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Crohn’s disease indicators manifest years before diagnosis
Changes in proteins and antibodies suggesting immune dysregulation may be detectable in serum years before clinical manifestation of complicated Crohn’s disease, shows a study recently published in Clinical Gastroenterology and Hepatology.
These preclinical signatures could one day play a role in screening for complicated Crohn’s disease (CD) and in mapping underlying disease pathways, potentially opening doors to new preventive approaches, wrote study authors who were led by Joseph A. Murray, MD, of the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn.
“Mounting evidence suggests that the diagnosis of CD is preceded by a lengthy asymptomatic preclinical period,” investigators wrote. “Gaining insight into this phase may allow a better understanding of the primary events that lead to its development and offer potential strategies to predict and prevent the disease including its complications.”
The study, which was a nested case-control study based on the PREDICTS study, included 201 patients with CD who had serum samples archived 2, 4, and 6 years prior to diagnosis, as well as 201 healthy controls who provided serum samples for comparison. Serum samples were analyzed with a comprehensive panel of 1,129 proteomic markers and antimicrobial antibodies.
At time of diagnosis, 47 of the patients with CD (24%) had a complicated phenotype, including stricturing behavior, penetrating behavior, or need for early surgery.
“The unique availability of preclinical samples collected at multiple time points allowed us to examine the sequence of immunological changes and protein biomarkers that occurred before diagnosis,” the investigators wrote. “We also evaluated a wide array of protein biomarkers, utilizing a novel proteomic platform, and applied novel rigorous statistical approaches, which allowed us to discover the potential biomarkers and biologic pathways for the complicated phenotypes even before diagnosis.”
As early as 6 years before diagnosis, patients with complicated CD had significantly higher levels of antimicrobial antibodies than patients with noncomplicated CD, as well as elevations in 22 protein biomarkers indicating immune dysregulation.
Specifically, complicated CD was preceded by elevated anti–Saccharomyces cerevisiae antibodies (ASCA) IgA/IgG, anti-Flagellin antibodies, and other proteins linked with fibrosis, adaptive immunity, and innate immunity. Simultaneously, the same patients had reduced levels of protein biomarkers linked with protection against fibrosis and tissue damage. Network analysis added weight to these findings by demonstrating a significant correlation between ASCA IgA/IgG and protein biomarkers tied to innate immunity and lack of factors for tissue protection.
“Altogether, the hypothesis can be proposed that the combination of increasing levels of inflammatory cytokines, loss of anti-inflammatory proteins, and production of antimicrobial antibodies could accelerate and magnify tissue destruction and fibrosis driving complications at diagnosis in CD,” the investigators wrote. “These data support the concept that complicated CD may not always be the result of the progression of an uncontrolled inflammatory disease but may also be the consequence of a unique pathophysiological process.”
The findings deserve further investigation as they could lead to new clinical tools for screening and intervention. “The serological signature that we identified could help to further select subjects at risk of developing complicated CD who could be preferential candidates for preventative strategies,” investigators wrote.
The investigators disclosed relationships with Janssen, AbbVie, Galapagos, and others.
Certainly, insights into the preclinical phase of a disease state such as IBD may allow for potential preventive interventions and possible avoidance of disease-related complications. In this important study by Choung and colleagues, pre-diagnosis serum analyses of protein biomarkers and antimicrobial antibodies revealed that certain signatures are associated with a complicated phenotype of Crohn’s disease at time of diagnosis compared to patients with uncomplicated Crohn’s disease. Specifically, patients with complicated Crohn’s disease at diagnosis had higher levels of anti-microbial antibodies and altered protein biomarkers with overproduction of inflammatory proteins 6 years before their date of diagnosis, likely reflecting a dysregulated innate immune system, excessive adaptive response to microbial antigens, and fibrosis.
Although the results of this study are very exciting and may help support further research to risk stratify and possibly prevent progression of Crohn’s disease in the pre-clinical stage, additional confirmatory studies are needed before these observations are ready for real world application.
Jana G. Al Hashash, MD, MSc, associate professor of medicine, Mayo Clinic, Florida. She has no conflicts.
Certainly, insights into the preclinical phase of a disease state such as IBD may allow for potential preventive interventions and possible avoidance of disease-related complications. In this important study by Choung and colleagues, pre-diagnosis serum analyses of protein biomarkers and antimicrobial antibodies revealed that certain signatures are associated with a complicated phenotype of Crohn’s disease at time of diagnosis compared to patients with uncomplicated Crohn’s disease. Specifically, patients with complicated Crohn’s disease at diagnosis had higher levels of anti-microbial antibodies and altered protein biomarkers with overproduction of inflammatory proteins 6 years before their date of diagnosis, likely reflecting a dysregulated innate immune system, excessive adaptive response to microbial antigens, and fibrosis.
Although the results of this study are very exciting and may help support further research to risk stratify and possibly prevent progression of Crohn’s disease in the pre-clinical stage, additional confirmatory studies are needed before these observations are ready for real world application.
Jana G. Al Hashash, MD, MSc, associate professor of medicine, Mayo Clinic, Florida. She has no conflicts.
Certainly, insights into the preclinical phase of a disease state such as IBD may allow for potential preventive interventions and possible avoidance of disease-related complications. In this important study by Choung and colleagues, pre-diagnosis serum analyses of protein biomarkers and antimicrobial antibodies revealed that certain signatures are associated with a complicated phenotype of Crohn’s disease at time of diagnosis compared to patients with uncomplicated Crohn’s disease. Specifically, patients with complicated Crohn’s disease at diagnosis had higher levels of anti-microbial antibodies and altered protein biomarkers with overproduction of inflammatory proteins 6 years before their date of diagnosis, likely reflecting a dysregulated innate immune system, excessive adaptive response to microbial antigens, and fibrosis.
Although the results of this study are very exciting and may help support further research to risk stratify and possibly prevent progression of Crohn’s disease in the pre-clinical stage, additional confirmatory studies are needed before these observations are ready for real world application.
Jana G. Al Hashash, MD, MSc, associate professor of medicine, Mayo Clinic, Florida. She has no conflicts.
Changes in proteins and antibodies suggesting immune dysregulation may be detectable in serum years before clinical manifestation of complicated Crohn’s disease, shows a study recently published in Clinical Gastroenterology and Hepatology.
These preclinical signatures could one day play a role in screening for complicated Crohn’s disease (CD) and in mapping underlying disease pathways, potentially opening doors to new preventive approaches, wrote study authors who were led by Joseph A. Murray, MD, of the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn.
“Mounting evidence suggests that the diagnosis of CD is preceded by a lengthy asymptomatic preclinical period,” investigators wrote. “Gaining insight into this phase may allow a better understanding of the primary events that lead to its development and offer potential strategies to predict and prevent the disease including its complications.”
The study, which was a nested case-control study based on the PREDICTS study, included 201 patients with CD who had serum samples archived 2, 4, and 6 years prior to diagnosis, as well as 201 healthy controls who provided serum samples for comparison. Serum samples were analyzed with a comprehensive panel of 1,129 proteomic markers and antimicrobial antibodies.
At time of diagnosis, 47 of the patients with CD (24%) had a complicated phenotype, including stricturing behavior, penetrating behavior, or need for early surgery.
“The unique availability of preclinical samples collected at multiple time points allowed us to examine the sequence of immunological changes and protein biomarkers that occurred before diagnosis,” the investigators wrote. “We also evaluated a wide array of protein biomarkers, utilizing a novel proteomic platform, and applied novel rigorous statistical approaches, which allowed us to discover the potential biomarkers and biologic pathways for the complicated phenotypes even before diagnosis.”
As early as 6 years before diagnosis, patients with complicated CD had significantly higher levels of antimicrobial antibodies than patients with noncomplicated CD, as well as elevations in 22 protein biomarkers indicating immune dysregulation.
Specifically, complicated CD was preceded by elevated anti–Saccharomyces cerevisiae antibodies (ASCA) IgA/IgG, anti-Flagellin antibodies, and other proteins linked with fibrosis, adaptive immunity, and innate immunity. Simultaneously, the same patients had reduced levels of protein biomarkers linked with protection against fibrosis and tissue damage. Network analysis added weight to these findings by demonstrating a significant correlation between ASCA IgA/IgG and protein biomarkers tied to innate immunity and lack of factors for tissue protection.
“Altogether, the hypothesis can be proposed that the combination of increasing levels of inflammatory cytokines, loss of anti-inflammatory proteins, and production of antimicrobial antibodies could accelerate and magnify tissue destruction and fibrosis driving complications at diagnosis in CD,” the investigators wrote. “These data support the concept that complicated CD may not always be the result of the progression of an uncontrolled inflammatory disease but may also be the consequence of a unique pathophysiological process.”
The findings deserve further investigation as they could lead to new clinical tools for screening and intervention. “The serological signature that we identified could help to further select subjects at risk of developing complicated CD who could be preferential candidates for preventative strategies,” investigators wrote.
The investigators disclosed relationships with Janssen, AbbVie, Galapagos, and others.
Changes in proteins and antibodies suggesting immune dysregulation may be detectable in serum years before clinical manifestation of complicated Crohn’s disease, shows a study recently published in Clinical Gastroenterology and Hepatology.
These preclinical signatures could one day play a role in screening for complicated Crohn’s disease (CD) and in mapping underlying disease pathways, potentially opening doors to new preventive approaches, wrote study authors who were led by Joseph A. Murray, MD, of the division of gastroenterology and hepatology at Mayo Clinic, Rochester, Minn.
“Mounting evidence suggests that the diagnosis of CD is preceded by a lengthy asymptomatic preclinical period,” investigators wrote. “Gaining insight into this phase may allow a better understanding of the primary events that lead to its development and offer potential strategies to predict and prevent the disease including its complications.”
The study, which was a nested case-control study based on the PREDICTS study, included 201 patients with CD who had serum samples archived 2, 4, and 6 years prior to diagnosis, as well as 201 healthy controls who provided serum samples for comparison. Serum samples were analyzed with a comprehensive panel of 1,129 proteomic markers and antimicrobial antibodies.
At time of diagnosis, 47 of the patients with CD (24%) had a complicated phenotype, including stricturing behavior, penetrating behavior, or need for early surgery.
“The unique availability of preclinical samples collected at multiple time points allowed us to examine the sequence of immunological changes and protein biomarkers that occurred before diagnosis,” the investigators wrote. “We also evaluated a wide array of protein biomarkers, utilizing a novel proteomic platform, and applied novel rigorous statistical approaches, which allowed us to discover the potential biomarkers and biologic pathways for the complicated phenotypes even before diagnosis.”
As early as 6 years before diagnosis, patients with complicated CD had significantly higher levels of antimicrobial antibodies than patients with noncomplicated CD, as well as elevations in 22 protein biomarkers indicating immune dysregulation.
Specifically, complicated CD was preceded by elevated anti–Saccharomyces cerevisiae antibodies (ASCA) IgA/IgG, anti-Flagellin antibodies, and other proteins linked with fibrosis, adaptive immunity, and innate immunity. Simultaneously, the same patients had reduced levels of protein biomarkers linked with protection against fibrosis and tissue damage. Network analysis added weight to these findings by demonstrating a significant correlation between ASCA IgA/IgG and protein biomarkers tied to innate immunity and lack of factors for tissue protection.
“Altogether, the hypothesis can be proposed that the combination of increasing levels of inflammatory cytokines, loss of anti-inflammatory proteins, and production of antimicrobial antibodies could accelerate and magnify tissue destruction and fibrosis driving complications at diagnosis in CD,” the investigators wrote. “These data support the concept that complicated CD may not always be the result of the progression of an uncontrolled inflammatory disease but may also be the consequence of a unique pathophysiological process.”
The findings deserve further investigation as they could lead to new clinical tools for screening and intervention. “The serological signature that we identified could help to further select subjects at risk of developing complicated CD who could be preferential candidates for preventative strategies,” investigators wrote.
The investigators disclosed relationships with Janssen, AbbVie, Galapagos, and others.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
AAP advises against low-carb diets for children with diabetes
according to a new clinical report.
Citing a lack of high-quality data and potential for adverse effects with carbohydrate restriction among younger individuals, lead author Anna Neyman, MD, of Indiana University, Indianapolis, and colleagues suggested that pediatric patients with type 2 diabetes should focus on reducing nutrient-poor carbohydrate intake, while those with type 1 diabetes should only pursue broader carbohydrate restriction under close medical supervision.
“There are no guidelines for restricting dietary carbohydrate consumption to reduce risk for diabetes or improve diabetes outcomes in youth,” the investigators wrote in Pediatrics. “Thus, there is a need to provide practical recommendations for pediatricians regarding the use of low-carbohydrate diets in patients who elect to follow these diets, including those with type 1 diabetes and for patients with obesity, prediabetes, and type 2 diabetes.”
Their new report includes a summary of the various types of carbohydrate-restricted diets, a review of available evidence for these diets among pediatric patients with type 1 and type 2 diabetes, and several practical recommendations based on their findings.
Dr. Neyman and colleagues first noted a lack of standardization in describing the various tiers of carbohydrate restriction; however, they offered some rough guidelines. Compared with a typical, balanced diet, which includes 45%-65% of calories from carbohydrates, a moderately restrictive diet includes 26%-44% of calories from carbohydrates, while a low-carb diet includes less than 26% of calories from carbs. Further down the scale, very low-carb diets and ketogenic diets call for 20-50 g of carbs per day or less than 20 g of carbs per day, respectively.
“There is evidence from adult studies that these diets can be associated with significant weight loss, reduction in insulin levels or insulin requirements, and improvement in glucose control,” the investigators noted. “Nevertheless, there is a lack of long-term safety and efficacy outcomes in youth.”
They went on to cite a range of safety concerns, including “growth deceleration, nutritional deficiencies, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors.”
“Body dissatisfaction associated with restrictive dieting practices places children and adolescents at risk for inadequate dietary intake, excessive weight gain resulting from binge-eating after restricting food intake, and use of harmful weight-control strategies,” the investigators wrote. “Moreover, restrictive dieting practices may negatively impact mental health and self-concept and are directly associated with decreased mood and increased feelings of anxiety.”
Until more evidence is available, Dr. Neyman and colleagues advised adherence to a balanced diet, including increased dietary fiber and reduced consumption of ultra-processed carbohydrates.
“Eliminating sugary beverages and juices significantly improves blood glucose and weight management in children and adolescents,” they noted.
For pediatric patients with type 1 diabetes, the investigators suggested that low-carb and very low-carb diets should only be pursued “under close diabetes care team supervision utilizing safety guidelines.”
Lack of evidence is the problem
David Ludwig, MD, PhD, codirector of the New Balance Foundation Obesity Prevention Center, Boston Children’s Hospital, and professor of pediatrics at Harvard Medical School, also in Boston, said the review is “rather general” and “reiterates common, although not always fair, concerns about carbohydrate restriction.”
“The main issue they highlight is the lack of evidence, especially from clinical trials, for a low-carbohydrate diet in children, as related to diabetes,” Dr. Ludwig said in a written comment, noting that this is indeed an issue. “However, what needs to be recognized is that a conventional high-carbohydrate diet has never been shown to be superior in adults or children for diabetes. Furthermore, whereas a poorly formulated low-carb diet may have adverse effects and risks (e.g., nutrient deficiencies), so can a high-carbohydrate diet – including an increase in triglycerides and other risk factors comprising metabolic syndrome.”
He said that the “main challenge in diabetes is to control blood glucose after eating,” and a high-carb makes this more difficult, as it requires more insulin after a meal than a low-carb meal would require, and increases risk of subsequent hypoglycemia.
For those interested in an alternative perspective to the AAP clinical report, Dr. Ludwig recommended two of his recent review articles, including one published in the Journal of Nutrition and another from the Journal of Clinical Investigation. In both, notes the long history of carbohydrate restriction for patients with diabetes, with usage dating back to the 1700s. Although the diet fell out of favor with the introduction of insulin, Dr. Ludwig believes that it needs to be reconsidered, and is more than a passing fad.
“Preliminary research suggests that this dietary approach might transform clinical management and perhaps normalize HbA1c for many people with diabetes, at substantially reduced treatment costs,” Dr. Ludwig and colleagues wrote in the JCI review. “High-quality randomized controlled trials, with intensive support for behavior changes, will be needed to address this possibility and assess long-term safety and sustainability. With total medical costs of diabetes in the United States approaching $1 billion a day, this research must assume high priority.”
This clinical report was commissioned by the AAP. Dr. Ludwig received royalties for books that recommend a carbohydrate-modified diet.
This article was updated 9/20/23.
according to a new clinical report.
Citing a lack of high-quality data and potential for adverse effects with carbohydrate restriction among younger individuals, lead author Anna Neyman, MD, of Indiana University, Indianapolis, and colleagues suggested that pediatric patients with type 2 diabetes should focus on reducing nutrient-poor carbohydrate intake, while those with type 1 diabetes should only pursue broader carbohydrate restriction under close medical supervision.
“There are no guidelines for restricting dietary carbohydrate consumption to reduce risk for diabetes or improve diabetes outcomes in youth,” the investigators wrote in Pediatrics. “Thus, there is a need to provide practical recommendations for pediatricians regarding the use of low-carbohydrate diets in patients who elect to follow these diets, including those with type 1 diabetes and for patients with obesity, prediabetes, and type 2 diabetes.”
Their new report includes a summary of the various types of carbohydrate-restricted diets, a review of available evidence for these diets among pediatric patients with type 1 and type 2 diabetes, and several practical recommendations based on their findings.
Dr. Neyman and colleagues first noted a lack of standardization in describing the various tiers of carbohydrate restriction; however, they offered some rough guidelines. Compared with a typical, balanced diet, which includes 45%-65% of calories from carbohydrates, a moderately restrictive diet includes 26%-44% of calories from carbohydrates, while a low-carb diet includes less than 26% of calories from carbs. Further down the scale, very low-carb diets and ketogenic diets call for 20-50 g of carbs per day or less than 20 g of carbs per day, respectively.
“There is evidence from adult studies that these diets can be associated with significant weight loss, reduction in insulin levels or insulin requirements, and improvement in glucose control,” the investigators noted. “Nevertheless, there is a lack of long-term safety and efficacy outcomes in youth.”
They went on to cite a range of safety concerns, including “growth deceleration, nutritional deficiencies, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors.”
“Body dissatisfaction associated with restrictive dieting practices places children and adolescents at risk for inadequate dietary intake, excessive weight gain resulting from binge-eating after restricting food intake, and use of harmful weight-control strategies,” the investigators wrote. “Moreover, restrictive dieting practices may negatively impact mental health and self-concept and are directly associated with decreased mood and increased feelings of anxiety.”
Until more evidence is available, Dr. Neyman and colleagues advised adherence to a balanced diet, including increased dietary fiber and reduced consumption of ultra-processed carbohydrates.
“Eliminating sugary beverages and juices significantly improves blood glucose and weight management in children and adolescents,” they noted.
For pediatric patients with type 1 diabetes, the investigators suggested that low-carb and very low-carb diets should only be pursued “under close diabetes care team supervision utilizing safety guidelines.”
Lack of evidence is the problem
David Ludwig, MD, PhD, codirector of the New Balance Foundation Obesity Prevention Center, Boston Children’s Hospital, and professor of pediatrics at Harvard Medical School, also in Boston, said the review is “rather general” and “reiterates common, although not always fair, concerns about carbohydrate restriction.”
“The main issue they highlight is the lack of evidence, especially from clinical trials, for a low-carbohydrate diet in children, as related to diabetes,” Dr. Ludwig said in a written comment, noting that this is indeed an issue. “However, what needs to be recognized is that a conventional high-carbohydrate diet has never been shown to be superior in adults or children for diabetes. Furthermore, whereas a poorly formulated low-carb diet may have adverse effects and risks (e.g., nutrient deficiencies), so can a high-carbohydrate diet – including an increase in triglycerides and other risk factors comprising metabolic syndrome.”
He said that the “main challenge in diabetes is to control blood glucose after eating,” and a high-carb makes this more difficult, as it requires more insulin after a meal than a low-carb meal would require, and increases risk of subsequent hypoglycemia.
For those interested in an alternative perspective to the AAP clinical report, Dr. Ludwig recommended two of his recent review articles, including one published in the Journal of Nutrition and another from the Journal of Clinical Investigation. In both, notes the long history of carbohydrate restriction for patients with diabetes, with usage dating back to the 1700s. Although the diet fell out of favor with the introduction of insulin, Dr. Ludwig believes that it needs to be reconsidered, and is more than a passing fad.
“Preliminary research suggests that this dietary approach might transform clinical management and perhaps normalize HbA1c for many people with diabetes, at substantially reduced treatment costs,” Dr. Ludwig and colleagues wrote in the JCI review. “High-quality randomized controlled trials, with intensive support for behavior changes, will be needed to address this possibility and assess long-term safety and sustainability. With total medical costs of diabetes in the United States approaching $1 billion a day, this research must assume high priority.”
This clinical report was commissioned by the AAP. Dr. Ludwig received royalties for books that recommend a carbohydrate-modified diet.
This article was updated 9/20/23.
according to a new clinical report.
Citing a lack of high-quality data and potential for adverse effects with carbohydrate restriction among younger individuals, lead author Anna Neyman, MD, of Indiana University, Indianapolis, and colleagues suggested that pediatric patients with type 2 diabetes should focus on reducing nutrient-poor carbohydrate intake, while those with type 1 diabetes should only pursue broader carbohydrate restriction under close medical supervision.
“There are no guidelines for restricting dietary carbohydrate consumption to reduce risk for diabetes or improve diabetes outcomes in youth,” the investigators wrote in Pediatrics. “Thus, there is a need to provide practical recommendations for pediatricians regarding the use of low-carbohydrate diets in patients who elect to follow these diets, including those with type 1 diabetes and for patients with obesity, prediabetes, and type 2 diabetes.”
Their new report includes a summary of the various types of carbohydrate-restricted diets, a review of available evidence for these diets among pediatric patients with type 1 and type 2 diabetes, and several practical recommendations based on their findings.
Dr. Neyman and colleagues first noted a lack of standardization in describing the various tiers of carbohydrate restriction; however, they offered some rough guidelines. Compared with a typical, balanced diet, which includes 45%-65% of calories from carbohydrates, a moderately restrictive diet includes 26%-44% of calories from carbohydrates, while a low-carb diet includes less than 26% of calories from carbs. Further down the scale, very low-carb diets and ketogenic diets call for 20-50 g of carbs per day or less than 20 g of carbs per day, respectively.
“There is evidence from adult studies that these diets can be associated with significant weight loss, reduction in insulin levels or insulin requirements, and improvement in glucose control,” the investigators noted. “Nevertheless, there is a lack of long-term safety and efficacy outcomes in youth.”
They went on to cite a range of safety concerns, including “growth deceleration, nutritional deficiencies, poor bone health, nutritional ketosis that cannot be distinguished from ketosis resulting from insulin deficiency, and disordered eating behaviors.”
“Body dissatisfaction associated with restrictive dieting practices places children and adolescents at risk for inadequate dietary intake, excessive weight gain resulting from binge-eating after restricting food intake, and use of harmful weight-control strategies,” the investigators wrote. “Moreover, restrictive dieting practices may negatively impact mental health and self-concept and are directly associated with decreased mood and increased feelings of anxiety.”
Until more evidence is available, Dr. Neyman and colleagues advised adherence to a balanced diet, including increased dietary fiber and reduced consumption of ultra-processed carbohydrates.
“Eliminating sugary beverages and juices significantly improves blood glucose and weight management in children and adolescents,” they noted.
For pediatric patients with type 1 diabetes, the investigators suggested that low-carb and very low-carb diets should only be pursued “under close diabetes care team supervision utilizing safety guidelines.”
Lack of evidence is the problem
David Ludwig, MD, PhD, codirector of the New Balance Foundation Obesity Prevention Center, Boston Children’s Hospital, and professor of pediatrics at Harvard Medical School, also in Boston, said the review is “rather general” and “reiterates common, although not always fair, concerns about carbohydrate restriction.”
“The main issue they highlight is the lack of evidence, especially from clinical trials, for a low-carbohydrate diet in children, as related to diabetes,” Dr. Ludwig said in a written comment, noting that this is indeed an issue. “However, what needs to be recognized is that a conventional high-carbohydrate diet has never been shown to be superior in adults or children for diabetes. Furthermore, whereas a poorly formulated low-carb diet may have adverse effects and risks (e.g., nutrient deficiencies), so can a high-carbohydrate diet – including an increase in triglycerides and other risk factors comprising metabolic syndrome.”
He said that the “main challenge in diabetes is to control blood glucose after eating,” and a high-carb makes this more difficult, as it requires more insulin after a meal than a low-carb meal would require, and increases risk of subsequent hypoglycemia.
For those interested in an alternative perspective to the AAP clinical report, Dr. Ludwig recommended two of his recent review articles, including one published in the Journal of Nutrition and another from the Journal of Clinical Investigation. In both, notes the long history of carbohydrate restriction for patients with diabetes, with usage dating back to the 1700s. Although the diet fell out of favor with the introduction of insulin, Dr. Ludwig believes that it needs to be reconsidered, and is more than a passing fad.
“Preliminary research suggests that this dietary approach might transform clinical management and perhaps normalize HbA1c for many people with diabetes, at substantially reduced treatment costs,” Dr. Ludwig and colleagues wrote in the JCI review. “High-quality randomized controlled trials, with intensive support for behavior changes, will be needed to address this possibility and assess long-term safety and sustainability. With total medical costs of diabetes in the United States approaching $1 billion a day, this research must assume high priority.”
This clinical report was commissioned by the AAP. Dr. Ludwig received royalties for books that recommend a carbohydrate-modified diet.
This article was updated 9/20/23.
FROM PEDIATRICS
Frequency and duration of GERD symptoms associated with poor sleep
of the Nurses’ Health Study II published in JAMA Network Open.
The findings suggest that treating gastroesophageal reflux may do more than offer symptomatic relief, but it could improve the chances of a good night’s rest by addressing comorbidities associated with poor sleep quality, wrote authors who were led by Andrew T. Chan, MD, MPH, of the Clinical and Translational Epidemiology Unit at Massachusetts General Hospital, Boston.
“Approximately 20% of the U.S. population experiences gastroesophageal reflux (GER) symptoms at least once a week, and the worldwide prevalence of GER disease (GERD) has been increasing. Beyond its association with quality of life, GERD is also associated with long-term complications, including Barrett esophagus and esophageal adenocarcinoma,” the authors wrote. “In this prospective cohort study, we found that GER symptoms were associated with an increase in subsequent risk of poor sleep quality. Although risk was somewhat attenuated among women who regularly used PPIs [proton pump inhibitors] and/or H2RAs [histamine2-receptor antagonists], the risk of poor sleep quality remained significantly higher among those who experienced GER symptoms at least once a week.”
A growing body of evidence suggests that GERD may be one of those lesser known risk factors of poor sleep quality (trouble falling asleep, sleep disturbance, daytime sleepiness, or restlessness of sleep). But data on the subject are scarce, compelling researchers to conduct the present investigation.
The analysis drew data from the Nurses’ Health Study II, an ongoing prospective study involving 116,429 female participants. Among the 48,536 women included in this analysis, 7,929 (16.3%) developed poor sleep quality during a 4-year follow-up period.
The multivariable relative risk for poor sleep quality among women who experienced GER symptoms more than once a week was 1.53 (95% confidence interval, 1.45-1.62). For those who experienced GER symptoms more than twice a week, the RR was 1.49 (95% CI, 1.39-1.58) for difficulty in falling asleep, 1.47 (95% CI, 1.39-1.56) for excessive daytime sleepiness, and 1.44 (95% CI, 1.36-1.53) for restlessness of sleep.
GER was more common in women who had higher body mass index, were less physically active, and had asthma and depression. Among women who experienced GER more than once a week, 48.2% regularly used PPIs and/or H2RAs which are commonly prescribed for GERD. However, researchers found that frequent GER symptoms were significantly associated with higher risk of poor sleep quality regardless of whether patients used PPIs and/or H2RAs. But poor sleep quality, in this case, was more common among those who did not use PPIs or H2RAs.
In an interview, Bradley M. Morganstern, MD, medical director of the Inflammatory Bowel Disease Center at NYU Long Island, Mineola, N.Y., brought up the potential for confounding variables. For example, obesity could confound the analysis, he said, as people who are overweight have increased risk of reflux, but also sleep apnea, a strong risk factor for poor sleep.
Despite this possible limitation, Dr. Morganstern said the results are important because they point to a possible practice gap. Physicians typically screen for the classic symptoms of reflux like discomfort and burning, but not sleep quality.
“It’s not something we usually ask about unless the patient volunteers that they’re actually having reflux symptoms at nighttime,” Dr. Morganstern said. This possible link between reflux and poor sleep quality should be on the radar for both gastroenterologists and primary care providers, he added.
“I think different specialties could be asking about it for different reasons,” Dr. Morganstern said, suggesting that it may be worth discussing during diagnosis of reflux or detection of poor sleep quality, and when monitoring symptoms and responses to therapy.
Dr. Chan reported receiving grants from Pfizer, Zoe, and Freenome and receiving personal fees from Pfizer and Boehringer Ingelheim outside the submitted work. Other authors disclosed receiving fees and grants from a number of companies, but outside of the scope of this work.
of the Nurses’ Health Study II published in JAMA Network Open.
The findings suggest that treating gastroesophageal reflux may do more than offer symptomatic relief, but it could improve the chances of a good night’s rest by addressing comorbidities associated with poor sleep quality, wrote authors who were led by Andrew T. Chan, MD, MPH, of the Clinical and Translational Epidemiology Unit at Massachusetts General Hospital, Boston.
“Approximately 20% of the U.S. population experiences gastroesophageal reflux (GER) symptoms at least once a week, and the worldwide prevalence of GER disease (GERD) has been increasing. Beyond its association with quality of life, GERD is also associated with long-term complications, including Barrett esophagus and esophageal adenocarcinoma,” the authors wrote. “In this prospective cohort study, we found that GER symptoms were associated with an increase in subsequent risk of poor sleep quality. Although risk was somewhat attenuated among women who regularly used PPIs [proton pump inhibitors] and/or H2RAs [histamine2-receptor antagonists], the risk of poor sleep quality remained significantly higher among those who experienced GER symptoms at least once a week.”
A growing body of evidence suggests that GERD may be one of those lesser known risk factors of poor sleep quality (trouble falling asleep, sleep disturbance, daytime sleepiness, or restlessness of sleep). But data on the subject are scarce, compelling researchers to conduct the present investigation.
The analysis drew data from the Nurses’ Health Study II, an ongoing prospective study involving 116,429 female participants. Among the 48,536 women included in this analysis, 7,929 (16.3%) developed poor sleep quality during a 4-year follow-up period.
The multivariable relative risk for poor sleep quality among women who experienced GER symptoms more than once a week was 1.53 (95% confidence interval, 1.45-1.62). For those who experienced GER symptoms more than twice a week, the RR was 1.49 (95% CI, 1.39-1.58) for difficulty in falling asleep, 1.47 (95% CI, 1.39-1.56) for excessive daytime sleepiness, and 1.44 (95% CI, 1.36-1.53) for restlessness of sleep.
GER was more common in women who had higher body mass index, were less physically active, and had asthma and depression. Among women who experienced GER more than once a week, 48.2% regularly used PPIs and/or H2RAs which are commonly prescribed for GERD. However, researchers found that frequent GER symptoms were significantly associated with higher risk of poor sleep quality regardless of whether patients used PPIs and/or H2RAs. But poor sleep quality, in this case, was more common among those who did not use PPIs or H2RAs.
In an interview, Bradley M. Morganstern, MD, medical director of the Inflammatory Bowel Disease Center at NYU Long Island, Mineola, N.Y., brought up the potential for confounding variables. For example, obesity could confound the analysis, he said, as people who are overweight have increased risk of reflux, but also sleep apnea, a strong risk factor for poor sleep.
Despite this possible limitation, Dr. Morganstern said the results are important because they point to a possible practice gap. Physicians typically screen for the classic symptoms of reflux like discomfort and burning, but not sleep quality.
“It’s not something we usually ask about unless the patient volunteers that they’re actually having reflux symptoms at nighttime,” Dr. Morganstern said. This possible link between reflux and poor sleep quality should be on the radar for both gastroenterologists and primary care providers, he added.
“I think different specialties could be asking about it for different reasons,” Dr. Morganstern said, suggesting that it may be worth discussing during diagnosis of reflux or detection of poor sleep quality, and when monitoring symptoms and responses to therapy.
Dr. Chan reported receiving grants from Pfizer, Zoe, and Freenome and receiving personal fees from Pfizer and Boehringer Ingelheim outside the submitted work. Other authors disclosed receiving fees and grants from a number of companies, but outside of the scope of this work.
of the Nurses’ Health Study II published in JAMA Network Open.
The findings suggest that treating gastroesophageal reflux may do more than offer symptomatic relief, but it could improve the chances of a good night’s rest by addressing comorbidities associated with poor sleep quality, wrote authors who were led by Andrew T. Chan, MD, MPH, of the Clinical and Translational Epidemiology Unit at Massachusetts General Hospital, Boston.
“Approximately 20% of the U.S. population experiences gastroesophageal reflux (GER) symptoms at least once a week, and the worldwide prevalence of GER disease (GERD) has been increasing. Beyond its association with quality of life, GERD is also associated with long-term complications, including Barrett esophagus and esophageal adenocarcinoma,” the authors wrote. “In this prospective cohort study, we found that GER symptoms were associated with an increase in subsequent risk of poor sleep quality. Although risk was somewhat attenuated among women who regularly used PPIs [proton pump inhibitors] and/or H2RAs [histamine2-receptor antagonists], the risk of poor sleep quality remained significantly higher among those who experienced GER symptoms at least once a week.”
A growing body of evidence suggests that GERD may be one of those lesser known risk factors of poor sleep quality (trouble falling asleep, sleep disturbance, daytime sleepiness, or restlessness of sleep). But data on the subject are scarce, compelling researchers to conduct the present investigation.
The analysis drew data from the Nurses’ Health Study II, an ongoing prospective study involving 116,429 female participants. Among the 48,536 women included in this analysis, 7,929 (16.3%) developed poor sleep quality during a 4-year follow-up period.
The multivariable relative risk for poor sleep quality among women who experienced GER symptoms more than once a week was 1.53 (95% confidence interval, 1.45-1.62). For those who experienced GER symptoms more than twice a week, the RR was 1.49 (95% CI, 1.39-1.58) for difficulty in falling asleep, 1.47 (95% CI, 1.39-1.56) for excessive daytime sleepiness, and 1.44 (95% CI, 1.36-1.53) for restlessness of sleep.
GER was more common in women who had higher body mass index, were less physically active, and had asthma and depression. Among women who experienced GER more than once a week, 48.2% regularly used PPIs and/or H2RAs which are commonly prescribed for GERD. However, researchers found that frequent GER symptoms were significantly associated with higher risk of poor sleep quality regardless of whether patients used PPIs and/or H2RAs. But poor sleep quality, in this case, was more common among those who did not use PPIs or H2RAs.
In an interview, Bradley M. Morganstern, MD, medical director of the Inflammatory Bowel Disease Center at NYU Long Island, Mineola, N.Y., brought up the potential for confounding variables. For example, obesity could confound the analysis, he said, as people who are overweight have increased risk of reflux, but also sleep apnea, a strong risk factor for poor sleep.
Despite this possible limitation, Dr. Morganstern said the results are important because they point to a possible practice gap. Physicians typically screen for the classic symptoms of reflux like discomfort and burning, but not sleep quality.
“It’s not something we usually ask about unless the patient volunteers that they’re actually having reflux symptoms at nighttime,” Dr. Morganstern said. This possible link between reflux and poor sleep quality should be on the radar for both gastroenterologists and primary care providers, he added.
“I think different specialties could be asking about it for different reasons,” Dr. Morganstern said, suggesting that it may be worth discussing during diagnosis of reflux or detection of poor sleep quality, and when monitoring symptoms and responses to therapy.
Dr. Chan reported receiving grants from Pfizer, Zoe, and Freenome and receiving personal fees from Pfizer and Boehringer Ingelheim outside the submitted work. Other authors disclosed receiving fees and grants from a number of companies, but outside of the scope of this work.
FROM JAMA NETWORK OPEN
IBD study characterizes biologic adherence, confirms nonadherence risk factors
, based on a retrospective study.
Nonadherence became increasingly common in the presence of four previously reported risk factors, including smoking status, narcotic use, psychiatric history, and prior biologic use, reported lead author Lauren A. George, MD, of the University of Maryland, Baltimore, and colleagues.
“Identifying patients at risk for nonadherence is important to develop strategies to improve adherence,” the investigators wrote in Gastro Hep Advances. “The aim of this analysis was to evaluate adherence across several academic centers with integrated specialty pharmacies, to assess if previously identified risk factors for nonadherence remained significant across several diverse IBD centers, and to evaluate outcomes associated with nonadherence.”
Three tertiary care IBD clinics provided data from 608 patients with IBD. Inclusion required at least three consecutive prescription claims. All biologics were self-injectable, including adalimumab, certolizumab, golimumab, and ustekinumab.
Primary outcomes were medication possession ratio (MPR) and adherence, with nonadherence defined by an MPR lower than 0.86. Secondary outcomes included ED visits and hospitalizations.
After a median follow-up period of 903 days, the overall MPR was 0.95, with adherence of 68%-70%, which is considered “high,” according to Dr. George and colleagues, as it exceeds previously reported national adherence rates.
“[Findings were] similar across all centers, geographic regions, and patient demographics,” the investigators noted.
The four previously described risk factors did in fact predict nonadherence, with likelihood of nonadherence significantly increasing with each additional risk factor present. Patients with all four risk factors had less than 50% adherence.
Nonadherence was also significantly associated with more ED visits and hospitalizations, highlighting “the impact of biologic adherence on direct patient outcomes and healthcare costs,” the investigators wrote.
“All healthcare industry stakeholders including healthcare systems, manufacturers, and third-party benefit providers need to understand the importance of improving patient adherence,” Dr. George and colleagues concluded. “Decreasing barriers to self-injectable medication acquisition, increasing direct patient interaction with integrated pharmacy teams, and comprehensive patient education are a start to improving patient adherence. In addition, we propose that enhanced care pathways for patients with risk factors for nonadherence would improve adherence and outcomes.”
No funding was reported. The investigators disclosed relationships with AbbVie, Janssen, UCB, and others.
This article was updated 7/13/23.
An important adage in medicine is that medications only work if patients take them. Inflammatory bowel disease is a chronic illness that, if inadequately treated, can lead to emergency department visits, hospitalizations, and surgery.
This study by George et al. showed that patients receiving care at academic medical centers with integrated pharmacies had high adherence to subcutaneous therapies. Unsurprisingly, patients with high adherence had fewer emergency room visits and hospitalizations.
An important contribution is the authors identified risk factors for nonadherence. Among others, opioid use, psychiatric illness, and Medicaid insurance were associated with lower adherence. Identifying patients with these risk factors may allow more intensive outreach to improve adherence. IBD centers with integrated pharmacies, such as those in this study, are likely best equipped to do this. Alternatively, these patients may be best served with infusions that are less frequent than injections and be regularly scheduled with an appointment.
While this study did not directly compare other practice models, adherence was much higher than in other studies. This suggests the addition of an integrated pharmacy improves adherence and lowers costs. Other factors such as highly trained IBD gastroenterologists and skilled support staff may have also helped improve adherence, but in any case the multidisciplinary care, especially integrated pharmacies, should be emulated by other IBD centers.
Martin H. Gregory, MD, MSCI, assistant professor of medicine, Washington University School of Medicine, St. Louis. Dr. Gregory disclosed serving on an advisory board for Bristol Myers Squibb.
An important adage in medicine is that medications only work if patients take them. Inflammatory bowel disease is a chronic illness that, if inadequately treated, can lead to emergency department visits, hospitalizations, and surgery.
This study by George et al. showed that patients receiving care at academic medical centers with integrated pharmacies had high adherence to subcutaneous therapies. Unsurprisingly, patients with high adherence had fewer emergency room visits and hospitalizations.
An important contribution is the authors identified risk factors for nonadherence. Among others, opioid use, psychiatric illness, and Medicaid insurance were associated with lower adherence. Identifying patients with these risk factors may allow more intensive outreach to improve adherence. IBD centers with integrated pharmacies, such as those in this study, are likely best equipped to do this. Alternatively, these patients may be best served with infusions that are less frequent than injections and be regularly scheduled with an appointment.
While this study did not directly compare other practice models, adherence was much higher than in other studies. This suggests the addition of an integrated pharmacy improves adherence and lowers costs. Other factors such as highly trained IBD gastroenterologists and skilled support staff may have also helped improve adherence, but in any case the multidisciplinary care, especially integrated pharmacies, should be emulated by other IBD centers.
Martin H. Gregory, MD, MSCI, assistant professor of medicine, Washington University School of Medicine, St. Louis. Dr. Gregory disclosed serving on an advisory board for Bristol Myers Squibb.
An important adage in medicine is that medications only work if patients take them. Inflammatory bowel disease is a chronic illness that, if inadequately treated, can lead to emergency department visits, hospitalizations, and surgery.
This study by George et al. showed that patients receiving care at academic medical centers with integrated pharmacies had high adherence to subcutaneous therapies. Unsurprisingly, patients with high adherence had fewer emergency room visits and hospitalizations.
An important contribution is the authors identified risk factors for nonadherence. Among others, opioid use, psychiatric illness, and Medicaid insurance were associated with lower adherence. Identifying patients with these risk factors may allow more intensive outreach to improve adherence. IBD centers with integrated pharmacies, such as those in this study, are likely best equipped to do this. Alternatively, these patients may be best served with infusions that are less frequent than injections and be regularly scheduled with an appointment.
While this study did not directly compare other practice models, adherence was much higher than in other studies. This suggests the addition of an integrated pharmacy improves adherence and lowers costs. Other factors such as highly trained IBD gastroenterologists and skilled support staff may have also helped improve adherence, but in any case the multidisciplinary care, especially integrated pharmacies, should be emulated by other IBD centers.
Martin H. Gregory, MD, MSCI, assistant professor of medicine, Washington University School of Medicine, St. Louis. Dr. Gregory disclosed serving on an advisory board for Bristol Myers Squibb.
, based on a retrospective study.
Nonadherence became increasingly common in the presence of four previously reported risk factors, including smoking status, narcotic use, psychiatric history, and prior biologic use, reported lead author Lauren A. George, MD, of the University of Maryland, Baltimore, and colleagues.
“Identifying patients at risk for nonadherence is important to develop strategies to improve adherence,” the investigators wrote in Gastro Hep Advances. “The aim of this analysis was to evaluate adherence across several academic centers with integrated specialty pharmacies, to assess if previously identified risk factors for nonadherence remained significant across several diverse IBD centers, and to evaluate outcomes associated with nonadherence.”
Three tertiary care IBD clinics provided data from 608 patients with IBD. Inclusion required at least three consecutive prescription claims. All biologics were self-injectable, including adalimumab, certolizumab, golimumab, and ustekinumab.
Primary outcomes were medication possession ratio (MPR) and adherence, with nonadherence defined by an MPR lower than 0.86. Secondary outcomes included ED visits and hospitalizations.
After a median follow-up period of 903 days, the overall MPR was 0.95, with adherence of 68%-70%, which is considered “high,” according to Dr. George and colleagues, as it exceeds previously reported national adherence rates.
“[Findings were] similar across all centers, geographic regions, and patient demographics,” the investigators noted.
The four previously described risk factors did in fact predict nonadherence, with likelihood of nonadherence significantly increasing with each additional risk factor present. Patients with all four risk factors had less than 50% adherence.
Nonadherence was also significantly associated with more ED visits and hospitalizations, highlighting “the impact of biologic adherence on direct patient outcomes and healthcare costs,” the investigators wrote.
“All healthcare industry stakeholders including healthcare systems, manufacturers, and third-party benefit providers need to understand the importance of improving patient adherence,” Dr. George and colleagues concluded. “Decreasing barriers to self-injectable medication acquisition, increasing direct patient interaction with integrated pharmacy teams, and comprehensive patient education are a start to improving patient adherence. In addition, we propose that enhanced care pathways for patients with risk factors for nonadherence would improve adherence and outcomes.”
No funding was reported. The investigators disclosed relationships with AbbVie, Janssen, UCB, and others.
This article was updated 7/13/23.
, based on a retrospective study.
Nonadherence became increasingly common in the presence of four previously reported risk factors, including smoking status, narcotic use, psychiatric history, and prior biologic use, reported lead author Lauren A. George, MD, of the University of Maryland, Baltimore, and colleagues.
“Identifying patients at risk for nonadherence is important to develop strategies to improve adherence,” the investigators wrote in Gastro Hep Advances. “The aim of this analysis was to evaluate adherence across several academic centers with integrated specialty pharmacies, to assess if previously identified risk factors for nonadherence remained significant across several diverse IBD centers, and to evaluate outcomes associated with nonadherence.”
Three tertiary care IBD clinics provided data from 608 patients with IBD. Inclusion required at least three consecutive prescription claims. All biologics were self-injectable, including adalimumab, certolizumab, golimumab, and ustekinumab.
Primary outcomes were medication possession ratio (MPR) and adherence, with nonadherence defined by an MPR lower than 0.86. Secondary outcomes included ED visits and hospitalizations.
After a median follow-up period of 903 days, the overall MPR was 0.95, with adherence of 68%-70%, which is considered “high,” according to Dr. George and colleagues, as it exceeds previously reported national adherence rates.
“[Findings were] similar across all centers, geographic regions, and patient demographics,” the investigators noted.
The four previously described risk factors did in fact predict nonadherence, with likelihood of nonadherence significantly increasing with each additional risk factor present. Patients with all four risk factors had less than 50% adherence.
Nonadherence was also significantly associated with more ED visits and hospitalizations, highlighting “the impact of biologic adherence on direct patient outcomes and healthcare costs,” the investigators wrote.
“All healthcare industry stakeholders including healthcare systems, manufacturers, and third-party benefit providers need to understand the importance of improving patient adherence,” Dr. George and colleagues concluded. “Decreasing barriers to self-injectable medication acquisition, increasing direct patient interaction with integrated pharmacy teams, and comprehensive patient education are a start to improving patient adherence. In addition, we propose that enhanced care pathways for patients with risk factors for nonadherence would improve adherence and outcomes.”
No funding was reported. The investigators disclosed relationships with AbbVie, Janssen, UCB, and others.
This article was updated 7/13/23.
FROM GASTRO HEP ADVANCES
New AGA CPU focuses on gastric peroral endoscopic myotomy for gastroparesis
Authored by Mouen A. Khashab, MD, director of therapeutic endoscopy at Johns Hopkins Medicine, Baltimore; Andrew Y. Wang, MD, AGAF, chief of interventional endoscopy, University of Virginia, Charlottesville; and, Qiang Cai, MD, PhD, chief of gastroenterology, Ochsner LSU Health Shreveport (La.), the update covers patient selection, procedural considerations, adverse events (AEs), and other topics.
“G-POEM is being performed worldwide to treat patients with refractory gastroparesis,” the investigators wrote in Gastroenterology). “G-POEM is an overall safe procedure with high technical success rates, particularly when performed by an endoscopist experienced in third-space endoscopy. Even if the durable clinical success of G-POEM is in the 50% to 60% range, this represents a huge clinical benefit to patients with refractory gastroparesis, which is a disease associated with substantial morbidity, poor quality of life, and a paucity of safe and effective treatments.”
The authors listed treatment alternatives, noting how associated clinical data have fallen short.
“Although endoscopic pyloric balloon dilation, intrapyloric botulinum toxin injection, gastric electrical stimulation, and transpyloric stenting have been used in patients [with gastroparesis] who have not responded to medical therapy, published studies concerning these therapies have been inconsistent, shown no benefit, or lacked methodologic rigor,” they wrote.
Patient selection
G-POEM should be considered in patients with medically refractory gastroparesis due to diabetes, prior surgery, or idiopathic causes. Candidates should undergo endoscopy to confirm no mechanical obstruction, as well as a solid-phase gastric emptying scan to confirm delayed emptying, with ideal candidates showing at least 20% retention at 4 hours, as this threshold has been linked with better clinical outcomes.
G-POEM is most beneficial when moderate to severe symptoms are present, the investigators wrote, particularly vomiting and nausea. The Gastroparesis Cardinal Symptom Index (GCSI) can be used to determine severity, with a score greater than 2 indicating moderate to severe presentation.
Procedural considerations
The CPU offers detailed procedural considerations, including preparation and equipment, technical guidance, and postprocedural strategy.
“G-POEM should only be performed by interventional endoscopists with expertise or training in third-space endoscopy,” Dr. Khashab and colleagues wrote. “Although experience in endoscopic submucosal dissection (ESD) is not mandatory before performing G-POEM, it likely shortens the learning curve.”
Equipment minimums are also described, including “a high-definition gastroscope, with a waterjet, affixed with a clear distal cap” and “a modern electrosurgical generator capable of modulating power based on tissue resistance and circuit impedance.”
While G-POEM is typically performed via a greater-curvature approach, similar outcomes have been documented for a lesser-curvature approach, Dr. Khashab and colleagues wrote. This alternative technique may increase difficulty of pyloromyotomy, they added.
Postprocedural care may involve an overnight stay, according to the update, with an upper GI study on the subsequent day to ensure no contrast leakage, though this is not mandatory.
Adverse events
“G-POEM is generally safe when performed by trained and/or experienced endoscopists, and AEs are uncommon,” the investigators wrote. “However, serious AEs can occur and have been reported.”
Reported AEs include capnoperitoneum, inadvertent mucosotomy, thermal-mucosal injury, abdominal pain, bleeding, gastric ulceration, and dumping syndrome.
Insurance companies called to action
After reviewing emerging data, the authors suggested the time has come to consider G-POEM as a routine, evidence-based procedure that deserves appropriate reimbursement by financial stakeholders.
“Many insurers still consider G-POEM investigational and refuse to cover this procedure for patients with medically refractory gastroparesis,” they wrote. “As the safety and clinical effectiveness of G-POEM is now well supported, insurance companies and payors should cover G-POEM for patients with significant gastroparesis.”
The clinical practice update was commissioned and approved by the American Gastroenterological Association. The investigators disclosed relationships with Boston Scientific, Medtronic, and Olympus, among others.
Authored by Mouen A. Khashab, MD, director of therapeutic endoscopy at Johns Hopkins Medicine, Baltimore; Andrew Y. Wang, MD, AGAF, chief of interventional endoscopy, University of Virginia, Charlottesville; and, Qiang Cai, MD, PhD, chief of gastroenterology, Ochsner LSU Health Shreveport (La.), the update covers patient selection, procedural considerations, adverse events (AEs), and other topics.
“G-POEM is being performed worldwide to treat patients with refractory gastroparesis,” the investigators wrote in Gastroenterology). “G-POEM is an overall safe procedure with high technical success rates, particularly when performed by an endoscopist experienced in third-space endoscopy. Even if the durable clinical success of G-POEM is in the 50% to 60% range, this represents a huge clinical benefit to patients with refractory gastroparesis, which is a disease associated with substantial morbidity, poor quality of life, and a paucity of safe and effective treatments.”
The authors listed treatment alternatives, noting how associated clinical data have fallen short.
“Although endoscopic pyloric balloon dilation, intrapyloric botulinum toxin injection, gastric electrical stimulation, and transpyloric stenting have been used in patients [with gastroparesis] who have not responded to medical therapy, published studies concerning these therapies have been inconsistent, shown no benefit, or lacked methodologic rigor,” they wrote.
Patient selection
G-POEM should be considered in patients with medically refractory gastroparesis due to diabetes, prior surgery, or idiopathic causes. Candidates should undergo endoscopy to confirm no mechanical obstruction, as well as a solid-phase gastric emptying scan to confirm delayed emptying, with ideal candidates showing at least 20% retention at 4 hours, as this threshold has been linked with better clinical outcomes.
G-POEM is most beneficial when moderate to severe symptoms are present, the investigators wrote, particularly vomiting and nausea. The Gastroparesis Cardinal Symptom Index (GCSI) can be used to determine severity, with a score greater than 2 indicating moderate to severe presentation.
Procedural considerations
The CPU offers detailed procedural considerations, including preparation and equipment, technical guidance, and postprocedural strategy.
“G-POEM should only be performed by interventional endoscopists with expertise or training in third-space endoscopy,” Dr. Khashab and colleagues wrote. “Although experience in endoscopic submucosal dissection (ESD) is not mandatory before performing G-POEM, it likely shortens the learning curve.”
Equipment minimums are also described, including “a high-definition gastroscope, with a waterjet, affixed with a clear distal cap” and “a modern electrosurgical generator capable of modulating power based on tissue resistance and circuit impedance.”
While G-POEM is typically performed via a greater-curvature approach, similar outcomes have been documented for a lesser-curvature approach, Dr. Khashab and colleagues wrote. This alternative technique may increase difficulty of pyloromyotomy, they added.
Postprocedural care may involve an overnight stay, according to the update, with an upper GI study on the subsequent day to ensure no contrast leakage, though this is not mandatory.
Adverse events
“G-POEM is generally safe when performed by trained and/or experienced endoscopists, and AEs are uncommon,” the investigators wrote. “However, serious AEs can occur and have been reported.”
Reported AEs include capnoperitoneum, inadvertent mucosotomy, thermal-mucosal injury, abdominal pain, bleeding, gastric ulceration, and dumping syndrome.
Insurance companies called to action
After reviewing emerging data, the authors suggested the time has come to consider G-POEM as a routine, evidence-based procedure that deserves appropriate reimbursement by financial stakeholders.
“Many insurers still consider G-POEM investigational and refuse to cover this procedure for patients with medically refractory gastroparesis,” they wrote. “As the safety and clinical effectiveness of G-POEM is now well supported, insurance companies and payors should cover G-POEM for patients with significant gastroparesis.”
The clinical practice update was commissioned and approved by the American Gastroenterological Association. The investigators disclosed relationships with Boston Scientific, Medtronic, and Olympus, among others.
Authored by Mouen A. Khashab, MD, director of therapeutic endoscopy at Johns Hopkins Medicine, Baltimore; Andrew Y. Wang, MD, AGAF, chief of interventional endoscopy, University of Virginia, Charlottesville; and, Qiang Cai, MD, PhD, chief of gastroenterology, Ochsner LSU Health Shreveport (La.), the update covers patient selection, procedural considerations, adverse events (AEs), and other topics.
“G-POEM is being performed worldwide to treat patients with refractory gastroparesis,” the investigators wrote in Gastroenterology). “G-POEM is an overall safe procedure with high technical success rates, particularly when performed by an endoscopist experienced in third-space endoscopy. Even if the durable clinical success of G-POEM is in the 50% to 60% range, this represents a huge clinical benefit to patients with refractory gastroparesis, which is a disease associated with substantial morbidity, poor quality of life, and a paucity of safe and effective treatments.”
The authors listed treatment alternatives, noting how associated clinical data have fallen short.
“Although endoscopic pyloric balloon dilation, intrapyloric botulinum toxin injection, gastric electrical stimulation, and transpyloric stenting have been used in patients [with gastroparesis] who have not responded to medical therapy, published studies concerning these therapies have been inconsistent, shown no benefit, or lacked methodologic rigor,” they wrote.
Patient selection
G-POEM should be considered in patients with medically refractory gastroparesis due to diabetes, prior surgery, or idiopathic causes. Candidates should undergo endoscopy to confirm no mechanical obstruction, as well as a solid-phase gastric emptying scan to confirm delayed emptying, with ideal candidates showing at least 20% retention at 4 hours, as this threshold has been linked with better clinical outcomes.
G-POEM is most beneficial when moderate to severe symptoms are present, the investigators wrote, particularly vomiting and nausea. The Gastroparesis Cardinal Symptom Index (GCSI) can be used to determine severity, with a score greater than 2 indicating moderate to severe presentation.
Procedural considerations
The CPU offers detailed procedural considerations, including preparation and equipment, technical guidance, and postprocedural strategy.
“G-POEM should only be performed by interventional endoscopists with expertise or training in third-space endoscopy,” Dr. Khashab and colleagues wrote. “Although experience in endoscopic submucosal dissection (ESD) is not mandatory before performing G-POEM, it likely shortens the learning curve.”
Equipment minimums are also described, including “a high-definition gastroscope, with a waterjet, affixed with a clear distal cap” and “a modern electrosurgical generator capable of modulating power based on tissue resistance and circuit impedance.”
While G-POEM is typically performed via a greater-curvature approach, similar outcomes have been documented for a lesser-curvature approach, Dr. Khashab and colleagues wrote. This alternative technique may increase difficulty of pyloromyotomy, they added.
Postprocedural care may involve an overnight stay, according to the update, with an upper GI study on the subsequent day to ensure no contrast leakage, though this is not mandatory.
Adverse events
“G-POEM is generally safe when performed by trained and/or experienced endoscopists, and AEs are uncommon,” the investigators wrote. “However, serious AEs can occur and have been reported.”
Reported AEs include capnoperitoneum, inadvertent mucosotomy, thermal-mucosal injury, abdominal pain, bleeding, gastric ulceration, and dumping syndrome.
Insurance companies called to action
After reviewing emerging data, the authors suggested the time has come to consider G-POEM as a routine, evidence-based procedure that deserves appropriate reimbursement by financial stakeholders.
“Many insurers still consider G-POEM investigational and refuse to cover this procedure for patients with medically refractory gastroparesis,” they wrote. “As the safety and clinical effectiveness of G-POEM is now well supported, insurance companies and payors should cover G-POEM for patients with significant gastroparesis.”
The clinical practice update was commissioned and approved by the American Gastroenterological Association. The investigators disclosed relationships with Boston Scientific, Medtronic, and Olympus, among others.
FROM GASTROENTEROLOGY
Mucosal exposure device boosts AI-assisted detection of adenomas
based on results of a randomized trial.
Using the mucosal exposure device increased adenoma detection rate by 12% without impacting safety or withdrawal time, suggesting that the two approaches have a synergistic effect, reported lead author Marco Spadaccini, MD, of Humanitas University, Pieve Emanuele, Italy, and colleagues.
“Recent advances in AI, deep learning, and computer vision led to implementation of computer-aided detection [CADe] of colorectal polyps,” the investigators wrote in Gastroenterology. “CADe-assisted colonoscopy already proved its efficacy by increasing adenoma detection in randomized parallel and crossover trials. However, such benefit is mostly related to the higher accuracy in spotting lesions already within the visual field, not affecting the amount of mucosa exposed by the endoscopist during the scope withdrawal. Increasing the mucosa exposure represents a complementary strategy to CADe in order to further improve detection of colorectal neoplasia.”
To test their hypothesis, the investigators conducted a randomized trial involving 1,316 subjects undergoing routine colonoscopy at six centers in Italy and Switzerland. Participants were randomized in a 1:1 ratio to undergo colonoscopy with CADe (GI Genius, Medtronic) or CADe plus a mucosal exposure device (Endocuff Vision, Olympus).
The combination approach yielded a 49.6% adenoma detection rate, compared with a 44.0% detection rate for CADe alone (relative risk, 1.12; 95% confidence interval, 1.00-1.26; P = .04). Adding the mucosal exposure device was also associated with a higher number of adenomas detected per colonoscopy. Withdrawal time and rate of unnecessary polypectomies did not differ between groups.
“The benefit of adding [the mucosal exposure device] to AI was expected due to the complementary nature of the interventions,” Dr. Spadaccini and colleagues wrote. “The benefit of [the mucosal exposure device] is limited to increase the quantity of mucosa exposed to the lens by flatting the folds and strengthening the angulations, and the benefit of AI is only in spotting a lesion that is already displayed within the field of view. Thus, we may speculate that the additional mucosal exposure was synergistic to the AI-assisted polyp recognition by AI.”
The benefits of a combination approach were not universal, however, as the mucosal exposure device did not improve detection of either serrated lesions or advanced adenomas. This result was anticipated, the investigators noted, since the miss rate for diminutive or proximal adenomas is higher than it is for larger or distal lesions, and previous research has suggested that AI-assisted and mucosal exposure techniques, when used alone, are most effective for detecting smaller, proximal lesions.
The study was funded by a European Society of Gastrointestinal Endoscopy Artificial Intelligence Award. The investigators disclosed additional relationships with Fujifilm, Medtronic, Olympus, and others.
The paradigm of adenoma detection is rapidly shifting within the context of screening-related colonoscopy. If one considers the various interventions available to improve one’s adenoma detection rate (ADR), the landscape is vastly different than it was 5-10 years ago. Two established interventions with robust supporting data from randomized controlled trials (RCTs) are computer-aided detection (CADe) platforms such as GI Genius (Medtronic) and distal attachment devices such as Endocuff Vision (Olympus). This RCT by Spadaccini and colleagues tested the intuitive hypothesis that these interventions applied together boost ADR, compared with CADe alone.
Real-world studies of CADe’s effectiveness on ADR are less impressive than efficacy data from trials. Whereas CADe platforms require a significant one-time investment, distal attachment devices represent a small fraction of single procedural costs which then incrementally add up when used over large volumes. More head-to-head studies, cost-effectiveness analyses, and real-world studies are needed to elucidate the best single and/or combination strategies for optimizing ADR. In the meantime, endoscopists should be aware of all evidence-based techniques for ADR improvement, including those that can be incorporated at little to no cost.
Nauzer Forbes, MD, MSc, FASGE, is an associate professor at the University of Calgary (Alta.), where he is the training program director for advanced/therapeutic endoscopy. He is a consultant for and has received speaker’s fees from Pentax Medical and Boston Scientific, is a consultant for AstraZeneca, and has received research funding from Pentax Medical.
The paradigm of adenoma detection is rapidly shifting within the context of screening-related colonoscopy. If one considers the various interventions available to improve one’s adenoma detection rate (ADR), the landscape is vastly different than it was 5-10 years ago. Two established interventions with robust supporting data from randomized controlled trials (RCTs) are computer-aided detection (CADe) platforms such as GI Genius (Medtronic) and distal attachment devices such as Endocuff Vision (Olympus). This RCT by Spadaccini and colleagues tested the intuitive hypothesis that these interventions applied together boost ADR, compared with CADe alone.
Real-world studies of CADe’s effectiveness on ADR are less impressive than efficacy data from trials. Whereas CADe platforms require a significant one-time investment, distal attachment devices represent a small fraction of single procedural costs which then incrementally add up when used over large volumes. More head-to-head studies, cost-effectiveness analyses, and real-world studies are needed to elucidate the best single and/or combination strategies for optimizing ADR. In the meantime, endoscopists should be aware of all evidence-based techniques for ADR improvement, including those that can be incorporated at little to no cost.
Nauzer Forbes, MD, MSc, FASGE, is an associate professor at the University of Calgary (Alta.), where he is the training program director for advanced/therapeutic endoscopy. He is a consultant for and has received speaker’s fees from Pentax Medical and Boston Scientific, is a consultant for AstraZeneca, and has received research funding from Pentax Medical.
The paradigm of adenoma detection is rapidly shifting within the context of screening-related colonoscopy. If one considers the various interventions available to improve one’s adenoma detection rate (ADR), the landscape is vastly different than it was 5-10 years ago. Two established interventions with robust supporting data from randomized controlled trials (RCTs) are computer-aided detection (CADe) platforms such as GI Genius (Medtronic) and distal attachment devices such as Endocuff Vision (Olympus). This RCT by Spadaccini and colleagues tested the intuitive hypothesis that these interventions applied together boost ADR, compared with CADe alone.
Real-world studies of CADe’s effectiveness on ADR are less impressive than efficacy data from trials. Whereas CADe platforms require a significant one-time investment, distal attachment devices represent a small fraction of single procedural costs which then incrementally add up when used over large volumes. More head-to-head studies, cost-effectiveness analyses, and real-world studies are needed to elucidate the best single and/or combination strategies for optimizing ADR. In the meantime, endoscopists should be aware of all evidence-based techniques for ADR improvement, including those that can be incorporated at little to no cost.
Nauzer Forbes, MD, MSc, FASGE, is an associate professor at the University of Calgary (Alta.), where he is the training program director for advanced/therapeutic endoscopy. He is a consultant for and has received speaker’s fees from Pentax Medical and Boston Scientific, is a consultant for AstraZeneca, and has received research funding from Pentax Medical.
based on results of a randomized trial.
Using the mucosal exposure device increased adenoma detection rate by 12% without impacting safety or withdrawal time, suggesting that the two approaches have a synergistic effect, reported lead author Marco Spadaccini, MD, of Humanitas University, Pieve Emanuele, Italy, and colleagues.
“Recent advances in AI, deep learning, and computer vision led to implementation of computer-aided detection [CADe] of colorectal polyps,” the investigators wrote in Gastroenterology. “CADe-assisted colonoscopy already proved its efficacy by increasing adenoma detection in randomized parallel and crossover trials. However, such benefit is mostly related to the higher accuracy in spotting lesions already within the visual field, not affecting the amount of mucosa exposed by the endoscopist during the scope withdrawal. Increasing the mucosa exposure represents a complementary strategy to CADe in order to further improve detection of colorectal neoplasia.”
To test their hypothesis, the investigators conducted a randomized trial involving 1,316 subjects undergoing routine colonoscopy at six centers in Italy and Switzerland. Participants were randomized in a 1:1 ratio to undergo colonoscopy with CADe (GI Genius, Medtronic) or CADe plus a mucosal exposure device (Endocuff Vision, Olympus).
The combination approach yielded a 49.6% adenoma detection rate, compared with a 44.0% detection rate for CADe alone (relative risk, 1.12; 95% confidence interval, 1.00-1.26; P = .04). Adding the mucosal exposure device was also associated with a higher number of adenomas detected per colonoscopy. Withdrawal time and rate of unnecessary polypectomies did not differ between groups.
“The benefit of adding [the mucosal exposure device] to AI was expected due to the complementary nature of the interventions,” Dr. Spadaccini and colleagues wrote. “The benefit of [the mucosal exposure device] is limited to increase the quantity of mucosa exposed to the lens by flatting the folds and strengthening the angulations, and the benefit of AI is only in spotting a lesion that is already displayed within the field of view. Thus, we may speculate that the additional mucosal exposure was synergistic to the AI-assisted polyp recognition by AI.”
The benefits of a combination approach were not universal, however, as the mucosal exposure device did not improve detection of either serrated lesions or advanced adenomas. This result was anticipated, the investigators noted, since the miss rate for diminutive or proximal adenomas is higher than it is for larger or distal lesions, and previous research has suggested that AI-assisted and mucosal exposure techniques, when used alone, are most effective for detecting smaller, proximal lesions.
The study was funded by a European Society of Gastrointestinal Endoscopy Artificial Intelligence Award. The investigators disclosed additional relationships with Fujifilm, Medtronic, Olympus, and others.
based on results of a randomized trial.
Using the mucosal exposure device increased adenoma detection rate by 12% without impacting safety or withdrawal time, suggesting that the two approaches have a synergistic effect, reported lead author Marco Spadaccini, MD, of Humanitas University, Pieve Emanuele, Italy, and colleagues.
“Recent advances in AI, deep learning, and computer vision led to implementation of computer-aided detection [CADe] of colorectal polyps,” the investigators wrote in Gastroenterology. “CADe-assisted colonoscopy already proved its efficacy by increasing adenoma detection in randomized parallel and crossover trials. However, such benefit is mostly related to the higher accuracy in spotting lesions already within the visual field, not affecting the amount of mucosa exposed by the endoscopist during the scope withdrawal. Increasing the mucosa exposure represents a complementary strategy to CADe in order to further improve detection of colorectal neoplasia.”
To test their hypothesis, the investigators conducted a randomized trial involving 1,316 subjects undergoing routine colonoscopy at six centers in Italy and Switzerland. Participants were randomized in a 1:1 ratio to undergo colonoscopy with CADe (GI Genius, Medtronic) or CADe plus a mucosal exposure device (Endocuff Vision, Olympus).
The combination approach yielded a 49.6% adenoma detection rate, compared with a 44.0% detection rate for CADe alone (relative risk, 1.12; 95% confidence interval, 1.00-1.26; P = .04). Adding the mucosal exposure device was also associated with a higher number of adenomas detected per colonoscopy. Withdrawal time and rate of unnecessary polypectomies did not differ between groups.
“The benefit of adding [the mucosal exposure device] to AI was expected due to the complementary nature of the interventions,” Dr. Spadaccini and colleagues wrote. “The benefit of [the mucosal exposure device] is limited to increase the quantity of mucosa exposed to the lens by flatting the folds and strengthening the angulations, and the benefit of AI is only in spotting a lesion that is already displayed within the field of view. Thus, we may speculate that the additional mucosal exposure was synergistic to the AI-assisted polyp recognition by AI.”
The benefits of a combination approach were not universal, however, as the mucosal exposure device did not improve detection of either serrated lesions or advanced adenomas. This result was anticipated, the investigators noted, since the miss rate for diminutive or proximal adenomas is higher than it is for larger or distal lesions, and previous research has suggested that AI-assisted and mucosal exposure techniques, when used alone, are most effective for detecting smaller, proximal lesions.
The study was funded by a European Society of Gastrointestinal Endoscopy Artificial Intelligence Award. The investigators disclosed additional relationships with Fujifilm, Medtronic, Olympus, and others.
FROM GASTROENTEROLOGY
Tips for addressing uptick in mental health visits: Primary care providers collaborate, innovate
This growth in the number of patients needing behavioral health–related care is likely driven by multiple factors, including a shortage of mental health care providers, an increasing incidence of psychiatric illness, and destigmatization of mental health in general, suggested Swetha P. Iruku, MD, MPH, associate professor of family medicine and community health at the University of Pennsylvania and Penn Medicine family physician in Philadelphia.
The Centers for Disease Control and Prevention noted that “the COVID-19 pandemic has been associated with mental health challenges related to the morbidity and mortality caused by the disease and to mitigation activities, including the impact of physical distancing and stay-at-home orders,” in a Morbidity and Mortality Weekly Report.
From June 24 to 30, 2020, U.S. adults reported considerably elevated adverse mental health conditions associated with COVID-19, and symptoms of anxiety disorder and depressive disorder climbed during the months of April through June of the same year, compared with the same period in 2019, they wrote.
Even before the pandemic got underway, multiple studies of national data published this year suggested mental issues were on the rise in the United States. For example, the proportion of adult patient visits to primary care providers that addressed mental health concerns rose from 10.7% to 15.9% from 2006 to 2018, according to research published in Health Affairs. Plus, the number and proportion of pediatric acute care hospitalizations because of mental health diagnoses increased significantly between 2009 and 2019, according to a paper published in JAMA.
“I truly believe that we can’t, as primary care physicians, take care of someone’s physical health without also taking care of their mental health,” Dr. Iruku said in an interview. “It’s all intertwined.”
To rise to this challenge, PCPs first need a collaborative mindset, she suggested, as well as familiarity with available resources, both locally and virtually.
This article examines strategies for managing mental illness in primary care, outlines clinical resources, and reviews related educational opportunities.
In addition, clinical pearls are shared by Dr. Iruku and five other clinicians who provide or have provided mental health care to primary care patients or work in close collaboration with a primary care practice, including a clinical psychologist, a nurse practitioner licensed in psychiatric health, a pediatrician, and a licensed clinical social worker.
Build a network
Most of the providers interviewed cited the importance of collaboration in mental health care, particularly for complex cases.
“I would recommend [that primary care providers get] to know the psychiatric providers [in their area],” said Jessica Viton, DNP, FNP, PMHNP, who delivers mental health care through a community-based primary care practice in Colorado which she requested remain anonymous.
Dr. Iruku suggested making an in-person connection first, if possible.
“So much of what we do is ‘see one, do one, teach one,’ so learn a little bit, then go off and trial,” she said. “[It can be valuable] having someone in your back pocket that you can contact in the case of an emergency, or in a situation where you just don’t know how to tackle it.”
Screen for depression and anxiety
William J. Sieber, PhD, a clinical psychologist, director of integrated behavioral health, and professor in the department of family medicine and public health and the department of psychiatry at the University of California, San Diego, said primary care providers should screen all adult patients for depression and anxiety with the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder Assessment (GAD-7), respectively.
To save time, he suggested a cascading approach.
“In primary care, everybody’s in a hurry,” Dr. Sieber said. “[With the cascading approach,] the first two items [from each questionnaire] are given, and if a person endorses either of those items … then they are asked to complete the other items.”
Jennifer Mullally, MD, a pediatrician at Sanford Health in Fargo, N.D., uses this cascading approach to depression and anxiety screening with all her patients aged 13-18. For younger kids, she screens only those who present with signs or symptoms of mental health issues, or if the parent shares a concern.
This approach differs slightly from U.S. Preventive Services Task Force recommendations, which suggest screening for anxiety in patients aged 8-18 years and depression in patients aged 12-18 years.
Use other screening tools only as needed
Dr. Sieber, the research director for the division of family medicine at UC San Diego, collaborates regularly with primary care providers via hallway consultations, by sharing cases, and through providing oversight of psychiatric care at 13 primary care practices within the UC San Diego network. He recommended against routine screening beyond depression and anxiety in the primary care setting.
“There are a lot of screening tools,” Dr. Sieber said. “It depends on what you’re presented with. The challenge in primary care is you’re going to see all kinds of things. It’s not like running a depression clinic.”
Other than the PHQ-9 and GAD-7, he suggested primary care providers establish familiarity with screening tools for posttraumatic stress disorder and attention-deficit/hyperactivity disorder, noting again that these should be used only when one of the conditions is already suspected.
Dr. Mullally follows a similar approach with her pediatric population. In addition to the GAD-7, she investigates whether a patient has anxiety with the Screen for Child Anxiety Related Disorders (SCARED). For depression, she couples the PHQ-9 with the Columbia Suicide Severity Rating Scale.
While additional screening tools like these are readily available online, Dr. Viton suggested that they should be employed only if the provider is trained to interpret and respond to those findings, and only if they know which tool to use, and when.
For example, she has recently observed PCPs diagnosing adults with ADHD using a three-question test, when in fact a full-length, standardized instrument should be administered by a provider with necessary training.
She also pointed out that bipolar disorder continues to be underdiagnosed, possibly because of providers detecting depression using a questionnaire like the PHQ-9, while failing to inquire about manic episodes.
Leverage online resources
If depression is confirmed, Dr. Iruku often directs the patient to the Mayo Clinic Depression Medication Choice Decision Aid. This website steers patients through medication options based on their answers to a questionnaire. Choices are listed alongside possible adverse effects.
For clinician use, Dr. Iruku recommended The Waco Guide to Psychopharmacology in Primary Care, which aids clinical decision-making for mental illness and substance abuse. The app processes case details to suggest first-, second-, and third-line pharmacotherapies, as well as modifications based on patient needs.
Even with tools like these, however, a referral may be needed.
“[Primary care providers] may not be the best fit for what the patient is looking for, from a mental health or behavioral standpoint,” Dr. Sieber said.
In this case, he encourages patients to visit Psychology Today, a “quite popular portal” that helps patients locate a suitable provider based on location, insurance, driving radius, and mental health concern. This usually generates 10-20 options, Dr. Sieber said, although results can vary.
“It may be discouraging, because maybe only three [providers] pop up based on your criteria, and the closest one is miles away,” he said.
Consider virtual support
If no local psychiatric help is available, Dr. Sieber suggested virtual support, highlighting that “it’s much easier now than it was 3 or 4 years ago” to connect patients with external mental health care.
But this strategy should be reserved for cases of actual need instead of pure convenience, cautioned Dr. Viton, who noted that virtual visits may fail to capture the nuance of an in-person meeting, as body language, mode of dress, and other clues can provide insights into mental health status.
“Occasionally, I think you do have to have an in-person visit, especially when you’re developing a rapport with someone,” Dr. Viton said.
Claire McArdle, a licensed clinical social worker in Fort Collins, Colo., noted that virtual care from an outside provider may also impede the collaboration needed to effectively address mental illness.
In her 11 years in primary care at Associates in Family Medicine, Ms. McArdle had countless interactions with colleagues seeking support when managing a complex case. “I’m coaching providers, front desk staff, and nursing staff on how to interact with patients [with] behavioral health needs,” she said, citing the multitude of nonmedical factors that need to be considered, such as family relationships and patient preferences.
These unscheduled conversations with colleagues throughout the day are impossible to have when sharing a case with an unknown, remote peer.
Ms. McArdle speaks from experience. She recently resigned from Associates in Family Medicine to start her own private therapy practice after her former employer was acquired by VillageMD, a national provider that terminated employment of most other social workers in the practice and began outsourcing mental health care to Mindoula Health, a virtual provider.
Dr. Sieber offered a similar perspective on in-person collaboration as the psychiatric specialist at his center. He routinely offers on-site support for both providers and patients, serving as “another set of eyes and ears” when there is a concern about patient safety or directly managing care when a patient is hospitalized for mental illness.
While virtual solutions may fall short of in-person management, they can offer care at a scale and cost impossible through traditional practice.
This could even be free. Zero-cost, automated software now allows individuals who are uninsured or unable to afford care at least one avenue to manage their mental health concerns.
For example, Bliss is a free, 8-session, interactive online therapy program for depression that was created by the Centre for Interactive Mental Health Solutions. The program offers a tool for monitoring mood and quizzes to test understanding of personal mental health management, among other features.
More advanced programs are emerging as artificial intelligence (AI) enables dialogues between humans and machines. This is the case with Woebot, an app that asks the user about their mood throughout the day, and responds with evidence-based strategies for managing concerns, all for free at press time.
Keep learning
A range of educational options and professional resources are available for primary care providers who would like to improve their knowledge of mental health care. These include formal fellowships in primary care psychiatry/behavioral health integration, free mental health webinars, and various other opportunities.
Eric Eschweiler, DNP, APRN, FNP-C, PHN, completed the University of California, Irvine, Train New Trainers (TNT) Primary Care Psychiatry (PCP) Fellowship in 2016, when he was working as a solo nurse practitioner.
“I was drowning in practice,” said Dr. Eschweiler, director of nursing and public health outreach services at Riverside-San Bernardino County Indian Health, Grand Terrace, Calif., in an interview. “I was a solo NP. There was no physician on site. We were seeing a lot of [individuals with] schizoaffective [disorder] in downtown San Bernardino, the homeless, unhoused – a lot of substance use. I felt I needed to have the skills to be able to treat them effectively. That’s what the fellowship did.”
The skills Dr. Eschweiler learned from participating in his fellowship allowed him to manage more cases of mental illness without need for referral. When a referral was needed for a complex or severe case, he had the confidence to bridge care and collaborate more effectively with psychiatric specialists.
“It was awesome, because we were able to communicate using the same language,” Dr. Eschweiler said of these collaborations. “It’s [about] talking that same language, starting those initial treatments, and then moving forward with specialty care, and vice versa. [Psychiatric specialists] would send me patients that needed medical care because of the types of medications they were taking. And I was then very well aware of those side effects and other issues that might come up from those treatments. So it’s a two-way street.”
Dr. Eschweiler was so impressed by his fellowship that he has since ushered multiple providers through the program since transitioning to an administrative role as director of nursing.
In Fargo, where psychiatric care is sparse and wait times for referral can be months long, Dr. Mullally, like Dr. Eschweiler, knew that she needed more training in mental health.
“I don’t feel like we get enough training in residency,” Dr. Mullally said. “So you do need to look at your options for further CME.”
Out of several CME courses she has taken to further her understanding of pediatric psychiatry, Dr. Mullally recommended The Reach Institute above all others, as their courses involve in-depth discussions and valuable handouts, particularly for medication selection.
“I think that a lot of the other CMEs tend to involve a lot more PowerPoint presentations,” Dr. Mullally said. “And you don’t necessarily leave with a lot of good documents. I still use my Reach handouts. I have them sitting right next to me. I use them every single day.”
Providers interested in The Reach Institute, however, should be prepared to invest both time and money, she added, citing a 2-3 day commitment, and calling it “not cheap.” To overcome these barriers, she suggested that providers get their institution to support their attendance.
For a lighter commitment, Dr. Iruku recommended the American Academy of Family Physicians CME portal, as this offers 13 online, accredited courses covering a range of topics, from adolescent health to substance abuse disorders.
Dr. Sieber suggested that primary care providers join the Collaborative Family Healthcare Association, which aims to integrate physical and behavioral health in routine practice. CFHA, of which he is a member, offers a “bevy of different resources” for interested providers, including a conference in Phoenix this October.
The interviewees disclosed no conflicts of interest.
This growth in the number of patients needing behavioral health–related care is likely driven by multiple factors, including a shortage of mental health care providers, an increasing incidence of psychiatric illness, and destigmatization of mental health in general, suggested Swetha P. Iruku, MD, MPH, associate professor of family medicine and community health at the University of Pennsylvania and Penn Medicine family physician in Philadelphia.
The Centers for Disease Control and Prevention noted that “the COVID-19 pandemic has been associated with mental health challenges related to the morbidity and mortality caused by the disease and to mitigation activities, including the impact of physical distancing and stay-at-home orders,” in a Morbidity and Mortality Weekly Report.
From June 24 to 30, 2020, U.S. adults reported considerably elevated adverse mental health conditions associated with COVID-19, and symptoms of anxiety disorder and depressive disorder climbed during the months of April through June of the same year, compared with the same period in 2019, they wrote.
Even before the pandemic got underway, multiple studies of national data published this year suggested mental issues were on the rise in the United States. For example, the proportion of adult patient visits to primary care providers that addressed mental health concerns rose from 10.7% to 15.9% from 2006 to 2018, according to research published in Health Affairs. Plus, the number and proportion of pediatric acute care hospitalizations because of mental health diagnoses increased significantly between 2009 and 2019, according to a paper published in JAMA.
“I truly believe that we can’t, as primary care physicians, take care of someone’s physical health without also taking care of their mental health,” Dr. Iruku said in an interview. “It’s all intertwined.”
To rise to this challenge, PCPs first need a collaborative mindset, she suggested, as well as familiarity with available resources, both locally and virtually.
This article examines strategies for managing mental illness in primary care, outlines clinical resources, and reviews related educational opportunities.
In addition, clinical pearls are shared by Dr. Iruku and five other clinicians who provide or have provided mental health care to primary care patients or work in close collaboration with a primary care practice, including a clinical psychologist, a nurse practitioner licensed in psychiatric health, a pediatrician, and a licensed clinical social worker.
Build a network
Most of the providers interviewed cited the importance of collaboration in mental health care, particularly for complex cases.
“I would recommend [that primary care providers get] to know the psychiatric providers [in their area],” said Jessica Viton, DNP, FNP, PMHNP, who delivers mental health care through a community-based primary care practice in Colorado which she requested remain anonymous.
Dr. Iruku suggested making an in-person connection first, if possible.
“So much of what we do is ‘see one, do one, teach one,’ so learn a little bit, then go off and trial,” she said. “[It can be valuable] having someone in your back pocket that you can contact in the case of an emergency, or in a situation where you just don’t know how to tackle it.”
Screen for depression and anxiety
William J. Sieber, PhD, a clinical psychologist, director of integrated behavioral health, and professor in the department of family medicine and public health and the department of psychiatry at the University of California, San Diego, said primary care providers should screen all adult patients for depression and anxiety with the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder Assessment (GAD-7), respectively.
To save time, he suggested a cascading approach.
“In primary care, everybody’s in a hurry,” Dr. Sieber said. “[With the cascading approach,] the first two items [from each questionnaire] are given, and if a person endorses either of those items … then they are asked to complete the other items.”
Jennifer Mullally, MD, a pediatrician at Sanford Health in Fargo, N.D., uses this cascading approach to depression and anxiety screening with all her patients aged 13-18. For younger kids, she screens only those who present with signs or symptoms of mental health issues, or if the parent shares a concern.
This approach differs slightly from U.S. Preventive Services Task Force recommendations, which suggest screening for anxiety in patients aged 8-18 years and depression in patients aged 12-18 years.
Use other screening tools only as needed
Dr. Sieber, the research director for the division of family medicine at UC San Diego, collaborates regularly with primary care providers via hallway consultations, by sharing cases, and through providing oversight of psychiatric care at 13 primary care practices within the UC San Diego network. He recommended against routine screening beyond depression and anxiety in the primary care setting.
“There are a lot of screening tools,” Dr. Sieber said. “It depends on what you’re presented with. The challenge in primary care is you’re going to see all kinds of things. It’s not like running a depression clinic.”
Other than the PHQ-9 and GAD-7, he suggested primary care providers establish familiarity with screening tools for posttraumatic stress disorder and attention-deficit/hyperactivity disorder, noting again that these should be used only when one of the conditions is already suspected.
Dr. Mullally follows a similar approach with her pediatric population. In addition to the GAD-7, she investigates whether a patient has anxiety with the Screen for Child Anxiety Related Disorders (SCARED). For depression, she couples the PHQ-9 with the Columbia Suicide Severity Rating Scale.
While additional screening tools like these are readily available online, Dr. Viton suggested that they should be employed only if the provider is trained to interpret and respond to those findings, and only if they know which tool to use, and when.
For example, she has recently observed PCPs diagnosing adults with ADHD using a three-question test, when in fact a full-length, standardized instrument should be administered by a provider with necessary training.
She also pointed out that bipolar disorder continues to be underdiagnosed, possibly because of providers detecting depression using a questionnaire like the PHQ-9, while failing to inquire about manic episodes.
Leverage online resources
If depression is confirmed, Dr. Iruku often directs the patient to the Mayo Clinic Depression Medication Choice Decision Aid. This website steers patients through medication options based on their answers to a questionnaire. Choices are listed alongside possible adverse effects.
For clinician use, Dr. Iruku recommended The Waco Guide to Psychopharmacology in Primary Care, which aids clinical decision-making for mental illness and substance abuse. The app processes case details to suggest first-, second-, and third-line pharmacotherapies, as well as modifications based on patient needs.
Even with tools like these, however, a referral may be needed.
“[Primary care providers] may not be the best fit for what the patient is looking for, from a mental health or behavioral standpoint,” Dr. Sieber said.
In this case, he encourages patients to visit Psychology Today, a “quite popular portal” that helps patients locate a suitable provider based on location, insurance, driving radius, and mental health concern. This usually generates 10-20 options, Dr. Sieber said, although results can vary.
“It may be discouraging, because maybe only three [providers] pop up based on your criteria, and the closest one is miles away,” he said.
Consider virtual support
If no local psychiatric help is available, Dr. Sieber suggested virtual support, highlighting that “it’s much easier now than it was 3 or 4 years ago” to connect patients with external mental health care.
But this strategy should be reserved for cases of actual need instead of pure convenience, cautioned Dr. Viton, who noted that virtual visits may fail to capture the nuance of an in-person meeting, as body language, mode of dress, and other clues can provide insights into mental health status.
“Occasionally, I think you do have to have an in-person visit, especially when you’re developing a rapport with someone,” Dr. Viton said.
Claire McArdle, a licensed clinical social worker in Fort Collins, Colo., noted that virtual care from an outside provider may also impede the collaboration needed to effectively address mental illness.
In her 11 years in primary care at Associates in Family Medicine, Ms. McArdle had countless interactions with colleagues seeking support when managing a complex case. “I’m coaching providers, front desk staff, and nursing staff on how to interact with patients [with] behavioral health needs,” she said, citing the multitude of nonmedical factors that need to be considered, such as family relationships and patient preferences.
These unscheduled conversations with colleagues throughout the day are impossible to have when sharing a case with an unknown, remote peer.
Ms. McArdle speaks from experience. She recently resigned from Associates in Family Medicine to start her own private therapy practice after her former employer was acquired by VillageMD, a national provider that terminated employment of most other social workers in the practice and began outsourcing mental health care to Mindoula Health, a virtual provider.
Dr. Sieber offered a similar perspective on in-person collaboration as the psychiatric specialist at his center. He routinely offers on-site support for both providers and patients, serving as “another set of eyes and ears” when there is a concern about patient safety or directly managing care when a patient is hospitalized for mental illness.
While virtual solutions may fall short of in-person management, they can offer care at a scale and cost impossible through traditional practice.
This could even be free. Zero-cost, automated software now allows individuals who are uninsured or unable to afford care at least one avenue to manage their mental health concerns.
For example, Bliss is a free, 8-session, interactive online therapy program for depression that was created by the Centre for Interactive Mental Health Solutions. The program offers a tool for monitoring mood and quizzes to test understanding of personal mental health management, among other features.
More advanced programs are emerging as artificial intelligence (AI) enables dialogues between humans and machines. This is the case with Woebot, an app that asks the user about their mood throughout the day, and responds with evidence-based strategies for managing concerns, all for free at press time.
Keep learning
A range of educational options and professional resources are available for primary care providers who would like to improve their knowledge of mental health care. These include formal fellowships in primary care psychiatry/behavioral health integration, free mental health webinars, and various other opportunities.
Eric Eschweiler, DNP, APRN, FNP-C, PHN, completed the University of California, Irvine, Train New Trainers (TNT) Primary Care Psychiatry (PCP) Fellowship in 2016, when he was working as a solo nurse practitioner.
“I was drowning in practice,” said Dr. Eschweiler, director of nursing and public health outreach services at Riverside-San Bernardino County Indian Health, Grand Terrace, Calif., in an interview. “I was a solo NP. There was no physician on site. We were seeing a lot of [individuals with] schizoaffective [disorder] in downtown San Bernardino, the homeless, unhoused – a lot of substance use. I felt I needed to have the skills to be able to treat them effectively. That’s what the fellowship did.”
The skills Dr. Eschweiler learned from participating in his fellowship allowed him to manage more cases of mental illness without need for referral. When a referral was needed for a complex or severe case, he had the confidence to bridge care and collaborate more effectively with psychiatric specialists.
“It was awesome, because we were able to communicate using the same language,” Dr. Eschweiler said of these collaborations. “It’s [about] talking that same language, starting those initial treatments, and then moving forward with specialty care, and vice versa. [Psychiatric specialists] would send me patients that needed medical care because of the types of medications they were taking. And I was then very well aware of those side effects and other issues that might come up from those treatments. So it’s a two-way street.”
Dr. Eschweiler was so impressed by his fellowship that he has since ushered multiple providers through the program since transitioning to an administrative role as director of nursing.
In Fargo, where psychiatric care is sparse and wait times for referral can be months long, Dr. Mullally, like Dr. Eschweiler, knew that she needed more training in mental health.
“I don’t feel like we get enough training in residency,” Dr. Mullally said. “So you do need to look at your options for further CME.”
Out of several CME courses she has taken to further her understanding of pediatric psychiatry, Dr. Mullally recommended The Reach Institute above all others, as their courses involve in-depth discussions and valuable handouts, particularly for medication selection.
“I think that a lot of the other CMEs tend to involve a lot more PowerPoint presentations,” Dr. Mullally said. “And you don’t necessarily leave with a lot of good documents. I still use my Reach handouts. I have them sitting right next to me. I use them every single day.”
Providers interested in The Reach Institute, however, should be prepared to invest both time and money, she added, citing a 2-3 day commitment, and calling it “not cheap.” To overcome these barriers, she suggested that providers get their institution to support their attendance.
For a lighter commitment, Dr. Iruku recommended the American Academy of Family Physicians CME portal, as this offers 13 online, accredited courses covering a range of topics, from adolescent health to substance abuse disorders.
Dr. Sieber suggested that primary care providers join the Collaborative Family Healthcare Association, which aims to integrate physical and behavioral health in routine practice. CFHA, of which he is a member, offers a “bevy of different resources” for interested providers, including a conference in Phoenix this October.
The interviewees disclosed no conflicts of interest.
This growth in the number of patients needing behavioral health–related care is likely driven by multiple factors, including a shortage of mental health care providers, an increasing incidence of psychiatric illness, and destigmatization of mental health in general, suggested Swetha P. Iruku, MD, MPH, associate professor of family medicine and community health at the University of Pennsylvania and Penn Medicine family physician in Philadelphia.
The Centers for Disease Control and Prevention noted that “the COVID-19 pandemic has been associated with mental health challenges related to the morbidity and mortality caused by the disease and to mitigation activities, including the impact of physical distancing and stay-at-home orders,” in a Morbidity and Mortality Weekly Report.
From June 24 to 30, 2020, U.S. adults reported considerably elevated adverse mental health conditions associated with COVID-19, and symptoms of anxiety disorder and depressive disorder climbed during the months of April through June of the same year, compared with the same period in 2019, they wrote.
Even before the pandemic got underway, multiple studies of national data published this year suggested mental issues were on the rise in the United States. For example, the proportion of adult patient visits to primary care providers that addressed mental health concerns rose from 10.7% to 15.9% from 2006 to 2018, according to research published in Health Affairs. Plus, the number and proportion of pediatric acute care hospitalizations because of mental health diagnoses increased significantly between 2009 and 2019, according to a paper published in JAMA.
“I truly believe that we can’t, as primary care physicians, take care of someone’s physical health without also taking care of their mental health,” Dr. Iruku said in an interview. “It’s all intertwined.”
To rise to this challenge, PCPs first need a collaborative mindset, she suggested, as well as familiarity with available resources, both locally and virtually.
This article examines strategies for managing mental illness in primary care, outlines clinical resources, and reviews related educational opportunities.
In addition, clinical pearls are shared by Dr. Iruku and five other clinicians who provide or have provided mental health care to primary care patients or work in close collaboration with a primary care practice, including a clinical psychologist, a nurse practitioner licensed in psychiatric health, a pediatrician, and a licensed clinical social worker.
Build a network
Most of the providers interviewed cited the importance of collaboration in mental health care, particularly for complex cases.
“I would recommend [that primary care providers get] to know the psychiatric providers [in their area],” said Jessica Viton, DNP, FNP, PMHNP, who delivers mental health care through a community-based primary care practice in Colorado which she requested remain anonymous.
Dr. Iruku suggested making an in-person connection first, if possible.
“So much of what we do is ‘see one, do one, teach one,’ so learn a little bit, then go off and trial,” she said. “[It can be valuable] having someone in your back pocket that you can contact in the case of an emergency, or in a situation where you just don’t know how to tackle it.”
Screen for depression and anxiety
William J. Sieber, PhD, a clinical psychologist, director of integrated behavioral health, and professor in the department of family medicine and public health and the department of psychiatry at the University of California, San Diego, said primary care providers should screen all adult patients for depression and anxiety with the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder Assessment (GAD-7), respectively.
To save time, he suggested a cascading approach.
“In primary care, everybody’s in a hurry,” Dr. Sieber said. “[With the cascading approach,] the first two items [from each questionnaire] are given, and if a person endorses either of those items … then they are asked to complete the other items.”
Jennifer Mullally, MD, a pediatrician at Sanford Health in Fargo, N.D., uses this cascading approach to depression and anxiety screening with all her patients aged 13-18. For younger kids, she screens only those who present with signs or symptoms of mental health issues, or if the parent shares a concern.
This approach differs slightly from U.S. Preventive Services Task Force recommendations, which suggest screening for anxiety in patients aged 8-18 years and depression in patients aged 12-18 years.
Use other screening tools only as needed
Dr. Sieber, the research director for the division of family medicine at UC San Diego, collaborates regularly with primary care providers via hallway consultations, by sharing cases, and through providing oversight of psychiatric care at 13 primary care practices within the UC San Diego network. He recommended against routine screening beyond depression and anxiety in the primary care setting.
“There are a lot of screening tools,” Dr. Sieber said. “It depends on what you’re presented with. The challenge in primary care is you’re going to see all kinds of things. It’s not like running a depression clinic.”
Other than the PHQ-9 and GAD-7, he suggested primary care providers establish familiarity with screening tools for posttraumatic stress disorder and attention-deficit/hyperactivity disorder, noting again that these should be used only when one of the conditions is already suspected.
Dr. Mullally follows a similar approach with her pediatric population. In addition to the GAD-7, she investigates whether a patient has anxiety with the Screen for Child Anxiety Related Disorders (SCARED). For depression, she couples the PHQ-9 with the Columbia Suicide Severity Rating Scale.
While additional screening tools like these are readily available online, Dr. Viton suggested that they should be employed only if the provider is trained to interpret and respond to those findings, and only if they know which tool to use, and when.
For example, she has recently observed PCPs diagnosing adults with ADHD using a three-question test, when in fact a full-length, standardized instrument should be administered by a provider with necessary training.
She also pointed out that bipolar disorder continues to be underdiagnosed, possibly because of providers detecting depression using a questionnaire like the PHQ-9, while failing to inquire about manic episodes.
Leverage online resources
If depression is confirmed, Dr. Iruku often directs the patient to the Mayo Clinic Depression Medication Choice Decision Aid. This website steers patients through medication options based on their answers to a questionnaire. Choices are listed alongside possible adverse effects.
For clinician use, Dr. Iruku recommended The Waco Guide to Psychopharmacology in Primary Care, which aids clinical decision-making for mental illness and substance abuse. The app processes case details to suggest first-, second-, and third-line pharmacotherapies, as well as modifications based on patient needs.
Even with tools like these, however, a referral may be needed.
“[Primary care providers] may not be the best fit for what the patient is looking for, from a mental health or behavioral standpoint,” Dr. Sieber said.
In this case, he encourages patients to visit Psychology Today, a “quite popular portal” that helps patients locate a suitable provider based on location, insurance, driving radius, and mental health concern. This usually generates 10-20 options, Dr. Sieber said, although results can vary.
“It may be discouraging, because maybe only three [providers] pop up based on your criteria, and the closest one is miles away,” he said.
Consider virtual support
If no local psychiatric help is available, Dr. Sieber suggested virtual support, highlighting that “it’s much easier now than it was 3 or 4 years ago” to connect patients with external mental health care.
But this strategy should be reserved for cases of actual need instead of pure convenience, cautioned Dr. Viton, who noted that virtual visits may fail to capture the nuance of an in-person meeting, as body language, mode of dress, and other clues can provide insights into mental health status.
“Occasionally, I think you do have to have an in-person visit, especially when you’re developing a rapport with someone,” Dr. Viton said.
Claire McArdle, a licensed clinical social worker in Fort Collins, Colo., noted that virtual care from an outside provider may also impede the collaboration needed to effectively address mental illness.
In her 11 years in primary care at Associates in Family Medicine, Ms. McArdle had countless interactions with colleagues seeking support when managing a complex case. “I’m coaching providers, front desk staff, and nursing staff on how to interact with patients [with] behavioral health needs,” she said, citing the multitude of nonmedical factors that need to be considered, such as family relationships and patient preferences.
These unscheduled conversations with colleagues throughout the day are impossible to have when sharing a case with an unknown, remote peer.
Ms. McArdle speaks from experience. She recently resigned from Associates in Family Medicine to start her own private therapy practice after her former employer was acquired by VillageMD, a national provider that terminated employment of most other social workers in the practice and began outsourcing mental health care to Mindoula Health, a virtual provider.
Dr. Sieber offered a similar perspective on in-person collaboration as the psychiatric specialist at his center. He routinely offers on-site support for both providers and patients, serving as “another set of eyes and ears” when there is a concern about patient safety or directly managing care when a patient is hospitalized for mental illness.
While virtual solutions may fall short of in-person management, they can offer care at a scale and cost impossible through traditional practice.
This could even be free. Zero-cost, automated software now allows individuals who are uninsured or unable to afford care at least one avenue to manage their mental health concerns.
For example, Bliss is a free, 8-session, interactive online therapy program for depression that was created by the Centre for Interactive Mental Health Solutions. The program offers a tool for monitoring mood and quizzes to test understanding of personal mental health management, among other features.
More advanced programs are emerging as artificial intelligence (AI) enables dialogues between humans and machines. This is the case with Woebot, an app that asks the user about their mood throughout the day, and responds with evidence-based strategies for managing concerns, all for free at press time.
Keep learning
A range of educational options and professional resources are available for primary care providers who would like to improve their knowledge of mental health care. These include formal fellowships in primary care psychiatry/behavioral health integration, free mental health webinars, and various other opportunities.
Eric Eschweiler, DNP, APRN, FNP-C, PHN, completed the University of California, Irvine, Train New Trainers (TNT) Primary Care Psychiatry (PCP) Fellowship in 2016, when he was working as a solo nurse practitioner.
“I was drowning in practice,” said Dr. Eschweiler, director of nursing and public health outreach services at Riverside-San Bernardino County Indian Health, Grand Terrace, Calif., in an interview. “I was a solo NP. There was no physician on site. We were seeing a lot of [individuals with] schizoaffective [disorder] in downtown San Bernardino, the homeless, unhoused – a lot of substance use. I felt I needed to have the skills to be able to treat them effectively. That’s what the fellowship did.”
The skills Dr. Eschweiler learned from participating in his fellowship allowed him to manage more cases of mental illness without need for referral. When a referral was needed for a complex or severe case, he had the confidence to bridge care and collaborate more effectively with psychiatric specialists.
“It was awesome, because we were able to communicate using the same language,” Dr. Eschweiler said of these collaborations. “It’s [about] talking that same language, starting those initial treatments, and then moving forward with specialty care, and vice versa. [Psychiatric specialists] would send me patients that needed medical care because of the types of medications they were taking. And I was then very well aware of those side effects and other issues that might come up from those treatments. So it’s a two-way street.”
Dr. Eschweiler was so impressed by his fellowship that he has since ushered multiple providers through the program since transitioning to an administrative role as director of nursing.
In Fargo, where psychiatric care is sparse and wait times for referral can be months long, Dr. Mullally, like Dr. Eschweiler, knew that she needed more training in mental health.
“I don’t feel like we get enough training in residency,” Dr. Mullally said. “So you do need to look at your options for further CME.”
Out of several CME courses she has taken to further her understanding of pediatric psychiatry, Dr. Mullally recommended The Reach Institute above all others, as their courses involve in-depth discussions and valuable handouts, particularly for medication selection.
“I think that a lot of the other CMEs tend to involve a lot more PowerPoint presentations,” Dr. Mullally said. “And you don’t necessarily leave with a lot of good documents. I still use my Reach handouts. I have them sitting right next to me. I use them every single day.”
Providers interested in The Reach Institute, however, should be prepared to invest both time and money, she added, citing a 2-3 day commitment, and calling it “not cheap.” To overcome these barriers, she suggested that providers get their institution to support their attendance.
For a lighter commitment, Dr. Iruku recommended the American Academy of Family Physicians CME portal, as this offers 13 online, accredited courses covering a range of topics, from adolescent health to substance abuse disorders.
Dr. Sieber suggested that primary care providers join the Collaborative Family Healthcare Association, which aims to integrate physical and behavioral health in routine practice. CFHA, of which he is a member, offers a “bevy of different resources” for interested providers, including a conference in Phoenix this October.
The interviewees disclosed no conflicts of interest.
Study explains link between fatty liver and CRC liver metastasis
according to the authors of new research.
These findings support the previously reported link between fatty liver and colorectal cancer (CRC) liver metastasis, and suggest that CRC patients with nonalcoholic fatty liver disease (NAFLD) may respond differently to treatment than CRC patients without NAFLD, wrote lead author Zhijun Wang, MD, PhD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues, in their paper.
“Obesity and NAFLD are the significant risk factors for CRC,” the investigators explained, in Cell Metabolism. “A growing body of epidemiological evidence indicates that fatty liver increases the occurrence of CRC liver metastasis and the local recurrence after resection of CRC liver metastases, thereby worsening prognosis ... There is an urgent need to understand the molecular mechanisms of metastasis in patients with fatty liver to manage those patients effectively.”
To this end, Dr. Wang and colleagues conducted a series of experiments involving mice, cell cultures, and human sera. They found that fatty liver increases risk of CRC liver metastasis via extracellular vesicles (EVs) that contain procarcinogenic miRNAs. As these EVs transfer microRNAs from fatty liver hepatocytes to metastatic cancer cells, YAP activity increases, which, in turn, suppresses immune activity within the tumor microenvironment, promoting growth of CRC metastasis.
Beyond the increased risk of liver metastasis presented by fatty liver, the investigators suggested that NAFLD may cause “more complex” metastatic tumor microenvironments, potentially explaining “diverse responses” to cancer therapies among patients with CRC and liver metastases.
“In summary, our study demonstrates that the pre- and prometastatic liver environment of fatty liver is induced by procarcinogenic EVs and results in an immunosuppressive tumor microenvironemnt, in which YAP plays an important role,” the investigators concluded. “Our study provides new insight into [the] distinct liver tumor microenvironment in patients with fatty liver and without fatty liver, which may contribute to the aggressiveness of metastatic tumors and weak responses to anticancer therapy in patients with fatty liver. Additional studies are warranted to develop precision medicine for treating patients with CRC and liver metastasis.”
One of the study authors disclosed relationships with Altimmune, Cytodyn, Novo Nordisk, and others. The other investigators had no relevant financial disclosures.
according to the authors of new research.
These findings support the previously reported link between fatty liver and colorectal cancer (CRC) liver metastasis, and suggest that CRC patients with nonalcoholic fatty liver disease (NAFLD) may respond differently to treatment than CRC patients without NAFLD, wrote lead author Zhijun Wang, MD, PhD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues, in their paper.
“Obesity and NAFLD are the significant risk factors for CRC,” the investigators explained, in Cell Metabolism. “A growing body of epidemiological evidence indicates that fatty liver increases the occurrence of CRC liver metastasis and the local recurrence after resection of CRC liver metastases, thereby worsening prognosis ... There is an urgent need to understand the molecular mechanisms of metastasis in patients with fatty liver to manage those patients effectively.”
To this end, Dr. Wang and colleagues conducted a series of experiments involving mice, cell cultures, and human sera. They found that fatty liver increases risk of CRC liver metastasis via extracellular vesicles (EVs) that contain procarcinogenic miRNAs. As these EVs transfer microRNAs from fatty liver hepatocytes to metastatic cancer cells, YAP activity increases, which, in turn, suppresses immune activity within the tumor microenvironment, promoting growth of CRC metastasis.
Beyond the increased risk of liver metastasis presented by fatty liver, the investigators suggested that NAFLD may cause “more complex” metastatic tumor microenvironments, potentially explaining “diverse responses” to cancer therapies among patients with CRC and liver metastases.
“In summary, our study demonstrates that the pre- and prometastatic liver environment of fatty liver is induced by procarcinogenic EVs and results in an immunosuppressive tumor microenvironemnt, in which YAP plays an important role,” the investigators concluded. “Our study provides new insight into [the] distinct liver tumor microenvironment in patients with fatty liver and without fatty liver, which may contribute to the aggressiveness of metastatic tumors and weak responses to anticancer therapy in patients with fatty liver. Additional studies are warranted to develop precision medicine for treating patients with CRC and liver metastasis.”
One of the study authors disclosed relationships with Altimmune, Cytodyn, Novo Nordisk, and others. The other investigators had no relevant financial disclosures.
according to the authors of new research.
These findings support the previously reported link between fatty liver and colorectal cancer (CRC) liver metastasis, and suggest that CRC patients with nonalcoholic fatty liver disease (NAFLD) may respond differently to treatment than CRC patients without NAFLD, wrote lead author Zhijun Wang, MD, PhD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues, in their paper.
“Obesity and NAFLD are the significant risk factors for CRC,” the investigators explained, in Cell Metabolism. “A growing body of epidemiological evidence indicates that fatty liver increases the occurrence of CRC liver metastasis and the local recurrence after resection of CRC liver metastases, thereby worsening prognosis ... There is an urgent need to understand the molecular mechanisms of metastasis in patients with fatty liver to manage those patients effectively.”
To this end, Dr. Wang and colleagues conducted a series of experiments involving mice, cell cultures, and human sera. They found that fatty liver increases risk of CRC liver metastasis via extracellular vesicles (EVs) that contain procarcinogenic miRNAs. As these EVs transfer microRNAs from fatty liver hepatocytes to metastatic cancer cells, YAP activity increases, which, in turn, suppresses immune activity within the tumor microenvironment, promoting growth of CRC metastasis.
Beyond the increased risk of liver metastasis presented by fatty liver, the investigators suggested that NAFLD may cause “more complex” metastatic tumor microenvironments, potentially explaining “diverse responses” to cancer therapies among patients with CRC and liver metastases.
“In summary, our study demonstrates that the pre- and prometastatic liver environment of fatty liver is induced by procarcinogenic EVs and results in an immunosuppressive tumor microenvironemnt, in which YAP plays an important role,” the investigators concluded. “Our study provides new insight into [the] distinct liver tumor microenvironment in patients with fatty liver and without fatty liver, which may contribute to the aggressiveness of metastatic tumors and weak responses to anticancer therapy in patients with fatty liver. Additional studies are warranted to develop precision medicine for treating patients with CRC and liver metastasis.”
One of the study authors disclosed relationships with Altimmune, Cytodyn, Novo Nordisk, and others. The other investigators had no relevant financial disclosures.
FROM CELL METABOLISM
Refined incidence rate of HCC with alcohol-associated cirrhosis encourages surveillance
Incidence rates were higher for cohorts that underwent HCC surveillance versus those that did not undergo surveillance, suggesting that such programs offer significant benefit, lead author Daniel Q. Huang, MBBS, of the University of California, San Diego, and colleagues reported.
“A systematic review of the incidence of HCC among patients with alcohol-associated cirrhosis has not been reported,” the investigators wrote in Clinical Gastroenterology and Hepatology, prompting the present research.
Previous studies have described a broad range of annual incidence findings for HCC in this population, from 0.6% to 5.6%, suggesting that a systematic approach was needed.
To this end, Dr. Huang and colleagues analyzed data from 18 studies that involved 148,333 patients with alcohol-associated cirrhosis. The primary analysis aimed to determine cumulative incidence rates over time, while the secondary analysis characterized the impact of participation in HCC surveillance programs.
“This meta-analysis used reconstructed individual participant data, which is considered to be the gold standard for reporting survival data because it accounts for censoring of events,” the investigators noted. “The current study provides important data that are useful for clinical practice and clinical trial design.”
The cumulative incidence rates of HCC were 1%, 3%, and 9% at 1 year, 5 years, and 10 years, respectively. Among 12 of the risk factors studied, smoking, diabetes, and decompensation were all significantly associated with rate of HCC.
“Therefore, patients with alcohol-associated cirrhosis should be screened for diabetes to identify the patients at high risk for HCC development,” the investigators wrote. “In addition, patients with alcohol-associated cirrhosis should be advised to stop smoking, while patients with hepatic decompensation should be monitored carefully for the development of HCC if clinically appropriate.”
The secondary analysis showed that HCC incidence rates were higher among patients participating in HCC surveillance programs than those who did not participate (18.6 vs. 4.8 per 1,000 person-years; P = .001).
“Patients with alcohol-associated cirrhosis are known to have lower HCC surveillance rates, which may be related to poor disease awareness, clinic time constraints caused by other active medical issues, and provider beliefs regarding the likelihood of adherence,” the investigators noted.
Increased efforts are needed to promote surveillance in this population, they added, suggesting a range of communication pathways, including social media, traditional news outlets, and direct mailing.
Dr. Huang and colleagues also suggested that the findings should be validated in large prospective studies.
The study was funded by the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Environmental Health Sciences, the National Center for Advancing Translational Sciences, and others. Dr. Huang disclosed funding from the Singapore Ministry of Health’s National Medical Research Council.
The association between cirrhosis and hepatocellular carcinoma (HCC) risk is well known and therefore routine surveillance is recommended by the American Association for the Study of Liver Diseases. More recent data has shown alcohol use to be an independent risk factor for HCC along with various other cancers.
Quite frequently, the focus of management in patients with alcohol-associated liver disease is alcohol cessation to prevent further decompensation, with screening often being overlooked. Previous studies have shown, however, that earlier detection is associated with improved survival. Another interesting finding of this study was that those patients who had concomitant smoking use, diabetes, and hepatic decompensation were more likely to develop HCC. When managing patients with alcohol related liver disease, confounding risk factors should be mitigated (that is, encouragement of smoking cessation, enhanced screening for diabetes, and more rigorous screening in decompensated patients).
This study brings to light the need for improved screening and concomitant risk factor mitigation for hepatocellular carcinoma given higher rates of detection in those undergoing surveillance. Larger, prospective studies are needed, however, to validate the findings in this study given the recent overall increase in rates of alcohol-associated liver disease.
Priya Maddur MD, is a visiting clinical associate professor of medicine, University of Arizona, Tucson. Dr. Maddur has no relevant disclosures.
The association between cirrhosis and hepatocellular carcinoma (HCC) risk is well known and therefore routine surveillance is recommended by the American Association for the Study of Liver Diseases. More recent data has shown alcohol use to be an independent risk factor for HCC along with various other cancers.
Quite frequently, the focus of management in patients with alcohol-associated liver disease is alcohol cessation to prevent further decompensation, with screening often being overlooked. Previous studies have shown, however, that earlier detection is associated with improved survival. Another interesting finding of this study was that those patients who had concomitant smoking use, diabetes, and hepatic decompensation were more likely to develop HCC. When managing patients with alcohol related liver disease, confounding risk factors should be mitigated (that is, encouragement of smoking cessation, enhanced screening for diabetes, and more rigorous screening in decompensated patients).
This study brings to light the need for improved screening and concomitant risk factor mitigation for hepatocellular carcinoma given higher rates of detection in those undergoing surveillance. Larger, prospective studies are needed, however, to validate the findings in this study given the recent overall increase in rates of alcohol-associated liver disease.
Priya Maddur MD, is a visiting clinical associate professor of medicine, University of Arizona, Tucson. Dr. Maddur has no relevant disclosures.
The association between cirrhosis and hepatocellular carcinoma (HCC) risk is well known and therefore routine surveillance is recommended by the American Association for the Study of Liver Diseases. More recent data has shown alcohol use to be an independent risk factor for HCC along with various other cancers.
Quite frequently, the focus of management in patients with alcohol-associated liver disease is alcohol cessation to prevent further decompensation, with screening often being overlooked. Previous studies have shown, however, that earlier detection is associated with improved survival. Another interesting finding of this study was that those patients who had concomitant smoking use, diabetes, and hepatic decompensation were more likely to develop HCC. When managing patients with alcohol related liver disease, confounding risk factors should be mitigated (that is, encouragement of smoking cessation, enhanced screening for diabetes, and more rigorous screening in decompensated patients).
This study brings to light the need for improved screening and concomitant risk factor mitigation for hepatocellular carcinoma given higher rates of detection in those undergoing surveillance. Larger, prospective studies are needed, however, to validate the findings in this study given the recent overall increase in rates of alcohol-associated liver disease.
Priya Maddur MD, is a visiting clinical associate professor of medicine, University of Arizona, Tucson. Dr. Maddur has no relevant disclosures.
Incidence rates were higher for cohorts that underwent HCC surveillance versus those that did not undergo surveillance, suggesting that such programs offer significant benefit, lead author Daniel Q. Huang, MBBS, of the University of California, San Diego, and colleagues reported.
“A systematic review of the incidence of HCC among patients with alcohol-associated cirrhosis has not been reported,” the investigators wrote in Clinical Gastroenterology and Hepatology, prompting the present research.
Previous studies have described a broad range of annual incidence findings for HCC in this population, from 0.6% to 5.6%, suggesting that a systematic approach was needed.
To this end, Dr. Huang and colleagues analyzed data from 18 studies that involved 148,333 patients with alcohol-associated cirrhosis. The primary analysis aimed to determine cumulative incidence rates over time, while the secondary analysis characterized the impact of participation in HCC surveillance programs.
“This meta-analysis used reconstructed individual participant data, which is considered to be the gold standard for reporting survival data because it accounts for censoring of events,” the investigators noted. “The current study provides important data that are useful for clinical practice and clinical trial design.”
The cumulative incidence rates of HCC were 1%, 3%, and 9% at 1 year, 5 years, and 10 years, respectively. Among 12 of the risk factors studied, smoking, diabetes, and decompensation were all significantly associated with rate of HCC.
“Therefore, patients with alcohol-associated cirrhosis should be screened for diabetes to identify the patients at high risk for HCC development,” the investigators wrote. “In addition, patients with alcohol-associated cirrhosis should be advised to stop smoking, while patients with hepatic decompensation should be monitored carefully for the development of HCC if clinically appropriate.”
The secondary analysis showed that HCC incidence rates were higher among patients participating in HCC surveillance programs than those who did not participate (18.6 vs. 4.8 per 1,000 person-years; P = .001).
“Patients with alcohol-associated cirrhosis are known to have lower HCC surveillance rates, which may be related to poor disease awareness, clinic time constraints caused by other active medical issues, and provider beliefs regarding the likelihood of adherence,” the investigators noted.
Increased efforts are needed to promote surveillance in this population, they added, suggesting a range of communication pathways, including social media, traditional news outlets, and direct mailing.
Dr. Huang and colleagues also suggested that the findings should be validated in large prospective studies.
The study was funded by the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Environmental Health Sciences, the National Center for Advancing Translational Sciences, and others. Dr. Huang disclosed funding from the Singapore Ministry of Health’s National Medical Research Council.
Incidence rates were higher for cohorts that underwent HCC surveillance versus those that did not undergo surveillance, suggesting that such programs offer significant benefit, lead author Daniel Q. Huang, MBBS, of the University of California, San Diego, and colleagues reported.
“A systematic review of the incidence of HCC among patients with alcohol-associated cirrhosis has not been reported,” the investigators wrote in Clinical Gastroenterology and Hepatology, prompting the present research.
Previous studies have described a broad range of annual incidence findings for HCC in this population, from 0.6% to 5.6%, suggesting that a systematic approach was needed.
To this end, Dr. Huang and colleagues analyzed data from 18 studies that involved 148,333 patients with alcohol-associated cirrhosis. The primary analysis aimed to determine cumulative incidence rates over time, while the secondary analysis characterized the impact of participation in HCC surveillance programs.
“This meta-analysis used reconstructed individual participant data, which is considered to be the gold standard for reporting survival data because it accounts for censoring of events,” the investigators noted. “The current study provides important data that are useful for clinical practice and clinical trial design.”
The cumulative incidence rates of HCC were 1%, 3%, and 9% at 1 year, 5 years, and 10 years, respectively. Among 12 of the risk factors studied, smoking, diabetes, and decompensation were all significantly associated with rate of HCC.
“Therefore, patients with alcohol-associated cirrhosis should be screened for diabetes to identify the patients at high risk for HCC development,” the investigators wrote. “In addition, patients with alcohol-associated cirrhosis should be advised to stop smoking, while patients with hepatic decompensation should be monitored carefully for the development of HCC if clinically appropriate.”
The secondary analysis showed that HCC incidence rates were higher among patients participating in HCC surveillance programs than those who did not participate (18.6 vs. 4.8 per 1,000 person-years; P = .001).
“Patients with alcohol-associated cirrhosis are known to have lower HCC surveillance rates, which may be related to poor disease awareness, clinic time constraints caused by other active medical issues, and provider beliefs regarding the likelihood of adherence,” the investigators noted.
Increased efforts are needed to promote surveillance in this population, they added, suggesting a range of communication pathways, including social media, traditional news outlets, and direct mailing.
Dr. Huang and colleagues also suggested that the findings should be validated in large prospective studies.
The study was funded by the National Institute on Alcohol Abuse and Alcoholism, the National Institute of Environmental Health Sciences, the National Center for Advancing Translational Sciences, and others. Dr. Huang disclosed funding from the Singapore Ministry of Health’s National Medical Research Council.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Clinical Practice Update: Alpha-gal syndrome often causes GI issues without anaphylaxis, skin changes
according to an American Gastroenterological Association clinical practice update.
Although the allergic response is best known for a combination of anaphylaxis, skin changes, and gastrointestinal symptoms that occurs within hours of consuming mammalian-derived food products, health care providers should know that many patients experience gastrointestinal distress in the absence of other clinical signs, lead author Sarah K. McGill, MD, MSc, of the University of North Carolina at Chapel Hill, and colleagues reported.
“It is important for gastroenterologists to be aware of this condition and to be capable of diagnosing and treating it in a timely manner,” the investigators wrote in Clinical Gastroenterology and Hepatology.
To this end, Dr. McGill and colleagues drafted the present clinical practice update, covering pathogenesis, clinical manifestations, diagnosis, and management.
“The allergy in alpha-gal syndrome is to galactose alpha-1,3-galactose, an oligosaccharide on the cells of all nonprimate mammals,” the investigators wrote. “Surprisingly, sensitization to alpha-gal, that is, the process by which human beings develop IgE antibodies to the sugar, is understood to occur after the bite of a tick or parasitic infection. In the United States, the Lone Star tick, an ectoparasite whose principal host is deer, is strongly implicated.”
Gastrointestinal focused clinical research is scarce, the investigators noted, citing two observational studies involving 375 patients positive for alpha-gal IgE. Almost half of these patients (40.7%) had gastrointestinal symptoms alone. Across the entire population, the most common gastrointestinal symptoms were abdominal pain (71%) and vomiting (22%). About three out of four patients reported improvement on an alpha-gal avoidance diet.
“Clinicians should consider alpha-gal syndrome in the differential diagnosis of patients with unexplained gastrointestinal symptoms of abdominal pain, diarrhea, nausea, and vomiting, particularly those who live or have lived in an alpha-gal–prevalent area,” the investigators wrote.
In the United States, these areas span the domain of the Lone Star tick, including most of the East Coast, the central Midwest, the South, and all of Texas. Overseas, alpha-gal syndrome has been reported in Japan, Australia, Western Europe, and South Africa.
Clinical suspicion should be increased in patients with a history of tick bite, engagement in outdoor activities, and awakening in the night with gastrointestinal distress (because of the delay between allergen ingestion and symptom onset). Workup should include serum testing for alpha-gal IgE antibodies, according to the update. Serum positivity alone, however, is not sufficient for diagnosis. Alpha-gal syndrome must be confirmed by symptom resolution or improvement upon adherence to an alpha-gal avoidance diet for at least a month.
“During this time, patients may want to avoid eating at restaurants, which can easily cross-contaminate food, and processed food, which may contain alpha-gal in additives,” Dr. McGill and colleagues wrote.
Patients with alpha-gal syndrome who accidentally consume alpha-gal should take 25-50 mg of diphenhydramine and ensure access to a self-injectable epinephrine if symptoms progress, particularly if respiratory compromise occurs, they added.
The coauthors are Jana G. Hasash, MD, and Thomas A. Platts-Mills, MD, PhD.
The investigators disclosed relationships with Olympus America, Exact Sciences, Guardant Health, Finch Therapeutics, and others.
according to an American Gastroenterological Association clinical practice update.
Although the allergic response is best known for a combination of anaphylaxis, skin changes, and gastrointestinal symptoms that occurs within hours of consuming mammalian-derived food products, health care providers should know that many patients experience gastrointestinal distress in the absence of other clinical signs, lead author Sarah K. McGill, MD, MSc, of the University of North Carolina at Chapel Hill, and colleagues reported.
“It is important for gastroenterologists to be aware of this condition and to be capable of diagnosing and treating it in a timely manner,” the investigators wrote in Clinical Gastroenterology and Hepatology.
To this end, Dr. McGill and colleagues drafted the present clinical practice update, covering pathogenesis, clinical manifestations, diagnosis, and management.
“The allergy in alpha-gal syndrome is to galactose alpha-1,3-galactose, an oligosaccharide on the cells of all nonprimate mammals,” the investigators wrote. “Surprisingly, sensitization to alpha-gal, that is, the process by which human beings develop IgE antibodies to the sugar, is understood to occur after the bite of a tick or parasitic infection. In the United States, the Lone Star tick, an ectoparasite whose principal host is deer, is strongly implicated.”
Gastrointestinal focused clinical research is scarce, the investigators noted, citing two observational studies involving 375 patients positive for alpha-gal IgE. Almost half of these patients (40.7%) had gastrointestinal symptoms alone. Across the entire population, the most common gastrointestinal symptoms were abdominal pain (71%) and vomiting (22%). About three out of four patients reported improvement on an alpha-gal avoidance diet.
“Clinicians should consider alpha-gal syndrome in the differential diagnosis of patients with unexplained gastrointestinal symptoms of abdominal pain, diarrhea, nausea, and vomiting, particularly those who live or have lived in an alpha-gal–prevalent area,” the investigators wrote.
In the United States, these areas span the domain of the Lone Star tick, including most of the East Coast, the central Midwest, the South, and all of Texas. Overseas, alpha-gal syndrome has been reported in Japan, Australia, Western Europe, and South Africa.
Clinical suspicion should be increased in patients with a history of tick bite, engagement in outdoor activities, and awakening in the night with gastrointestinal distress (because of the delay between allergen ingestion and symptom onset). Workup should include serum testing for alpha-gal IgE antibodies, according to the update. Serum positivity alone, however, is not sufficient for diagnosis. Alpha-gal syndrome must be confirmed by symptom resolution or improvement upon adherence to an alpha-gal avoidance diet for at least a month.
“During this time, patients may want to avoid eating at restaurants, which can easily cross-contaminate food, and processed food, which may contain alpha-gal in additives,” Dr. McGill and colleagues wrote.
Patients with alpha-gal syndrome who accidentally consume alpha-gal should take 25-50 mg of diphenhydramine and ensure access to a self-injectable epinephrine if symptoms progress, particularly if respiratory compromise occurs, they added.
The coauthors are Jana G. Hasash, MD, and Thomas A. Platts-Mills, MD, PhD.
The investigators disclosed relationships with Olympus America, Exact Sciences, Guardant Health, Finch Therapeutics, and others.
according to an American Gastroenterological Association clinical practice update.
Although the allergic response is best known for a combination of anaphylaxis, skin changes, and gastrointestinal symptoms that occurs within hours of consuming mammalian-derived food products, health care providers should know that many patients experience gastrointestinal distress in the absence of other clinical signs, lead author Sarah K. McGill, MD, MSc, of the University of North Carolina at Chapel Hill, and colleagues reported.
“It is important for gastroenterologists to be aware of this condition and to be capable of diagnosing and treating it in a timely manner,” the investigators wrote in Clinical Gastroenterology and Hepatology.
To this end, Dr. McGill and colleagues drafted the present clinical practice update, covering pathogenesis, clinical manifestations, diagnosis, and management.
“The allergy in alpha-gal syndrome is to galactose alpha-1,3-galactose, an oligosaccharide on the cells of all nonprimate mammals,” the investigators wrote. “Surprisingly, sensitization to alpha-gal, that is, the process by which human beings develop IgE antibodies to the sugar, is understood to occur after the bite of a tick or parasitic infection. In the United States, the Lone Star tick, an ectoparasite whose principal host is deer, is strongly implicated.”
Gastrointestinal focused clinical research is scarce, the investigators noted, citing two observational studies involving 375 patients positive for alpha-gal IgE. Almost half of these patients (40.7%) had gastrointestinal symptoms alone. Across the entire population, the most common gastrointestinal symptoms were abdominal pain (71%) and vomiting (22%). About three out of four patients reported improvement on an alpha-gal avoidance diet.
“Clinicians should consider alpha-gal syndrome in the differential diagnosis of patients with unexplained gastrointestinal symptoms of abdominal pain, diarrhea, nausea, and vomiting, particularly those who live or have lived in an alpha-gal–prevalent area,” the investigators wrote.
In the United States, these areas span the domain of the Lone Star tick, including most of the East Coast, the central Midwest, the South, and all of Texas. Overseas, alpha-gal syndrome has been reported in Japan, Australia, Western Europe, and South Africa.
Clinical suspicion should be increased in patients with a history of tick bite, engagement in outdoor activities, and awakening in the night with gastrointestinal distress (because of the delay between allergen ingestion and symptom onset). Workup should include serum testing for alpha-gal IgE antibodies, according to the update. Serum positivity alone, however, is not sufficient for diagnosis. Alpha-gal syndrome must be confirmed by symptom resolution or improvement upon adherence to an alpha-gal avoidance diet for at least a month.
“During this time, patients may want to avoid eating at restaurants, which can easily cross-contaminate food, and processed food, which may contain alpha-gal in additives,” Dr. McGill and colleagues wrote.
Patients with alpha-gal syndrome who accidentally consume alpha-gal should take 25-50 mg of diphenhydramine and ensure access to a self-injectable epinephrine if symptoms progress, particularly if respiratory compromise occurs, they added.
The coauthors are Jana G. Hasash, MD, and Thomas A. Platts-Mills, MD, PhD.
The investigators disclosed relationships with Olympus America, Exact Sciences, Guardant Health, Finch Therapeutics, and others.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY