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Is Pancreatic Cancer Really Rising in Young People?
TOPLINE:
Given the stable mortality rates in this population, the increase in incidence likely reflects previously undetected cases instead of a true rise in new cases, researchers say.
METHODOLOGY:
- Data from several registries have indicated that the incidence of pancreatic cancer among younger individuals, particularly women, is on the rise in the United States and worldwide.
- In a new analysis, researchers wanted to see if the observed increase in pancreatic cancer incidence among young Americans represented a true rise in cancer occurrence or indicated greater diagnostic scrutiny. If pancreatic cancer incidence is really increasing, “incidence and mortality would be expected to increase concurrently, as would early- and late-stage diagnoses,” the researchers explained.
- The researchers collected data on pancreatic cancer incidence, histology, and stage distribution for individuals aged 15-39 years from US Cancer Statistics, a database covering almost the entire US population from 2001 to 2020. Pancreatic cancer mortality data from the same timeframe came from the National Vital Statistics System.
- The researchers looked at four histologic categories: Adenocarcinoma, the dominant pancreatic cancer histology, as well as more rare subtypes — endocrine and solid pseudopapillary — and “other” category. Researchers also categorized stage-specific incidence as early stage (in situ or localized) or late stage (regional or distant).
TAKEAWAY:
- The incidence of pancreatic cancer increased 2.1-fold in young women (incidence, 3.3-6.9 per million) and 1.6-fold in young men (incidence, 3.9-6.2 per million) between 2001 and 2019. However, mortality rates remained stable for women (1.5 deaths per million; annual percent change [AAPC], −0.5%; 95% CI, –1.4% to 0.5%) and men (2.5 deaths per million; AAPC, –0.1%; 95% CI, –0.8% to 0.6%) over this period.
- Looking at cancer subtypes, the increase in incidence was largely caused by early-stage endocrine cancer and solid pseudopapillary neoplasms in women, not adenocarcinoma (which remained stable over the study period).
- Looking at cancer stage, most of the increase in incidence came from detection of smaller tumors (< 2 cm) and early-stage cancer, which rose from 0.6 to 3.7 per million in women and from 0.4 to 2.2 per million in men. The authors also found no statistically significant change in the incidence of late-stage cancer in women or men.
- Rates of surgical treatment for pancreatic cancer increased, more than tripling among women (from 1.5 to 4.7 per million) and more than doubling among men (from 1.1 to 2.3 per million).
IN PRACTICE:
“Pancreatic cancer now can be another cancer subject to overdiagnosis: The detection of disease not destined to cause symptoms or death,” the authors concluded. “Although the observed changes in incidence are small, overdiagnosis is especially concerning for pancreatic cancer, as pancreatic surgery has substantial risk for morbidity (in particular, pancreatic fistulas) and mortality.”
SOURCE:
The study, with first author Vishal R. Patel, MD, MPH, and corresponding author H. Gilbert Welch, MD, MPH, from Brigham and Women’s Hospital, Boston, was published online on November 19 in Annals of Internal Medicine.
LIMITATIONS:
The study was limited by the lack of data on the method of cancer detection, which may have affected the interpretation of the findings.
DISCLOSURES:
Disclosure forms are available with the article online.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Given the stable mortality rates in this population, the increase in incidence likely reflects previously undetected cases instead of a true rise in new cases, researchers say.
METHODOLOGY:
- Data from several registries have indicated that the incidence of pancreatic cancer among younger individuals, particularly women, is on the rise in the United States and worldwide.
- In a new analysis, researchers wanted to see if the observed increase in pancreatic cancer incidence among young Americans represented a true rise in cancer occurrence or indicated greater diagnostic scrutiny. If pancreatic cancer incidence is really increasing, “incidence and mortality would be expected to increase concurrently, as would early- and late-stage diagnoses,” the researchers explained.
- The researchers collected data on pancreatic cancer incidence, histology, and stage distribution for individuals aged 15-39 years from US Cancer Statistics, a database covering almost the entire US population from 2001 to 2020. Pancreatic cancer mortality data from the same timeframe came from the National Vital Statistics System.
- The researchers looked at four histologic categories: Adenocarcinoma, the dominant pancreatic cancer histology, as well as more rare subtypes — endocrine and solid pseudopapillary — and “other” category. Researchers also categorized stage-specific incidence as early stage (in situ or localized) or late stage (regional or distant).
TAKEAWAY:
- The incidence of pancreatic cancer increased 2.1-fold in young women (incidence, 3.3-6.9 per million) and 1.6-fold in young men (incidence, 3.9-6.2 per million) between 2001 and 2019. However, mortality rates remained stable for women (1.5 deaths per million; annual percent change [AAPC], −0.5%; 95% CI, –1.4% to 0.5%) and men (2.5 deaths per million; AAPC, –0.1%; 95% CI, –0.8% to 0.6%) over this period.
- Looking at cancer subtypes, the increase in incidence was largely caused by early-stage endocrine cancer and solid pseudopapillary neoplasms in women, not adenocarcinoma (which remained stable over the study period).
- Looking at cancer stage, most of the increase in incidence came from detection of smaller tumors (< 2 cm) and early-stage cancer, which rose from 0.6 to 3.7 per million in women and from 0.4 to 2.2 per million in men. The authors also found no statistically significant change in the incidence of late-stage cancer in women or men.
- Rates of surgical treatment for pancreatic cancer increased, more than tripling among women (from 1.5 to 4.7 per million) and more than doubling among men (from 1.1 to 2.3 per million).
IN PRACTICE:
“Pancreatic cancer now can be another cancer subject to overdiagnosis: The detection of disease not destined to cause symptoms or death,” the authors concluded. “Although the observed changes in incidence are small, overdiagnosis is especially concerning for pancreatic cancer, as pancreatic surgery has substantial risk for morbidity (in particular, pancreatic fistulas) and mortality.”
SOURCE:
The study, with first author Vishal R. Patel, MD, MPH, and corresponding author H. Gilbert Welch, MD, MPH, from Brigham and Women’s Hospital, Boston, was published online on November 19 in Annals of Internal Medicine.
LIMITATIONS:
The study was limited by the lack of data on the method of cancer detection, which may have affected the interpretation of the findings.
DISCLOSURES:
Disclosure forms are available with the article online.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
TOPLINE:
Given the stable mortality rates in this population, the increase in incidence likely reflects previously undetected cases instead of a true rise in new cases, researchers say.
METHODOLOGY:
- Data from several registries have indicated that the incidence of pancreatic cancer among younger individuals, particularly women, is on the rise in the United States and worldwide.
- In a new analysis, researchers wanted to see if the observed increase in pancreatic cancer incidence among young Americans represented a true rise in cancer occurrence or indicated greater diagnostic scrutiny. If pancreatic cancer incidence is really increasing, “incidence and mortality would be expected to increase concurrently, as would early- and late-stage diagnoses,” the researchers explained.
- The researchers collected data on pancreatic cancer incidence, histology, and stage distribution for individuals aged 15-39 years from US Cancer Statistics, a database covering almost the entire US population from 2001 to 2020. Pancreatic cancer mortality data from the same timeframe came from the National Vital Statistics System.
- The researchers looked at four histologic categories: Adenocarcinoma, the dominant pancreatic cancer histology, as well as more rare subtypes — endocrine and solid pseudopapillary — and “other” category. Researchers also categorized stage-specific incidence as early stage (in situ or localized) or late stage (regional or distant).
TAKEAWAY:
- The incidence of pancreatic cancer increased 2.1-fold in young women (incidence, 3.3-6.9 per million) and 1.6-fold in young men (incidence, 3.9-6.2 per million) between 2001 and 2019. However, mortality rates remained stable for women (1.5 deaths per million; annual percent change [AAPC], −0.5%; 95% CI, –1.4% to 0.5%) and men (2.5 deaths per million; AAPC, –0.1%; 95% CI, –0.8% to 0.6%) over this period.
- Looking at cancer subtypes, the increase in incidence was largely caused by early-stage endocrine cancer and solid pseudopapillary neoplasms in women, not adenocarcinoma (which remained stable over the study period).
- Looking at cancer stage, most of the increase in incidence came from detection of smaller tumors (< 2 cm) and early-stage cancer, which rose from 0.6 to 3.7 per million in women and from 0.4 to 2.2 per million in men. The authors also found no statistically significant change in the incidence of late-stage cancer in women or men.
- Rates of surgical treatment for pancreatic cancer increased, more than tripling among women (from 1.5 to 4.7 per million) and more than doubling among men (from 1.1 to 2.3 per million).
IN PRACTICE:
“Pancreatic cancer now can be another cancer subject to overdiagnosis: The detection of disease not destined to cause symptoms or death,” the authors concluded. “Although the observed changes in incidence are small, overdiagnosis is especially concerning for pancreatic cancer, as pancreatic surgery has substantial risk for morbidity (in particular, pancreatic fistulas) and mortality.”
SOURCE:
The study, with first author Vishal R. Patel, MD, MPH, and corresponding author H. Gilbert Welch, MD, MPH, from Brigham and Women’s Hospital, Boston, was published online on November 19 in Annals of Internal Medicine.
LIMITATIONS:
The study was limited by the lack of data on the method of cancer detection, which may have affected the interpretation of the findings.
DISCLOSURES:
Disclosure forms are available with the article online.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.
Prostate Cancer: Has Active Surveillance Solved the Problem of Overtreatment?
“Overtreatment of men with limited longevity for intermediate- and high-risk tumors has not only failed to improve but has actually worsened over the last 20 years,” Timothy Daskivich, MD, MSHPM, with Cedars-Sinai Medical Center, Los Angeles, said in an interview.
“Many doctors assume that the increase in uptake of active surveillance for low-risk prostate cancers has solved the problem of overtreatment, but this trend has not affected overtreatment of men with low likelihood of living long enough to benefit from treatment who have higher-risk tumors,” Daskivich said.
The study was published online on November 11 in JAMA Internal Medicine.
‘Concerning’ Real-World Data
For men with low- and intermediate-risk prostate cancer expected to live fewer than 10 years, prostate cancer screening and aggressive treatment are not recommended.
Daskivich and colleagues analyzed data on 243,928 men (mean age, 66 years) in the Veterans Affairs (VA) Health System with clinically localized prostate cancer diagnosed between 2000 and 2019.
About 21% had LE < 10 years, and about 4% had LE < 5 years, according to the validated age-adjusted Prostate Cancer Comorbidity Index.
Overtreatment was defined as aggressive treatment (surgery or radiation) in those with LE < 10 years and low- to intermediate-risk disease and in those with LE < 5 years and high-risk disease, in line with current guidelines.
Among men with LE < 10 years, the proportion of men overtreated with surgery or radiotherapy for low-risk disease decreased 22% but increased 22% for intermediate-risk disease during the study period.
Among men with LE < 5 years, the proportion of men treated with definitive treatment for high-risk disease increased 29%.
“While lower-risk tumors are treated less aggressively across the board, including in men with limited longevity, it seems that we are more indiscriminately treating men with higher-risk disease without considering their expected longevity,” Daskivich said in an interview.
Is This Happening in the General US Population?
Daskivich noted that the sample included a large sample of men diagnosed with localized prostate cancer in the VA Health System.
“Rates of overtreatment are likely to be lower in the VA [Health System], so the problem may be worse in the community setting. The VA [Health System] has been exemplary in its uptake of active surveillance for low-risk cancers, leading the effort to reduce overtreatment of men with low-risk cancers. However, the problem of overtreatment of men with limited longevity persists in the VA [Health System], underscoring the pervasiveness of this problem,” he explained.
“We don’t have a perfect head-to-head comparison of overtreatment in the VA setting vs in the community. [However, one study shows] that this is not a VA-specific phenomenon and that there is an increase in overtreatment of men with limited longevity in a Medicare population as well,” Daskivich noted.
Is Overtreatment All Bad?
Overtreatment of prostate cancer, especially in cases where the cancer is unlikely to progress or cause symptoms, can lead to significant physical, psychological, and financial harms, Christopher Anderson, MD, urologist with Columbia University Irving Medical Center in New York City, who wasn’t involved in the study, noted in an interview.
In the study by Daskivich and colleagues, over three quarters of the overtreatment was radiation therapy, which carries the risk for urinary, bowel, and sexual issues.
“Overscreening, which can lead to overtreatment, is a core issue,” Anderson said. It’s easy to order a “simple” prostate-specific antigen blood test, but in an older man with limited LE, that can lead to a host of further testing, he said.
Stopping the pipeline of overscreening that then feeds into the cascade of overtreatment is the first step in addressing the problem of prostate cancer overtreatment, Nancy Li Schoenborn, MD, MHS, with Johns Hopkins University School of Medicine, Baltimore, and Louise C. Walter, MD, with University of California San Francisco, wrote in an editorial in JAMA Internal Medicine.
Considering LE during screening decision-making is “fundamental to reducing harms of prostate cancer overdiagnosis and overtreatment” because limited LE increases the likelihood of experiencing “harms all along the diagnostic and treatment cascade following screening,” the editorial writers said.
The time spent diagnosing, monitoring, and treating asymptomatic prostate cancer in men with limited LE distracts from monitoring and treating chronic symptomatic life-limiting illnesses, they noted.
Tough to Talk About?
Anderson noted that, in general, doctors are not great at estimating and counseling patients on LE. “It’s sometimes difficult to have that conversation,” he said.
Daskivich said physicians may fail to include average LE when advising patients on treatments because they believe that the patients do not want to discuss this topic. “Yet, in interviews with patients, we found that prostate cancer patients reported they wanted this information,” he continued, in an interview.
Solving the problem of overscreening and overtreatment will require a “multifaceted approach, including improving access to life expectancy data at the point of care for providers, educating providers on how to communicate this information, and improving data sources to predict longevity,” Daskivich said.
He said it’s equally important to note that some men with prostate cancer may choose treatment even if they have a limited longevity.
“Not all patients will choose conservative management, even if it is recommended by guidelines. However, they need to be given the opportunity to make a good decision for themselves with the best possible data,” Daskivich said.
This work was supported in part by a US Department of VA Merit Review. Daskivich reported receiving personal fees from the Medical Education Speakers Network, EDAP, and RAND; research support from Lantheus and Janssen; and a patent pending for a system for healthcare visit quality assessment outside the submitted work. Schoenborn, Walter, and Anderson had no relevant disclosures.
A version of this article appeared on Medscape.com.
“Overtreatment of men with limited longevity for intermediate- and high-risk tumors has not only failed to improve but has actually worsened over the last 20 years,” Timothy Daskivich, MD, MSHPM, with Cedars-Sinai Medical Center, Los Angeles, said in an interview.
“Many doctors assume that the increase in uptake of active surveillance for low-risk prostate cancers has solved the problem of overtreatment, but this trend has not affected overtreatment of men with low likelihood of living long enough to benefit from treatment who have higher-risk tumors,” Daskivich said.
The study was published online on November 11 in JAMA Internal Medicine.
‘Concerning’ Real-World Data
For men with low- and intermediate-risk prostate cancer expected to live fewer than 10 years, prostate cancer screening and aggressive treatment are not recommended.
Daskivich and colleagues analyzed data on 243,928 men (mean age, 66 years) in the Veterans Affairs (VA) Health System with clinically localized prostate cancer diagnosed between 2000 and 2019.
About 21% had LE < 10 years, and about 4% had LE < 5 years, according to the validated age-adjusted Prostate Cancer Comorbidity Index.
Overtreatment was defined as aggressive treatment (surgery or radiation) in those with LE < 10 years and low- to intermediate-risk disease and in those with LE < 5 years and high-risk disease, in line with current guidelines.
Among men with LE < 10 years, the proportion of men overtreated with surgery or radiotherapy for low-risk disease decreased 22% but increased 22% for intermediate-risk disease during the study period.
Among men with LE < 5 years, the proportion of men treated with definitive treatment for high-risk disease increased 29%.
“While lower-risk tumors are treated less aggressively across the board, including in men with limited longevity, it seems that we are more indiscriminately treating men with higher-risk disease without considering their expected longevity,” Daskivich said in an interview.
Is This Happening in the General US Population?
Daskivich noted that the sample included a large sample of men diagnosed with localized prostate cancer in the VA Health System.
“Rates of overtreatment are likely to be lower in the VA [Health System], so the problem may be worse in the community setting. The VA [Health System] has been exemplary in its uptake of active surveillance for low-risk cancers, leading the effort to reduce overtreatment of men with low-risk cancers. However, the problem of overtreatment of men with limited longevity persists in the VA [Health System], underscoring the pervasiveness of this problem,” he explained.
“We don’t have a perfect head-to-head comparison of overtreatment in the VA setting vs in the community. [However, one study shows] that this is not a VA-specific phenomenon and that there is an increase in overtreatment of men with limited longevity in a Medicare population as well,” Daskivich noted.
Is Overtreatment All Bad?
Overtreatment of prostate cancer, especially in cases where the cancer is unlikely to progress or cause symptoms, can lead to significant physical, psychological, and financial harms, Christopher Anderson, MD, urologist with Columbia University Irving Medical Center in New York City, who wasn’t involved in the study, noted in an interview.
In the study by Daskivich and colleagues, over three quarters of the overtreatment was radiation therapy, which carries the risk for urinary, bowel, and sexual issues.
“Overscreening, which can lead to overtreatment, is a core issue,” Anderson said. It’s easy to order a “simple” prostate-specific antigen blood test, but in an older man with limited LE, that can lead to a host of further testing, he said.
Stopping the pipeline of overscreening that then feeds into the cascade of overtreatment is the first step in addressing the problem of prostate cancer overtreatment, Nancy Li Schoenborn, MD, MHS, with Johns Hopkins University School of Medicine, Baltimore, and Louise C. Walter, MD, with University of California San Francisco, wrote in an editorial in JAMA Internal Medicine.
Considering LE during screening decision-making is “fundamental to reducing harms of prostate cancer overdiagnosis and overtreatment” because limited LE increases the likelihood of experiencing “harms all along the diagnostic and treatment cascade following screening,” the editorial writers said.
The time spent diagnosing, monitoring, and treating asymptomatic prostate cancer in men with limited LE distracts from monitoring and treating chronic symptomatic life-limiting illnesses, they noted.
Tough to Talk About?
Anderson noted that, in general, doctors are not great at estimating and counseling patients on LE. “It’s sometimes difficult to have that conversation,” he said.
Daskivich said physicians may fail to include average LE when advising patients on treatments because they believe that the patients do not want to discuss this topic. “Yet, in interviews with patients, we found that prostate cancer patients reported they wanted this information,” he continued, in an interview.
Solving the problem of overscreening and overtreatment will require a “multifaceted approach, including improving access to life expectancy data at the point of care for providers, educating providers on how to communicate this information, and improving data sources to predict longevity,” Daskivich said.
He said it’s equally important to note that some men with prostate cancer may choose treatment even if they have a limited longevity.
“Not all patients will choose conservative management, even if it is recommended by guidelines. However, they need to be given the opportunity to make a good decision for themselves with the best possible data,” Daskivich said.
This work was supported in part by a US Department of VA Merit Review. Daskivich reported receiving personal fees from the Medical Education Speakers Network, EDAP, and RAND; research support from Lantheus and Janssen; and a patent pending for a system for healthcare visit quality assessment outside the submitted work. Schoenborn, Walter, and Anderson had no relevant disclosures.
A version of this article appeared on Medscape.com.
“Overtreatment of men with limited longevity for intermediate- and high-risk tumors has not only failed to improve but has actually worsened over the last 20 years,” Timothy Daskivich, MD, MSHPM, with Cedars-Sinai Medical Center, Los Angeles, said in an interview.
“Many doctors assume that the increase in uptake of active surveillance for low-risk prostate cancers has solved the problem of overtreatment, but this trend has not affected overtreatment of men with low likelihood of living long enough to benefit from treatment who have higher-risk tumors,” Daskivich said.
The study was published online on November 11 in JAMA Internal Medicine.
‘Concerning’ Real-World Data
For men with low- and intermediate-risk prostate cancer expected to live fewer than 10 years, prostate cancer screening and aggressive treatment are not recommended.
Daskivich and colleagues analyzed data on 243,928 men (mean age, 66 years) in the Veterans Affairs (VA) Health System with clinically localized prostate cancer diagnosed between 2000 and 2019.
About 21% had LE < 10 years, and about 4% had LE < 5 years, according to the validated age-adjusted Prostate Cancer Comorbidity Index.
Overtreatment was defined as aggressive treatment (surgery or radiation) in those with LE < 10 years and low- to intermediate-risk disease and in those with LE < 5 years and high-risk disease, in line with current guidelines.
Among men with LE < 10 years, the proportion of men overtreated with surgery or radiotherapy for low-risk disease decreased 22% but increased 22% for intermediate-risk disease during the study period.
Among men with LE < 5 years, the proportion of men treated with definitive treatment for high-risk disease increased 29%.
“While lower-risk tumors are treated less aggressively across the board, including in men with limited longevity, it seems that we are more indiscriminately treating men with higher-risk disease without considering their expected longevity,” Daskivich said in an interview.
Is This Happening in the General US Population?
Daskivich noted that the sample included a large sample of men diagnosed with localized prostate cancer in the VA Health System.
“Rates of overtreatment are likely to be lower in the VA [Health System], so the problem may be worse in the community setting. The VA [Health System] has been exemplary in its uptake of active surveillance for low-risk cancers, leading the effort to reduce overtreatment of men with low-risk cancers. However, the problem of overtreatment of men with limited longevity persists in the VA [Health System], underscoring the pervasiveness of this problem,” he explained.
“We don’t have a perfect head-to-head comparison of overtreatment in the VA setting vs in the community. [However, one study shows] that this is not a VA-specific phenomenon and that there is an increase in overtreatment of men with limited longevity in a Medicare population as well,” Daskivich noted.
Is Overtreatment All Bad?
Overtreatment of prostate cancer, especially in cases where the cancer is unlikely to progress or cause symptoms, can lead to significant physical, psychological, and financial harms, Christopher Anderson, MD, urologist with Columbia University Irving Medical Center in New York City, who wasn’t involved in the study, noted in an interview.
In the study by Daskivich and colleagues, over three quarters of the overtreatment was radiation therapy, which carries the risk for urinary, bowel, and sexual issues.
“Overscreening, which can lead to overtreatment, is a core issue,” Anderson said. It’s easy to order a “simple” prostate-specific antigen blood test, but in an older man with limited LE, that can lead to a host of further testing, he said.
Stopping the pipeline of overscreening that then feeds into the cascade of overtreatment is the first step in addressing the problem of prostate cancer overtreatment, Nancy Li Schoenborn, MD, MHS, with Johns Hopkins University School of Medicine, Baltimore, and Louise C. Walter, MD, with University of California San Francisco, wrote in an editorial in JAMA Internal Medicine.
Considering LE during screening decision-making is “fundamental to reducing harms of prostate cancer overdiagnosis and overtreatment” because limited LE increases the likelihood of experiencing “harms all along the diagnostic and treatment cascade following screening,” the editorial writers said.
The time spent diagnosing, monitoring, and treating asymptomatic prostate cancer in men with limited LE distracts from monitoring and treating chronic symptomatic life-limiting illnesses, they noted.
Tough to Talk About?
Anderson noted that, in general, doctors are not great at estimating and counseling patients on LE. “It’s sometimes difficult to have that conversation,” he said.
Daskivich said physicians may fail to include average LE when advising patients on treatments because they believe that the patients do not want to discuss this topic. “Yet, in interviews with patients, we found that prostate cancer patients reported they wanted this information,” he continued, in an interview.
Solving the problem of overscreening and overtreatment will require a “multifaceted approach, including improving access to life expectancy data at the point of care for providers, educating providers on how to communicate this information, and improving data sources to predict longevity,” Daskivich said.
He said it’s equally important to note that some men with prostate cancer may choose treatment even if they have a limited longevity.
“Not all patients will choose conservative management, even if it is recommended by guidelines. However, they need to be given the opportunity to make a good decision for themselves with the best possible data,” Daskivich said.
This work was supported in part by a US Department of VA Merit Review. Daskivich reported receiving personal fees from the Medical Education Speakers Network, EDAP, and RAND; research support from Lantheus and Janssen; and a patent pending for a system for healthcare visit quality assessment outside the submitted work. Schoenborn, Walter, and Anderson had no relevant disclosures.
A version of this article appeared on Medscape.com.
How Do Novel CRC Blood Tests Fare Against Established Tests?
TOPLINE:
METHODOLOGY:
- Researchers estimated the clinical and economic impacts of emerging blood- and stool-based CRC screening tests with established alternatives in average-risk adults aged 45 years and older.
- The established screening tools were colonoscopy, a fecal immunochemical test (FIT), and a multitarget stool DNA test (MT-sDNA, Exact Sciences Cologuard).
- The four emerging screening methods were two cf-bDNA tests (Guardant Shield and Freenome); an enhanced, a next-generation multitarget stool test (ngMT-sDNA), and a novel FIT-RNA test (Geneoscopy ColoSense).
TAKEAWAY:
- Assuming 100% participation in all screening steps, colonoscopy and FIT yielded reductions of more than 70% in CRC incidence and 75% in mortality vs no screening.
- The MT-sDNA test reduced CRC incidence by 68% and mortality by 73%, with similar rates for the ngMT-sDNA and FIT-RNA tests vs no screening. The cf-bDNA tests yielded CRC incidence and mortality reductions of only 42% and 56%.
- Colonoscopy and FIT were more effective and less costly than the cf-bDNA and MT-sDNA tests, and the MT-sDNA test was more effective and less costly than the cf-bDNA test.
- Population benefits from blood tests were seen only in those who declined colonoscopy and stool tests. Substituting a blood test for those already using colonoscopy or stool tests led to worse population-level outcomes.
IN PRACTICE:
“First-generation novel cf-bDNA tests have the potential to decrease meaningfully the incidence and mortality of CRC compared with no screening but substantially less profoundly than screening colonoscopy or stool tests. Net population benefit or harm can follow incorporation of first-generation cf-bDNA CRC screening tests into practice, depending on the balance between bringing unscreened persons into screening (addition) vs shifting persons away from the more effective strategies of colonoscopy or stool testing (substitution),” the authors concluded.
SOURCE:
The study, with first author Uri Ladabaum, MD, MS, Stanford University School of Medicine, California, was published online in Annals of Internal Medicine.
LIMITATIONS:
Limitations included test-specific participation patterns being unknown over time.
DISCLOSURES:
Disclosure forms for the authors are available with the article online. Funding was provided by the Gorrindo Family Fund.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers estimated the clinical and economic impacts of emerging blood- and stool-based CRC screening tests with established alternatives in average-risk adults aged 45 years and older.
- The established screening tools were colonoscopy, a fecal immunochemical test (FIT), and a multitarget stool DNA test (MT-sDNA, Exact Sciences Cologuard).
- The four emerging screening methods were two cf-bDNA tests (Guardant Shield and Freenome); an enhanced, a next-generation multitarget stool test (ngMT-sDNA), and a novel FIT-RNA test (Geneoscopy ColoSense).
TAKEAWAY:
- Assuming 100% participation in all screening steps, colonoscopy and FIT yielded reductions of more than 70% in CRC incidence and 75% in mortality vs no screening.
- The MT-sDNA test reduced CRC incidence by 68% and mortality by 73%, with similar rates for the ngMT-sDNA and FIT-RNA tests vs no screening. The cf-bDNA tests yielded CRC incidence and mortality reductions of only 42% and 56%.
- Colonoscopy and FIT were more effective and less costly than the cf-bDNA and MT-sDNA tests, and the MT-sDNA test was more effective and less costly than the cf-bDNA test.
- Population benefits from blood tests were seen only in those who declined colonoscopy and stool tests. Substituting a blood test for those already using colonoscopy or stool tests led to worse population-level outcomes.
IN PRACTICE:
“First-generation novel cf-bDNA tests have the potential to decrease meaningfully the incidence and mortality of CRC compared with no screening but substantially less profoundly than screening colonoscopy or stool tests. Net population benefit or harm can follow incorporation of first-generation cf-bDNA CRC screening tests into practice, depending on the balance between bringing unscreened persons into screening (addition) vs shifting persons away from the more effective strategies of colonoscopy or stool testing (substitution),” the authors concluded.
SOURCE:
The study, with first author Uri Ladabaum, MD, MS, Stanford University School of Medicine, California, was published online in Annals of Internal Medicine.
LIMITATIONS:
Limitations included test-specific participation patterns being unknown over time.
DISCLOSURES:
Disclosure forms for the authors are available with the article online. Funding was provided by the Gorrindo Family Fund.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Researchers estimated the clinical and economic impacts of emerging blood- and stool-based CRC screening tests with established alternatives in average-risk adults aged 45 years and older.
- The established screening tools were colonoscopy, a fecal immunochemical test (FIT), and a multitarget stool DNA test (MT-sDNA, Exact Sciences Cologuard).
- The four emerging screening methods were two cf-bDNA tests (Guardant Shield and Freenome); an enhanced, a next-generation multitarget stool test (ngMT-sDNA), and a novel FIT-RNA test (Geneoscopy ColoSense).
TAKEAWAY:
- Assuming 100% participation in all screening steps, colonoscopy and FIT yielded reductions of more than 70% in CRC incidence and 75% in mortality vs no screening.
- The MT-sDNA test reduced CRC incidence by 68% and mortality by 73%, with similar rates for the ngMT-sDNA and FIT-RNA tests vs no screening. The cf-bDNA tests yielded CRC incidence and mortality reductions of only 42% and 56%.
- Colonoscopy and FIT were more effective and less costly than the cf-bDNA and MT-sDNA tests, and the MT-sDNA test was more effective and less costly than the cf-bDNA test.
- Population benefits from blood tests were seen only in those who declined colonoscopy and stool tests. Substituting a blood test for those already using colonoscopy or stool tests led to worse population-level outcomes.
IN PRACTICE:
“First-generation novel cf-bDNA tests have the potential to decrease meaningfully the incidence and mortality of CRC compared with no screening but substantially less profoundly than screening colonoscopy or stool tests. Net population benefit or harm can follow incorporation of first-generation cf-bDNA CRC screening tests into practice, depending on the balance between bringing unscreened persons into screening (addition) vs shifting persons away from the more effective strategies of colonoscopy or stool testing (substitution),” the authors concluded.
SOURCE:
The study, with first author Uri Ladabaum, MD, MS, Stanford University School of Medicine, California, was published online in Annals of Internal Medicine.
LIMITATIONS:
Limitations included test-specific participation patterns being unknown over time.
DISCLOSURES:
Disclosure forms for the authors are available with the article online. Funding was provided by the Gorrindo Family Fund.
A version of this article appeared on Medscape.com.
New Strategy Led to Modest Decline in Antibiotic Misuse
TOPLINE:
particularly in general practice.
METHODOLOGY:
- Researchers conducted this study to assess the impact of an intervention on antibiotic prescribing and dispensing for common infections.
- Healthcare professionals from general practice, out-of-hours services, nursing homes, and community pharmacies in France, Greece, Lithuania, Poland, and Spain registered their interactions with patients related to antibiotic prescribing and dispensing both prior to and following the intervention.
- Overall, 407 healthcare professionals participated in the first registration, of whom 345 undertook the intervention and participated in the second registration; they documented 10,744 infections during the initial registration and 10,132 cases during the second period.
- The 5-hour intervention included evaluating and discussing feedback on the outcomes of the initial registration, improving communication skills, and offering communication tools.
- The impact of this intervention was calculated from potential unnecessary antibiotic prescriptions, non–first-line antibiotic choices, and percentage of good and wrong safety advice given for each prescription.
TAKEAWAY:
- General practice clinicians showed a significant overall reduction in unnecessary antibiotic prescriptions from 72.2% during the first registration to 65.2% after the intervention (P < .001), with variations across countries ranging from a 19.9% reduction in Lithuania to a 1.3% increase in Greece.
- Out-of-hours services showed a minimal change in unnecessary antibiotic prescribing from 52.5% to 52.1%, whereas nursing homes showed a slight increase from 56.1% to 58.6%.
- Community pharmacies showed significant improvements, with the provision of correct advice increasing by 17% (P < .001) and safety checks improving from 47% to 55.3% in 1 year (P < .001).
- However, the choice of non–first-line antibiotics significantly increased by 29.2% in the second registration period (P < .001).
IN PRACTICE:
“These findings highlight the need for alternative and tailored approaches in antimicrobial stewardship programs in long-term care facilities, with a greater focus on nurses. This includes implementing hygiene measures and empowering nurses to improve the diagnosis of suspected infections, such as urinary tract infections, while debunking prevalent myths and providing clear-cut information for better management of these common infections,” the authors wrote.
SOURCE:
The study was led by Ana García-Sangenís, of Fundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina, Barcelona, Spain, and was published online on November 12, 2024, in Family Practice.
LIMITATIONS:
The study lacked a control group, which limited the ability to attribute changes solely to the intervention. The voluntary participation of healthcare professionals might have introduced selection bias, as participants might have had a greater interest in quality improvement programs than the general population of healthcare providers. Clinical outcomes were not evaluated, which may have created ambiguity regarding whether complication rates or clinical failures varied between the groups.
DISCLOSURES:
This study received funding from the European Union’s Third Health Programme. One author reported receiving fees from pharmaceutical companies and acting as a member of the board of Steno Diabetes Center, Odense, Denmark.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
particularly in general practice.
METHODOLOGY:
- Researchers conducted this study to assess the impact of an intervention on antibiotic prescribing and dispensing for common infections.
- Healthcare professionals from general practice, out-of-hours services, nursing homes, and community pharmacies in France, Greece, Lithuania, Poland, and Spain registered their interactions with patients related to antibiotic prescribing and dispensing both prior to and following the intervention.
- Overall, 407 healthcare professionals participated in the first registration, of whom 345 undertook the intervention and participated in the second registration; they documented 10,744 infections during the initial registration and 10,132 cases during the second period.
- The 5-hour intervention included evaluating and discussing feedback on the outcomes of the initial registration, improving communication skills, and offering communication tools.
- The impact of this intervention was calculated from potential unnecessary antibiotic prescriptions, non–first-line antibiotic choices, and percentage of good and wrong safety advice given for each prescription.
TAKEAWAY:
- General practice clinicians showed a significant overall reduction in unnecessary antibiotic prescriptions from 72.2% during the first registration to 65.2% after the intervention (P < .001), with variations across countries ranging from a 19.9% reduction in Lithuania to a 1.3% increase in Greece.
- Out-of-hours services showed a minimal change in unnecessary antibiotic prescribing from 52.5% to 52.1%, whereas nursing homes showed a slight increase from 56.1% to 58.6%.
- Community pharmacies showed significant improvements, with the provision of correct advice increasing by 17% (P < .001) and safety checks improving from 47% to 55.3% in 1 year (P < .001).
- However, the choice of non–first-line antibiotics significantly increased by 29.2% in the second registration period (P < .001).
IN PRACTICE:
“These findings highlight the need for alternative and tailored approaches in antimicrobial stewardship programs in long-term care facilities, with a greater focus on nurses. This includes implementing hygiene measures and empowering nurses to improve the diagnosis of suspected infections, such as urinary tract infections, while debunking prevalent myths and providing clear-cut information for better management of these common infections,” the authors wrote.
SOURCE:
The study was led by Ana García-Sangenís, of Fundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina, Barcelona, Spain, and was published online on November 12, 2024, in Family Practice.
LIMITATIONS:
The study lacked a control group, which limited the ability to attribute changes solely to the intervention. The voluntary participation of healthcare professionals might have introduced selection bias, as participants might have had a greater interest in quality improvement programs than the general population of healthcare providers. Clinical outcomes were not evaluated, which may have created ambiguity regarding whether complication rates or clinical failures varied between the groups.
DISCLOSURES:
This study received funding from the European Union’s Third Health Programme. One author reported receiving fees from pharmaceutical companies and acting as a member of the board of Steno Diabetes Center, Odense, Denmark.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
TOPLINE:
particularly in general practice.
METHODOLOGY:
- Researchers conducted this study to assess the impact of an intervention on antibiotic prescribing and dispensing for common infections.
- Healthcare professionals from general practice, out-of-hours services, nursing homes, and community pharmacies in France, Greece, Lithuania, Poland, and Spain registered their interactions with patients related to antibiotic prescribing and dispensing both prior to and following the intervention.
- Overall, 407 healthcare professionals participated in the first registration, of whom 345 undertook the intervention and participated in the second registration; they documented 10,744 infections during the initial registration and 10,132 cases during the second period.
- The 5-hour intervention included evaluating and discussing feedback on the outcomes of the initial registration, improving communication skills, and offering communication tools.
- The impact of this intervention was calculated from potential unnecessary antibiotic prescriptions, non–first-line antibiotic choices, and percentage of good and wrong safety advice given for each prescription.
TAKEAWAY:
- General practice clinicians showed a significant overall reduction in unnecessary antibiotic prescriptions from 72.2% during the first registration to 65.2% after the intervention (P < .001), with variations across countries ranging from a 19.9% reduction in Lithuania to a 1.3% increase in Greece.
- Out-of-hours services showed a minimal change in unnecessary antibiotic prescribing from 52.5% to 52.1%, whereas nursing homes showed a slight increase from 56.1% to 58.6%.
- Community pharmacies showed significant improvements, with the provision of correct advice increasing by 17% (P < .001) and safety checks improving from 47% to 55.3% in 1 year (P < .001).
- However, the choice of non–first-line antibiotics significantly increased by 29.2% in the second registration period (P < .001).
IN PRACTICE:
“These findings highlight the need for alternative and tailored approaches in antimicrobial stewardship programs in long-term care facilities, with a greater focus on nurses. This includes implementing hygiene measures and empowering nurses to improve the diagnosis of suspected infections, such as urinary tract infections, while debunking prevalent myths and providing clear-cut information for better management of these common infections,” the authors wrote.
SOURCE:
The study was led by Ana García-Sangenís, of Fundació Institut Universitari per a la Recerca a l’Atenció Primària de Salut Jordi Gol i Gurina, Barcelona, Spain, and was published online on November 12, 2024, in Family Practice.
LIMITATIONS:
The study lacked a control group, which limited the ability to attribute changes solely to the intervention. The voluntary participation of healthcare professionals might have introduced selection bias, as participants might have had a greater interest in quality improvement programs than the general population of healthcare providers. Clinical outcomes were not evaluated, which may have created ambiguity regarding whether complication rates or clinical failures varied between the groups.
DISCLOSURES:
This study received funding from the European Union’s Third Health Programme. One author reported receiving fees from pharmaceutical companies and acting as a member of the board of Steno Diabetes Center, Odense, Denmark.
This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Key Updates in Resuscitation Procedure After Drowning
New recommendations on rescuing adults and children who have drowned include an important update for healthcare professionals, trained rescuers, and untrained lay rescuers.
The American Heart Association (AHA) and the American Academy of Pediatrics (AAP) have issued recommendations that highlight delivering rescue breaths as well as calling 911 and performing chest compressions in cardiopulmonary resuscitation (CPR) as first steps when a person pulled from the water is in cardiac arrest.
This is the first collaboration between the two organizations on resuscitation after drowning. The recommendations were published simultaneously in Circulation and Pediatrics.
Included in the recommendations are two key principles:
- Anyone pulled from the water who has no signs of normal breathing or consciousness should be presumed to be in cardiac arrest.
- Rescuers should immediately start CPR that includes rescue breathing in addition to chest compressions. Multiple large studies show more people with cardiac arrest from noncardiac causes such as drowning survive when CPR includes rescue breaths, compared with hands-only CPR (calling 911 and pushing hard and fast in the center of the chest).
If someone is untrained, unwilling, or unable to give breaths, they can perform chest compressions until help arrives, the recommendations advise.
Reasoning Behind the Update
The authors, led by writing group cochair Tracy E. McCallin, MD, associate professor in the division of pediatric emergency medicine at Rainbow Babies and Children’s Hospital in Cleveland , Ohio, explained that drowning generally advances from initial respiratory arrest from submersion-related hypoxia to cardiac arrest, and therefore it can be difficult to distinguish respiratory arrest from cardiac arrest because pulses are difficult to accurately palpate within the recommended 10-second window.
“Therefore, resuscitation from cardiac arrest due to this specific circumstance must focus on restoring breathing as much as it does circulation,” the authors wrote.
Resuscitation after drowning may begin in the water with rescue breathing when safely provided by trained rescuers and should continue with chest compressions, once the drowned person and the rescuer are on land or in a boat, the report authors wrote.
“The focused update on drowning contains the most up-to-date, evidence-based recommendations on how to resuscitate someone who has drowned,” McCallin states in a press release.
In addition to the new guidance on rescue breaths, the update includes new topics that the AHA has not previously addressed with treatment recommendations, such as oxygen administration after drowning; automated external defibrillator use in cardiac arrest after drowning and public-access defibrillation programs.
Pediatricians Can Help Spread the Word
Alexandra Stern, MD, assistant professor in the Department of Pediatrics at University of Florida, Gainesville, who was not part of the update, said pediatricians can help disseminate this new information.
“Water safety is a topic frequently discussed as a pediatrician, with focus often being on primary prevention of drowning,” she said. “We stress the importance of the multiple layers of protection against drowning, such as touch supervision (staying within arm’s length); secure fencing, access to appropriate life jackets, and teaching our children to swim. Learning CPR is a large part of these measures and continuing these discussions with our patients and families is important.”
She added that updating the recommended procedures will likely require changes to all forms of education and community outreach regarding drowning from basic life support classes to more advanced lifeguard training. She noted that the update provides practical guidance not just for trained rescuers and healthcare professionals, but also for family members.
The paper notes that drowning is the third leading cause of death from unintentional injury globally, accounting for 7% of all injury-related deaths. In the United States, drowning is the leading cause of death in children aged 1-4 years and the second leading cause of death from unintentional injury in children aged 5-14 years.
The update is based on systematic reviews from 2021 to 2023 performed by the International Liaison Committee on Resuscitation related to the resuscitation of drowning.
The authors and Stern reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
New recommendations on rescuing adults and children who have drowned include an important update for healthcare professionals, trained rescuers, and untrained lay rescuers.
The American Heart Association (AHA) and the American Academy of Pediatrics (AAP) have issued recommendations that highlight delivering rescue breaths as well as calling 911 and performing chest compressions in cardiopulmonary resuscitation (CPR) as first steps when a person pulled from the water is in cardiac arrest.
This is the first collaboration between the two organizations on resuscitation after drowning. The recommendations were published simultaneously in Circulation and Pediatrics.
Included in the recommendations are two key principles:
- Anyone pulled from the water who has no signs of normal breathing or consciousness should be presumed to be in cardiac arrest.
- Rescuers should immediately start CPR that includes rescue breathing in addition to chest compressions. Multiple large studies show more people with cardiac arrest from noncardiac causes such as drowning survive when CPR includes rescue breaths, compared with hands-only CPR (calling 911 and pushing hard and fast in the center of the chest).
If someone is untrained, unwilling, or unable to give breaths, they can perform chest compressions until help arrives, the recommendations advise.
Reasoning Behind the Update
The authors, led by writing group cochair Tracy E. McCallin, MD, associate professor in the division of pediatric emergency medicine at Rainbow Babies and Children’s Hospital in Cleveland , Ohio, explained that drowning generally advances from initial respiratory arrest from submersion-related hypoxia to cardiac arrest, and therefore it can be difficult to distinguish respiratory arrest from cardiac arrest because pulses are difficult to accurately palpate within the recommended 10-second window.
“Therefore, resuscitation from cardiac arrest due to this specific circumstance must focus on restoring breathing as much as it does circulation,” the authors wrote.
Resuscitation after drowning may begin in the water with rescue breathing when safely provided by trained rescuers and should continue with chest compressions, once the drowned person and the rescuer are on land or in a boat, the report authors wrote.
“The focused update on drowning contains the most up-to-date, evidence-based recommendations on how to resuscitate someone who has drowned,” McCallin states in a press release.
In addition to the new guidance on rescue breaths, the update includes new topics that the AHA has not previously addressed with treatment recommendations, such as oxygen administration after drowning; automated external defibrillator use in cardiac arrest after drowning and public-access defibrillation programs.
Pediatricians Can Help Spread the Word
Alexandra Stern, MD, assistant professor in the Department of Pediatrics at University of Florida, Gainesville, who was not part of the update, said pediatricians can help disseminate this new information.
“Water safety is a topic frequently discussed as a pediatrician, with focus often being on primary prevention of drowning,” she said. “We stress the importance of the multiple layers of protection against drowning, such as touch supervision (staying within arm’s length); secure fencing, access to appropriate life jackets, and teaching our children to swim. Learning CPR is a large part of these measures and continuing these discussions with our patients and families is important.”
She added that updating the recommended procedures will likely require changes to all forms of education and community outreach regarding drowning from basic life support classes to more advanced lifeguard training. She noted that the update provides practical guidance not just for trained rescuers and healthcare professionals, but also for family members.
The paper notes that drowning is the third leading cause of death from unintentional injury globally, accounting for 7% of all injury-related deaths. In the United States, drowning is the leading cause of death in children aged 1-4 years and the second leading cause of death from unintentional injury in children aged 5-14 years.
The update is based on systematic reviews from 2021 to 2023 performed by the International Liaison Committee on Resuscitation related to the resuscitation of drowning.
The authors and Stern reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
New recommendations on rescuing adults and children who have drowned include an important update for healthcare professionals, trained rescuers, and untrained lay rescuers.
The American Heart Association (AHA) and the American Academy of Pediatrics (AAP) have issued recommendations that highlight delivering rescue breaths as well as calling 911 and performing chest compressions in cardiopulmonary resuscitation (CPR) as first steps when a person pulled from the water is in cardiac arrest.
This is the first collaboration between the two organizations on resuscitation after drowning. The recommendations were published simultaneously in Circulation and Pediatrics.
Included in the recommendations are two key principles:
- Anyone pulled from the water who has no signs of normal breathing or consciousness should be presumed to be in cardiac arrest.
- Rescuers should immediately start CPR that includes rescue breathing in addition to chest compressions. Multiple large studies show more people with cardiac arrest from noncardiac causes such as drowning survive when CPR includes rescue breaths, compared with hands-only CPR (calling 911 and pushing hard and fast in the center of the chest).
If someone is untrained, unwilling, or unable to give breaths, they can perform chest compressions until help arrives, the recommendations advise.
Reasoning Behind the Update
The authors, led by writing group cochair Tracy E. McCallin, MD, associate professor in the division of pediatric emergency medicine at Rainbow Babies and Children’s Hospital in Cleveland , Ohio, explained that drowning generally advances from initial respiratory arrest from submersion-related hypoxia to cardiac arrest, and therefore it can be difficult to distinguish respiratory arrest from cardiac arrest because pulses are difficult to accurately palpate within the recommended 10-second window.
“Therefore, resuscitation from cardiac arrest due to this specific circumstance must focus on restoring breathing as much as it does circulation,” the authors wrote.
Resuscitation after drowning may begin in the water with rescue breathing when safely provided by trained rescuers and should continue with chest compressions, once the drowned person and the rescuer are on land or in a boat, the report authors wrote.
“The focused update on drowning contains the most up-to-date, evidence-based recommendations on how to resuscitate someone who has drowned,” McCallin states in a press release.
In addition to the new guidance on rescue breaths, the update includes new topics that the AHA has not previously addressed with treatment recommendations, such as oxygen administration after drowning; automated external defibrillator use in cardiac arrest after drowning and public-access defibrillation programs.
Pediatricians Can Help Spread the Word
Alexandra Stern, MD, assistant professor in the Department of Pediatrics at University of Florida, Gainesville, who was not part of the update, said pediatricians can help disseminate this new information.
“Water safety is a topic frequently discussed as a pediatrician, with focus often being on primary prevention of drowning,” she said. “We stress the importance of the multiple layers of protection against drowning, such as touch supervision (staying within arm’s length); secure fencing, access to appropriate life jackets, and teaching our children to swim. Learning CPR is a large part of these measures and continuing these discussions with our patients and families is important.”
She added that updating the recommended procedures will likely require changes to all forms of education and community outreach regarding drowning from basic life support classes to more advanced lifeguard training. She noted that the update provides practical guidance not just for trained rescuers and healthcare professionals, but also for family members.
The paper notes that drowning is the third leading cause of death from unintentional injury globally, accounting for 7% of all injury-related deaths. In the United States, drowning is the leading cause of death in children aged 1-4 years and the second leading cause of death from unintentional injury in children aged 5-14 years.
The update is based on systematic reviews from 2021 to 2023 performed by the International Liaison Committee on Resuscitation related to the resuscitation of drowning.
The authors and Stern reported no relevant financial relationships.
A version of this article appeared on Medscape.com.
From Pediatrics
New UTI Guideline Offers Treatment Clarity, Reveals Gaps in Knowledge
New recommendations from the WikiGuidelines Group offer strategies for the prevention, diagnosis, and management of urinary tract infections (UTIs) in children and adults.
While the guideline covers a range of clinical topics, including prophylaxis and antimicrobial stewardship, many key clinical questions remain unanswered because of a lack of high-quality evidence, according to lead author Zachary Nelson, PharmD, MPH, of HealthPartners and Park Nicollet Health Services, St. Louis Park, Minnesota, and colleagues.
“This guideline fills a critical gap by providing pragmatic, broadly applicable recommendations tailored for generalist care and systems-based practice,” Nelson and colleagues wrote in JAMA Network Open. “Our guidance is rooted in the best available evidence and is designed for clinicians from various backgrounds and healthcare environments. It emphasizes a patient-centered approach to the diagnosis, prevention, and treatment of UTIs and related genitourinary infections.”
The guideline panelists, including 54 experts from 12 countries, developed the document in accordance with Standards for Quality Improvement Reporting Excellence and the WikiGuidelines charter. The latter requires that “clear recommendations” are based on data from at least two concordant randomized clinical trials (RCTs), or one RCT plus one concordant prospective observational study.
This approach allowed the panel to provide clear recommendations for 6 out of 37 unique questions, while 3 other questions were partially answered. In other words, 75% of the questions lacked sufficient evidence for answers.
“These guidelines are important because they illuminate the clinical data and lack of data we have for approaching diagnosis and treatment of this common infection that leads to a wide array of morbidity and sometimes mortality, as well as significant cost burden to the healthcare system,” said coauthor Sarah Kurz, MD, clinical assistant professor of internal medicine at Michigan Medicine, Ann Arbor, in a written comment.
Jessica Hammett, MD, a urologist at Emory Healthcare, Atlanta, Georgia, who was not an author of the study, suggested that the guideline is additionally impactful because of the panel’s geographic diversity.
“It is an international collaboration that takes into account regional and international practice patterns and differences,” Hammett said in a written comment.
The key guideline recommendations are briefly summarized below.
Preventive Strategies for UTI
The guideline endorses cranberry products as preventive for UTI-prone women, children, and post-intervention patients, though data are insufficient to recommend them for older adults, those with bladder issues, or pregnant women.
Topical estrogen is recommended for postmenopausal women with recurrent UTIs, as it helps restore the vaginal microbiome with minimal systemic absorption. It may also benefit patients with breast cancer when nonhormonal alternatives fail.
For those with intact bladder anatomy, methenamine hippurate is suggested as a noninferior alternative to low-dose antibiotics for preventing recurrent UTIs.
“These findings confirm the best practice of starting postmenopausal women on vaginal estrogen to prevent UTIs, which is a treatment option that should be implemented more commonly,” Hammett said. “Interestingly as compared to the AUA guidelines, this paper recommends the use of cranberry supplementation and methenamine as antibiotic alternatives for preventing UTIs.”
Empirical Treatment Recommendations
According to the guideline, empirical treatment for UTIs should focus on antimicrobials with high urinary tract concentration and local pathogen efficacy.
Nitrofurantoin is recommended for uncomplicated cystitis, while trimethoprim/sulfamethoxazole (TMP/SMX) and first-generation cephalosporins are advised for pyelonephritis.
For intravenous therapy, ceftriaxone is preferred unless there are risk factors for multidrug resistance.
Recommended treatment durations include 5 days for nitrofurantoin, 3 days for TMP/SMX and fluoroquinolones, and a single dose for fosfomycin in acute cystitis cases. For acute pyelonephritis, fluoroquinolones are advised for 5-7 days, with dose-optimized beta-lactams for 7 days. Gram-negative bacteremia from urinary sources warrants a 7-day course.
Stewardship and Clinical Management
The guideline emphasizes antimicrobial stewardship, with support for antibiotic de-escalation and oral regimens where feasible, to reduce adverse effects and hospital stays. Although evidence is limited, the authors suggest thorough allergy assessment and selective reporting of susceptibility results to enhance antibiotic selection.
While data were insufficient to make clear recommendations about the treatment of asymptomatic bacteriuria, Nelson and colleagues suggested that this practice “risks side effects without benefit” while threatening antimicrobial sustainability.
Hammett agreed, noting that “[this] serves as an important reminder not to treat asymptomatic bacteriuria, as it increases side effects and bacterial resistance without any improvement as compared to placebo.”
Special Considerations for Urologic Procedures
Finally, patients undergoing urologic procedures, routine cystoscopy, and urodynamic studies generally do not require prophylactic antibiotics, according to the guideline. Single-dose antibiotic prophylaxis is recommended for low-risk nephrolithotomy patients, though high-risk individuals, such as those who are pregnant or post kidney transplant, may require extended prophylaxis.
Kurz suggested that the guideline consolidates and supports the foundation of evidence driving common practices.
“I don’t think these guidelines offer any strikingly new strategies, which is unsurprising, as they were created after a deep dive into existing literature,” Kurz said. “But more importantly, what I think they do is to highlight where and what the evidence is for many of the clinical strategies that are commonly employed. For example, in terms of prevention, it is common for primary care physicians, urologists, and infectious diseases doctors to recommend cranberry and hydration and to use methenamine. These guidelines highlight that there is sufficient quality and quantity of evidence to support these interventions.”
She also noted how the guidelines emphasize the need for symptoms to make a UTI diagnosis and advise against routine testing of asymptomatic individuals.
“Despite this not being new information, typical clinical practice is often out of step here, and this [guideline] reemphasizes the important factors when considering UTI diagnosis,” Kurz said.
Finally, she expressed frustration for the numerous knowledge gaps remaining in this area, which may be traced back to barriers ranging from the semantic to the more systemic.
“Some of the difficulty is lack of clear definitions and precise terminology regarding UTIs,” Kurz said, noting the unclear distinction between complicated and uncomplicated UTIs. “I would also argue that UTIs are a disease that predominantly affects women, and like many other diseases where this is the case, [they] tend to be less studied. Hopefully, this guideline’s spotlight on all that we do not know can inspire high-quality research to address these gaps, leading to optimal patient care along with decreased burden on the system as a whole in terms of cost and antimicrobial resistance.”
The study was funded by Merck. The WikiGuidelines Group that established this guideline is entirely voluntary and unpaid; the group intends to establish a nonprofit organization to support the development of other guidelines using this novel methodology and eventually intends to trademark the name WikiGuidelines. The authors disclosed relationships with Pfizer, Eumedica, GSK, and others.
A version of this article first appeared on Medscape.com.
New recommendations from the WikiGuidelines Group offer strategies for the prevention, diagnosis, and management of urinary tract infections (UTIs) in children and adults.
While the guideline covers a range of clinical topics, including prophylaxis and antimicrobial stewardship, many key clinical questions remain unanswered because of a lack of high-quality evidence, according to lead author Zachary Nelson, PharmD, MPH, of HealthPartners and Park Nicollet Health Services, St. Louis Park, Minnesota, and colleagues.
“This guideline fills a critical gap by providing pragmatic, broadly applicable recommendations tailored for generalist care and systems-based practice,” Nelson and colleagues wrote in JAMA Network Open. “Our guidance is rooted in the best available evidence and is designed for clinicians from various backgrounds and healthcare environments. It emphasizes a patient-centered approach to the diagnosis, prevention, and treatment of UTIs and related genitourinary infections.”
The guideline panelists, including 54 experts from 12 countries, developed the document in accordance with Standards for Quality Improvement Reporting Excellence and the WikiGuidelines charter. The latter requires that “clear recommendations” are based on data from at least two concordant randomized clinical trials (RCTs), or one RCT plus one concordant prospective observational study.
This approach allowed the panel to provide clear recommendations for 6 out of 37 unique questions, while 3 other questions were partially answered. In other words, 75% of the questions lacked sufficient evidence for answers.
“These guidelines are important because they illuminate the clinical data and lack of data we have for approaching diagnosis and treatment of this common infection that leads to a wide array of morbidity and sometimes mortality, as well as significant cost burden to the healthcare system,” said coauthor Sarah Kurz, MD, clinical assistant professor of internal medicine at Michigan Medicine, Ann Arbor, in a written comment.
Jessica Hammett, MD, a urologist at Emory Healthcare, Atlanta, Georgia, who was not an author of the study, suggested that the guideline is additionally impactful because of the panel’s geographic diversity.
“It is an international collaboration that takes into account regional and international practice patterns and differences,” Hammett said in a written comment.
The key guideline recommendations are briefly summarized below.
Preventive Strategies for UTI
The guideline endorses cranberry products as preventive for UTI-prone women, children, and post-intervention patients, though data are insufficient to recommend them for older adults, those with bladder issues, or pregnant women.
Topical estrogen is recommended for postmenopausal women with recurrent UTIs, as it helps restore the vaginal microbiome with minimal systemic absorption. It may also benefit patients with breast cancer when nonhormonal alternatives fail.
For those with intact bladder anatomy, methenamine hippurate is suggested as a noninferior alternative to low-dose antibiotics for preventing recurrent UTIs.
“These findings confirm the best practice of starting postmenopausal women on vaginal estrogen to prevent UTIs, which is a treatment option that should be implemented more commonly,” Hammett said. “Interestingly as compared to the AUA guidelines, this paper recommends the use of cranberry supplementation and methenamine as antibiotic alternatives for preventing UTIs.”
Empirical Treatment Recommendations
According to the guideline, empirical treatment for UTIs should focus on antimicrobials with high urinary tract concentration and local pathogen efficacy.
Nitrofurantoin is recommended for uncomplicated cystitis, while trimethoprim/sulfamethoxazole (TMP/SMX) and first-generation cephalosporins are advised for pyelonephritis.
For intravenous therapy, ceftriaxone is preferred unless there are risk factors for multidrug resistance.
Recommended treatment durations include 5 days for nitrofurantoin, 3 days for TMP/SMX and fluoroquinolones, and a single dose for fosfomycin in acute cystitis cases. For acute pyelonephritis, fluoroquinolones are advised for 5-7 days, with dose-optimized beta-lactams for 7 days. Gram-negative bacteremia from urinary sources warrants a 7-day course.
Stewardship and Clinical Management
The guideline emphasizes antimicrobial stewardship, with support for antibiotic de-escalation and oral regimens where feasible, to reduce adverse effects and hospital stays. Although evidence is limited, the authors suggest thorough allergy assessment and selective reporting of susceptibility results to enhance antibiotic selection.
While data were insufficient to make clear recommendations about the treatment of asymptomatic bacteriuria, Nelson and colleagues suggested that this practice “risks side effects without benefit” while threatening antimicrobial sustainability.
Hammett agreed, noting that “[this] serves as an important reminder not to treat asymptomatic bacteriuria, as it increases side effects and bacterial resistance without any improvement as compared to placebo.”
Special Considerations for Urologic Procedures
Finally, patients undergoing urologic procedures, routine cystoscopy, and urodynamic studies generally do not require prophylactic antibiotics, according to the guideline. Single-dose antibiotic prophylaxis is recommended for low-risk nephrolithotomy patients, though high-risk individuals, such as those who are pregnant or post kidney transplant, may require extended prophylaxis.
Kurz suggested that the guideline consolidates and supports the foundation of evidence driving common practices.
“I don’t think these guidelines offer any strikingly new strategies, which is unsurprising, as they were created after a deep dive into existing literature,” Kurz said. “But more importantly, what I think they do is to highlight where and what the evidence is for many of the clinical strategies that are commonly employed. For example, in terms of prevention, it is common for primary care physicians, urologists, and infectious diseases doctors to recommend cranberry and hydration and to use methenamine. These guidelines highlight that there is sufficient quality and quantity of evidence to support these interventions.”
She also noted how the guidelines emphasize the need for symptoms to make a UTI diagnosis and advise against routine testing of asymptomatic individuals.
“Despite this not being new information, typical clinical practice is often out of step here, and this [guideline] reemphasizes the important factors when considering UTI diagnosis,” Kurz said.
Finally, she expressed frustration for the numerous knowledge gaps remaining in this area, which may be traced back to barriers ranging from the semantic to the more systemic.
“Some of the difficulty is lack of clear definitions and precise terminology regarding UTIs,” Kurz said, noting the unclear distinction between complicated and uncomplicated UTIs. “I would also argue that UTIs are a disease that predominantly affects women, and like many other diseases where this is the case, [they] tend to be less studied. Hopefully, this guideline’s spotlight on all that we do not know can inspire high-quality research to address these gaps, leading to optimal patient care along with decreased burden on the system as a whole in terms of cost and antimicrobial resistance.”
The study was funded by Merck. The WikiGuidelines Group that established this guideline is entirely voluntary and unpaid; the group intends to establish a nonprofit organization to support the development of other guidelines using this novel methodology and eventually intends to trademark the name WikiGuidelines. The authors disclosed relationships with Pfizer, Eumedica, GSK, and others.
A version of this article first appeared on Medscape.com.
New recommendations from the WikiGuidelines Group offer strategies for the prevention, diagnosis, and management of urinary tract infections (UTIs) in children and adults.
While the guideline covers a range of clinical topics, including prophylaxis and antimicrobial stewardship, many key clinical questions remain unanswered because of a lack of high-quality evidence, according to lead author Zachary Nelson, PharmD, MPH, of HealthPartners and Park Nicollet Health Services, St. Louis Park, Minnesota, and colleagues.
“This guideline fills a critical gap by providing pragmatic, broadly applicable recommendations tailored for generalist care and systems-based practice,” Nelson and colleagues wrote in JAMA Network Open. “Our guidance is rooted in the best available evidence and is designed for clinicians from various backgrounds and healthcare environments. It emphasizes a patient-centered approach to the diagnosis, prevention, and treatment of UTIs and related genitourinary infections.”
The guideline panelists, including 54 experts from 12 countries, developed the document in accordance with Standards for Quality Improvement Reporting Excellence and the WikiGuidelines charter. The latter requires that “clear recommendations” are based on data from at least two concordant randomized clinical trials (RCTs), or one RCT plus one concordant prospective observational study.
This approach allowed the panel to provide clear recommendations for 6 out of 37 unique questions, while 3 other questions were partially answered. In other words, 75% of the questions lacked sufficient evidence for answers.
“These guidelines are important because they illuminate the clinical data and lack of data we have for approaching diagnosis and treatment of this common infection that leads to a wide array of morbidity and sometimes mortality, as well as significant cost burden to the healthcare system,” said coauthor Sarah Kurz, MD, clinical assistant professor of internal medicine at Michigan Medicine, Ann Arbor, in a written comment.
Jessica Hammett, MD, a urologist at Emory Healthcare, Atlanta, Georgia, who was not an author of the study, suggested that the guideline is additionally impactful because of the panel’s geographic diversity.
“It is an international collaboration that takes into account regional and international practice patterns and differences,” Hammett said in a written comment.
The key guideline recommendations are briefly summarized below.
Preventive Strategies for UTI
The guideline endorses cranberry products as preventive for UTI-prone women, children, and post-intervention patients, though data are insufficient to recommend them for older adults, those with bladder issues, or pregnant women.
Topical estrogen is recommended for postmenopausal women with recurrent UTIs, as it helps restore the vaginal microbiome with minimal systemic absorption. It may also benefit patients with breast cancer when nonhormonal alternatives fail.
For those with intact bladder anatomy, methenamine hippurate is suggested as a noninferior alternative to low-dose antibiotics for preventing recurrent UTIs.
“These findings confirm the best practice of starting postmenopausal women on vaginal estrogen to prevent UTIs, which is a treatment option that should be implemented more commonly,” Hammett said. “Interestingly as compared to the AUA guidelines, this paper recommends the use of cranberry supplementation and methenamine as antibiotic alternatives for preventing UTIs.”
Empirical Treatment Recommendations
According to the guideline, empirical treatment for UTIs should focus on antimicrobials with high urinary tract concentration and local pathogen efficacy.
Nitrofurantoin is recommended for uncomplicated cystitis, while trimethoprim/sulfamethoxazole (TMP/SMX) and first-generation cephalosporins are advised for pyelonephritis.
For intravenous therapy, ceftriaxone is preferred unless there are risk factors for multidrug resistance.
Recommended treatment durations include 5 days for nitrofurantoin, 3 days for TMP/SMX and fluoroquinolones, and a single dose for fosfomycin in acute cystitis cases. For acute pyelonephritis, fluoroquinolones are advised for 5-7 days, with dose-optimized beta-lactams for 7 days. Gram-negative bacteremia from urinary sources warrants a 7-day course.
Stewardship and Clinical Management
The guideline emphasizes antimicrobial stewardship, with support for antibiotic de-escalation and oral regimens where feasible, to reduce adverse effects and hospital stays. Although evidence is limited, the authors suggest thorough allergy assessment and selective reporting of susceptibility results to enhance antibiotic selection.
While data were insufficient to make clear recommendations about the treatment of asymptomatic bacteriuria, Nelson and colleagues suggested that this practice “risks side effects without benefit” while threatening antimicrobial sustainability.
Hammett agreed, noting that “[this] serves as an important reminder not to treat asymptomatic bacteriuria, as it increases side effects and bacterial resistance without any improvement as compared to placebo.”
Special Considerations for Urologic Procedures
Finally, patients undergoing urologic procedures, routine cystoscopy, and urodynamic studies generally do not require prophylactic antibiotics, according to the guideline. Single-dose antibiotic prophylaxis is recommended for low-risk nephrolithotomy patients, though high-risk individuals, such as those who are pregnant or post kidney transplant, may require extended prophylaxis.
Kurz suggested that the guideline consolidates and supports the foundation of evidence driving common practices.
“I don’t think these guidelines offer any strikingly new strategies, which is unsurprising, as they were created after a deep dive into existing literature,” Kurz said. “But more importantly, what I think they do is to highlight where and what the evidence is for many of the clinical strategies that are commonly employed. For example, in terms of prevention, it is common for primary care physicians, urologists, and infectious diseases doctors to recommend cranberry and hydration and to use methenamine. These guidelines highlight that there is sufficient quality and quantity of evidence to support these interventions.”
She also noted how the guidelines emphasize the need for symptoms to make a UTI diagnosis and advise against routine testing of asymptomatic individuals.
“Despite this not being new information, typical clinical practice is often out of step here, and this [guideline] reemphasizes the important factors when considering UTI diagnosis,” Kurz said.
Finally, she expressed frustration for the numerous knowledge gaps remaining in this area, which may be traced back to barriers ranging from the semantic to the more systemic.
“Some of the difficulty is lack of clear definitions and precise terminology regarding UTIs,” Kurz said, noting the unclear distinction between complicated and uncomplicated UTIs. “I would also argue that UTIs are a disease that predominantly affects women, and like many other diseases where this is the case, [they] tend to be less studied. Hopefully, this guideline’s spotlight on all that we do not know can inspire high-quality research to address these gaps, leading to optimal patient care along with decreased burden on the system as a whole in terms of cost and antimicrobial resistance.”
The study was funded by Merck. The WikiGuidelines Group that established this guideline is entirely voluntary and unpaid; the group intends to establish a nonprofit organization to support the development of other guidelines using this novel methodology and eventually intends to trademark the name WikiGuidelines. The authors disclosed relationships with Pfizer, Eumedica, GSK, and others.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
PRECISE-DAPT Score Predicts GI Bleeding Risk Among Post-PCI Patients
PHILADELPHIA — Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year.
“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.
Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.
“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”
Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.
In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.
Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.
The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.
Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.
In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).
However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.
“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.
“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”
Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.
“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”
The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA — Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year.
“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.
Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.
“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”
Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.
In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.
Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.
The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.
Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.
In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).
However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.
“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.
“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”
Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.
“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”
The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
PHILADELPHIA — Gastrointestinal (GI) bleeding after percutaneous coronary intervention (PCI) among patients on dual antiplatelet therapy (DAPT) remains risky in terms of morbidity and mortality, but the Predicting Bleeding Complications in Patients Undergoing Stent Implantation and Subsequent Dual Antiplatelet Therapy (PRECISE-DAPT) score could help predict that risk, according to a study presented at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting.
In a predominantly Hispanic population in Texas, 2.5% of post-PCI patients on DAPT had GI bleeding in the first year.
“Our study established that the PRECISE-DAPT score possesses a moderate predictive accuracy not only for overall bleeding risk but also specifically for gastrointestinal bleeding,” said lead author Jesus Guzman, MD, a gastroenterology fellow at the Texas Tech University Health Sciences Center El Paso.
Current guidelines from the American College of Cardiology and American Heart Association recommend DAPT for 6-12 months post-PCI, with consideration for shorter durations in patients with lower ischemic risks but higher bleeding risks.
“Interestingly, some of these patients were on DAPT for more than 2 years, which goes beyond the guidelines,” he said. “In this patient population, this has to do with them being lost to follow-up and getting reestablished, and they kept refilling their prescriptions.”
Guzman and colleagues conducted a retrospective cohort study of patients receiving DAPT after PCI from 2014 to 2021. They looked for GI bleeding rates at 1 year and across the duration of the study period, as well as endoscopic indications, findings, concurrent antiplatelet therapy, and the primary cause of bleeding.
In addition, the research team evaluated the predictive value of the PRECISE-DAPT score, which categorizes patients based on low risk (≤ 17), moderate risk (18-24), and high risk (≥ 25) for bleeding. The score aims to optimize the balance between bleeding and ischemic risks, Guzman said, by incorporating five factors: Age, creatinine clearance, hemoglobin, white blood cell count, and history of spontaneous bleeding.
Among 1067 patients, 563 (57.9%) received clopidogrel and 409 (42%) received ticagrelor. The overall cohort was 66.6% men, 77.1% Hispanic, and had a mean age of 62 years.
The GI bleeding rate was 2.5% at 1-year post-PCI among 27 patients and 3.7% for the study duration among 39 patients, with a median follow-up of 2.2 years.
Among the 39 GI bleeds, 41% were lower GI bleeds, 28% were upper GI bleeds, 15% were small bowel bleeds, and 15% were undetermined. The most frequent etiology was colon cancer, accounting for 18% of bleeds, followed by 15% for gastric ulcers, 10% for diverticular bleeds, and 10% for hemorrhoidal bleeds.
In general, analyses indicated no significant differences in GI bleeding between patients on clopidogrel (21.2%) and those on ticagrelor (19.2%).
However, the odds of GI bleeding were significantly higher in patients with high-risk PRECISE-DAPT scores (odds ratio [OR], 2.5) and moderate-risk scores (OR, 2.8) than in those with low-risk scores. The majority of patients without GI bleeding had scores < 17, whereas the majority of patients with GI bleeding had scores > 24. An optimal threshold for the PRECISE-DAPT score was identified as ≥ 19.
“When patients on DAPT present with GI bleeding, it can be a clinical conundrum for gastroenterologists and cardiologists, especially when it can be a life-or-death event, and stopping DAPT can increase risk of thrombosis,” said Jeff Taclob, MD, a hepatology fellow at The University of Tennessee Health Science Center in Memphis. Taclob, who wasn’t involved with the study, attended the conference session.
“In this population in El Paso, in particular, many patients don’t have adequate healthcare, may be lost to follow-up, and get their prescriptions filled elsewhere, such as Juárez, Mexico,” he said. “Then they come in with this life-threatening bleed, so we need to focus more on their risks.”
Paying attention to specific patient populations, cultures, and values remains important for patient communication and clinical decision-making, Taclob noted.
“In this population of older men, there’s often a macho persona where they don’t want to seek help,” he said. “DAPT criteria could differ in other populations, but here, the PRECISE-DAPT score appeared to help.”
The study was awarded the ACG Outstanding Research Award in the GI Bleeding Category (Trainee). Guzman and Taclob reported no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM ACG 2024
Periodontitis Management: GPs Should Play a Role
Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.
Diabetes and Periodontitis
A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.
GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.
Cardiovascular Diseases and Periodontitis
Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.
Respiratory Diseases and Periodontitis
The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.
Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.
This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.
Diabetes and Periodontitis
A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.
GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.
Cardiovascular Diseases and Periodontitis
Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.
Respiratory Diseases and Periodontitis
The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.
Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.
This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Periodontitis is a chronic inflammatory disease that triggers a local immuno-inflammatory response, potentially leading to periodontal tissue destruction and tooth loss. Affecting 1.1 billion people worldwide, periodontitis is recognized as a significant public health issue. It is also linked to a number of other conditions, such as diabetes, cardiovascular disease, and respiratory disorders. The European Federation of Periodontology recently published a consensus report recommending that the optimal management of periodontitis should involve a collaboration between general practitioners (GPs) and oral health professionals.
Diabetes and Periodontitis
A bidirectional association exists between diabetes and periodontitis. Hyperglycemia accelerates periodontitis progression by promoting inflammation and hindering the healing process, while periodontitis is associated with higher hemoglobin A1c levels in patients with diabetes and an increased risk for diabetes development in others. Intervention studies have demonstrated the positive effect of glycemic control on periodontitis and vice versa, with periodontal treatment improving A1c levels.
GPs can raise awareness of the links between these conditions as well as emphasize the benefits of addressing both metabolic and periodontal abnormalities. They should refer patients with diabetes to oral health specialists and look for signs of periodontitis, such as bleeding gums and loose teeth, in patients with diabetes and those with prediabetes.
Cardiovascular Diseases and Periodontitis
Cardiovascular diseases and periodontitis are linked by their epidemiological associations and common biologic mechanisms. This connection can be explained by some of their shared risk factors, such as smoking and systemic inflammatory pathways. Although no intervention studies have shown a direct reduction in cardiovascular risk from periodontal care, two studies have demonstrated improvements in surrogate markers such as blood pressure and arterial stiffness. GPs should inquire about symptoms of periodontitis in cardiovascular patients and, if necessary, refer them to oral health specialists. Periodontal treatments, whether surgical or nonsurgical, pose no risk for patients receiving well-managed secondary preventive treatments.
Respiratory Diseases and Periodontitis
The primary evidence linking periodontitis with chronic respiratory diseases concerns chronic obstructive pulmonary disease (COPD). Individuals with periodontitis have a 33% higher risk of developing COPD, and patients with COPD and periodontitis may experience a greater decline in lung function. An established association also exists between periodontitis and obstructive sleep apnea, although the data remain inconclusive regarding a link with asthma. GPs should encourage patients with COPD to quit smoking, as it benefits both respiratory and oral health.
Finally, based on meta-analyses of COVID-19, experts note significant associations between periodontitis and the need for assisted ventilation or the risk for death during a COVID-19 infection.
This story was translated from Univadis France using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.
Building an AI Army of Digital Twins to Fight Cancer
A patient has cancer. It’s decision time.
Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.
“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.
What if there were a way to test — quickly and accurately — all the potential paths forward?
That’s the goal of digital twins.
“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.
A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
How to Deliver a Twin
To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.
Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.
Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.
“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
Digital Twins to Predict Cancer Outcomes
Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.
At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.
Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.
“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.
“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.
Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.
The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
What Else Can a Twin Do? A Lot
While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.
For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.
Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.
The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.
Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.
And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
Faster, More Effective Research With Twins
Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.
Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.
It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.
Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.
Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
The Long Push Forward
One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.
“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.
“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.
And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.
With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
A version of this article appeared on Medscape.com.
A patient has cancer. It’s decision time.
Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.
“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.
What if there were a way to test — quickly and accurately — all the potential paths forward?
That’s the goal of digital twins.
“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.
A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
How to Deliver a Twin
To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.
Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.
Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.
“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
Digital Twins to Predict Cancer Outcomes
Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.
At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.
Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.
“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.
“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.
Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.
The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
What Else Can a Twin Do? A Lot
While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.
For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.
Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.
The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.
Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.
And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
Faster, More Effective Research With Twins
Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.
Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.
It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.
Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.
Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
The Long Push Forward
One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.
“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.
“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.
And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.
With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
A version of this article appeared on Medscape.com.
A patient has cancer. It’s decision time.
Clinician and patient alike face, really, the ultimate challenge when making those decisions. They have to consider the patient’s individual circumstances, available treatment options, potential side effects, relevant clinical data such as the patient’s genetic profile and cancer specifics, and more.
“That’s a lot of information to hold,” said Uzma Asghar, PhD, MRCP, a British consultant medical oncologist at The Royal Marsden Hospital and a chief scientific officer at Concr LTD.
What if there were a way to test — quickly and accurately — all the potential paths forward?
That’s the goal of digital twins.
“What the [digital twin] model can do for the clinician is to hold all that information and process it really quickly, within a couple of minutes,” Asghar noted.
A digital twin is more than just a computer model or simulation because it copies a real-world person and relies on real-world data. Some digital twin programs also integrate new information as it becomes available. This technology holds promise for personalized medicine, drug discovery, developing screening strategies, and better understanding diseases.
How to Deliver a Twin
To create a digital twin, experts develop a computer model with data to hone its expertise in an area of medicine, such as cancer types and treatments. Then “you train the model on information it’s seen, and then introduce a patient and patient’s information,” said Asghar.
Asghar is currently working with colleagues to develop digital twins that could eventually help solve the aforementioned cancer scenario — a doctor and patient decide the best course of cancer treatment. But their applications are manifold, particularly in clinical research.
Digital twins often include a machine learning component, which would fall under the umbrella term of AI, said Asghar, but it’s not like ChatGPT or other generative AI modules many people are now familiar with.
“The difference here is the model is not there to replace the clinician or to replace clinical trials,” Asghar noted. Instead, digital twins help make decisions faster in a way that can be more affordable.
Digital Twins to Predict Cancer Outcomes
Asghar is currently involved in UK clinical trials enrolling patients with cancer to test the accuracy of digital twin programs.
At this point, these studies do not yet use digital twins to guide the course of treatment, which is something they hope to do eventually. For now, they are still at the validation phase — the digital twin program makes predictions about the treatments and then the researchers later evaluate how accurate the predictions turned out to be based on real information from the enrolled patients.
Their current model gives predictions for RECIST (response evaluation criteria in solid tumor), treatment response, and survival. In addition to collecting data from ongoing clinical trials, they’ve used retrospective data, such as from the Cancer Tumor Atlas, to test the model.
“We’ve clinically validated it now in over 9000 patients,” said Asghar, who noted that they are constantly testing it on new patients. Their data include 30 chemotherapies and 23 cancer types, but they are focusing on four: Triple-negative breast cancer, cancer of unknown primary, pancreatic cancer, and colorectal cancer.
“The reason for choosing those four cancer types is that they are aggressive, their response to chemotherapy isn’t as great, and the outcome for those patient populations, there’s significant room for improvement,” Asghar explained.
Currently, Asghar said, the model is around 80%-90% correct in predicting what the actual clinical outcomes turn out to be.
The final stage of their work, before it becomes widely available to clinicians, will be to integrate it into a clinical trial in which some clinicians use the model to make decisions about treatment vs some who don’t use the model. By studying patient outcomes in both groups, they will be able to determine the value of the digital twin program they created.
What Else Can a Twin Do? A Lot
While a model that helps clinicians make decisions about cancer treatments may be among the first digital twin programs that become widely available, there are many other kinds of digital twins in the works.
For example, a digital twin could be used as a benchmark for a patient to determine how their cancer might have progressed without treatment. Say a patient’s tumor grew during treatment, it might seem like the treatment failed, but a digital twin might show that if left untreated, the tumor would have grown five times as fast, said Paul Macklin, PhD, professor in the Department of Intelligent Systems Engineering at Indiana University Bloomington.
Alternatively, if the virtual patient’s tumor is around the same size as the real patient’s tumor, “that means that treatment has lost its efficacy. It’s time to do something new,” said Macklin. And a digital twin could help with not only choosing a therapy but also choosing a dosing schedule, he noted.
The models can also be updated as new treatments come out, which could help clinicians virtually explore how they might affect a patient before having that patient switch treatments.
Digital twins could also assist in decision-making based on a patient’s priorities and real-life circumstances. “Maybe your priority is not necessarily to shrink this [tumor] at all costs ... maybe your priority is some mix of that and also quality of life,” Macklin said, referring to potential side effects. Or if someone lives 3 hours from the nearest cancer center, a digital twin could help determine whether less frequent treatments could still be effective.
And while much of the activity around digital twins in biomedical research has been focused on cancer, Asghar said the technology has the potential to be applied to other diseases as well. A digital twin for cardiovascular disease could help doctors choose the best treatment. It could also integrate new information from a smartwatch or glucose monitor to make better predictions and help doctors adjust the treatment plan.
Faster, More Effective Research With Twins
Because digital twin programs can quickly analyze large datasets, they can also make real-world studies more effective and efficient.
Though digital twins would not fully replace real clinical trials, they could help run through preliminary scenarios before starting a full clinical trial, which would “save everybody some money, time and pain and risk,” said Macklin.
It’s also possible to use digital twins to design better screening strategies for early cancer detection and monitoring, said Ioannis Zervantonakis, PhD, a bioengineering professor at the University of Pittsburgh.
Zervantonakis is tapping digital twin technology for research that homes in on understanding tumors. In this case, the digital twin is a virtual representation of a real tumor, complete with its complex network of cells and the surrounding tissue.
Zervantonakis’ lab is using the technology to study cell-cell interactions in the tumor microenvironment, with a focus on human epidermal growth factor receptor 2–targeted therapy resistance in breast cancer. The digital twin they developed will simulate tumor growth, predict drug response, analyze cellular interactions, and optimize treatment strategies.
The Long Push Forward
One big hurdle to making digital twins more widely available is that regulation for the technology is still in progress.
“We’re developing the technology, and what’s also happening is the regulatory framework is being developed in parallel. So we’re almost developing things blindly on the basis that we think this is what the regulators would want,” explained Asghar.
“It’s really important that these technologies are regulated properly, just like drugs, and that’s what we’re pushing and advocating for,” said Asghar, noting that people need to know that like drugs, a digital twin has strengths and limitations.
And while a digital twin can be a cost-saving approach in the long run, it does require funding to get a program built, and finding funds can be difficult because not everyone knows about the technology. More funding means more trials.
With more data, Asghar is hopeful that within a few years, a digital twin model could be available for clinicians to use to help inform treatment decisions. This could lead to more effective treatments and, ultimately, better patient outcomes.
A version of this article appeared on Medscape.com.
Smokeless Tobacco, Areca Nut Chewing Behind 1 in 3 Oral Cancers: IARC Report
“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” Harriet Rumgay, PhD, a scientist in the Cancer Surveillance Branch at IARC and first author of the study in Lancet Oncology, said in a news release.
Worldwide, about 300 million people use smokeless tobacco and 600 million people use areca (also called betel) nut, one of the most popular psychoactive substances in the world after nicotine, alcohol, and caffeine. Smokeless tobacco products are consumed without burning and can be chewed, sucked, inhaled, applied locally, or ingested. Areca nut is the seed of the areca palm and can be consumed in various forms.
“Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nut,” Rumgay said.
According to the new report, in 2022, an estimated 120,200 of the 389,800 (30.8%) global cases of oral cancer were attributable to these products.
More than three quarters (77%) of attributable cases were among men and about one quarter (23%) among women.
The vast majority (96%) of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries.
Regions with the highest burden of oral cancers from these products were Southcentral Asia — with 105,500 of 120,200 cases (nearly 88%), including 83,400 in India, 9700 in Bangladesh, 8900 in Pakistan, and 1300 in Sri Lanka — followed by Southeastern Asia with a total of 3900 cases (1600 in Myanmar, 990 in Indonesia, and 785 in Thailand) and East Asia with 3300 cases (3200 in China).
Limitations and Action Points
The authors noted a limitation of the analysis is not accounting for the potential synergistic effects of combined use of smokeless tobacco or areca nut products with other risk factors for oral cancer, such as smoking tobacco or drinking alcohol.
The researchers explained that combined consumption of smokeless tobacco or areca nut, smoked tobacco, and alcohol has a “multiplicative effect” on oral cancer risk, with reported odds ratios increasing from 2.7 for smokeless tobacco only, 7.0 for smoked tobacco only, and 1.6 for alcohol only to 16.2 for all three exposures (vs no use).
However, the proportion of people who chewed tobacco and also smoked in countries with high smokeless tobacco or areca nut use was small. In India, for example, 6% of men and 0.5% of women in 2016-2017 were dual users of both smoked and smokeless tobacco, compared with 23% of men and 12% of women who only used smokeless tobacco.
Overall, curbing or preventing smokeless tobacco and areca nut use could help avoid many instances of oral cancer.
Despite “encouraging trends” in control of tobacco smoking in many regions of the world over the past two decades, progress in reducing the prevalence of smokeless tobacco consumption has stalled in many countries that are major consumers, the authors said.
Compounding the problem, areca nut does not fall within the WHO framework of tobacco control and there are very few areca nut control policies worldwide.
Smokeless tobacco control must be “prioritized” and a framework on areca nut control should be developed with guidelines to incorporate areca nut prevention into cancer control programs, the authors concluded.
Funding for the study was provided by the French National Cancer Institute. The authors had no relevant disclosures.
A version of this article first appeared on Medscape.com.
“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” Harriet Rumgay, PhD, a scientist in the Cancer Surveillance Branch at IARC and first author of the study in Lancet Oncology, said in a news release.
Worldwide, about 300 million people use smokeless tobacco and 600 million people use areca (also called betel) nut, one of the most popular psychoactive substances in the world after nicotine, alcohol, and caffeine. Smokeless tobacco products are consumed without burning and can be chewed, sucked, inhaled, applied locally, or ingested. Areca nut is the seed of the areca palm and can be consumed in various forms.
“Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nut,” Rumgay said.
According to the new report, in 2022, an estimated 120,200 of the 389,800 (30.8%) global cases of oral cancer were attributable to these products.
More than three quarters (77%) of attributable cases were among men and about one quarter (23%) among women.
The vast majority (96%) of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries.
Regions with the highest burden of oral cancers from these products were Southcentral Asia — with 105,500 of 120,200 cases (nearly 88%), including 83,400 in India, 9700 in Bangladesh, 8900 in Pakistan, and 1300 in Sri Lanka — followed by Southeastern Asia with a total of 3900 cases (1600 in Myanmar, 990 in Indonesia, and 785 in Thailand) and East Asia with 3300 cases (3200 in China).
Limitations and Action Points
The authors noted a limitation of the analysis is not accounting for the potential synergistic effects of combined use of smokeless tobacco or areca nut products with other risk factors for oral cancer, such as smoking tobacco or drinking alcohol.
The researchers explained that combined consumption of smokeless tobacco or areca nut, smoked tobacco, and alcohol has a “multiplicative effect” on oral cancer risk, with reported odds ratios increasing from 2.7 for smokeless tobacco only, 7.0 for smoked tobacco only, and 1.6 for alcohol only to 16.2 for all three exposures (vs no use).
However, the proportion of people who chewed tobacco and also smoked in countries with high smokeless tobacco or areca nut use was small. In India, for example, 6% of men and 0.5% of women in 2016-2017 were dual users of both smoked and smokeless tobacco, compared with 23% of men and 12% of women who only used smokeless tobacco.
Overall, curbing or preventing smokeless tobacco and areca nut use could help avoid many instances of oral cancer.
Despite “encouraging trends” in control of tobacco smoking in many regions of the world over the past two decades, progress in reducing the prevalence of smokeless tobacco consumption has stalled in many countries that are major consumers, the authors said.
Compounding the problem, areca nut does not fall within the WHO framework of tobacco control and there are very few areca nut control policies worldwide.
Smokeless tobacco control must be “prioritized” and a framework on areca nut control should be developed with guidelines to incorporate areca nut prevention into cancer control programs, the authors concluded.
Funding for the study was provided by the French National Cancer Institute. The authors had no relevant disclosures.
A version of this article first appeared on Medscape.com.
“Smokeless tobacco and areca nut products are available to consumers in many different forms across the world, but consuming smokeless tobacco and areca nut is linked to multiple diseases, including oral cancer,” Harriet Rumgay, PhD, a scientist in the Cancer Surveillance Branch at IARC and first author of the study in Lancet Oncology, said in a news release.
Worldwide, about 300 million people use smokeless tobacco and 600 million people use areca (also called betel) nut, one of the most popular psychoactive substances in the world after nicotine, alcohol, and caffeine. Smokeless tobacco products are consumed without burning and can be chewed, sucked, inhaled, applied locally, or ingested. Areca nut is the seed of the areca palm and can be consumed in various forms.
“Our estimates highlight the burden these products pose on health care and the importance of prevention strategies to reduce consumption of smokeless tobacco and areca nut,” Rumgay said.
According to the new report, in 2022, an estimated 120,200 of the 389,800 (30.8%) global cases of oral cancer were attributable to these products.
More than three quarters (77%) of attributable cases were among men and about one quarter (23%) among women.
The vast majority (96%) of all oral cancer cases caused by smokeless tobacco and areca nut use occurred in low- and middle-income countries.
Regions with the highest burden of oral cancers from these products were Southcentral Asia — with 105,500 of 120,200 cases (nearly 88%), including 83,400 in India, 9700 in Bangladesh, 8900 in Pakistan, and 1300 in Sri Lanka — followed by Southeastern Asia with a total of 3900 cases (1600 in Myanmar, 990 in Indonesia, and 785 in Thailand) and East Asia with 3300 cases (3200 in China).
Limitations and Action Points
The authors noted a limitation of the analysis is not accounting for the potential synergistic effects of combined use of smokeless tobacco or areca nut products with other risk factors for oral cancer, such as smoking tobacco or drinking alcohol.
The researchers explained that combined consumption of smokeless tobacco or areca nut, smoked tobacco, and alcohol has a “multiplicative effect” on oral cancer risk, with reported odds ratios increasing from 2.7 for smokeless tobacco only, 7.0 for smoked tobacco only, and 1.6 for alcohol only to 16.2 for all three exposures (vs no use).
However, the proportion of people who chewed tobacco and also smoked in countries with high smokeless tobacco or areca nut use was small. In India, for example, 6% of men and 0.5% of women in 2016-2017 were dual users of both smoked and smokeless tobacco, compared with 23% of men and 12% of women who only used smokeless tobacco.
Overall, curbing or preventing smokeless tobacco and areca nut use could help avoid many instances of oral cancer.
Despite “encouraging trends” in control of tobacco smoking in many regions of the world over the past two decades, progress in reducing the prevalence of smokeless tobacco consumption has stalled in many countries that are major consumers, the authors said.
Compounding the problem, areca nut does not fall within the WHO framework of tobacco control and there are very few areca nut control policies worldwide.
Smokeless tobacco control must be “prioritized” and a framework on areca nut control should be developed with guidelines to incorporate areca nut prevention into cancer control programs, the authors concluded.
Funding for the study was provided by the French National Cancer Institute. The authors had no relevant disclosures.
A version of this article first appeared on Medscape.com.
FROM THE LANCET ONCOLOGY