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Diet Rich in Ultraprocessed Grains Increases Risk for IBD
, a large study has found.
The sweeping analysis of 124,590 adults from 21 countries found that those eating at least 19 g of ultraprocessed grains a day were about twice as likely to be diagnosed with IBD as peers eating less than 9 g daily.
“Our study adds robust evidence from a large, diverse global cohort that frequent consumption of ultraprocessed grains is associated with an increased risk of developing inflammatory bowel disease,” Neeraj Narula, MD, MPH, gastroenterologist and associate professor of medicine, McMaster University, Hamilton, Ontario, Canada, told GI & Hepatology News.
The study also “further clarifies that not all grains carry risk — minimally processed grains like fresh bread and rice were associated with lower risk even. These results build on and specify previous findings linking ultraprocessed foods more broadly to IBD,” Narula said.
The study was published in The American Journal of Gastroenterology.
Diet Matters to IBD Risk
According to the latest US data (2021-2023), ultraprocessed foods made up 62% of daily calories for young people and 53% for adults in 2021-2023.
The Prospective Urban Rural Epidemiology (PURE) study has followed participants aged 35-70 years for a median of nearly 13 years. At enrollment, volunteers completed country-specific food-frequency questionnaires, enabling researchers to quantify usual intake of more than 130 food items and track new cases of IBD reported at biennial follow-ups.
The researchers classified packaged breads, sweet breakfast cereals, crackers, pastries and ready-to-heat pizza or pasta as ultraprocessed grains because they are refined and typically contain additives such as emulsifiers and preservatives. Fresh bakery bread and plain rice were analyzed separately as minimally processed grain references.
During a median of 12.9 years, 605 participants developed IBD; 497 developed ulcerative colitis (UC) and 108 developed Crohn’s disease.
Increased intake of ultraprocessed grains was associated with a higher risk for IBD, with hazard ratios (HR) of 2.08 for intake of ≥ 50 g/d and 1.37 for 19-50 g/d compared to intake of < 19 g/d. The increased risk was largely driven by a significantly increased risk for UC (HR, 2.46) and not Crohn’s disease (HR, 0.98).
Among the different ultraprocessed grain products, packaged bread stood out: Consuming ≥ 30 g/d of packaged bread (a little more than one slice) was associated with a greater than twofold increased risk for IBD (HR, 2.11) compared to no intake of packaged bread.
In contrast, greater consumption of fresh bread was associated with a reduced risk of developing IBD (HR, 0.61 for ≥ 65 g/d and 0.45 for 16-65 g/d compared to < 16 g/d).
Increased intake of rice was also associated with a lower risk of developing IBD (HR, 0.63 for ≥ 1 serving/d and 0.99 for < 1 serving/d).
When the researchers widened the lens to all ultraprocessed foods — from sodas to salty snacks — the risk for IBD climbed further.
Participants eating at least five servings a day had nearly a fourfold greater odds of IBD than those eating fewer than one serving (HR, 3.95) — a finding consistent with other data from the PURE study cohort.
What to Tell Patients?
The authors acknowledged in their paper that it’s difficult — if not impossible — to completely avoid ultraprocessed food in the Western diet.
They said their findings support “public health strategies to promote consumption of whole and minimally processed foods while reducing the consumption of highly processed alternatives.”
“I tell my patients that emerging literature shows an association between ultraprocessed food intake and IBD risk, but it’s not yet clear whether simply cutting out those foods will improve disease activity once IBD is established,” Narula told GI & Hepatology News.
“However, I still encourage patients to reduce ultraprocessed foods and to follow a Mediterranean-style diet — focusing on minimally processed grains, fruits, vegetables, healthy fats, and lean proteins — to support overall gut and general health,” Narula said.
Reached for comment, Ashwin Ananthakrishnan, MD, MPH, AGAF, associate professor of medicine, Massachusetts General Hospital, Boston, who wasn’t part of the study, said it “adds incrementally to the growing data on how ultraprocessed foods may affect the risk of IBD.”
“They (and others) have previously shown a link between general ultraprocessed food consumption and risk of IBD. Others have shown that some of this is mediated through refined grains. This study more specifically studies that question and demonstrates an association,” said Ananthkrishnan.
“This should not be used, however, to counsel patients. It does not study the impact of grain intake on patients with IBD. It may help inform population level preventive strategies (or in high-risk individuals) but requires more confirmation since there is significant heterogeneity between the various countries in this cohort. Countries that have high refined grain intake are also enriched in several other IBD risk factors (including genetics),” Ananthkrishnan told GI & Hepatology News.
The PURE study is an investigator-initiated study funded by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, and Heart and Stroke Foundation of Ontario. It received support from Canadian Institutes of Health Research’s Strategy for Patient Oriented Research, Ontario SPOR Support Unit, and Ontario Ministry of Health and Long-Term Care and unrestricted grants from several pharmaceutical companies. Narula declared receiving honoraria from Janssen, Abbvie, Takeda, Pfizer, Sandoz, Novartis, Iterative Health, Innomar Strategies, Fresinius Kabi, Amgen, Organon, Eli Lilly, and Ferring. Ananthkrishnan declared having no relevant disclosures.
A version of this article appeared on Medscape.com.
, a large study has found.
The sweeping analysis of 124,590 adults from 21 countries found that those eating at least 19 g of ultraprocessed grains a day were about twice as likely to be diagnosed with IBD as peers eating less than 9 g daily.
“Our study adds robust evidence from a large, diverse global cohort that frequent consumption of ultraprocessed grains is associated with an increased risk of developing inflammatory bowel disease,” Neeraj Narula, MD, MPH, gastroenterologist and associate professor of medicine, McMaster University, Hamilton, Ontario, Canada, told GI & Hepatology News.
The study also “further clarifies that not all grains carry risk — minimally processed grains like fresh bread and rice were associated with lower risk even. These results build on and specify previous findings linking ultraprocessed foods more broadly to IBD,” Narula said.
The study was published in The American Journal of Gastroenterology.
Diet Matters to IBD Risk
According to the latest US data (2021-2023), ultraprocessed foods made up 62% of daily calories for young people and 53% for adults in 2021-2023.
The Prospective Urban Rural Epidemiology (PURE) study has followed participants aged 35-70 years for a median of nearly 13 years. At enrollment, volunteers completed country-specific food-frequency questionnaires, enabling researchers to quantify usual intake of more than 130 food items and track new cases of IBD reported at biennial follow-ups.
The researchers classified packaged breads, sweet breakfast cereals, crackers, pastries and ready-to-heat pizza or pasta as ultraprocessed grains because they are refined and typically contain additives such as emulsifiers and preservatives. Fresh bakery bread and plain rice were analyzed separately as minimally processed grain references.
During a median of 12.9 years, 605 participants developed IBD; 497 developed ulcerative colitis (UC) and 108 developed Crohn’s disease.
Increased intake of ultraprocessed grains was associated with a higher risk for IBD, with hazard ratios (HR) of 2.08 for intake of ≥ 50 g/d and 1.37 for 19-50 g/d compared to intake of < 19 g/d. The increased risk was largely driven by a significantly increased risk for UC (HR, 2.46) and not Crohn’s disease (HR, 0.98).
Among the different ultraprocessed grain products, packaged bread stood out: Consuming ≥ 30 g/d of packaged bread (a little more than one slice) was associated with a greater than twofold increased risk for IBD (HR, 2.11) compared to no intake of packaged bread.
In contrast, greater consumption of fresh bread was associated with a reduced risk of developing IBD (HR, 0.61 for ≥ 65 g/d and 0.45 for 16-65 g/d compared to < 16 g/d).
Increased intake of rice was also associated with a lower risk of developing IBD (HR, 0.63 for ≥ 1 serving/d and 0.99 for < 1 serving/d).
When the researchers widened the lens to all ultraprocessed foods — from sodas to salty snacks — the risk for IBD climbed further.
Participants eating at least five servings a day had nearly a fourfold greater odds of IBD than those eating fewer than one serving (HR, 3.95) — a finding consistent with other data from the PURE study cohort.
What to Tell Patients?
The authors acknowledged in their paper that it’s difficult — if not impossible — to completely avoid ultraprocessed food in the Western diet.
They said their findings support “public health strategies to promote consumption of whole and minimally processed foods while reducing the consumption of highly processed alternatives.”
“I tell my patients that emerging literature shows an association between ultraprocessed food intake and IBD risk, but it’s not yet clear whether simply cutting out those foods will improve disease activity once IBD is established,” Narula told GI & Hepatology News.
“However, I still encourage patients to reduce ultraprocessed foods and to follow a Mediterranean-style diet — focusing on minimally processed grains, fruits, vegetables, healthy fats, and lean proteins — to support overall gut and general health,” Narula said.
Reached for comment, Ashwin Ananthakrishnan, MD, MPH, AGAF, associate professor of medicine, Massachusetts General Hospital, Boston, who wasn’t part of the study, said it “adds incrementally to the growing data on how ultraprocessed foods may affect the risk of IBD.”
“They (and others) have previously shown a link between general ultraprocessed food consumption and risk of IBD. Others have shown that some of this is mediated through refined grains. This study more specifically studies that question and demonstrates an association,” said Ananthkrishnan.
“This should not be used, however, to counsel patients. It does not study the impact of grain intake on patients with IBD. It may help inform population level preventive strategies (or in high-risk individuals) but requires more confirmation since there is significant heterogeneity between the various countries in this cohort. Countries that have high refined grain intake are also enriched in several other IBD risk factors (including genetics),” Ananthkrishnan told GI & Hepatology News.
The PURE study is an investigator-initiated study funded by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, and Heart and Stroke Foundation of Ontario. It received support from Canadian Institutes of Health Research’s Strategy for Patient Oriented Research, Ontario SPOR Support Unit, and Ontario Ministry of Health and Long-Term Care and unrestricted grants from several pharmaceutical companies. Narula declared receiving honoraria from Janssen, Abbvie, Takeda, Pfizer, Sandoz, Novartis, Iterative Health, Innomar Strategies, Fresinius Kabi, Amgen, Organon, Eli Lilly, and Ferring. Ananthkrishnan declared having no relevant disclosures.
A version of this article appeared on Medscape.com.
, a large study has found.
The sweeping analysis of 124,590 adults from 21 countries found that those eating at least 19 g of ultraprocessed grains a day were about twice as likely to be diagnosed with IBD as peers eating less than 9 g daily.
“Our study adds robust evidence from a large, diverse global cohort that frequent consumption of ultraprocessed grains is associated with an increased risk of developing inflammatory bowel disease,” Neeraj Narula, MD, MPH, gastroenterologist and associate professor of medicine, McMaster University, Hamilton, Ontario, Canada, told GI & Hepatology News.
The study also “further clarifies that not all grains carry risk — minimally processed grains like fresh bread and rice were associated with lower risk even. These results build on and specify previous findings linking ultraprocessed foods more broadly to IBD,” Narula said.
The study was published in The American Journal of Gastroenterology.
Diet Matters to IBD Risk
According to the latest US data (2021-2023), ultraprocessed foods made up 62% of daily calories for young people and 53% for adults in 2021-2023.
The Prospective Urban Rural Epidemiology (PURE) study has followed participants aged 35-70 years for a median of nearly 13 years. At enrollment, volunteers completed country-specific food-frequency questionnaires, enabling researchers to quantify usual intake of more than 130 food items and track new cases of IBD reported at biennial follow-ups.
The researchers classified packaged breads, sweet breakfast cereals, crackers, pastries and ready-to-heat pizza or pasta as ultraprocessed grains because they are refined and typically contain additives such as emulsifiers and preservatives. Fresh bakery bread and plain rice were analyzed separately as minimally processed grain references.
During a median of 12.9 years, 605 participants developed IBD; 497 developed ulcerative colitis (UC) and 108 developed Crohn’s disease.
Increased intake of ultraprocessed grains was associated with a higher risk for IBD, with hazard ratios (HR) of 2.08 for intake of ≥ 50 g/d and 1.37 for 19-50 g/d compared to intake of < 19 g/d. The increased risk was largely driven by a significantly increased risk for UC (HR, 2.46) and not Crohn’s disease (HR, 0.98).
Among the different ultraprocessed grain products, packaged bread stood out: Consuming ≥ 30 g/d of packaged bread (a little more than one slice) was associated with a greater than twofold increased risk for IBD (HR, 2.11) compared to no intake of packaged bread.
In contrast, greater consumption of fresh bread was associated with a reduced risk of developing IBD (HR, 0.61 for ≥ 65 g/d and 0.45 for 16-65 g/d compared to < 16 g/d).
Increased intake of rice was also associated with a lower risk of developing IBD (HR, 0.63 for ≥ 1 serving/d and 0.99 for < 1 serving/d).
When the researchers widened the lens to all ultraprocessed foods — from sodas to salty snacks — the risk for IBD climbed further.
Participants eating at least five servings a day had nearly a fourfold greater odds of IBD than those eating fewer than one serving (HR, 3.95) — a finding consistent with other data from the PURE study cohort.
What to Tell Patients?
The authors acknowledged in their paper that it’s difficult — if not impossible — to completely avoid ultraprocessed food in the Western diet.
They said their findings support “public health strategies to promote consumption of whole and minimally processed foods while reducing the consumption of highly processed alternatives.”
“I tell my patients that emerging literature shows an association between ultraprocessed food intake and IBD risk, but it’s not yet clear whether simply cutting out those foods will improve disease activity once IBD is established,” Narula told GI & Hepatology News.
“However, I still encourage patients to reduce ultraprocessed foods and to follow a Mediterranean-style diet — focusing on minimally processed grains, fruits, vegetables, healthy fats, and lean proteins — to support overall gut and general health,” Narula said.
Reached for comment, Ashwin Ananthakrishnan, MD, MPH, AGAF, associate professor of medicine, Massachusetts General Hospital, Boston, who wasn’t part of the study, said it “adds incrementally to the growing data on how ultraprocessed foods may affect the risk of IBD.”
“They (and others) have previously shown a link between general ultraprocessed food consumption and risk of IBD. Others have shown that some of this is mediated through refined grains. This study more specifically studies that question and demonstrates an association,” said Ananthkrishnan.
“This should not be used, however, to counsel patients. It does not study the impact of grain intake on patients with IBD. It may help inform population level preventive strategies (or in high-risk individuals) but requires more confirmation since there is significant heterogeneity between the various countries in this cohort. Countries that have high refined grain intake are also enriched in several other IBD risk factors (including genetics),” Ananthkrishnan told GI & Hepatology News.
The PURE study is an investigator-initiated study funded by the Population Health Research Institute, Hamilton Health Sciences Research Institute, Canadian Institutes of Health Research, and Heart and Stroke Foundation of Ontario. It received support from Canadian Institutes of Health Research’s Strategy for Patient Oriented Research, Ontario SPOR Support Unit, and Ontario Ministry of Health and Long-Term Care and unrestricted grants from several pharmaceutical companies. Narula declared receiving honoraria from Janssen, Abbvie, Takeda, Pfizer, Sandoz, Novartis, Iterative Health, Innomar Strategies, Fresinius Kabi, Amgen, Organon, Eli Lilly, and Ferring. Ananthkrishnan declared having no relevant disclosures.
A version of this article appeared on Medscape.com.
Follow-Up Colonoscopies Low After Blood-Based Screening
Most GI Service Chiefs Support POCUS Training, But Uptake Is Slow
, according to a national survey.
Low POCUS uptake may be explained by substantial barriers to implementation, including lack of trained instructors, necessary equipment, and support staff, lead author Keerthi Thallapureddy, MD, of the University of Texas Health San Antonio, and colleagues, reported.
“POCUS is being increasingly used by gastroenterologists due to its portability and real-time diagnostic ability,” the investigators wrote in Gastro Hep Advances, but “there is limited understanding of how gastroenterologists use POCUS.”
To learn more, the investigators conducted a nationwide survey of the VA healthcare system. Separate questionnaires were sent to chiefs of staff (n = 130) and GI service chiefs (n = 117), yielding response rates of 100% and 79%, respectively.
Respondents represented a wide distribution of geographic regions and institutional complexity levels, with 80% of GI groups based at high-complexity centers and 92% in urban locations. A minority (8%) reported the presence of a liver transplant program.
Data collection focused on the prevalence of POCUS use, types of clinical applications, institutional policies and training processes, and perceived or actual barriers to wider adoption. Barriers were sorted into three categories: training, equipment, and infrastructure.
Of the 93 GI service chiefs who participated in the survey, 44% reported that at least 1 gastroenterologist at their facility currently uses POCUS. Most common procedural uses were paracentesis (23%) and liver biopsy (13%), while ascites assessment (19%) and biliary visualization (7%) were the most common diagnostic uses.
Among the same respondents, 69% said they would support sending clinicians to a POCUS training course, and 37% said their teams had expressed an active interest in pursuing such training. Only 17% of facilities had a formal process in place to obtain POCUS training, and an equal proportion had implemented a facility-wide policy to guide its use.
Barriers to implementation were widespread and often multifactorial.
Most challenges related to training: 48% of sites reported a lack of trained providers, 28% cited insufficient funding for training, 24% noted a lack of training opportunities, and 14% reported difficulty securing travel funds.
Equipment limitations were also common, with 41% of sites lacking ultrasound machines and 27% lacking funding to purchase them.
Institutional infrastructure posed further hurdles. Nearly a quarter of GI chiefs (23%) reported lacking a clinician champion to lead implementation, while others cited a lack of support staff, simulation space, privileging criteria, image archiving capabilities, or standardized reporting forms.
“Our findings on current POCUS use, training, barriers, and infrastructure can guide expansion of POCUS use and training among GI groups,” Dr. Thallapureddy and colleagues wrote, noting that early efforts to expand access to GI-specific POCUS training are already underway.
They cited growing interest from national organizations such as the American Gastroenterological Association and the American Association for the Study of Liver Diseases, the latter of which piloted training workshops at the 2024 Liver Meeting. Similarly, the International Bowel Ultrasound Group now offers a 3-part certification program in intestinal ultrasound and is developing additional online and interactive modules to improve training accessibility.
The study was supported by the US Department of Veterans Affairs, Quality Enhancement Research Initiative Partnered Evaluation Initiative Grant, and the VA National Center for Patient Safety. The investigators reported no conflicts of interest.
, according to a national survey.
Low POCUS uptake may be explained by substantial barriers to implementation, including lack of trained instructors, necessary equipment, and support staff, lead author Keerthi Thallapureddy, MD, of the University of Texas Health San Antonio, and colleagues, reported.
“POCUS is being increasingly used by gastroenterologists due to its portability and real-time diagnostic ability,” the investigators wrote in Gastro Hep Advances, but “there is limited understanding of how gastroenterologists use POCUS.”
To learn more, the investigators conducted a nationwide survey of the VA healthcare system. Separate questionnaires were sent to chiefs of staff (n = 130) and GI service chiefs (n = 117), yielding response rates of 100% and 79%, respectively.
Respondents represented a wide distribution of geographic regions and institutional complexity levels, with 80% of GI groups based at high-complexity centers and 92% in urban locations. A minority (8%) reported the presence of a liver transplant program.
Data collection focused on the prevalence of POCUS use, types of clinical applications, institutional policies and training processes, and perceived or actual barriers to wider adoption. Barriers were sorted into three categories: training, equipment, and infrastructure.
Of the 93 GI service chiefs who participated in the survey, 44% reported that at least 1 gastroenterologist at their facility currently uses POCUS. Most common procedural uses were paracentesis (23%) and liver biopsy (13%), while ascites assessment (19%) and biliary visualization (7%) were the most common diagnostic uses.
Among the same respondents, 69% said they would support sending clinicians to a POCUS training course, and 37% said their teams had expressed an active interest in pursuing such training. Only 17% of facilities had a formal process in place to obtain POCUS training, and an equal proportion had implemented a facility-wide policy to guide its use.
Barriers to implementation were widespread and often multifactorial.
Most challenges related to training: 48% of sites reported a lack of trained providers, 28% cited insufficient funding for training, 24% noted a lack of training opportunities, and 14% reported difficulty securing travel funds.
Equipment limitations were also common, with 41% of sites lacking ultrasound machines and 27% lacking funding to purchase them.
Institutional infrastructure posed further hurdles. Nearly a quarter of GI chiefs (23%) reported lacking a clinician champion to lead implementation, while others cited a lack of support staff, simulation space, privileging criteria, image archiving capabilities, or standardized reporting forms.
“Our findings on current POCUS use, training, barriers, and infrastructure can guide expansion of POCUS use and training among GI groups,” Dr. Thallapureddy and colleagues wrote, noting that early efforts to expand access to GI-specific POCUS training are already underway.
They cited growing interest from national organizations such as the American Gastroenterological Association and the American Association for the Study of Liver Diseases, the latter of which piloted training workshops at the 2024 Liver Meeting. Similarly, the International Bowel Ultrasound Group now offers a 3-part certification program in intestinal ultrasound and is developing additional online and interactive modules to improve training accessibility.
The study was supported by the US Department of Veterans Affairs, Quality Enhancement Research Initiative Partnered Evaluation Initiative Grant, and the VA National Center for Patient Safety. The investigators reported no conflicts of interest.
, according to a national survey.
Low POCUS uptake may be explained by substantial barriers to implementation, including lack of trained instructors, necessary equipment, and support staff, lead author Keerthi Thallapureddy, MD, of the University of Texas Health San Antonio, and colleagues, reported.
“POCUS is being increasingly used by gastroenterologists due to its portability and real-time diagnostic ability,” the investigators wrote in Gastro Hep Advances, but “there is limited understanding of how gastroenterologists use POCUS.”
To learn more, the investigators conducted a nationwide survey of the VA healthcare system. Separate questionnaires were sent to chiefs of staff (n = 130) and GI service chiefs (n = 117), yielding response rates of 100% and 79%, respectively.
Respondents represented a wide distribution of geographic regions and institutional complexity levels, with 80% of GI groups based at high-complexity centers and 92% in urban locations. A minority (8%) reported the presence of a liver transplant program.
Data collection focused on the prevalence of POCUS use, types of clinical applications, institutional policies and training processes, and perceived or actual barriers to wider adoption. Barriers were sorted into three categories: training, equipment, and infrastructure.
Of the 93 GI service chiefs who participated in the survey, 44% reported that at least 1 gastroenterologist at their facility currently uses POCUS. Most common procedural uses were paracentesis (23%) and liver biopsy (13%), while ascites assessment (19%) and biliary visualization (7%) were the most common diagnostic uses.
Among the same respondents, 69% said they would support sending clinicians to a POCUS training course, and 37% said their teams had expressed an active interest in pursuing such training. Only 17% of facilities had a formal process in place to obtain POCUS training, and an equal proportion had implemented a facility-wide policy to guide its use.
Barriers to implementation were widespread and often multifactorial.
Most challenges related to training: 48% of sites reported a lack of trained providers, 28% cited insufficient funding for training, 24% noted a lack of training opportunities, and 14% reported difficulty securing travel funds.
Equipment limitations were also common, with 41% of sites lacking ultrasound machines and 27% lacking funding to purchase them.
Institutional infrastructure posed further hurdles. Nearly a quarter of GI chiefs (23%) reported lacking a clinician champion to lead implementation, while others cited a lack of support staff, simulation space, privileging criteria, image archiving capabilities, or standardized reporting forms.
“Our findings on current POCUS use, training, barriers, and infrastructure can guide expansion of POCUS use and training among GI groups,” Dr. Thallapureddy and colleagues wrote, noting that early efforts to expand access to GI-specific POCUS training are already underway.
They cited growing interest from national organizations such as the American Gastroenterological Association and the American Association for the Study of Liver Diseases, the latter of which piloted training workshops at the 2024 Liver Meeting. Similarly, the International Bowel Ultrasound Group now offers a 3-part certification program in intestinal ultrasound and is developing additional online and interactive modules to improve training accessibility.
The study was supported by the US Department of Veterans Affairs, Quality Enhancement Research Initiative Partnered Evaluation Initiative Grant, and the VA National Center for Patient Safety. The investigators reported no conflicts of interest.
FROM GASTRO HEP ADVANCES
IBD Medications Show No Link with Breast Cancer Recurrence
, according to investigators.
These findings diminish concerns that IBD therapy could theoretically reactivate dormant micrometastases, lead author Guillaume Le Cosquer, MD, of Toulouse University Hospital, Toulouse, France, and colleagues, reported.
“In patients with IBD, medical management of subjects with a history of breast cancer is a frequent and unresolved problem for clinicians,” the investigators wrote in Clinical Gastroenterology and Hepatology (2024 Nov. doi: 10.1016/j.cgh.2024.09.034).
Previous studies have reported that conventional immunosuppressants and biologics do not increase risk of incident cancer among IBD patients with a prior nondigestive malignancy; however, recent guidelines from the European Crohn’s and Colitis Organisation (ECCO) suggest that data are insufficient to make associated recommendations, prompting the present study.
“[T]he major strength of our work is that it is the first to focus on the most frequent cancer (breast cancer) in patients with IBD only, with the longest follow-up after breast cancer in patients with IBD ever published,” Dr. Le Cosquer and colleagues noted.
The dataset included 207 patients with IBD and a history of breast cancer, drawn from 7 tertiary centers across France.
The index date was the time of breast cancer diagnosis, and patients were followed for a median of 71 months. The median time from cancer diagnosis to initiation of IBD treatment was 28 months.
First-line post-cancer treatments included conventional immunosuppressants (19.3%), anti–tumor necrosis factor (anti-TNF) agents (19.8%), vedolizumab (7.2%), and ustekinumab (1.9%). Approximately half (51.6%) received no immunosuppressive therapy during follow-up.
Over the study period, 42 incident cancers were recorded (20.3%), among which 34 were breast cancer recurrences. Adjusted incidence rates per 1000 person-years were 10.2 (95% CI, 6.0–16.4) in the untreated group and 28.9 (95% CI, 11.6–59.6) in patients exposed to immunosuppressive or biologic therapies (P = .0519). Incident cancer–free survival did not differ significantly between treated and untreated groups (P = .4796).
On multivariable analysis, independent predictors of incident cancer included T4d stage (P = .036), triple-negative status (P = .016), and follow-up duration shorter than 71 months (P = .005).
“[I]mmunosuppressant and biologic use in selected patients with IBD with prior breast cancer does not seem to increase the risk of incident cancer,” the investigators wrote, noting that the main predictors of cancer recurrence were known poor prognostic features of breast cancer.
Dr. Le Cosquer and colleagues acknowledged a lack of prospective safety data for biologic therapies among patients with prior malignancy, as these individuals are often excluded from clinical trials. Still, they underscored alignment between their findings and earlier retrospective studies, including analyses from the SAPPHIRE registry and Medicare data, which also found no significant increase in breast cancer recurrence with anti-TNF agents or newer biologics such as vedolizumab and ustekinumab.
“Our findings will help clinicians to make decisions in multidisciplinary meetings to start immunosuppressants or biologics in case of IBD flare-up in these patients,” they concluded.
The investigators disclosed relationships with AbbVie, Janssen, Takeda, and others.
Patients with inflammatory bowel disease (IBD) are at risk for a host of other illnesses, including cancer, at rates similar to or greater than the general population. When faced with uncertainty about drug safety with a cancer diagnosis, the reflex is to avoid the therapy altogether. This may lead to significant flares which may in turn lead to difficulty in tolerating cancer therapy and a shortened and lower quality life.
Le Cosquer et al. address the question of the risk of incident cancer among patients with a history of breast cancer. The authors found that the risk was related to poor prognostic factors for breast cancer and not IBD therapy. This should be interpreted with caution as the numbers, though the largest reported, are 207 patients. After propensity score matching, crude incidence rates per 1000 person years appeared greater in the treatment arm (28.9) versus the untreated arm (10.2), P = .0519. With a greater number of patients, it is conceivable the difference is significant.
On the flip side, prior to diagnosis, the majority of IBD patients received immunosuppressant or biologic therapy; however, after the index cancer, 51.6% of patients received no treatment. The survival curves show a near 25% difference in favor of treated patients after 300 months, albeit with very small numbers, raising the question of whether withholding IBD therapy is more harmful.
It is reassuring that the multiple papers cited in the article have not shown an increase in solid organ tumors to date. However, the practitioner needs to balance maintenance of IBD remission and overall health with the risk of complications in the patient with underlying malignancy. This complex decision making will shift over time and should involve the patient, the oncologist, and the gastroenterologist. In my practice, thiopurines are avoided and anti-integrins and IL-23s are preferred. However, anti-TNF agents and JAK-inhibitors are used when the patients’ overall benefit from disease control outweighs their (theoretical) risk for recurrence, infection, and thromboembolism.
Uma Mahadevan, MD, AGAF, is the Lynne and Marc Benioff Professor of Gastroenterology, and director of the Colitis and Crohn’s Disease Center at the University of California, San Francisco. She declared research support from the Leona M. and Harry B. Helmsley Trust, and has served as a consultant for multiple pharmaceutical firms.
Patients with inflammatory bowel disease (IBD) are at risk for a host of other illnesses, including cancer, at rates similar to or greater than the general population. When faced with uncertainty about drug safety with a cancer diagnosis, the reflex is to avoid the therapy altogether. This may lead to significant flares which may in turn lead to difficulty in tolerating cancer therapy and a shortened and lower quality life.
Le Cosquer et al. address the question of the risk of incident cancer among patients with a history of breast cancer. The authors found that the risk was related to poor prognostic factors for breast cancer and not IBD therapy. This should be interpreted with caution as the numbers, though the largest reported, are 207 patients. After propensity score matching, crude incidence rates per 1000 person years appeared greater in the treatment arm (28.9) versus the untreated arm (10.2), P = .0519. With a greater number of patients, it is conceivable the difference is significant.
On the flip side, prior to diagnosis, the majority of IBD patients received immunosuppressant or biologic therapy; however, after the index cancer, 51.6% of patients received no treatment. The survival curves show a near 25% difference in favor of treated patients after 300 months, albeit with very small numbers, raising the question of whether withholding IBD therapy is more harmful.
It is reassuring that the multiple papers cited in the article have not shown an increase in solid organ tumors to date. However, the practitioner needs to balance maintenance of IBD remission and overall health with the risk of complications in the patient with underlying malignancy. This complex decision making will shift over time and should involve the patient, the oncologist, and the gastroenterologist. In my practice, thiopurines are avoided and anti-integrins and IL-23s are preferred. However, anti-TNF agents and JAK-inhibitors are used when the patients’ overall benefit from disease control outweighs their (theoretical) risk for recurrence, infection, and thromboembolism.
Uma Mahadevan, MD, AGAF, is the Lynne and Marc Benioff Professor of Gastroenterology, and director of the Colitis and Crohn’s Disease Center at the University of California, San Francisco. She declared research support from the Leona M. and Harry B. Helmsley Trust, and has served as a consultant for multiple pharmaceutical firms.
Patients with inflammatory bowel disease (IBD) are at risk for a host of other illnesses, including cancer, at rates similar to or greater than the general population. When faced with uncertainty about drug safety with a cancer diagnosis, the reflex is to avoid the therapy altogether. This may lead to significant flares which may in turn lead to difficulty in tolerating cancer therapy and a shortened and lower quality life.
Le Cosquer et al. address the question of the risk of incident cancer among patients with a history of breast cancer. The authors found that the risk was related to poor prognostic factors for breast cancer and not IBD therapy. This should be interpreted with caution as the numbers, though the largest reported, are 207 patients. After propensity score matching, crude incidence rates per 1000 person years appeared greater in the treatment arm (28.9) versus the untreated arm (10.2), P = .0519. With a greater number of patients, it is conceivable the difference is significant.
On the flip side, prior to diagnosis, the majority of IBD patients received immunosuppressant or biologic therapy; however, after the index cancer, 51.6% of patients received no treatment. The survival curves show a near 25% difference in favor of treated patients after 300 months, albeit with very small numbers, raising the question of whether withholding IBD therapy is more harmful.
It is reassuring that the multiple papers cited in the article have not shown an increase in solid organ tumors to date. However, the practitioner needs to balance maintenance of IBD remission and overall health with the risk of complications in the patient with underlying malignancy. This complex decision making will shift over time and should involve the patient, the oncologist, and the gastroenterologist. In my practice, thiopurines are avoided and anti-integrins and IL-23s are preferred. However, anti-TNF agents and JAK-inhibitors are used when the patients’ overall benefit from disease control outweighs their (theoretical) risk for recurrence, infection, and thromboembolism.
Uma Mahadevan, MD, AGAF, is the Lynne and Marc Benioff Professor of Gastroenterology, and director of the Colitis and Crohn’s Disease Center at the University of California, San Francisco. She declared research support from the Leona M. and Harry B. Helmsley Trust, and has served as a consultant for multiple pharmaceutical firms.
, according to investigators.
These findings diminish concerns that IBD therapy could theoretically reactivate dormant micrometastases, lead author Guillaume Le Cosquer, MD, of Toulouse University Hospital, Toulouse, France, and colleagues, reported.
“In patients with IBD, medical management of subjects with a history of breast cancer is a frequent and unresolved problem for clinicians,” the investigators wrote in Clinical Gastroenterology and Hepatology (2024 Nov. doi: 10.1016/j.cgh.2024.09.034).
Previous studies have reported that conventional immunosuppressants and biologics do not increase risk of incident cancer among IBD patients with a prior nondigestive malignancy; however, recent guidelines from the European Crohn’s and Colitis Organisation (ECCO) suggest that data are insufficient to make associated recommendations, prompting the present study.
“[T]he major strength of our work is that it is the first to focus on the most frequent cancer (breast cancer) in patients with IBD only, with the longest follow-up after breast cancer in patients with IBD ever published,” Dr. Le Cosquer and colleagues noted.
The dataset included 207 patients with IBD and a history of breast cancer, drawn from 7 tertiary centers across France.
The index date was the time of breast cancer diagnosis, and patients were followed for a median of 71 months. The median time from cancer diagnosis to initiation of IBD treatment was 28 months.
First-line post-cancer treatments included conventional immunosuppressants (19.3%), anti–tumor necrosis factor (anti-TNF) agents (19.8%), vedolizumab (7.2%), and ustekinumab (1.9%). Approximately half (51.6%) received no immunosuppressive therapy during follow-up.
Over the study period, 42 incident cancers were recorded (20.3%), among which 34 were breast cancer recurrences. Adjusted incidence rates per 1000 person-years were 10.2 (95% CI, 6.0–16.4) in the untreated group and 28.9 (95% CI, 11.6–59.6) in patients exposed to immunosuppressive or biologic therapies (P = .0519). Incident cancer–free survival did not differ significantly between treated and untreated groups (P = .4796).
On multivariable analysis, independent predictors of incident cancer included T4d stage (P = .036), triple-negative status (P = .016), and follow-up duration shorter than 71 months (P = .005).
“[I]mmunosuppressant and biologic use in selected patients with IBD with prior breast cancer does not seem to increase the risk of incident cancer,” the investigators wrote, noting that the main predictors of cancer recurrence were known poor prognostic features of breast cancer.
Dr. Le Cosquer and colleagues acknowledged a lack of prospective safety data for biologic therapies among patients with prior malignancy, as these individuals are often excluded from clinical trials. Still, they underscored alignment between their findings and earlier retrospective studies, including analyses from the SAPPHIRE registry and Medicare data, which also found no significant increase in breast cancer recurrence with anti-TNF agents or newer biologics such as vedolizumab and ustekinumab.
“Our findings will help clinicians to make decisions in multidisciplinary meetings to start immunosuppressants or biologics in case of IBD flare-up in these patients,” they concluded.
The investigators disclosed relationships with AbbVie, Janssen, Takeda, and others.
, according to investigators.
These findings diminish concerns that IBD therapy could theoretically reactivate dormant micrometastases, lead author Guillaume Le Cosquer, MD, of Toulouse University Hospital, Toulouse, France, and colleagues, reported.
“In patients with IBD, medical management of subjects with a history of breast cancer is a frequent and unresolved problem for clinicians,” the investigators wrote in Clinical Gastroenterology and Hepatology (2024 Nov. doi: 10.1016/j.cgh.2024.09.034).
Previous studies have reported that conventional immunosuppressants and biologics do not increase risk of incident cancer among IBD patients with a prior nondigestive malignancy; however, recent guidelines from the European Crohn’s and Colitis Organisation (ECCO) suggest that data are insufficient to make associated recommendations, prompting the present study.
“[T]he major strength of our work is that it is the first to focus on the most frequent cancer (breast cancer) in patients with IBD only, with the longest follow-up after breast cancer in patients with IBD ever published,” Dr. Le Cosquer and colleagues noted.
The dataset included 207 patients with IBD and a history of breast cancer, drawn from 7 tertiary centers across France.
The index date was the time of breast cancer diagnosis, and patients were followed for a median of 71 months. The median time from cancer diagnosis to initiation of IBD treatment was 28 months.
First-line post-cancer treatments included conventional immunosuppressants (19.3%), anti–tumor necrosis factor (anti-TNF) agents (19.8%), vedolizumab (7.2%), and ustekinumab (1.9%). Approximately half (51.6%) received no immunosuppressive therapy during follow-up.
Over the study period, 42 incident cancers were recorded (20.3%), among which 34 were breast cancer recurrences. Adjusted incidence rates per 1000 person-years were 10.2 (95% CI, 6.0–16.4) in the untreated group and 28.9 (95% CI, 11.6–59.6) in patients exposed to immunosuppressive or biologic therapies (P = .0519). Incident cancer–free survival did not differ significantly between treated and untreated groups (P = .4796).
On multivariable analysis, independent predictors of incident cancer included T4d stage (P = .036), triple-negative status (P = .016), and follow-up duration shorter than 71 months (P = .005).
“[I]mmunosuppressant and biologic use in selected patients with IBD with prior breast cancer does not seem to increase the risk of incident cancer,” the investigators wrote, noting that the main predictors of cancer recurrence were known poor prognostic features of breast cancer.
Dr. Le Cosquer and colleagues acknowledged a lack of prospective safety data for biologic therapies among patients with prior malignancy, as these individuals are often excluded from clinical trials. Still, they underscored alignment between their findings and earlier retrospective studies, including analyses from the SAPPHIRE registry and Medicare data, which also found no significant increase in breast cancer recurrence with anti-TNF agents or newer biologics such as vedolizumab and ustekinumab.
“Our findings will help clinicians to make decisions in multidisciplinary meetings to start immunosuppressants or biologics in case of IBD flare-up in these patients,” they concluded.
The investigators disclosed relationships with AbbVie, Janssen, Takeda, and others.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY
Alarming Rise in Early-Onset GI Cancers Calls for Early Screening, Lifestyle Change
, said the authors of a JAMA review.
In the US, early-onset GI cancers are increasing faster than any other type of early-onset cancer, including breast cancer. The trend is not limited to colorectal cancer (CRC). Gastric, pancreatic, esophageal, as well as many biliary tract and appendix cancers, are also on the rise in young adults, Kimmie Ng, MD, MPH, and Thejus Jayakrishnan, MD, both with Dana-Farber Cancer Institute, Boston, noted in their article.
The increase in early-onset GI cancers follows a “birth cohort effect,” with generational variation in risk, suggesting a potential association with changes in environmental exposures, Ng explained in an accompanying JAMA podcast.
All these GI cancers link strongly to multiple modifiable risk factors, and it is a “top area of investigation to determine exactly what environmental exposures are at play,” Ng added.
For many of these GI cancers, obesity has been the “leading hypothesis” given that rising rates seem to parallel the increase in incidence of these early-onset GI cancers, Ng explained.
“But we also have evidence, particularly strong for colorectal cancer, that dietary patterns, such as consuming a Western diet, as well as sedentary behavior and lifestyles seem to be associated with a significantly higher risk of developing these cancers at an age under 50,” Ng said.
Rising Incidence
Globally, among early-onset GI cancers reported in 2022, CRC was the most common (54%), followed by gastric cancer (24%), esophageal cancer (13%), and pancreatic cancer (9%).
In the US in 2022, 20,805 individuals were diagnosed with early-onset CRC, 2689 with early-onset gastric cancer, 2657 with early-onset pancreatic cancer, and 875 with early-onset esophageal cancer.
Since the mid-1990s, CRC among adults of all ages in the US declined by 1.3%-4.2% annually but early-onset CRC increased by roughly 2% per year in both men and women, and currently makes up about 14% of all CRC cases.
Early-onset pancreatic cancer and esophageal cancer each currently make up about 5% of all cases of these cancers in the US.
Between 2010 and 2019, the number of newly diagnosed cases of early-onset GI cancers rose by nearly about 15%, with Black, Hispanic, Indigenous ancestry, and women disproportionately affected, Ng and coauthors noted in a related review published in the British Journal of Surgery.
Modifiable and Nonmodifiable Risk Factors
Along with obesity and poor diet, other modifiable risk factors for early-onset GI cancers include sedentary lifestyle, cigarette smoking, and alcohol consumption.
Nonmodifiable risk factors include family history, hereditary cancer syndromes such as Lynch syndrome and inflammatory bowel disease.
Roughly 15%-30% of early-onset GI cancers have pathogenic germline variants in genes such as DNA mismatch repair genes and BRCA1/2.
All individuals with early-onset GI cancers should undergo germline and somatic genetic testing to guide treatment, screen for other cancers (eg, endometrial cancer in Lynch syndrome), and assess familial risk, Ng and Jayakrishnan advised.
Treatment Challenges
Treatment for early-onset GI cancers is generally similar to later-onset GI cancers and prognosis for patients with early-onset GI cancers is “similar to or worse” than that for patients with later-onset GI cancers, highlighting the need for improved methods of prevention and early detection, the authors said.
Ng noted that younger cancer patients often face more challenges after diagnosis than older patients and benefit from multidisciplinary care, including referral for fertility counseling and preservation if appropriate, and psychosocial support.
“It is very difficult and challenging to receive a cancer diagnosis no matter what age you are, but when a person is diagnosed in their 20s, 30s, or 40s, there are unique challenges,” Ng said.
Studies have documented “much higher levels of psychosocial distress, depression and anxiety” in early-onset cancer patients, “and they also often experience more financial toxicity, disruptions in their education as well as their career and there may be fertility concerns,” Ng added.
Diagnostic Delays and Screening
Currently, screening is not recommended for most early-onset GI cancers — with the exception of CRC, with screening recommended for average-risk adults in the US starting at age 45.
Yet, despite this recommendation, fewer than 1 in 5 (19.7%) US adults aged 45-49 years were screened in 2021, indicating a significant gap in early detection efforts.
High-risk individuals, such as those with Lynch syndrome, a first-degree relative with CRC, or advanced colorectal adenoma, should begin CRC screening earlier, at an age determined by the specific risk factor.
“Studies have shown significant delays in diagnosis among younger patients. It’s important that prompt diagnosis happens so that these patients do not end up being diagnosed with advanced or metastatic stages of cancer, as they often are,” Ng said.
“Screening adherence is absolutely critical,” co-author Jayakrishnan added in a news release.
“We have strong evidence that colorectal cancer screening saves lives by reducing both the number of people who develop colorectal cancer and the number of people who die from it. Each missed screening is a lost opportunity to detect cancer early when it is more treatable, or to prevent cancer altogether by identifying and removing precancerous polyps,” Jayakrishnan said.This research had no funding. Ng reported receipt of nonfinancial support from Pharmavite, institutional grants from Janssen, and personal fees from Bayer, Seagen, GlaxoSmithKline, Pfizer, CytomX, Jazz Pharmaceuticals, Revolution Medicines, Redesign Health, AbbVie, Etiome, and CRICO. Ng is an associate editor of JAMA but was not involved in any of the decisions regarding review of the manuscript or its acceptance. Jayakrishnan had no disclosures.
A version of this article appeared on Medscape.com.
, said the authors of a JAMA review.
In the US, early-onset GI cancers are increasing faster than any other type of early-onset cancer, including breast cancer. The trend is not limited to colorectal cancer (CRC). Gastric, pancreatic, esophageal, as well as many biliary tract and appendix cancers, are also on the rise in young adults, Kimmie Ng, MD, MPH, and Thejus Jayakrishnan, MD, both with Dana-Farber Cancer Institute, Boston, noted in their article.
The increase in early-onset GI cancers follows a “birth cohort effect,” with generational variation in risk, suggesting a potential association with changes in environmental exposures, Ng explained in an accompanying JAMA podcast.
All these GI cancers link strongly to multiple modifiable risk factors, and it is a “top area of investigation to determine exactly what environmental exposures are at play,” Ng added.
For many of these GI cancers, obesity has been the “leading hypothesis” given that rising rates seem to parallel the increase in incidence of these early-onset GI cancers, Ng explained.
“But we also have evidence, particularly strong for colorectal cancer, that dietary patterns, such as consuming a Western diet, as well as sedentary behavior and lifestyles seem to be associated with a significantly higher risk of developing these cancers at an age under 50,” Ng said.
Rising Incidence
Globally, among early-onset GI cancers reported in 2022, CRC was the most common (54%), followed by gastric cancer (24%), esophageal cancer (13%), and pancreatic cancer (9%).
In the US in 2022, 20,805 individuals were diagnosed with early-onset CRC, 2689 with early-onset gastric cancer, 2657 with early-onset pancreatic cancer, and 875 with early-onset esophageal cancer.
Since the mid-1990s, CRC among adults of all ages in the US declined by 1.3%-4.2% annually but early-onset CRC increased by roughly 2% per year in both men and women, and currently makes up about 14% of all CRC cases.
Early-onset pancreatic cancer and esophageal cancer each currently make up about 5% of all cases of these cancers in the US.
Between 2010 and 2019, the number of newly diagnosed cases of early-onset GI cancers rose by nearly about 15%, with Black, Hispanic, Indigenous ancestry, and women disproportionately affected, Ng and coauthors noted in a related review published in the British Journal of Surgery.
Modifiable and Nonmodifiable Risk Factors
Along with obesity and poor diet, other modifiable risk factors for early-onset GI cancers include sedentary lifestyle, cigarette smoking, and alcohol consumption.
Nonmodifiable risk factors include family history, hereditary cancer syndromes such as Lynch syndrome and inflammatory bowel disease.
Roughly 15%-30% of early-onset GI cancers have pathogenic germline variants in genes such as DNA mismatch repair genes and BRCA1/2.
All individuals with early-onset GI cancers should undergo germline and somatic genetic testing to guide treatment, screen for other cancers (eg, endometrial cancer in Lynch syndrome), and assess familial risk, Ng and Jayakrishnan advised.
Treatment Challenges
Treatment for early-onset GI cancers is generally similar to later-onset GI cancers and prognosis for patients with early-onset GI cancers is “similar to or worse” than that for patients with later-onset GI cancers, highlighting the need for improved methods of prevention and early detection, the authors said.
Ng noted that younger cancer patients often face more challenges after diagnosis than older patients and benefit from multidisciplinary care, including referral for fertility counseling and preservation if appropriate, and psychosocial support.
“It is very difficult and challenging to receive a cancer diagnosis no matter what age you are, but when a person is diagnosed in their 20s, 30s, or 40s, there are unique challenges,” Ng said.
Studies have documented “much higher levels of psychosocial distress, depression and anxiety” in early-onset cancer patients, “and they also often experience more financial toxicity, disruptions in their education as well as their career and there may be fertility concerns,” Ng added.
Diagnostic Delays and Screening
Currently, screening is not recommended for most early-onset GI cancers — with the exception of CRC, with screening recommended for average-risk adults in the US starting at age 45.
Yet, despite this recommendation, fewer than 1 in 5 (19.7%) US adults aged 45-49 years were screened in 2021, indicating a significant gap in early detection efforts.
High-risk individuals, such as those with Lynch syndrome, a first-degree relative with CRC, or advanced colorectal adenoma, should begin CRC screening earlier, at an age determined by the specific risk factor.
“Studies have shown significant delays in diagnosis among younger patients. It’s important that prompt diagnosis happens so that these patients do not end up being diagnosed with advanced or metastatic stages of cancer, as they often are,” Ng said.
“Screening adherence is absolutely critical,” co-author Jayakrishnan added in a news release.
“We have strong evidence that colorectal cancer screening saves lives by reducing both the number of people who develop colorectal cancer and the number of people who die from it. Each missed screening is a lost opportunity to detect cancer early when it is more treatable, or to prevent cancer altogether by identifying and removing precancerous polyps,” Jayakrishnan said.This research had no funding. Ng reported receipt of nonfinancial support from Pharmavite, institutional grants from Janssen, and personal fees from Bayer, Seagen, GlaxoSmithKline, Pfizer, CytomX, Jazz Pharmaceuticals, Revolution Medicines, Redesign Health, AbbVie, Etiome, and CRICO. Ng is an associate editor of JAMA but was not involved in any of the decisions regarding review of the manuscript or its acceptance. Jayakrishnan had no disclosures.
A version of this article appeared on Medscape.com.
, said the authors of a JAMA review.
In the US, early-onset GI cancers are increasing faster than any other type of early-onset cancer, including breast cancer. The trend is not limited to colorectal cancer (CRC). Gastric, pancreatic, esophageal, as well as many biliary tract and appendix cancers, are also on the rise in young adults, Kimmie Ng, MD, MPH, and Thejus Jayakrishnan, MD, both with Dana-Farber Cancer Institute, Boston, noted in their article.
The increase in early-onset GI cancers follows a “birth cohort effect,” with generational variation in risk, suggesting a potential association with changes in environmental exposures, Ng explained in an accompanying JAMA podcast.
All these GI cancers link strongly to multiple modifiable risk factors, and it is a “top area of investigation to determine exactly what environmental exposures are at play,” Ng added.
For many of these GI cancers, obesity has been the “leading hypothesis” given that rising rates seem to parallel the increase in incidence of these early-onset GI cancers, Ng explained.
“But we also have evidence, particularly strong for colorectal cancer, that dietary patterns, such as consuming a Western diet, as well as sedentary behavior and lifestyles seem to be associated with a significantly higher risk of developing these cancers at an age under 50,” Ng said.
Rising Incidence
Globally, among early-onset GI cancers reported in 2022, CRC was the most common (54%), followed by gastric cancer (24%), esophageal cancer (13%), and pancreatic cancer (9%).
In the US in 2022, 20,805 individuals were diagnosed with early-onset CRC, 2689 with early-onset gastric cancer, 2657 with early-onset pancreatic cancer, and 875 with early-onset esophageal cancer.
Since the mid-1990s, CRC among adults of all ages in the US declined by 1.3%-4.2% annually but early-onset CRC increased by roughly 2% per year in both men and women, and currently makes up about 14% of all CRC cases.
Early-onset pancreatic cancer and esophageal cancer each currently make up about 5% of all cases of these cancers in the US.
Between 2010 and 2019, the number of newly diagnosed cases of early-onset GI cancers rose by nearly about 15%, with Black, Hispanic, Indigenous ancestry, and women disproportionately affected, Ng and coauthors noted in a related review published in the British Journal of Surgery.
Modifiable and Nonmodifiable Risk Factors
Along with obesity and poor diet, other modifiable risk factors for early-onset GI cancers include sedentary lifestyle, cigarette smoking, and alcohol consumption.
Nonmodifiable risk factors include family history, hereditary cancer syndromes such as Lynch syndrome and inflammatory bowel disease.
Roughly 15%-30% of early-onset GI cancers have pathogenic germline variants in genes such as DNA mismatch repair genes and BRCA1/2.
All individuals with early-onset GI cancers should undergo germline and somatic genetic testing to guide treatment, screen for other cancers (eg, endometrial cancer in Lynch syndrome), and assess familial risk, Ng and Jayakrishnan advised.
Treatment Challenges
Treatment for early-onset GI cancers is generally similar to later-onset GI cancers and prognosis for patients with early-onset GI cancers is “similar to or worse” than that for patients with later-onset GI cancers, highlighting the need for improved methods of prevention and early detection, the authors said.
Ng noted that younger cancer patients often face more challenges after diagnosis than older patients and benefit from multidisciplinary care, including referral for fertility counseling and preservation if appropriate, and psychosocial support.
“It is very difficult and challenging to receive a cancer diagnosis no matter what age you are, but when a person is diagnosed in their 20s, 30s, or 40s, there are unique challenges,” Ng said.
Studies have documented “much higher levels of psychosocial distress, depression and anxiety” in early-onset cancer patients, “and they also often experience more financial toxicity, disruptions in their education as well as their career and there may be fertility concerns,” Ng added.
Diagnostic Delays and Screening
Currently, screening is not recommended for most early-onset GI cancers — with the exception of CRC, with screening recommended for average-risk adults in the US starting at age 45.
Yet, despite this recommendation, fewer than 1 in 5 (19.7%) US adults aged 45-49 years were screened in 2021, indicating a significant gap in early detection efforts.
High-risk individuals, such as those with Lynch syndrome, a first-degree relative with CRC, or advanced colorectal adenoma, should begin CRC screening earlier, at an age determined by the specific risk factor.
“Studies have shown significant delays in diagnosis among younger patients. It’s important that prompt diagnosis happens so that these patients do not end up being diagnosed with advanced or metastatic stages of cancer, as they often are,” Ng said.
“Screening adherence is absolutely critical,” co-author Jayakrishnan added in a news release.
“We have strong evidence that colorectal cancer screening saves lives by reducing both the number of people who develop colorectal cancer and the number of people who die from it. Each missed screening is a lost opportunity to detect cancer early when it is more treatable, or to prevent cancer altogether by identifying and removing precancerous polyps,” Jayakrishnan said.This research had no funding. Ng reported receipt of nonfinancial support from Pharmavite, institutional grants from Janssen, and personal fees from Bayer, Seagen, GlaxoSmithKline, Pfizer, CytomX, Jazz Pharmaceuticals, Revolution Medicines, Redesign Health, AbbVie, Etiome, and CRICO. Ng is an associate editor of JAMA but was not involved in any of the decisions regarding review of the manuscript or its acceptance. Jayakrishnan had no disclosures.
A version of this article appeared on Medscape.com.
Sterile Water Bottles Deemed Unnecessary for Endoscopy
Like diners saving on drinks,
“No direct evidence supports the recommendation and widespread use of sterile water during gastrointestinal endosco-py procedures,” lead author Deepak Agrawal, MD, chief of gastroenterology & hepatology at the Dell Medical School, University Texas at Austin, and colleagues, wrote in Gastro Hep Advances. “Guidelines recommending sterile water during endoscopy are based on limited evidence and mostly expert opinions.”
After reviewing the literature back to 1975, Dr. Agrawal and colleagues considered the use of sterile water in endoscopy via three frameworks: medical evidence and guidelines, environmental and broader health effects, and financial costs.
Only 2 studies – both from the 1990s – directly compared sterile and tap water use in endoscopy. Neither showed an increased risk of infection from tap water. In fact, some cultures from allegedly sterile water bottles grew pathogenic bacteria, while no patient complications were reported in either study.
“The recommendations for sterile water contradict observations in other medical care scenarios, for example, for the irrigation of open wounds,” Dr. Agrawal and colleagues noted. “Similarly, there is no benefit in using sterile water for enteral feeds in immunosuppressed patients, and tap water enemas are routinely acceptable for colon cleansing before sigmoidoscopies in all patients, irrespective of immune status.”
Current guidelines, including the 2021 US multisociety guideline on reprocessing flexible GI endoscopes and accessories, recommend sterile water for procedures involving mucosal penetration but acknowledge low-quality supporting evidence. These recommendations are based on outdated studies, some unrelated to GI endoscopy, Dr. Agrawal and colleagues pointed out, and rely heavily on cross-referenced opinion statements rather than clinical data.
They went on to suggest a concerning possibility: all those plastic bottles may actually cause more health problems than prevent them. The review estimates that the production and transportation of sterile water bottles contributes over 6,000 metric tons of emissions per year from US endoscopy units alone. What’s more, as discarded bottles break down, they release greenhouse gases and microplastics, the latter of which have been linked to cardiovascular disease, inflammatory bowel disease, and endocrine disruption.
Dr. Agrawal and colleagues also underscored the financial toxicity of sterile water bottles. Considering a 1-liter bottle of sterile water costs $3-10, an endoscopy unit performing 30 procedures per day spends approximately $1,000-3,000 per month on bottled water alone. Scaled nationally, the routine use of sterile water costs tens of millions of dollars each year, not counting indirect expenses associated with stocking and waste disposal.
Considering the dubious clinical upside against the apparent environmental and financial downsides, Dr. Agrawal and colleagues urged endoscopy units to rethink routine sterile water use.
They proposed a pragmatic model: start the day with a new sterile or reusable bottle, refill with tap water for subsequent cases, and recycle the bottle at day’s end. Institutions should ensure their tap water meets safety standards, they added, such as those outlined in the Joint Commission’s 2022 R3 Report on standards for water management.
Dr. Agrawal and colleagues also called on GI societies to revise existing guidance to reflect today’s clinical and environmental realities. Until strong evidence supports the need for sterile water, they wrote, the smarter, safer, and more sustainable option may be simply turning on the tap.
The investigators disclosed relationships with Guardant, Exact Sciences, Freenome, and others.
In an editorial accompanying the study and comments to GI & Hepatology News, Dr. Seth A. Gross of NYU Langone Health urged gastroenterologists to reconsider the use of sterile water in endoscopy.
While the rationale for bottled water has centered on infection prevention, Gross argued that the evidence does not hold up, noting that this practice contradicts modern values around sustainability and evidence-based care.
The two relevant clinical studies comparing sterile versus tap water in endoscopy are almost 30 years old, he said, and neither detected an increased risk of infection with tap water, leading both to conclude that tap water is “safe and practical” for routine endoscopy.
Gross also pointed out the inconsistency of sterile water use in medical practice, noting that tap water is acceptable in procedures with higher infection risk than endoscopy.
“Lastly,” he added, “most people drink tap water and not sterile water on a daily basis without outbreaks of gastroenteritis from bacterial infections.”
Gross’s comments went beyond the data to emphasize the obvious but overlooked environmental impacts of sterile water bottles. He suggested several challenging suggestions to make medicine more ecofriendly, like reducing travel to conferences, increasing the availability of telehealth, and choosing reusable devices over disposables.
But “what’s hiding in plain sight,” he said, “is our use of sterile water.”
While acknowledging that some patients, like those who are immunocompromised, might still warrant sterile water, Gross supported the review’s recommendation to use tap water instead. He called on GI societies and regulatory bodies to re-examine current policy and pursue updated guidance.
“Sometimes going back to the basics,” he concluded, “could be the most innovative strategy with tremendous impact.”
Seth A. Gross, MD, AGAF, is clinical chief in the Division of Gastroenterology & Hepatology at NYU Langone Health, and professor at the NYU Grossman School of Medicine, both in New York City. He reported no conflicts of interest.
In an editorial accompanying the study and comments to GI & Hepatology News, Dr. Seth A. Gross of NYU Langone Health urged gastroenterologists to reconsider the use of sterile water in endoscopy.
While the rationale for bottled water has centered on infection prevention, Gross argued that the evidence does not hold up, noting that this practice contradicts modern values around sustainability and evidence-based care.
The two relevant clinical studies comparing sterile versus tap water in endoscopy are almost 30 years old, he said, and neither detected an increased risk of infection with tap water, leading both to conclude that tap water is “safe and practical” for routine endoscopy.
Gross also pointed out the inconsistency of sterile water use in medical practice, noting that tap water is acceptable in procedures with higher infection risk than endoscopy.
“Lastly,” he added, “most people drink tap water and not sterile water on a daily basis without outbreaks of gastroenteritis from bacterial infections.”
Gross’s comments went beyond the data to emphasize the obvious but overlooked environmental impacts of sterile water bottles. He suggested several challenging suggestions to make medicine more ecofriendly, like reducing travel to conferences, increasing the availability of telehealth, and choosing reusable devices over disposables.
But “what’s hiding in plain sight,” he said, “is our use of sterile water.”
While acknowledging that some patients, like those who are immunocompromised, might still warrant sterile water, Gross supported the review’s recommendation to use tap water instead. He called on GI societies and regulatory bodies to re-examine current policy and pursue updated guidance.
“Sometimes going back to the basics,” he concluded, “could be the most innovative strategy with tremendous impact.”
Seth A. Gross, MD, AGAF, is clinical chief in the Division of Gastroenterology & Hepatology at NYU Langone Health, and professor at the NYU Grossman School of Medicine, both in New York City. He reported no conflicts of interest.
In an editorial accompanying the study and comments to GI & Hepatology News, Dr. Seth A. Gross of NYU Langone Health urged gastroenterologists to reconsider the use of sterile water in endoscopy.
While the rationale for bottled water has centered on infection prevention, Gross argued that the evidence does not hold up, noting that this practice contradicts modern values around sustainability and evidence-based care.
The two relevant clinical studies comparing sterile versus tap water in endoscopy are almost 30 years old, he said, and neither detected an increased risk of infection with tap water, leading both to conclude that tap water is “safe and practical” for routine endoscopy.
Gross also pointed out the inconsistency of sterile water use in medical practice, noting that tap water is acceptable in procedures with higher infection risk than endoscopy.
“Lastly,” he added, “most people drink tap water and not sterile water on a daily basis without outbreaks of gastroenteritis from bacterial infections.”
Gross’s comments went beyond the data to emphasize the obvious but overlooked environmental impacts of sterile water bottles. He suggested several challenging suggestions to make medicine more ecofriendly, like reducing travel to conferences, increasing the availability of telehealth, and choosing reusable devices over disposables.
But “what’s hiding in plain sight,” he said, “is our use of sterile water.”
While acknowledging that some patients, like those who are immunocompromised, might still warrant sterile water, Gross supported the review’s recommendation to use tap water instead. He called on GI societies and regulatory bodies to re-examine current policy and pursue updated guidance.
“Sometimes going back to the basics,” he concluded, “could be the most innovative strategy with tremendous impact.”
Seth A. Gross, MD, AGAF, is clinical chief in the Division of Gastroenterology & Hepatology at NYU Langone Health, and professor at the NYU Grossman School of Medicine, both in New York City. He reported no conflicts of interest.
Like diners saving on drinks,
“No direct evidence supports the recommendation and widespread use of sterile water during gastrointestinal endosco-py procedures,” lead author Deepak Agrawal, MD, chief of gastroenterology & hepatology at the Dell Medical School, University Texas at Austin, and colleagues, wrote in Gastro Hep Advances. “Guidelines recommending sterile water during endoscopy are based on limited evidence and mostly expert opinions.”
After reviewing the literature back to 1975, Dr. Agrawal and colleagues considered the use of sterile water in endoscopy via three frameworks: medical evidence and guidelines, environmental and broader health effects, and financial costs.
Only 2 studies – both from the 1990s – directly compared sterile and tap water use in endoscopy. Neither showed an increased risk of infection from tap water. In fact, some cultures from allegedly sterile water bottles grew pathogenic bacteria, while no patient complications were reported in either study.
“The recommendations for sterile water contradict observations in other medical care scenarios, for example, for the irrigation of open wounds,” Dr. Agrawal and colleagues noted. “Similarly, there is no benefit in using sterile water for enteral feeds in immunosuppressed patients, and tap water enemas are routinely acceptable for colon cleansing before sigmoidoscopies in all patients, irrespective of immune status.”
Current guidelines, including the 2021 US multisociety guideline on reprocessing flexible GI endoscopes and accessories, recommend sterile water for procedures involving mucosal penetration but acknowledge low-quality supporting evidence. These recommendations are based on outdated studies, some unrelated to GI endoscopy, Dr. Agrawal and colleagues pointed out, and rely heavily on cross-referenced opinion statements rather than clinical data.
They went on to suggest a concerning possibility: all those plastic bottles may actually cause more health problems than prevent them. The review estimates that the production and transportation of sterile water bottles contributes over 6,000 metric tons of emissions per year from US endoscopy units alone. What’s more, as discarded bottles break down, they release greenhouse gases and microplastics, the latter of which have been linked to cardiovascular disease, inflammatory bowel disease, and endocrine disruption.
Dr. Agrawal and colleagues also underscored the financial toxicity of sterile water bottles. Considering a 1-liter bottle of sterile water costs $3-10, an endoscopy unit performing 30 procedures per day spends approximately $1,000-3,000 per month on bottled water alone. Scaled nationally, the routine use of sterile water costs tens of millions of dollars each year, not counting indirect expenses associated with stocking and waste disposal.
Considering the dubious clinical upside against the apparent environmental and financial downsides, Dr. Agrawal and colleagues urged endoscopy units to rethink routine sterile water use.
They proposed a pragmatic model: start the day with a new sterile or reusable bottle, refill with tap water for subsequent cases, and recycle the bottle at day’s end. Institutions should ensure their tap water meets safety standards, they added, such as those outlined in the Joint Commission’s 2022 R3 Report on standards for water management.
Dr. Agrawal and colleagues also called on GI societies to revise existing guidance to reflect today’s clinical and environmental realities. Until strong evidence supports the need for sterile water, they wrote, the smarter, safer, and more sustainable option may be simply turning on the tap.
The investigators disclosed relationships with Guardant, Exact Sciences, Freenome, and others.
Like diners saving on drinks,
“No direct evidence supports the recommendation and widespread use of sterile water during gastrointestinal endosco-py procedures,” lead author Deepak Agrawal, MD, chief of gastroenterology & hepatology at the Dell Medical School, University Texas at Austin, and colleagues, wrote in Gastro Hep Advances. “Guidelines recommending sterile water during endoscopy are based on limited evidence and mostly expert opinions.”
After reviewing the literature back to 1975, Dr. Agrawal and colleagues considered the use of sterile water in endoscopy via three frameworks: medical evidence and guidelines, environmental and broader health effects, and financial costs.
Only 2 studies – both from the 1990s – directly compared sterile and tap water use in endoscopy. Neither showed an increased risk of infection from tap water. In fact, some cultures from allegedly sterile water bottles grew pathogenic bacteria, while no patient complications were reported in either study.
“The recommendations for sterile water contradict observations in other medical care scenarios, for example, for the irrigation of open wounds,” Dr. Agrawal and colleagues noted. “Similarly, there is no benefit in using sterile water for enteral feeds in immunosuppressed patients, and tap water enemas are routinely acceptable for colon cleansing before sigmoidoscopies in all patients, irrespective of immune status.”
Current guidelines, including the 2021 US multisociety guideline on reprocessing flexible GI endoscopes and accessories, recommend sterile water for procedures involving mucosal penetration but acknowledge low-quality supporting evidence. These recommendations are based on outdated studies, some unrelated to GI endoscopy, Dr. Agrawal and colleagues pointed out, and rely heavily on cross-referenced opinion statements rather than clinical data.
They went on to suggest a concerning possibility: all those plastic bottles may actually cause more health problems than prevent them. The review estimates that the production and transportation of sterile water bottles contributes over 6,000 metric tons of emissions per year from US endoscopy units alone. What’s more, as discarded bottles break down, they release greenhouse gases and microplastics, the latter of which have been linked to cardiovascular disease, inflammatory bowel disease, and endocrine disruption.
Dr. Agrawal and colleagues also underscored the financial toxicity of sterile water bottles. Considering a 1-liter bottle of sterile water costs $3-10, an endoscopy unit performing 30 procedures per day spends approximately $1,000-3,000 per month on bottled water alone. Scaled nationally, the routine use of sterile water costs tens of millions of dollars each year, not counting indirect expenses associated with stocking and waste disposal.
Considering the dubious clinical upside against the apparent environmental and financial downsides, Dr. Agrawal and colleagues urged endoscopy units to rethink routine sterile water use.
They proposed a pragmatic model: start the day with a new sterile or reusable bottle, refill with tap water for subsequent cases, and recycle the bottle at day’s end. Institutions should ensure their tap water meets safety standards, they added, such as those outlined in the Joint Commission’s 2022 R3 Report on standards for water management.
Dr. Agrawal and colleagues also called on GI societies to revise existing guidance to reflect today’s clinical and environmental realities. Until strong evidence supports the need for sterile water, they wrote, the smarter, safer, and more sustainable option may be simply turning on the tap.
The investigators disclosed relationships with Guardant, Exact Sciences, Freenome, and others.
FROM GASTRO HEP ADVANCES
Cirrhosis Mortality Prediction Boosted by Machine Learning
“This highly inclusive, representative, and globally derived model has been externally validated,” Jasmohan Bajaj, MD, AGAF, professor of medicine at Virginia Commonwealth University in Richmond, Virginia, told GI & Hepatology News. “This gives us a crystal ball. It helps hospital teams, transplant centers, gastroenterology and intensive care unit services triage and prioritize patients more effectively.”
The study supporting the model, which Bajaj said “could be used at this stage,” was published online in Gastroenterology. The model is available for downloading at https://silveys.shinyapps.io/app_cleared/.
CLEARED Cohort Analyzed
Wide variations across the world regarding available resources, outpatient services, reasons for admission, and etiologies of cirrhosis can influence patient outcomes, according to Bajaj and colleagues. Therefore, they sought to use ML approaches to improve prognostication for all countries.
They analyzed admission-day data from the prospective Chronic Liver Disease Evolution And Registry for Events and Decompensation (CLEARED) consortium, which includes inpatients with cirrhosis enrolled from six continents. The analysis compared ML approaches with logistical regression to predict inpatient mortality.
The researchers performed internal validation (75/25 split) and subdivision using World-Bank income status: low/low-middle (L-LMIC), upper middle (UMIC), and high (HIC). They determined that the ML model with the best area-under-the-curve (AUC) would be externally validated in a US-Veteran cirrhosis inpatient population.
The CLEARED cohort included 7239 cirrhosis inpatients (mean age, 56 years; 64% men; median MELD-Na, 25) from 115 centers globally; 22.5% of centers belonged to LMICs, 41% to UMICs, and 34% to HICs.
A total of 808 patients (11.1%) died in the hospital.
Random-Forest analysis showed the best AUC (0.815) with high calibration. This was significantly better than parametric logistic regression (AUC, 0.774) and LASSO (AUC, 0.787) models.
Random-Forest also was better than logistic regression regardless of country income-level: HIC (AUC,0.806), UMIC (AUC, 0.867), and L-LMICs (AUC, 0.768).
Of the top 15 important variables selected from Random-Forest, admission for acute kidney injury, hepatic encephalopathy, high MELD-Na/white blood count, and not being in high income country were variables most predictive of mortality.
In contrast, higher albumin, hemoglobin, diuretic use on admission, viral etiology, and being in a high-income country were most protective.
The Random-Forest model was validated in 28,670 veterans (mean age, 67 years; 96% men; median MELD-Na,15), with an inpatient mortality of 4% (1158 patients).
The final Random-Forest model, using 48 of the 67 original covariates, attained a strong AUC of 0.859. A refit version using only the top 15 variables achieved a comparable AUC of 0.851.
Clinical Relevance
“Cirrhosis and resultant organ failures remain a dynamic and multidisciplinary problem,” Bajaj noted. “Machine learning techniques are one part of multi-faceted management strategy that is required in this population.”
If patients fall into the high-risk category, he said, “careful consultation with patients, families, and clinical teams is needed before providing information, including where this model was derived from. The results of these discussions could be instructive regarding decisions for transfer, more aggressive monitoring/ICU transfer, palliative care or transplant assessments.”
Meena B. Bansal, MD, system chief, Division of Liver Diseases, Mount Sinai Health System in New York City, called the tool “very promising.” However, she told GI & Hepatology News, “it was validated on a VA [Veterans Affairs] cohort, which is a bit different than the cohort of patients seen at Mount Sinai. Therefore, validation in more academic tertiary care medical centers with high volume liver transplant would be helpful.”
Furthermore, said Bansal, who was not involved in the study, “they excluded those that receiving a liver transplant, and while only a small number, this is an important limitation.”
Nevertheless, she added, “Artificial intelligence has great potential in predictive risk models and will likely be a tool that assists for risk stratification, clinical management, and hopefully improved clinical outcomes.”
This study was partly supported by a VA Merit review to Bajaj and the National Center for Advancing Translational Sciences, National Institutes of Health. No conflicts of interest were reported by any author.
A version of this article appeared on Medscape.com.
“This highly inclusive, representative, and globally derived model has been externally validated,” Jasmohan Bajaj, MD, AGAF, professor of medicine at Virginia Commonwealth University in Richmond, Virginia, told GI & Hepatology News. “This gives us a crystal ball. It helps hospital teams, transplant centers, gastroenterology and intensive care unit services triage and prioritize patients more effectively.”
The study supporting the model, which Bajaj said “could be used at this stage,” was published online in Gastroenterology. The model is available for downloading at https://silveys.shinyapps.io/app_cleared/.
CLEARED Cohort Analyzed
Wide variations across the world regarding available resources, outpatient services, reasons for admission, and etiologies of cirrhosis can influence patient outcomes, according to Bajaj and colleagues. Therefore, they sought to use ML approaches to improve prognostication for all countries.
They analyzed admission-day data from the prospective Chronic Liver Disease Evolution And Registry for Events and Decompensation (CLEARED) consortium, which includes inpatients with cirrhosis enrolled from six continents. The analysis compared ML approaches with logistical regression to predict inpatient mortality.
The researchers performed internal validation (75/25 split) and subdivision using World-Bank income status: low/low-middle (L-LMIC), upper middle (UMIC), and high (HIC). They determined that the ML model with the best area-under-the-curve (AUC) would be externally validated in a US-Veteran cirrhosis inpatient population.
The CLEARED cohort included 7239 cirrhosis inpatients (mean age, 56 years; 64% men; median MELD-Na, 25) from 115 centers globally; 22.5% of centers belonged to LMICs, 41% to UMICs, and 34% to HICs.
A total of 808 patients (11.1%) died in the hospital.
Random-Forest analysis showed the best AUC (0.815) with high calibration. This was significantly better than parametric logistic regression (AUC, 0.774) and LASSO (AUC, 0.787) models.
Random-Forest also was better than logistic regression regardless of country income-level: HIC (AUC,0.806), UMIC (AUC, 0.867), and L-LMICs (AUC, 0.768).
Of the top 15 important variables selected from Random-Forest, admission for acute kidney injury, hepatic encephalopathy, high MELD-Na/white blood count, and not being in high income country were variables most predictive of mortality.
In contrast, higher albumin, hemoglobin, diuretic use on admission, viral etiology, and being in a high-income country were most protective.
The Random-Forest model was validated in 28,670 veterans (mean age, 67 years; 96% men; median MELD-Na,15), with an inpatient mortality of 4% (1158 patients).
The final Random-Forest model, using 48 of the 67 original covariates, attained a strong AUC of 0.859. A refit version using only the top 15 variables achieved a comparable AUC of 0.851.
Clinical Relevance
“Cirrhosis and resultant organ failures remain a dynamic and multidisciplinary problem,” Bajaj noted. “Machine learning techniques are one part of multi-faceted management strategy that is required in this population.”
If patients fall into the high-risk category, he said, “careful consultation with patients, families, and clinical teams is needed before providing information, including where this model was derived from. The results of these discussions could be instructive regarding decisions for transfer, more aggressive monitoring/ICU transfer, palliative care or transplant assessments.”
Meena B. Bansal, MD, system chief, Division of Liver Diseases, Mount Sinai Health System in New York City, called the tool “very promising.” However, she told GI & Hepatology News, “it was validated on a VA [Veterans Affairs] cohort, which is a bit different than the cohort of patients seen at Mount Sinai. Therefore, validation in more academic tertiary care medical centers with high volume liver transplant would be helpful.”
Furthermore, said Bansal, who was not involved in the study, “they excluded those that receiving a liver transplant, and while only a small number, this is an important limitation.”
Nevertheless, she added, “Artificial intelligence has great potential in predictive risk models and will likely be a tool that assists for risk stratification, clinical management, and hopefully improved clinical outcomes.”
This study was partly supported by a VA Merit review to Bajaj and the National Center for Advancing Translational Sciences, National Institutes of Health. No conflicts of interest were reported by any author.
A version of this article appeared on Medscape.com.
“This highly inclusive, representative, and globally derived model has been externally validated,” Jasmohan Bajaj, MD, AGAF, professor of medicine at Virginia Commonwealth University in Richmond, Virginia, told GI & Hepatology News. “This gives us a crystal ball. It helps hospital teams, transplant centers, gastroenterology and intensive care unit services triage and prioritize patients more effectively.”
The study supporting the model, which Bajaj said “could be used at this stage,” was published online in Gastroenterology. The model is available for downloading at https://silveys.shinyapps.io/app_cleared/.
CLEARED Cohort Analyzed
Wide variations across the world regarding available resources, outpatient services, reasons for admission, and etiologies of cirrhosis can influence patient outcomes, according to Bajaj and colleagues. Therefore, they sought to use ML approaches to improve prognostication for all countries.
They analyzed admission-day data from the prospective Chronic Liver Disease Evolution And Registry for Events and Decompensation (CLEARED) consortium, which includes inpatients with cirrhosis enrolled from six continents. The analysis compared ML approaches with logistical regression to predict inpatient mortality.
The researchers performed internal validation (75/25 split) and subdivision using World-Bank income status: low/low-middle (L-LMIC), upper middle (UMIC), and high (HIC). They determined that the ML model with the best area-under-the-curve (AUC) would be externally validated in a US-Veteran cirrhosis inpatient population.
The CLEARED cohort included 7239 cirrhosis inpatients (mean age, 56 years; 64% men; median MELD-Na, 25) from 115 centers globally; 22.5% of centers belonged to LMICs, 41% to UMICs, and 34% to HICs.
A total of 808 patients (11.1%) died in the hospital.
Random-Forest analysis showed the best AUC (0.815) with high calibration. This was significantly better than parametric logistic regression (AUC, 0.774) and LASSO (AUC, 0.787) models.
Random-Forest also was better than logistic regression regardless of country income-level: HIC (AUC,0.806), UMIC (AUC, 0.867), and L-LMICs (AUC, 0.768).
Of the top 15 important variables selected from Random-Forest, admission for acute kidney injury, hepatic encephalopathy, high MELD-Na/white blood count, and not being in high income country were variables most predictive of mortality.
In contrast, higher albumin, hemoglobin, diuretic use on admission, viral etiology, and being in a high-income country were most protective.
The Random-Forest model was validated in 28,670 veterans (mean age, 67 years; 96% men; median MELD-Na,15), with an inpatient mortality of 4% (1158 patients).
The final Random-Forest model, using 48 of the 67 original covariates, attained a strong AUC of 0.859. A refit version using only the top 15 variables achieved a comparable AUC of 0.851.
Clinical Relevance
“Cirrhosis and resultant organ failures remain a dynamic and multidisciplinary problem,” Bajaj noted. “Machine learning techniques are one part of multi-faceted management strategy that is required in this population.”
If patients fall into the high-risk category, he said, “careful consultation with patients, families, and clinical teams is needed before providing information, including where this model was derived from. The results of these discussions could be instructive regarding decisions for transfer, more aggressive monitoring/ICU transfer, palliative care or transplant assessments.”
Meena B. Bansal, MD, system chief, Division of Liver Diseases, Mount Sinai Health System in New York City, called the tool “very promising.” However, she told GI & Hepatology News, “it was validated on a VA [Veterans Affairs] cohort, which is a bit different than the cohort of patients seen at Mount Sinai. Therefore, validation in more academic tertiary care medical centers with high volume liver transplant would be helpful.”
Furthermore, said Bansal, who was not involved in the study, “they excluded those that receiving a liver transplant, and while only a small number, this is an important limitation.”
Nevertheless, she added, “Artificial intelligence has great potential in predictive risk models and will likely be a tool that assists for risk stratification, clinical management, and hopefully improved clinical outcomes.”
This study was partly supported by a VA Merit review to Bajaj and the National Center for Advancing Translational Sciences, National Institutes of Health. No conflicts of interest were reported by any author.
A version of this article appeared on Medscape.com.
FROM GASTROENTEROLOGY
Colonoscopy Costs Rise When Private Equity Acquires GI Practices, but Quality Does Not
Price increases ranged from about 5% to about 7%.
In view of the growing trend to such acquisitions, policy makers should monitor the impact of PE investment in medical practices, according to researchers led by health economist Daniel R. Arnold, PhD, of the Department of Health Services, Policy & Practice in the School of Public Health at Brown University in Providence, Rhode Island. “In a previous study of ours, gastroenterology stood out as a particularly attractive specialty to private equity,” Arnold told GI & Hepatology News.
Published in JAMA Health Forum, the economic evaluation of more than 1.1 million patients and 1.3 million colonoscopies concluded that PE acquisitions of GI sites are difficult to justify.
The Study
This difference-in-differences event study and economic evaluation analyzed data from US GI practices acquired by PE firms from 2015 to 2021. Commercial insurance claims covering more than 50 million enrollees were used to calculate price, spending, utilization, and quality measures from 2012 to 2021, with all data analyzed from April to September 2024.
The main outcomes were price, spending per physician, number of colonoscopies per physician, number of unique patients per physician, and quality, as defined by polyp detection, incomplete colonoscopies, and four adverse event measures: cardiovascular, serious and nonserious GI events, and any other adverse events.
The mean age of patients was 47.1 years, and 47.8% were men. The sample included 718, 851 colonoscopies conducted by 1494 physicians in 590, 900 patients across 1240 PE-acquired practice sites and 637, 990 control colonoscopies conducted by 2550 physicians in 527,380 patients across 2657 independent practice sites.
Among the findings:
- Colonoscopy prices at PE-acquired sites increased by 4.5% (95% CI, 2.5-6.6; P < .001) vs independent practices. That increase was much lower than that reported by Singh and colleagues for .
- The estimated price increase was 6.7% (95% CI, 4.2-9.3; P < .001) when only colonoscopies at PE practices with market shares above the 75th percentile (24.4%) in 2021 were considered. Both increases were in line with other research, Arnold said.
- Colonoscopy spending per physician increased by 16.0% (95% CI, 8.4%-24.0%; P < .001), while the number of colonoscopies and the number of unique patients per physician increased by 12.1% (95% CI, 5.3-19.4; P < .001) and 11.3% (95% CI, 4.4%-18.5%; P < .001), respectively. These measures, however, were already increasing before PE acquisition.
- No statistically significant associations were detected for the six quality measures analyzed.
Could such cost-raising acquisitions potentially be blocked by concerned regulators?
“No. Generally the purchases are at prices below what would require notification to federal authorities,” Arnold said. “The Department of Justice/Federal Trade Commission hinted at being willing to look at serial acquisitions in their 2023 Merger Guidelines, but until that happens, these will likely continue to fly under the radar.”
Still, as evidence of PE-associated poorer quality outcomes as well as clinician burnout continues to emerge, Arnold added, “I would advise physicians who get buyout offers from PE to educate themselves on what could happen to patients and staff if they choose to sell.”
Offering an outsider’s perspective on the study, health economist Atul Gupta, PhD, an assistant professor of healthcare management in the Wharton School at the University of Pennsylvania in Philadelphia, called it an “excellent addition to the developing literature examining the effects of private equity ownership of healthcare providers.” Very few studies have examined the effects on prices and quality for the same set of deals and providers. “This is important because we want to be able to do an apples-to-apples comparison of the effects on both outcomes before judging PE ownership,” he told GI & Hepatology News.
In an accompanying editorial , primary care physician Jane M. Zhu, MD, an associate professor of medicine at Oregon Health & Science University in Portland, Oregon, and not involved in the commercial-insurance-based study, said one interpretation of the findings may be that PE acquisition focuses on reducing inefficiencies, improving access by expanding practice capacity, and increasing throughput. “Another interpretation may be that PE acquisition is focused on the strategic exploitation of market and pricing power. The latter may have less of an impact on clinical measures like quality of care, but potentially, both strategies could be at play.”
Since this analysis focused on the commercial population, understanding how patient demographics may change after PE acquisition is a future avenue for exploration. “For instance, a potential explanation for both the price and utilization shifts might be if payer mix shifted toward more commercially insured patients at the expense of Medicaid or Medicare patients,” she wrote.
Zhu added that the impact of PE on prices and spending, by now replicated across different settings and specialties, is far clearer than the effect of PE on access and quality. “The analysis by Arnold et al is a welcome addition to the literature, generating important questions for future study and transparent monitoring as investor-owners become increasingly influential in healthcare.”
Going forward, said Gupta, an open question is whether the harmful effects of PE ownership of practices are differentially worse than those of other corporate entities such as insurers and hospital systems.
“There are reasons to believe that PE could be worse in theory. For example, their short-term investment horizon may force them to take measures that others will not as well as avoid investing into capital improvements that have a long-run payoff,” he said. “Their uniquely high dependence on debt and unbundling of real estate can severely hurt financial solvency of providers.” But high-quality evidence is lacking to compare the effects from these two distinct forms of corporatization.
The trend away from individual private practice is a reality, Arnold said. “The administrative burden on solo docs is becoming too much and physicians just seem to want to treat patients and not deal with it. So the options at this point really become selling to a hospital system or private equity.”
This study was funded by a grant from the philanthropic foundation Arnold Ventures (no family relation to Daniel Arnold).
Arnold reported receiving grants from Arnold Ventures during the conduct of the study. Gupta had no competing interests to declare. Zhu reported receiving grants from the Agency for Healthcare Research and Quality during the submitted work and from the National Institutes of Health, National Institute for Health Care Management Foundation, and American Psychological Association, as well as personal fees from Cambia outside the submitted work.
A version of this article appeared on Medscape.com.
Price increases ranged from about 5% to about 7%.
In view of the growing trend to such acquisitions, policy makers should monitor the impact of PE investment in medical practices, according to researchers led by health economist Daniel R. Arnold, PhD, of the Department of Health Services, Policy & Practice in the School of Public Health at Brown University in Providence, Rhode Island. “In a previous study of ours, gastroenterology stood out as a particularly attractive specialty to private equity,” Arnold told GI & Hepatology News.
Published in JAMA Health Forum, the economic evaluation of more than 1.1 million patients and 1.3 million colonoscopies concluded that PE acquisitions of GI sites are difficult to justify.
The Study
This difference-in-differences event study and economic evaluation analyzed data from US GI practices acquired by PE firms from 2015 to 2021. Commercial insurance claims covering more than 50 million enrollees were used to calculate price, spending, utilization, and quality measures from 2012 to 2021, with all data analyzed from April to September 2024.
The main outcomes were price, spending per physician, number of colonoscopies per physician, number of unique patients per physician, and quality, as defined by polyp detection, incomplete colonoscopies, and four adverse event measures: cardiovascular, serious and nonserious GI events, and any other adverse events.
The mean age of patients was 47.1 years, and 47.8% were men. The sample included 718, 851 colonoscopies conducted by 1494 physicians in 590, 900 patients across 1240 PE-acquired practice sites and 637, 990 control colonoscopies conducted by 2550 physicians in 527,380 patients across 2657 independent practice sites.
Among the findings:
- Colonoscopy prices at PE-acquired sites increased by 4.5% (95% CI, 2.5-6.6; P < .001) vs independent practices. That increase was much lower than that reported by Singh and colleagues for .
- The estimated price increase was 6.7% (95% CI, 4.2-9.3; P < .001) when only colonoscopies at PE practices with market shares above the 75th percentile (24.4%) in 2021 were considered. Both increases were in line with other research, Arnold said.
- Colonoscopy spending per physician increased by 16.0% (95% CI, 8.4%-24.0%; P < .001), while the number of colonoscopies and the number of unique patients per physician increased by 12.1% (95% CI, 5.3-19.4; P < .001) and 11.3% (95% CI, 4.4%-18.5%; P < .001), respectively. These measures, however, were already increasing before PE acquisition.
- No statistically significant associations were detected for the six quality measures analyzed.
Could such cost-raising acquisitions potentially be blocked by concerned regulators?
“No. Generally the purchases are at prices below what would require notification to federal authorities,” Arnold said. “The Department of Justice/Federal Trade Commission hinted at being willing to look at serial acquisitions in their 2023 Merger Guidelines, but until that happens, these will likely continue to fly under the radar.”
Still, as evidence of PE-associated poorer quality outcomes as well as clinician burnout continues to emerge, Arnold added, “I would advise physicians who get buyout offers from PE to educate themselves on what could happen to patients and staff if they choose to sell.”
Offering an outsider’s perspective on the study, health economist Atul Gupta, PhD, an assistant professor of healthcare management in the Wharton School at the University of Pennsylvania in Philadelphia, called it an “excellent addition to the developing literature examining the effects of private equity ownership of healthcare providers.” Very few studies have examined the effects on prices and quality for the same set of deals and providers. “This is important because we want to be able to do an apples-to-apples comparison of the effects on both outcomes before judging PE ownership,” he told GI & Hepatology News.
In an accompanying editorial , primary care physician Jane M. Zhu, MD, an associate professor of medicine at Oregon Health & Science University in Portland, Oregon, and not involved in the commercial-insurance-based study, said one interpretation of the findings may be that PE acquisition focuses on reducing inefficiencies, improving access by expanding practice capacity, and increasing throughput. “Another interpretation may be that PE acquisition is focused on the strategic exploitation of market and pricing power. The latter may have less of an impact on clinical measures like quality of care, but potentially, both strategies could be at play.”
Since this analysis focused on the commercial population, understanding how patient demographics may change after PE acquisition is a future avenue for exploration. “For instance, a potential explanation for both the price and utilization shifts might be if payer mix shifted toward more commercially insured patients at the expense of Medicaid or Medicare patients,” she wrote.
Zhu added that the impact of PE on prices and spending, by now replicated across different settings and specialties, is far clearer than the effect of PE on access and quality. “The analysis by Arnold et al is a welcome addition to the literature, generating important questions for future study and transparent monitoring as investor-owners become increasingly influential in healthcare.”
Going forward, said Gupta, an open question is whether the harmful effects of PE ownership of practices are differentially worse than those of other corporate entities such as insurers and hospital systems.
“There are reasons to believe that PE could be worse in theory. For example, their short-term investment horizon may force them to take measures that others will not as well as avoid investing into capital improvements that have a long-run payoff,” he said. “Their uniquely high dependence on debt and unbundling of real estate can severely hurt financial solvency of providers.” But high-quality evidence is lacking to compare the effects from these two distinct forms of corporatization.
The trend away from individual private practice is a reality, Arnold said. “The administrative burden on solo docs is becoming too much and physicians just seem to want to treat patients and not deal with it. So the options at this point really become selling to a hospital system or private equity.”
This study was funded by a grant from the philanthropic foundation Arnold Ventures (no family relation to Daniel Arnold).
Arnold reported receiving grants from Arnold Ventures during the conduct of the study. Gupta had no competing interests to declare. Zhu reported receiving grants from the Agency for Healthcare Research and Quality during the submitted work and from the National Institutes of Health, National Institute for Health Care Management Foundation, and American Psychological Association, as well as personal fees from Cambia outside the submitted work.
A version of this article appeared on Medscape.com.
Price increases ranged from about 5% to about 7%.
In view of the growing trend to such acquisitions, policy makers should monitor the impact of PE investment in medical practices, according to researchers led by health economist Daniel R. Arnold, PhD, of the Department of Health Services, Policy & Practice in the School of Public Health at Brown University in Providence, Rhode Island. “In a previous study of ours, gastroenterology stood out as a particularly attractive specialty to private equity,” Arnold told GI & Hepatology News.
Published in JAMA Health Forum, the economic evaluation of more than 1.1 million patients and 1.3 million colonoscopies concluded that PE acquisitions of GI sites are difficult to justify.
The Study
This difference-in-differences event study and economic evaluation analyzed data from US GI practices acquired by PE firms from 2015 to 2021. Commercial insurance claims covering more than 50 million enrollees were used to calculate price, spending, utilization, and quality measures from 2012 to 2021, with all data analyzed from April to September 2024.
The main outcomes were price, spending per physician, number of colonoscopies per physician, number of unique patients per physician, and quality, as defined by polyp detection, incomplete colonoscopies, and four adverse event measures: cardiovascular, serious and nonserious GI events, and any other adverse events.
The mean age of patients was 47.1 years, and 47.8% were men. The sample included 718, 851 colonoscopies conducted by 1494 physicians in 590, 900 patients across 1240 PE-acquired practice sites and 637, 990 control colonoscopies conducted by 2550 physicians in 527,380 patients across 2657 independent practice sites.
Among the findings:
- Colonoscopy prices at PE-acquired sites increased by 4.5% (95% CI, 2.5-6.6; P < .001) vs independent practices. That increase was much lower than that reported by Singh and colleagues for .
- The estimated price increase was 6.7% (95% CI, 4.2-9.3; P < .001) when only colonoscopies at PE practices with market shares above the 75th percentile (24.4%) in 2021 were considered. Both increases were in line with other research, Arnold said.
- Colonoscopy spending per physician increased by 16.0% (95% CI, 8.4%-24.0%; P < .001), while the number of colonoscopies and the number of unique patients per physician increased by 12.1% (95% CI, 5.3-19.4; P < .001) and 11.3% (95% CI, 4.4%-18.5%; P < .001), respectively. These measures, however, were already increasing before PE acquisition.
- No statistically significant associations were detected for the six quality measures analyzed.
Could such cost-raising acquisitions potentially be blocked by concerned regulators?
“No. Generally the purchases are at prices below what would require notification to federal authorities,” Arnold said. “The Department of Justice/Federal Trade Commission hinted at being willing to look at serial acquisitions in their 2023 Merger Guidelines, but until that happens, these will likely continue to fly under the radar.”
Still, as evidence of PE-associated poorer quality outcomes as well as clinician burnout continues to emerge, Arnold added, “I would advise physicians who get buyout offers from PE to educate themselves on what could happen to patients and staff if they choose to sell.”
Offering an outsider’s perspective on the study, health economist Atul Gupta, PhD, an assistant professor of healthcare management in the Wharton School at the University of Pennsylvania in Philadelphia, called it an “excellent addition to the developing literature examining the effects of private equity ownership of healthcare providers.” Very few studies have examined the effects on prices and quality for the same set of deals and providers. “This is important because we want to be able to do an apples-to-apples comparison of the effects on both outcomes before judging PE ownership,” he told GI & Hepatology News.
In an accompanying editorial , primary care physician Jane M. Zhu, MD, an associate professor of medicine at Oregon Health & Science University in Portland, Oregon, and not involved in the commercial-insurance-based study, said one interpretation of the findings may be that PE acquisition focuses on reducing inefficiencies, improving access by expanding practice capacity, and increasing throughput. “Another interpretation may be that PE acquisition is focused on the strategic exploitation of market and pricing power. The latter may have less of an impact on clinical measures like quality of care, but potentially, both strategies could be at play.”
Since this analysis focused on the commercial population, understanding how patient demographics may change after PE acquisition is a future avenue for exploration. “For instance, a potential explanation for both the price and utilization shifts might be if payer mix shifted toward more commercially insured patients at the expense of Medicaid or Medicare patients,” she wrote.
Zhu added that the impact of PE on prices and spending, by now replicated across different settings and specialties, is far clearer than the effect of PE on access and quality. “The analysis by Arnold et al is a welcome addition to the literature, generating important questions for future study and transparent monitoring as investor-owners become increasingly influential in healthcare.”
Going forward, said Gupta, an open question is whether the harmful effects of PE ownership of practices are differentially worse than those of other corporate entities such as insurers and hospital systems.
“There are reasons to believe that PE could be worse in theory. For example, their short-term investment horizon may force them to take measures that others will not as well as avoid investing into capital improvements that have a long-run payoff,” he said. “Their uniquely high dependence on debt and unbundling of real estate can severely hurt financial solvency of providers.” But high-quality evidence is lacking to compare the effects from these two distinct forms of corporatization.
The trend away from individual private practice is a reality, Arnold said. “The administrative burden on solo docs is becoming too much and physicians just seem to want to treat patients and not deal with it. So the options at this point really become selling to a hospital system or private equity.”
This study was funded by a grant from the philanthropic foundation Arnold Ventures (no family relation to Daniel Arnold).
Arnold reported receiving grants from Arnold Ventures during the conduct of the study. Gupta had no competing interests to declare. Zhu reported receiving grants from the Agency for Healthcare Research and Quality during the submitted work and from the National Institutes of Health, National Institute for Health Care Management Foundation, and American Psychological Association, as well as personal fees from Cambia outside the submitted work.
A version of this article appeared on Medscape.com.
Less Invasive Sponge Test Stratifies Risk in Patients With Barrett’s Esophagus
The biomarker risk panel collected by the panesophageal Cytosponge-on-a-string in more than 900 UK patients helped identify those at highest risk for dysplasia or cancer and needing endoscopy. It was found safe for following low-risk patients who did not need endoscopy.
Endoscopic surveillance is the clinical standard for BE, but its effectiveness is inconsistent, wrote Rebecca C. Fitzgerald, MD, AGAF, professor in the Early Cancer Institute at the University of Cambridge in Cambridge, England, and colleagues in The Lancet.
“It is often performed by nonspecialists, and recent trials show that around 10% of cases of dysplasia and cancer are missed, which means some patients re-present within a year of their surveillance procedure with a symptomatic cancer that should have been diagnosed earlier,” Fitzgerald told GI & Hepatology News.
Moreover, repeated endoscopy monitoring is stressful. “A simple nonendoscopic capsule sponge test done nearer to home is less scary and could be less operator-dependent. By reducing the burden of endoscopy in patients at very low risk we can focus more on the patients at higher risk,” she said.
In 2022, her research group had reported that the capsule sponge test, coupled with a centralized lab test for p53 and atypia, can risk-stratify patients into low-, moderate-, and high-risk groups. “In the current study, we wanted to check this risk stratification capsule sponge test in the real world. Our main aim was to see if we could conform the 2022 results with the hypothesis that the low-risk patients — more than 50% of patients in surveillance — would have a risk of high-grade dysplasia or cancer that was sufficiently low — that is, less than from 3% — and could therefore have follow-up with the capsule sponge without requiring endoscopy.”
The investigators hypothesized that the 15% at high risk would have a significant chance of dysplasia warranting endoscopy in a specialist center.
“Our results showed that in the low-risk group the risk of high-grade dysplasia or cancer was 0.4%, suggesting these patients could be offered follow-up with the capsule sponge test,” Fitzgerald said.
The high-risk group with a double biomarker positive (p53 and atypia) had an 85% risk for dysplasia or cancer. “We call this a tier 1 or ultra-high risk, and this suggests these cases merit a specialist endoscopy in a center that could treat the dysplasia/cancer,” she said.
Study Details
Adult participants (n = 910) were recruited from August 2020 to December 2024 in two multicenter, prospective, pragmatic implementation studies from 13 hospitals. Patients with nondysplastic BE on last endoscopy had a capsule sponge test.
Patient risk was assigned as low (clinical and capsule sponge biomarkers negative), moderate (negative for capsule sponge biomarkers, positive clinical biomarkers: age, sex, and segment length), or high risk (p53 abnormality, glandular atypia regardless of clinical biomarkers, or both). The primary outcome was a diagnosis of high-grade dysplasia or cancer necessitating treatment, according to the risk group.
In the cohort, 138 (15%) were classified as having high risk, 283 (31%) had moderate risk, and 489 (54%) had low risk.
The positive predictive value for any dysplasia or worse in the high-risk group was 37.7% (95% CI, 29.7-46.4). Patients with both atypia and aberrant p53 had the highest risk for high-grade dysplasia or cancer with a relative risk of 135.8 (95% CI, 32.7-564.0) vs the low-risk group.
The prevalence of high-grade dysplasia or cancer in the low-risk group was, as mentioned, just 0.4% (95% CI, 0.1-1.6), while the negative predictive value for any dysplasia or cancer was 97.8% (95% CI, 95.9-98.8). Applying a machine learning algorithm reduced the proportion needing p53 pathology review to 32% without missing any positive cases.
Offering a US perspective on the study, Nicholas J. Shaheen, MD, MPH, AGAF, professor of medicine and director of the NC Translational & Clinical Sciences Institute at the University of North Carolina School of Medicine in Chapel Hill, called the findings “very provocative.”
“We have known for some time that nonendoscopic techniques could be used to screen for Barrett’s esophagus and esophageal cancer, allowing us to screen larger groups of patients in a more cost-effective manner compared to traditional upper endoscopy,” he told GI & Hepatology News. “This study suggests that, in addition to case-finding for Barrett’s [esophagus], a nonendoscopic sponge-based technique can also help us stratify risk, finding cases that either already harbor cancer or are at high risk to do so.”
Shaheen said these cases deserve immediate attention since they are most likely to benefit from timely endoscopic intervention. “The study also suggests that a nonendoscopic result could someday be used to decide subsequent follow-up, with low-risk patients undergoing further nonendoscopic surveillance, while higher-risk patients would move on to endoscopy. Such a paradigm could unburden our endoscopy units from low-risk patients unlikely to benefit from endoscopy as well as increase the numbers of patients who are able to be screened.”
Fitzgerald added, “The GI community is realizing that we need a better approach to managing patients with Barrett’s [esophagus]. In the UK this evidence is being considered by our guideline committee, and it would influence the upcoming guidelines in 2025 with a requirement to continue to audit the results. Outside of the UK we hope this will pave the way for nonendoscopic approaches to Barrett’s [esophagus] surveillance.”
One ongoing goal is to optimize the biomarkers, Fitzgerald said. “For patients with longer segments we would like to add additional genomic biomarkers to refine the risk predictions,” she said. “We need a more operator-independent, consistent method for monitoring Barrett’s [esophagus]. This large real-world study is highly encouraging for a more personalized and patient-friendly approach to Barrett’s [esophagus] surveillance.”
This study was funded by Innovate UK, Cancer Research UK, National Health Service England Cancer Alliance. Cytosponge technology is licensed by the Medical Research Council to Medtronic. Fitzgerald declared holding patents related to this test. Fitzgerald reported being a shareholder in Cyted Health.
Shaheen reported receiving research funding from Lucid Diagnostics and Cyted Health, both of which are manufacturers of nonendoscopic screening devices for BE.
A version of this article appeared on Medscape.com.
The biomarker risk panel collected by the panesophageal Cytosponge-on-a-string in more than 900 UK patients helped identify those at highest risk for dysplasia or cancer and needing endoscopy. It was found safe for following low-risk patients who did not need endoscopy.
Endoscopic surveillance is the clinical standard for BE, but its effectiveness is inconsistent, wrote Rebecca C. Fitzgerald, MD, AGAF, professor in the Early Cancer Institute at the University of Cambridge in Cambridge, England, and colleagues in The Lancet.
“It is often performed by nonspecialists, and recent trials show that around 10% of cases of dysplasia and cancer are missed, which means some patients re-present within a year of their surveillance procedure with a symptomatic cancer that should have been diagnosed earlier,” Fitzgerald told GI & Hepatology News.
Moreover, repeated endoscopy monitoring is stressful. “A simple nonendoscopic capsule sponge test done nearer to home is less scary and could be less operator-dependent. By reducing the burden of endoscopy in patients at very low risk we can focus more on the patients at higher risk,” she said.
In 2022, her research group had reported that the capsule sponge test, coupled with a centralized lab test for p53 and atypia, can risk-stratify patients into low-, moderate-, and high-risk groups. “In the current study, we wanted to check this risk stratification capsule sponge test in the real world. Our main aim was to see if we could conform the 2022 results with the hypothesis that the low-risk patients — more than 50% of patients in surveillance — would have a risk of high-grade dysplasia or cancer that was sufficiently low — that is, less than from 3% — and could therefore have follow-up with the capsule sponge without requiring endoscopy.”
The investigators hypothesized that the 15% at high risk would have a significant chance of dysplasia warranting endoscopy in a specialist center.
“Our results showed that in the low-risk group the risk of high-grade dysplasia or cancer was 0.4%, suggesting these patients could be offered follow-up with the capsule sponge test,” Fitzgerald said.
The high-risk group with a double biomarker positive (p53 and atypia) had an 85% risk for dysplasia or cancer. “We call this a tier 1 or ultra-high risk, and this suggests these cases merit a specialist endoscopy in a center that could treat the dysplasia/cancer,” she said.
Study Details
Adult participants (n = 910) were recruited from August 2020 to December 2024 in two multicenter, prospective, pragmatic implementation studies from 13 hospitals. Patients with nondysplastic BE on last endoscopy had a capsule sponge test.
Patient risk was assigned as low (clinical and capsule sponge biomarkers negative), moderate (negative for capsule sponge biomarkers, positive clinical biomarkers: age, sex, and segment length), or high risk (p53 abnormality, glandular atypia regardless of clinical biomarkers, or both). The primary outcome was a diagnosis of high-grade dysplasia or cancer necessitating treatment, according to the risk group.
In the cohort, 138 (15%) were classified as having high risk, 283 (31%) had moderate risk, and 489 (54%) had low risk.
The positive predictive value for any dysplasia or worse in the high-risk group was 37.7% (95% CI, 29.7-46.4). Patients with both atypia and aberrant p53 had the highest risk for high-grade dysplasia or cancer with a relative risk of 135.8 (95% CI, 32.7-564.0) vs the low-risk group.
The prevalence of high-grade dysplasia or cancer in the low-risk group was, as mentioned, just 0.4% (95% CI, 0.1-1.6), while the negative predictive value for any dysplasia or cancer was 97.8% (95% CI, 95.9-98.8). Applying a machine learning algorithm reduced the proportion needing p53 pathology review to 32% without missing any positive cases.
Offering a US perspective on the study, Nicholas J. Shaheen, MD, MPH, AGAF, professor of medicine and director of the NC Translational & Clinical Sciences Institute at the University of North Carolina School of Medicine in Chapel Hill, called the findings “very provocative.”
“We have known for some time that nonendoscopic techniques could be used to screen for Barrett’s esophagus and esophageal cancer, allowing us to screen larger groups of patients in a more cost-effective manner compared to traditional upper endoscopy,” he told GI & Hepatology News. “This study suggests that, in addition to case-finding for Barrett’s [esophagus], a nonendoscopic sponge-based technique can also help us stratify risk, finding cases that either already harbor cancer or are at high risk to do so.”
Shaheen said these cases deserve immediate attention since they are most likely to benefit from timely endoscopic intervention. “The study also suggests that a nonendoscopic result could someday be used to decide subsequent follow-up, with low-risk patients undergoing further nonendoscopic surveillance, while higher-risk patients would move on to endoscopy. Such a paradigm could unburden our endoscopy units from low-risk patients unlikely to benefit from endoscopy as well as increase the numbers of patients who are able to be screened.”
Fitzgerald added, “The GI community is realizing that we need a better approach to managing patients with Barrett’s [esophagus]. In the UK this evidence is being considered by our guideline committee, and it would influence the upcoming guidelines in 2025 with a requirement to continue to audit the results. Outside of the UK we hope this will pave the way for nonendoscopic approaches to Barrett’s [esophagus] surveillance.”
One ongoing goal is to optimize the biomarkers, Fitzgerald said. “For patients with longer segments we would like to add additional genomic biomarkers to refine the risk predictions,” she said. “We need a more operator-independent, consistent method for monitoring Barrett’s [esophagus]. This large real-world study is highly encouraging for a more personalized and patient-friendly approach to Barrett’s [esophagus] surveillance.”
This study was funded by Innovate UK, Cancer Research UK, National Health Service England Cancer Alliance. Cytosponge technology is licensed by the Medical Research Council to Medtronic. Fitzgerald declared holding patents related to this test. Fitzgerald reported being a shareholder in Cyted Health.
Shaheen reported receiving research funding from Lucid Diagnostics and Cyted Health, both of which are manufacturers of nonendoscopic screening devices for BE.
A version of this article appeared on Medscape.com.
The biomarker risk panel collected by the panesophageal Cytosponge-on-a-string in more than 900 UK patients helped identify those at highest risk for dysplasia or cancer and needing endoscopy. It was found safe for following low-risk patients who did not need endoscopy.
Endoscopic surveillance is the clinical standard for BE, but its effectiveness is inconsistent, wrote Rebecca C. Fitzgerald, MD, AGAF, professor in the Early Cancer Institute at the University of Cambridge in Cambridge, England, and colleagues in The Lancet.
“It is often performed by nonspecialists, and recent trials show that around 10% of cases of dysplasia and cancer are missed, which means some patients re-present within a year of their surveillance procedure with a symptomatic cancer that should have been diagnosed earlier,” Fitzgerald told GI & Hepatology News.
Moreover, repeated endoscopy monitoring is stressful. “A simple nonendoscopic capsule sponge test done nearer to home is less scary and could be less operator-dependent. By reducing the burden of endoscopy in patients at very low risk we can focus more on the patients at higher risk,” she said.
In 2022, her research group had reported that the capsule sponge test, coupled with a centralized lab test for p53 and atypia, can risk-stratify patients into low-, moderate-, and high-risk groups. “In the current study, we wanted to check this risk stratification capsule sponge test in the real world. Our main aim was to see if we could conform the 2022 results with the hypothesis that the low-risk patients — more than 50% of patients in surveillance — would have a risk of high-grade dysplasia or cancer that was sufficiently low — that is, less than from 3% — and could therefore have follow-up with the capsule sponge without requiring endoscopy.”
The investigators hypothesized that the 15% at high risk would have a significant chance of dysplasia warranting endoscopy in a specialist center.
“Our results showed that in the low-risk group the risk of high-grade dysplasia or cancer was 0.4%, suggesting these patients could be offered follow-up with the capsule sponge test,” Fitzgerald said.
The high-risk group with a double biomarker positive (p53 and atypia) had an 85% risk for dysplasia or cancer. “We call this a tier 1 or ultra-high risk, and this suggests these cases merit a specialist endoscopy in a center that could treat the dysplasia/cancer,” she said.
Study Details
Adult participants (n = 910) were recruited from August 2020 to December 2024 in two multicenter, prospective, pragmatic implementation studies from 13 hospitals. Patients with nondysplastic BE on last endoscopy had a capsule sponge test.
Patient risk was assigned as low (clinical and capsule sponge biomarkers negative), moderate (negative for capsule sponge biomarkers, positive clinical biomarkers: age, sex, and segment length), or high risk (p53 abnormality, glandular atypia regardless of clinical biomarkers, or both). The primary outcome was a diagnosis of high-grade dysplasia or cancer necessitating treatment, according to the risk group.
In the cohort, 138 (15%) were classified as having high risk, 283 (31%) had moderate risk, and 489 (54%) had low risk.
The positive predictive value for any dysplasia or worse in the high-risk group was 37.7% (95% CI, 29.7-46.4). Patients with both atypia and aberrant p53 had the highest risk for high-grade dysplasia or cancer with a relative risk of 135.8 (95% CI, 32.7-564.0) vs the low-risk group.
The prevalence of high-grade dysplasia or cancer in the low-risk group was, as mentioned, just 0.4% (95% CI, 0.1-1.6), while the negative predictive value for any dysplasia or cancer was 97.8% (95% CI, 95.9-98.8). Applying a machine learning algorithm reduced the proportion needing p53 pathology review to 32% without missing any positive cases.
Offering a US perspective on the study, Nicholas J. Shaheen, MD, MPH, AGAF, professor of medicine and director of the NC Translational & Clinical Sciences Institute at the University of North Carolina School of Medicine in Chapel Hill, called the findings “very provocative.”
“We have known for some time that nonendoscopic techniques could be used to screen for Barrett’s esophagus and esophageal cancer, allowing us to screen larger groups of patients in a more cost-effective manner compared to traditional upper endoscopy,” he told GI & Hepatology News. “This study suggests that, in addition to case-finding for Barrett’s [esophagus], a nonendoscopic sponge-based technique can also help us stratify risk, finding cases that either already harbor cancer or are at high risk to do so.”
Shaheen said these cases deserve immediate attention since they are most likely to benefit from timely endoscopic intervention. “The study also suggests that a nonendoscopic result could someday be used to decide subsequent follow-up, with low-risk patients undergoing further nonendoscopic surveillance, while higher-risk patients would move on to endoscopy. Such a paradigm could unburden our endoscopy units from low-risk patients unlikely to benefit from endoscopy as well as increase the numbers of patients who are able to be screened.”
Fitzgerald added, “The GI community is realizing that we need a better approach to managing patients with Barrett’s [esophagus]. In the UK this evidence is being considered by our guideline committee, and it would influence the upcoming guidelines in 2025 with a requirement to continue to audit the results. Outside of the UK we hope this will pave the way for nonendoscopic approaches to Barrett’s [esophagus] surveillance.”
One ongoing goal is to optimize the biomarkers, Fitzgerald said. “For patients with longer segments we would like to add additional genomic biomarkers to refine the risk predictions,” she said. “We need a more operator-independent, consistent method for monitoring Barrett’s [esophagus]. This large real-world study is highly encouraging for a more personalized and patient-friendly approach to Barrett’s [esophagus] surveillance.”
This study was funded by Innovate UK, Cancer Research UK, National Health Service England Cancer Alliance. Cytosponge technology is licensed by the Medical Research Council to Medtronic. Fitzgerald declared holding patents related to this test. Fitzgerald reported being a shareholder in Cyted Health.
Shaheen reported receiving research funding from Lucid Diagnostics and Cyted Health, both of which are manufacturers of nonendoscopic screening devices for BE.
A version of this article appeared on Medscape.com.
Sleep Changes in IBD Could Signal Inflammation, Flareups
, an observational study suggested.
Sleep data from 101 study participants over a mean duration of about 228 days revealed that altered sleep architecture was only apparent when inflammation was present — symptoms alone did not impact sleep cycles or signal inflammation.
“We thought symptoms might have an impact on sleep, but interestingly, our data showed that measurable changes like reduced rapid eye movement (REM) sleep and increased light sleep only occurred during periods of active inflammation,” Robert Hirten, MD, associate professor of Medicine (Gastroenterology), and Artificial Intelligence and Human Health, at the Icahn School of Medicine at Mount Sinai, New York City, told GI & Hepatology News.
“It was also interesting to see distinct patterns in sleep metrics begin to shift over the 45 days before a flare, suggesting the potential for sleep to serve as an early indicator of disease activity,” he added.
“Sleep is often overlooked in the management of IBD, but it may provide valuable insights into a patient’s underlying disease state,” he said. “While sleep monitoring isn’t yet a standard part of IBD care, this study highlights its potential as a noninvasive window into disease activity, and a promising area for future clinical integration.”
The study was published online in Clinical Gastroenterology and Hepatology.
Less REM Sleep, More Light Sleep
Researchers assessed the impact of inflammation and symptoms on sleep architecture in IBD by analyzing data from 101 individuals who answered daily disease activity surveys and wore a wearable device.
The mean age of participants was 41 years and 65.3% were women. Sixty-three participants (62.4%) had Crohn’s disease (CD) and 38 (37.6%) had ulcerative colitis (UC).
Almost 40 (39.6%) participants used an Apple Watch; 50 (49.5%) used a Fitbit; and 11 (10.9%) used an Oura ring. Sleep architecture, sleep efficiency, and total hours asleep were collected from the devices. Participants were encouraged to wear their devices for at least 4 days per week and 8 hours per day and were not required to wear them at night. Participants provided data by linking their devices to ehive, Mount Sinai’s custom app.
Daily clinical disease activity was assessed using the UC or CD Patient Reported Outcome-2 survey. Participants were asked to answer at least four daily surveys each week.
Associations between sleep metrics and periods of symptomatic and inflammatory flares, and combinations of symptomatic and inflammatory activity, were compared to periods of symptomatic and inflammatory remission.
Furthermore, researchers explored the rate of change in sleep metrics for 45 days before and after inflammatory and symptomatic flares.
Participants contributed a mean duration of 228.16 nights of wearable data. During active inflammation, they spent a lower percentage of sleep time in REM (20% vs 21.59%) and a greater percentage of sleep time in light sleep (62.23% vs 59.95%) than during inflammatory remission. No differences were observed in the mean percentage of time in deep sleep, sleep efficiency, or total time asleep.
During symptomatic flares, there were no differences in the percentage of sleep time in REM sleep, deep sleep, light sleep, or sleep efficiency compared with periods of inflammatory remission. However, participants slept less overall during symptomatic flares compared with during symptomatic remission.
Compared with during asymptomatic and uninflamed periods, during asymptomatic but inflamed periods, participants spent a lower percentage of time in REM sleep, and more time in light sleep; however, there were no differences in sleep efficiency or total time asleep.
Similarly, participants had more light sleep and less REM sleep during symptomatic and inflammatory flares than during asymptomatic and uninflamed periods — but there were no differences in the percentage of time spent in deep sleep, in sleep efficiency, and the total time asleep.
Symptomatic flares alone, without inflammation, did not impact sleep metrics, the researchers concluded. However, periods with active inflammation were associated with a significantly smaller percentage of sleep time in REM sleep and a greater percentage of sleep time in light sleep.
The team also performed longitudinal mapping of sleep patterns before, during, and after disease exacerbations by analyzing sleep data for 6 weeks before and 6 weeks after flare episodes.
They found that sleep disturbances significantly worsen leading up to inflammatory flares and improve afterward, suggesting that sleep changes may signal upcoming increased disease activity. Evaluating the intersection of inflammatory and symptomatic flares, altered sleep architecture was only evident when inflammation was present.
“These findings raise important questions about whether intervening on sleep can actually impact inflammation or disease trajectory in IBD,” Hirten said. “Next steps include studying whether targeted sleep interventions can improve both sleep and IBD outcomes.”
While this research is still in the early stages, he said, “it suggests that sleep may have a relationship with inflammatory activity in IBD. For patients, it reinforces the value of paying attention to sleep changes.”
The findings also show the potential of wearable devices to guide more personalized monitoring, he added. “More work is needed before sleep metrics can be used routinely in clinical decision-making.”
Validates the Use of Wearables
Commenting on the study for GI & Hepatology News, Michael Mintz, MD, a gastroenterologist at Weill Cornell Medicine and NewYork-Presbyterian in New York City, observed, “Gastrointestinal symptoms often do not correlate with objective disease activity in IBD, creating a diagnostic challenge for gastroenterologists. Burdensome, expensive, and/or invasive testing, such as colonoscopies, stool tests, or imaging, are frequently required to monitor disease activity.”
“This study is a first step in objectively monitoring inflammation in a patient-centric way that does not create undue burden to our patients,” he said. “It also provides longitudinal data that suggests changes in sleep patterns can pre-date disease flares, which ideally can lead to earlier intervention to prevent disease complications.”
Like Hirten, he noted that clinical decisions, such as changing IBD therapy, should not be based on the results of this study. “Rather this provides validation that wearable technology can provide useful objective data that correlates with disease activity.”
Furthermore, he said, it is not clear whether analyzing sleep data is a cost-effective way of monitoring IBD disease activity, or whether that data should be used alone or in combination with other objective disease markers, to influence clinical decision-making.
“This study provides proof of concept that there is a relationship between sleep characteristics and objective inflammation, but further studies are needed,” he said. “I am hopeful that this technology will give us another tool that we can use in clinical practice to monitor disease activity and improve outcomes in a way that is comfortable and convenient for our patients.”
This study was supported by a grant to Hirten from the US National Institutes of Health. Hirten reported receiving consulting fees from Bristol Meyers Squibb, AbbVie; stock options from Salvo Health; and research support from Janssen, Intralytix, EnLiSense, Crohn’s and Colitis Foundation. Mintz declared no competing interests.
A version of this article appeared on Medscape.com.
, an observational study suggested.
Sleep data from 101 study participants over a mean duration of about 228 days revealed that altered sleep architecture was only apparent when inflammation was present — symptoms alone did not impact sleep cycles or signal inflammation.
“We thought symptoms might have an impact on sleep, but interestingly, our data showed that measurable changes like reduced rapid eye movement (REM) sleep and increased light sleep only occurred during periods of active inflammation,” Robert Hirten, MD, associate professor of Medicine (Gastroenterology), and Artificial Intelligence and Human Health, at the Icahn School of Medicine at Mount Sinai, New York City, told GI & Hepatology News.
“It was also interesting to see distinct patterns in sleep metrics begin to shift over the 45 days before a flare, suggesting the potential for sleep to serve as an early indicator of disease activity,” he added.
“Sleep is often overlooked in the management of IBD, but it may provide valuable insights into a patient’s underlying disease state,” he said. “While sleep monitoring isn’t yet a standard part of IBD care, this study highlights its potential as a noninvasive window into disease activity, and a promising area for future clinical integration.”
The study was published online in Clinical Gastroenterology and Hepatology.
Less REM Sleep, More Light Sleep
Researchers assessed the impact of inflammation and symptoms on sleep architecture in IBD by analyzing data from 101 individuals who answered daily disease activity surveys and wore a wearable device.
The mean age of participants was 41 years and 65.3% were women. Sixty-three participants (62.4%) had Crohn’s disease (CD) and 38 (37.6%) had ulcerative colitis (UC).
Almost 40 (39.6%) participants used an Apple Watch; 50 (49.5%) used a Fitbit; and 11 (10.9%) used an Oura ring. Sleep architecture, sleep efficiency, and total hours asleep were collected from the devices. Participants were encouraged to wear their devices for at least 4 days per week and 8 hours per day and were not required to wear them at night. Participants provided data by linking their devices to ehive, Mount Sinai’s custom app.
Daily clinical disease activity was assessed using the UC or CD Patient Reported Outcome-2 survey. Participants were asked to answer at least four daily surveys each week.
Associations between sleep metrics and periods of symptomatic and inflammatory flares, and combinations of symptomatic and inflammatory activity, were compared to periods of symptomatic and inflammatory remission.
Furthermore, researchers explored the rate of change in sleep metrics for 45 days before and after inflammatory and symptomatic flares.
Participants contributed a mean duration of 228.16 nights of wearable data. During active inflammation, they spent a lower percentage of sleep time in REM (20% vs 21.59%) and a greater percentage of sleep time in light sleep (62.23% vs 59.95%) than during inflammatory remission. No differences were observed in the mean percentage of time in deep sleep, sleep efficiency, or total time asleep.
During symptomatic flares, there were no differences in the percentage of sleep time in REM sleep, deep sleep, light sleep, or sleep efficiency compared with periods of inflammatory remission. However, participants slept less overall during symptomatic flares compared with during symptomatic remission.
Compared with during asymptomatic and uninflamed periods, during asymptomatic but inflamed periods, participants spent a lower percentage of time in REM sleep, and more time in light sleep; however, there were no differences in sleep efficiency or total time asleep.
Similarly, participants had more light sleep and less REM sleep during symptomatic and inflammatory flares than during asymptomatic and uninflamed periods — but there were no differences in the percentage of time spent in deep sleep, in sleep efficiency, and the total time asleep.
Symptomatic flares alone, without inflammation, did not impact sleep metrics, the researchers concluded. However, periods with active inflammation were associated with a significantly smaller percentage of sleep time in REM sleep and a greater percentage of sleep time in light sleep.
The team also performed longitudinal mapping of sleep patterns before, during, and after disease exacerbations by analyzing sleep data for 6 weeks before and 6 weeks after flare episodes.
They found that sleep disturbances significantly worsen leading up to inflammatory flares and improve afterward, suggesting that sleep changes may signal upcoming increased disease activity. Evaluating the intersection of inflammatory and symptomatic flares, altered sleep architecture was only evident when inflammation was present.
“These findings raise important questions about whether intervening on sleep can actually impact inflammation or disease trajectory in IBD,” Hirten said. “Next steps include studying whether targeted sleep interventions can improve both sleep and IBD outcomes.”
While this research is still in the early stages, he said, “it suggests that sleep may have a relationship with inflammatory activity in IBD. For patients, it reinforces the value of paying attention to sleep changes.”
The findings also show the potential of wearable devices to guide more personalized monitoring, he added. “More work is needed before sleep metrics can be used routinely in clinical decision-making.”
Validates the Use of Wearables
Commenting on the study for GI & Hepatology News, Michael Mintz, MD, a gastroenterologist at Weill Cornell Medicine and NewYork-Presbyterian in New York City, observed, “Gastrointestinal symptoms often do not correlate with objective disease activity in IBD, creating a diagnostic challenge for gastroenterologists. Burdensome, expensive, and/or invasive testing, such as colonoscopies, stool tests, or imaging, are frequently required to monitor disease activity.”
“This study is a first step in objectively monitoring inflammation in a patient-centric way that does not create undue burden to our patients,” he said. “It also provides longitudinal data that suggests changes in sleep patterns can pre-date disease flares, which ideally can lead to earlier intervention to prevent disease complications.”
Like Hirten, he noted that clinical decisions, such as changing IBD therapy, should not be based on the results of this study. “Rather this provides validation that wearable technology can provide useful objective data that correlates with disease activity.”
Furthermore, he said, it is not clear whether analyzing sleep data is a cost-effective way of monitoring IBD disease activity, or whether that data should be used alone or in combination with other objective disease markers, to influence clinical decision-making.
“This study provides proof of concept that there is a relationship between sleep characteristics and objective inflammation, but further studies are needed,” he said. “I am hopeful that this technology will give us another tool that we can use in clinical practice to monitor disease activity and improve outcomes in a way that is comfortable and convenient for our patients.”
This study was supported by a grant to Hirten from the US National Institutes of Health. Hirten reported receiving consulting fees from Bristol Meyers Squibb, AbbVie; stock options from Salvo Health; and research support from Janssen, Intralytix, EnLiSense, Crohn’s and Colitis Foundation. Mintz declared no competing interests.
A version of this article appeared on Medscape.com.
, an observational study suggested.
Sleep data from 101 study participants over a mean duration of about 228 days revealed that altered sleep architecture was only apparent when inflammation was present — symptoms alone did not impact sleep cycles or signal inflammation.
“We thought symptoms might have an impact on sleep, but interestingly, our data showed that measurable changes like reduced rapid eye movement (REM) sleep and increased light sleep only occurred during periods of active inflammation,” Robert Hirten, MD, associate professor of Medicine (Gastroenterology), and Artificial Intelligence and Human Health, at the Icahn School of Medicine at Mount Sinai, New York City, told GI & Hepatology News.
“It was also interesting to see distinct patterns in sleep metrics begin to shift over the 45 days before a flare, suggesting the potential for sleep to serve as an early indicator of disease activity,” he added.
“Sleep is often overlooked in the management of IBD, but it may provide valuable insights into a patient’s underlying disease state,” he said. “While sleep monitoring isn’t yet a standard part of IBD care, this study highlights its potential as a noninvasive window into disease activity, and a promising area for future clinical integration.”
The study was published online in Clinical Gastroenterology and Hepatology.
Less REM Sleep, More Light Sleep
Researchers assessed the impact of inflammation and symptoms on sleep architecture in IBD by analyzing data from 101 individuals who answered daily disease activity surveys and wore a wearable device.
The mean age of participants was 41 years and 65.3% were women. Sixty-three participants (62.4%) had Crohn’s disease (CD) and 38 (37.6%) had ulcerative colitis (UC).
Almost 40 (39.6%) participants used an Apple Watch; 50 (49.5%) used a Fitbit; and 11 (10.9%) used an Oura ring. Sleep architecture, sleep efficiency, and total hours asleep were collected from the devices. Participants were encouraged to wear their devices for at least 4 days per week and 8 hours per day and were not required to wear them at night. Participants provided data by linking their devices to ehive, Mount Sinai’s custom app.
Daily clinical disease activity was assessed using the UC or CD Patient Reported Outcome-2 survey. Participants were asked to answer at least four daily surveys each week.
Associations between sleep metrics and periods of symptomatic and inflammatory flares, and combinations of symptomatic and inflammatory activity, were compared to periods of symptomatic and inflammatory remission.
Furthermore, researchers explored the rate of change in sleep metrics for 45 days before and after inflammatory and symptomatic flares.
Participants contributed a mean duration of 228.16 nights of wearable data. During active inflammation, they spent a lower percentage of sleep time in REM (20% vs 21.59%) and a greater percentage of sleep time in light sleep (62.23% vs 59.95%) than during inflammatory remission. No differences were observed in the mean percentage of time in deep sleep, sleep efficiency, or total time asleep.
During symptomatic flares, there were no differences in the percentage of sleep time in REM sleep, deep sleep, light sleep, or sleep efficiency compared with periods of inflammatory remission. However, participants slept less overall during symptomatic flares compared with during symptomatic remission.
Compared with during asymptomatic and uninflamed periods, during asymptomatic but inflamed periods, participants spent a lower percentage of time in REM sleep, and more time in light sleep; however, there were no differences in sleep efficiency or total time asleep.
Similarly, participants had more light sleep and less REM sleep during symptomatic and inflammatory flares than during asymptomatic and uninflamed periods — but there were no differences in the percentage of time spent in deep sleep, in sleep efficiency, and the total time asleep.
Symptomatic flares alone, without inflammation, did not impact sleep metrics, the researchers concluded. However, periods with active inflammation were associated with a significantly smaller percentage of sleep time in REM sleep and a greater percentage of sleep time in light sleep.
The team also performed longitudinal mapping of sleep patterns before, during, and after disease exacerbations by analyzing sleep data for 6 weeks before and 6 weeks after flare episodes.
They found that sleep disturbances significantly worsen leading up to inflammatory flares and improve afterward, suggesting that sleep changes may signal upcoming increased disease activity. Evaluating the intersection of inflammatory and symptomatic flares, altered sleep architecture was only evident when inflammation was present.
“These findings raise important questions about whether intervening on sleep can actually impact inflammation or disease trajectory in IBD,” Hirten said. “Next steps include studying whether targeted sleep interventions can improve both sleep and IBD outcomes.”
While this research is still in the early stages, he said, “it suggests that sleep may have a relationship with inflammatory activity in IBD. For patients, it reinforces the value of paying attention to sleep changes.”
The findings also show the potential of wearable devices to guide more personalized monitoring, he added. “More work is needed before sleep metrics can be used routinely in clinical decision-making.”
Validates the Use of Wearables
Commenting on the study for GI & Hepatology News, Michael Mintz, MD, a gastroenterologist at Weill Cornell Medicine and NewYork-Presbyterian in New York City, observed, “Gastrointestinal symptoms often do not correlate with objective disease activity in IBD, creating a diagnostic challenge for gastroenterologists. Burdensome, expensive, and/or invasive testing, such as colonoscopies, stool tests, or imaging, are frequently required to monitor disease activity.”
“This study is a first step in objectively monitoring inflammation in a patient-centric way that does not create undue burden to our patients,” he said. “It also provides longitudinal data that suggests changes in sleep patterns can pre-date disease flares, which ideally can lead to earlier intervention to prevent disease complications.”
Like Hirten, he noted that clinical decisions, such as changing IBD therapy, should not be based on the results of this study. “Rather this provides validation that wearable technology can provide useful objective data that correlates with disease activity.”
Furthermore, he said, it is not clear whether analyzing sleep data is a cost-effective way of monitoring IBD disease activity, or whether that data should be used alone or in combination with other objective disease markers, to influence clinical decision-making.
“This study provides proof of concept that there is a relationship between sleep characteristics and objective inflammation, but further studies are needed,” he said. “I am hopeful that this technology will give us another tool that we can use in clinical practice to monitor disease activity and improve outcomes in a way that is comfortable and convenient for our patients.”
This study was supported by a grant to Hirten from the US National Institutes of Health. Hirten reported receiving consulting fees from Bristol Meyers Squibb, AbbVie; stock options from Salvo Health; and research support from Janssen, Intralytix, EnLiSense, Crohn’s and Colitis Foundation. Mintz declared no competing interests.
A version of this article appeared on Medscape.com.
FROM CLINICAL GASTROENTEROLOGY AND HEPATOLOGY