Family Practice News

TOPLINE:

Higher plasma levels of omega-6 and omega-3 fatty acids are associated with a lower incidence of cancer. However, omega-3 fatty acids are linked to an increased risk for prostate cancer, specifically.

METHODOLOGY:

• Researchers looked for associations of plasma omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) with the incidence of cancer overall and 19 site-specific cancers in the large population-based prospective UK Biobank cohort.
• They included 253,138 participants aged 37-73 years who were followed for an average of 12.9 years, with 29,838 diagnosed with cancer.
• Plasma levels of omega-3 and omega-6 fatty acids were measured using nuclear magnetic resonance and expressed as percentages of total fatty acids.
• Participants with cancer diagnoses at baseline, those who withdrew from the study, and those with missing data on plasma PUFAs were excluded.
• The study adjusted for multiple covariates, including age, sex, ethnicity, socioeconomic status, lifestyle behaviors, and family history of diseases.

TAKEAWAY:

• Higher plasma levels of omega-6 and omega-3 fatty acids were associated with a 2% and 1% reduction in overall cancer risk per SD increase, respectively (P = .001 and P = .03).
• Omega-6 fatty acids were inversely associated with 14 site-specific cancers, whereas omega-3 fatty acids were inversely associated with five site-specific cancers.
• Prostate cancer was positively associated with omega-3 fatty acids, with a 3% increased risk per SD increase (P = .049).
• A higher omega-6/omega-3 ratio was associated with an increased risk for overall cancer, and three site-specific cancers showed positive associations with the ratio. “Each standard deviation increase, corresponding to a 13.13 increase in the omega ratio, was associated with a 2% increase in the risk of rectum cancer,” for example, the authors wrote.

IN PRACTICE:

“Overall, our findings provide support for possible small net protective roles of omega-3 and omega-6 PUFAs in the development of new cancer incidence. Our study also suggests that the usage of circulating blood biomarkers captures different aspects of dietary intake, reduces measurement errors, and thus enhances statistical power. The differential effects of omega-6% and omega-3% in age and sex subgroups warrant future investigation,” wrote the authors of the study.

SOURCE:

The study was led by Yuchen Zhang of the University of Georgia in Athens, Georgia. It was published online in the International Journal of Cancer.

LIMITATIONS:

The study’s potential for selective bias persists due to the participant sample skewing heavily toward European ancestry and White ethnicity. The number of events was small for some specific cancer sites, which may have limited the statistical power. The study focused on total omega-3 and omega-6 PUFAs, with only two individual fatty acids measured. Future studies are needed to examine the roles of other individual PUFAs and specific genetic variants. 

DISCLOSURES:

This study was supported by grants from the National Institute of General Medical Sciences of the National Institutes of Health. No relevant conflicts of interest were disclosed by the authors.
 

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:

Higher plasma levels of omega-6 and omega-3 fatty acids are associated with a lower incidence of cancer. However, omega-3 fatty acids are linked to an increased risk for prostate cancer, specifically.

METHODOLOGY:

• Researchers looked for associations of plasma omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) with the incidence of cancer overall and 19 site-specific cancers in the large population-based prospective UK Biobank cohort.
• They included 253,138 participants aged 37-73 years who were followed for an average of 12.9 years, with 29,838 diagnosed with cancer.
• Plasma levels of omega-3 and omega-6 fatty acids were measured using nuclear magnetic resonance and expressed as percentages of total fatty acids.
• Participants with cancer diagnoses at baseline, those who withdrew from the study, and those with missing data on plasma PUFAs were excluded.
• The study adjusted for multiple covariates, including age, sex, ethnicity, socioeconomic status, lifestyle behaviors, and family history of diseases.

TAKEAWAY:

• Higher plasma levels of omega-6 and omega-3 fatty acids were associated with a 2% and 1% reduction in overall cancer risk per SD increase, respectively (P = .001 and P = .03).
• Omega-6 fatty acids were inversely associated with 14 site-specific cancers, whereas omega-3 fatty acids were inversely associated with five site-specific cancers.
• Prostate cancer was positively associated with omega-3 fatty acids, with a 3% increased risk per SD increase (P = .049).
• A higher omega-6/omega-3 ratio was associated with an increased risk for overall cancer, and three site-specific cancers showed positive associations with the ratio. “Each standard deviation increase, corresponding to a 13.13 increase in the omega ratio, was associated with a 2% increase in the risk of rectum cancer,” for example, the authors wrote.

IN PRACTICE:

“Overall, our findings provide support for possible small net protective roles of omega-3 and omega-6 PUFAs in the development of new cancer incidence. Our study also suggests that the usage of circulating blood biomarkers captures different aspects of dietary intake, reduces measurement errors, and thus enhances statistical power. The differential effects of omega-6% and omega-3% in age and sex subgroups warrant future investigation,” wrote the authors of the study.

SOURCE:

The study was led by Yuchen Zhang of the University of Georgia in Athens, Georgia. It was published online in the International Journal of Cancer.

LIMITATIONS:

The study’s potential for selective bias persists due to the participant sample skewing heavily toward European ancestry and White ethnicity. The number of events was small for some specific cancer sites, which may have limited the statistical power. The study focused on total omega-3 and omega-6 PUFAs, with only two individual fatty acids measured. Future studies are needed to examine the roles of other individual PUFAs and specific genetic variants. 

DISCLOSURES:

This study was supported by grants from the National Institute of General Medical Sciences of the National Institutes of Health. No relevant conflicts of interest were disclosed by the authors.
 

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:

Higher plasma levels of omega-6 and omega-3 fatty acids are associated with a lower incidence of cancer. However, omega-3 fatty acids are linked to an increased risk for prostate cancer, specifically.

METHODOLOGY:

• Researchers looked for associations of plasma omega-3 and omega-6 polyunsaturated fatty acids (PUFAs) with the incidence of cancer overall and 19 site-specific cancers in the large population-based prospective UK Biobank cohort.
• They included 253,138 participants aged 37-73 years who were followed for an average of 12.9 years, with 29,838 diagnosed with cancer.
• Plasma levels of omega-3 and omega-6 fatty acids were measured using nuclear magnetic resonance and expressed as percentages of total fatty acids.
• Participants with cancer diagnoses at baseline, those who withdrew from the study, and those with missing data on plasma PUFAs were excluded.
• The study adjusted for multiple covariates, including age, sex, ethnicity, socioeconomic status, lifestyle behaviors, and family history of diseases.

TAKEAWAY:

• Higher plasma levels of omega-6 and omega-3 fatty acids were associated with a 2% and 1% reduction in overall cancer risk per SD increase, respectively (P = .001 and P = .03).
• Omega-6 fatty acids were inversely associated with 14 site-specific cancers, whereas omega-3 fatty acids were inversely associated with five site-specific cancers.
• Prostate cancer was positively associated with omega-3 fatty acids, with a 3% increased risk per SD increase (P = .049).
• A higher omega-6/omega-3 ratio was associated with an increased risk for overall cancer, and three site-specific cancers showed positive associations with the ratio. “Each standard deviation increase, corresponding to a 13.13 increase in the omega ratio, was associated with a 2% increase in the risk of rectum cancer,” for example, the authors wrote.

IN PRACTICE:

“Overall, our findings provide support for possible small net protective roles of omega-3 and omega-6 PUFAs in the development of new cancer incidence. Our study also suggests that the usage of circulating blood biomarkers captures different aspects of dietary intake, reduces measurement errors, and thus enhances statistical power. The differential effects of omega-6% and omega-3% in age and sex subgroups warrant future investigation,” wrote the authors of the study.

SOURCE:

The study was led by Yuchen Zhang of the University of Georgia in Athens, Georgia. It was published online in the International Journal of Cancer.

LIMITATIONS:

The study’s potential for selective bias persists due to the participant sample skewing heavily toward European ancestry and White ethnicity. The number of events was small for some specific cancer sites, which may have limited the statistical power. The study focused on total omega-3 and omega-6 PUFAs, with only two individual fatty acids measured. Future studies are needed to examine the roles of other individual PUFAs and specific genetic variants. 

DISCLOSURES:

This study was supported by grants from the National Institute of General Medical Sciences of the National Institutes of Health. No relevant conflicts of interest were disclosed by the authors.
 

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:

Patients treated for prostate cancer had higher rates of complications, including urinary and sexual issues, than a control group of men. Radiotherapy increases the risk for bladder cancer and radiation-specific complications, according to the new cohort study.
 

METHODOLOGY:

• Researchers conducted a cohort study to try to characterize long-term treatment-related adverse effects and complications in patients treated for prostate cancer, compared with a general population of older males.
• They used data from the Prostate Cancer Prevention Trial and the Selenium and Vitamin E Cancer Prevention Trial, linked with Medicare claims. A total of 29,196 participants were included in the study’s control group. Of 3946 patients diagnosed with prostate cancer, 655 were treated with prostatectomy, and 1056 were treated with radiotherapy.
• Participants were followed for a median of 10.2 years, with specific follow-up durations being 10.5 years and 8.5 years for the prostatectomy and radiotherapy groups, respectively.
• The study analyzed ten potential treatment-related complications using Medicare claims data, including urinary incontinence, erectile dysfunction, and secondary cancers. 
• Multivariable Cox regression was used to adjust for age, race, and year of time-at-risk initiation, with stratification by study and intervention arm. 

TAKEAWAY:

• At 12 years, there was a 7.23 increase in hazard risk for urinary or sexual complications for patients who had prostatectomy, compared with controls (P < .001).
• Radiotherapy-treated patients had a nearly three times greater hazard risk for bladder cancer and a 100-fold increased hazard risk for radiation-specific complications, such as radiation cystitis and radiation proctitis (P < .001).
• The incidence of any treatment-related complication per 1000 person-years was 124.26 for prostatectomy, 62.15 for radiotherapy, and 23.61 for untreated participants.
• The authors stated that these findings highlight the importance of patient counseling before prostate cancer screening and treatment.

IN PRACTICE:

“We found that, after accounting for baseline population rates, most patients with PCA undergoing treatment experience complications associated with worse quality of life and/or new health risks. The magnitude of these risks, compared with the relatively small benefit found by randomized clinical trials of PCA screening and treatment, should be explicitly reflected in national cancer screening and treatment guidelines and be integral to shared decision-making with patients before initiation of PSA screening, biopsy, or PCA treatment,” wrote the authors of the study.
 

SOURCE:

The study was led by Joseph M. Unger, PhD, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center in Seattle, Washington. It was published online on November 7, 2024, in JAMA Oncology.
 

LIMITATIONS:

The study did not account for multiple comparisons, which may affect the statistical significance of some findings. Claims data are subject to misclassification and may underreport complications that are not reported to a physician. The study did not differentiate among strategies of prostatectomy or radiotherapy, which may result in different patterns of complications. The cohort comprised men enrolled in large, randomized prevention trials, which may limit the generalizability of the incidence estimates. Confounding by unknown factors cannot be ruled out, affecting the attribution of risks to prostate cancer treatment alone.
 

DISCLOSURES:

Unger disclosed consulting fees from AstraZeneca and Loxo/Lilly outside the submitted work. One coauthor reported grants from the US National Cancer Institute during the conduct of the study. Another coauthor reported employment with Flatiron Health at the time of manuscript submission and review. Additional disclosures are noted in the original article.

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:

Patients treated for prostate cancer had higher rates of complications, including urinary and sexual issues, than a control group of men. Radiotherapy increases the risk for bladder cancer and radiation-specific complications, according to the new cohort study.
 

METHODOLOGY:

• Researchers conducted a cohort study to try to characterize long-term treatment-related adverse effects and complications in patients treated for prostate cancer, compared with a general population of older males.
• They used data from the Prostate Cancer Prevention Trial and the Selenium and Vitamin E Cancer Prevention Trial, linked with Medicare claims. A total of 29,196 participants were included in the study’s control group. Of 3946 patients diagnosed with prostate cancer, 655 were treated with prostatectomy, and 1056 were treated with radiotherapy.
• Participants were followed for a median of 10.2 years, with specific follow-up durations being 10.5 years and 8.5 years for the prostatectomy and radiotherapy groups, respectively.
• The study analyzed ten potential treatment-related complications using Medicare claims data, including urinary incontinence, erectile dysfunction, and secondary cancers. 
• Multivariable Cox regression was used to adjust for age, race, and year of time-at-risk initiation, with stratification by study and intervention arm. 

TAKEAWAY:

• At 12 years, there was a 7.23 increase in hazard risk for urinary or sexual complications for patients who had prostatectomy, compared with controls (P < .001).
• Radiotherapy-treated patients had a nearly three times greater hazard risk for bladder cancer and a 100-fold increased hazard risk for radiation-specific complications, such as radiation cystitis and radiation proctitis (P < .001).
• The incidence of any treatment-related complication per 1000 person-years was 124.26 for prostatectomy, 62.15 for radiotherapy, and 23.61 for untreated participants.
• The authors stated that these findings highlight the importance of patient counseling before prostate cancer screening and treatment.

IN PRACTICE:

“We found that, after accounting for baseline population rates, most patients with PCA undergoing treatment experience complications associated with worse quality of life and/or new health risks. The magnitude of these risks, compared with the relatively small benefit found by randomized clinical trials of PCA screening and treatment, should be explicitly reflected in national cancer screening and treatment guidelines and be integral to shared decision-making with patients before initiation of PSA screening, biopsy, or PCA treatment,” wrote the authors of the study.
 

SOURCE:

The study was led by Joseph M. Unger, PhD, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center in Seattle, Washington. It was published online on November 7, 2024, in JAMA Oncology.
 

LIMITATIONS:

The study did not account for multiple comparisons, which may affect the statistical significance of some findings. Claims data are subject to misclassification and may underreport complications that are not reported to a physician. The study did not differentiate among strategies of prostatectomy or radiotherapy, which may result in different patterns of complications. The cohort comprised men enrolled in large, randomized prevention trials, which may limit the generalizability of the incidence estimates. Confounding by unknown factors cannot be ruled out, affecting the attribution of risks to prostate cancer treatment alone.
 

DISCLOSURES:

Unger disclosed consulting fees from AstraZeneca and Loxo/Lilly outside the submitted work. One coauthor reported grants from the US National Cancer Institute during the conduct of the study. Another coauthor reported employment with Flatiron Health at the time of manuscript submission and review. Additional disclosures are noted in the original article.

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:

Patients treated for prostate cancer had higher rates of complications, including urinary and sexual issues, than a control group of men. Radiotherapy increases the risk for bladder cancer and radiation-specific complications, according to the new cohort study.
 

METHODOLOGY:

• Researchers conducted a cohort study to try to characterize long-term treatment-related adverse effects and complications in patients treated for prostate cancer, compared with a general population of older males.
• They used data from the Prostate Cancer Prevention Trial and the Selenium and Vitamin E Cancer Prevention Trial, linked with Medicare claims. A total of 29,196 participants were included in the study’s control group. Of 3946 patients diagnosed with prostate cancer, 655 were treated with prostatectomy, and 1056 were treated with radiotherapy.
• Participants were followed for a median of 10.2 years, with specific follow-up durations being 10.5 years and 8.5 years for the prostatectomy and radiotherapy groups, respectively.
• The study analyzed ten potential treatment-related complications using Medicare claims data, including urinary incontinence, erectile dysfunction, and secondary cancers. 
• Multivariable Cox regression was used to adjust for age, race, and year of time-at-risk initiation, with stratification by study and intervention arm. 

TAKEAWAY:

• At 12 years, there was a 7.23 increase in hazard risk for urinary or sexual complications for patients who had prostatectomy, compared with controls (P < .001).
• Radiotherapy-treated patients had a nearly three times greater hazard risk for bladder cancer and a 100-fold increased hazard risk for radiation-specific complications, such as radiation cystitis and radiation proctitis (P < .001).
• The incidence of any treatment-related complication per 1000 person-years was 124.26 for prostatectomy, 62.15 for radiotherapy, and 23.61 for untreated participants.
• The authors stated that these findings highlight the importance of patient counseling before prostate cancer screening and treatment.

IN PRACTICE:

“We found that, after accounting for baseline population rates, most patients with PCA undergoing treatment experience complications associated with worse quality of life and/or new health risks. The magnitude of these risks, compared with the relatively small benefit found by randomized clinical trials of PCA screening and treatment, should be explicitly reflected in national cancer screening and treatment guidelines and be integral to shared decision-making with patients before initiation of PSA screening, biopsy, or PCA treatment,” wrote the authors of the study.
 

SOURCE:

The study was led by Joseph M. Unger, PhD, SWOG Statistics and Data Management Center, Fred Hutchinson Cancer Center in Seattle, Washington. It was published online on November 7, 2024, in JAMA Oncology.
 

LIMITATIONS:

The study did not account for multiple comparisons, which may affect the statistical significance of some findings. Claims data are subject to misclassification and may underreport complications that are not reported to a physician. The study did not differentiate among strategies of prostatectomy or radiotherapy, which may result in different patterns of complications. The cohort comprised men enrolled in large, randomized prevention trials, which may limit the generalizability of the incidence estimates. Confounding by unknown factors cannot be ruled out, affecting the attribution of risks to prostate cancer treatment alone.
 

DISCLOSURES:

Unger disclosed consulting fees from AstraZeneca and Loxo/Lilly outside the submitted work. One coauthor reported grants from the US National Cancer Institute during the conduct of the study. Another coauthor reported employment with Flatiron Health at the time of manuscript submission and review. Additional disclosures are noted in the original article.

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.

On September 27, 2024, UMC Health System in Lubbock, Texas, experienced an IT outage because of a cybersecurity incident that temporarily diverted patients to other healthcare facilities. So far, in 2024, there have been 386 cyberattacks on healthcare organizations. These high-impact ransomware attacks disrupt and delay patient care.

In recent years, many healthcare systems, including Scripps Health, Universal Health Services, Vastaamo, Sky Lakes, and the University of Vermont, have paid millions — even tens of millions — to recover data after a cyberattack or data breach. When healthcare systems come under cyber fire, the impact extends far past disrupting workflows and compromising data, patient safety can be also be compromised, vital information may be lost, and imaging and lab results can go missing or be held for ransom, making physicians’ job difficult or impossible.

In fact, cyberattacks on hospitals are far more common than you may realize. A new report issued by Ponemon and Proofpoint found that 92% of healthcare organizations have experienced a cyberattack in the past 12 months. Even more sobering is that about half of the organizations affected suffered disruptions in patient care.
 

Healthcare Systems = ‘Soft Targets’

Healthcare systems are a “soft target” for hackers for several reasons, pointed out Matthew Radolec, vice president, incident response and cloud operations at Varonis, a data security company. “One, they’re usually an amalgamation of many healthcare systems that are interconnected,” said Radolec. “A lot of hospitals are connected to other hospitals or connected to educational institutions, which means their computer vulnerabilities are shared ... and if they have an issue, it could very easily spread to your network.”

Another factor is the cost of securing data. “[With hospitals], they’ll say that a dollar spent on security is a dollar not spent on patient care,” said Radolec. “So the idea of investing in security is really tough from a budget standpoint…they’re choosing between a new MRI machine or better antivirus, backups, or data security.”

Because of the wealth of private data and healthcare information they maintain, hospitals are considered “high impact” for cybercriminals. Attackers know that if they get a foothold in a hospital, it’s more likely to pay — and pay quickly, Radolec told this news organization. Hospitals are also likely to have cyber insurance to help cover the cost of having their data stolen, encrypted, and ransomed.

The 2024 Microsoft Digital Defense Report also found that the bad actors are more sophisticated and better resourced and can challenge even the best cybersecurity. Improved defenses may not be good enough, and the sheer volume of attacks must be met with effective deterrence and government solutions that impose consequences for cybercriminals.
 

Vulnerable Users

Whether through a phishing email or text, password attack, or web attack, “the moment a ‘threat actor’ gets into your institution and gets credentials ... that’s the Nirvana state of a threat actor,” warned Ryan Witt, chair of the healthcare customer advisory board and vice president of Industry Solutions at Proofpoint, a cybersecurity platform. “They have those credentials and will go into deep reconnaissance mode. It often takes healthcare up to 6 months to even ascertain whether somebody’s actually in the network.” During that time, the hacker is learning how the institution works, what job functions matter, and how best to plan their attack.

“Attackers are getting in because they’re buying databases of usernames and passwords. And they’re trying them by the millions,” added Radolec. “For a sophisticated actor, all it takes is time and motivation. They have the skills. It’s just a matter of how persistent they want to be.”

Certain hospital staff are also more likely to be targeted by cyberhackers than others. “About 10% of a healthcare organization’s user base is much more vulnerable for all sorts of reasons — how they work, the value of their job title and job function, and therefore their access to systems,” said Witt.

High-profile staff are more likely to be targeted than those in lower-level positions; the so-called “CEO attack” is typical. However, staff in other hospital departments are also subject to cybercriminals, including hospice departments/hospice organizations and research arms of hospitals.
 

The Impact of Cyberattacks on Patients 

Physicians and healthcare execs may have considered cybersecurity more of a compliance issue than a true threat to patients in the past. But this attitude is rapidly changing. “We are starting to see a very clear connection between a cyber event and how it can impact patient care and patient safety,” said Witt.

According to the Proofpoint report, cyber breaches can severely affect patient care. In 2024:

• 56% of respondents saw a delay in patient tests/procedures
• 53% experienced increased patient complications from medical procedures
• 52% noted a longer patient length of stay
• 44% saw an increase in patient transfers to other facilities
• 28% had an increase in mortality rate

What Hospitals and Physicians Can Do

Fortunately, hospitals can take measures to better protect their data and their patients. One strategy is segmenting networks to reduce the amount of data or systems one person or system can access. Educating staff about the dangers of phishing and spoofing emails also help protect organizations from ransomware attacks. Having staff avoid reusing passwords and updating logins and passwords frequently helps.

Most hospitals also need more robust security controls. Physicians and healthcare facilities must also embrace the cybersecurity controls found in other industries, said Witt. “Multifactor authentication is one of those things that can cause us frustration,” he said. “The controls can seem onerous, but they’re really valuable overall…and should become standard practice.”

Doctors can also prepare for a ransomware attack and protect patients by practicing some “old-school” medicine, like using paper systems and maintaining good patient notes — often, those notes are synced locally as well as offsite, so you’d be able to access them even during a data breach. “It’s smart to write prescriptions on pads sometimes,” said Radolec. “Don’t forget how to do those things because that will make you more resilient in the event of a ransomware attack.”
 

A Continuing Threat

Cyberattacks will continue. “When you look at the high likelihood [of success] and the soft target, you end up with ... a perfect storm,” said Radolec. “Hospitals have a lot of vulnerabilities. They have to keep operations going just to receive income, but also to deliver care to people.”

That means that the burden is on healthcare organizations — including physicians, nurses, staff, and C-level execs — to help keep the “security” in cybersecurity. “We are all part of the cybersecurity defense,” said Witt. Helping to maintain that defense has become a critical aspect of caring for patients.

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

On September 27, 2024, UMC Health System in Lubbock, Texas, experienced an IT outage because of a cybersecurity incident that temporarily diverted patients to other healthcare facilities. So far, in 2024, there have been 386 cyberattacks on healthcare organizations. These high-impact ransomware attacks disrupt and delay patient care.

In recent years, many healthcare systems, including Scripps Health, Universal Health Services, Vastaamo, Sky Lakes, and the University of Vermont, have paid millions — even tens of millions — to recover data after a cyberattack or data breach. When healthcare systems come under cyber fire, the impact extends far past disrupting workflows and compromising data, patient safety can be also be compromised, vital information may be lost, and imaging and lab results can go missing or be held for ransom, making physicians’ job difficult or impossible.

In fact, cyberattacks on hospitals are far more common than you may realize. A new report issued by Ponemon and Proofpoint found that 92% of healthcare organizations have experienced a cyberattack in the past 12 months. Even more sobering is that about half of the organizations affected suffered disruptions in patient care.
 

Healthcare Systems = ‘Soft Targets’

Healthcare systems are a “soft target” for hackers for several reasons, pointed out Matthew Radolec, vice president, incident response and cloud operations at Varonis, a data security company. “One, they’re usually an amalgamation of many healthcare systems that are interconnected,” said Radolec. “A lot of hospitals are connected to other hospitals or connected to educational institutions, which means their computer vulnerabilities are shared ... and if they have an issue, it could very easily spread to your network.”

Another factor is the cost of securing data. “[With hospitals], they’ll say that a dollar spent on security is a dollar not spent on patient care,” said Radolec. “So the idea of investing in security is really tough from a budget standpoint…they’re choosing between a new MRI machine or better antivirus, backups, or data security.”

Because of the wealth of private data and healthcare information they maintain, hospitals are considered “high impact” for cybercriminals. Attackers know that if they get a foothold in a hospital, it’s more likely to pay — and pay quickly, Radolec told this news organization. Hospitals are also likely to have cyber insurance to help cover the cost of having their data stolen, encrypted, and ransomed.

The 2024 Microsoft Digital Defense Report also found that the bad actors are more sophisticated and better resourced and can challenge even the best cybersecurity. Improved defenses may not be good enough, and the sheer volume of attacks must be met with effective deterrence and government solutions that impose consequences for cybercriminals.
 

Vulnerable Users

Whether through a phishing email or text, password attack, or web attack, “the moment a ‘threat actor’ gets into your institution and gets credentials ... that’s the Nirvana state of a threat actor,” warned Ryan Witt, chair of the healthcare customer advisory board and vice president of Industry Solutions at Proofpoint, a cybersecurity platform. “They have those credentials and will go into deep reconnaissance mode. It often takes healthcare up to 6 months to even ascertain whether somebody’s actually in the network.” During that time, the hacker is learning how the institution works, what job functions matter, and how best to plan their attack.

“Attackers are getting in because they’re buying databases of usernames and passwords. And they’re trying them by the millions,” added Radolec. “For a sophisticated actor, all it takes is time and motivation. They have the skills. It’s just a matter of how persistent they want to be.”

Certain hospital staff are also more likely to be targeted by cyberhackers than others. “About 10% of a healthcare organization’s user base is much more vulnerable for all sorts of reasons — how they work, the value of their job title and job function, and therefore their access to systems,” said Witt.

High-profile staff are more likely to be targeted than those in lower-level positions; the so-called “CEO attack” is typical. However, staff in other hospital departments are also subject to cybercriminals, including hospice departments/hospice organizations and research arms of hospitals.
 

The Impact of Cyberattacks on Patients 

Physicians and healthcare execs may have considered cybersecurity more of a compliance issue than a true threat to patients in the past. But this attitude is rapidly changing. “We are starting to see a very clear connection between a cyber event and how it can impact patient care and patient safety,” said Witt.

According to the Proofpoint report, cyber breaches can severely affect patient care. In 2024:

• 56% of respondents saw a delay in patient tests/procedures
• 53% experienced increased patient complications from medical procedures
• 52% noted a longer patient length of stay
• 44% saw an increase in patient transfers to other facilities
• 28% had an increase in mortality rate

What Hospitals and Physicians Can Do

Fortunately, hospitals can take measures to better protect their data and their patients. One strategy is segmenting networks to reduce the amount of data or systems one person or system can access. Educating staff about the dangers of phishing and spoofing emails also help protect organizations from ransomware attacks. Having staff avoid reusing passwords and updating logins and passwords frequently helps.

Most hospitals also need more robust security controls. Physicians and healthcare facilities must also embrace the cybersecurity controls found in other industries, said Witt. “Multifactor authentication is one of those things that can cause us frustration,” he said. “The controls can seem onerous, but they’re really valuable overall…and should become standard practice.”

Doctors can also prepare for a ransomware attack and protect patients by practicing some “old-school” medicine, like using paper systems and maintaining good patient notes — often, those notes are synced locally as well as offsite, so you’d be able to access them even during a data breach. “It’s smart to write prescriptions on pads sometimes,” said Radolec. “Don’t forget how to do those things because that will make you more resilient in the event of a ransomware attack.”
 

A Continuing Threat

Cyberattacks will continue. “When you look at the high likelihood [of success] and the soft target, you end up with ... a perfect storm,” said Radolec. “Hospitals have a lot of vulnerabilities. They have to keep operations going just to receive income, but also to deliver care to people.”

That means that the burden is on healthcare organizations — including physicians, nurses, staff, and C-level execs — to help keep the “security” in cybersecurity. “We are all part of the cybersecurity defense,” said Witt. Helping to maintain that defense has become a critical aspect of caring for patients.

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

On September 27, 2024, UMC Health System in Lubbock, Texas, experienced an IT outage because of a cybersecurity incident that temporarily diverted patients to other healthcare facilities. So far, in 2024, there have been 386 cyberattacks on healthcare organizations. These high-impact ransomware attacks disrupt and delay patient care.

In recent years, many healthcare systems, including Scripps Health, Universal Health Services, Vastaamo, Sky Lakes, and the University of Vermont, have paid millions — even tens of millions — to recover data after a cyberattack or data breach. When healthcare systems come under cyber fire, the impact extends far past disrupting workflows and compromising data, patient safety can be also be compromised, vital information may be lost, and imaging and lab results can go missing or be held for ransom, making physicians’ job difficult or impossible.

In fact, cyberattacks on hospitals are far more common than you may realize. A new report issued by Ponemon and Proofpoint found that 92% of healthcare organizations have experienced a cyberattack in the past 12 months. Even more sobering is that about half of the organizations affected suffered disruptions in patient care.
 

Healthcare Systems = ‘Soft Targets’

Healthcare systems are a “soft target” for hackers for several reasons, pointed out Matthew Radolec, vice president, incident response and cloud operations at Varonis, a data security company. “One, they’re usually an amalgamation of many healthcare systems that are interconnected,” said Radolec. “A lot of hospitals are connected to other hospitals or connected to educational institutions, which means their computer vulnerabilities are shared ... and if they have an issue, it could very easily spread to your network.”

Another factor is the cost of securing data. “[With hospitals], they’ll say that a dollar spent on security is a dollar not spent on patient care,” said Radolec. “So the idea of investing in security is really tough from a budget standpoint…they’re choosing between a new MRI machine or better antivirus, backups, or data security.”

Because of the wealth of private data and healthcare information they maintain, hospitals are considered “high impact” for cybercriminals. Attackers know that if they get a foothold in a hospital, it’s more likely to pay — and pay quickly, Radolec told this news organization. Hospitals are also likely to have cyber insurance to help cover the cost of having their data stolen, encrypted, and ransomed.

The 2024 Microsoft Digital Defense Report also found that the bad actors are more sophisticated and better resourced and can challenge even the best cybersecurity. Improved defenses may not be good enough, and the sheer volume of attacks must be met with effective deterrence and government solutions that impose consequences for cybercriminals.
 

Vulnerable Users

Whether through a phishing email or text, password attack, or web attack, “the moment a ‘threat actor’ gets into your institution and gets credentials ... that’s the Nirvana state of a threat actor,” warned Ryan Witt, chair of the healthcare customer advisory board and vice president of Industry Solutions at Proofpoint, a cybersecurity platform. “They have those credentials and will go into deep reconnaissance mode. It often takes healthcare up to 6 months to even ascertain whether somebody’s actually in the network.” During that time, the hacker is learning how the institution works, what job functions matter, and how best to plan their attack.

“Attackers are getting in because they’re buying databases of usernames and passwords. And they’re trying them by the millions,” added Radolec. “For a sophisticated actor, all it takes is time and motivation. They have the skills. It’s just a matter of how persistent they want to be.”

Certain hospital staff are also more likely to be targeted by cyberhackers than others. “About 10% of a healthcare organization’s user base is much more vulnerable for all sorts of reasons — how they work, the value of their job title and job function, and therefore their access to systems,” said Witt.

High-profile staff are more likely to be targeted than those in lower-level positions; the so-called “CEO attack” is typical. However, staff in other hospital departments are also subject to cybercriminals, including hospice departments/hospice organizations and research arms of hospitals.
 

The Impact of Cyberattacks on Patients 

Physicians and healthcare execs may have considered cybersecurity more of a compliance issue than a true threat to patients in the past. But this attitude is rapidly changing. “We are starting to see a very clear connection between a cyber event and how it can impact patient care and patient safety,” said Witt.

According to the Proofpoint report, cyber breaches can severely affect patient care. In 2024:

• 56% of respondents saw a delay in patient tests/procedures
• 53% experienced increased patient complications from medical procedures
• 52% noted a longer patient length of stay
• 44% saw an increase in patient transfers to other facilities
• 28% had an increase in mortality rate

What Hospitals and Physicians Can Do

Fortunately, hospitals can take measures to better protect their data and their patients. One strategy is segmenting networks to reduce the amount of data or systems one person or system can access. Educating staff about the dangers of phishing and spoofing emails also help protect organizations from ransomware attacks. Having staff avoid reusing passwords and updating logins and passwords frequently helps.

Most hospitals also need more robust security controls. Physicians and healthcare facilities must also embrace the cybersecurity controls found in other industries, said Witt. “Multifactor authentication is one of those things that can cause us frustration,” he said. “The controls can seem onerous, but they’re really valuable overall…and should become standard practice.”

Doctors can also prepare for a ransomware attack and protect patients by practicing some “old-school” medicine, like using paper systems and maintaining good patient notes — often, those notes are synced locally as well as offsite, so you’d be able to access them even during a data breach. “It’s smart to write prescriptions on pads sometimes,” said Radolec. “Don’t forget how to do those things because that will make you more resilient in the event of a ransomware attack.”
 

A Continuing Threat

Cyberattacks will continue. “When you look at the high likelihood [of success] and the soft target, you end up with ... a perfect storm,” said Radolec. “Hospitals have a lot of vulnerabilities. They have to keep operations going just to receive income, but also to deliver care to people.”

That means that the burden is on healthcare organizations — including physicians, nurses, staff, and C-level execs — to help keep the “security” in cybersecurity. “We are all part of the cybersecurity defense,” said Witt. Helping to maintain that defense has become a critical aspect of caring for patients.

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

Although a 2019 World Health Organization (WHO) report concluded that microplastics in drinking water posed no risk to human health, accumulating evidence is beginning to challenge these findings.

Since plastics became widely used in the mid-20th century, they have evolved from a novel substance to an essential component in countless applications, with global production reaching 368 million tons in 2019 and expected to double by 2039. The production and degradation of plastics involve physical, chemical, and biological processes, leading to the formation of tiny fragments known as microplastics (MPs) and nanoplastics (NPs), which accumulate in the environment. Beyond the well-documented environmental harms of MPs and NPs, growing evidence of their presence within the human body raises concerns about their potential to trigger various harmful biological processes. Their detection in the urinary tract and their potential links to kidney and bladder diseases, as shown in animal studies, are particularly alarming.
 

Impacts Becoming Apparent

As the impact of plastic pollution becomes increasingly apparent, the need for standardized international definitions of MPs and NPs is pressing. Government publications reveal notable discrepancies between organizations in defining these fragmented plastics. The lack of consensus among regulatory bodies highlights the challenges in mitigating the environmental and health impacts of MPs and NPs. The International Organization for Standardization offers the most precise classification, defining MPs as solid, insoluble plastic particles ranging from 1 µm to 1 mm and NPs as particles smaller than 1 µm.

The intrusion of MPs and NPs into the human body, whether through inhalation, ingestion, or skin exposure (via wounds, hair follicles, or sweat glands), has been linked to harmful biological effects, including inflammation, alterations in cellular metabolism, physical cellular damage, and reduced cell viability.
 

Urinary Tract Plastics

The detection of MPs and NPs in the human urinary tract, combined with limited understanding of their effects, is a growing concern. An exploratory study published earlier this year aimed to systematically summarize the existing literature regarding the presence of MPs and NPs in the urinary tract and their potential consequences, guided by these research questions:

• What are the characteristics of the plastics detected in the human urinary tract?
• How are MPs and NPs defined in the current literature?
• What methodologies are used to explore the presence and effects of MPs and NPs?
• What are the pathophysiologic consequences of the presence of MPs and NPs in the human urinary tract?

For this study, the “urinary tract” included the kidneys, bladder, ureter, urethra, and urine. By focusing on the urinary tract, the study aimed to consolidate current understanding of MPs and NPs, raise awareness of this emerging issue, and lay the groundwork for further research that could contribute to public health policies and clinical practice guidelines.

The researchers conducted a scoping literature review following the recommendations of the JBI [formerly known as the Joanna Briggs Institute). They systematically searched five databases — PubMed, Scopus, CINAHL, Web of Science, and Embase — as well as gray literature sources.
 

Concerning Study Results

Eighteen articles were identified. The authors represent seven countries: Pakistan (n = 1), the Netherlands (n = 1), the US (n = 1), Taiwan (n = 1), Germany (n = 3), China (n = 5), and Italy (n = 6). Among these studies, six investigated and characterized the presence of MPs and NPs in the human urinary tract. MPs and NPs were detected in urine samples (n = 5), kidney cancer samples (n = 2), and bladder cancer samples (n = 1).

Additionally, 12 studies examined the effects of MPs and NPs on human urinary tract cell lines. Their findings suggest that MPs and NPs have cytotoxic effects, increase inflammation, reduce cell viability, and alter mitogen-activated protein kinase signaling pathways.

Raman spectroscopy was the primary method used to detect and characterize MPs and NPs in human samples (five out of six studies; 83%). Alternatively, pyrolysis-gas chromatography-mass spectrometry combined with direct laser infrared spectroscopy was used in one study.
 

Further Research Needed

This exploratory study underscores the urgent need for further research and policy development to address the challenges posed by microplastic contamination. It highlights the rapidly emerging threat of human urinary tract contamination by microplastics, questioning the WHO’s claim that microplastics pose no public health risk. The documented cytotoxic effects of microplastics, and their ability to induce inflammation, reduce cell viability, and disrupt signaling pathways, raise significant public health concerns related to bladder cancer, chronic kidney disease, chronic urinary infections, and incontinence.

Bernard-Alex Gauzere, retired physician formerly with the national health system in France (intensive care unit, tropical medicine), has disclosed no relevant financial relationships.
 

This story was translated from JIM 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.

Although a 2019 World Health Organization (WHO) report concluded that microplastics in drinking water posed no risk to human health, accumulating evidence is beginning to challenge these findings.

Since plastics became widely used in the mid-20th century, they have evolved from a novel substance to an essential component in countless applications, with global production reaching 368 million tons in 2019 and expected to double by 2039. The production and degradation of plastics involve physical, chemical, and biological processes, leading to the formation of tiny fragments known as microplastics (MPs) and nanoplastics (NPs), which accumulate in the environment. Beyond the well-documented environmental harms of MPs and NPs, growing evidence of their presence within the human body raises concerns about their potential to trigger various harmful biological processes. Their detection in the urinary tract and their potential links to kidney and bladder diseases, as shown in animal studies, are particularly alarming.
 

Impacts Becoming Apparent

As the impact of plastic pollution becomes increasingly apparent, the need for standardized international definitions of MPs and NPs is pressing. Government publications reveal notable discrepancies between organizations in defining these fragmented plastics. The lack of consensus among regulatory bodies highlights the challenges in mitigating the environmental and health impacts of MPs and NPs. The International Organization for Standardization offers the most precise classification, defining MPs as solid, insoluble plastic particles ranging from 1 µm to 1 mm and NPs as particles smaller than 1 µm.

The intrusion of MPs and NPs into the human body, whether through inhalation, ingestion, or skin exposure (via wounds, hair follicles, or sweat glands), has been linked to harmful biological effects, including inflammation, alterations in cellular metabolism, physical cellular damage, and reduced cell viability.
 

Urinary Tract Plastics

The detection of MPs and NPs in the human urinary tract, combined with limited understanding of their effects, is a growing concern. An exploratory study published earlier this year aimed to systematically summarize the existing literature regarding the presence of MPs and NPs in the urinary tract and their potential consequences, guided by these research questions:

• What are the characteristics of the plastics detected in the human urinary tract?
• How are MPs and NPs defined in the current literature?
• What methodologies are used to explore the presence and effects of MPs and NPs?
• What are the pathophysiologic consequences of the presence of MPs and NPs in the human urinary tract?

For this study, the “urinary tract” included the kidneys, bladder, ureter, urethra, and urine. By focusing on the urinary tract, the study aimed to consolidate current understanding of MPs and NPs, raise awareness of this emerging issue, and lay the groundwork for further research that could contribute to public health policies and clinical practice guidelines.

The researchers conducted a scoping literature review following the recommendations of the JBI [formerly known as the Joanna Briggs Institute). They systematically searched five databases — PubMed, Scopus, CINAHL, Web of Science, and Embase — as well as gray literature sources.
 

Concerning Study Results

Eighteen articles were identified. The authors represent seven countries: Pakistan (n = 1), the Netherlands (n = 1), the US (n = 1), Taiwan (n = 1), Germany (n = 3), China (n = 5), and Italy (n = 6). Among these studies, six investigated and characterized the presence of MPs and NPs in the human urinary tract. MPs and NPs were detected in urine samples (n = 5), kidney cancer samples (n = 2), and bladder cancer samples (n = 1).

Additionally, 12 studies examined the effects of MPs and NPs on human urinary tract cell lines. Their findings suggest that MPs and NPs have cytotoxic effects, increase inflammation, reduce cell viability, and alter mitogen-activated protein kinase signaling pathways.

Raman spectroscopy was the primary method used to detect and characterize MPs and NPs in human samples (five out of six studies; 83%). Alternatively, pyrolysis-gas chromatography-mass spectrometry combined with direct laser infrared spectroscopy was used in one study.
 

Further Research Needed

This exploratory study underscores the urgent need for further research and policy development to address the challenges posed by microplastic contamination. It highlights the rapidly emerging threat of human urinary tract contamination by microplastics, questioning the WHO’s claim that microplastics pose no public health risk. The documented cytotoxic effects of microplastics, and their ability to induce inflammation, reduce cell viability, and disrupt signaling pathways, raise significant public health concerns related to bladder cancer, chronic kidney disease, chronic urinary infections, and incontinence.

Bernard-Alex Gauzere, retired physician formerly with the national health system in France (intensive care unit, tropical medicine), has disclosed no relevant financial relationships.
 

This story was translated from JIM 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.

Although a 2019 World Health Organization (WHO) report concluded that microplastics in drinking water posed no risk to human health, accumulating evidence is beginning to challenge these findings.

Since plastics became widely used in the mid-20th century, they have evolved from a novel substance to an essential component in countless applications, with global production reaching 368 million tons in 2019 and expected to double by 2039. The production and degradation of plastics involve physical, chemical, and biological processes, leading to the formation of tiny fragments known as microplastics (MPs) and nanoplastics (NPs), which accumulate in the environment. Beyond the well-documented environmental harms of MPs and NPs, growing evidence of their presence within the human body raises concerns about their potential to trigger various harmful biological processes. Their detection in the urinary tract and their potential links to kidney and bladder diseases, as shown in animal studies, are particularly alarming.
 

Impacts Becoming Apparent

As the impact of plastic pollution becomes increasingly apparent, the need for standardized international definitions of MPs and NPs is pressing. Government publications reveal notable discrepancies between organizations in defining these fragmented plastics. The lack of consensus among regulatory bodies highlights the challenges in mitigating the environmental and health impacts of MPs and NPs. The International Organization for Standardization offers the most precise classification, defining MPs as solid, insoluble plastic particles ranging from 1 µm to 1 mm and NPs as particles smaller than 1 µm.

The intrusion of MPs and NPs into the human body, whether through inhalation, ingestion, or skin exposure (via wounds, hair follicles, or sweat glands), has been linked to harmful biological effects, including inflammation, alterations in cellular metabolism, physical cellular damage, and reduced cell viability.
 

Urinary Tract Plastics

The detection of MPs and NPs in the human urinary tract, combined with limited understanding of their effects, is a growing concern. An exploratory study published earlier this year aimed to systematically summarize the existing literature regarding the presence of MPs and NPs in the urinary tract and their potential consequences, guided by these research questions:

• What are the characteristics of the plastics detected in the human urinary tract?
• How are MPs and NPs defined in the current literature?
• What methodologies are used to explore the presence and effects of MPs and NPs?
• What are the pathophysiologic consequences of the presence of MPs and NPs in the human urinary tract?

For this study, the “urinary tract” included the kidneys, bladder, ureter, urethra, and urine. By focusing on the urinary tract, the study aimed to consolidate current understanding of MPs and NPs, raise awareness of this emerging issue, and lay the groundwork for further research that could contribute to public health policies and clinical practice guidelines.

The researchers conducted a scoping literature review following the recommendations of the JBI [formerly known as the Joanna Briggs Institute). They systematically searched five databases — PubMed, Scopus, CINAHL, Web of Science, and Embase — as well as gray literature sources.
 

Concerning Study Results

Eighteen articles were identified. The authors represent seven countries: Pakistan (n = 1), the Netherlands (n = 1), the US (n = 1), Taiwan (n = 1), Germany (n = 3), China (n = 5), and Italy (n = 6). Among these studies, six investigated and characterized the presence of MPs and NPs in the human urinary tract. MPs and NPs were detected in urine samples (n = 5), kidney cancer samples (n = 2), and bladder cancer samples (n = 1).

Additionally, 12 studies examined the effects of MPs and NPs on human urinary tract cell lines. Their findings suggest that MPs and NPs have cytotoxic effects, increase inflammation, reduce cell viability, and alter mitogen-activated protein kinase signaling pathways.

Raman spectroscopy was the primary method used to detect and characterize MPs and NPs in human samples (five out of six studies; 83%). Alternatively, pyrolysis-gas chromatography-mass spectrometry combined with direct laser infrared spectroscopy was used in one study.
 

Further Research Needed

This exploratory study underscores the urgent need for further research and policy development to address the challenges posed by microplastic contamination. It highlights the rapidly emerging threat of human urinary tract contamination by microplastics, questioning the WHO’s claim that microplastics pose no public health risk. The documented cytotoxic effects of microplastics, and their ability to induce inflammation, reduce cell viability, and disrupt signaling pathways, raise significant public health concerns related to bladder cancer, chronic kidney disease, chronic urinary infections, and incontinence.

Bernard-Alex Gauzere, retired physician formerly with the national health system in France (intensive care unit, tropical medicine), has disclosed no relevant financial relationships.
 

This story was translated from JIM 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:

About one in six women experience symptoms of postpartum depression (PPD) 2 months after cesarean delivery, with certain obstetric factors such as emergency cesarean delivery before labor, cesarean delivery after labor induction, lack of social support in the operating room, and severe postoperative pain influencing the risk.

METHODOLOGY:

• Researchers conducted a prospective ancillary cohort study of the Tranexamic Acid for Preventing Postpartum Hemorrhage after Cesarean Delivery (TRAAP2) trial to examine the prevalence of PPD 2 months after cesarean delivery and associated risk factors.
• A total of 2793 women (median age, 33.5 years) were included who had a cesarean delivery at 34 or more weeks of gestation; they completed the Edinburgh Postnatal Depression Scale (EPDS), a self-administered questionnaire, at 2 months after delivery.
• Information about the cesarean delivery, postpartum blood loss, immediate postpartum period, psychiatric history, and memories of delivery and postoperative pain were prospectively collected.
• Medical records were used to obtain details about characteristics of patients; 5.0% had a psychiatric history (2.4% composed of depression).
• The main endpoint was a positive screening for symptoms consistent with this depression — defined as a PPD diagnosis — 2 months after caesarian delivery, with an EPDS score of 13 or higher.

TAKEAWAY:

• The prevalence of a provisional PPD diagnosis at 2 months after cesarean delivery was 16.4% (95% CI, 14.9-18.0) with an EPDS score of 13 or higher and was 23.1% (95% CI, 21.4-24.9%) with a cutoff value of 11 or higher.
• Women who had an emergency cesarean delivery before labor had a higher risk for PPD than those who had a normal cesarean delivery before labor started (adjusted odds ratio [aOR], 1.70; 95% CI, 1.15-2.50); women who had started labor after induction but then had a cesarean delivery also had a higher risk for PPD than those who had a cesarean delivery before going into labor (aOR, 1.36; 95% CI, 1.03-1.84).
• Severe pain during the postpartum stay (aOR, 1.73; 95% CI, 1.32-2.26) and bad memories of delivery (aOR, 1.67; 95% CI, 1.14-2.45) were also risk factors for PPD.
• However, women who had social support in the operating room showed a 27% lower risk for PPD (P = .02).

IN PRACTICE:

“Identifying subgroups of women at risk for PPD based on aspects of their obstetric experience could help to screen for women who might benefit from early screening and interventions,” the authors wrote.

SOURCE:

This study was led by Alizée Froeliger, MD, MPH, of the Department of Obstetrics and Gynecology at Bordeaux University Hospital in France, and was published online in American Journal of Obstetrics & Gynecology.

LIMITATIONS:

The study population was derived from a randomized controlled trial, which may have underestimated the prevalence of PPD. The use of a self-administered questionnaire for PPD screening may not have provided a definitive diagnosis. Moreover, this study did not assess the prevalence of depressive symptoms during pregnancy.

DISCLOSURES:

The TRAAP2 trial was supported by a grant from the French Ministry of Health under its Clinical Research Hospital Program. One author reported carrying out consultancy work and lecturing for Ferring Laboratories, GlaxoSmithKline, and other pharmaceutical companies.

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:

About one in six women experience symptoms of postpartum depression (PPD) 2 months after cesarean delivery, with certain obstetric factors such as emergency cesarean delivery before labor, cesarean delivery after labor induction, lack of social support in the operating room, and severe postoperative pain influencing the risk.

METHODOLOGY:

• Researchers conducted a prospective ancillary cohort study of the Tranexamic Acid for Preventing Postpartum Hemorrhage after Cesarean Delivery (TRAAP2) trial to examine the prevalence of PPD 2 months after cesarean delivery and associated risk factors.
• A total of 2793 women (median age, 33.5 years) were included who had a cesarean delivery at 34 or more weeks of gestation; they completed the Edinburgh Postnatal Depression Scale (EPDS), a self-administered questionnaire, at 2 months after delivery.
• Information about the cesarean delivery, postpartum blood loss, immediate postpartum period, psychiatric history, and memories of delivery and postoperative pain were prospectively collected.
• Medical records were used to obtain details about characteristics of patients; 5.0% had a psychiatric history (2.4% composed of depression).
• The main endpoint was a positive screening for symptoms consistent with this depression — defined as a PPD diagnosis — 2 months after caesarian delivery, with an EPDS score of 13 or higher.

TAKEAWAY:

• The prevalence of a provisional PPD diagnosis at 2 months after cesarean delivery was 16.4% (95% CI, 14.9-18.0) with an EPDS score of 13 or higher and was 23.1% (95% CI, 21.4-24.9%) with a cutoff value of 11 or higher.
• Women who had an emergency cesarean delivery before labor had a higher risk for PPD than those who had a normal cesarean delivery before labor started (adjusted odds ratio [aOR], 1.70; 95% CI, 1.15-2.50); women who had started labor after induction but then had a cesarean delivery also had a higher risk for PPD than those who had a cesarean delivery before going into labor (aOR, 1.36; 95% CI, 1.03-1.84).
• Severe pain during the postpartum stay (aOR, 1.73; 95% CI, 1.32-2.26) and bad memories of delivery (aOR, 1.67; 95% CI, 1.14-2.45) were also risk factors for PPD.
• However, women who had social support in the operating room showed a 27% lower risk for PPD (P = .02).

IN PRACTICE:

“Identifying subgroups of women at risk for PPD based on aspects of their obstetric experience could help to screen for women who might benefit from early screening and interventions,” the authors wrote.

SOURCE:

This study was led by Alizée Froeliger, MD, MPH, of the Department of Obstetrics and Gynecology at Bordeaux University Hospital in France, and was published online in American Journal of Obstetrics & Gynecology.

LIMITATIONS:

The study population was derived from a randomized controlled trial, which may have underestimated the prevalence of PPD. The use of a self-administered questionnaire for PPD screening may not have provided a definitive diagnosis. Moreover, this study did not assess the prevalence of depressive symptoms during pregnancy.

DISCLOSURES:

The TRAAP2 trial was supported by a grant from the French Ministry of Health under its Clinical Research Hospital Program. One author reported carrying out consultancy work and lecturing for Ferring Laboratories, GlaxoSmithKline, and other pharmaceutical companies.

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:

About one in six women experience symptoms of postpartum depression (PPD) 2 months after cesarean delivery, with certain obstetric factors such as emergency cesarean delivery before labor, cesarean delivery after labor induction, lack of social support in the operating room, and severe postoperative pain influencing the risk.

METHODOLOGY:

• Researchers conducted a prospective ancillary cohort study of the Tranexamic Acid for Preventing Postpartum Hemorrhage after Cesarean Delivery (TRAAP2) trial to examine the prevalence of PPD 2 months after cesarean delivery and associated risk factors.
• A total of 2793 women (median age, 33.5 years) were included who had a cesarean delivery at 34 or more weeks of gestation; they completed the Edinburgh Postnatal Depression Scale (EPDS), a self-administered questionnaire, at 2 months after delivery.
• Information about the cesarean delivery, postpartum blood loss, immediate postpartum period, psychiatric history, and memories of delivery and postoperative pain were prospectively collected.
• Medical records were used to obtain details about characteristics of patients; 5.0% had a psychiatric history (2.4% composed of depression).
• The main endpoint was a positive screening for symptoms consistent with this depression — defined as a PPD diagnosis — 2 months after caesarian delivery, with an EPDS score of 13 or higher.

TAKEAWAY:

• The prevalence of a provisional PPD diagnosis at 2 months after cesarean delivery was 16.4% (95% CI, 14.9-18.0) with an EPDS score of 13 or higher and was 23.1% (95% CI, 21.4-24.9%) with a cutoff value of 11 or higher.
• Women who had an emergency cesarean delivery before labor had a higher risk for PPD than those who had a normal cesarean delivery before labor started (adjusted odds ratio [aOR], 1.70; 95% CI, 1.15-2.50); women who had started labor after induction but then had a cesarean delivery also had a higher risk for PPD than those who had a cesarean delivery before going into labor (aOR, 1.36; 95% CI, 1.03-1.84).
• Severe pain during the postpartum stay (aOR, 1.73; 95% CI, 1.32-2.26) and bad memories of delivery (aOR, 1.67; 95% CI, 1.14-2.45) were also risk factors for PPD.
• However, women who had social support in the operating room showed a 27% lower risk for PPD (P = .02).

IN PRACTICE:

“Identifying subgroups of women at risk for PPD based on aspects of their obstetric experience could help to screen for women who might benefit from early screening and interventions,” the authors wrote.

SOURCE:

This study was led by Alizée Froeliger, MD, MPH, of the Department of Obstetrics and Gynecology at Bordeaux University Hospital in France, and was published online in American Journal of Obstetrics & Gynecology.

LIMITATIONS:

The study population was derived from a randomized controlled trial, which may have underestimated the prevalence of PPD. The use of a self-administered questionnaire for PPD screening may not have provided a definitive diagnosis. Moreover, this study did not assess the prevalence of depressive symptoms during pregnancy.

DISCLOSURES:

The TRAAP2 trial was supported by a grant from the French Ministry of Health under its Clinical Research Hospital Program. One author reported carrying out consultancy work and lecturing for Ferring Laboratories, GlaxoSmithKline, and other pharmaceutical companies.

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:

Increased telehealth use in primary care practices is associated with reduced rates of low-value cervical cancer screening and thyroid testing. No significant association is found between telehealth use and most other low-value care services.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using Medicare fee-for-service claims data from January 1, 2019, to December 31, 2022.
• A total of 577,928 Medicare beneficiaries attributed to 2552 primary care practices in Michigan were included in the study.
• Telehealth use was stratified into low, medium, and high tertiles based on the number of telehealth services per 1000 beneficiaries in 2022.
• Low-value care was assessed using eight claims-based measures relevant to primary care, grouped into office-based, laboratory-based, imaging-based, and mixed-modality services.
• Poisson regression models were used to estimate the association between practice-level telehealth use and rates of low-value care services, controlling for practice-level characteristics.

TAKEAWAY:

• High practice-level telehealth use was associated with lower rates of low-value cervical cancer screening (–2.9 services per 1000 beneficiaries; 95% CI, –5.3 to –0.4).
• High practice-level telehealth use was associated with lower rates of low-value thyroid testing (–40 tests per 1000 beneficiaries; 95% CI, –70 to –9).
• No significant association was found between practice-level telehealth use and rates of other low-value care services.
• The findings suggested that telehealth can be used to deliver primary care services without introducing wasteful or unnecessary care and can even reduce low-value care.

IN PRACTICE:

“While the rapid growth of telehealth has enhanced access to care for individuals, it has also raised concern for unintended consequences in the form of wasteful or unnecessary care, ie, low-value care. Our study suggests that increased practice-level telehealth use was not associated with the delivery of low-value care services in primary care and may even help reduce office-based low-value care,” the authors of the study wrote.

SOURCE:

This study was led by Terrence Liu, MD, MS, University of Michigan, Ann Arbor. It was published online in JAMA Network Open.

LIMITATIONS:

This study was performed among Medicare fee-for-service beneficiaries with a Michigan residence and may not be generalizable to the broader Medicare beneficiary population. Administrative claims data do not include clinical information, which limited the ability to measure overall quality of care. The study defined telehealth use at the practice level and did not assess individual outcomes. Additional research is needed at a national level to determine the impact of telehealth on low-value care services in primary care.

DISCLOSURES:

This study was supported by grants from the Agency for Healthcare Research and Quality. Liu received funding from the University of Michigan National Clinician Scholars Program and Veterans Affairs Center for Clinical Management Research. Additional disclosures are noted in the original article.

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:

Increased telehealth use in primary care practices is associated with reduced rates of low-value cervical cancer screening and thyroid testing. No significant association is found between telehealth use and most other low-value care services.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using Medicare fee-for-service claims data from January 1, 2019, to December 31, 2022.
• A total of 577,928 Medicare beneficiaries attributed to 2552 primary care practices in Michigan were included in the study.
• Telehealth use was stratified into low, medium, and high tertiles based on the number of telehealth services per 1000 beneficiaries in 2022.
• Low-value care was assessed using eight claims-based measures relevant to primary care, grouped into office-based, laboratory-based, imaging-based, and mixed-modality services.
• Poisson regression models were used to estimate the association between practice-level telehealth use and rates of low-value care services, controlling for practice-level characteristics.

TAKEAWAY:

• High practice-level telehealth use was associated with lower rates of low-value cervical cancer screening (–2.9 services per 1000 beneficiaries; 95% CI, –5.3 to –0.4).
• High practice-level telehealth use was associated with lower rates of low-value thyroid testing (–40 tests per 1000 beneficiaries; 95% CI, –70 to –9).
• No significant association was found between practice-level telehealth use and rates of other low-value care services.
• The findings suggested that telehealth can be used to deliver primary care services without introducing wasteful or unnecessary care and can even reduce low-value care.

IN PRACTICE:

“While the rapid growth of telehealth has enhanced access to care for individuals, it has also raised concern for unintended consequences in the form of wasteful or unnecessary care, ie, low-value care. Our study suggests that increased practice-level telehealth use was not associated with the delivery of low-value care services in primary care and may even help reduce office-based low-value care,” the authors of the study wrote.

SOURCE:

This study was led by Terrence Liu, MD, MS, University of Michigan, Ann Arbor. It was published online in JAMA Network Open.

LIMITATIONS:

This study was performed among Medicare fee-for-service beneficiaries with a Michigan residence and may not be generalizable to the broader Medicare beneficiary population. Administrative claims data do not include clinical information, which limited the ability to measure overall quality of care. The study defined telehealth use at the practice level and did not assess individual outcomes. Additional research is needed at a national level to determine the impact of telehealth on low-value care services in primary care.

DISCLOSURES:

This study was supported by grants from the Agency for Healthcare Research and Quality. Liu received funding from the University of Michigan National Clinician Scholars Program and Veterans Affairs Center for Clinical Management Research. Additional disclosures are noted in the original article.

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:

Increased telehealth use in primary care practices is associated with reduced rates of low-value cervical cancer screening and thyroid testing. No significant association is found between telehealth use and most other low-value care services.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using Medicare fee-for-service claims data from January 1, 2019, to December 31, 2022.
• A total of 577,928 Medicare beneficiaries attributed to 2552 primary care practices in Michigan were included in the study.
• Telehealth use was stratified into low, medium, and high tertiles based on the number of telehealth services per 1000 beneficiaries in 2022.
• Low-value care was assessed using eight claims-based measures relevant to primary care, grouped into office-based, laboratory-based, imaging-based, and mixed-modality services.
• Poisson regression models were used to estimate the association between practice-level telehealth use and rates of low-value care services, controlling for practice-level characteristics.

TAKEAWAY:

• High practice-level telehealth use was associated with lower rates of low-value cervical cancer screening (–2.9 services per 1000 beneficiaries; 95% CI, –5.3 to –0.4).
• High practice-level telehealth use was associated with lower rates of low-value thyroid testing (–40 tests per 1000 beneficiaries; 95% CI, –70 to –9).
• No significant association was found between practice-level telehealth use and rates of other low-value care services.
• The findings suggested that telehealth can be used to deliver primary care services without introducing wasteful or unnecessary care and can even reduce low-value care.

IN PRACTICE:

“While the rapid growth of telehealth has enhanced access to care for individuals, it has also raised concern for unintended consequences in the form of wasteful or unnecessary care, ie, low-value care. Our study suggests that increased practice-level telehealth use was not associated with the delivery of low-value care services in primary care and may even help reduce office-based low-value care,” the authors of the study wrote.

SOURCE:

This study was led by Terrence Liu, MD, MS, University of Michigan, Ann Arbor. It was published online in JAMA Network Open.

LIMITATIONS:

This study was performed among Medicare fee-for-service beneficiaries with a Michigan residence and may not be generalizable to the broader Medicare beneficiary population. Administrative claims data do not include clinical information, which limited the ability to measure overall quality of care. The study defined telehealth use at the practice level and did not assess individual outcomes. Additional research is needed at a national level to determine the impact of telehealth on low-value care services in primary care.

DISCLOSURES:

This study was supported by grants from the Agency for Healthcare Research and Quality. Liu received funding from the University of Michigan National Clinician Scholars Program and Veterans Affairs Center for Clinical Management Research. Additional disclosures are noted in the original article.

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.

The majority of patients may safely take glucagon-like peptide 1 receptor agonists (GLP-1 RAs) before elective surgery and gastrointestinal endoscopies, according to updated guidance from five medical societies.

The new guidance, contrasting with earlier recommendations, says these incrementally used agents can be taken up until the day of surgery, but patients are advised to follow a liquid diet for 24 hours before the procedure. The decision to proceed with endoscopy and other procedures should be based on shared decision-making with the patient and interdisciplinary care teams in conjunction with minimization of the aspiration risk from delayed gastric emptying, the guidance stresses.

The five endorsing organizations are the American Society for Metabolic and Bariatric Surgery, American Society of Anesthesiologists (ASA), American Gastroenterological Association, International Society of Perioperative Care of Patients with Obesity, and Society of American Gastrointestinal and Endoscopic Surgeons. The societies emphasize that the statement is intended as guidance only and is not an evidence-based formal guideline.

GLP-1 RAs are known to delay gastric emptying, raising concerns about regurgitation, aspiration, and airway compromise during anesthesia. Rare serious adverse events have also been observed, prompting the ASA in 2023 to recommend holding these agents for 1 week for the injectable form and 1 day for the oral form before all procedures requiring anesthesia. 

University of Michigan

That abundance of caution, however, had negative impacts of its own. “This guidance has led to cancellations and postponements of many endoscopic and surgical procedures or required patients to undergo general anesthesia who may otherwise have had their procedures performed under moderate sedation,” said guidance coauthor Allison R. Schulman, MD, MPH, an associate professor of medicine and surgery and chief of endoscopy at the University of Michigan in Ann Arbor. “Nearly all institutions have been forced to revise preprocedural protocols, despite a lack of high-level evidence to suggest that these adjustments are necessary.”

“Studies have yielded mixed results as to whether patients on GLP-1s are at increased risk of these events, and the limited data available are inconsistent,” Schulman said. “As a result, there are inconsistencies in the recommendations from various societies leading to growing uncertainty with proceduralists on how to provide safe, effective, and timely procedural care to patients taking GLP-1 RAs.”

The new joint-society guidance may alleviate some of the uncertainty. Among the recommendations:

• Continuing GLP-1 RAs in the perioperative period should be based on shared decision-making with the patient and all care teams balancing the metabolic need for the GLP-1 RA with individual patient risk.
• Certain variables may increase the risk for delayed gastric emptying and aspiration with the periprocedural use of GLP-1 RAs: escalation phase — This phase vs the maintenance phase is associated with a higher risk for delayed gastric emptying; higher dose — the higher the dose, the greater the risk for gastrointestinal (GI) side effects; weekly dosing — GI side effects are more common with weekly vs daily formulations; presence of GI symptoms — nausea, vomiting, abdominal pain, dyspepsia, and constipation may suggest delayed gastric emptying; and medical problems beyond GLP-1 RA indications with GI effects — assess for such conditions as bowel dysmotility, gastroparesis, and Parkinson’s disease.
• Risk factors should be assessed in advance to allow sufficient time to adjust preoperative care, including diet modification and medication bridging if GLP-1 RA cessation is deemed advisable.
• If retained gastric contents are a concern on the day of a procedure, point-of-care gastric ultrasound could be used to assess aspiration risk, resources permitting.
• The aspiration risk from delayed gastric emptying should be minimized by preoperative diet modification and/or altering the anesthesia plan to consider rapid sequence induction of general anesthesia for tracheal intubation. A 24-hour preoperative liquid diet, as before colonoscopy and bariatric surgery, can be utilized when delayed gastric emptying is a concern.
• When concern about retained gastric contents exists on procedure day, providers should engage patients in a shared decision-making model and consider the benefits and risks of rapid-sequence induction of general anesthesia for tracheal intubation to minimize aspiration risk vs procedure cancellation.

“Safe continuation of surgery and gastrointestinal endoscopy, and prevention of procedure cancellation, for patients on GLP-1 RAs can be prioritized following the recommendations above, as would occur for other patient populations with gastroparesis,” the guidance panel wrote.

Digestive Health Center of Huntington

Commenting on the statement but not involved in it, David B. Purow, MD, managing director of the Digestive Health Center at Northwell Health/Huntington Hospital in Huntington, New York, said the recommendations will encourage clinicians to be more discerning about actual risk in individual cases rather than follow the previous blanket recommendation to stop these agents before procedures requiring sedation. 

While GLP-1 RAs were prescribed for the relatively small number of patients with diabetes, he said, the risk was not apparent but became clearer with the widespread use of these agents for weight loss — often unregulated and undisclosed to care providers.

“The pendulum shifted too far the other way, and now it’s shifted back,” he said in an interview. “The new guidance is great because now we can be more thoughtful about managing individual patients.” He cited, for instance, the recommendations on the greater risk in patients in the dose escalation phase or on higher doses, and the risk-reducing measure of a liquid diet for 24 hours before surgery.

His center is already using point-of-care ultrasound and recently had a case in which a patient who forgot and took his GLP-1 RA before a scheduled procedure was found on ultrasound to have a full stomach. “In some cases, these drugs can cause an almost gastroparesis level of delayed emptying,” Purow said.

Purow thinks this early guidance will probably progress to firm guidelines within a year. Schulman is more cautious. “Our understanding of this complex topic is increasing rapidly, and ongoing clinical research will ultimately lead to evidence-based guidelines in this changing landscape,” she said.

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Schulman is a consultant for Apollo Endosurgery, Boston Scientific, Olympus, Microtech, and Fractyl. Purow had no competing interests to declare.

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

The majority of patients may safely take glucagon-like peptide 1 receptor agonists (GLP-1 RAs) before elective surgery and gastrointestinal endoscopies, according to updated guidance from five medical societies.

The new guidance, contrasting with earlier recommendations, says these incrementally used agents can be taken up until the day of surgery, but patients are advised to follow a liquid diet for 24 hours before the procedure. The decision to proceed with endoscopy and other procedures should be based on shared decision-making with the patient and interdisciplinary care teams in conjunction with minimization of the aspiration risk from delayed gastric emptying, the guidance stresses.

The five endorsing organizations are the American Society for Metabolic and Bariatric Surgery, American Society of Anesthesiologists (ASA), American Gastroenterological Association, International Society of Perioperative Care of Patients with Obesity, and Society of American Gastrointestinal and Endoscopic Surgeons. The societies emphasize that the statement is intended as guidance only and is not an evidence-based formal guideline.

GLP-1 RAs are known to delay gastric emptying, raising concerns about regurgitation, aspiration, and airway compromise during anesthesia. Rare serious adverse events have also been observed, prompting the ASA in 2023 to recommend holding these agents for 1 week for the injectable form and 1 day for the oral form before all procedures requiring anesthesia. 

University of Michigan

That abundance of caution, however, had negative impacts of its own. “This guidance has led to cancellations and postponements of many endoscopic and surgical procedures or required patients to undergo general anesthesia who may otherwise have had their procedures performed under moderate sedation,” said guidance coauthor Allison R. Schulman, MD, MPH, an associate professor of medicine and surgery and chief of endoscopy at the University of Michigan in Ann Arbor. “Nearly all institutions have been forced to revise preprocedural protocols, despite a lack of high-level evidence to suggest that these adjustments are necessary.”

“Studies have yielded mixed results as to whether patients on GLP-1s are at increased risk of these events, and the limited data available are inconsistent,” Schulman said. “As a result, there are inconsistencies in the recommendations from various societies leading to growing uncertainty with proceduralists on how to provide safe, effective, and timely procedural care to patients taking GLP-1 RAs.”

The new joint-society guidance may alleviate some of the uncertainty. Among the recommendations:

• Continuing GLP-1 RAs in the perioperative period should be based on shared decision-making with the patient and all care teams balancing the metabolic need for the GLP-1 RA with individual patient risk.
• Certain variables may increase the risk for delayed gastric emptying and aspiration with the periprocedural use of GLP-1 RAs: escalation phase — This phase vs the maintenance phase is associated with a higher risk for delayed gastric emptying; higher dose — the higher the dose, the greater the risk for gastrointestinal (GI) side effects; weekly dosing — GI side effects are more common with weekly vs daily formulations; presence of GI symptoms — nausea, vomiting, abdominal pain, dyspepsia, and constipation may suggest delayed gastric emptying; and medical problems beyond GLP-1 RA indications with GI effects — assess for such conditions as bowel dysmotility, gastroparesis, and Parkinson’s disease.
• Risk factors should be assessed in advance to allow sufficient time to adjust preoperative care, including diet modification and medication bridging if GLP-1 RA cessation is deemed advisable.
• If retained gastric contents are a concern on the day of a procedure, point-of-care gastric ultrasound could be used to assess aspiration risk, resources permitting.
• The aspiration risk from delayed gastric emptying should be minimized by preoperative diet modification and/or altering the anesthesia plan to consider rapid sequence induction of general anesthesia for tracheal intubation. A 24-hour preoperative liquid diet, as before colonoscopy and bariatric surgery, can be utilized when delayed gastric emptying is a concern.
• When concern about retained gastric contents exists on procedure day, providers should engage patients in a shared decision-making model and consider the benefits and risks of rapid-sequence induction of general anesthesia for tracheal intubation to minimize aspiration risk vs procedure cancellation.

“Safe continuation of surgery and gastrointestinal endoscopy, and prevention of procedure cancellation, for patients on GLP-1 RAs can be prioritized following the recommendations above, as would occur for other patient populations with gastroparesis,” the guidance panel wrote.

Digestive Health Center of Huntington

Commenting on the statement but not involved in it, David B. Purow, MD, managing director of the Digestive Health Center at Northwell Health/Huntington Hospital in Huntington, New York, said the recommendations will encourage clinicians to be more discerning about actual risk in individual cases rather than follow the previous blanket recommendation to stop these agents before procedures requiring sedation. 

While GLP-1 RAs were prescribed for the relatively small number of patients with diabetes, he said, the risk was not apparent but became clearer with the widespread use of these agents for weight loss — often unregulated and undisclosed to care providers.

“The pendulum shifted too far the other way, and now it’s shifted back,” he said in an interview. “The new guidance is great because now we can be more thoughtful about managing individual patients.” He cited, for instance, the recommendations on the greater risk in patients in the dose escalation phase or on higher doses, and the risk-reducing measure of a liquid diet for 24 hours before surgery.

His center is already using point-of-care ultrasound and recently had a case in which a patient who forgot and took his GLP-1 RA before a scheduled procedure was found on ultrasound to have a full stomach. “In some cases, these drugs can cause an almost gastroparesis level of delayed emptying,” Purow said.

Purow thinks this early guidance will probably progress to firm guidelines within a year. Schulman is more cautious. “Our understanding of this complex topic is increasing rapidly, and ongoing clinical research will ultimately lead to evidence-based guidelines in this changing landscape,” she said.

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Schulman is a consultant for Apollo Endosurgery, Boston Scientific, Olympus, Microtech, and Fractyl. Purow had no competing interests to declare.

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

The majority of patients may safely take glucagon-like peptide 1 receptor agonists (GLP-1 RAs) before elective surgery and gastrointestinal endoscopies, according to updated guidance from five medical societies.

The new guidance, contrasting with earlier recommendations, says these incrementally used agents can be taken up until the day of surgery, but patients are advised to follow a liquid diet for 24 hours before the procedure. The decision to proceed with endoscopy and other procedures should be based on shared decision-making with the patient and interdisciplinary care teams in conjunction with minimization of the aspiration risk from delayed gastric emptying, the guidance stresses.

The five endorsing organizations are the American Society for Metabolic and Bariatric Surgery, American Society of Anesthesiologists (ASA), American Gastroenterological Association, International Society of Perioperative Care of Patients with Obesity, and Society of American Gastrointestinal and Endoscopic Surgeons. The societies emphasize that the statement is intended as guidance only and is not an evidence-based formal guideline.

GLP-1 RAs are known to delay gastric emptying, raising concerns about regurgitation, aspiration, and airway compromise during anesthesia. Rare serious adverse events have also been observed, prompting the ASA in 2023 to recommend holding these agents for 1 week for the injectable form and 1 day for the oral form before all procedures requiring anesthesia. 

University of Michigan

That abundance of caution, however, had negative impacts of its own. “This guidance has led to cancellations and postponements of many endoscopic and surgical procedures or required patients to undergo general anesthesia who may otherwise have had their procedures performed under moderate sedation,” said guidance coauthor Allison R. Schulman, MD, MPH, an associate professor of medicine and surgery and chief of endoscopy at the University of Michigan in Ann Arbor. “Nearly all institutions have been forced to revise preprocedural protocols, despite a lack of high-level evidence to suggest that these adjustments are necessary.”

“Studies have yielded mixed results as to whether patients on GLP-1s are at increased risk of these events, and the limited data available are inconsistent,” Schulman said. “As a result, there are inconsistencies in the recommendations from various societies leading to growing uncertainty with proceduralists on how to provide safe, effective, and timely procedural care to patients taking GLP-1 RAs.”

The new joint-society guidance may alleviate some of the uncertainty. Among the recommendations:

• Continuing GLP-1 RAs in the perioperative period should be based on shared decision-making with the patient and all care teams balancing the metabolic need for the GLP-1 RA with individual patient risk.
• Certain variables may increase the risk for delayed gastric emptying and aspiration with the periprocedural use of GLP-1 RAs: escalation phase — This phase vs the maintenance phase is associated with a higher risk for delayed gastric emptying; higher dose — the higher the dose, the greater the risk for gastrointestinal (GI) side effects; weekly dosing — GI side effects are more common with weekly vs daily formulations; presence of GI symptoms — nausea, vomiting, abdominal pain, dyspepsia, and constipation may suggest delayed gastric emptying; and medical problems beyond GLP-1 RA indications with GI effects — assess for such conditions as bowel dysmotility, gastroparesis, and Parkinson’s disease.
• Risk factors should be assessed in advance to allow sufficient time to adjust preoperative care, including diet modification and medication bridging if GLP-1 RA cessation is deemed advisable.
• If retained gastric contents are a concern on the day of a procedure, point-of-care gastric ultrasound could be used to assess aspiration risk, resources permitting.
• The aspiration risk from delayed gastric emptying should be minimized by preoperative diet modification and/or altering the anesthesia plan to consider rapid sequence induction of general anesthesia for tracheal intubation. A 24-hour preoperative liquid diet, as before colonoscopy and bariatric surgery, can be utilized when delayed gastric emptying is a concern.
• When concern about retained gastric contents exists on procedure day, providers should engage patients in a shared decision-making model and consider the benefits and risks of rapid-sequence induction of general anesthesia for tracheal intubation to minimize aspiration risk vs procedure cancellation.

“Safe continuation of surgery and gastrointestinal endoscopy, and prevention of procedure cancellation, for patients on GLP-1 RAs can be prioritized following the recommendations above, as would occur for other patient populations with gastroparesis,” the guidance panel wrote.

Digestive Health Center of Huntington

Commenting on the statement but not involved in it, David B. Purow, MD, managing director of the Digestive Health Center at Northwell Health/Huntington Hospital in Huntington, New York, said the recommendations will encourage clinicians to be more discerning about actual risk in individual cases rather than follow the previous blanket recommendation to stop these agents before procedures requiring sedation. 

While GLP-1 RAs were prescribed for the relatively small number of patients with diabetes, he said, the risk was not apparent but became clearer with the widespread use of these agents for weight loss — often unregulated and undisclosed to care providers.

“The pendulum shifted too far the other way, and now it’s shifted back,” he said in an interview. “The new guidance is great because now we can be more thoughtful about managing individual patients.” He cited, for instance, the recommendations on the greater risk in patients in the dose escalation phase or on higher doses, and the risk-reducing measure of a liquid diet for 24 hours before surgery.

His center is already using point-of-care ultrasound and recently had a case in which a patient who forgot and took his GLP-1 RA before a scheduled procedure was found on ultrasound to have a full stomach. “In some cases, these drugs can cause an almost gastroparesis level of delayed emptying,” Purow said.

Purow thinks this early guidance will probably progress to firm guidelines within a year. Schulman is more cautious. “Our understanding of this complex topic is increasing rapidly, and ongoing clinical research will ultimately lead to evidence-based guidelines in this changing landscape,” she said.

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Schulman is a consultant for Apollo Endosurgery, Boston Scientific, Olympus, Microtech, and Fractyl. Purow had no competing interests to declare.

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

PHILADELPHIA — A new 10-day treatment regimen with the oral potassium-competitive acid blocker vonoprazan, and the antibiotics levofloxacin and amoxicillin, was significantly more effective at eradicating Helicobacter pylori infection than triple therapy with omeprazole, amoxicillin, and clarithromycin, according to the results of a randomized, multicenter study.

In addition, the triple therapy regimen with vonoprazan was generally better tolerated than the 14-day omeprazole-based regimen.

The new treatment combination was created to tackle the two main reasons that patients with H pylori experience treatment failure: Inadequate acid suppressant activity and antibiotic resistance, said principal investigator Kachonsak Yongwatana, MD, from Phramongkutklao Hospital in Bangkok, Thailand.

“Vonoprazan” is the more potent option for acid suppression, and “levofloxacin” addresses antibiotic resistance, he explained.

Yongwatana presented the findings (Abstract 41) at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. The ACG recently released a clinical guideline on the treatment of H pylori infection. 
 

Robust Eradication Rates

Yongwatana and colleagues enrolled adult patients with H pylori infections at four hospitals in Thailand between December 2022 and September 2023. The presence of H pylori was confirmed by upper gastrointestinal endoscopy with positive rapid urease test or positive test on tissue biopsy. 

Patients were then randomized into two treatment groups: The 10-day VAL group (vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and levofloxacin 500 mg once daily for 10 days) and the 14-day OAC group (omeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily for 14 days). Eradication was assessed by urea breath test 4 weeks after completion of treatment.

There were 280 patients in total, with 140 in each group. There were no significant differences in baseline characteristics between the groups. The most common endoscopic findings among all participants included erosive gastritis (38%), nonerosive gastritis (27%), and gastric ulcer (17%). 

In comparing the treatments, the researchers found that 10-day VAL led to significantly greater H pylori eradication rate than the 14-day OAC group in both intention-to-treat analysis (91.4 % vs 80.7%, P = .009) and per-protocol analysis (93.4% vs 83.7%, P = .012). 

Vonoprazan-based therapy was also well tolerated by participants. Patients in the 10-day VAL group had significantly lower rates of experiencing a bitter taste (2.1% vs 42.9%, P < .001) and bloating (5% vs 12.1%, P = .033) than those in the 14-day OAC group. 
 

Isolating the BMI Effect

The researchers conducted a subgroup analysis on potential factors influencing response, which revealed that having a body mass index (BMI) < 23.5 was significantly associated with a higher chance at successful H pylori eradication (relative risk [RR], 2.27; P = .049). 

They then analyzed whether this BMI threshold was predictive in the separate treatment regimens. Although having a BMI < 23.5 was significantly associated with a higher eradication rate in the 14-day OAC group (RR, 3.34; P = .026), no such effect was noted in the 10-day VAL group (RR, 1.10; P = .888).

The influence of BMI could be caused by the bioavailability of the treatments used in the regimen, Younwatana said in an interview. He and his colleagues recommended against using the 14-day OAC regimen in those with BMI ≥ 23.5.

“In patients with a high BMI, we should be concerned that normal proton pump inhibitors may not work,” he said. “You have to step up to the higher-potency options.” 
 

Seeking Confirmation in Other Populations

Session comoderator Felice Schnoll-Sussman, MD, MSc, professor of clinical medicine and the director of the Jay Monahan Center for Gastrointestinal Health, director of the DIGEST program, and the associate chair of medicine for Outreach and Network at New York–Presbyterian Brooklyn Methodist Hospital in New York City, said in an interview that the promising results merit confirmation in other populations. 

“When you see a study that is coming out of one country, when there could be issues related to antibiotic sensitivity in H pylori, it really is important to decide whether or not this is applicable to other patient populations,” said Schnoll-Sussman, who was not involved in the study. 

She noted that this is also true of the findings from the subgroup as it is unclear whether average rates of BMI are notably lower in Thailand from other countries.

“As we know, BMI affects so many things with disease states. So, it’s a possibility in a country where the BMI is actually lower, there may be something else about these individuals in terms of their wellness status that could be underlying the effect.” 

The study had no specific funding, although Takeda supplied treatments used in the analysis. Yongwatana reported no relevant financial relationships. Schnoll-Sussman reported serving as an advisory committee/board member for Braintree, Ethicon, Implantica, and Phathom. 

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

PHILADELPHIA — A new 10-day treatment regimen with the oral potassium-competitive acid blocker vonoprazan, and the antibiotics levofloxacin and amoxicillin, was significantly more effective at eradicating Helicobacter pylori infection than triple therapy with omeprazole, amoxicillin, and clarithromycin, according to the results of a randomized, multicenter study.

In addition, the triple therapy regimen with vonoprazan was generally better tolerated than the 14-day omeprazole-based regimen.

The new treatment combination was created to tackle the two main reasons that patients with H pylori experience treatment failure: Inadequate acid suppressant activity and antibiotic resistance, said principal investigator Kachonsak Yongwatana, MD, from Phramongkutklao Hospital in Bangkok, Thailand.

“Vonoprazan” is the more potent option for acid suppression, and “levofloxacin” addresses antibiotic resistance, he explained.

Yongwatana presented the findings (Abstract 41) at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. The ACG recently released a clinical guideline on the treatment of H pylori infection. 
 

Robust Eradication Rates

Yongwatana and colleagues enrolled adult patients with H pylori infections at four hospitals in Thailand between December 2022 and September 2023. The presence of H pylori was confirmed by upper gastrointestinal endoscopy with positive rapid urease test or positive test on tissue biopsy. 

Patients were then randomized into two treatment groups: The 10-day VAL group (vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and levofloxacin 500 mg once daily for 10 days) and the 14-day OAC group (omeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily for 14 days). Eradication was assessed by urea breath test 4 weeks after completion of treatment.

There were 280 patients in total, with 140 in each group. There were no significant differences in baseline characteristics between the groups. The most common endoscopic findings among all participants included erosive gastritis (38%), nonerosive gastritis (27%), and gastric ulcer (17%). 

In comparing the treatments, the researchers found that 10-day VAL led to significantly greater H pylori eradication rate than the 14-day OAC group in both intention-to-treat analysis (91.4 % vs 80.7%, P = .009) and per-protocol analysis (93.4% vs 83.7%, P = .012). 

Vonoprazan-based therapy was also well tolerated by participants. Patients in the 10-day VAL group had significantly lower rates of experiencing a bitter taste (2.1% vs 42.9%, P < .001) and bloating (5% vs 12.1%, P = .033) than those in the 14-day OAC group. 
 

Isolating the BMI Effect

The researchers conducted a subgroup analysis on potential factors influencing response, which revealed that having a body mass index (BMI) < 23.5 was significantly associated with a higher chance at successful H pylori eradication (relative risk [RR], 2.27; P = .049). 

They then analyzed whether this BMI threshold was predictive in the separate treatment regimens. Although having a BMI < 23.5 was significantly associated with a higher eradication rate in the 14-day OAC group (RR, 3.34; P = .026), no such effect was noted in the 10-day VAL group (RR, 1.10; P = .888).

The influence of BMI could be caused by the bioavailability of the treatments used in the regimen, Younwatana said in an interview. He and his colleagues recommended against using the 14-day OAC regimen in those with BMI ≥ 23.5.

“In patients with a high BMI, we should be concerned that normal proton pump inhibitors may not work,” he said. “You have to step up to the higher-potency options.” 
 

Seeking Confirmation in Other Populations

Session comoderator Felice Schnoll-Sussman, MD, MSc, professor of clinical medicine and the director of the Jay Monahan Center for Gastrointestinal Health, director of the DIGEST program, and the associate chair of medicine for Outreach and Network at New York–Presbyterian Brooklyn Methodist Hospital in New York City, said in an interview that the promising results merit confirmation in other populations. 

“When you see a study that is coming out of one country, when there could be issues related to antibiotic sensitivity in H pylori, it really is important to decide whether or not this is applicable to other patient populations,” said Schnoll-Sussman, who was not involved in the study. 

She noted that this is also true of the findings from the subgroup as it is unclear whether average rates of BMI are notably lower in Thailand from other countries.

“As we know, BMI affects so many things with disease states. So, it’s a possibility in a country where the BMI is actually lower, there may be something else about these individuals in terms of their wellness status that could be underlying the effect.” 

The study had no specific funding, although Takeda supplied treatments used in the analysis. Yongwatana reported no relevant financial relationships. Schnoll-Sussman reported serving as an advisory committee/board member for Braintree, Ethicon, Implantica, and Phathom. 

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

PHILADELPHIA — A new 10-day treatment regimen with the oral potassium-competitive acid blocker vonoprazan, and the antibiotics levofloxacin and amoxicillin, was significantly more effective at eradicating Helicobacter pylori infection than triple therapy with omeprazole, amoxicillin, and clarithromycin, according to the results of a randomized, multicenter study.

In addition, the triple therapy regimen with vonoprazan was generally better tolerated than the 14-day omeprazole-based regimen.

The new treatment combination was created to tackle the two main reasons that patients with H pylori experience treatment failure: Inadequate acid suppressant activity and antibiotic resistance, said principal investigator Kachonsak Yongwatana, MD, from Phramongkutklao Hospital in Bangkok, Thailand.

“Vonoprazan” is the more potent option for acid suppression, and “levofloxacin” addresses antibiotic resistance, he explained.

Yongwatana presented the findings (Abstract 41) at the American College of Gastroenterology (ACG) 2024 Annual Scientific Meeting. The ACG recently released a clinical guideline on the treatment of H pylori infection. 
 

Robust Eradication Rates

Yongwatana and colleagues enrolled adult patients with H pylori infections at four hospitals in Thailand between December 2022 and September 2023. The presence of H pylori was confirmed by upper gastrointestinal endoscopy with positive rapid urease test or positive test on tissue biopsy. 

Patients were then randomized into two treatment groups: The 10-day VAL group (vonoprazan 20 mg twice daily, amoxicillin 1000 mg twice daily, and levofloxacin 500 mg once daily for 10 days) and the 14-day OAC group (omeprazole 20 mg twice daily, amoxicillin 1000 mg twice daily, and clarithromycin 500 mg twice daily for 14 days). Eradication was assessed by urea breath test 4 weeks after completion of treatment.

There were 280 patients in total, with 140 in each group. There were no significant differences in baseline characteristics between the groups. The most common endoscopic findings among all participants included erosive gastritis (38%), nonerosive gastritis (27%), and gastric ulcer (17%). 

In comparing the treatments, the researchers found that 10-day VAL led to significantly greater H pylori eradication rate than the 14-day OAC group in both intention-to-treat analysis (91.4 % vs 80.7%, P = .009) and per-protocol analysis (93.4% vs 83.7%, P = .012). 

Vonoprazan-based therapy was also well tolerated by participants. Patients in the 10-day VAL group had significantly lower rates of experiencing a bitter taste (2.1% vs 42.9%, P < .001) and bloating (5% vs 12.1%, P = .033) than those in the 14-day OAC group. 
 

Isolating the BMI Effect

The researchers conducted a subgroup analysis on potential factors influencing response, which revealed that having a body mass index (BMI) < 23.5 was significantly associated with a higher chance at successful H pylori eradication (relative risk [RR], 2.27; P = .049). 

They then analyzed whether this BMI threshold was predictive in the separate treatment regimens. Although having a BMI < 23.5 was significantly associated with a higher eradication rate in the 14-day OAC group (RR, 3.34; P = .026), no such effect was noted in the 10-day VAL group (RR, 1.10; P = .888).

The influence of BMI could be caused by the bioavailability of the treatments used in the regimen, Younwatana said in an interview. He and his colleagues recommended against using the 14-day OAC regimen in those with BMI ≥ 23.5.

“In patients with a high BMI, we should be concerned that normal proton pump inhibitors may not work,” he said. “You have to step up to the higher-potency options.” 
 

Seeking Confirmation in Other Populations

Session comoderator Felice Schnoll-Sussman, MD, MSc, professor of clinical medicine and the director of the Jay Monahan Center for Gastrointestinal Health, director of the DIGEST program, and the associate chair of medicine for Outreach and Network at New York–Presbyterian Brooklyn Methodist Hospital in New York City, said in an interview that the promising results merit confirmation in other populations. 

“When you see a study that is coming out of one country, when there could be issues related to antibiotic sensitivity in H pylori, it really is important to decide whether or not this is applicable to other patient populations,” said Schnoll-Sussman, who was not involved in the study. 

She noted that this is also true of the findings from the subgroup as it is unclear whether average rates of BMI are notably lower in Thailand from other countries.

“As we know, BMI affects so many things with disease states. So, it’s a possibility in a country where the BMI is actually lower, there may be something else about these individuals in terms of their wellness status that could be underlying the effect.” 

The study had no specific funding, although Takeda supplied treatments used in the analysis. Yongwatana reported no relevant financial relationships. Schnoll-Sussman reported serving as an advisory committee/board member for Braintree, Ethicon, Implantica, and Phathom. 

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

TOPLINE:

There is no significant association between the use of proton pump inhibitors (PPIs) and risk for cardiovascular events, a meta-analysis shows. However, patients with gastroesophageal reflux disease (GERD) do experience a slight increase in cardiovascular events with PPI use.

METHODOLOGY:

• PPIs are commonly used gastric acid suppressants; however, they have pleiotropic effects, some of which have been hypothesized to augment cardiovascular disorders.
• Researchers conducted a meta-analysis of randomized clinical trials with at least 100 patients and treatment durations > 30 days, which compared groups receiving PPIs to those on placebo or other active treatments.
• The primary outcome was a composite of nonfatal myocardial infarctions, nonfatal strokes, fatal cardiovascular adverse events, coronary revascularizations, and hospitalizations for unstable angina.

TAKEAWAY:

• Researchers included data from 52 placebo-controlled trials, with 14,988 patients and 8323 patients randomized to receive a PPI or placebo, respectively; the mean treatment duration was 0.45 person-years for those treated with PPIs and 0.32 person-years for those treated with placebo.
• Among placebo-controlled trials, 24 were conducted in patients with GERD.
• Researchers also included 61 active-controlled trials that compared PPIs with histamine-2 receptor antagonists (51 trials) or other active treatments.
• The incidence rate ratio for the primary outcome was 0.72 when comparing PPI to placebo, indicating no significant association between PPI and cardiovascular events.
• Among patients with GERD, cardiovascular events occurred only in those treated with PPIs, leading to approximately one excess cardiovascular event per 100 person-years of PPI treatment relative to placebo.
• Researchers found no association between PPI treatment and the risk for cardiovascular events in trials comparing PPIs with other active treatments.

IN PRACTICE:

“We found no association of cardiovascular events with PPI treatment,” the authors wrote. “Cardiovascular events appeared more frequent with PPI treatment in GERD trials, but results from this subgroup should be interpreted with the limitations of the analysis in mind.”

SOURCE:

The study, led by Andrew D. Mosholder, MD, MPH, Division of Epidemiology, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, Maryland, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

This study lacked individual patient data, which precluded a time-to-event analysis or an analysis accounting for patient characteristics such as age or sex. The mean duration of PPI treatment in these trials was a few months, limiting the assessment of cardiovascular risk with extended use. The risk estimates were influenced the most by data on omeprazole and esomeprazole.

DISCLOSURES:

This study did not receive any funding. The authors declared no conflicts of interests.

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:

There is no significant association between the use of proton pump inhibitors (PPIs) and risk for cardiovascular events, a meta-analysis shows. However, patients with gastroesophageal reflux disease (GERD) do experience a slight increase in cardiovascular events with PPI use.

METHODOLOGY:

• PPIs are commonly used gastric acid suppressants; however, they have pleiotropic effects, some of which have been hypothesized to augment cardiovascular disorders.
• Researchers conducted a meta-analysis of randomized clinical trials with at least 100 patients and treatment durations > 30 days, which compared groups receiving PPIs to those on placebo or other active treatments.
• The primary outcome was a composite of nonfatal myocardial infarctions, nonfatal strokes, fatal cardiovascular adverse events, coronary revascularizations, and hospitalizations for unstable angina.

TAKEAWAY:

• Researchers included data from 52 placebo-controlled trials, with 14,988 patients and 8323 patients randomized to receive a PPI or placebo, respectively; the mean treatment duration was 0.45 person-years for those treated with PPIs and 0.32 person-years for those treated with placebo.
• Among placebo-controlled trials, 24 were conducted in patients with GERD.
• Researchers also included 61 active-controlled trials that compared PPIs with histamine-2 receptor antagonists (51 trials) or other active treatments.
• The incidence rate ratio for the primary outcome was 0.72 when comparing PPI to placebo, indicating no significant association between PPI and cardiovascular events.
• Among patients with GERD, cardiovascular events occurred only in those treated with PPIs, leading to approximately one excess cardiovascular event per 100 person-years of PPI treatment relative to placebo.
• Researchers found no association between PPI treatment and the risk for cardiovascular events in trials comparing PPIs with other active treatments.

IN PRACTICE:

“We found no association of cardiovascular events with PPI treatment,” the authors wrote. “Cardiovascular events appeared more frequent with PPI treatment in GERD trials, but results from this subgroup should be interpreted with the limitations of the analysis in mind.”

SOURCE:

The study, led by Andrew D. Mosholder, MD, MPH, Division of Epidemiology, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, Maryland, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

This study lacked individual patient data, which precluded a time-to-event analysis or an analysis accounting for patient characteristics such as age or sex. The mean duration of PPI treatment in these trials was a few months, limiting the assessment of cardiovascular risk with extended use. The risk estimates were influenced the most by data on omeprazole and esomeprazole.

DISCLOSURES:

This study did not receive any funding. The authors declared no conflicts of interests.

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:

There is no significant association between the use of proton pump inhibitors (PPIs) and risk for cardiovascular events, a meta-analysis shows. However, patients with gastroesophageal reflux disease (GERD) do experience a slight increase in cardiovascular events with PPI use.

METHODOLOGY:

• PPIs are commonly used gastric acid suppressants; however, they have pleiotropic effects, some of which have been hypothesized to augment cardiovascular disorders.
• Researchers conducted a meta-analysis of randomized clinical trials with at least 100 patients and treatment durations > 30 days, which compared groups receiving PPIs to those on placebo or other active treatments.
• The primary outcome was a composite of nonfatal myocardial infarctions, nonfatal strokes, fatal cardiovascular adverse events, coronary revascularizations, and hospitalizations for unstable angina.

TAKEAWAY:

• Researchers included data from 52 placebo-controlled trials, with 14,988 patients and 8323 patients randomized to receive a PPI or placebo, respectively; the mean treatment duration was 0.45 person-years for those treated with PPIs and 0.32 person-years for those treated with placebo.
• Among placebo-controlled trials, 24 were conducted in patients with GERD.
• Researchers also included 61 active-controlled trials that compared PPIs with histamine-2 receptor antagonists (51 trials) or other active treatments.
• The incidence rate ratio for the primary outcome was 0.72 when comparing PPI to placebo, indicating no significant association between PPI and cardiovascular events.
• Among patients with GERD, cardiovascular events occurred only in those treated with PPIs, leading to approximately one excess cardiovascular event per 100 person-years of PPI treatment relative to placebo.
• Researchers found no association between PPI treatment and the risk for cardiovascular events in trials comparing PPIs with other active treatments.

IN PRACTICE:

“We found no association of cardiovascular events with PPI treatment,” the authors wrote. “Cardiovascular events appeared more frequent with PPI treatment in GERD trials, but results from this subgroup should be interpreted with the limitations of the analysis in mind.”

SOURCE:

The study, led by Andrew D. Mosholder, MD, MPH, Division of Epidemiology, US Food and Drug Administration Center for Drug Evaluation and Research, Silver Spring, Maryland, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

This study lacked individual patient data, which precluded a time-to-event analysis or an analysis accounting for patient characteristics such as age or sex. The mean duration of PPI treatment in these trials was a few months, limiting the assessment of cardiovascular risk with extended use. The risk estimates were influenced the most by data on omeprazole and esomeprazole.

DISCLOSURES:

This study did not receive any funding. The authors declared no conflicts of interests.

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.

When psychiatrist Paul Sartain, MD (not his real name), received a letter from his state’s medical board, he was concerned. A patient’s family complained that he made sexual advances to a young woman he treated for psychotic depression.

“There was absolutely no evidence, and the claims were vague,” he said. “I think the family was angry at me and with the system — the woman had not gotten better.” Sartain reviewed his medical records and then called his malpractice insurer.

The insurer asked about his involvement with the patient’s case, if there was anything credible to the patient’s complaint, and if he had thorough documentation. Then, the carrier offered Sartain his choice of several attorneys who could represent him. The medical board ultimately closed the case with no findings against him, and the patient’s family never sued him.

While Sartain said he trusted his carrier-provided attorney, he would have considered hiring his own attorney as well if a criminal issue was also alleged.

“If I’m wrongly accused, I’m defended (by the carrier). If I had stolen money or had a sexual relationship with the patient, then you’re acting outside the bounds of what is protected (by the carrier),” he said.
 

How Medical Board and Malpractice Insurer Investigations Differ

Medical board complaints differ from malpractice claims, in which patients seek damages. The investigation process also varies.

When a patient reports a doctor to a state medical board, they may also sue the doctor for monetary damages in civil court. The medical board responds to patient complaints made directly to them, but it also may also initiate its own investigations. Those can be prompted by a malpractice claim resolution, with a court verdict against the doctor, or a settlement recorded in the National Practitioner Data Bank.

Malpractice insurers may offer limited legal representation for medical board investigations, requiring the doctor to report the medical board issue to them before the doctor takes any action. Often, they will cover up to $50,000 in defense costs but not cover any subsequent medical board fines or required classes or medical board fees.

When a doctor contacts the carrier about a medical board investigation, the carrier may ask for the medical board document and the medical records, said Alex Keoskey, a partner in Frier Levitt’s life sciences group.

The carrier may want to ask about the patient, staff members involved, the doctor’s background, if there have been previous medical board investigations or lawsuits against this doctor, and the doctor’s opinion of the allegations. The doctor should be transparent with the carrier, Keoskey said.

Some carriers conduct more in-depth investigations, examining record-keeping, prescription practices, patient consent processes, and continuing medical education status. That’s because the medical board may inquire about these as well should its own investigation expand.

Not all carriers explore cases like these, even if reimbursing for defense costs, said Karen Frisella, director of professional liability claims at BETA Healthcare Group in California. In her experience, a licensing investigation usually follows a claim resolution that was already worked up by the carrier. If a complaint was made directly to the licensing board without an accompanying liability claim, the carrier’s ability to initiate an investigation on the incident depends on the policy terms or coverage available.

“Typically, a professional liability policy requires that the insured report a claim to trigger coverage. The carrier can’t unilaterally decide to open a claim,” she said. A licensing board investigation is not a claim by definition and therefore does not provide a mechanism for the carrier to open a liability claim file, she added.

If the medical board ultimately restricts the doctor’s license or puts the doctor on probation, that becomes public, and the underwriting department may then look into it.

Malpractice insurers routinely monitor licensing board discipline notices. A reprimand or restrictions on a doctor’s license could trigger a review of the physician’s future insurability and lead to higher premiums or even nonrenewal, Frisella said.

If a carrier investigates a reported claim and determines there are issues with the care rendered, whether there is an accompanying medical board action, that also can affect underwriting decisions, Frisella said.