the guideline “followed state-of-the-art methodology.”
 

First steps

The guideline recommends beginning with assessment of the patient and determination of the treatment plan.

Patients should be “treated with an antipsychotic medication and monitored for effectiveness and side effects.” Even after the patient’s symptoms have improved, antipsychotic treatment should continue.

For patients whose symptoms have improved, treatment should continue with the same antipsychotic and should not be switched.

“The problem we’re addressing in this recommendation is that patients are often treated with an effective medication and then forced, by circumstances or their insurance company, to switch to another that may not be effective for them, resulting in unnecessary relapses of the illness,” said Dr. Keepers.

“All we can do is recommend appropriate treatment and hope that the decision makers of the insurance companies will heed these recommendations and do what’s in the best interest of the patient,” he said.

“The guideline called out that antipsychotics that are effective and tolerated should be continued, without specifying a duration of treatment, thereby indicating indirectly that there is no clear end of the recommendation for ongoing maintenance treatment in individuals with schizophrenia,” said Dr. Correll.
 

Clozapine underutilized

The guideline highlights the role of clozapine and recommends its use for patients with treatment-resistant schizophrenia and those at risk for suicide. Clozapine is also recommended for patients at “substantial” risk for aggressive behavior, regardless of other treatments.

“Clozapine is underutilized for treatment of schizophrenia in the U.S. and a number of other countries, but it is a really important treatment for patients who don’t respond to other antipsychotic agents,” said Dr. Keepers.

“With this recommendation, we hope that more patients will wind up receiving the medication and benefiting from it,” he added.

In addition, patients should receive treatment with a long-acting injectable antipsychotic “if they prefer such treatment or if they have a history of poor or uncertain adherence” (level of evidence, 2B).

The guideline authors “are recommending long-acting injectable medications for people who want them, not just people with poor prior adherence, which is a critical step,” said Dr. Harvey, director of the division of psychology at the University of Miami.
 

Managing antipsychotic side effects

The guideline offers recommendations for patients experiencing antipsychotic-induced side effects. 

VMAT2s, which represent a “class of drugs that have become available since the last schizophrenia guidelines, are effective in tardive dyskinesia. It is important that patients with tardive dyskinesia have access to these drugs because they do work,” Dr. Keepers said.
 

Adequate funding needed

Recommended psychosocial interventions include treatment in a specialty care program for patients with schizophrenia who are experiencing a first episode of psychosis, use of cognitive-behavioral therapy for psychosis, psychoeducation, and supported employment services (2B).

“We reviewed very good data showing that patients who receive these services are more likely to be able to be employed and less likely to be rehospitalized or have a relapse,” Dr. Keepers observed.

In addition, patients with schizophrenia should receive assertive community treatment interventions if there is a “history of poor engagement with services leading to frequent relapse or social disruption.”

Family interventions are recommended for patients who have ongoing contact with their families (2B), and patients should also receive interventions “aimed at developing self-management skills and enhancing person-oriented recovery.” They should receive cognitive remediation, social skills training, and supportive psychotherapy.

Dr. Keepers pointed to “major barriers” to providing some of these psychosocial treatments. “They are beyond the scope of someone in an individual private practice situation, so they need to be delivered within the context of treatment programs that are either publicly or privately based,” he said.

“Psychiatrists can and do work closely with community and mental health centers, psychologists, and social workers who can provide these kinds of treatments,” but “many [treatments] require specialized skills and training before they can be offered, and there is a shortage of personnel to deliver them,” he noted.

“Both the national and state governments have not provided adequate funding for treatment of individuals with this condition [schizophrenia],” he added.

Dr. Keepers reports no relevant financial relationships. The other authors’ disclosures are listed in the original article. Dr. Harvey reports no relevant financial relationships. Dr. Correll disclosed ties to Acadia, Alkermes, Allergan, Angelini, Axsome, Gedeon Richter, Gerson Lehrman Group, Indivior, IntraCellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, Medscape, Merck, Mylan, Neurocrine, Noven, Otsuka, Pfizer, Recordati, Rovi, Servier, Sumitomo Dainippon, Sunovion, Supernus, Takeda, and Teva. He has received grant support from Janssen and Takeda. He is also a stock option holder of LB Pharma.
 

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

The American Psychiatric Association has released a new evidence-based practice guideline for the treatment of schizophrenia.

The guideline focuses on assessment and treatment planning, which are integral to patient-centered care, and includes recommendations regarding pharmacotherapy, with particular focus on clozapine, as well as previously recommended and new psychosocial interventions.

“Our intention was to make recommendations to treat the whole person and take into account their family and other significant people in their lives,” George Keepers, MD, chair of the guideline writing group, said in an interview.
 

‘State-of-the-art methodology’

Dr. Keepers, professor of psychiatry at Oregon Health and Science University, Portland, explained the rigorous process that informs the current guideline, which was “based not solely on expert consensus but was preceded by an evidence-based review of the literature that was then discussed, digested, and distilled into specific recommendations.”

Many current recommendations are “similar to previous recommendations, but there are a few important differences,” he said.

Two experts in schizophrenia who were not involved in guideline authorship praised it for its usefulness and methodology.

Philip D. Harvey, PhD, Leonard M. Miller Professor of Psychiatry and Behavioral Sciences, University of Miami, said in an interview that the guideline “clarified the typical treatment algorithm from first episode to treatment resistance [which is] very clearly laid out for the first time.”

Christoph Correll, MD, professor of psychiatry and molecular medicine, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Hempstead, N.Y., said in an interview that the guideline “followed state-of-the-art methodology.”
 

First steps

The guideline recommends beginning with assessment of the patient and determination of the treatment plan.

Patients should be “treated with an antipsychotic medication and monitored for effectiveness and side effects.” Even after the patient’s symptoms have improved, antipsychotic treatment should continue.

For patients whose symptoms have improved, treatment should continue with the same antipsychotic and should not be switched.

“The problem we’re addressing in this recommendation is that patients are often treated with an effective medication and then forced, by circumstances or their insurance company, to switch to another that may not be effective for them, resulting in unnecessary relapses of the illness,” said Dr. Keepers.

“All we can do is recommend appropriate treatment and hope that the decision makers of the insurance companies will heed these recommendations and do what’s in the best interest of the patient,” he said.

“The guideline called out that antipsychotics that are effective and tolerated should be continued, without specifying a duration of treatment, thereby indicating indirectly that there is no clear end of the recommendation for ongoing maintenance treatment in individuals with schizophrenia,” said Dr. Correll.
 

Clozapine underutilized

The guideline highlights the role of clozapine and recommends its use for patients with treatment-resistant schizophrenia and those at risk for suicide. Clozapine is also recommended for patients at “substantial” risk for aggressive behavior, regardless of other treatments.

“Clozapine is underutilized for treatment of schizophrenia in the U.S. and a number of other countries, but it is a really important treatment for patients who don’t respond to other antipsychotic agents,” said Dr. Keepers.

“With this recommendation, we hope that more patients will wind up receiving the medication and benefiting from it,” he added.

In addition, patients should receive treatment with a long-acting injectable antipsychotic “if they prefer such treatment or if they have a history of poor or uncertain adherence” (level of evidence, 2B).

The guideline authors “are recommending long-acting injectable medications for people who want them, not just people with poor prior adherence, which is a critical step,” said Dr. Harvey, director of the division of psychology at the University of Miami.
 

Managing antipsychotic side effects

The guideline offers recommendations for patients experiencing antipsychotic-induced side effects. 

VMAT2s, which represent a “class of drugs that have become available since the last schizophrenia guidelines, are effective in tardive dyskinesia. It is important that patients with tardive dyskinesia have access to these drugs because they do work,” Dr. Keepers said.
 

Adequate funding needed

Recommended psychosocial interventions include treatment in a specialty care program for patients with schizophrenia who are experiencing a first episode of psychosis, use of cognitive-behavioral therapy for psychosis, psychoeducation, and supported employment services (2B).

“We reviewed very good data showing that patients who receive these services are more likely to be able to be employed and less likely to be rehospitalized or have a relapse,” Dr. Keepers observed.

In addition, patients with schizophrenia should receive assertive community treatment interventions if there is a “history of poor engagement with services leading to frequent relapse or social disruption.”

Family interventions are recommended for patients who have ongoing contact with their families (2B), and patients should also receive interventions “aimed at developing self-management skills and enhancing person-oriented recovery.” They should receive cognitive remediation, social skills training, and supportive psychotherapy.

Dr. Keepers pointed to “major barriers” to providing some of these psychosocial treatments. “They are beyond the scope of someone in an individual private practice situation, so they need to be delivered within the context of treatment programs that are either publicly or privately based,” he said.

“Psychiatrists can and do work closely with community and mental health centers, psychologists, and social workers who can provide these kinds of treatments,” but “many [treatments] require specialized skills and training before they can be offered, and there is a shortage of personnel to deliver them,” he noted.

“Both the national and state governments have not provided adequate funding for treatment of individuals with this condition [schizophrenia],” he added.

Dr. Keepers reports no relevant financial relationships. The other authors’ disclosures are listed in the original article. Dr. Harvey reports no relevant financial relationships. Dr. Correll disclosed ties to Acadia, Alkermes, Allergan, Angelini, Axsome, Gedeon Richter, Gerson Lehrman Group, Indivior, IntraCellular Therapies, Janssen/J&J, LB Pharma, Lundbeck, MedAvante-ProPhase, Medscape, Merck, Mylan, Neurocrine, Noven, Otsuka, Pfizer, Recordati, Rovi, Servier, Sumitomo Dainippon, Sunovion, Supernus, Takeda, and Teva. He has received grant support from Janssen and Takeda. He is also a stock option holder of LB Pharma.
 

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

The American Gastroenterological Association (AGA) has published a clinical practice update for endoscopic management of nonvariceal upper GI bleeding (NVUGIB).

The update includes 10 best practice recommendations based on clinical experience and a comprehensive literature review, reported lead author Daniel K. Mullady, MD, of Washington University in St. Louis.

“Numerous endoscopic devices have been developed over the past 30 years with demonstrated effectiveness in treating NVUGIB,” Dr. Mullady and colleagues wrote in Gastroenterology. “The purpose of this clinical practice update is to review the key concepts, new devices, and therapeutic strategies in endoscopically combating this age-old clinical dilemma.”

According to the investigators, endoscopy is central to management of NVUGIB, but only after patients are appropriately triaged and stabilized.

“[E]ndoscopy should be performed to determine the source of bleeding, to assess rebleeding risk, and to treat lesions at high risk for rebleeding,” they wrote. “Exactly when the endoscopy should be performed is a clinical judgment made by the gastroenterologist in consultation with the primary service.”

The investigators recommended that endoscopy be performed within 12 hours for emergent cases and within 24 hours for urgent cases, whereas elective cases could wait longer.

They noted that NVUGIB can range from mild and self-limiting, allowing for outpatient management, to severe and life-threatening, necessitating intensive care. Because of this broad range, the investigators recommended familiarity with triage scoring systems, including the Glasgow-Blatchford Score, the Rockall Score, and AIMS-65.

“A common decision is deciding whether or not to wait until the next morning to perform endoscopy on a patient presenting after hours with suspected NVUGIB,” the investigators wrote.

The investigators cautioned that emergent endoscopy may actually be associated with poorer outcomes because of “inadequate resuscitation,” and suggested that “[p]atients who are hemodynamically stable, do not have ongoing hematemesis, and have melena only can generally be deferred to the following morning.”

Concerning hemostatic technique, Dr. Mullady and colleagues recommended familiarity with conventional thermal therapy and placement of hemoclips. If these approaches are unsuccessful, or deemed unlikely to succeed, they recommended an over-the-scope clip.

For ulcers “with a rigid and fibrotic base,” or those that are hard to reach, the investigators recommended monopolar hemostatic forceps with low-voltage coagulation.

According to the update, hemostatic powder should be reserved for scenarios in which bleeding is diffuse and difficult to locate.

“In most instances, hemostatic powder should be preferentially used as a rescue therapy and not for primary hemostasis, except in cases of malignant bleeding or massive bleeding with inability to perform thermal therapy or hemoclip placement,” the investigators wrote.

They noted that hemostatic powder generally dissolves in less than 24 hours, so additional treatment approaches should be considered, particular when there is a high risk of rebleeding.

When deciding between transcatheter arterial embolization (TAE) and surgery after endoscopic failure, the update calls for a comprehensive clinical assessment that incorporates patient factors, such as coagulopathy, hemodynamic instability, and multiorgan failure; bleeding etiology; potential adverse effects; and rebleeding risk.

“An important point is that prophylactic TAE of high-risk ulcers after successful endoscopic therapy is not recommended,” the investigators wrote.

Beyond these recommendations, the update includes a comprehensive discussion of relevant literature and strategies for effective clinical decision making. The discussion concludes with global remarks about the evolving role of endoscopy in managing NVUGIB, including a note about cost-effectiveness despite up-front expenses associated with some methods.

“With this expanded endoscopic armamentarium, endoscopic therapy should achieve hemostasis in the majority of patients with NVUGIB,” the investigators wrote. “Despite the increased costs of newer devices or multimodal therapy, effective hemostasis to preventing rebleeding and the need for hospital readmission is likely to be a dominant cost-saving strategy.”

Dr. Mullady disclosed relationships with Boston Scientific, ConMed, and Cook Medical.

This story was updated on 9/9/2020.

SOURCE: Mullady DK et al. Gastro. 2020 Jun 20. doi: 10.1053/j.gastro.2020.05.095.

The American Gastroenterological Association (AGA) has published a clinical practice update for endoscopic management of nonvariceal upper GI bleeding (NVUGIB).

The update includes 10 best practice recommendations based on clinical experience and a comprehensive literature review, reported lead author Daniel K. Mullady, MD, of Washington University in St. Louis.

“Numerous endoscopic devices have been developed over the past 30 years with demonstrated effectiveness in treating NVUGIB,” Dr. Mullady and colleagues wrote in Gastroenterology. “The purpose of this clinical practice update is to review the key concepts, new devices, and therapeutic strategies in endoscopically combating this age-old clinical dilemma.”

According to the investigators, endoscopy is central to management of NVUGIB, but only after patients are appropriately triaged and stabilized.

“[E]ndoscopy should be performed to determine the source of bleeding, to assess rebleeding risk, and to treat lesions at high risk for rebleeding,” they wrote. “Exactly when the endoscopy should be performed is a clinical judgment made by the gastroenterologist in consultation with the primary service.”

The investigators recommended that endoscopy be performed within 12 hours for emergent cases and within 24 hours for urgent cases, whereas elective cases could wait longer.

They noted that NVUGIB can range from mild and self-limiting, allowing for outpatient management, to severe and life-threatening, necessitating intensive care. Because of this broad range, the investigators recommended familiarity with triage scoring systems, including the Glasgow-Blatchford Score, the Rockall Score, and AIMS-65.

“A common decision is deciding whether or not to wait until the next morning to perform endoscopy on a patient presenting after hours with suspected NVUGIB,” the investigators wrote.

The investigators cautioned that emergent endoscopy may actually be associated with poorer outcomes because of “inadequate resuscitation,” and suggested that “[p]atients who are hemodynamically stable, do not have ongoing hematemesis, and have melena only can generally be deferred to the following morning.”

Concerning hemostatic technique, Dr. Mullady and colleagues recommended familiarity with conventional thermal therapy and placement of hemoclips. If these approaches are unsuccessful, or deemed unlikely to succeed, they recommended an over-the-scope clip.

For ulcers “with a rigid and fibrotic base,” or those that are hard to reach, the investigators recommended monopolar hemostatic forceps with low-voltage coagulation.

According to the update, hemostatic powder should be reserved for scenarios in which bleeding is diffuse and difficult to locate.

“In most instances, hemostatic powder should be preferentially used as a rescue therapy and not for primary hemostasis, except in cases of malignant bleeding or massive bleeding with inability to perform thermal therapy or hemoclip placement,” the investigators wrote.

They noted that hemostatic powder generally dissolves in less than 24 hours, so additional treatment approaches should be considered, particular when there is a high risk of rebleeding.

When deciding between transcatheter arterial embolization (TAE) and surgery after endoscopic failure, the update calls for a comprehensive clinical assessment that incorporates patient factors, such as coagulopathy, hemodynamic instability, and multiorgan failure; bleeding etiology; potential adverse effects; and rebleeding risk.

“An important point is that prophylactic TAE of high-risk ulcers after successful endoscopic therapy is not recommended,” the investigators wrote.

Beyond these recommendations, the update includes a comprehensive discussion of relevant literature and strategies for effective clinical decision making. The discussion concludes with global remarks about the evolving role of endoscopy in managing NVUGIB, including a note about cost-effectiveness despite up-front expenses associated with some methods.

“With this expanded endoscopic armamentarium, endoscopic therapy should achieve hemostasis in the majority of patients with NVUGIB,” the investigators wrote. “Despite the increased costs of newer devices or multimodal therapy, effective hemostasis to preventing rebleeding and the need for hospital readmission is likely to be a dominant cost-saving strategy.”

Dr. Mullady disclosed relationships with Boston Scientific, ConMed, and Cook Medical.

This story was updated on 9/9/2020.

SOURCE: Mullady DK et al. Gastro. 2020 Jun 20. doi: 10.1053/j.gastro.2020.05.095.

The American Gastroenterological Association (AGA) has published a clinical practice update for endoscopic management of nonvariceal upper GI bleeding (NVUGIB).

The update includes 10 best practice recommendations based on clinical experience and a comprehensive literature review, reported lead author Daniel K. Mullady, MD, of Washington University in St. Louis.

“Numerous endoscopic devices have been developed over the past 30 years with demonstrated effectiveness in treating NVUGIB,” Dr. Mullady and colleagues wrote in Gastroenterology. “The purpose of this clinical practice update is to review the key concepts, new devices, and therapeutic strategies in endoscopically combating this age-old clinical dilemma.”

According to the investigators, endoscopy is central to management of NVUGIB, but only after patients are appropriately triaged and stabilized.

“[E]ndoscopy should be performed to determine the source of bleeding, to assess rebleeding risk, and to treat lesions at high risk for rebleeding,” they wrote. “Exactly when the endoscopy should be performed is a clinical judgment made by the gastroenterologist in consultation with the primary service.”

The investigators recommended that endoscopy be performed within 12 hours for emergent cases and within 24 hours for urgent cases, whereas elective cases could wait longer.

They noted that NVUGIB can range from mild and self-limiting, allowing for outpatient management, to severe and life-threatening, necessitating intensive care. Because of this broad range, the investigators recommended familiarity with triage scoring systems, including the Glasgow-Blatchford Score, the Rockall Score, and AIMS-65.

“A common decision is deciding whether or not to wait until the next morning to perform endoscopy on a patient presenting after hours with suspected NVUGIB,” the investigators wrote.

The investigators cautioned that emergent endoscopy may actually be associated with poorer outcomes because of “inadequate resuscitation,” and suggested that “[p]atients who are hemodynamically stable, do not have ongoing hematemesis, and have melena only can generally be deferred to the following morning.”

Concerning hemostatic technique, Dr. Mullady and colleagues recommended familiarity with conventional thermal therapy and placement of hemoclips. If these approaches are unsuccessful, or deemed unlikely to succeed, they recommended an over-the-scope clip.

For ulcers “with a rigid and fibrotic base,” or those that are hard to reach, the investigators recommended monopolar hemostatic forceps with low-voltage coagulation.

According to the update, hemostatic powder should be reserved for scenarios in which bleeding is diffuse and difficult to locate.

“In most instances, hemostatic powder should be preferentially used as a rescue therapy and not for primary hemostasis, except in cases of malignant bleeding or massive bleeding with inability to perform thermal therapy or hemoclip placement,” the investigators wrote.

They noted that hemostatic powder generally dissolves in less than 24 hours, so additional treatment approaches should be considered, particular when there is a high risk of rebleeding.

When deciding between transcatheter arterial embolization (TAE) and surgery after endoscopic failure, the update calls for a comprehensive clinical assessment that incorporates patient factors, such as coagulopathy, hemodynamic instability, and multiorgan failure; bleeding etiology; potential adverse effects; and rebleeding risk.

“An important point is that prophylactic TAE of high-risk ulcers after successful endoscopic therapy is not recommended,” the investigators wrote.

Beyond these recommendations, the update includes a comprehensive discussion of relevant literature and strategies for effective clinical decision making. The discussion concludes with global remarks about the evolving role of endoscopy in managing NVUGIB, including a note about cost-effectiveness despite up-front expenses associated with some methods.

“With this expanded endoscopic armamentarium, endoscopic therapy should achieve hemostasis in the majority of patients with NVUGIB,” the investigators wrote. “Despite the increased costs of newer devices or multimodal therapy, effective hemostasis to preventing rebleeding and the need for hospital readmission is likely to be a dominant cost-saving strategy.”

Dr. Mullady disclosed relationships with Boston Scientific, ConMed, and Cook Medical.

This story was updated on 9/9/2020.

SOURCE: Mullady DK et al. Gastro. 2020 Jun 20. doi: 10.1053/j.gastro.2020.05.095.

New atrial fibrillation (AFib) management guidelines from the European Society of Cardiology (ESC) call for diagnostic confirmation and structured characterization of AFib and the need to streamline integrated care with the Atrial fibrillation Better Care (ABC) pathway.

“It’s as simple as CC to ABC,” quipped one task force member during the virtual unveiling of the guidelines at the ESC Congress 2020.

The guidelines were developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS) and published simultaneously August 29 in the European Heart Journal.

Acknowledging the slew of novel screening tools now available and their reported sensitivity and specificity rates, the document supports opportunistic screening for AFib by pulse taking or electrocardiogram (ECG) rhythm strip in patients at least 65 years of age, with a class 1 recommendation, evidence level B.

Systematic ECG screening should also be considered to detect AFib in individuals at least 75 years of age or in those at high risk for stroke (class IIa, level B).

Other new class I screening recommendations are to inform individuals undergoing screening about the significance and treatment implications of detecting AFib and to have a structured referral platform in place for further physician-led evaluation.

A definite diagnosis of clinical AFib is established only after confirmation by a conventional 12-lead ECG or single-lead ECG strip with at least 30 seconds of AFib.

In line with ESC’s 2016 AFib guidelines, the new iteration classifies AFib as first diagnosed, paroxysmal, persistent, long-standing persistent, and permanent. But it’s also important to classify the clinical profile of AFib, task force member Giuseppe Boriani, MD, PhD, University of Modena, Italy, said in the first of five presentations.

“So the novelty of the 2020 guidelines is related to the proposal of the 4S-AF scheme for a structured characterization of atrial fibrillation that takes into account Stroke risk, severity of Symptoms, Severity of atrial fibrillation burden, and Substrate severity,” he said.

This represents a paradigm shift from a single-domain conventional classification of AFib toward a structured characterization that streamlines assessment, informs treatment decision-making, and facilitates communication among physicians of various specialties, said Tatjana Potpara, MD, PhD, guideline co-chair and head of the Department for Intensive Arrhythmia Care, Clinical Centre of Serbia, Belgrade.

“The beauty of this approach is that, at present, the assessment of the ‘S’ components are performed using available tools, but in the future, the 4S-AF has a great potential to incorporate whatever becomes available for a more precision assessment of substrate or symptoms or arrhythmia burden and so forth,” she said.


 

ABC pathway

The guidelines advocate the previously described ABC pathway for integrated care management, which includes ‘A’ for Anticoagulation/Avoid stroke, ‘B’ for Better symptom control, and ‘C’ for Comorbidity/Cardiovascular risk factor optimization.

The document strengthens support for formal risk score–based assessment of bleeding risk in all patients, including use of the HAS-BLED score to help address modifiable bleeding risk factors and to identify patients at high bleeding risk (HAS-BLED score ≥3) for early and more frequent follow-up.

These assessments should be done regularly, given that both stroke and bleeding risk are dynamic and change over time with aging and comorbidities, Dr. Potpara stressed. In patients with AFib initially at low risk for stroke, the next assessment should be optimally performed at 4-6 months.

The guideline also targets weight loss in patients who are obese and have AFib, particularly those being evaluated for ablation, and good blood pressure control in patients with AFib and hypertension to reduce AFib recurrences and risk for stroke and bleeding (both class I, up from IIa). 

It’s particularly important that these risk factors are addressed, and that modifiable risk factors that go along with increased AFib occurrence and persistence are addressed and communicated to patients, said Gerhard Hindricks, MD, PhD, guideline cochair and medical director of the Rhythmology Department, Heart Centre Leipzig (Germany).

“I have to confess, as an interventional electrophysiologist, there has been a time where I have not appreciated these risk factors intensely enough,” he said. “But we have learned, also in the field of catheter ablation, that weight loss is an essential basis for a good procedure. If we can motivate patients to lose weight and then come to the intervention with better outcome, it’s a true benefit for the patient and addresses patient values. So I’m particularly happy we have introduced that with such intensity in the guidelines.”
 

Rate and rhythm control

The guidelines make no recommendation of one novel oral anticoagulant (NOAC) over another. However, in patients already receiving vitamin K antagonists with low time in the therapeutic range, they recommend switching to a different NOAC but ensuring good adherence and persistence with therapy (class I recommendation) or efforts to improve time in therapeutic range (class IIa).

Catheter ablation takes on a more prominent role for rhythm control and is now recommended after one antiarrhythmic drug therapy fails to improve symptoms of AF recurrence in patients with paroxysmal AFib, or persistent AFib with or without major risk factors for recurrence. The class I recommendation is based on results from the CAPTAF and CABANA trials, said task force member Carina Blomström-Lundqvist, MD, PhD, Uppsala University, Sweden.

Catheter ablation is also now a first-line therapy for patients with AFib who have a high likelihood of tachycardia-induced cardiomyopathy, independent of symptom status. “In this subset of patients, catheter ablation may offer a lot with respect to restoration of left ventricular function,” observed Dr. Hindricks.

Complete electrical isolation of the pulmonary veins is recommended during all AFib catheter ablation procedures (class I).

“Even as a medical conservative, I think it is totally reasonable to move to catheter ablation after a failed drug trial,” commented John Mandrola, MD, Baptist Health, Louisville, Ky., who was not a part of the guideline development. 

Although the chance of a second drug working after one failure is low, he noted that operators in the United States have dofetilide, which is not used much in Europe, and sometimes works surprisingly well.

“That said, the caveat is that moving to catheter ablation after drug failure is only appropriate if we have addressed all the pertinent risk factors: sleep apnea, weight loss, lack of fitness, blood pressure control, and alcohol excess,” he said. 

As for tachycardia-mediated cardiomyopathy, this too can be reasonable, Dr. Mandrola said. “I often get people ‘out of a hole’ with amiodarone plus cardioversion for a few months and then proceed to ablation.”

Notably, the 2020 iteration sharpens its recommendation that amiodarone not be used first-line for long-term rhythm control in all patients with AFib, including those with heart failure with reduced ejection fraction, given its extracardiac toxicity (class I, up from IIa).
 

Quality counts

In response to growing evidence that guideline-adherence is associated with significantly better outcomes in AFib, the 2020 ESC/EACTS guidelines explicitly included a recommendation on the need to measure quality of care to identify opportunities for improvement.

With this framework in mind, a task force with 23 people – including members from ESC and heart rhythm societies in the United States, Asia Pacific, and Latin America, along with patient representatives – was created to develop a list of quality indicators (QIs), ultimately settling on 17 main QIs and 17 secondary ones, said Elena Arbelo, MD, PhD, MSc, University of Barcelona.

The QIs are classified into six domains: patient assessment, anticoagulation, rate control, rhythm control, risk factor modification, and, importantly, outcome measures. A full list is accessible in a paper, simultaneously published in EP EuroPace.

Five patient-reported outcomes fall under the outcomes domain but only one – health-related quality of life – is a main quality indicator. The remaining outcomes are still important but are listed as secondary because of the lack of evidence to sustain or defend their systematic implementation, particularly evidence on how to measure them appropriately, Dr. Arbelo said.

“Hopefully, following the [class I] recommendation by the 2020 ESC guidelines to routinely collect patient-reported outcomes will allow us to collect further evidence and in the future have sufficient evidence to include these as a main outcome,” she said.

The QI work was driven in parallel with the guidelines and had a huge impact on its development, including inclusion of clear recommendations on how to measure quality, Dr. Hindricks said. “I believe that the whole issue of quality management in the treatment of patients with a focus on patient values cannot be overestimated.”

Disclosure information for all writing committee members is in the report. Dr. Mandrola is a writer and podcaster for Medscape.
 

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

New atrial fibrillation (AFib) management guidelines from the European Society of Cardiology (ESC) call for diagnostic confirmation and structured characterization of AFib and the need to streamline integrated care with the Atrial fibrillation Better Care (ABC) pathway.

“It’s as simple as CC to ABC,” quipped one task force member during the virtual unveiling of the guidelines at the ESC Congress 2020.

The guidelines were developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS) and published simultaneously August 29 in the European Heart Journal.

Acknowledging the slew of novel screening tools now available and their reported sensitivity and specificity rates, the document supports opportunistic screening for AFib by pulse taking or electrocardiogram (ECG) rhythm strip in patients at least 65 years of age, with a class 1 recommendation, evidence level B.

Systematic ECG screening should also be considered to detect AFib in individuals at least 75 years of age or in those at high risk for stroke (class IIa, level B).

Other new class I screening recommendations are to inform individuals undergoing screening about the significance and treatment implications of detecting AFib and to have a structured referral platform in place for further physician-led evaluation.

A definite diagnosis of clinical AFib is established only after confirmation by a conventional 12-lead ECG or single-lead ECG strip with at least 30 seconds of AFib.

In line with ESC’s 2016 AFib guidelines, the new iteration classifies AFib as first diagnosed, paroxysmal, persistent, long-standing persistent, and permanent. But it’s also important to classify the clinical profile of AFib, task force member Giuseppe Boriani, MD, PhD, University of Modena, Italy, said in the first of five presentations.

“So the novelty of the 2020 guidelines is related to the proposal of the 4S-AF scheme for a structured characterization of atrial fibrillation that takes into account Stroke risk, severity of Symptoms, Severity of atrial fibrillation burden, and Substrate severity,” he said.

This represents a paradigm shift from a single-domain conventional classification of AFib toward a structured characterization that streamlines assessment, informs treatment decision-making, and facilitates communication among physicians of various specialties, said Tatjana Potpara, MD, PhD, guideline co-chair and head of the Department for Intensive Arrhythmia Care, Clinical Centre of Serbia, Belgrade.

“The beauty of this approach is that, at present, the assessment of the ‘S’ components are performed using available tools, but in the future, the 4S-AF has a great potential to incorporate whatever becomes available for a more precision assessment of substrate or symptoms or arrhythmia burden and so forth,” she said.


 

ABC pathway

The guidelines advocate the previously described ABC pathway for integrated care management, which includes ‘A’ for Anticoagulation/Avoid stroke, ‘B’ for Better symptom control, and ‘C’ for Comorbidity/Cardiovascular risk factor optimization.

The document strengthens support for formal risk score–based assessment of bleeding risk in all patients, including use of the HAS-BLED score to help address modifiable bleeding risk factors and to identify patients at high bleeding risk (HAS-BLED score ≥3) for early and more frequent follow-up.

These assessments should be done regularly, given that both stroke and bleeding risk are dynamic and change over time with aging and comorbidities, Dr. Potpara stressed. In patients with AFib initially at low risk for stroke, the next assessment should be optimally performed at 4-6 months.

The guideline also targets weight loss in patients who are obese and have AFib, particularly those being evaluated for ablation, and good blood pressure control in patients with AFib and hypertension to reduce AFib recurrences and risk for stroke and bleeding (both class I, up from IIa). 

It’s particularly important that these risk factors are addressed, and that modifiable risk factors that go along with increased AFib occurrence and persistence are addressed and communicated to patients, said Gerhard Hindricks, MD, PhD, guideline cochair and medical director of the Rhythmology Department, Heart Centre Leipzig (Germany).

“I have to confess, as an interventional electrophysiologist, there has been a time where I have not appreciated these risk factors intensely enough,” he said. “But we have learned, also in the field of catheter ablation, that weight loss is an essential basis for a good procedure. If we can motivate patients to lose weight and then come to the intervention with better outcome, it’s a true benefit for the patient and addresses patient values. So I’m particularly happy we have introduced that with such intensity in the guidelines.”
 

Rate and rhythm control

The guidelines make no recommendation of one novel oral anticoagulant (NOAC) over another. However, in patients already receiving vitamin K antagonists with low time in the therapeutic range, they recommend switching to a different NOAC but ensuring good adherence and persistence with therapy (class I recommendation) or efforts to improve time in therapeutic range (class IIa).

Catheter ablation takes on a more prominent role for rhythm control and is now recommended after one antiarrhythmic drug therapy fails to improve symptoms of AF recurrence in patients with paroxysmal AFib, or persistent AFib with or without major risk factors for recurrence. The class I recommendation is based on results from the CAPTAF and CABANA trials, said task force member Carina Blomström-Lundqvist, MD, PhD, Uppsala University, Sweden.

Catheter ablation is also now a first-line therapy for patients with AFib who have a high likelihood of tachycardia-induced cardiomyopathy, independent of symptom status. “In this subset of patients, catheter ablation may offer a lot with respect to restoration of left ventricular function,” observed Dr. Hindricks.

Complete electrical isolation of the pulmonary veins is recommended during all AFib catheter ablation procedures (class I).

“Even as a medical conservative, I think it is totally reasonable to move to catheter ablation after a failed drug trial,” commented John Mandrola, MD, Baptist Health, Louisville, Ky., who was not a part of the guideline development. 

Although the chance of a second drug working after one failure is low, he noted that operators in the United States have dofetilide, which is not used much in Europe, and sometimes works surprisingly well.

“That said, the caveat is that moving to catheter ablation after drug failure is only appropriate if we have addressed all the pertinent risk factors: sleep apnea, weight loss, lack of fitness, blood pressure control, and alcohol excess,” he said. 

As for tachycardia-mediated cardiomyopathy, this too can be reasonable, Dr. Mandrola said. “I often get people ‘out of a hole’ with amiodarone plus cardioversion for a few months and then proceed to ablation.”

Notably, the 2020 iteration sharpens its recommendation that amiodarone not be used first-line for long-term rhythm control in all patients with AFib, including those with heart failure with reduced ejection fraction, given its extracardiac toxicity (class I, up from IIa).
 

Quality counts

In response to growing evidence that guideline-adherence is associated with significantly better outcomes in AFib, the 2020 ESC/EACTS guidelines explicitly included a recommendation on the need to measure quality of care to identify opportunities for improvement.

With this framework in mind, a task force with 23 people – including members from ESC and heart rhythm societies in the United States, Asia Pacific, and Latin America, along with patient representatives – was created to develop a list of quality indicators (QIs), ultimately settling on 17 main QIs and 17 secondary ones, said Elena Arbelo, MD, PhD, MSc, University of Barcelona.

The QIs are classified into six domains: patient assessment, anticoagulation, rate control, rhythm control, risk factor modification, and, importantly, outcome measures. A full list is accessible in a paper, simultaneously published in EP EuroPace.

Five patient-reported outcomes fall under the outcomes domain but only one – health-related quality of life – is a main quality indicator. The remaining outcomes are still important but are listed as secondary because of the lack of evidence to sustain or defend their systematic implementation, particularly evidence on how to measure them appropriately, Dr. Arbelo said.

“Hopefully, following the [class I] recommendation by the 2020 ESC guidelines to routinely collect patient-reported outcomes will allow us to collect further evidence and in the future have sufficient evidence to include these as a main outcome,” she said.

The QI work was driven in parallel with the guidelines and had a huge impact on its development, including inclusion of clear recommendations on how to measure quality, Dr. Hindricks said. “I believe that the whole issue of quality management in the treatment of patients with a focus on patient values cannot be overestimated.”

Disclosure information for all writing committee members is in the report. Dr. Mandrola is a writer and podcaster for Medscape.
 

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

New atrial fibrillation (AFib) management guidelines from the European Society of Cardiology (ESC) call for diagnostic confirmation and structured characterization of AFib and the need to streamline integrated care with the Atrial fibrillation Better Care (ABC) pathway.

“It’s as simple as CC to ABC,” quipped one task force member during the virtual unveiling of the guidelines at the ESC Congress 2020.

The guidelines were developed in collaboration with the European Association of Cardio-Thoracic Surgery (EACTS) and published simultaneously August 29 in the European Heart Journal.

Acknowledging the slew of novel screening tools now available and their reported sensitivity and specificity rates, the document supports opportunistic screening for AFib by pulse taking or electrocardiogram (ECG) rhythm strip in patients at least 65 years of age, with a class 1 recommendation, evidence level B.

Systematic ECG screening should also be considered to detect AFib in individuals at least 75 years of age or in those at high risk for stroke (class IIa, level B).

Other new class I screening recommendations are to inform individuals undergoing screening about the significance and treatment implications of detecting AFib and to have a structured referral platform in place for further physician-led evaluation.

A definite diagnosis of clinical AFib is established only after confirmation by a conventional 12-lead ECG or single-lead ECG strip with at least 30 seconds of AFib.

In line with ESC’s 2016 AFib guidelines, the new iteration classifies AFib as first diagnosed, paroxysmal, persistent, long-standing persistent, and permanent. But it’s also important to classify the clinical profile of AFib, task force member Giuseppe Boriani, MD, PhD, University of Modena, Italy, said in the first of five presentations.

“So the novelty of the 2020 guidelines is related to the proposal of the 4S-AF scheme for a structured characterization of atrial fibrillation that takes into account Stroke risk, severity of Symptoms, Severity of atrial fibrillation burden, and Substrate severity,” he said.

This represents a paradigm shift from a single-domain conventional classification of AFib toward a structured characterization that streamlines assessment, informs treatment decision-making, and facilitates communication among physicians of various specialties, said Tatjana Potpara, MD, PhD, guideline co-chair and head of the Department for Intensive Arrhythmia Care, Clinical Centre of Serbia, Belgrade.

“The beauty of this approach is that, at present, the assessment of the ‘S’ components are performed using available tools, but in the future, the 4S-AF has a great potential to incorporate whatever becomes available for a more precision assessment of substrate or symptoms or arrhythmia burden and so forth,” she said.


 

ABC pathway

The guidelines advocate the previously described ABC pathway for integrated care management, which includes ‘A’ for Anticoagulation/Avoid stroke, ‘B’ for Better symptom control, and ‘C’ for Comorbidity/Cardiovascular risk factor optimization.

The document strengthens support for formal risk score–based assessment of bleeding risk in all patients, including use of the HAS-BLED score to help address modifiable bleeding risk factors and to identify patients at high bleeding risk (HAS-BLED score ≥3) for early and more frequent follow-up.

These assessments should be done regularly, given that both stroke and bleeding risk are dynamic and change over time with aging and comorbidities, Dr. Potpara stressed. In patients with AFib initially at low risk for stroke, the next assessment should be optimally performed at 4-6 months.

The guideline also targets weight loss in patients who are obese and have AFib, particularly those being evaluated for ablation, and good blood pressure control in patients with AFib and hypertension to reduce AFib recurrences and risk for stroke and bleeding (both class I, up from IIa). 

It’s particularly important that these risk factors are addressed, and that modifiable risk factors that go along with increased AFib occurrence and persistence are addressed and communicated to patients, said Gerhard Hindricks, MD, PhD, guideline cochair and medical director of the Rhythmology Department, Heart Centre Leipzig (Germany).

“I have to confess, as an interventional electrophysiologist, there has been a time where I have not appreciated these risk factors intensely enough,” he said. “But we have learned, also in the field of catheter ablation, that weight loss is an essential basis for a good procedure. If we can motivate patients to lose weight and then come to the intervention with better outcome, it’s a true benefit for the patient and addresses patient values. So I’m particularly happy we have introduced that with such intensity in the guidelines.”
 

Rate and rhythm control

The guidelines make no recommendation of one novel oral anticoagulant (NOAC) over another. However, in patients already receiving vitamin K antagonists with low time in the therapeutic range, they recommend switching to a different NOAC but ensuring good adherence and persistence with therapy (class I recommendation) or efforts to improve time in therapeutic range (class IIa).

Catheter ablation takes on a more prominent role for rhythm control and is now recommended after one antiarrhythmic drug therapy fails to improve symptoms of AF recurrence in patients with paroxysmal AFib, or persistent AFib with or without major risk factors for recurrence. The class I recommendation is based on results from the CAPTAF and CABANA trials, said task force member Carina Blomström-Lundqvist, MD, PhD, Uppsala University, Sweden.

Catheter ablation is also now a first-line therapy for patients with AFib who have a high likelihood of tachycardia-induced cardiomyopathy, independent of symptom status. “In this subset of patients, catheter ablation may offer a lot with respect to restoration of left ventricular function,” observed Dr. Hindricks.

Complete electrical isolation of the pulmonary veins is recommended during all AFib catheter ablation procedures (class I).

“Even as a medical conservative, I think it is totally reasonable to move to catheter ablation after a failed drug trial,” commented John Mandrola, MD, Baptist Health, Louisville, Ky., who was not a part of the guideline development. 

Although the chance of a second drug working after one failure is low, he noted that operators in the United States have dofetilide, which is not used much in Europe, and sometimes works surprisingly well.

“That said, the caveat is that moving to catheter ablation after drug failure is only appropriate if we have addressed all the pertinent risk factors: sleep apnea, weight loss, lack of fitness, blood pressure control, and alcohol excess,” he said. 

As for tachycardia-mediated cardiomyopathy, this too can be reasonable, Dr. Mandrola said. “I often get people ‘out of a hole’ with amiodarone plus cardioversion for a few months and then proceed to ablation.”

Notably, the 2020 iteration sharpens its recommendation that amiodarone not be used first-line for long-term rhythm control in all patients with AFib, including those with heart failure with reduced ejection fraction, given its extracardiac toxicity (class I, up from IIa).
 

Quality counts

In response to growing evidence that guideline-adherence is associated with significantly better outcomes in AFib, the 2020 ESC/EACTS guidelines explicitly included a recommendation on the need to measure quality of care to identify opportunities for improvement.

With this framework in mind, a task force with 23 people – including members from ESC and heart rhythm societies in the United States, Asia Pacific, and Latin America, along with patient representatives – was created to develop a list of quality indicators (QIs), ultimately settling on 17 main QIs and 17 secondary ones, said Elena Arbelo, MD, PhD, MSc, University of Barcelona.

The QIs are classified into six domains: patient assessment, anticoagulation, rate control, rhythm control, risk factor modification, and, importantly, outcome measures. A full list is accessible in a paper, simultaneously published in EP EuroPace.

Five patient-reported outcomes fall under the outcomes domain but only one – health-related quality of life – is a main quality indicator. The remaining outcomes are still important but are listed as secondary because of the lack of evidence to sustain or defend their systematic implementation, particularly evidence on how to measure them appropriately, Dr. Arbelo said.

“Hopefully, following the [class I] recommendation by the 2020 ESC guidelines to routinely collect patient-reported outcomes will allow us to collect further evidence and in the future have sufficient evidence to include these as a main outcome,” she said.

The QI work was driven in parallel with the guidelines and had a huge impact on its development, including inclusion of clear recommendations on how to measure quality, Dr. Hindricks said. “I believe that the whole issue of quality management in the treatment of patients with a focus on patient values cannot be overestimated.”

Disclosure information for all writing committee members is in the report. Dr. Mandrola is a writer and podcaster for Medscape.
 

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

Recommendations on the use of next-generation sequencing (NGS) tests for patients with metastatic cancer have been issued by the European Society for Medical Oncology, the first recommendations of their kind to be published by any medical society.

“Until now, there were no recommendations from scientific societies on how to use this technique in daily clinical practice to profile metastatic cancers,” Fernanda Mosele, MD, medical oncologist, Gustave Roussy, Villejuif, France, said in a statement.

NGS testing is already used extensively in oncology, particularly in metastatic cancer, she noted. The technology is used to assess the sequence of DNA in genes from a tumor tissue sample. Numerous genes can be quickly sequenced at the same time at relatively low cost. The results provide information on mutations that are present, which, in turn, helps with deciding which treatments to use, including drugs targeting the identified mutations.

“Our intent is that they [the guidelines] will unify decision-making about how NGS should be used for patients with metastatic cancer,” Dr. Mosele said.

The recommendations were published online August 25 in Annals of Oncology.

Overall, ESMO recommends the use of tumor multigene NGS for non–small cell lung cancer (NSCLC), prostate cancer, ovarian cancer, and cholangiocarcinoma.

For other cancers, the authors said that NGS is not recommended in clinical practice but could be used for research purposes.

However, patients should be informed that it is unlikely that test results would benefit them much personally.

Physicians and patients may decide together to subject the tumor to mutational testing using a large panel of genes, provided testing doesn’t burden the health care system with additional costs.

“This recommendation acknowledges that a small number of patients could benefit from a drug because they have a rare mutation,” Joaquin Mateo, MD, chair of the ESMO working group, said in a statement.

“So beyond the cancers in which everyone should receive NGS, there is room for physicians and patients to discuss the pros and cons of ordering these tests,” he added.

ESMO also does not recommend the use of off-label drugs matched to any genomic alteration detected by NGS unless an access program and a decisional procedure have been developed, either regionally or nationally.
 

No need for NGS testing of other cancers

In contrast to NSCLC, “there is currently no need to perform tumor multigene NGS for patients with mBC [metastatic breast cancer] in the context of daily practice,” ESMO stated.

This is largely because somatic sequencing cannot fully substitute for germline testing for BRCA status, and other mutations, such as HER2, can be detected using immunohistochemistry (IHC).

The same can be said for patients with metastatic gastric cancer, inasmuch as detection of alterations can and should be done using cheaper testing methods, ESMO pointed out.

However, ESMO members still emphasized that it’s important to include patients with metastatic breast cancer in molecular screening programs as well as in clinical trials testing targeted agents.

Similarly, there is no need to test metastatic colorectal cancer (mCRC) using multigene NGS in daily practice, inasmuch as most level 1 alterations in mCRC can be determined by IHC or PCR.

However, NGS can be considered as an alternative to PCR-based tests in mCRC, provided NGS is not associated with additional cost.

ESMO again recommended that research centers include mCRC patients in molecular screening programs in order for them to have access to innovative clinical trial agents.

As for advanced prostate cancer, ESMO does recommend that clinicians perform NGS on tissue samples to assess the tumor’s mutational status, at least for the presence of BRCA1 and BRCA2 mutations, when patients have access to the poly (ADP-ribose) polymerase inhibitors for treatment.

The authors cautioned, however, that this strategy is unlikely to be cost-effective, so larger panels should be used only when there are specific agreements with payers.

Multigene NGS is also not recommended for patients with advanced pancreatic ductal adenocarcinoma (PDAC), although ESMO points out that it is the role of research centers to propose multigene sequencing for these patients in the context of molecular screening programs.

This is again to facilitate access to innovative drugs for these patients.

Similar to recommendations for patients with advanced PDAC, patients with advanced hepatocellular carcinoma (HCC) do not need to have tumor multigene NGS either.

Considering the high unmet needs of HCC patients, ESMO feels that research centers should propose multigene sequencing to patients with advanced HCC in the context of molecular screening programs.

In contrast, ESMO recommended that tumor multigene NGS be used to detect actionable alterations in patients with advanced cholangiocarcinoma.

Again, they predict that this strategy is unlikely to be cost-effective, so larger panels should only be used if a specific agreement is in place with payers.

ESMO also assessed the frequency of level 1 alterations in less frequent tumor types, including ovarian cancers. Because BRCA1 and BRCA2 somatic mutations in ovarian tumors have been associated with increased response to the PARP inhibitors, the use of multigene NGS is justified with this malignancy, ESMO states.

The authors also recommend that tumor mutational burden be determined in cervical cancer, moderately differentiated neuroendocrine tumors, salivary cancers, vulvar cancer, and thyroid cancers.

Dr. Mosele has disclosed no relevant financial relationships. Many coauthors have relationships with the pharmaceutical industry, as listed in the article.

This article first appeared on Medscape.com.

Recommendations on the use of next-generation sequencing (NGS) tests for patients with metastatic cancer have been issued by the European Society for Medical Oncology, the first recommendations of their kind to be published by any medical society.

“Until now, there were no recommendations from scientific societies on how to use this technique in daily clinical practice to profile metastatic cancers,” Fernanda Mosele, MD, medical oncologist, Gustave Roussy, Villejuif, France, said in a statement.

NGS testing is already used extensively in oncology, particularly in metastatic cancer, she noted. The technology is used to assess the sequence of DNA in genes from a tumor tissue sample. Numerous genes can be quickly sequenced at the same time at relatively low cost. The results provide information on mutations that are present, which, in turn, helps with deciding which treatments to use, including drugs targeting the identified mutations.

“Our intent is that they [the guidelines] will unify decision-making about how NGS should be used for patients with metastatic cancer,” Dr. Mosele said.

The recommendations were published online August 25 in Annals of Oncology.

Overall, ESMO recommends the use of tumor multigene NGS for non–small cell lung cancer (NSCLC), prostate cancer, ovarian cancer, and cholangiocarcinoma.

For other cancers, the authors said that NGS is not recommended in clinical practice but could be used for research purposes.

However, patients should be informed that it is unlikely that test results would benefit them much personally.

Physicians and patients may decide together to subject the tumor to mutational testing using a large panel of genes, provided testing doesn’t burden the health care system with additional costs.

“This recommendation acknowledges that a small number of patients could benefit from a drug because they have a rare mutation,” Joaquin Mateo, MD, chair of the ESMO working group, said in a statement.

“So beyond the cancers in which everyone should receive NGS, there is room for physicians and patients to discuss the pros and cons of ordering these tests,” he added.

ESMO also does not recommend the use of off-label drugs matched to any genomic alteration detected by NGS unless an access program and a decisional procedure have been developed, either regionally or nationally.
 

No need for NGS testing of other cancers

In contrast to NSCLC, “there is currently no need to perform tumor multigene NGS for patients with mBC [metastatic breast cancer] in the context of daily practice,” ESMO stated.

This is largely because somatic sequencing cannot fully substitute for germline testing for BRCA status, and other mutations, such as HER2, can be detected using immunohistochemistry (IHC).

The same can be said for patients with metastatic gastric cancer, inasmuch as detection of alterations can and should be done using cheaper testing methods, ESMO pointed out.

However, ESMO members still emphasized that it’s important to include patients with metastatic breast cancer in molecular screening programs as well as in clinical trials testing targeted agents.

Similarly, there is no need to test metastatic colorectal cancer (mCRC) using multigene NGS in daily practice, inasmuch as most level 1 alterations in mCRC can be determined by IHC or PCR.

However, NGS can be considered as an alternative to PCR-based tests in mCRC, provided NGS is not associated with additional cost.

ESMO again recommended that research centers include mCRC patients in molecular screening programs in order for them to have access to innovative clinical trial agents.

As for advanced prostate cancer, ESMO does recommend that clinicians perform NGS on tissue samples to assess the tumor’s mutational status, at least for the presence of BRCA1 and BRCA2 mutations, when patients have access to the poly (ADP-ribose) polymerase inhibitors for treatment.

The authors cautioned, however, that this strategy is unlikely to be cost-effective, so larger panels should be used only when there are specific agreements with payers.

Multigene NGS is also not recommended for patients with advanced pancreatic ductal adenocarcinoma (PDAC), although ESMO points out that it is the role of research centers to propose multigene sequencing for these patients in the context of molecular screening programs.

This is again to facilitate access to innovative drugs for these patients.

Similar to recommendations for patients with advanced PDAC, patients with advanced hepatocellular carcinoma (HCC) do not need to have tumor multigene NGS either.

Considering the high unmet needs of HCC patients, ESMO feels that research centers should propose multigene sequencing to patients with advanced HCC in the context of molecular screening programs.

In contrast, ESMO recommended that tumor multigene NGS be used to detect actionable alterations in patients with advanced cholangiocarcinoma.

Again, they predict that this strategy is unlikely to be cost-effective, so larger panels should only be used if a specific agreement is in place with payers.

ESMO also assessed the frequency of level 1 alterations in less frequent tumor types, including ovarian cancers. Because BRCA1 and BRCA2 somatic mutations in ovarian tumors have been associated with increased response to the PARP inhibitors, the use of multigene NGS is justified with this malignancy, ESMO states.

The authors also recommend that tumor mutational burden be determined in cervical cancer, moderately differentiated neuroendocrine tumors, salivary cancers, vulvar cancer, and thyroid cancers.

Dr. Mosele has disclosed no relevant financial relationships. Many coauthors have relationships with the pharmaceutical industry, as listed in the article.

This article first appeared on Medscape.com.

Recommendations on the use of next-generation sequencing (NGS) tests for patients with metastatic cancer have been issued by the European Society for Medical Oncology, the first recommendations of their kind to be published by any medical society.

“Until now, there were no recommendations from scientific societies on how to use this technique in daily clinical practice to profile metastatic cancers,” Fernanda Mosele, MD, medical oncologist, Gustave Roussy, Villejuif, France, said in a statement.

NGS testing is already used extensively in oncology, particularly in metastatic cancer, she noted. The technology is used to assess the sequence of DNA in genes from a tumor tissue sample. Numerous genes can be quickly sequenced at the same time at relatively low cost. The results provide information on mutations that are present, which, in turn, helps with deciding which treatments to use, including drugs targeting the identified mutations.

“Our intent is that they [the guidelines] will unify decision-making about how NGS should be used for patients with metastatic cancer,” Dr. Mosele said.

The recommendations were published online August 25 in Annals of Oncology.

Overall, ESMO recommends the use of tumor multigene NGS for non–small cell lung cancer (NSCLC), prostate cancer, ovarian cancer, and cholangiocarcinoma.

For other cancers, the authors said that NGS is not recommended in clinical practice but could be used for research purposes.

However, patients should be informed that it is unlikely that test results would benefit them much personally.

Physicians and patients may decide together to subject the tumor to mutational testing using a large panel of genes, provided testing doesn’t burden the health care system with additional costs.

“This recommendation acknowledges that a small number of patients could benefit from a drug because they have a rare mutation,” Joaquin Mateo, MD, chair of the ESMO working group, said in a statement.

“So beyond the cancers in which everyone should receive NGS, there is room for physicians and patients to discuss the pros and cons of ordering these tests,” he added.

ESMO also does not recommend the use of off-label drugs matched to any genomic alteration detected by NGS unless an access program and a decisional procedure have been developed, either regionally or nationally.
 

No need for NGS testing of other cancers

In contrast to NSCLC, “there is currently no need to perform tumor multigene NGS for patients with mBC [metastatic breast cancer] in the context of daily practice,” ESMO stated.

This is largely because somatic sequencing cannot fully substitute for germline testing for BRCA status, and other mutations, such as HER2, can be detected using immunohistochemistry (IHC).

The same can be said for patients with metastatic gastric cancer, inasmuch as detection of alterations can and should be done using cheaper testing methods, ESMO pointed out.

However, ESMO members still emphasized that it’s important to include patients with metastatic breast cancer in molecular screening programs as well as in clinical trials testing targeted agents.

Similarly, there is no need to test metastatic colorectal cancer (mCRC) using multigene NGS in daily practice, inasmuch as most level 1 alterations in mCRC can be determined by IHC or PCR.

However, NGS can be considered as an alternative to PCR-based tests in mCRC, provided NGS is not associated with additional cost.

ESMO again recommended that research centers include mCRC patients in molecular screening programs in order for them to have access to innovative clinical trial agents.

As for advanced prostate cancer, ESMO does recommend that clinicians perform NGS on tissue samples to assess the tumor’s mutational status, at least for the presence of BRCA1 and BRCA2 mutations, when patients have access to the poly (ADP-ribose) polymerase inhibitors for treatment.

The authors cautioned, however, that this strategy is unlikely to be cost-effective, so larger panels should be used only when there are specific agreements with payers.

Multigene NGS is also not recommended for patients with advanced pancreatic ductal adenocarcinoma (PDAC), although ESMO points out that it is the role of research centers to propose multigene sequencing for these patients in the context of molecular screening programs.

This is again to facilitate access to innovative drugs for these patients.

Similar to recommendations for patients with advanced PDAC, patients with advanced hepatocellular carcinoma (HCC) do not need to have tumor multigene NGS either.

Considering the high unmet needs of HCC patients, ESMO feels that research centers should propose multigene sequencing to patients with advanced HCC in the context of molecular screening programs.

In contrast, ESMO recommended that tumor multigene NGS be used to detect actionable alterations in patients with advanced cholangiocarcinoma.

Again, they predict that this strategy is unlikely to be cost-effective, so larger panels should only be used if a specific agreement is in place with payers.

ESMO also assessed the frequency of level 1 alterations in less frequent tumor types, including ovarian cancers. Because BRCA1 and BRCA2 somatic mutations in ovarian tumors have been associated with increased response to the PARP inhibitors, the use of multigene NGS is justified with this malignancy, ESMO states.

The authors also recommend that tumor mutational burden be determined in cervical cancer, moderately differentiated neuroendocrine tumors, salivary cancers, vulvar cancer, and thyroid cancers.

Dr. Mosele has disclosed no relevant financial relationships. Many coauthors have relationships with the pharmaceutical industry, as listed in the article.

This article first appeared on Medscape.com.

A new Canadian clinical practice guideline for treating adults with obesity emphasizes improving health rather than simply losing weight, among other things.

A summary of the guideline, which was developed by Obesity Canada and the Canadian Association of Bariatric Physicians and Surgeons, was published online August 4 in the Canadian Medical Association Journal.

This patient-centered update to the 2006 guidelines is “provocative,” starting with its definition of obesity, co–lead author Sean Wharton, MD, adjunct professor at McMaster University, Hamilton, Ont., said in an interview.

The guideline was authored by more than 60 health care professionals and researchers who assessed more than 500,000 peer-reviewed articles and made 80 key recommendations.

These reflect substantial recent advances in the understanding of obesity. Individuals with obesity (from a patient committee of the Obesity Society) helped to shape the key messages.

“People who live with obesity have been shut out of receiving quality health care because of the biased, deeply flawed misconceptions about what drives obesity and how we can improve health,” Lisa Schaffer, chair of Obesity Canada’s Public Engagement Committee, said in a press release.

“Obesity is widely seen as the result of poor personal decisions, but research tells us it is far more complicated than that. Our hope with the [new] clinical practice guideline is that more health care professionals, health policy makers, benefits providers and people living with obesity will have a better understanding of it, so we can help more of those who need it.”

“Obesity management should be about compassion and empathy, and then everything falls into place,” Dr. Wharton said. “Think of obesity like breast cancer.”

Address the root causes of obesity

The guideline defines obesity as “a prevalent, complex, progressive and relapsing chronic disease, characterized by abnormal or excessive body fat (adiposity) that impairs health.”

Aimed at primary care providers, the document stresses that clinicians need to “move beyond simplistic approaches of ‘eat less, move more,’ and address the root drivers of obesity.”

As a first step, doctors should ask a patient for permission to discuss weight (e.g., they can ask: “Would it be all right if we discussed your weight?”) – which demonstrates empathy and can help build patient-provider trust.

Clinicians can still measure body mass index as part of a routine physical examination, but they should also obtain a comprehensive patient history to identify the root causes of any weight gain (which could include genetics or psychological factors such as depression and anxiety), as well as any barriers to managing obesity.

‘Eat less, move more’ is too simple: Employ three pillars

Advice to “eat less and move more is dangerously simplistic,” coauthor Arya M. Sharma, MD, from the University of Alberta, Edmonton, and scientific director of Obesity Canada, said in an interview that “the body fights to put back any lost weight.”

Patients with obesity need “medical nutrition therapy.” For patients at risk for heart disease, that may mean following a Mediterranean diet, Dr. Wharton said.

“Physical activity and medical nutrition therapy are absolutely necessary” to manage obesity, he clarified. As a person loses weight, their body “releases a cascade of neurochemicals and hormones that try to push the weight back up” to the original weight or even higher.

Therefore, to maintain weight loss, people need support from one or more of what he calls the “three pillars” of effective long-term weight loss – pharmacotherapy, bariatric surgery, and cognitive-behavioral therapy – which tempers this cascade of neurochemicals.

Cognitive-behavioral therapy could be given by various health care professionals, he noted. A behavioral strategy to stop snacking, for example, is to wait 5 minutes before eating a desired snack to make sure you still want it.

Similarly, Dr. Sharma noted, “the reason obesity is a chronic disease is that once you’ve gained the weight, your body is not going to want to lose it. That is what I tell all my patients: ‘Your body doesn’t care why you put on the weight, but it does care about keeping it there, and it’s going to fight you’ when you try to maintain weight loss.”

“Clinicians should feel very comfortable” treating obesity as a chronic disease, he added, because they are already treating chronic diseases such as heart, lung, and kidney disease.

Don’t play the blame game: ‘Think of obesity like breast cancer’

Clinicians also need to avoid “shaming and blaming patients with obesity,” said Dr. Sharma.

He noted that many patients have internalized weight bias and blame their excess weight on their lack of willpower. They may not want to talk about weight-loss medications or bariatric surgery because they feel that’s “cheating.”

By thinking of obesity in a similar way to cancer, doctors can help themselves respond to patients in a kinder way. “What would we do with somebody who has breast cancer? We would have compassion. We would talk about surgery to get the lump out and medication to keep the cancer from coming back, and we would engage them in psychological treatment or counseling for some of the challenges they have to face,” Dr. Wharton said.

“The right answer is to treat [obesity] like a disease – with surgery, medication, and psychological intervention,” depending on the individual patient, he added.

The complete guideline is available on the Obesity Canada website.

The study was funded by Obesity Canada, the Canadian Association of Bariatric Physicians and Surgeons, and the Canadian Institutes of Health Research. Dr. Wharton has received honoraria and travel expenses and has participated in academic advisory boards for Novo Nordisk, Bausch Health, Eli Lilly, and Janssen. He is the medical director of a medical clinic specializing in weight management and diabetes. Dr. Sharma has received speaker’s bureau and consulting fees from Novo Nordisk, Bausch Pharmaceuticals, and AstraZeneca.

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

A new Canadian clinical practice guideline for treating adults with obesity emphasizes improving health rather than simply losing weight, among other things.

A summary of the guideline, which was developed by Obesity Canada and the Canadian Association of Bariatric Physicians and Surgeons, was published online August 4 in the Canadian Medical Association Journal.

This patient-centered update to the 2006 guidelines is “provocative,” starting with its definition of obesity, co–lead author Sean Wharton, MD, adjunct professor at McMaster University, Hamilton, Ont., said in an interview.

The guideline was authored by more than 60 health care professionals and researchers who assessed more than 500,000 peer-reviewed articles and made 80 key recommendations.

These reflect substantial recent advances in the understanding of obesity. Individuals with obesity (from a patient committee of the Obesity Society) helped to shape the key messages.

“People who live with obesity have been shut out of receiving quality health care because of the biased, deeply flawed misconceptions about what drives obesity and how we can improve health,” Lisa Schaffer, chair of Obesity Canada’s Public Engagement Committee, said in a press release.

“Obesity is widely seen as the result of poor personal decisions, but research tells us it is far more complicated than that. Our hope with the [new] clinical practice guideline is that more health care professionals, health policy makers, benefits providers and people living with obesity will have a better understanding of it, so we can help more of those who need it.”

“Obesity management should be about compassion and empathy, and then everything falls into place,” Dr. Wharton said. “Think of obesity like breast cancer.”

Address the root causes of obesity

The guideline defines obesity as “a prevalent, complex, progressive and relapsing chronic disease, characterized by abnormal or excessive body fat (adiposity) that impairs health.”

Aimed at primary care providers, the document stresses that clinicians need to “move beyond simplistic approaches of ‘eat less, move more,’ and address the root drivers of obesity.”

As a first step, doctors should ask a patient for permission to discuss weight (e.g., they can ask: “Would it be all right if we discussed your weight?”) – which demonstrates empathy and can help build patient-provider trust.

Clinicians can still measure body mass index as part of a routine physical examination, but they should also obtain a comprehensive patient history to identify the root causes of any weight gain (which could include genetics or psychological factors such as depression and anxiety), as well as any barriers to managing obesity.

‘Eat less, move more’ is too simple: Employ three pillars

Advice to “eat less and move more is dangerously simplistic,” coauthor Arya M. Sharma, MD, from the University of Alberta, Edmonton, and scientific director of Obesity Canada, said in an interview that “the body fights to put back any lost weight.”

Patients with obesity need “medical nutrition therapy.” For patients at risk for heart disease, that may mean following a Mediterranean diet, Dr. Wharton said.

“Physical activity and medical nutrition therapy are absolutely necessary” to manage obesity, he clarified. As a person loses weight, their body “releases a cascade of neurochemicals and hormones that try to push the weight back up” to the original weight or even higher.

Therefore, to maintain weight loss, people need support from one or more of what he calls the “three pillars” of effective long-term weight loss – pharmacotherapy, bariatric surgery, and cognitive-behavioral therapy – which tempers this cascade of neurochemicals.

Cognitive-behavioral therapy could be given by various health care professionals, he noted. A behavioral strategy to stop snacking, for example, is to wait 5 minutes before eating a desired snack to make sure you still want it.

Similarly, Dr. Sharma noted, “the reason obesity is a chronic disease is that once you’ve gained the weight, your body is not going to want to lose it. That is what I tell all my patients: ‘Your body doesn’t care why you put on the weight, but it does care about keeping it there, and it’s going to fight you’ when you try to maintain weight loss.”

“Clinicians should feel very comfortable” treating obesity as a chronic disease, he added, because they are already treating chronic diseases such as heart, lung, and kidney disease.

Don’t play the blame game: ‘Think of obesity like breast cancer’

Clinicians also need to avoid “shaming and blaming patients with obesity,” said Dr. Sharma.

He noted that many patients have internalized weight bias and blame their excess weight on their lack of willpower. They may not want to talk about weight-loss medications or bariatric surgery because they feel that’s “cheating.”

By thinking of obesity in a similar way to cancer, doctors can help themselves respond to patients in a kinder way. “What would we do with somebody who has breast cancer? We would have compassion. We would talk about surgery to get the lump out and medication to keep the cancer from coming back, and we would engage them in psychological treatment or counseling for some of the challenges they have to face,” Dr. Wharton said.

“The right answer is to treat [obesity] like a disease – with surgery, medication, and psychological intervention,” depending on the individual patient, he added.

The complete guideline is available on the Obesity Canada website.

The study was funded by Obesity Canada, the Canadian Association of Bariatric Physicians and Surgeons, and the Canadian Institutes of Health Research. Dr. Wharton has received honoraria and travel expenses and has participated in academic advisory boards for Novo Nordisk, Bausch Health, Eli Lilly, and Janssen. He is the medical director of a medical clinic specializing in weight management and diabetes. Dr. Sharma has received speaker’s bureau and consulting fees from Novo Nordisk, Bausch Pharmaceuticals, and AstraZeneca.

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

A new Canadian clinical practice guideline for treating adults with obesity emphasizes improving health rather than simply losing weight, among other things.

A summary of the guideline, which was developed by Obesity Canada and the Canadian Association of Bariatric Physicians and Surgeons, was published online August 4 in the Canadian Medical Association Journal.

This patient-centered update to the 2006 guidelines is “provocative,” starting with its definition of obesity, co–lead author Sean Wharton, MD, adjunct professor at McMaster University, Hamilton, Ont., said in an interview.

The guideline was authored by more than 60 health care professionals and researchers who assessed more than 500,000 peer-reviewed articles and made 80 key recommendations.

These reflect substantial recent advances in the understanding of obesity. Individuals with obesity (from a patient committee of the Obesity Society) helped to shape the key messages.

“People who live with obesity have been shut out of receiving quality health care because of the biased, deeply flawed misconceptions about what drives obesity and how we can improve health,” Lisa Schaffer, chair of Obesity Canada’s Public Engagement Committee, said in a press release.

“Obesity is widely seen as the result of poor personal decisions, but research tells us it is far more complicated than that. Our hope with the [new] clinical practice guideline is that more health care professionals, health policy makers, benefits providers and people living with obesity will have a better understanding of it, so we can help more of those who need it.”

“Obesity management should be about compassion and empathy, and then everything falls into place,” Dr. Wharton said. “Think of obesity like breast cancer.”

Address the root causes of obesity

The guideline defines obesity as “a prevalent, complex, progressive and relapsing chronic disease, characterized by abnormal or excessive body fat (adiposity) that impairs health.”

Aimed at primary care providers, the document stresses that clinicians need to “move beyond simplistic approaches of ‘eat less, move more,’ and address the root drivers of obesity.”

As a first step, doctors should ask a patient for permission to discuss weight (e.g., they can ask: “Would it be all right if we discussed your weight?”) – which demonstrates empathy and can help build patient-provider trust.

Clinicians can still measure body mass index as part of a routine physical examination, but they should also obtain a comprehensive patient history to identify the root causes of any weight gain (which could include genetics or psychological factors such as depression and anxiety), as well as any barriers to managing obesity.

‘Eat less, move more’ is too simple: Employ three pillars

Advice to “eat less and move more is dangerously simplistic,” coauthor Arya M. Sharma, MD, from the University of Alberta, Edmonton, and scientific director of Obesity Canada, said in an interview that “the body fights to put back any lost weight.”

Patients with obesity need “medical nutrition therapy.” For patients at risk for heart disease, that may mean following a Mediterranean diet, Dr. Wharton said.

“Physical activity and medical nutrition therapy are absolutely necessary” to manage obesity, he clarified. As a person loses weight, their body “releases a cascade of neurochemicals and hormones that try to push the weight back up” to the original weight or even higher.

Therefore, to maintain weight loss, people need support from one or more of what he calls the “three pillars” of effective long-term weight loss – pharmacotherapy, bariatric surgery, and cognitive-behavioral therapy – which tempers this cascade of neurochemicals.

Cognitive-behavioral therapy could be given by various health care professionals, he noted. A behavioral strategy to stop snacking, for example, is to wait 5 minutes before eating a desired snack to make sure you still want it.

Similarly, Dr. Sharma noted, “the reason obesity is a chronic disease is that once you’ve gained the weight, your body is not going to want to lose it. That is what I tell all my patients: ‘Your body doesn’t care why you put on the weight, but it does care about keeping it there, and it’s going to fight you’ when you try to maintain weight loss.”

“Clinicians should feel very comfortable” treating obesity as a chronic disease, he added, because they are already treating chronic diseases such as heart, lung, and kidney disease.

Don’t play the blame game: ‘Think of obesity like breast cancer’

Clinicians also need to avoid “shaming and blaming patients with obesity,” said Dr. Sharma.

He noted that many patients have internalized weight bias and blame their excess weight on their lack of willpower. They may not want to talk about weight-loss medications or bariatric surgery because they feel that’s “cheating.”

By thinking of obesity in a similar way to cancer, doctors can help themselves respond to patients in a kinder way. “What would we do with somebody who has breast cancer? We would have compassion. We would talk about surgery to get the lump out and medication to keep the cancer from coming back, and we would engage them in psychological treatment or counseling for some of the challenges they have to face,” Dr. Wharton said.

“The right answer is to treat [obesity] like a disease – with surgery, medication, and psychological intervention,” depending on the individual patient, he added.

The complete guideline is available on the Obesity Canada website.

The study was funded by Obesity Canada, the Canadian Association of Bariatric Physicians and Surgeons, and the Canadian Institutes of Health Research. Dr. Wharton has received honoraria and travel expenses and has participated in academic advisory boards for Novo Nordisk, Bausch Health, Eli Lilly, and Janssen. He is the medical director of a medical clinic specializing in weight management and diabetes. Dr. Sharma has received speaker’s bureau and consulting fees from Novo Nordisk, Bausch Pharmaceuticals, and AstraZeneca.

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

Early testing for actionable genomic alterations is now recommended for metastatic pancreatic cancer patients who progress on therapy or experience intolerable toxicity and who are potential candidates for additional treatment after first-line therapy, according to an American Society of Clinical Oncology guideline update.

Both germline and somatic testing, including for microsatellite instability/mismatch repair deficiency, BRCA mutations with known significance, and NTRK gene fusions, are recommended in this population, reported Davendra P.S. Sohal, MD, MPH, of the University of Cincinnati, and colleagues on ASCO’s expert panel. The update was published online Aug. 5 in the Journal of Clinical Oncology.

The ASCO guideline on clinical decision making for patients with metastatic pancreatic cancer was first published in 2016 to address initial assessment and first- and second-line treatment options, supportive care, and follow-up and was updated in 2018. The current update is based on new evidence of benefit with targeted therapy options after first-line therapy or as maintenance therapy.

The phase 3 POLO trial, for example, showed significantly improved progression-free survival with the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib for maintenance therapy after first-line treatment in patients with a germline BRCA1 or BRCA2 mutation and metastatic pancreatic cancer that had not progressed during first-line platinum-based chemotherapy. An integrated analysis of three studies showed that entrectinib, a potent inhibitor of tropomyosin receptor kinase (TRK) A, B, and C, safely induced durable and clinically meaningful responses in patients with NTRK fusion-positive solid tumors, and a phase 1-2 study showed that the highly selective TRK inhibitor larotrectinib had marked and durable antitumor activity in both children and adults with TRK fusion-positive solid tumors.

With respect to the new recommendation endorsing early testing for actionable genomic alterations (Recommendation 1.5), the authors noted that the results of testing can lead to treatment with PARP inhibitors, programmed death-1 (PD-1) checkpoint inhibitor therapy, TRK fusion inhibitors, and clinical trials of targeted therapies.

“Genomic testing is recommended as part of an initial assessment to ensure that the results of testing are available at the time of treatment decision where applicable after first-line therapy,” the new recommendation states.

A “qualifying statement” further notes that the decision to test should “involve a discussion between the patient and physician regarding the frequency of actionable findings, treatment implications of testing results, and genetic counseling related to germline testing.”

Recommendation 1.5 is rated by the panel as “strong” and is based on informal consensus.

The panel also added two recommendations on treatment options after first-line therapy:

• Recommendation 3.1 calls for treatment with larotrectinib or entrectinib in patient with tumors harboring NTRK fusions.
• Recommendation 3.3 states that patients with a germline BRCA1 or BCA2 mutation who have received first-line platinum-based chemotherapy without disease progression for at least 16 weeks can receive chemotherapy or PARP inhibition with olaparib.

The relevant evidence for these two recommendations is of low quality, but shows that the benefits outweigh the harms; the strength of both recommendations is “moderate.”

A qualifying statement for the latter notes that “the decision to continue treatment with chemotherapy or proceed to maintenance therapy with olaparib should be based on a discussion between the patient and the oncologist, including consideration of whether a maximum response and plateau in response to chemotherapy have been achieved, the level of cumulative toxicities associated with chemotherapy treatment, patient preference, convenience, toxicity, goals of care, cost, and clinical evidence, including a lack of overall survival benefit demonstrated in the POLO randomized controlled trial.”

This focused update includes minor modifications to three existing recommendations:

• In addition to capecitabine or erlotinib, nab-paclitaxel is now included in Recommendation 2.3 as another possible add-on to gemcitabine alone for patients with either an Eastern Cooperative Oncology Group (ECOG) performance score of 2 or a comorbidity profile that precludes more aggressive regimens. The recommendation was also updated to encourage proactive dose and schedule adjustments to minimize toxicities.
• Recommendation 3.5 now includes patients treated previously with a gemcitabine-based regimen in the criteria for the preferred second-line treatment combination of fluorouracil plus nanoliposomal irinotecan or fluorouracil plus irinotecan “where the former is unavailable.”
• Recommendation 3.7 now includes nab-paclitaxel as an add-on option to gemcitabine, and nanoliposomal irinotecan as an add-on option to fluorouracil for second-line therapy – with proactive dose and schedule adjustments to minimize toxicities – in patients with ECOG performance score of 2 or a comorbidity profile that precludes more aggressive regimens.

These three minor modifications reflect new evidence in the first-line treatment setting, including from the FRAGRANCE trial, and are based on expert panel consensus. All other recommendations in the 2018 update are endorsed for the current update, which is available at the ASCO website.

Dr. Sohal reported honoraria from Foundation Medicine, and consulting or advisory roles with Perthera, Ability Pharma, and PierianDx. He reported research funding to his institution from Novartis, Celgene, OncoMed, Bayer, Genentech, Bristol Myers Squibb, Agios, Incyte, Loxo, and Rafael Pharmaceuticals.

[email protected]

SOURCE: Sohal D et al. J Clin Oncol. 2020 Aug 5. doi: 10.1200/JCO.20.01364.

Early testing for actionable genomic alterations is now recommended for metastatic pancreatic cancer patients who progress on therapy or experience intolerable toxicity and who are potential candidates for additional treatment after first-line therapy, according to an American Society of Clinical Oncology guideline update.

Both germline and somatic testing, including for microsatellite instability/mismatch repair deficiency, BRCA mutations with known significance, and NTRK gene fusions, are recommended in this population, reported Davendra P.S. Sohal, MD, MPH, of the University of Cincinnati, and colleagues on ASCO’s expert panel. The update was published online Aug. 5 in the Journal of Clinical Oncology.

The ASCO guideline on clinical decision making for patients with metastatic pancreatic cancer was first published in 2016 to address initial assessment and first- and second-line treatment options, supportive care, and follow-up and was updated in 2018. The current update is based on new evidence of benefit with targeted therapy options after first-line therapy or as maintenance therapy.

The phase 3 POLO trial, for example, showed significantly improved progression-free survival with the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib for maintenance therapy after first-line treatment in patients with a germline BRCA1 or BRCA2 mutation and metastatic pancreatic cancer that had not progressed during first-line platinum-based chemotherapy. An integrated analysis of three studies showed that entrectinib, a potent inhibitor of tropomyosin receptor kinase (TRK) A, B, and C, safely induced durable and clinically meaningful responses in patients with NTRK fusion-positive solid tumors, and a phase 1-2 study showed that the highly selective TRK inhibitor larotrectinib had marked and durable antitumor activity in both children and adults with TRK fusion-positive solid tumors.

With respect to the new recommendation endorsing early testing for actionable genomic alterations (Recommendation 1.5), the authors noted that the results of testing can lead to treatment with PARP inhibitors, programmed death-1 (PD-1) checkpoint inhibitor therapy, TRK fusion inhibitors, and clinical trials of targeted therapies.

“Genomic testing is recommended as part of an initial assessment to ensure that the results of testing are available at the time of treatment decision where applicable after first-line therapy,” the new recommendation states.

A “qualifying statement” further notes that the decision to test should “involve a discussion between the patient and physician regarding the frequency of actionable findings, treatment implications of testing results, and genetic counseling related to germline testing.”

Recommendation 1.5 is rated by the panel as “strong” and is based on informal consensus.

The panel also added two recommendations on treatment options after first-line therapy:

• Recommendation 3.1 calls for treatment with larotrectinib or entrectinib in patient with tumors harboring NTRK fusions.
• Recommendation 3.3 states that patients with a germline BRCA1 or BCA2 mutation who have received first-line platinum-based chemotherapy without disease progression for at least 16 weeks can receive chemotherapy or PARP inhibition with olaparib.

The relevant evidence for these two recommendations is of low quality, but shows that the benefits outweigh the harms; the strength of both recommendations is “moderate.”

A qualifying statement for the latter notes that “the decision to continue treatment with chemotherapy or proceed to maintenance therapy with olaparib should be based on a discussion between the patient and the oncologist, including consideration of whether a maximum response and plateau in response to chemotherapy have been achieved, the level of cumulative toxicities associated with chemotherapy treatment, patient preference, convenience, toxicity, goals of care, cost, and clinical evidence, including a lack of overall survival benefit demonstrated in the POLO randomized controlled trial.”

This focused update includes minor modifications to three existing recommendations:

• In addition to capecitabine or erlotinib, nab-paclitaxel is now included in Recommendation 2.3 as another possible add-on to gemcitabine alone for patients with either an Eastern Cooperative Oncology Group (ECOG) performance score of 2 or a comorbidity profile that precludes more aggressive regimens. The recommendation was also updated to encourage proactive dose and schedule adjustments to minimize toxicities.
• Recommendation 3.5 now includes patients treated previously with a gemcitabine-based regimen in the criteria for the preferred second-line treatment combination of fluorouracil plus nanoliposomal irinotecan or fluorouracil plus irinotecan “where the former is unavailable.”
• Recommendation 3.7 now includes nab-paclitaxel as an add-on option to gemcitabine, and nanoliposomal irinotecan as an add-on option to fluorouracil for second-line therapy – with proactive dose and schedule adjustments to minimize toxicities – in patients with ECOG performance score of 2 or a comorbidity profile that precludes more aggressive regimens.

These three minor modifications reflect new evidence in the first-line treatment setting, including from the FRAGRANCE trial, and are based on expert panel consensus. All other recommendations in the 2018 update are endorsed for the current update, which is available at the ASCO website.

Dr. Sohal reported honoraria from Foundation Medicine, and consulting or advisory roles with Perthera, Ability Pharma, and PierianDx. He reported research funding to his institution from Novartis, Celgene, OncoMed, Bayer, Genentech, Bristol Myers Squibb, Agios, Incyte, Loxo, and Rafael Pharmaceuticals.

[email protected]

SOURCE: Sohal D et al. J Clin Oncol. 2020 Aug 5. doi: 10.1200/JCO.20.01364.

Early testing for actionable genomic alterations is now recommended for metastatic pancreatic cancer patients who progress on therapy or experience intolerable toxicity and who are potential candidates for additional treatment after first-line therapy, according to an American Society of Clinical Oncology guideline update.

Both germline and somatic testing, including for microsatellite instability/mismatch repair deficiency, BRCA mutations with known significance, and NTRK gene fusions, are recommended in this population, reported Davendra P.S. Sohal, MD, MPH, of the University of Cincinnati, and colleagues on ASCO’s expert panel. The update was published online Aug. 5 in the Journal of Clinical Oncology.

The ASCO guideline on clinical decision making for patients with metastatic pancreatic cancer was first published in 2016 to address initial assessment and first- and second-line treatment options, supportive care, and follow-up and was updated in 2018. The current update is based on new evidence of benefit with targeted therapy options after first-line therapy or as maintenance therapy.

The phase 3 POLO trial, for example, showed significantly improved progression-free survival with the poly (ADP-ribose) polymerase (PARP) inhibitor olaparib for maintenance therapy after first-line treatment in patients with a germline BRCA1 or BRCA2 mutation and metastatic pancreatic cancer that had not progressed during first-line platinum-based chemotherapy. An integrated analysis of three studies showed that entrectinib, a potent inhibitor of tropomyosin receptor kinase (TRK) A, B, and C, safely induced durable and clinically meaningful responses in patients with NTRK fusion-positive solid tumors, and a phase 1-2 study showed that the highly selective TRK inhibitor larotrectinib had marked and durable antitumor activity in both children and adults with TRK fusion-positive solid tumors.

With respect to the new recommendation endorsing early testing for actionable genomic alterations (Recommendation 1.5), the authors noted that the results of testing can lead to treatment with PARP inhibitors, programmed death-1 (PD-1) checkpoint inhibitor therapy, TRK fusion inhibitors, and clinical trials of targeted therapies.

“Genomic testing is recommended as part of an initial assessment to ensure that the results of testing are available at the time of treatment decision where applicable after first-line therapy,” the new recommendation states.

A “qualifying statement” further notes that the decision to test should “involve a discussion between the patient and physician regarding the frequency of actionable findings, treatment implications of testing results, and genetic counseling related to germline testing.”

Recommendation 1.5 is rated by the panel as “strong” and is based on informal consensus.

The panel also added two recommendations on treatment options after first-line therapy:

• Recommendation 3.1 calls for treatment with larotrectinib or entrectinib in patient with tumors harboring NTRK fusions.
• Recommendation 3.3 states that patients with a germline BRCA1 or BCA2 mutation who have received first-line platinum-based chemotherapy without disease progression for at least 16 weeks can receive chemotherapy or PARP inhibition with olaparib.

The relevant evidence for these two recommendations is of low quality, but shows that the benefits outweigh the harms; the strength of both recommendations is “moderate.”

A qualifying statement for the latter notes that “the decision to continue treatment with chemotherapy or proceed to maintenance therapy with olaparib should be based on a discussion between the patient and the oncologist, including consideration of whether a maximum response and plateau in response to chemotherapy have been achieved, the level of cumulative toxicities associated with chemotherapy treatment, patient preference, convenience, toxicity, goals of care, cost, and clinical evidence, including a lack of overall survival benefit demonstrated in the POLO randomized controlled trial.”

This focused update includes minor modifications to three existing recommendations:

• In addition to capecitabine or erlotinib, nab-paclitaxel is now included in Recommendation 2.3 as another possible add-on to gemcitabine alone for patients with either an Eastern Cooperative Oncology Group (ECOG) performance score of 2 or a comorbidity profile that precludes more aggressive regimens. The recommendation was also updated to encourage proactive dose and schedule adjustments to minimize toxicities.
• Recommendation 3.5 now includes patients treated previously with a gemcitabine-based regimen in the criteria for the preferred second-line treatment combination of fluorouracil plus nanoliposomal irinotecan or fluorouracil plus irinotecan “where the former is unavailable.”
• Recommendation 3.7 now includes nab-paclitaxel as an add-on option to gemcitabine, and nanoliposomal irinotecan as an add-on option to fluorouracil for second-line therapy – with proactive dose and schedule adjustments to minimize toxicities – in patients with ECOG performance score of 2 or a comorbidity profile that precludes more aggressive regimens.

These three minor modifications reflect new evidence in the first-line treatment setting, including from the FRAGRANCE trial, and are based on expert panel consensus. All other recommendations in the 2018 update are endorsed for the current update, which is available at the ASCO website.

Dr. Sohal reported honoraria from Foundation Medicine, and consulting or advisory roles with Perthera, Ability Pharma, and PierianDx. He reported research funding to his institution from Novartis, Celgene, OncoMed, Bayer, Genentech, Bristol Myers Squibb, Agios, Incyte, Loxo, and Rafael Pharmaceuticals.

[email protected]

SOURCE: Sohal D et al. J Clin Oncol. 2020 Aug 5. doi: 10.1200/JCO.20.01364.

A new scientific statement from the American Heart Association recommends incorporating a rapid diet-screening tool into routine primary care visits to inform dietary counseling and integrating the tool into patients’ electronic health record platforms across all healthcare settings.

American Heart Association

The statement authors evaluated 15 existing screening tools and, although they did not recommend a specific tool, they did present advantages and disadvantages of some of the tools and encouraged “critical conversations” among clinicians and other specialists to arrive at a tool that would be most appropriate for use in a particular health care setting.

“The key takeaway is for clinicians to incorporate discussion of dietary patterns into routine preventive care appointments because a suboptimal diet is the No. 1 risk factor for cardiovascular disease,” Maya Vadiveloo, PhD, RD, chair of the statement group, said in an interview.

“We also wanted to touch on the fact the screening tool could be incorporated into the EHR and then used for clinical support and for tracking and monitoring the patient’s dietary patterns over time,” said Dr. Vadiveloo, assistant professor of nutrition and food sciences in the College of Health Science, University of Rhode Island, Kingston.

The statement was published online Aug. 7 in Circulation: Cardiovascular Quality and Outcomes.
 

Competing demands

Poor dietary quality has “surpassed all other mortality risk factors, accounting for 11 million deaths and about 50% of cardiovascular disease (CVD) deaths globally,” the authors wrote.

Diets deficient in fruits, vegetables, and whole grains and high in red and processed meat, added sugars, sodium, and total energy are the “leading determinants” of the risks for CVD and other conditions, so “strategies that promote holistically healthier dietary patterns to reduce chronic disease risk are of contemporary importance.”

Most clinicians and other members of health care teams “do not currently assess or counsel patients about their food and beverage intake during routine clinical care,” the authors observed.

Reasons for this may include lack of training and knowledge, insufficient time, insufficient integration of nutrition services into health care settings, insufficient reimbursement, and “competing demands during the visit,” they noted.

Dr. Vadiveloo said that an evidence-based rapid screening tool can go a long way toward helping to overcome these barriers.

“Research shows that when primary care practitioners discuss diet with patients, the patients are receptive, but we also know that clinical workloads are already very compressed, and adding another thing to a routine preventive care appointment is challenging,” she said. “So we wanted to look and see if there were already screening tools that showed promise as valid, reliable, reflective of the best science, and easy to incorporate into various types of practice settings.”
 

Top picks

The authors established “theoretical and practice-based criteria” for an optimal diet screening tool for use in the adult population (aged 20 to 75 years). The tool had to:

• Be developed or used within clinical practice in the past 10 years.
• Be evidence-based, reliable, and valid.
• Assess total dietary pattern rather than focusing on a single food or nutrient.
• Be able to be completed and scored at administration without special knowledge or software.
• Give actionable next steps and support to patients.
• Be able track and monitor dietary change over time.
• Be brief.
• Be useful for chronic disease management.

Of the 15 tools reviewed, the three that met the most theoretical and practice-based validity criteria were the Mediterranean Diet Adherence Screener (MEDAS) and its variations; the modified, shortened Rapid Eating Assessment for Participants (REAP), and the modified version of the Starting the Conversation Tool. However, the authors noted that the Powell and Greenberg Screening Tool was the “least time-intensive.”
 

One size does not fit all

No single tool will be appropriate for all practice settings, so “we would like clinicians to discuss what will work in their particular setting,” Dr. Vadiveloo emphasized.

For example, should the screening tool be completed by the clinician, a member of the health care team, or the patient? Advantages of a tool completed by clinicians or team members include collection of the information in real time, where it can be used in shared decision-making during the encounter and increased reliability because the screen has been completed by a clinician. On the other hand, the clinician might not be able to prioritize administering the screening tool during a short clinical encounter.

Advantages of a tool completed by the patient via an EHR portal is that the patient may feel less risk of judgment by the clinician or health care professional and patients can complete the screen at their convenience. Disadvantages are limited reach into underserved populations and, potentially, less reliability than clinician-administered tools.

“It is advantageous to have tools that can be administered by multiple members of health care teams to ease the demand on clinicians, if such staff is available, but in other settings, self-administration might be better, so we tried to leave it open-ended,” Dr. Vadiveloo explained.
 

‘Ideal platform’

“The EHR is the ideal platform to prompt clinicians and other members of the health care team to capture dietary data and deliver dietary advice to patients,” the authors observed.

EHRs allow secure storage of data and also enable access to these data when needed at the point of care. They are also important for documentation purposes.

The authors noted that the use of “myriad EHR platforms and versions of platforms” have created “technical challenges.” They recommended “standardized approaches” for transmitting health data that will “more seamlessly allow rapid diet screeners to be implemented in the EHR.”

They also recommended that the prototypes of rapid diet screeners be tested by end users prior to implementation within particular clinics. “Gathering these data ahead of time can improve the uptake of the application in the real world,” they stated.

Dr. Vadiveloo added that dietary counseling can be conducted by several members of a health care team, such as a dietitian, not just by the physician. Or the patient may need to be referred to a dietitian for counseling and follow-up.

The authors concluded by characterizing the AHA statement as “a call to action ... designed to accelerate efforts to make diet quality assessment an integral part of office-based care delivery by encouraging critical conversations among clinicians, individuals with diet/lifestyle expertise, and specialists in information technology.”

Dr. Vadiveloo has disclosed no relevant financial relationships. The other authors’ disclosures are listed in the original paper.

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

A new scientific statement from the American Heart Association recommends incorporating a rapid diet-screening tool into routine primary care visits to inform dietary counseling and integrating the tool into patients’ electronic health record platforms across all healthcare settings.

American Heart Association

The statement authors evaluated 15 existing screening tools and, although they did not recommend a specific tool, they did present advantages and disadvantages of some of the tools and encouraged “critical conversations” among clinicians and other specialists to arrive at a tool that would be most appropriate for use in a particular health care setting.

“The key takeaway is for clinicians to incorporate discussion of dietary patterns into routine preventive care appointments because a suboptimal diet is the No. 1 risk factor for cardiovascular disease,” Maya Vadiveloo, PhD, RD, chair of the statement group, said in an interview.

“We also wanted to touch on the fact the screening tool could be incorporated into the EHR and then used for clinical support and for tracking and monitoring the patient’s dietary patterns over time,” said Dr. Vadiveloo, assistant professor of nutrition and food sciences in the College of Health Science, University of Rhode Island, Kingston.

The statement was published online Aug. 7 in Circulation: Cardiovascular Quality and Outcomes.
 

Competing demands

Poor dietary quality has “surpassed all other mortality risk factors, accounting for 11 million deaths and about 50% of cardiovascular disease (CVD) deaths globally,” the authors wrote.

Diets deficient in fruits, vegetables, and whole grains and high in red and processed meat, added sugars, sodium, and total energy are the “leading determinants” of the risks for CVD and other conditions, so “strategies that promote holistically healthier dietary patterns to reduce chronic disease risk are of contemporary importance.”

Most clinicians and other members of health care teams “do not currently assess or counsel patients about their food and beverage intake during routine clinical care,” the authors observed.

Reasons for this may include lack of training and knowledge, insufficient time, insufficient integration of nutrition services into health care settings, insufficient reimbursement, and “competing demands during the visit,” they noted.

Dr. Vadiveloo said that an evidence-based rapid screening tool can go a long way toward helping to overcome these barriers.

“Research shows that when primary care practitioners discuss diet with patients, the patients are receptive, but we also know that clinical workloads are already very compressed, and adding another thing to a routine preventive care appointment is challenging,” she said. “So we wanted to look and see if there were already screening tools that showed promise as valid, reliable, reflective of the best science, and easy to incorporate into various types of practice settings.”
 

Top picks

The authors established “theoretical and practice-based criteria” for an optimal diet screening tool for use in the adult population (aged 20 to 75 years). The tool had to:

• Be developed or used within clinical practice in the past 10 years.
• Be evidence-based, reliable, and valid.
• Assess total dietary pattern rather than focusing on a single food or nutrient.
• Be able to be completed and scored at administration without special knowledge or software.
• Give actionable next steps and support to patients.
• Be able track and monitor dietary change over time.
• Be brief.
• Be useful for chronic disease management.

Of the 15 tools reviewed, the three that met the most theoretical and practice-based validity criteria were the Mediterranean Diet Adherence Screener (MEDAS) and its variations; the modified, shortened Rapid Eating Assessment for Participants (REAP), and the modified version of the Starting the Conversation Tool. However, the authors noted that the Powell and Greenberg Screening Tool was the “least time-intensive.”
 

One size does not fit all

No single tool will be appropriate for all practice settings, so “we would like clinicians to discuss what will work in their particular setting,” Dr. Vadiveloo emphasized.

For example, should the screening tool be completed by the clinician, a member of the health care team, or the patient? Advantages of a tool completed by clinicians or team members include collection of the information in real time, where it can be used in shared decision-making during the encounter and increased reliability because the screen has been completed by a clinician. On the other hand, the clinician might not be able to prioritize administering the screening tool during a short clinical encounter.

Advantages of a tool completed by the patient via an EHR portal is that the patient may feel less risk of judgment by the clinician or health care professional and patients can complete the screen at their convenience. Disadvantages are limited reach into underserved populations and, potentially, less reliability than clinician-administered tools.

“It is advantageous to have tools that can be administered by multiple members of health care teams to ease the demand on clinicians, if such staff is available, but in other settings, self-administration might be better, so we tried to leave it open-ended,” Dr. Vadiveloo explained.
 

‘Ideal platform’

“The EHR is the ideal platform to prompt clinicians and other members of the health care team to capture dietary data and deliver dietary advice to patients,” the authors observed.

EHRs allow secure storage of data and also enable access to these data when needed at the point of care. They are also important for documentation purposes.

The authors noted that the use of “myriad EHR platforms and versions of platforms” have created “technical challenges.” They recommended “standardized approaches” for transmitting health data that will “more seamlessly allow rapid diet screeners to be implemented in the EHR.”

They also recommended that the prototypes of rapid diet screeners be tested by end users prior to implementation within particular clinics. “Gathering these data ahead of time can improve the uptake of the application in the real world,” they stated.

Dr. Vadiveloo added that dietary counseling can be conducted by several members of a health care team, such as a dietitian, not just by the physician. Or the patient may need to be referred to a dietitian for counseling and follow-up.

The authors concluded by characterizing the AHA statement as “a call to action ... designed to accelerate efforts to make diet quality assessment an integral part of office-based care delivery by encouraging critical conversations among clinicians, individuals with diet/lifestyle expertise, and specialists in information technology.”

Dr. Vadiveloo has disclosed no relevant financial relationships. The other authors’ disclosures are listed in the original paper.

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

A new scientific statement from the American Heart Association recommends incorporating a rapid diet-screening tool into routine primary care visits to inform dietary counseling and integrating the tool into patients’ electronic health record platforms across all healthcare settings.

American Heart Association

The statement authors evaluated 15 existing screening tools and, although they did not recommend a specific tool, they did present advantages and disadvantages of some of the tools and encouraged “critical conversations” among clinicians and other specialists to arrive at a tool that would be most appropriate for use in a particular health care setting.

“The key takeaway is for clinicians to incorporate discussion of dietary patterns into routine preventive care appointments because a suboptimal diet is the No. 1 risk factor for cardiovascular disease,” Maya Vadiveloo, PhD, RD, chair of the statement group, said in an interview.

“We also wanted to touch on the fact the screening tool could be incorporated into the EHR and then used for clinical support and for tracking and monitoring the patient’s dietary patterns over time,” said Dr. Vadiveloo, assistant professor of nutrition and food sciences in the College of Health Science, University of Rhode Island, Kingston.

The statement was published online Aug. 7 in Circulation: Cardiovascular Quality and Outcomes.
 

Competing demands

Poor dietary quality has “surpassed all other mortality risk factors, accounting for 11 million deaths and about 50% of cardiovascular disease (CVD) deaths globally,” the authors wrote.

Diets deficient in fruits, vegetables, and whole grains and high in red and processed meat, added sugars, sodium, and total energy are the “leading determinants” of the risks for CVD and other conditions, so “strategies that promote holistically healthier dietary patterns to reduce chronic disease risk are of contemporary importance.”

Most clinicians and other members of health care teams “do not currently assess or counsel patients about their food and beverage intake during routine clinical care,” the authors observed.

Reasons for this may include lack of training and knowledge, insufficient time, insufficient integration of nutrition services into health care settings, insufficient reimbursement, and “competing demands during the visit,” they noted.

Dr. Vadiveloo said that an evidence-based rapid screening tool can go a long way toward helping to overcome these barriers.

“Research shows that when primary care practitioners discuss diet with patients, the patients are receptive, but we also know that clinical workloads are already very compressed, and adding another thing to a routine preventive care appointment is challenging,” she said. “So we wanted to look and see if there were already screening tools that showed promise as valid, reliable, reflective of the best science, and easy to incorporate into various types of practice settings.”
 

Top picks

The authors established “theoretical and practice-based criteria” for an optimal diet screening tool for use in the adult population (aged 20 to 75 years). The tool had to:

• Be developed or used within clinical practice in the past 10 years.
• Be evidence-based, reliable, and valid.
• Assess total dietary pattern rather than focusing on a single food or nutrient.
• Be able to be completed and scored at administration without special knowledge or software.
• Give actionable next steps and support to patients.
• Be able track and monitor dietary change over time.
• Be brief.
• Be useful for chronic disease management.

Of the 15 tools reviewed, the three that met the most theoretical and practice-based validity criteria were the Mediterranean Diet Adherence Screener (MEDAS) and its variations; the modified, shortened Rapid Eating Assessment for Participants (REAP), and the modified version of the Starting the Conversation Tool. However, the authors noted that the Powell and Greenberg Screening Tool was the “least time-intensive.”
 

One size does not fit all

No single tool will be appropriate for all practice settings, so “we would like clinicians to discuss what will work in their particular setting,” Dr. Vadiveloo emphasized.

For example, should the screening tool be completed by the clinician, a member of the health care team, or the patient? Advantages of a tool completed by clinicians or team members include collection of the information in real time, where it can be used in shared decision-making during the encounter and increased reliability because the screen has been completed by a clinician. On the other hand, the clinician might not be able to prioritize administering the screening tool during a short clinical encounter.

Advantages of a tool completed by the patient via an EHR portal is that the patient may feel less risk of judgment by the clinician or health care professional and patients can complete the screen at their convenience. Disadvantages are limited reach into underserved populations and, potentially, less reliability than clinician-administered tools.

“It is advantageous to have tools that can be administered by multiple members of health care teams to ease the demand on clinicians, if such staff is available, but in other settings, self-administration might be better, so we tried to leave it open-ended,” Dr. Vadiveloo explained.
 

‘Ideal platform’

“The EHR is the ideal platform to prompt clinicians and other members of the health care team to capture dietary data and deliver dietary advice to patients,” the authors observed.

EHRs allow secure storage of data and also enable access to these data when needed at the point of care. They are also important for documentation purposes.

The authors noted that the use of “myriad EHR platforms and versions of platforms” have created “technical challenges.” They recommended “standardized approaches” for transmitting health data that will “more seamlessly allow rapid diet screeners to be implemented in the EHR.”

They also recommended that the prototypes of rapid diet screeners be tested by end users prior to implementation within particular clinics. “Gathering these data ahead of time can improve the uptake of the application in the real world,” they stated.

Dr. Vadiveloo added that dietary counseling can be conducted by several members of a health care team, such as a dietitian, not just by the physician. Or the patient may need to be referred to a dietitian for counseling and follow-up.

The authors concluded by characterizing the AHA statement as “a call to action ... designed to accelerate efforts to make diet quality assessment an integral part of office-based care delivery by encouraging critical conversations among clinicians, individuals with diet/lifestyle expertise, and specialists in information technology.”

Dr. Vadiveloo has disclosed no relevant financial relationships. The other authors’ disclosures are listed in the original paper.

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