Diana Swift

The US National Institute of Standards and Technology (NIST) has developed precisely measured human fecal material to foster a new era in gut microbiome research. 

According to AGA’s Center for Gut Microbiome Research & Education, this critical resource will help advance the utility and reproducibility of microbiome-based diagnostics — “which still remain relatively meaningless clinically, although patients continue to buy direct-to-consumer tests, and a standard reference material will mean there’s a better way to ensure quality control and accuracy.” 

Though not a therapeutic, Human Fecal Material RM is expected to speed up gastrointestinal (GI) therapeutics since many microbiome-based drugs are inspired by fecal transplants with human stool as the developmental starting point. A standardized reference material will be an important resource as industry develops and tests new drugs. It can be purchased online at the NIST Store (shop.nist.gov).

The product consists of eight frozen vials of exhaustively studied human feces suspended in aqueous solution. Available are more than 25 pages of data identifying the key microbes and biomolecules in the material. Scientists, including those working at biopharmaceutical and biotech companies, can use this material to further their research and develop new drugs that target the microbiome, including treatments that contain living bacteria. 

 

Development

According to NIST, the stool material is “the most precisely measured, scientifically analyzed, and richly characterized human fecal standard ever produced. 

“The project ran for about 6 years from start to finish, the last 2 for manufacturing, characterization, and writing,” said NIST molecular geneticist Scott A. Jackson, PhD, who helped develop the product. “We hope our reference material will lay the foundation for gut microbiome research to thrive and reach its full potential.” 

As founder of NIST’s Complex Microbial Systems Group, Jackson is leading international efforts to improve microbiome and metagenomic measurements by organizing inter-lab studies and refining reference materials and methods. 

The project collected stool from two cohorts of donors, ie, vegetarians and omnivores, with each cohort comprising four to six donors. Material from each cohort was pooled and homogenized before being aliquoted into 5000 vials per cohort. About 300 tubes from each cohort were picked, and aliquots then underwent multiomic analyses. 

Offering his perspective on the new product, Sudhir K. Dutta, MBBS, associate professor in the Division of Gastroenterology and Hepatology at Johns Hopkins University School of Medicine, Baltimore, said, “This tool will be 100% useful for microbiome research.”

And according to Lori Holtz, MD, MSPH, professor of pediatric gastroenterology, hepatology, and nutrition at Washington University School of Medicine in St. Louis, Missouri, the material will aid microbiome research by allowing interpretability and repeatability across studies. “Microbiome research is a relatively new field, and protocols differ from group to group and lab to lab, so it’s been difficult to compare results across studies,” she told GI & Hepatology News. “A standard stool product will allow for greater comparability in preclinical studies and later clinical trials testing interventions to alter the microbiome.”

The NIST developers are looking forward to reaction from the GI research community. “Over the last several years, we’ve released smaller pilot batches of material to smaller groups of stakeholders,” said Jackson. “We’ve used the feedback on these earlier batches to inform the manufacturing and characterization of the final batch that was released in March, but we don’t yet have any feedback yet on the current material.”

Jackson, Dutta, and Holtz disclosed having no relevant competing interests.

A version of this article appeared on Medscape.com.

The US National Institute of Standards and Technology (NIST) has developed precisely measured human fecal material to foster a new era in gut microbiome research. 

According to AGA’s Center for Gut Microbiome Research & Education, this critical resource will help advance the utility and reproducibility of microbiome-based diagnostics — “which still remain relatively meaningless clinically, although patients continue to buy direct-to-consumer tests, and a standard reference material will mean there’s a better way to ensure quality control and accuracy.” 

Though not a therapeutic, Human Fecal Material RM is expected to speed up gastrointestinal (GI) therapeutics since many microbiome-based drugs are inspired by fecal transplants with human stool as the developmental starting point. A standardized reference material will be an important resource as industry develops and tests new drugs. It can be purchased online at the NIST Store (shop.nist.gov).

The product consists of eight frozen vials of exhaustively studied human feces suspended in aqueous solution. Available are more than 25 pages of data identifying the key microbes and biomolecules in the material. Scientists, including those working at biopharmaceutical and biotech companies, can use this material to further their research and develop new drugs that target the microbiome, including treatments that contain living bacteria. 

 

Development

According to NIST, the stool material is “the most precisely measured, scientifically analyzed, and richly characterized human fecal standard ever produced. 

“The project ran for about 6 years from start to finish, the last 2 for manufacturing, characterization, and writing,” said NIST molecular geneticist Scott A. Jackson, PhD, who helped develop the product. “We hope our reference material will lay the foundation for gut microbiome research to thrive and reach its full potential.” 

As founder of NIST’s Complex Microbial Systems Group, Jackson is leading international efforts to improve microbiome and metagenomic measurements by organizing inter-lab studies and refining reference materials and methods. 

The project collected stool from two cohorts of donors, ie, vegetarians and omnivores, with each cohort comprising four to six donors. Material from each cohort was pooled and homogenized before being aliquoted into 5000 vials per cohort. About 300 tubes from each cohort were picked, and aliquots then underwent multiomic analyses. 

Offering his perspective on the new product, Sudhir K. Dutta, MBBS, associate professor in the Division of Gastroenterology and Hepatology at Johns Hopkins University School of Medicine, Baltimore, said, “This tool will be 100% useful for microbiome research.”

And according to Lori Holtz, MD, MSPH, professor of pediatric gastroenterology, hepatology, and nutrition at Washington University School of Medicine in St. Louis, Missouri, the material will aid microbiome research by allowing interpretability and repeatability across studies. “Microbiome research is a relatively new field, and protocols differ from group to group and lab to lab, so it’s been difficult to compare results across studies,” she told GI & Hepatology News. “A standard stool product will allow for greater comparability in preclinical studies and later clinical trials testing interventions to alter the microbiome.”

The NIST developers are looking forward to reaction from the GI research community. “Over the last several years, we’ve released smaller pilot batches of material to smaller groups of stakeholders,” said Jackson. “We’ve used the feedback on these earlier batches to inform the manufacturing and characterization of the final batch that was released in March, but we don’t yet have any feedback yet on the current material.”

Jackson, Dutta, and Holtz disclosed having no relevant competing interests.

A version of this article appeared on Medscape.com.

The US National Institute of Standards and Technology (NIST) has developed precisely measured human fecal material to foster a new era in gut microbiome research. 

According to AGA’s Center for Gut Microbiome Research & Education, this critical resource will help advance the utility and reproducibility of microbiome-based diagnostics — “which still remain relatively meaningless clinically, although patients continue to buy direct-to-consumer tests, and a standard reference material will mean there’s a better way to ensure quality control and accuracy.” 

Though not a therapeutic, Human Fecal Material RM is expected to speed up gastrointestinal (GI) therapeutics since many microbiome-based drugs are inspired by fecal transplants with human stool as the developmental starting point. A standardized reference material will be an important resource as industry develops and tests new drugs. It can be purchased online at the NIST Store (shop.nist.gov).

The product consists of eight frozen vials of exhaustively studied human feces suspended in aqueous solution. Available are more than 25 pages of data identifying the key microbes and biomolecules in the material. Scientists, including those working at biopharmaceutical and biotech companies, can use this material to further their research and develop new drugs that target the microbiome, including treatments that contain living bacteria. 

 

Development

According to NIST, the stool material is “the most precisely measured, scientifically analyzed, and richly characterized human fecal standard ever produced. 

“The project ran for about 6 years from start to finish, the last 2 for manufacturing, characterization, and writing,” said NIST molecular geneticist Scott A. Jackson, PhD, who helped develop the product. “We hope our reference material will lay the foundation for gut microbiome research to thrive and reach its full potential.” 

As founder of NIST’s Complex Microbial Systems Group, Jackson is leading international efforts to improve microbiome and metagenomic measurements by organizing inter-lab studies and refining reference materials and methods. 

The project collected stool from two cohorts of donors, ie, vegetarians and omnivores, with each cohort comprising four to six donors. Material from each cohort was pooled and homogenized before being aliquoted into 5000 vials per cohort. About 300 tubes from each cohort were picked, and aliquots then underwent multiomic analyses. 

Offering his perspective on the new product, Sudhir K. Dutta, MBBS, associate professor in the Division of Gastroenterology and Hepatology at Johns Hopkins University School of Medicine, Baltimore, said, “This tool will be 100% useful for microbiome research.”

And according to Lori Holtz, MD, MSPH, professor of pediatric gastroenterology, hepatology, and nutrition at Washington University School of Medicine in St. Louis, Missouri, the material will aid microbiome research by allowing interpretability and repeatability across studies. “Microbiome research is a relatively new field, and protocols differ from group to group and lab to lab, so it’s been difficult to compare results across studies,” she told GI & Hepatology News. “A standard stool product will allow for greater comparability in preclinical studies and later clinical trials testing interventions to alter the microbiome.”

The NIST developers are looking forward to reaction from the GI research community. “Over the last several years, we’ve released smaller pilot batches of material to smaller groups of stakeholders,” said Jackson. “We’ve used the feedback on these earlier batches to inform the manufacturing and characterization of the final batch that was released in March, but we don’t yet have any feedback yet on the current material.”

Jackson, Dutta, and Holtz disclosed having no relevant competing interests.

A version of this article appeared on Medscape.com.

An AGA multidisciplinary panel has reached the conclusion that no recommendation can be made for or against the use of computer-aided detection (CADe)–assisted colonoscopy for colorectal cancer (CRC), the third most common cause of cancer mortality in the United States.

The systematic data review is a collaboration between AGA and The BMJ’s MAGIC Rapid Recommendations. The BMJ issued a separate recommendation against CADe shortly after the AGA guideline was published.

Led by Shahnaz S. Sultan, MD, MHSc, AGAF, of the Division of Gastroenterology, Hepatology, and Nutrition at University of Minnesota, Minneapolis, and recently published in Gastroenterology, found only very low certainty of GRADE-based evidence for several critical long-term outcomes, both desirable and undesirable. These included the following: 11 fewer CRCs per 10,000 individuals and two fewer CRC deaths per 10,000 individuals, an increased burden of more intensive surveillance colonoscopies (635 more per 10,000 individuals), and cost and resource implications.

This technology did, however, yield an 8% (95% CI, 6-10) absolute increase in the adenoma detection rate (ADR) and a 2% (95% CI, 0-4) increase in the detection rate of advanced adenomas and/or sessile serrated lesions. “How this translates into a reduction in CRC incidence or death is where we were uncertain,” Sultan said. “Our best effort at trying to translate the ADR and other endoscopy outcomes to CRC incidence and CRC death relied on the modeling study, which included a lot of assumptions, which also contributed to our overall lower certainty.”

The systematic and meta-analysis included 41 randomized controlled trials with more than 32,108 participants who underwent CADe-assisted colonoscopy. This technology was associated with a higher polyp detection rate than standard colonoscopy: 56.1% vs 47.9% (relative risk [RR], 1.22, 95% CI, 1.15-1.28). It also had a higher ADR: 44.8% vs 37.4% (RR, 1.22; 95% CI, 1.16-1.29).

But although CADe-assisted colonoscopy may increase ADR, it carries a risk for overdiagnosis, as most polyps detected during colonoscopy are diminutive (< 5 mm) and of low malignant potential, the panel noted. Approximately 25% of lesions are missed at colonoscopy. More than 15 million colonoscopies are performed annually in the United States, but studies have demonstrated variable quality of colonoscopies across key quality indicators.

“Artificial intelligence [AI] is revolutionizing medicine and healthcare in the field of GI [gastroenterology], and CADe in colonoscopy has been brought to commercialization,” Sultan told GI & Hepatology News. “Unlike many areas of endoscopic research where we often have a finite number of clinical trial data, CADe-assisted colonoscopy intervention has been studied in over 44 randomized controlled trials and numerous nonrandomized, real-world studies. The question of whether or not to adopt this intervention at a health system or practice level is an important question that was prioritized to be addressed as guidance was needed.”

Commenting on the guideline but not involved in its formulation, Larry S. Kim, MD, MBA, AGAF, a gastroenterologist at South Denver Gastroenterology in Denver, Colorado, said his practice group has used the GI Genius AI system in its affiliated hospitals but has so far chosen not to implement the technology at its endoscopy centers. “At the hospital, our physicians have the ability to utilize the system for select patients or not at all,” he told GI & Hepatology News.

The fact that The BMJ reached a different conclusion based on the same data, evidence-grading system, and microsimulation, Kim added, “highlights the point that when evidence for benefit is uncertain, underlying values are critical.” In declining to make a recommendation, the AGA panel balanced the benefit of improved detection of potentially precancerous adenomas vs increased resource utilization in the face of unclear benefit. “With different priorities, other bodies could reasonably decide to recommend either for or against CADe.”

 

The Future

According to Sultan, gastroenterologists need a better understanding of patient values and preferences and the value placed on increased adenoma detection, which may also lead to more lifetime colonoscopies without reducing the risk for CRC. “We need better intermediate- and long-term data on the impact of adenoma detection on interval cancers and CRC incidence,” she said. “We need data on detection of polyps that are more clinically significant such as those 6-10 mm in size, as well as serrated sessile lesions. We also need to understand at the population or health system level what the impact is on resources, cost, and access.”

Ultimately, the living guideline underscores the trade-off between desirable and undesirable effects and the limitations of current evidence to support a recommendation, but CADe has to improve as an iterative AI application with further validation and better training.

With the anticipated improvement in software accuracy as AI machine learning reads increasing numbers of images, Sultan added, “the next version of the software may perform better, especially for polyps that are more clinically significant or for flat sessile serrated polyps, which are harder to detect. We plan to revisit the question in the next year or two and potentially revise the guideline.”

These guidelines were fully funded by the AGA Institute with no funding from any outside agency or industry.

Sultan is supported by the US Food and Drug Administration. Co-authors Shazia Mehmood Siddique, Dennis L. Shung, and Benjamin Lebwohl are supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Theodore R. Levin is supported by the Permanente Medical Group Delivery Science and Applied Research Program. Cesare Hassan is a consultant for Fujifilm and Olympus. Peter S. Liang reported doing research work for Freenome and advisory board work for Guardant Health and Natera.

Kim is the AGA president-elect. He disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

An AGA multidisciplinary panel has reached the conclusion that no recommendation can be made for or against the use of computer-aided detection (CADe)–assisted colonoscopy for colorectal cancer (CRC), the third most common cause of cancer mortality in the United States.

The systematic data review is a collaboration between AGA and The BMJ’s MAGIC Rapid Recommendations. The BMJ issued a separate recommendation against CADe shortly after the AGA guideline was published.

Led by Shahnaz S. Sultan, MD, MHSc, AGAF, of the Division of Gastroenterology, Hepatology, and Nutrition at University of Minnesota, Minneapolis, and recently published in Gastroenterology, found only very low certainty of GRADE-based evidence for several critical long-term outcomes, both desirable and undesirable. These included the following: 11 fewer CRCs per 10,000 individuals and two fewer CRC deaths per 10,000 individuals, an increased burden of more intensive surveillance colonoscopies (635 more per 10,000 individuals), and cost and resource implications.

This technology did, however, yield an 8% (95% CI, 6-10) absolute increase in the adenoma detection rate (ADR) and a 2% (95% CI, 0-4) increase in the detection rate of advanced adenomas and/or sessile serrated lesions. “How this translates into a reduction in CRC incidence or death is where we were uncertain,” Sultan said. “Our best effort at trying to translate the ADR and other endoscopy outcomes to CRC incidence and CRC death relied on the modeling study, which included a lot of assumptions, which also contributed to our overall lower certainty.”

The systematic and meta-analysis included 41 randomized controlled trials with more than 32,108 participants who underwent CADe-assisted colonoscopy. This technology was associated with a higher polyp detection rate than standard colonoscopy: 56.1% vs 47.9% (relative risk [RR], 1.22, 95% CI, 1.15-1.28). It also had a higher ADR: 44.8% vs 37.4% (RR, 1.22; 95% CI, 1.16-1.29).

But although CADe-assisted colonoscopy may increase ADR, it carries a risk for overdiagnosis, as most polyps detected during colonoscopy are diminutive (< 5 mm) and of low malignant potential, the panel noted. Approximately 25% of lesions are missed at colonoscopy. More than 15 million colonoscopies are performed annually in the United States, but studies have demonstrated variable quality of colonoscopies across key quality indicators.

“Artificial intelligence [AI] is revolutionizing medicine and healthcare in the field of GI [gastroenterology], and CADe in colonoscopy has been brought to commercialization,” Sultan told GI & Hepatology News. “Unlike many areas of endoscopic research where we often have a finite number of clinical trial data, CADe-assisted colonoscopy intervention has been studied in over 44 randomized controlled trials and numerous nonrandomized, real-world studies. The question of whether or not to adopt this intervention at a health system or practice level is an important question that was prioritized to be addressed as guidance was needed.”

Commenting on the guideline but not involved in its formulation, Larry S. Kim, MD, MBA, AGAF, a gastroenterologist at South Denver Gastroenterology in Denver, Colorado, said his practice group has used the GI Genius AI system in its affiliated hospitals but has so far chosen not to implement the technology at its endoscopy centers. “At the hospital, our physicians have the ability to utilize the system for select patients or not at all,” he told GI & Hepatology News.

The fact that The BMJ reached a different conclusion based on the same data, evidence-grading system, and microsimulation, Kim added, “highlights the point that when evidence for benefit is uncertain, underlying values are critical.” In declining to make a recommendation, the AGA panel balanced the benefit of improved detection of potentially precancerous adenomas vs increased resource utilization in the face of unclear benefit. “With different priorities, other bodies could reasonably decide to recommend either for or against CADe.”

 

The Future

According to Sultan, gastroenterologists need a better understanding of patient values and preferences and the value placed on increased adenoma detection, which may also lead to more lifetime colonoscopies without reducing the risk for CRC. “We need better intermediate- and long-term data on the impact of adenoma detection on interval cancers and CRC incidence,” she said. “We need data on detection of polyps that are more clinically significant such as those 6-10 mm in size, as well as serrated sessile lesions. We also need to understand at the population or health system level what the impact is on resources, cost, and access.”

Ultimately, the living guideline underscores the trade-off between desirable and undesirable effects and the limitations of current evidence to support a recommendation, but CADe has to improve as an iterative AI application with further validation and better training.

With the anticipated improvement in software accuracy as AI machine learning reads increasing numbers of images, Sultan added, “the next version of the software may perform better, especially for polyps that are more clinically significant or for flat sessile serrated polyps, which are harder to detect. We plan to revisit the question in the next year or two and potentially revise the guideline.”

These guidelines were fully funded by the AGA Institute with no funding from any outside agency or industry.

Sultan is supported by the US Food and Drug Administration. Co-authors Shazia Mehmood Siddique, Dennis L. Shung, and Benjamin Lebwohl are supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Theodore R. Levin is supported by the Permanente Medical Group Delivery Science and Applied Research Program. Cesare Hassan is a consultant for Fujifilm and Olympus. Peter S. Liang reported doing research work for Freenome and advisory board work for Guardant Health and Natera.

Kim is the AGA president-elect. He disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

An AGA multidisciplinary panel has reached the conclusion that no recommendation can be made for or against the use of computer-aided detection (CADe)–assisted colonoscopy for colorectal cancer (CRC), the third most common cause of cancer mortality in the United States.

The systematic data review is a collaboration between AGA and The BMJ’s MAGIC Rapid Recommendations. The BMJ issued a separate recommendation against CADe shortly after the AGA guideline was published.

Led by Shahnaz S. Sultan, MD, MHSc, AGAF, of the Division of Gastroenterology, Hepatology, and Nutrition at University of Minnesota, Minneapolis, and recently published in Gastroenterology, found only very low certainty of GRADE-based evidence for several critical long-term outcomes, both desirable and undesirable. These included the following: 11 fewer CRCs per 10,000 individuals and two fewer CRC deaths per 10,000 individuals, an increased burden of more intensive surveillance colonoscopies (635 more per 10,000 individuals), and cost and resource implications.

This technology did, however, yield an 8% (95% CI, 6-10) absolute increase in the adenoma detection rate (ADR) and a 2% (95% CI, 0-4) increase in the detection rate of advanced adenomas and/or sessile serrated lesions. “How this translates into a reduction in CRC incidence or death is where we were uncertain,” Sultan said. “Our best effort at trying to translate the ADR and other endoscopy outcomes to CRC incidence and CRC death relied on the modeling study, which included a lot of assumptions, which also contributed to our overall lower certainty.”

The systematic and meta-analysis included 41 randomized controlled trials with more than 32,108 participants who underwent CADe-assisted colonoscopy. This technology was associated with a higher polyp detection rate than standard colonoscopy: 56.1% vs 47.9% (relative risk [RR], 1.22, 95% CI, 1.15-1.28). It also had a higher ADR: 44.8% vs 37.4% (RR, 1.22; 95% CI, 1.16-1.29).

But although CADe-assisted colonoscopy may increase ADR, it carries a risk for overdiagnosis, as most polyps detected during colonoscopy are diminutive (< 5 mm) and of low malignant potential, the panel noted. Approximately 25% of lesions are missed at colonoscopy. More than 15 million colonoscopies are performed annually in the United States, but studies have demonstrated variable quality of colonoscopies across key quality indicators.

“Artificial intelligence [AI] is revolutionizing medicine and healthcare in the field of GI [gastroenterology], and CADe in colonoscopy has been brought to commercialization,” Sultan told GI & Hepatology News. “Unlike many areas of endoscopic research where we often have a finite number of clinical trial data, CADe-assisted colonoscopy intervention has been studied in over 44 randomized controlled trials and numerous nonrandomized, real-world studies. The question of whether or not to adopt this intervention at a health system or practice level is an important question that was prioritized to be addressed as guidance was needed.”

Commenting on the guideline but not involved in its formulation, Larry S. Kim, MD, MBA, AGAF, a gastroenterologist at South Denver Gastroenterology in Denver, Colorado, said his practice group has used the GI Genius AI system in its affiliated hospitals but has so far chosen not to implement the technology at its endoscopy centers. “At the hospital, our physicians have the ability to utilize the system for select patients or not at all,” he told GI & Hepatology News.

The fact that The BMJ reached a different conclusion based on the same data, evidence-grading system, and microsimulation, Kim added, “highlights the point that when evidence for benefit is uncertain, underlying values are critical.” In declining to make a recommendation, the AGA panel balanced the benefit of improved detection of potentially precancerous adenomas vs increased resource utilization in the face of unclear benefit. “With different priorities, other bodies could reasonably decide to recommend either for or against CADe.”

 

The Future

According to Sultan, gastroenterologists need a better understanding of patient values and preferences and the value placed on increased adenoma detection, which may also lead to more lifetime colonoscopies without reducing the risk for CRC. “We need better intermediate- and long-term data on the impact of adenoma detection on interval cancers and CRC incidence,” she said. “We need data on detection of polyps that are more clinically significant such as those 6-10 mm in size, as well as serrated sessile lesions. We also need to understand at the population or health system level what the impact is on resources, cost, and access.”

Ultimately, the living guideline underscores the trade-off between desirable and undesirable effects and the limitations of current evidence to support a recommendation, but CADe has to improve as an iterative AI application with further validation and better training.

With the anticipated improvement in software accuracy as AI machine learning reads increasing numbers of images, Sultan added, “the next version of the software may perform better, especially for polyps that are more clinically significant or for flat sessile serrated polyps, which are harder to detect. We plan to revisit the question in the next year or two and potentially revise the guideline.”

These guidelines were fully funded by the AGA Institute with no funding from any outside agency or industry.

Sultan is supported by the US Food and Drug Administration. Co-authors Shazia Mehmood Siddique, Dennis L. Shung, and Benjamin Lebwohl are supported by grants from the National Institute of Diabetes and Digestive and Kidney Diseases. Theodore R. Levin is supported by the Permanente Medical Group Delivery Science and Applied Research Program. Cesare Hassan is a consultant for Fujifilm and Olympus. Peter S. Liang reported doing research work for Freenome and advisory board work for Guardant Health and Natera.

Kim is the AGA president-elect. He disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

Intermittent fasting (IMF) with behavioral support may be more effective and better tolerated by patients than standard daily caloric restriction (DCR) in weight-loss programs, a randomized study found.

A 4:3 IMF program produced modestly superior weight loss than DCR of 2.89 kg over 12 months in the context of a guidelines-based, high-intensity, comprehensive behavioral weight loss program, according to Danielle M. Ostendorf, PhD, MS, co–lead author and an assistant professor at the University of Tennessee, Knoxville, and Victoria Catenacci, MD, study principal investigator, co–lead author, and an associate professor located at the University of Colorado Anschutz Medical Campus, Aurora.

The study, published in Annals of Internal Medicine, found that objectively measured percentage caloric restriction was greater in the 4:3 IMF group, whereas there was no between-group difference in change in total moderate to vigorous physical activity, suggesting that differences in weight loss may have been caused by greater adherence to 4:3 IMF. The 4:3 IMF program was well tolerated and attrition was lower in this group: 19% for IMF group vs 30% for DCR group.

The authors noted that alternative patterns for restricting dietary energy intake are gaining attention owing to the difficulty of adhering to a reduced-calorie diet daily, with most adults who lose weight through DCR showing significant weight regain a year later.

According to Ostendorf and Catenacci, fasting strategies “come in two different flavors and oftentimes get confused in the lay press and by patients and researchers. And there is a difference between IMF and time-restricted eating (TRE),” they said in an interview. “TRE involves limiting the daily window of food intake to 8-10 hours or less on most days of the week — for example, 16:8 or 14:10 strategies. TRE is done every day, consistently and involves eating in the predefined window, and fasting outside of that window.” 

IMF is a more periodic and significant fast and involves cycling between complete or near-complete (> 75%) energy restriction on fast days and ad libitum energy intake on nonfast days.

An appealing feature of IMF is that dieters do not have to focus on counting calories and restricting intake every day as they do with DCR, the authors wrote. Furthermore, the periodic nature of fasting is simpler and may mitigate the constant hunger associated with DCR.

Some said the diet was dreadful, but many said it was the easiest diet they had ever been on. “But it did take time for people to adjust to this strategy,” Catenacci said. “It was reassuring to see no evidence of increased binge-eating behaviors.”

Although objectively measured adherence to the targeted energy deficit (percentage caloric restriction from baseline) was below the target of 34.3% in both groups, the 4:3 IMF group showed greater percentage caloric restriction over 12 months. This suggests that, on average, the 4:3 IMF group may be more sustainable over a year than the DCR group. However, weight loss varied in both groups. Future studies should evaluate biological and behavioral predictors of response to both 4:3 IMF and DCR groups in order to personalize recommendations for weight loss.

 

Study Details

The investigators randomized 165 patients at the University of Colorado Anschutz Medical Campus, with a mean age of 42 years (18-60), a mean baseline weight of 97.4 kg, and a mean baseline body mass index (BMI) of 34.1 to IMF (n = 84) or DCR (n = 81). Of these, 74% were women and 86% were White individuals, and 125 (76%) completed the trial.

The 4:3 IMF group restricted energy intake by 80% on 3 nonconsecutive fast days per week, with ad libitum intake on the other 4 days (4:3 IMF). The 80% calorie reduction fasting corresponded to about 400-600 kcals/d for women and 500-700 kcals/d for men.

“Participants were only required to count calories on their fast days, which is part of the appeal,” Ostendorf said. Although permitted to eat what they wanted on nonfast days, participants were encouraged to make healthy food choices and consume healthy portion sizes.

For its part, the DCR group reduced daily energy intake by 34% to match the weekly energy deficit of 4:3 IMF.

Both groups participated in a high-intensity comprehensive weight loss program with group-based behavioral support and a recommended increase in moderate-intensity physical activity to 300 min/wk.

On the primary endpoint, the 4:3 IMF group showed a weight loss of 7.7 kg (95% CI, –9.6 to –5.9 kg) compared with 4.8 kg (95% CI, –6.8 to –2.8 kg, P =.040) in the DCR group at 12 months. The percentage change in body weight from baseline was –7.6% (95% CI, –9.5% to –5.7%) in the 4:3 IMF group and –5% (95% CI, –6.9% to –3.1%) in the DCR group.

At 12 months, 58% (n = 50) of participants in the 4:3 IMF group achieved weight loss of at least 5% vs 47% (n = 27) of those in the DCR group. In addition, 38% (n = 26) of participants in the 4:3 IMF group achieved weight loss of at least 10% at 12 months vs 16% (n = 9) of those in the DCR group. Changes in body composition, BMI, and waist circumference also tended to favor the 4:3 IMF group.

On other 12-month measures, point estimates of change in systolic blood pressure, total and low-density lipoprotein cholesterol levels, triglyceride level, homeostasis model assessment of insulin resistance, fasting glucose level, and hemoglobin A1c level favored 4:3 IMF. Point estimates of change in diastolic blood pressure and high-density lipoprotein cholesterol level favored DCR.

Currently lacking, the authors said, are data on safety in children and older adults, and adults affected by a long list of conditions: Diabetes, cardiovascular disease, kidney disease (stage 4 or 5), cancer, and eating disorders. Also, people of normal weight or only mild overweight, and pregnant or lactating women. “There have been concerns about IMF causing eating disorders, so we did not include people with eating disorders in our study,” Ostendorf and Catenacci said.

Offering an outside perspective on the findings, James O. Hill, PhD, director of the Nutrition Obesity Research Center and a professor at the University of Alabama at Birmingham believes IMF is a viable option for people trying to lose weight and has prescribed this approach for some in his practice. “But there is no one strategy that works for everyone,” he said in an interview. “I recommend IMF as a science-based strategy that can be effective for some people, and I think it should be on the list of science-based tools that people can consider using.” But as it won’t work for everyone, “we need to consider both metabolic success and behavioral success. In other words, would it be more effective if people could do it and how easy or hard is it for people to do?”

Audra Wilson, MS, RD, a bariatric dietitian at Northwestern Medicine Delnor Hospital in Geneva, Illinois, who was not involved in the study, expressed more reservations. “We do not specifically recommend intermittent fasting at Northwestern Medicine. There is no set protocol for this diet, and it can vary in ways that can limit nutrition to the point where we are not meeting needs on a regular basis,” she said in an interview.

Moreover, this study did not specify exact nutritional recommendations for participants but merely reduced overall caloric intake. “Although intermittent fasting may be helpful to some, in my nearly 10 years of experience I have not seen it be effective for many and especially not long term,” Wilson added.

Concerningly, IMF can foster disordered eating patterns of restriction followed by binging. “Although a balanced diet is more difficult to achieve, guidance from professionals like dietitians can give patients the tools to achieve balance, meet all nutrient needs, achieve satiety, and maybe most importantly, have a better relationship with food,” she said.

As for the influence of metabolic factors that may be associated with better weight loss, Ostendorf said, “be on the lookout for future publications in this area. We are analyzing data around changes in energy expenditure and changes in hunger-related hormones, among others.” A colleague is collecting biological samples to study genetics in this context. “However, in general, it appeared that the difference in weight loss was due to a greater caloric deficit in the 4:3 IMF group.”

Ostendorf and Catenacci are currently conducting a pilot study testing 4:3 IMF in breast cancer survivors. “We think this is a promising strategy for weight loss in breast cancer survivors who struggle with overweight/obesity in addition to their cancer diagnosis,” Ostendorf said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Ostendorf, Catenacci, Hill, and Wilson disclosed no relevant financial conflicts of interest.

A version of this article appeared on Medscape.com.

Intermittent fasting (IMF) with behavioral support may be more effective and better tolerated by patients than standard daily caloric restriction (DCR) in weight-loss programs, a randomized study found.

A 4:3 IMF program produced modestly superior weight loss than DCR of 2.89 kg over 12 months in the context of a guidelines-based, high-intensity, comprehensive behavioral weight loss program, according to Danielle M. Ostendorf, PhD, MS, co–lead author and an assistant professor at the University of Tennessee, Knoxville, and Victoria Catenacci, MD, study principal investigator, co–lead author, and an associate professor located at the University of Colorado Anschutz Medical Campus, Aurora.

The study, published in Annals of Internal Medicine, found that objectively measured percentage caloric restriction was greater in the 4:3 IMF group, whereas there was no between-group difference in change in total moderate to vigorous physical activity, suggesting that differences in weight loss may have been caused by greater adherence to 4:3 IMF. The 4:3 IMF program was well tolerated and attrition was lower in this group: 19% for IMF group vs 30% for DCR group.

The authors noted that alternative patterns for restricting dietary energy intake are gaining attention owing to the difficulty of adhering to a reduced-calorie diet daily, with most adults who lose weight through DCR showing significant weight regain a year later.

According to Ostendorf and Catenacci, fasting strategies “come in two different flavors and oftentimes get confused in the lay press and by patients and researchers. And there is a difference between IMF and time-restricted eating (TRE),” they said in an interview. “TRE involves limiting the daily window of food intake to 8-10 hours or less on most days of the week — for example, 16:8 or 14:10 strategies. TRE is done every day, consistently and involves eating in the predefined window, and fasting outside of that window.” 

IMF is a more periodic and significant fast and involves cycling between complete or near-complete (> 75%) energy restriction on fast days and ad libitum energy intake on nonfast days.

An appealing feature of IMF is that dieters do not have to focus on counting calories and restricting intake every day as they do with DCR, the authors wrote. Furthermore, the periodic nature of fasting is simpler and may mitigate the constant hunger associated with DCR.

Some said the diet was dreadful, but many said it was the easiest diet they had ever been on. “But it did take time for people to adjust to this strategy,” Catenacci said. “It was reassuring to see no evidence of increased binge-eating behaviors.”

Although objectively measured adherence to the targeted energy deficit (percentage caloric restriction from baseline) was below the target of 34.3% in both groups, the 4:3 IMF group showed greater percentage caloric restriction over 12 months. This suggests that, on average, the 4:3 IMF group may be more sustainable over a year than the DCR group. However, weight loss varied in both groups. Future studies should evaluate biological and behavioral predictors of response to both 4:3 IMF and DCR groups in order to personalize recommendations for weight loss.

 

Study Details

The investigators randomized 165 patients at the University of Colorado Anschutz Medical Campus, with a mean age of 42 years (18-60), a mean baseline weight of 97.4 kg, and a mean baseline body mass index (BMI) of 34.1 to IMF (n = 84) or DCR (n = 81). Of these, 74% were women and 86% were White individuals, and 125 (76%) completed the trial.

The 4:3 IMF group restricted energy intake by 80% on 3 nonconsecutive fast days per week, with ad libitum intake on the other 4 days (4:3 IMF). The 80% calorie reduction fasting corresponded to about 400-600 kcals/d for women and 500-700 kcals/d for men.

“Participants were only required to count calories on their fast days, which is part of the appeal,” Ostendorf said. Although permitted to eat what they wanted on nonfast days, participants were encouraged to make healthy food choices and consume healthy portion sizes.

For its part, the DCR group reduced daily energy intake by 34% to match the weekly energy deficit of 4:3 IMF.

Both groups participated in a high-intensity comprehensive weight loss program with group-based behavioral support and a recommended increase in moderate-intensity physical activity to 300 min/wk.

On the primary endpoint, the 4:3 IMF group showed a weight loss of 7.7 kg (95% CI, –9.6 to –5.9 kg) compared with 4.8 kg (95% CI, –6.8 to –2.8 kg, P =.040) in the DCR group at 12 months. The percentage change in body weight from baseline was –7.6% (95% CI, –9.5% to –5.7%) in the 4:3 IMF group and –5% (95% CI, –6.9% to –3.1%) in the DCR group.

At 12 months, 58% (n = 50) of participants in the 4:3 IMF group achieved weight loss of at least 5% vs 47% (n = 27) of those in the DCR group. In addition, 38% (n = 26) of participants in the 4:3 IMF group achieved weight loss of at least 10% at 12 months vs 16% (n = 9) of those in the DCR group. Changes in body composition, BMI, and waist circumference also tended to favor the 4:3 IMF group.

On other 12-month measures, point estimates of change in systolic blood pressure, total and low-density lipoprotein cholesterol levels, triglyceride level, homeostasis model assessment of insulin resistance, fasting glucose level, and hemoglobin A1c level favored 4:3 IMF. Point estimates of change in diastolic blood pressure and high-density lipoprotein cholesterol level favored DCR.

Currently lacking, the authors said, are data on safety in children and older adults, and adults affected by a long list of conditions: Diabetes, cardiovascular disease, kidney disease (stage 4 or 5), cancer, and eating disorders. Also, people of normal weight or only mild overweight, and pregnant or lactating women. “There have been concerns about IMF causing eating disorders, so we did not include people with eating disorders in our study,” Ostendorf and Catenacci said.

Offering an outside perspective on the findings, James O. Hill, PhD, director of the Nutrition Obesity Research Center and a professor at the University of Alabama at Birmingham believes IMF is a viable option for people trying to lose weight and has prescribed this approach for some in his practice. “But there is no one strategy that works for everyone,” he said in an interview. “I recommend IMF as a science-based strategy that can be effective for some people, and I think it should be on the list of science-based tools that people can consider using.” But as it won’t work for everyone, “we need to consider both metabolic success and behavioral success. In other words, would it be more effective if people could do it and how easy or hard is it for people to do?”

Audra Wilson, MS, RD, a bariatric dietitian at Northwestern Medicine Delnor Hospital in Geneva, Illinois, who was not involved in the study, expressed more reservations. “We do not specifically recommend intermittent fasting at Northwestern Medicine. There is no set protocol for this diet, and it can vary in ways that can limit nutrition to the point where we are not meeting needs on a regular basis,” she said in an interview.

Moreover, this study did not specify exact nutritional recommendations for participants but merely reduced overall caloric intake. “Although intermittent fasting may be helpful to some, in my nearly 10 years of experience I have not seen it be effective for many and especially not long term,” Wilson added.

Concerningly, IMF can foster disordered eating patterns of restriction followed by binging. “Although a balanced diet is more difficult to achieve, guidance from professionals like dietitians can give patients the tools to achieve balance, meet all nutrient needs, achieve satiety, and maybe most importantly, have a better relationship with food,” she said.

As for the influence of metabolic factors that may be associated with better weight loss, Ostendorf said, “be on the lookout for future publications in this area. We are analyzing data around changes in energy expenditure and changes in hunger-related hormones, among others.” A colleague is collecting biological samples to study genetics in this context. “However, in general, it appeared that the difference in weight loss was due to a greater caloric deficit in the 4:3 IMF group.”

Ostendorf and Catenacci are currently conducting a pilot study testing 4:3 IMF in breast cancer survivors. “We think this is a promising strategy for weight loss in breast cancer survivors who struggle with overweight/obesity in addition to their cancer diagnosis,” Ostendorf said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Ostendorf, Catenacci, Hill, and Wilson disclosed no relevant financial conflicts of interest.

A version of this article appeared on Medscape.com.

Intermittent fasting (IMF) with behavioral support may be more effective and better tolerated by patients than standard daily caloric restriction (DCR) in weight-loss programs, a randomized study found.

A 4:3 IMF program produced modestly superior weight loss than DCR of 2.89 kg over 12 months in the context of a guidelines-based, high-intensity, comprehensive behavioral weight loss program, according to Danielle M. Ostendorf, PhD, MS, co–lead author and an assistant professor at the University of Tennessee, Knoxville, and Victoria Catenacci, MD, study principal investigator, co–lead author, and an associate professor located at the University of Colorado Anschutz Medical Campus, Aurora.

The study, published in Annals of Internal Medicine, found that objectively measured percentage caloric restriction was greater in the 4:3 IMF group, whereas there was no between-group difference in change in total moderate to vigorous physical activity, suggesting that differences in weight loss may have been caused by greater adherence to 4:3 IMF. The 4:3 IMF program was well tolerated and attrition was lower in this group: 19% for IMF group vs 30% for DCR group.

The authors noted that alternative patterns for restricting dietary energy intake are gaining attention owing to the difficulty of adhering to a reduced-calorie diet daily, with most adults who lose weight through DCR showing significant weight regain a year later.

According to Ostendorf and Catenacci, fasting strategies “come in two different flavors and oftentimes get confused in the lay press and by patients and researchers. And there is a difference between IMF and time-restricted eating (TRE),” they said in an interview. “TRE involves limiting the daily window of food intake to 8-10 hours or less on most days of the week — for example, 16:8 or 14:10 strategies. TRE is done every day, consistently and involves eating in the predefined window, and fasting outside of that window.” 

IMF is a more periodic and significant fast and involves cycling between complete or near-complete (> 75%) energy restriction on fast days and ad libitum energy intake on nonfast days.

An appealing feature of IMF is that dieters do not have to focus on counting calories and restricting intake every day as they do with DCR, the authors wrote. Furthermore, the periodic nature of fasting is simpler and may mitigate the constant hunger associated with DCR.

Some said the diet was dreadful, but many said it was the easiest diet they had ever been on. “But it did take time for people to adjust to this strategy,” Catenacci said. “It was reassuring to see no evidence of increased binge-eating behaviors.”

Although objectively measured adherence to the targeted energy deficit (percentage caloric restriction from baseline) was below the target of 34.3% in both groups, the 4:3 IMF group showed greater percentage caloric restriction over 12 months. This suggests that, on average, the 4:3 IMF group may be more sustainable over a year than the DCR group. However, weight loss varied in both groups. Future studies should evaluate biological and behavioral predictors of response to both 4:3 IMF and DCR groups in order to personalize recommendations for weight loss.

 

Study Details

The investigators randomized 165 patients at the University of Colorado Anschutz Medical Campus, with a mean age of 42 years (18-60), a mean baseline weight of 97.4 kg, and a mean baseline body mass index (BMI) of 34.1 to IMF (n = 84) or DCR (n = 81). Of these, 74% were women and 86% were White individuals, and 125 (76%) completed the trial.

The 4:3 IMF group restricted energy intake by 80% on 3 nonconsecutive fast days per week, with ad libitum intake on the other 4 days (4:3 IMF). The 80% calorie reduction fasting corresponded to about 400-600 kcals/d for women and 500-700 kcals/d for men.

“Participants were only required to count calories on their fast days, which is part of the appeal,” Ostendorf said. Although permitted to eat what they wanted on nonfast days, participants were encouraged to make healthy food choices and consume healthy portion sizes.

For its part, the DCR group reduced daily energy intake by 34% to match the weekly energy deficit of 4:3 IMF.

Both groups participated in a high-intensity comprehensive weight loss program with group-based behavioral support and a recommended increase in moderate-intensity physical activity to 300 min/wk.

On the primary endpoint, the 4:3 IMF group showed a weight loss of 7.7 kg (95% CI, –9.6 to –5.9 kg) compared with 4.8 kg (95% CI, –6.8 to –2.8 kg, P =.040) in the DCR group at 12 months. The percentage change in body weight from baseline was –7.6% (95% CI, –9.5% to –5.7%) in the 4:3 IMF group and –5% (95% CI, –6.9% to –3.1%) in the DCR group.

At 12 months, 58% (n = 50) of participants in the 4:3 IMF group achieved weight loss of at least 5% vs 47% (n = 27) of those in the DCR group. In addition, 38% (n = 26) of participants in the 4:3 IMF group achieved weight loss of at least 10% at 12 months vs 16% (n = 9) of those in the DCR group. Changes in body composition, BMI, and waist circumference also tended to favor the 4:3 IMF group.

On other 12-month measures, point estimates of change in systolic blood pressure, total and low-density lipoprotein cholesterol levels, triglyceride level, homeostasis model assessment of insulin resistance, fasting glucose level, and hemoglobin A1c level favored 4:3 IMF. Point estimates of change in diastolic blood pressure and high-density lipoprotein cholesterol level favored DCR.

Currently lacking, the authors said, are data on safety in children and older adults, and adults affected by a long list of conditions: Diabetes, cardiovascular disease, kidney disease (stage 4 or 5), cancer, and eating disorders. Also, people of normal weight or only mild overweight, and pregnant or lactating women. “There have been concerns about IMF causing eating disorders, so we did not include people with eating disorders in our study,” Ostendorf and Catenacci said.

Offering an outside perspective on the findings, James O. Hill, PhD, director of the Nutrition Obesity Research Center and a professor at the University of Alabama at Birmingham believes IMF is a viable option for people trying to lose weight and has prescribed this approach for some in his practice. “But there is no one strategy that works for everyone,” he said in an interview. “I recommend IMF as a science-based strategy that can be effective for some people, and I think it should be on the list of science-based tools that people can consider using.” But as it won’t work for everyone, “we need to consider both metabolic success and behavioral success. In other words, would it be more effective if people could do it and how easy or hard is it for people to do?”

Audra Wilson, MS, RD, a bariatric dietitian at Northwestern Medicine Delnor Hospital in Geneva, Illinois, who was not involved in the study, expressed more reservations. “We do not specifically recommend intermittent fasting at Northwestern Medicine. There is no set protocol for this diet, and it can vary in ways that can limit nutrition to the point where we are not meeting needs on a regular basis,” she said in an interview.

Moreover, this study did not specify exact nutritional recommendations for participants but merely reduced overall caloric intake. “Although intermittent fasting may be helpful to some, in my nearly 10 years of experience I have not seen it be effective for many and especially not long term,” Wilson added.

Concerningly, IMF can foster disordered eating patterns of restriction followed by binging. “Although a balanced diet is more difficult to achieve, guidance from professionals like dietitians can give patients the tools to achieve balance, meet all nutrient needs, achieve satiety, and maybe most importantly, have a better relationship with food,” she said.

As for the influence of metabolic factors that may be associated with better weight loss, Ostendorf said, “be on the lookout for future publications in this area. We are analyzing data around changes in energy expenditure and changes in hunger-related hormones, among others.” A colleague is collecting biological samples to study genetics in this context. “However, in general, it appeared that the difference in weight loss was due to a greater caloric deficit in the 4:3 IMF group.”

Ostendorf and Catenacci are currently conducting a pilot study testing 4:3 IMF in breast cancer survivors. “We think this is a promising strategy for weight loss in breast cancer survivors who struggle with overweight/obesity in addition to their cancer diagnosis,” Ostendorf said.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases. Ostendorf, Catenacci, Hill, and Wilson disclosed no relevant financial conflicts of interest.

A version of this article appeared on Medscape.com.

The American Gastroenterological Association (AGA) has released an updated clinical practice guideline on the prevention of hepatitis B virus reactivation (HBVr) in at-risk persons. The document was published in Gastroenterology and replaces a previous guideline on prophylaxis for immunosuppressed patients issued in 2014.

Since then, many novel classes of immunosuppressives have been approved for various conditions, and potentially immunosuppressive therapies such as transcatheter arterial chemoembolization have been recognized as relevant to potential HBVr.

With reactivation a risk after immune-modulating exposures, such as to multiple drug classes and disease states, the update provides frontline clinicians with evidence-based advice for the management of HBVr in vulnerable individuals. And while antiviral prophylaxis is recommended for many, in select cases careful clinical monitoring may suffice for risk management.

 

“The risk of HBV reactivation depends on patient-, drug-, and disease-specific factors — and so it can range from very rare to more frequent,” said guideline coauthor Tracey G. Simon, MD, MPH, a hepatologist in the division of gastroenterology at Massachusetts General Hospital and an instructor at Harvard Medical School, both in Boston. “Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors.”

Simon stressed the importance of creating this guideline to include many new therapies that carry varying degrees of reactivation risk. As to the strength of the evidence, she added, “for some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.”

 

Main Recommendations

AGA based its clinical recommendations on balancing desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. It also provided a clinical decision support tool for making pharmacologic management decisions.

The panelists reviewed data on multiple immunosuppressive therapies from older agents such as anthracycline derivatives, corticosteroids, and anti–tumor necrosis factor (anti-TNF) drugs to chimeric antigen receptor T cells and recent biologics and inhibitors.

1. For individuals at high risk for HBVr, AGA recommended antiviral prophylaxis over monitoring alone. Strong recommendation, moderate-certainty evidence.

Implementation considerations: Use antivirals with a high barrier to resistance. Prophylaxis should be started before initiating medications that carry a risk for HBVr and should be continued for at least 6 months after discontinuation of risk-imposing therapy (at least 12 months for B cell–depleting agents).

2. For individuals at moderate risk for HBVr, antiviral prophylaxis was recommended over monitoring alone. Conditional recommendation, moderate-certainty evidence.

Implementation considerations: Use antivirals with a high barrier to resistance. Patients who place a higher value on avoiding long-term antiviral therapy and its associated cost and place a lower value on avoiding the small risk of reactivation (particularly those who are hepatitis B surface antigen [HBsAg]–negative) may reasonably select active monitoring over antiviral prophylaxis.

Careful consideration should be given to the feasibility and likelihood of adherence to long-term monitoring performed at 1- to 3-month intervals and including assessment of hepatitis B viral load and alanine aminotransferase.

3. For low-risk individuals, the AGA said monitoring alone may be used. Conditional recommendation, moderate-certainty evidence.

Implementation considerations: This recommendation assumes regular and sufficient follow-up with continued monitoring. Patients who place a higher value on avoiding the small risk of reactivation (particularly those on more than one low-risk immunosuppressive) and a lower value on the burden and cost of antiviral therapy may reasonably select antiviral therapy.

4. For individuals at risk for HBVr, the guideline recommended testing for hepatitis B. Strong recommendation, moderate-certainty evidence.

Implementation considerations: Given the Centers for Disease Control and Prevention’s universal screening guidance on hepatitis B for everyone aged 18 years or older by testing for HBsAg, anti-HBs, and total anti-hepatitis B core (HBc), the guideline said that stratifying screening practices by magnitude of HBVr risk is no longer needed.

It is reasonable to test initially for serologic markers alone (at minimum for HBsAg or anti-HBc) followed by viral load testing (HBV-DNA) if HBsAg and/or anti-HBc is positive.

 

Hepatitis C Virus (HCV) Coinfection With Direct-Acting Antiviral (DAA) Treatment

The panel identified 11 studies that provided data for the computation of baseline risk for HBVr in the HCV coinfection cohort undergoing DAA therapy.

In patients who were HBsAg-positive, the pooled baseline risk for HBVr was 240 per 1000, categorizing them to be at high risk for HBVr. The panel stated it is therefore reasonable to extend antiviral prophylaxis beyond the 12-24 weeks of DAA therapy to 6-12 months after cessation of DAA therapy, tailored by clinician judgment and patient preference.

 

A ‘Useful Clinical Tool’

Commenting on the guideline but not involved in it, Saikiran Kilaru, MD, a hepatologist at NYU Langone Health in New York City, said the update is “absolutely a useful clinical tool. Since the prior guidance was published, there has been a deluge of new medications and medication classes. Prior to the guidance, I was making recommendations based on the limited data available for hepatitis B reactivation risk for these new medications, using the 1%-10% moderate-risk category as guidance.”

In addition, Kilaru said, this guidance is driven by a higher level of evidence certainty than the mostly retrospective evidence that was previously available.

She cautioned that few downgraded risk categories are likely to cause consternation among physicians who have been operating without the benefit of larger meta-analyses of HBVr in new medication categories. “For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk.” And other medications such as immune checkpoint inhibitors, which seemed to pose at least moderate risk based on smaller, retrospective studies are now considered to be in the low-risk category.

“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years,” Kilaru said.

Kilaru pointed out that the guidance update does not clearly cover some standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens, such as mycophenolate, tacrolimus, and cyclosporine. Nor does it address HBVr risk in some liver cancer treatments such as yttrium-90, which have been associated with reports of HBV reactivation.

 

The Future

According to Simon, more data are needed to better estimate HBVr risk in several important settings, including treatment with the most recently approved immunosuppressive drugs for which data are still limited, as well as combination treatments.

Kilaru noted that guideline updates such as this become increasingly relevant as cancer diagnoses rise and hepatitis B exposure and detection increase as well.

The AGA panel acknowledged that uncertainty remains in some patient risk categorizations. “As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr,” the panelists wrote.

AGA provided all financial support for the development of this guideline. No funding from industry was offered or accepted to support the writing effort.

The authors reported no relevant competing interests, but one coauthor is an adviser for Gilead Sciences, and other authors disclosed various relationships with multiple private sector companies. Kilaru had no competing interests to disclose.

A version of this article appeared on Medscape.com.

The American Gastroenterological Association (AGA) has released an updated clinical practice guideline on the prevention of hepatitis B virus reactivation (HBVr) in at-risk persons. The document was published in Gastroenterology and replaces a previous guideline on prophylaxis for immunosuppressed patients issued in 2014.

Since then, many novel classes of immunosuppressives have been approved for various conditions, and potentially immunosuppressive therapies such as transcatheter arterial chemoembolization have been recognized as relevant to potential HBVr.

With reactivation a risk after immune-modulating exposures, such as to multiple drug classes and disease states, the update provides frontline clinicians with evidence-based advice for the management of HBVr in vulnerable individuals. And while antiviral prophylaxis is recommended for many, in select cases careful clinical monitoring may suffice for risk management.

 

“The risk of HBV reactivation depends on patient-, drug-, and disease-specific factors — and so it can range from very rare to more frequent,” said guideline coauthor Tracey G. Simon, MD, MPH, a hepatologist in the division of gastroenterology at Massachusetts General Hospital and an instructor at Harvard Medical School, both in Boston. “Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors.”

Simon stressed the importance of creating this guideline to include many new therapies that carry varying degrees of reactivation risk. As to the strength of the evidence, she added, “for some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.”

 

Main Recommendations

AGA based its clinical recommendations on balancing desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. It also provided a clinical decision support tool for making pharmacologic management decisions.

The panelists reviewed data on multiple immunosuppressive therapies from older agents such as anthracycline derivatives, corticosteroids, and anti–tumor necrosis factor (anti-TNF) drugs to chimeric antigen receptor T cells and recent biologics and inhibitors.

1. For individuals at high risk for HBVr, AGA recommended antiviral prophylaxis over monitoring alone. Strong recommendation, moderate-certainty evidence.

Implementation considerations: Use antivirals with a high barrier to resistance. Prophylaxis should be started before initiating medications that carry a risk for HBVr and should be continued for at least 6 months after discontinuation of risk-imposing therapy (at least 12 months for B cell–depleting agents).

2. For individuals at moderate risk for HBVr, antiviral prophylaxis was recommended over monitoring alone. Conditional recommendation, moderate-certainty evidence.

Implementation considerations: Use antivirals with a high barrier to resistance. Patients who place a higher value on avoiding long-term antiviral therapy and its associated cost and place a lower value on avoiding the small risk of reactivation (particularly those who are hepatitis B surface antigen [HBsAg]–negative) may reasonably select active monitoring over antiviral prophylaxis.

Careful consideration should be given to the feasibility and likelihood of adherence to long-term monitoring performed at 1- to 3-month intervals and including assessment of hepatitis B viral load and alanine aminotransferase.

3. For low-risk individuals, the AGA said monitoring alone may be used. Conditional recommendation, moderate-certainty evidence.

Implementation considerations: This recommendation assumes regular and sufficient follow-up with continued monitoring. Patients who place a higher value on avoiding the small risk of reactivation (particularly those on more than one low-risk immunosuppressive) and a lower value on the burden and cost of antiviral therapy may reasonably select antiviral therapy.

4. For individuals at risk for HBVr, the guideline recommended testing for hepatitis B. Strong recommendation, moderate-certainty evidence.

Implementation considerations: Given the Centers for Disease Control and Prevention’s universal screening guidance on hepatitis B for everyone aged 18 years or older by testing for HBsAg, anti-HBs, and total anti-hepatitis B core (HBc), the guideline said that stratifying screening practices by magnitude of HBVr risk is no longer needed.

It is reasonable to test initially for serologic markers alone (at minimum for HBsAg or anti-HBc) followed by viral load testing (HBV-DNA) if HBsAg and/or anti-HBc is positive.

 

Hepatitis C Virus (HCV) Coinfection With Direct-Acting Antiviral (DAA) Treatment

The panel identified 11 studies that provided data for the computation of baseline risk for HBVr in the HCV coinfection cohort undergoing DAA therapy.

In patients who were HBsAg-positive, the pooled baseline risk for HBVr was 240 per 1000, categorizing them to be at high risk for HBVr. The panel stated it is therefore reasonable to extend antiviral prophylaxis beyond the 12-24 weeks of DAA therapy to 6-12 months after cessation of DAA therapy, tailored by clinician judgment and patient preference.

 

A ‘Useful Clinical Tool’

Commenting on the guideline but not involved in it, Saikiran Kilaru, MD, a hepatologist at NYU Langone Health in New York City, said the update is “absolutely a useful clinical tool. Since the prior guidance was published, there has been a deluge of new medications and medication classes. Prior to the guidance, I was making recommendations based on the limited data available for hepatitis B reactivation risk for these new medications, using the 1%-10% moderate-risk category as guidance.”

In addition, Kilaru said, this guidance is driven by a higher level of evidence certainty than the mostly retrospective evidence that was previously available.

She cautioned that few downgraded risk categories are likely to cause consternation among physicians who have been operating without the benefit of larger meta-analyses of HBVr in new medication categories. “For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk.” And other medications such as immune checkpoint inhibitors, which seemed to pose at least moderate risk based on smaller, retrospective studies are now considered to be in the low-risk category.

“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years,” Kilaru said.

Kilaru pointed out that the guidance update does not clearly cover some standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens, such as mycophenolate, tacrolimus, and cyclosporine. Nor does it address HBVr risk in some liver cancer treatments such as yttrium-90, which have been associated with reports of HBV reactivation.

 

The Future

According to Simon, more data are needed to better estimate HBVr risk in several important settings, including treatment with the most recently approved immunosuppressive drugs for which data are still limited, as well as combination treatments.

Kilaru noted that guideline updates such as this become increasingly relevant as cancer diagnoses rise and hepatitis B exposure and detection increase as well.

The AGA panel acknowledged that uncertainty remains in some patient risk categorizations. “As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr,” the panelists wrote.

AGA provided all financial support for the development of this guideline. No funding from industry was offered or accepted to support the writing effort.

The authors reported no relevant competing interests, but one coauthor is an adviser for Gilead Sciences, and other authors disclosed various relationships with multiple private sector companies. Kilaru had no competing interests to disclose.

A version of this article appeared on Medscape.com.

The American Gastroenterological Association (AGA) has released an updated clinical practice guideline on the prevention of hepatitis B virus reactivation (HBVr) in at-risk persons. The document was published in Gastroenterology and replaces a previous guideline on prophylaxis for immunosuppressed patients issued in 2014.

Since then, many novel classes of immunosuppressives have been approved for various conditions, and potentially immunosuppressive therapies such as transcatheter arterial chemoembolization have been recognized as relevant to potential HBVr.

With reactivation a risk after immune-modulating exposures, such as to multiple drug classes and disease states, the update provides frontline clinicians with evidence-based advice for the management of HBVr in vulnerable individuals. And while antiviral prophylaxis is recommended for many, in select cases careful clinical monitoring may suffice for risk management.

 

“The risk of HBV reactivation depends on patient-, drug-, and disease-specific factors — and so it can range from very rare to more frequent,” said guideline coauthor Tracey G. Simon, MD, MPH, a hepatologist in the division of gastroenterology at Massachusetts General Hospital and an instructor at Harvard Medical School, both in Boston. “Not every at-risk individual needs pharmacologic treatment, but some certainly do, and this guideline was designed to try to better identify who needs treatment, based on those important drug- and virus-specific factors.”

Simon stressed the importance of creating this guideline to include many new therapies that carry varying degrees of reactivation risk. As to the strength of the evidence, she added, “for some of the questions, the panel was satisfied with the level of certainty. However, for other questions, the data are still very sparse, and so we have tried to ensure that these areas of uncertainty are highlighted clearly for providers and patients.”

 

Main Recommendations

AGA based its clinical recommendations on balancing desirable and undesirable effects, patient values and preferences, costs, and health equity considerations. It also provided a clinical decision support tool for making pharmacologic management decisions.

The panelists reviewed data on multiple immunosuppressive therapies from older agents such as anthracycline derivatives, corticosteroids, and anti–tumor necrosis factor (anti-TNF) drugs to chimeric antigen receptor T cells and recent biologics and inhibitors.

1. For individuals at high risk for HBVr, AGA recommended antiviral prophylaxis over monitoring alone. Strong recommendation, moderate-certainty evidence.

Implementation considerations: Use antivirals with a high barrier to resistance. Prophylaxis should be started before initiating medications that carry a risk for HBVr and should be continued for at least 6 months after discontinuation of risk-imposing therapy (at least 12 months for B cell–depleting agents).

2. For individuals at moderate risk for HBVr, antiviral prophylaxis was recommended over monitoring alone. Conditional recommendation, moderate-certainty evidence.

Implementation considerations: Use antivirals with a high barrier to resistance. Patients who place a higher value on avoiding long-term antiviral therapy and its associated cost and place a lower value on avoiding the small risk of reactivation (particularly those who are hepatitis B surface antigen [HBsAg]–negative) may reasonably select active monitoring over antiviral prophylaxis.

Careful consideration should be given to the feasibility and likelihood of adherence to long-term monitoring performed at 1- to 3-month intervals and including assessment of hepatitis B viral load and alanine aminotransferase.

3. For low-risk individuals, the AGA said monitoring alone may be used. Conditional recommendation, moderate-certainty evidence.

Implementation considerations: This recommendation assumes regular and sufficient follow-up with continued monitoring. Patients who place a higher value on avoiding the small risk of reactivation (particularly those on more than one low-risk immunosuppressive) and a lower value on the burden and cost of antiviral therapy may reasonably select antiviral therapy.

4. For individuals at risk for HBVr, the guideline recommended testing for hepatitis B. Strong recommendation, moderate-certainty evidence.

Implementation considerations: Given the Centers for Disease Control and Prevention’s universal screening guidance on hepatitis B for everyone aged 18 years or older by testing for HBsAg, anti-HBs, and total anti-hepatitis B core (HBc), the guideline said that stratifying screening practices by magnitude of HBVr risk is no longer needed.

It is reasonable to test initially for serologic markers alone (at minimum for HBsAg or anti-HBc) followed by viral load testing (HBV-DNA) if HBsAg and/or anti-HBc is positive.

 

Hepatitis C Virus (HCV) Coinfection With Direct-Acting Antiviral (DAA) Treatment

The panel identified 11 studies that provided data for the computation of baseline risk for HBVr in the HCV coinfection cohort undergoing DAA therapy.

In patients who were HBsAg-positive, the pooled baseline risk for HBVr was 240 per 1000, categorizing them to be at high risk for HBVr. The panel stated it is therefore reasonable to extend antiviral prophylaxis beyond the 12-24 weeks of DAA therapy to 6-12 months after cessation of DAA therapy, tailored by clinician judgment and patient preference.

 

A ‘Useful Clinical Tool’

Commenting on the guideline but not involved in it, Saikiran Kilaru, MD, a hepatologist at NYU Langone Health in New York City, said the update is “absolutely a useful clinical tool. Since the prior guidance was published, there has been a deluge of new medications and medication classes. Prior to the guidance, I was making recommendations based on the limited data available for hepatitis B reactivation risk for these new medications, using the 1%-10% moderate-risk category as guidance.”

In addition, Kilaru said, this guidance is driven by a higher level of evidence certainty than the mostly retrospective evidence that was previously available.

She cautioned that few downgraded risk categories are likely to cause consternation among physicians who have been operating without the benefit of larger meta-analyses of HBVr in new medication categories. “For example, the prior guidance had put anti-TNF as of moderate risk for hepatitis B core–positive-only patients and is now downgraded to low risk.” And other medications such as immune checkpoint inhibitors, which seemed to pose at least moderate risk based on smaller, retrospective studies are now considered to be in the low-risk category.

“It may take some time for these recommendations to be adopted, especially for physicians in the community who have seen fatal or severe reactivations in the past few years,” Kilaru said.

Kilaru pointed out that the guidance update does not clearly cover some standard immunosuppressive therapies used in autoimmune, rheumatologic, and posttransplant regimens, such as mycophenolate, tacrolimus, and cyclosporine. Nor does it address HBVr risk in some liver cancer treatments such as yttrium-90, which have been associated with reports of HBV reactivation.

 

The Future

According to Simon, more data are needed to better estimate HBVr risk in several important settings, including treatment with the most recently approved immunosuppressive drugs for which data are still limited, as well as combination treatments.

Kilaru noted that guideline updates such as this become increasingly relevant as cancer diagnoses rise and hepatitis B exposure and detection increase as well.

The AGA panel acknowledged that uncertainty remains in some patient risk categorizations. “As the armamentarium of immunotherapeutics evolves, it will be crucial to search for, use, and maintain studies that provide baseline HBV serologies; include a clear definition of HBVr; and enroll a large, nonselective cohort that can guide categorization of risk of HBVr,” the panelists wrote.

AGA provided all financial support for the development of this guideline. No funding from industry was offered or accepted to support the writing effort.

The authors reported no relevant competing interests, but one coauthor is an adviser for Gilead Sciences, and other authors disclosed various relationships with multiple private sector companies. Kilaru had no competing interests to disclose.

A version of this article appeared on Medscape.com.

At least 250,000 US hospitalized patients a year require enteral support using an artificial pathway into the gastrointestinal (GI) tract to deliver nutrition or medication. In light of this, AGA has issued a clinical practice update to improve the practice of endoscopic enteral access.

Covering indications, placement techniques, and management, the comprehensive document is a response to the increasing use of enteral access devices in chronic GI conditions. The update, published in Gastroenterology, addresses patient factors complicating placement decision-making such as thrombocytopenia, use of dual antiplatelet therapy, or performance of percutaneous access in the setting of cirrhosis.

 

“We provide clinical recommendations in these various scenarios understanding that the final decision-making is in the hands of the provider and care team,” said first author Dejan Micic, MD, a gastroenterologist and associate professor at University of Chicago Medical Center in Illinois at the time of the update (since relocated to Loyola University Medical Center in Chicago). “We hope this can serve a day-to-day purpose for clinical gastroenterologists and can be referenced as they encounter individuals with or needing an enteral access device.”

Traditionally, enteral access was reserved for patients with severe malnutrition or those unable to maintain oral intake. Recent recommendations emphasize early nutritional intervention including prehabilitation before major surgery, adjunctive therapy for oncology patients, and in specific inflammatory conditions such as Crohn’s disease. “These shifts recognize the role of enteral nutrition not only in preventing malnutrition but also as a therapeutic strategy,” Micic said in an interview.

There is, however, variability in the use of devices including the selection of appropriate units, technical aspects of placement, and subsequent management. “Such variability can lead to complications, suboptimal patient outcomes, and inefficiencies in care delivery,” Micic said.

He added that enteral access has been historically underemphasized in GI endoscopic training. “While procedural skill in placing devices such as percutaneous endoscopic gastrostomy, or PEG, tubes is often taught, a comprehensive understanding of the broader clinical context — such as proper patient selection, prevention of complications, and postplacement care — is not always thoroughly covered.”

The current update aims to bridge knowledge gaps with evidence-based-guidance. “It also underscores the importance of interdisciplinary collaboration with dietitians, nurses, and care givers to achieve the best outcomes for patients,” Micic said.

 

Commenting on the update but not involved with creating it, Shirley C. Paski, MD, MS, a gastroenterologist at the Cleveland Clinic, Ohio, called it timely, adding: “As GI training is becoming more subspecialized and interventional radiology has been able to provide enteral access, gastroenterology training in enteral access has declined to where some fellows are graduating with limited enteral access experience.”

Yet malnutrition remains a common consequence when GI disease is severe, chronic, or refractory to treatment, or in the setting of postsurgical anatomy, she added. “Enteral nutrition is increasingly being considered a therapeutic or adjunct treatment in some cases of Crohn’s disease or small intestinal bacterial overgrowth. Gastroenterologists need the endoscopic skill to secure enteral access tubes, particularly in more challenging anatomy.”

 

Also commenting on the document but not involved in it, Steven Shamah, MD, director of Endoscopy at Northwell Lenox Hill Hospital in New York City, said: “This should serve as a concise review for any general hospitalist or gastroenterologist to understand what we have and when we should offer the proper feeding tube options.” He stressed, however, that all gastroenterologists should be trained in the placing of all of tube options.

“The axiom ‘If the gut works, we should use it’ is something that I was taught when I was a medical student and it still holds true,” Shamah continued. “There’s been a jump in interventional procedures to assure continuity of the GI tract even in progressive malignancy. So there’s a rise in moving away from intravenous nutrition and a rise in tube-delivered enteral nutrition.” Options for reducing reflux and aspiration will likely take on more importance, he said.

 

Tubing Options

According to Micic and colleagues, recent data suggest a favorable safety profile of enteral feeding tubes placed endoscopically compared with surgical or radiologic placement. The illustrated AGA document outlines such approaches as synthetic flexible tubes placed into the stomach or small bowel via the oral (orogastric and oroenteral) or nasal routes (nasogastric [NG] and nasojejunal [NJ]) and percutaneous tubes accessing the stomach. The choice of tube, access point, delivery site, and feeding method varies with indication, expected duration of use, and patient anatomy, the authors stressed.

The update notes that NG and NJ tubes can be used immediately after confirmation of placement, most often with abdominal radiography. PEG tubes can be used immediately for medications and after 4 hours for tube feedings. A multidisciplinary team approach after placement provides improved patient care. “Dietitians assist with formula choice, volume, free water needs, and delivery method, and nurses and advanced practice clinicians assist with tube site assessment and troubleshooting,” the authors wrote.

Complications can occur but should be infrequent, Micic said. “Frankly, most complications can be predicted based on the duration of use and prevented with appropriate monitoring.” Common complications include tube dislodgement, clogging, site infections, buried bumper syndrome, and aspiration. “Minimizing these risks requires a thorough understanding of patient-specific factors, careful technique during placement, and ongoing monitoring after the device is in use,” he added.

Paski said the update aligns with established guidelines for enteral access but also offers suggestions to mitigate the risk of tube placement in patients in whom placement has traditionally been more challenging. “This is a helpful addition to the literature because if enteral access cannot be obtained in a patient unable to meet their needs orally, total paternal nutrition is the next and much more invasive step for nutrition support.”

She called the practice update a concise, comprehensive reference for trainees and experienced gastroenterologists to optimize placement conditions and reduce complication risk, noting that training in nutrition is suboptimal in many GI fellowships.

Becoming familiar with common and advanced enteral access techniques is within the armamentarium of all practicing gastroenterologists, the authors stated. Because malnutrition affects nearly all GI disorders, “understanding common routes of enteral access and the basic principles of nutrition support promotes the initiation of optimal enteral nutrition, mitigating the impact of malnutrition, and improving prognosis for patients at nutritional risk,” they wrote.

Micic served on the advisory board for Ironwood Pharmaceuticals and is on the speaker’s bureau for Takeda Pharmaceuticals. One coauthor served as a consultant for Merit Medical, Circa Scientific, and Aspero Medical. Paski and Shamah had disclosed no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

At least 250,000 US hospitalized patients a year require enteral support using an artificial pathway into the gastrointestinal (GI) tract to deliver nutrition or medication. In light of this, AGA has issued a clinical practice update to improve the practice of endoscopic enteral access.

Covering indications, placement techniques, and management, the comprehensive document is a response to the increasing use of enteral access devices in chronic GI conditions. The update, published in Gastroenterology, addresses patient factors complicating placement decision-making such as thrombocytopenia, use of dual antiplatelet therapy, or performance of percutaneous access in the setting of cirrhosis.

 

“We provide clinical recommendations in these various scenarios understanding that the final decision-making is in the hands of the provider and care team,” said first author Dejan Micic, MD, a gastroenterologist and associate professor at University of Chicago Medical Center in Illinois at the time of the update (since relocated to Loyola University Medical Center in Chicago). “We hope this can serve a day-to-day purpose for clinical gastroenterologists and can be referenced as they encounter individuals with or needing an enteral access device.”

Traditionally, enteral access was reserved for patients with severe malnutrition or those unable to maintain oral intake. Recent recommendations emphasize early nutritional intervention including prehabilitation before major surgery, adjunctive therapy for oncology patients, and in specific inflammatory conditions such as Crohn’s disease. “These shifts recognize the role of enteral nutrition not only in preventing malnutrition but also as a therapeutic strategy,” Micic said in an interview.

There is, however, variability in the use of devices including the selection of appropriate units, technical aspects of placement, and subsequent management. “Such variability can lead to complications, suboptimal patient outcomes, and inefficiencies in care delivery,” Micic said.

He added that enteral access has been historically underemphasized in GI endoscopic training. “While procedural skill in placing devices such as percutaneous endoscopic gastrostomy, or PEG, tubes is often taught, a comprehensive understanding of the broader clinical context — such as proper patient selection, prevention of complications, and postplacement care — is not always thoroughly covered.”

The current update aims to bridge knowledge gaps with evidence-based-guidance. “It also underscores the importance of interdisciplinary collaboration with dietitians, nurses, and care givers to achieve the best outcomes for patients,” Micic said.

 

Commenting on the update but not involved with creating it, Shirley C. Paski, MD, MS, a gastroenterologist at the Cleveland Clinic, Ohio, called it timely, adding: “As GI training is becoming more subspecialized and interventional radiology has been able to provide enteral access, gastroenterology training in enteral access has declined to where some fellows are graduating with limited enteral access experience.”

Yet malnutrition remains a common consequence when GI disease is severe, chronic, or refractory to treatment, or in the setting of postsurgical anatomy, she added. “Enteral nutrition is increasingly being considered a therapeutic or adjunct treatment in some cases of Crohn’s disease or small intestinal bacterial overgrowth. Gastroenterologists need the endoscopic skill to secure enteral access tubes, particularly in more challenging anatomy.”

 

Also commenting on the document but not involved in it, Steven Shamah, MD, director of Endoscopy at Northwell Lenox Hill Hospital in New York City, said: “This should serve as a concise review for any general hospitalist or gastroenterologist to understand what we have and when we should offer the proper feeding tube options.” He stressed, however, that all gastroenterologists should be trained in the placing of all of tube options.

“The axiom ‘If the gut works, we should use it’ is something that I was taught when I was a medical student and it still holds true,” Shamah continued. “There’s been a jump in interventional procedures to assure continuity of the GI tract even in progressive malignancy. So there’s a rise in moving away from intravenous nutrition and a rise in tube-delivered enteral nutrition.” Options for reducing reflux and aspiration will likely take on more importance, he said.

 

Tubing Options

According to Micic and colleagues, recent data suggest a favorable safety profile of enteral feeding tubes placed endoscopically compared with surgical or radiologic placement. The illustrated AGA document outlines such approaches as synthetic flexible tubes placed into the stomach or small bowel via the oral (orogastric and oroenteral) or nasal routes (nasogastric [NG] and nasojejunal [NJ]) and percutaneous tubes accessing the stomach. The choice of tube, access point, delivery site, and feeding method varies with indication, expected duration of use, and patient anatomy, the authors stressed.

The update notes that NG and NJ tubes can be used immediately after confirmation of placement, most often with abdominal radiography. PEG tubes can be used immediately for medications and after 4 hours for tube feedings. A multidisciplinary team approach after placement provides improved patient care. “Dietitians assist with formula choice, volume, free water needs, and delivery method, and nurses and advanced practice clinicians assist with tube site assessment and troubleshooting,” the authors wrote.

Complications can occur but should be infrequent, Micic said. “Frankly, most complications can be predicted based on the duration of use and prevented with appropriate monitoring.” Common complications include tube dislodgement, clogging, site infections, buried bumper syndrome, and aspiration. “Minimizing these risks requires a thorough understanding of patient-specific factors, careful technique during placement, and ongoing monitoring after the device is in use,” he added.

Paski said the update aligns with established guidelines for enteral access but also offers suggestions to mitigate the risk of tube placement in patients in whom placement has traditionally been more challenging. “This is a helpful addition to the literature because if enteral access cannot be obtained in a patient unable to meet their needs orally, total paternal nutrition is the next and much more invasive step for nutrition support.”

She called the practice update a concise, comprehensive reference for trainees and experienced gastroenterologists to optimize placement conditions and reduce complication risk, noting that training in nutrition is suboptimal in many GI fellowships.

Becoming familiar with common and advanced enteral access techniques is within the armamentarium of all practicing gastroenterologists, the authors stated. Because malnutrition affects nearly all GI disorders, “understanding common routes of enteral access and the basic principles of nutrition support promotes the initiation of optimal enteral nutrition, mitigating the impact of malnutrition, and improving prognosis for patients at nutritional risk,” they wrote.

Micic served on the advisory board for Ironwood Pharmaceuticals and is on the speaker’s bureau for Takeda Pharmaceuticals. One coauthor served as a consultant for Merit Medical, Circa Scientific, and Aspero Medical. Paski and Shamah had disclosed no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

At least 250,000 US hospitalized patients a year require enteral support using an artificial pathway into the gastrointestinal (GI) tract to deliver nutrition or medication. In light of this, AGA has issued a clinical practice update to improve the practice of endoscopic enteral access.

Covering indications, placement techniques, and management, the comprehensive document is a response to the increasing use of enteral access devices in chronic GI conditions. The update, published in Gastroenterology, addresses patient factors complicating placement decision-making such as thrombocytopenia, use of dual antiplatelet therapy, or performance of percutaneous access in the setting of cirrhosis.

 

“We provide clinical recommendations in these various scenarios understanding that the final decision-making is in the hands of the provider and care team,” said first author Dejan Micic, MD, a gastroenterologist and associate professor at University of Chicago Medical Center in Illinois at the time of the update (since relocated to Loyola University Medical Center in Chicago). “We hope this can serve a day-to-day purpose for clinical gastroenterologists and can be referenced as they encounter individuals with or needing an enteral access device.”

Traditionally, enteral access was reserved for patients with severe malnutrition or those unable to maintain oral intake. Recent recommendations emphasize early nutritional intervention including prehabilitation before major surgery, adjunctive therapy for oncology patients, and in specific inflammatory conditions such as Crohn’s disease. “These shifts recognize the role of enteral nutrition not only in preventing malnutrition but also as a therapeutic strategy,” Micic said in an interview.

There is, however, variability in the use of devices including the selection of appropriate units, technical aspects of placement, and subsequent management. “Such variability can lead to complications, suboptimal patient outcomes, and inefficiencies in care delivery,” Micic said.

He added that enteral access has been historically underemphasized in GI endoscopic training. “While procedural skill in placing devices such as percutaneous endoscopic gastrostomy, or PEG, tubes is often taught, a comprehensive understanding of the broader clinical context — such as proper patient selection, prevention of complications, and postplacement care — is not always thoroughly covered.”

The current update aims to bridge knowledge gaps with evidence-based-guidance. “It also underscores the importance of interdisciplinary collaboration with dietitians, nurses, and care givers to achieve the best outcomes for patients,” Micic said.

 

Commenting on the update but not involved with creating it, Shirley C. Paski, MD, MS, a gastroenterologist at the Cleveland Clinic, Ohio, called it timely, adding: “As GI training is becoming more subspecialized and interventional radiology has been able to provide enteral access, gastroenterology training in enteral access has declined to where some fellows are graduating with limited enteral access experience.”

Yet malnutrition remains a common consequence when GI disease is severe, chronic, or refractory to treatment, or in the setting of postsurgical anatomy, she added. “Enteral nutrition is increasingly being considered a therapeutic or adjunct treatment in some cases of Crohn’s disease or small intestinal bacterial overgrowth. Gastroenterologists need the endoscopic skill to secure enteral access tubes, particularly in more challenging anatomy.”

 

Also commenting on the document but not involved in it, Steven Shamah, MD, director of Endoscopy at Northwell Lenox Hill Hospital in New York City, said: “This should serve as a concise review for any general hospitalist or gastroenterologist to understand what we have and when we should offer the proper feeding tube options.” He stressed, however, that all gastroenterologists should be trained in the placing of all of tube options.

“The axiom ‘If the gut works, we should use it’ is something that I was taught when I was a medical student and it still holds true,” Shamah continued. “There’s been a jump in interventional procedures to assure continuity of the GI tract even in progressive malignancy. So there’s a rise in moving away from intravenous nutrition and a rise in tube-delivered enteral nutrition.” Options for reducing reflux and aspiration will likely take on more importance, he said.

 

Tubing Options

According to Micic and colleagues, recent data suggest a favorable safety profile of enteral feeding tubes placed endoscopically compared with surgical or radiologic placement. The illustrated AGA document outlines such approaches as synthetic flexible tubes placed into the stomach or small bowel via the oral (orogastric and oroenteral) or nasal routes (nasogastric [NG] and nasojejunal [NJ]) and percutaneous tubes accessing the stomach. The choice of tube, access point, delivery site, and feeding method varies with indication, expected duration of use, and patient anatomy, the authors stressed.

The update notes that NG and NJ tubes can be used immediately after confirmation of placement, most often with abdominal radiography. PEG tubes can be used immediately for medications and after 4 hours for tube feedings. A multidisciplinary team approach after placement provides improved patient care. “Dietitians assist with formula choice, volume, free water needs, and delivery method, and nurses and advanced practice clinicians assist with tube site assessment and troubleshooting,” the authors wrote.

Complications can occur but should be infrequent, Micic said. “Frankly, most complications can be predicted based on the duration of use and prevented with appropriate monitoring.” Common complications include tube dislodgement, clogging, site infections, buried bumper syndrome, and aspiration. “Minimizing these risks requires a thorough understanding of patient-specific factors, careful technique during placement, and ongoing monitoring after the device is in use,” he added.

Paski said the update aligns with established guidelines for enteral access but also offers suggestions to mitigate the risk of tube placement in patients in whom placement has traditionally been more challenging. “This is a helpful addition to the literature because if enteral access cannot be obtained in a patient unable to meet their needs orally, total paternal nutrition is the next and much more invasive step for nutrition support.”

She called the practice update a concise, comprehensive reference for trainees and experienced gastroenterologists to optimize placement conditions and reduce complication risk, noting that training in nutrition is suboptimal in many GI fellowships.

Becoming familiar with common and advanced enteral access techniques is within the armamentarium of all practicing gastroenterologists, the authors stated. Because malnutrition affects nearly all GI disorders, “understanding common routes of enteral access and the basic principles of nutrition support promotes the initiation of optimal enteral nutrition, mitigating the impact of malnutrition, and improving prognosis for patients at nutritional risk,” they wrote.

Micic served on the advisory board for Ironwood Pharmaceuticals and is on the speaker’s bureau for Takeda Pharmaceuticals. One coauthor served as a consultant for Merit Medical, Circa Scientific, and Aspero Medical. Paski and Shamah had disclosed no competing interests relevant to their comments.

A version of this article appeared on Medscape.com.

The risk of detecting colorectal cancer (CRC) increases by up to 13-fold in the presence of prior fecal hemoglobin (f-Hb) concentrations in fecal immunochemical tests (FIT), especially negative ones, according to a large international dose-response meta-analysis.

Although the association with neoplasia decreased as f-Hb levels rose, the findings support the development of risk-stratified screening strategies based on these concentrations, according to researchers led by Danica M.N. van den Berg, MSc, a PhD candidate and econometrics researcher in the Department of Public Health at Erasmus MC, University Medical Center in Rotterdam, the Netherlands.

Higher f-Hb concentrations in prior negative screening tests are strongly associated with an increased risk of detecting colorectal neoplasia in subsequent screenings, van den Berg said in an interview. “Gastroenterologists and other clinicians should consider the value of f-Hb concentrations in refining screening protocols and personalizing patient care to detect colorectal neoplasia earlier and more accurately.”

Published in Gastroenterology, the study was prompted by prior research showing individuals with f-Hb concentrations just below the positivity cutoff had an elevated CRC risk vs those with low or no f-Hb. “However, global variations in FIT positivity cutoffs and f-Hb category definitions complicated cross-study comparisons,” van den Berg said. Given the lack of an established dose-response relationship, the study aimed to clarify how f-Hb levels in previous screenings correlate with colorectal neoplasia detection. “Understanding this relationship is crucial for developing risk-stratified colorectal cancer screening strategies based on prior FIT results, which could improve the harm-benefit balance of screening,” she said.

According to van den Berg, f-Hb concentrations could help determine optimal CRC screening intervals by identifying higher-risk individuals who could benefit from more frequent testing, while those with lower concentrations could be screened less frequently.

 

Study Details

The systematic review and meta-analysis are the first to focus on the dose-response relationship between f-Hb levels in prior FIT screenings and colorectal neoplasia detection, van den Berg said. It included 13 ethnically diverse studies published during 2011-2023 with 4,493,223 individuals from Spain, France, the Netherlands, Taiwan, Denmark, Scotland, Ireland, Korea, Italy, and Norway. Most studies were cohort-based, and one was a randomized controlled trial.

All studies demonstrated a positive association between f-Hb in previous screenings and colorectal neoplasia detection. Almost all reported the f-Hb concentration measured in the prior screening round, while one study combined the f-Hb concentration of two previous screening rounds by using the cumulative f-Hb value. There was, however, wide variability in the stool positivity cut-offs in the included studies, ranging from 10 μg f-Hb/g to 80 μg f-Hb/g.

With an overall effect size of 0.69 (95% CI, 0.59-0.79), pooled analysis revealed that in the next screening round, individuals with f-Hb concentrations in stool of 5, 10, 20, and 40 μg/g had a threefold, fivefold, eightfold, and 13-fold higher risk for colorectal neoplasia, respectively, vs individuals showing 0 μg/g. Although there was significant study heterogeneity (I2 = 97.5%, P < .001), sensitivity analyses confirmed the consistency of findings. Interestingly, subgroup analyses indicated that f-Hb concentrations from a previous negative test were especially predictive of advanced neoplasia in subsequent screenings.

“This is a strategy worth pursuing and evaluating in the United States,” said gastroenterologist Theodore R. Levin, MD, a research scientist at Kaiser Permanente Division of Research in Northern California, commenting on the study but not involved in it. “However, there is no currently available FIT brand in the US that reports f-Hb concentration. All FITs in the US report as a qualitative positive-negative result.”

The Dutch investigation aligns with prior studies demonstrating a positive association between f-Hb concentrations in previous screenings and the detection of colorectal neoplasia. “Our working hypothesis was that risk increases in a decreasing manner as f-Hb concentrations rise, and the findings supported this hypothesis,” van den Berg said.

Other research has projected f-Hb level risk stratification to be effective and perhaps cost-effective in reducing delayed diagnosis of CRC.

 

Feasibility of Implementation

In large national screening programs in Europe, Asia, and Australia, as well as those of Kaiser Permanente and the Veterans Health Administration in the United States, information on f-Hb concentrations is already available.

“Therefore, incorporating an Hb-based approach should be relatively easy and affordable,” van den Berg said, and may help to optimize resource use while maintaining high detection rates. “However, the more critical question is whether such an approach would be acceptable to the target population.” To that end, randomized controlled trials in Italy and the Netherlands are offering tailored invitation intervals based on prior f-Hb concentrations and may provide insight into the real-world application of risk-stratified screening.

Among the many variables to be considered in the context of population-wide screening are cost-effectiveness, acceptability, and practicality, as well as invitation intervals, positivity cut-off levels, and start and stop ages for screening. “A key focus will be understanding the acceptability of risk-stratified colorectal cancer screening based on f-Hb among the target population and addressing any information needs they may have, as these are critical factors for successful implementation,” said van den Berg. Her group is currently studying the most effective and cost-effective risk-based strategy for CRC screening based on f-Hb levels.

The authors cautioned that since individuals with undetectable f-Hb levels make up the majority of those with negative FIT results, care must be taken that reducing screening frequency for this low-risk group does not lead to unfavorable outcomes at the population level.

This study was funded by the Dutch Organization for Scientific Research, which had no role in study design, data collection, analysis, interpretation, or writing. 

The authors declared no competing interests. Levin disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

The risk of detecting colorectal cancer (CRC) increases by up to 13-fold in the presence of prior fecal hemoglobin (f-Hb) concentrations in fecal immunochemical tests (FIT), especially negative ones, according to a large international dose-response meta-analysis.

Although the association with neoplasia decreased as f-Hb levels rose, the findings support the development of risk-stratified screening strategies based on these concentrations, according to researchers led by Danica M.N. van den Berg, MSc, a PhD candidate and econometrics researcher in the Department of Public Health at Erasmus MC, University Medical Center in Rotterdam, the Netherlands.

Higher f-Hb concentrations in prior negative screening tests are strongly associated with an increased risk of detecting colorectal neoplasia in subsequent screenings, van den Berg said in an interview. “Gastroenterologists and other clinicians should consider the value of f-Hb concentrations in refining screening protocols and personalizing patient care to detect colorectal neoplasia earlier and more accurately.”

Published in Gastroenterology, the study was prompted by prior research showing individuals with f-Hb concentrations just below the positivity cutoff had an elevated CRC risk vs those with low or no f-Hb. “However, global variations in FIT positivity cutoffs and f-Hb category definitions complicated cross-study comparisons,” van den Berg said. Given the lack of an established dose-response relationship, the study aimed to clarify how f-Hb levels in previous screenings correlate with colorectal neoplasia detection. “Understanding this relationship is crucial for developing risk-stratified colorectal cancer screening strategies based on prior FIT results, which could improve the harm-benefit balance of screening,” she said.

According to van den Berg, f-Hb concentrations could help determine optimal CRC screening intervals by identifying higher-risk individuals who could benefit from more frequent testing, while those with lower concentrations could be screened less frequently.

 

Study Details

The systematic review and meta-analysis are the first to focus on the dose-response relationship between f-Hb levels in prior FIT screenings and colorectal neoplasia detection, van den Berg said. It included 13 ethnically diverse studies published during 2011-2023 with 4,493,223 individuals from Spain, France, the Netherlands, Taiwan, Denmark, Scotland, Ireland, Korea, Italy, and Norway. Most studies were cohort-based, and one was a randomized controlled trial.

All studies demonstrated a positive association between f-Hb in previous screenings and colorectal neoplasia detection. Almost all reported the f-Hb concentration measured in the prior screening round, while one study combined the f-Hb concentration of two previous screening rounds by using the cumulative f-Hb value. There was, however, wide variability in the stool positivity cut-offs in the included studies, ranging from 10 μg f-Hb/g to 80 μg f-Hb/g.

With an overall effect size of 0.69 (95% CI, 0.59-0.79), pooled analysis revealed that in the next screening round, individuals with f-Hb concentrations in stool of 5, 10, 20, and 40 μg/g had a threefold, fivefold, eightfold, and 13-fold higher risk for colorectal neoplasia, respectively, vs individuals showing 0 μg/g. Although there was significant study heterogeneity (I2 = 97.5%, P < .001), sensitivity analyses confirmed the consistency of findings. Interestingly, subgroup analyses indicated that f-Hb concentrations from a previous negative test were especially predictive of advanced neoplasia in subsequent screenings.

“This is a strategy worth pursuing and evaluating in the United States,” said gastroenterologist Theodore R. Levin, MD, a research scientist at Kaiser Permanente Division of Research in Northern California, commenting on the study but not involved in it. “However, there is no currently available FIT brand in the US that reports f-Hb concentration. All FITs in the US report as a qualitative positive-negative result.”

The Dutch investigation aligns with prior studies demonstrating a positive association between f-Hb concentrations in previous screenings and the detection of colorectal neoplasia. “Our working hypothesis was that risk increases in a decreasing manner as f-Hb concentrations rise, and the findings supported this hypothesis,” van den Berg said.

Other research has projected f-Hb level risk stratification to be effective and perhaps cost-effective in reducing delayed diagnosis of CRC.

 

Feasibility of Implementation

In large national screening programs in Europe, Asia, and Australia, as well as those of Kaiser Permanente and the Veterans Health Administration in the United States, information on f-Hb concentrations is already available.

“Therefore, incorporating an Hb-based approach should be relatively easy and affordable,” van den Berg said, and may help to optimize resource use while maintaining high detection rates. “However, the more critical question is whether such an approach would be acceptable to the target population.” To that end, randomized controlled trials in Italy and the Netherlands are offering tailored invitation intervals based on prior f-Hb concentrations and may provide insight into the real-world application of risk-stratified screening.

Among the many variables to be considered in the context of population-wide screening are cost-effectiveness, acceptability, and practicality, as well as invitation intervals, positivity cut-off levels, and start and stop ages for screening. “A key focus will be understanding the acceptability of risk-stratified colorectal cancer screening based on f-Hb among the target population and addressing any information needs they may have, as these are critical factors for successful implementation,” said van den Berg. Her group is currently studying the most effective and cost-effective risk-based strategy for CRC screening based on f-Hb levels.

The authors cautioned that since individuals with undetectable f-Hb levels make up the majority of those with negative FIT results, care must be taken that reducing screening frequency for this low-risk group does not lead to unfavorable outcomes at the population level.

This study was funded by the Dutch Organization for Scientific Research, which had no role in study design, data collection, analysis, interpretation, or writing. 

The authors declared no competing interests. Levin disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

The risk of detecting colorectal cancer (CRC) increases by up to 13-fold in the presence of prior fecal hemoglobin (f-Hb) concentrations in fecal immunochemical tests (FIT), especially negative ones, according to a large international dose-response meta-analysis.

Although the association with neoplasia decreased as f-Hb levels rose, the findings support the development of risk-stratified screening strategies based on these concentrations, according to researchers led by Danica M.N. van den Berg, MSc, a PhD candidate and econometrics researcher in the Department of Public Health at Erasmus MC, University Medical Center in Rotterdam, the Netherlands.

Higher f-Hb concentrations in prior negative screening tests are strongly associated with an increased risk of detecting colorectal neoplasia in subsequent screenings, van den Berg said in an interview. “Gastroenterologists and other clinicians should consider the value of f-Hb concentrations in refining screening protocols and personalizing patient care to detect colorectal neoplasia earlier and more accurately.”

Published in Gastroenterology, the study was prompted by prior research showing individuals with f-Hb concentrations just below the positivity cutoff had an elevated CRC risk vs those with low or no f-Hb. “However, global variations in FIT positivity cutoffs and f-Hb category definitions complicated cross-study comparisons,” van den Berg said. Given the lack of an established dose-response relationship, the study aimed to clarify how f-Hb levels in previous screenings correlate with colorectal neoplasia detection. “Understanding this relationship is crucial for developing risk-stratified colorectal cancer screening strategies based on prior FIT results, which could improve the harm-benefit balance of screening,” she said.

According to van den Berg, f-Hb concentrations could help determine optimal CRC screening intervals by identifying higher-risk individuals who could benefit from more frequent testing, while those with lower concentrations could be screened less frequently.

 

Study Details

The systematic review and meta-analysis are the first to focus on the dose-response relationship between f-Hb levels in prior FIT screenings and colorectal neoplasia detection, van den Berg said. It included 13 ethnically diverse studies published during 2011-2023 with 4,493,223 individuals from Spain, France, the Netherlands, Taiwan, Denmark, Scotland, Ireland, Korea, Italy, and Norway. Most studies were cohort-based, and one was a randomized controlled trial.

All studies demonstrated a positive association between f-Hb in previous screenings and colorectal neoplasia detection. Almost all reported the f-Hb concentration measured in the prior screening round, while one study combined the f-Hb concentration of two previous screening rounds by using the cumulative f-Hb value. There was, however, wide variability in the stool positivity cut-offs in the included studies, ranging from 10 μg f-Hb/g to 80 μg f-Hb/g.

With an overall effect size of 0.69 (95% CI, 0.59-0.79), pooled analysis revealed that in the next screening round, individuals with f-Hb concentrations in stool of 5, 10, 20, and 40 μg/g had a threefold, fivefold, eightfold, and 13-fold higher risk for colorectal neoplasia, respectively, vs individuals showing 0 μg/g. Although there was significant study heterogeneity (I2 = 97.5%, P < .001), sensitivity analyses confirmed the consistency of findings. Interestingly, subgroup analyses indicated that f-Hb concentrations from a previous negative test were especially predictive of advanced neoplasia in subsequent screenings.

“This is a strategy worth pursuing and evaluating in the United States,” said gastroenterologist Theodore R. Levin, MD, a research scientist at Kaiser Permanente Division of Research in Northern California, commenting on the study but not involved in it. “However, there is no currently available FIT brand in the US that reports f-Hb concentration. All FITs in the US report as a qualitative positive-negative result.”

The Dutch investigation aligns with prior studies demonstrating a positive association between f-Hb concentrations in previous screenings and the detection of colorectal neoplasia. “Our working hypothesis was that risk increases in a decreasing manner as f-Hb concentrations rise, and the findings supported this hypothesis,” van den Berg said.

Other research has projected f-Hb level risk stratification to be effective and perhaps cost-effective in reducing delayed diagnosis of CRC.

 

Feasibility of Implementation

In large national screening programs in Europe, Asia, and Australia, as well as those of Kaiser Permanente and the Veterans Health Administration in the United States, information on f-Hb concentrations is already available.

“Therefore, incorporating an Hb-based approach should be relatively easy and affordable,” van den Berg said, and may help to optimize resource use while maintaining high detection rates. “However, the more critical question is whether such an approach would be acceptable to the target population.” To that end, randomized controlled trials in Italy and the Netherlands are offering tailored invitation intervals based on prior f-Hb concentrations and may provide insight into the real-world application of risk-stratified screening.

Among the many variables to be considered in the context of population-wide screening are cost-effectiveness, acceptability, and practicality, as well as invitation intervals, positivity cut-off levels, and start and stop ages for screening. “A key focus will be understanding the acceptability of risk-stratified colorectal cancer screening based on f-Hb among the target population and addressing any information needs they may have, as these are critical factors for successful implementation,” said van den Berg. Her group is currently studying the most effective and cost-effective risk-based strategy for CRC screening based on f-Hb levels.

The authors cautioned that since individuals with undetectable f-Hb levels make up the majority of those with negative FIT results, care must be taken that reducing screening frequency for this low-risk group does not lead to unfavorable outcomes at the population level.

This study was funded by the Dutch Organization for Scientific Research, which had no role in study design, data collection, analysis, interpretation, or writing. 

The authors declared no competing interests. Levin disclosed no competing interests relevant to his comments.

A version of this article appeared on Medscape.com.

More than one in five of new gastrointestinal (GI) cancer cases globally were attributable to suboptimal dietary intake, according to a recent study.

Writing in Gastroenterology, researchers led by Li Liu, PhD, of the department of epidemiology and biostatistics, Ministry of Education Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology in Wuhan, China, reported that excessive consumption of processed meats (the biggest culprit), insufficient fruit intake, and insufficient whole grain intake were the leading dietary risk factors. In addition, the number of diet-related cases doubled from 1990 to 2018.

 

“In regions with limited access to healthy foods, policy interventions like taxing unhealthy foods and subsidizing nutritious options may help shift dietary patterns and reduce cancer risk,” Liu said in an interview.

The study examined meta-analyses from 184 countries in seven regions for the period 1990-2018 looking at rates of six major GI cancers: colorectal, liver, esophageal, pancreatic, and gallbladder/biliary tract. Among these, the age-standardized incidence of liver, pancreatic, and colorectal increased significantly over the past 3 decades.

The research team used a comparative risk assessment model to estimate the impact of diet on GI cancer independent of energy intake and adiposity. Although the principal dietary risk factors varied across individual cancers, suboptimal intake of the three aforementioned components was responsible for 66.51% of all diet-attributable GI cancers in 2018. The global mean processed meat consumption was 17 g/d in 2018, falling to a low in South Asia of 3 g/d.

The investigators also found diet-linked cancer incidence positively correlated with the Sociodemographic Index (SDI), an integrated measure of national development, income, and fertility. Incidence varied across world regions, with the highest proportion of cases in Central and Eastern Europe, Central Asia, Latin America, the Caribbean, and in high-income countries. The findings support the development of targeted diet-related public health interventions in various regions and nations to reduce GI cancer incidence, the authors wrote.

Among the study’s specific findings:

• In 2018, 21.5% (95% uncertainty interval [UI], 19.1-24.5) of incident GI cancer cases globally were attributable to suboptimal diets, a relatively stable proportion since 1990 (22.4%; 95% UI, 19.7-25.6).
• Absolute diet-attributable cases doubled from 580,862 (95% UI, 510,658-664,076) in 1990 to 1,039,877 (95% UI, 923,482-1,187,244) in 2018.
• Excessive processed meat consumption (5.9%; 95% UI, 4.2%-7.9%), insufficient fruit intake (4.8%; 95% UI, 3.8%-5.9%), and insufficient whole grain intake (3.6%; 95% UI, 2.8%-5.1%) were the most significant dietary risk factors in 2018 — a shift from 1990 when the third major concern was insufficient non-starchy vegetable intake.

Given the well-established link between diet and GI cancers, the incidence findings came as no surprise. “However, the dramatic doubling of diet-attributable cases over the past few decades was truly unexpected,” Liu said. “This increase can likely be attributed to global population growth and aging. While aging is an irreversible process, we can still reduce the growing burden of diet-related GI cancers by focusing on modifiable behaviors, particularly through targeted dietary interventions.”

 

A Modifiable Risk Factor

Commenting on the analysis but not involved in it, Andrew T. Chan, MD, MPH, a professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, both in Boston, noted that his own group’s studies also support the association of diet with an increased risk for GI cancers, particularly colorectal cancers.

“Although much work needs to be done to clarify the precise mechanisms underlying this association, there are substantial data that diet may cause changes in the gut microbiome, which in turn promotes cancer,” Chan said in an interview. “Going forward, we are working to develop strategies in which diet is modified to mitigate the risk of cancer associated with suboptimal diets.”

In other study findings, Liu’s group observed that two regional groups, Central and Eastern Europe, Central Asia, Latin America, and the Caribbean, as well as high-income countries, bore the top three diet-attributable burdens worldwide in 2018, all driven mostly by an upward-trending excess of processed meat.

By regions, Central and Eastern Europe and Central Asia experienced the highest attributable burden across regions in 1990 (31.6%; UI, 27.0%-37.4%) and 2018 (31.6%; UI, 27.3%-36.5%).

As for the impact of the SDI, the authors explained that diet-attributable GI cancer burden was higher among adults with higher education and living in urban areas than among those with lower education and rural residency. “Some dietary habits tended to be worse in higher-SDI countries, specifically, higher consumption of processed meats,” they wrote.

Although the proportional attributable GI incidence remains relatively stable, they added, the doubling of absolute cases from 1990 to 2018, along with the discrepancies between urbanicity and countries/regions, supports more targeted preventive measures.

And while the diet-GI cancer connection is clear, they agreed with Chan in that “the precise pathogenesis from suboptimal diets to these cancers remains unclear and requires further basic studies to clarify the mechanism.”

In the meantime, the findings “underscore the urgent need for proactive public health interventions. Diet, as a modifiable risk factor, still offers substantial potential for improvement,” Liu said.

This study was funded by the National Natural Science Foundation of China and the American Cancer Society. The authors and Chan disclosed no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

More than one in five of new gastrointestinal (GI) cancer cases globally were attributable to suboptimal dietary intake, according to a recent study.

Writing in Gastroenterology, researchers led by Li Liu, PhD, of the department of epidemiology and biostatistics, Ministry of Education Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology in Wuhan, China, reported that excessive consumption of processed meats (the biggest culprit), insufficient fruit intake, and insufficient whole grain intake were the leading dietary risk factors. In addition, the number of diet-related cases doubled from 1990 to 2018.

 

“In regions with limited access to healthy foods, policy interventions like taxing unhealthy foods and subsidizing nutritious options may help shift dietary patterns and reduce cancer risk,” Liu said in an interview.

The study examined meta-analyses from 184 countries in seven regions for the period 1990-2018 looking at rates of six major GI cancers: colorectal, liver, esophageal, pancreatic, and gallbladder/biliary tract. Among these, the age-standardized incidence of liver, pancreatic, and colorectal increased significantly over the past 3 decades.

The research team used a comparative risk assessment model to estimate the impact of diet on GI cancer independent of energy intake and adiposity. Although the principal dietary risk factors varied across individual cancers, suboptimal intake of the three aforementioned components was responsible for 66.51% of all diet-attributable GI cancers in 2018. The global mean processed meat consumption was 17 g/d in 2018, falling to a low in South Asia of 3 g/d.

The investigators also found diet-linked cancer incidence positively correlated with the Sociodemographic Index (SDI), an integrated measure of national development, income, and fertility. Incidence varied across world regions, with the highest proportion of cases in Central and Eastern Europe, Central Asia, Latin America, the Caribbean, and in high-income countries. The findings support the development of targeted diet-related public health interventions in various regions and nations to reduce GI cancer incidence, the authors wrote.

Among the study’s specific findings:

• In 2018, 21.5% (95% uncertainty interval [UI], 19.1-24.5) of incident GI cancer cases globally were attributable to suboptimal diets, a relatively stable proportion since 1990 (22.4%; 95% UI, 19.7-25.6).
• Absolute diet-attributable cases doubled from 580,862 (95% UI, 510,658-664,076) in 1990 to 1,039,877 (95% UI, 923,482-1,187,244) in 2018.
• Excessive processed meat consumption (5.9%; 95% UI, 4.2%-7.9%), insufficient fruit intake (4.8%; 95% UI, 3.8%-5.9%), and insufficient whole grain intake (3.6%; 95% UI, 2.8%-5.1%) were the most significant dietary risk factors in 2018 — a shift from 1990 when the third major concern was insufficient non-starchy vegetable intake.

Given the well-established link between diet and GI cancers, the incidence findings came as no surprise. “However, the dramatic doubling of diet-attributable cases over the past few decades was truly unexpected,” Liu said. “This increase can likely be attributed to global population growth and aging. While aging is an irreversible process, we can still reduce the growing burden of diet-related GI cancers by focusing on modifiable behaviors, particularly through targeted dietary interventions.”

 

A Modifiable Risk Factor

Commenting on the analysis but not involved in it, Andrew T. Chan, MD, MPH, a professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, both in Boston, noted that his own group’s studies also support the association of diet with an increased risk for GI cancers, particularly colorectal cancers.

“Although much work needs to be done to clarify the precise mechanisms underlying this association, there are substantial data that diet may cause changes in the gut microbiome, which in turn promotes cancer,” Chan said in an interview. “Going forward, we are working to develop strategies in which diet is modified to mitigate the risk of cancer associated with suboptimal diets.”

In other study findings, Liu’s group observed that two regional groups, Central and Eastern Europe, Central Asia, Latin America, and the Caribbean, as well as high-income countries, bore the top three diet-attributable burdens worldwide in 2018, all driven mostly by an upward-trending excess of processed meat.

By regions, Central and Eastern Europe and Central Asia experienced the highest attributable burden across regions in 1990 (31.6%; UI, 27.0%-37.4%) and 2018 (31.6%; UI, 27.3%-36.5%).

As for the impact of the SDI, the authors explained that diet-attributable GI cancer burden was higher among adults with higher education and living in urban areas than among those with lower education and rural residency. “Some dietary habits tended to be worse in higher-SDI countries, specifically, higher consumption of processed meats,” they wrote.

Although the proportional attributable GI incidence remains relatively stable, they added, the doubling of absolute cases from 1990 to 2018, along with the discrepancies between urbanicity and countries/regions, supports more targeted preventive measures.

And while the diet-GI cancer connection is clear, they agreed with Chan in that “the precise pathogenesis from suboptimal diets to these cancers remains unclear and requires further basic studies to clarify the mechanism.”

In the meantime, the findings “underscore the urgent need for proactive public health interventions. Diet, as a modifiable risk factor, still offers substantial potential for improvement,” Liu said.

This study was funded by the National Natural Science Foundation of China and the American Cancer Society. The authors and Chan disclosed no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

More than one in five of new gastrointestinal (GI) cancer cases globally were attributable to suboptimal dietary intake, according to a recent study.

Writing in Gastroenterology, researchers led by Li Liu, PhD, of the department of epidemiology and biostatistics, Ministry of Education Key Lab of Environment and Health, School of Public Health, Tongji Medical College, Huazhong University of Science and Technology in Wuhan, China, reported that excessive consumption of processed meats (the biggest culprit), insufficient fruit intake, and insufficient whole grain intake were the leading dietary risk factors. In addition, the number of diet-related cases doubled from 1990 to 2018.

 

“In regions with limited access to healthy foods, policy interventions like taxing unhealthy foods and subsidizing nutritious options may help shift dietary patterns and reduce cancer risk,” Liu said in an interview.

The study examined meta-analyses from 184 countries in seven regions for the period 1990-2018 looking at rates of six major GI cancers: colorectal, liver, esophageal, pancreatic, and gallbladder/biliary tract. Among these, the age-standardized incidence of liver, pancreatic, and colorectal increased significantly over the past 3 decades.

The research team used a comparative risk assessment model to estimate the impact of diet on GI cancer independent of energy intake and adiposity. Although the principal dietary risk factors varied across individual cancers, suboptimal intake of the three aforementioned components was responsible for 66.51% of all diet-attributable GI cancers in 2018. The global mean processed meat consumption was 17 g/d in 2018, falling to a low in South Asia of 3 g/d.

The investigators also found diet-linked cancer incidence positively correlated with the Sociodemographic Index (SDI), an integrated measure of national development, income, and fertility. Incidence varied across world regions, with the highest proportion of cases in Central and Eastern Europe, Central Asia, Latin America, the Caribbean, and in high-income countries. The findings support the development of targeted diet-related public health interventions in various regions and nations to reduce GI cancer incidence, the authors wrote.

Among the study’s specific findings:

• In 2018, 21.5% (95% uncertainty interval [UI], 19.1-24.5) of incident GI cancer cases globally were attributable to suboptimal diets, a relatively stable proportion since 1990 (22.4%; 95% UI, 19.7-25.6).
• Absolute diet-attributable cases doubled from 580,862 (95% UI, 510,658-664,076) in 1990 to 1,039,877 (95% UI, 923,482-1,187,244) in 2018.
• Excessive processed meat consumption (5.9%; 95% UI, 4.2%-7.9%), insufficient fruit intake (4.8%; 95% UI, 3.8%-5.9%), and insufficient whole grain intake (3.6%; 95% UI, 2.8%-5.1%) were the most significant dietary risk factors in 2018 — a shift from 1990 when the third major concern was insufficient non-starchy vegetable intake.

Given the well-established link between diet and GI cancers, the incidence findings came as no surprise. “However, the dramatic doubling of diet-attributable cases over the past few decades was truly unexpected,” Liu said. “This increase can likely be attributed to global population growth and aging. While aging is an irreversible process, we can still reduce the growing burden of diet-related GI cancers by focusing on modifiable behaviors, particularly through targeted dietary interventions.”

 

A Modifiable Risk Factor

Commenting on the analysis but not involved in it, Andrew T. Chan, MD, MPH, a professor of medicine at Harvard Medical School and a gastroenterologist at Massachusetts General Hospital, both in Boston, noted that his own group’s studies also support the association of diet with an increased risk for GI cancers, particularly colorectal cancers.

“Although much work needs to be done to clarify the precise mechanisms underlying this association, there are substantial data that diet may cause changes in the gut microbiome, which in turn promotes cancer,” Chan said in an interview. “Going forward, we are working to develop strategies in which diet is modified to mitigate the risk of cancer associated with suboptimal diets.”

In other study findings, Liu’s group observed that two regional groups, Central and Eastern Europe, Central Asia, Latin America, and the Caribbean, as well as high-income countries, bore the top three diet-attributable burdens worldwide in 2018, all driven mostly by an upward-trending excess of processed meat.

By regions, Central and Eastern Europe and Central Asia experienced the highest attributable burden across regions in 1990 (31.6%; UI, 27.0%-37.4%) and 2018 (31.6%; UI, 27.3%-36.5%).

As for the impact of the SDI, the authors explained that diet-attributable GI cancer burden was higher among adults with higher education and living in urban areas than among those with lower education and rural residency. “Some dietary habits tended to be worse in higher-SDI countries, specifically, higher consumption of processed meats,” they wrote.

Although the proportional attributable GI incidence remains relatively stable, they added, the doubling of absolute cases from 1990 to 2018, along with the discrepancies between urbanicity and countries/regions, supports more targeted preventive measures.

And while the diet-GI cancer connection is clear, they agreed with Chan in that “the precise pathogenesis from suboptimal diets to these cancers remains unclear and requires further basic studies to clarify the mechanism.”

In the meantime, the findings “underscore the urgent need for proactive public health interventions. Diet, as a modifiable risk factor, still offers substantial potential for improvement,” Liu said.

This study was funded by the National Natural Science Foundation of China and the American Cancer Society. The authors and Chan disclosed no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

A recent study found that despite their growing presence in inflammatory bowel disease (IBD) research, women investigators were inequitably represented at scientific presentations sponsored by the pharmaceutical industry. The study was published in Gastroenterology  and also appeared concurrently in Clinical Gastroenterology and Hepatology .

Indeed, among gastrointestinal (GI) subspecialties, IBD was selected by 26.5% of all women GI physicians, compared with 18.9% of all their male counterparts, according to a 2021 study.

Thus, conference organizers and pharmaceutical companies should promote speaker diversity by seeking out women presenters, according to a group led by Maria A. Quintero, MD, of the Division of Gastroenterology at the Leonard Miller School of Medicine at the University of Miami, Florida.

“Seeing more women IBD leaders at the podium will inspire other women to engage in IBD clinical research,” Quintero and associates wrote.

In addition, women investigators should be included at every stage of the study process in industry-sponsored research, both as principal investigators and members of steering committees involved in study design, the authors said. Training more women clinical trial investigators in the IBD setting is another way forward.

In another recommendation, pharmaceutical companies need to be more transparent about the way first and senior authors on IBD studies are chosen because in the past the principal investigator who enrolled the most patients became the first author of the study. “That is no longer the case. However, it remains unclear whether all investigators have an equal opportunity to be the first or senior author,” Quintero and associates wrote.

The Study

The investigators analyzed IBD abstracts of presentations at five conferences for two large GI meetings, Digestive Disease Week (DDW) and United European Gastroenterology (UEG) in the period 2021-2023.

They asked whether women investigators were as likely as their male counterparts to present abstracts based on results from industry-supported clinical trials. As a point of comparison, they also looked for possible gender differences in invited-speaker vs investigator-initiated IBD sessions. To do this, they examined all IBD-related abstracts from the two meetings, identified the lead author of each oral presentation, and divided them into women or men. They also assessed whether the presentation was pharma-sponsored, investigator-initiated, or presented by an invited speaker.

Among the study findings: 

• Across categories there were 178 invited lectures, 336 investigator-submitted presentations, and 150 industry-supported presentations for UEG (2021, 2022, and 2023) and DDW (2022 and 2023).
• The gender gap for men vs women was significant for industry-supported oral presentations (78.7% vs 21.3%; P < .0001) and for invited lectures (67.4% vs 32.6%; P < .0001) — but not for investigator-submitted abstracts (49.7% vs 50.3%; P = .91).
• The gender gap for industry-supported abstracts, however, was significantly larger than for investigator-submitted abstracts (57.3% vs 0.6%; P < .0001) and larger than for invited lectures (57.3% vs 34.9%; P = .09).
• The gender gap for invited lectures was significantly larger than for investigator-submitted oral presentations (34.9% vs 0.6%; P = .0009).

Why the Discordance?

This disparity may be due to the paucity of women investigators on steering committees for clinical trials. “Although the number of women doing IBD research continues to increase, then number of women senior investigators is still smaller than the number of men senior investigators,” the researchers wrote. “Ideally, there would be transparency in terms of the metrics used by pharma to choose who will be a presenting author and more intentional recruitment of women investigators to steering committees.”

Commenting on the study but not involved in it, internist Shannon M. Ruzycki, MD, MPH, an assistant professor in the Cumming School of Medicine at the University of Calgary Medical Centre in Alberta, Canada, said the findings are not surprising. “In nearly every setting where gender differences are studied in academic medicine, women are found to be disadvantaged compared to men. These differences are not attributable to skill, merit, or career attainment, but rather appear to be arbitrary and due to biases. They add up across time and likely contribute to the larger differences we see between men and women in promotion, compensation, and awards.”

Ruzycki, lead author of a study of women presenters at medical conferences, noted that differences in gender representation in academia, academic medicine, and clinical trials are similar “because the underlying causes are similar.” On the positive side, she added, conference planning committees are using strategies to reduce bias in how presenters are selected by masking the names and/or institutions of those are submitting abstracts and are being more intentional in inviting a diverse panel of qualified speakers.

“However, one strategy alone is unlikely to address such an insidious problem that affects all parts of selection,” she said. “For example, if pharmaceutical companies believe that men presenters are seen as more authoritative or knowledgeable than women presenters, they will select men to be the first author on submitted abstracts which could deprive these opportunities for deserving women candidates.”

Ruzycki attributed the imbalance to systems (academia, medicine, science) designed by men who lack empathy for the experiences of women. “In the same way you can never really understand how exhausting it is to be a parent until you become a parent or how challenging it can be to have a physical disability until you break a leg and have to navigate the world on crutches, it is really challenging for men to understand how cold and hostile these settings can be for women.”

Many of the things that make conferences, academia, and medicine so challenging for women have straightforward solutions, however, Ruzycki added. Onsite childcare, scrubs that fit women, operating room equipment that is ergonomic for women surgeons — even more washroom stalls would help. “If only we listened and cared about things that didn’t directly impact us.”

This study was supported by the 2023 Travel Grant from the International Organization for the Study of Inflammatory Bowel Diseases. One coauthor serves as a consultant or on advisory boards for AbbVie, Amgen, Bristol Myers Squibb, Celsius Therapeutics, Eli Lilly, Gilead Sciences, Janssen Pharmaceuticals, and Pfizer Pharmaceutical. She is a teacher, lecturer, and speaker for Janssen and Takeda Pharmaceuticals. The remaining authors disclosed no conflicts. Ruzycki had no relevant conflicts of interest to declare. 

A version of this article appeared on Medscape.com.

A recent study found that despite their growing presence in inflammatory bowel disease (IBD) research, women investigators were inequitably represented at scientific presentations sponsored by the pharmaceutical industry. The study was published in Gastroenterology  and also appeared concurrently in Clinical Gastroenterology and Hepatology .

Indeed, among gastrointestinal (GI) subspecialties, IBD was selected by 26.5% of all women GI physicians, compared with 18.9% of all their male counterparts, according to a 2021 study.

Thus, conference organizers and pharmaceutical companies should promote speaker diversity by seeking out women presenters, according to a group led by Maria A. Quintero, MD, of the Division of Gastroenterology at the Leonard Miller School of Medicine at the University of Miami, Florida.

“Seeing more women IBD leaders at the podium will inspire other women to engage in IBD clinical research,” Quintero and associates wrote.

In addition, women investigators should be included at every stage of the study process in industry-sponsored research, both as principal investigators and members of steering committees involved in study design, the authors said. Training more women clinical trial investigators in the IBD setting is another way forward.

In another recommendation, pharmaceutical companies need to be more transparent about the way first and senior authors on IBD studies are chosen because in the past the principal investigator who enrolled the most patients became the first author of the study. “That is no longer the case. However, it remains unclear whether all investigators have an equal opportunity to be the first or senior author,” Quintero and associates wrote.

The Study

The investigators analyzed IBD abstracts of presentations at five conferences for two large GI meetings, Digestive Disease Week (DDW) and United European Gastroenterology (UEG) in the period 2021-2023.

They asked whether women investigators were as likely as their male counterparts to present abstracts based on results from industry-supported clinical trials. As a point of comparison, they also looked for possible gender differences in invited-speaker vs investigator-initiated IBD sessions. To do this, they examined all IBD-related abstracts from the two meetings, identified the lead author of each oral presentation, and divided them into women or men. They also assessed whether the presentation was pharma-sponsored, investigator-initiated, or presented by an invited speaker.

Among the study findings: 

• Across categories there were 178 invited lectures, 336 investigator-submitted presentations, and 150 industry-supported presentations for UEG (2021, 2022, and 2023) and DDW (2022 and 2023).
• The gender gap for men vs women was significant for industry-supported oral presentations (78.7% vs 21.3%; P < .0001) and for invited lectures (67.4% vs 32.6%; P < .0001) — but not for investigator-submitted abstracts (49.7% vs 50.3%; P = .91).
• The gender gap for industry-supported abstracts, however, was significantly larger than for investigator-submitted abstracts (57.3% vs 0.6%; P < .0001) and larger than for invited lectures (57.3% vs 34.9%; P = .09).
• The gender gap for invited lectures was significantly larger than for investigator-submitted oral presentations (34.9% vs 0.6%; P = .0009).

Why the Discordance?

This disparity may be due to the paucity of women investigators on steering committees for clinical trials. “Although the number of women doing IBD research continues to increase, then number of women senior investigators is still smaller than the number of men senior investigators,” the researchers wrote. “Ideally, there would be transparency in terms of the metrics used by pharma to choose who will be a presenting author and more intentional recruitment of women investigators to steering committees.”

Commenting on the study but not involved in it, internist Shannon M. Ruzycki, MD, MPH, an assistant professor in the Cumming School of Medicine at the University of Calgary Medical Centre in Alberta, Canada, said the findings are not surprising. “In nearly every setting where gender differences are studied in academic medicine, women are found to be disadvantaged compared to men. These differences are not attributable to skill, merit, or career attainment, but rather appear to be arbitrary and due to biases. They add up across time and likely contribute to the larger differences we see between men and women in promotion, compensation, and awards.”

Ruzycki, lead author of a study of women presenters at medical conferences, noted that differences in gender representation in academia, academic medicine, and clinical trials are similar “because the underlying causes are similar.” On the positive side, she added, conference planning committees are using strategies to reduce bias in how presenters are selected by masking the names and/or institutions of those are submitting abstracts and are being more intentional in inviting a diverse panel of qualified speakers.

“However, one strategy alone is unlikely to address such an insidious problem that affects all parts of selection,” she said. “For example, if pharmaceutical companies believe that men presenters are seen as more authoritative or knowledgeable than women presenters, they will select men to be the first author on submitted abstracts which could deprive these opportunities for deserving women candidates.”

Ruzycki attributed the imbalance to systems (academia, medicine, science) designed by men who lack empathy for the experiences of women. “In the same way you can never really understand how exhausting it is to be a parent until you become a parent or how challenging it can be to have a physical disability until you break a leg and have to navigate the world on crutches, it is really challenging for men to understand how cold and hostile these settings can be for women.”

Many of the things that make conferences, academia, and medicine so challenging for women have straightforward solutions, however, Ruzycki added. Onsite childcare, scrubs that fit women, operating room equipment that is ergonomic for women surgeons — even more washroom stalls would help. “If only we listened and cared about things that didn’t directly impact us.”

This study was supported by the 2023 Travel Grant from the International Organization for the Study of Inflammatory Bowel Diseases. One coauthor serves as a consultant or on advisory boards for AbbVie, Amgen, Bristol Myers Squibb, Celsius Therapeutics, Eli Lilly, Gilead Sciences, Janssen Pharmaceuticals, and Pfizer Pharmaceutical. She is a teacher, lecturer, and speaker for Janssen and Takeda Pharmaceuticals. The remaining authors disclosed no conflicts. Ruzycki had no relevant conflicts of interest to declare. 

A version of this article appeared on Medscape.com.

A recent study found that despite their growing presence in inflammatory bowel disease (IBD) research, women investigators were inequitably represented at scientific presentations sponsored by the pharmaceutical industry. The study was published in Gastroenterology  and also appeared concurrently in Clinical Gastroenterology and Hepatology .

Indeed, among gastrointestinal (GI) subspecialties, IBD was selected by 26.5% of all women GI physicians, compared with 18.9% of all their male counterparts, according to a 2021 study.

Thus, conference organizers and pharmaceutical companies should promote speaker diversity by seeking out women presenters, according to a group led by Maria A. Quintero, MD, of the Division of Gastroenterology at the Leonard Miller School of Medicine at the University of Miami, Florida.

“Seeing more women IBD leaders at the podium will inspire other women to engage in IBD clinical research,” Quintero and associates wrote.

In addition, women investigators should be included at every stage of the study process in industry-sponsored research, both as principal investigators and members of steering committees involved in study design, the authors said. Training more women clinical trial investigators in the IBD setting is another way forward.

In another recommendation, pharmaceutical companies need to be more transparent about the way first and senior authors on IBD studies are chosen because in the past the principal investigator who enrolled the most patients became the first author of the study. “That is no longer the case. However, it remains unclear whether all investigators have an equal opportunity to be the first or senior author,” Quintero and associates wrote.

The Study

The investigators analyzed IBD abstracts of presentations at five conferences for two large GI meetings, Digestive Disease Week (DDW) and United European Gastroenterology (UEG) in the period 2021-2023.

They asked whether women investigators were as likely as their male counterparts to present abstracts based on results from industry-supported clinical trials. As a point of comparison, they also looked for possible gender differences in invited-speaker vs investigator-initiated IBD sessions. To do this, they examined all IBD-related abstracts from the two meetings, identified the lead author of each oral presentation, and divided them into women or men. They also assessed whether the presentation was pharma-sponsored, investigator-initiated, or presented by an invited speaker.

Among the study findings: 

• Across categories there were 178 invited lectures, 336 investigator-submitted presentations, and 150 industry-supported presentations for UEG (2021, 2022, and 2023) and DDW (2022 and 2023).
• The gender gap for men vs women was significant for industry-supported oral presentations (78.7% vs 21.3%; P < .0001) and for invited lectures (67.4% vs 32.6%; P < .0001) — but not for investigator-submitted abstracts (49.7% vs 50.3%; P = .91).
• The gender gap for industry-supported abstracts, however, was significantly larger than for investigator-submitted abstracts (57.3% vs 0.6%; P < .0001) and larger than for invited lectures (57.3% vs 34.9%; P = .09).
• The gender gap for invited lectures was significantly larger than for investigator-submitted oral presentations (34.9% vs 0.6%; P = .0009).

Why the Discordance?

This disparity may be due to the paucity of women investigators on steering committees for clinical trials. “Although the number of women doing IBD research continues to increase, then number of women senior investigators is still smaller than the number of men senior investigators,” the researchers wrote. “Ideally, there would be transparency in terms of the metrics used by pharma to choose who will be a presenting author and more intentional recruitment of women investigators to steering committees.”

Commenting on the study but not involved in it, internist Shannon M. Ruzycki, MD, MPH, an assistant professor in the Cumming School of Medicine at the University of Calgary Medical Centre in Alberta, Canada, said the findings are not surprising. “In nearly every setting where gender differences are studied in academic medicine, women are found to be disadvantaged compared to men. These differences are not attributable to skill, merit, or career attainment, but rather appear to be arbitrary and due to biases. They add up across time and likely contribute to the larger differences we see between men and women in promotion, compensation, and awards.”

Ruzycki, lead author of a study of women presenters at medical conferences, noted that differences in gender representation in academia, academic medicine, and clinical trials are similar “because the underlying causes are similar.” On the positive side, she added, conference planning committees are using strategies to reduce bias in how presenters are selected by masking the names and/or institutions of those are submitting abstracts and are being more intentional in inviting a diverse panel of qualified speakers.

“However, one strategy alone is unlikely to address such an insidious problem that affects all parts of selection,” she said. “For example, if pharmaceutical companies believe that men presenters are seen as more authoritative or knowledgeable than women presenters, they will select men to be the first author on submitted abstracts which could deprive these opportunities for deserving women candidates.”

Ruzycki attributed the imbalance to systems (academia, medicine, science) designed by men who lack empathy for the experiences of women. “In the same way you can never really understand how exhausting it is to be a parent until you become a parent or how challenging it can be to have a physical disability until you break a leg and have to navigate the world on crutches, it is really challenging for men to understand how cold and hostile these settings can be for women.”

Many of the things that make conferences, academia, and medicine so challenging for women have straightforward solutions, however, Ruzycki added. Onsite childcare, scrubs that fit women, operating room equipment that is ergonomic for women surgeons — even more washroom stalls would help. “If only we listened and cared about things that didn’t directly impact us.”

This study was supported by the 2023 Travel Grant from the International Organization for the Study of Inflammatory Bowel Diseases. One coauthor serves as a consultant or on advisory boards for AbbVie, Amgen, Bristol Myers Squibb, Celsius Therapeutics, Eli Lilly, Gilead Sciences, Janssen Pharmaceuticals, and Pfizer Pharmaceutical. She is a teacher, lecturer, and speaker for Janssen and Takeda Pharmaceuticals. The remaining authors disclosed no conflicts. Ruzycki had no relevant conflicts of interest to declare. 

A version of this article appeared on Medscape.com.