Traditionally, the presence of ductal carcinoma in situ with invasive HER2-positive breast cancer has made surgeons hesitant to offer women breast conserving surgery following neoadjuvant therapy.

The concern has been that ductal carcinoma in situ (DCIS) doesn’t respond well to neoadjuvant treatment, so leaving it behind could increase the risk of recurrence.

A new study, however, calls that thinking into question.

In a nationwide review of over 5,000 women in the Netherlands, Dutch investigators found that neoadjuvant therapy eradicates DCIS about half of the time in women with invasive HER2-positive breast cancer.

The study is the largest look into the issue to date and confirms similar reports from a handful of smaller studies.

“These findings are important to create awareness that the presence of a DCIS component ... should not necessarily indicate the need for mastectomy,” said Roxanne Ploumen, PhD, of Maastricht (the Netherlands) University Medical Centre and colleagues.

The study was published in Breast Cancer Research and Treatment.

The research team compared biopsy results before neoadjuvant therapy with pathology reports following surgery. DCIS had a pathologic complete response rate of 52%. Neoadjuvant therapy generally consisted of anthracyclines followed by docetaxel or paclitaxel, in combination with trastuzumab.

The study also supports the assertion that women with DCIS are less likely to have breast-conserving surgery. Patients with DCIS were more likely to get mastectomies in the study (53.6% vs. 41%; P < .001) although the exact reasons are unclear because the data didn’t capture information relevant to surgical decision-making, including patient preferences and the extent of calcifications on mammography.

The key now is to find a way to assess how well DCIS responds to neoadjuvant therapy to better guide surgical decisions. Future studies should “investigate the evaluation of DCIS response by imaging” to increase the chance of breast-conserving surgery. “Moreover, a thorough investigation of pathologic characteristics” that predict response “could be useful,” Dr. Ploumen and associates said.

The investigators did find a few correlations that might help with response prediction; complete resolution of DCIS was associated with a complete response of the primary tumor to neoadjuvant therapy as well as negative estrogen receptor status and more recent breast cancer diagnosis, likely because of recent improvements in neoadjuvant therapy, including dual anti-HER2 blockade from 2017 onward, the team said.

Asked for comment, Kathy Miller, MD, a breast medical oncologist at Indiana University, Indianapolis, called the findings “interesting.”

“I suspect the challenge is that DCIS is often associated with microcalcifications” that don’t go away with therapy, “so it is common for [surgeons] to remove all areas” with microcalcifications. For now, “we can’t determine if the DCIS has” resolved with neoadjuvant therapy, so leaving calcifications behind “means accepting the possibility that you might be leaving residual disease behind,” she said.

The analysis included 5,598 women diagnosed with HER2-positive invasive breast cancer treated with neoadjuvant therapy and surgery between 2010 and 2020. The investigators coupled the Netherlands Cancer Registry with the Dutch Nationwide Pathology Databank to conduct their analysis.

About a quarter of the women had a DCIS component to their breast tumors.

The work was funded by the Jules Coenegracht Senior Foundation. Dr. Ploumen and Dr. Miller reported no conflicts of interest. Three investigators reported ties to Servier Pharmaceuticals, Bayer, Novartis, and other companies.

Traditionally, the presence of ductal carcinoma in situ with invasive HER2-positive breast cancer has made surgeons hesitant to offer women breast conserving surgery following neoadjuvant therapy.

The concern has been that ductal carcinoma in situ (DCIS) doesn’t respond well to neoadjuvant treatment, so leaving it behind could increase the risk of recurrence.

A new study, however, calls that thinking into question.

In a nationwide review of over 5,000 women in the Netherlands, Dutch investigators found that neoadjuvant therapy eradicates DCIS about half of the time in women with invasive HER2-positive breast cancer.

The study is the largest look into the issue to date and confirms similar reports from a handful of smaller studies.

“These findings are important to create awareness that the presence of a DCIS component ... should not necessarily indicate the need for mastectomy,” said Roxanne Ploumen, PhD, of Maastricht (the Netherlands) University Medical Centre and colleagues.

The study was published in Breast Cancer Research and Treatment.

The research team compared biopsy results before neoadjuvant therapy with pathology reports following surgery. DCIS had a pathologic complete response rate of 52%. Neoadjuvant therapy generally consisted of anthracyclines followed by docetaxel or paclitaxel, in combination with trastuzumab.

The study also supports the assertion that women with DCIS are less likely to have breast-conserving surgery. Patients with DCIS were more likely to get mastectomies in the study (53.6% vs. 41%; P < .001) although the exact reasons are unclear because the data didn’t capture information relevant to surgical decision-making, including patient preferences and the extent of calcifications on mammography.

The key now is to find a way to assess how well DCIS responds to neoadjuvant therapy to better guide surgical decisions. Future studies should “investigate the evaluation of DCIS response by imaging” to increase the chance of breast-conserving surgery. “Moreover, a thorough investigation of pathologic characteristics” that predict response “could be useful,” Dr. Ploumen and associates said.

The investigators did find a few correlations that might help with response prediction; complete resolution of DCIS was associated with a complete response of the primary tumor to neoadjuvant therapy as well as negative estrogen receptor status and more recent breast cancer diagnosis, likely because of recent improvements in neoadjuvant therapy, including dual anti-HER2 blockade from 2017 onward, the team said.

Asked for comment, Kathy Miller, MD, a breast medical oncologist at Indiana University, Indianapolis, called the findings “interesting.”

“I suspect the challenge is that DCIS is often associated with microcalcifications” that don’t go away with therapy, “so it is common for [surgeons] to remove all areas” with microcalcifications. For now, “we can’t determine if the DCIS has” resolved with neoadjuvant therapy, so leaving calcifications behind “means accepting the possibility that you might be leaving residual disease behind,” she said.

The analysis included 5,598 women diagnosed with HER2-positive invasive breast cancer treated with neoadjuvant therapy and surgery between 2010 and 2020. The investigators coupled the Netherlands Cancer Registry with the Dutch Nationwide Pathology Databank to conduct their analysis.

About a quarter of the women had a DCIS component to their breast tumors.

The work was funded by the Jules Coenegracht Senior Foundation. Dr. Ploumen and Dr. Miller reported no conflicts of interest. Three investigators reported ties to Servier Pharmaceuticals, Bayer, Novartis, and other companies.

Traditionally, the presence of ductal carcinoma in situ with invasive HER2-positive breast cancer has made surgeons hesitant to offer women breast conserving surgery following neoadjuvant therapy.

The concern has been that ductal carcinoma in situ (DCIS) doesn’t respond well to neoadjuvant treatment, so leaving it behind could increase the risk of recurrence.

A new study, however, calls that thinking into question.

In a nationwide review of over 5,000 women in the Netherlands, Dutch investigators found that neoadjuvant therapy eradicates DCIS about half of the time in women with invasive HER2-positive breast cancer.

The study is the largest look into the issue to date and confirms similar reports from a handful of smaller studies.

“These findings are important to create awareness that the presence of a DCIS component ... should not necessarily indicate the need for mastectomy,” said Roxanne Ploumen, PhD, of Maastricht (the Netherlands) University Medical Centre and colleagues.

The study was published in Breast Cancer Research and Treatment.

The research team compared biopsy results before neoadjuvant therapy with pathology reports following surgery. DCIS had a pathologic complete response rate of 52%. Neoadjuvant therapy generally consisted of anthracyclines followed by docetaxel or paclitaxel, in combination with trastuzumab.

The study also supports the assertion that women with DCIS are less likely to have breast-conserving surgery. Patients with DCIS were more likely to get mastectomies in the study (53.6% vs. 41%; P < .001) although the exact reasons are unclear because the data didn’t capture information relevant to surgical decision-making, including patient preferences and the extent of calcifications on mammography.

The key now is to find a way to assess how well DCIS responds to neoadjuvant therapy to better guide surgical decisions. Future studies should “investigate the evaluation of DCIS response by imaging” to increase the chance of breast-conserving surgery. “Moreover, a thorough investigation of pathologic characteristics” that predict response “could be useful,” Dr. Ploumen and associates said.

The investigators did find a few correlations that might help with response prediction; complete resolution of DCIS was associated with a complete response of the primary tumor to neoadjuvant therapy as well as negative estrogen receptor status and more recent breast cancer diagnosis, likely because of recent improvements in neoadjuvant therapy, including dual anti-HER2 blockade from 2017 onward, the team said.

Asked for comment, Kathy Miller, MD, a breast medical oncologist at Indiana University, Indianapolis, called the findings “interesting.”

“I suspect the challenge is that DCIS is often associated with microcalcifications” that don’t go away with therapy, “so it is common for [surgeons] to remove all areas” with microcalcifications. For now, “we can’t determine if the DCIS has” resolved with neoadjuvant therapy, so leaving calcifications behind “means accepting the possibility that you might be leaving residual disease behind,” she said.

The analysis included 5,598 women diagnosed with HER2-positive invasive breast cancer treated with neoadjuvant therapy and surgery between 2010 and 2020. The investigators coupled the Netherlands Cancer Registry with the Dutch Nationwide Pathology Databank to conduct their analysis.

About a quarter of the women had a DCIS component to their breast tumors.

The work was funded by the Jules Coenegracht Senior Foundation. Dr. Ploumen and Dr. Miller reported no conflicts of interest. Three investigators reported ties to Servier Pharmaceuticals, Bayer, Novartis, and other companies.

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

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

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

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

A Washington state hospital will pay the government $240,000 to resolve a data privacy investigation after nearly two dozen security guards were caught snooping through medical records without a job-related purpose.

Yakima Valley Memorial Hospital agreed to the voluntary settlement after an investigation into the actions of 23 emergency department security guards who allegedly used their login credentials to access the patient medical records of 419 patients.

The information accessed included names, dates of birth, medical record numbers, addresses, certain notes related to treatment, and insurance information, according to a release by the U.S .Department of Health & Human Services’ Office for Civil Rights (OCR). A breach notification report alerted OCR to the snooping.

As part of the agreement, OCR will monitor Yakima Valley Memorial Hospital for 2 years and the hospital must conduct a thorough risk analysis as well as develop a risk management plan to address and mitigate identified security risks and vulnerabilities. The settlement is not considered an admission of guilt by the hospital.
 

Is such snooping common?

The incident highlights the frequent practice of employees snooping through medical records and the steep consequences that can result for providers, said Paul Redding, vice president of partner engagement and cybersecurity at Compliancy Group, a company that offers guided HIPAA compliance software for healthcare providers and vendors.

“I think the problem is absolutely growing,” he said. “What’s crazy about this case is it’s actually a really small HIPAA violation. Less than 500 people were affected, and the hospital still must pay a quarter-of-a-million-dollar settlement. If you take the average HIPAA violation, which is in the thousands and thousands of [patients], this amount would be magnified many times over.”

In general, employees snoop through records out of curiosity or to find out information about people they know – or want to learn about, said J. David Sims, a cybersecurity expert and CEO of Security First IT, a company that provides cybersecurity solutions and IT support to health care businesses.

Mr. Sims says he has heard of cases where health professionals snooped through records to find information about the new love interests of ex-partners or to learn about people on dating websites whom they’re interested in dating.

“Most of the time, it’s people being nosy,” he said. “In a lot of cases, it’s curiosity about famous people. You see it a lot in areas where you have football players who come in with injuries or you have an actor or actress who come in for something.”

“Data breaches caused by current and former workforce members impermissibly accessing patient records are a recurring issue across the health care industry. Health care organizations must ensure that workforce members can only access the patient information needed to do their jobs,” OCR director Melanie Fontes Rainer said in a June statement. “HIPAA-covered entities must have robust policies and procedures in place to ensure patient health information is protected from identify theft and fraud.”

Yakima Valley Memorial Hospital did not return a message seeking comment.

According to OCR’s latest report to Congress, complaints about HIPAA violations increased by 39% between 2017 and 2021. Breaches affecting fewer than 500 individuals rose by 5% during the same time period, and breaches impacting 500 or more individuals increased by 58%.
 

Common reasons employees snoop

The OCR announcement does not specify why the 23 security guards were accessing the medical records, but the incident raises questions about why the security guards had access to protected health information (PHI) in the first place, Mr. Redding said.

“I have yet to have anyone explain to me why the security guards would have access to PHI at all, at any level,” he said. “Was it by design or was it by error?”

In 2019 for instance, dozens of employees at Northwestern Memorial Hospital in Chicago were fired for accessing the health records of former Empire actor Jussie Smollett. In another high-profile case, nearly a dozen emergency medical service employees were caught snooping through 911 records connected to the treatment and, later, death of Joan Rivers.

“Sadly, there is a lack of education around what compliance really means inside the medical industry as a whole,” Mr. Redding said. “There is a lack of employee training and a lack of emphasis on accountability for employees.”
 

Privacy breaches fuel lawsuits

Health professionals caught snooping through records are frequently terminated and employers can face a range of ramifications, including civil and criminal penalties.

A growing trend is class action lawsuits associated with privacy violations, Mr. Redding adds.

Because patients are unable to sue in civil court for HIPAA breaches, they frequently sue for “breach of an implied contract,” he explained. In such cases, patients allege that the privacy documents they signed with health care providers established an implied contract, and their records being exposed constituted a contract breach.

“Class action lawsuits are starting to become extremely common,” Mr. Redding said. “It’s happening in many cases, even sometimes before Health & Human Services issue a fine, that [providers] are being wrapped into a class action lawsuit.”

Mayo Clinic, for example, was recently slapped with a class action suit after a former employee inappropriately accessed the records of 1,600 patients. Mayo settled the suit in January 2023, the terms of which were not publicly disclosed.

Multiple patients also filed a class action suit against San Diego–based Scripps Health after its data were hit with a cyberattack and subsequent breach that impacted close to 2 million people. Scripps reached a $3.5 million settlement with the plaintiffs in 2023.

Some practices and employers may also face state penalties for data privacy breaches, depending on their jurisdiction. In July, Connecticut became the fifth state to enact a comprehensive data privacy law. The measure, which creates a robust framework for protecting health-related records and other data, includes civil penalties of up to $5,000 for violations. Other states, including California, Virginia, Utah, and Colorado, also have state data privacy laws on the books.
 

How can practices stop snooping?

A first step to preventing snooping is conducting a thorough risk assessment, said David Harlow, a health care attorney and chief compliance and privacy officer for Insulet Corporation, a medical device company. The analysis should address who has access to what data and whether they really need such access, he said.

“Then it’s putting in place the proper controls to ensure access is limited and use is limited to the appropriate individuals and circumstances,” Mr. Harlow said.

Regulators don’t expect a giant academic medical center and a small private physician practice to take an identical HIPAA compliance approach, he stressed. The ideal approach will vary by entity. Providers just need to address the standards in a way that makes sense for their operation, he said.

Training is also a critical component, adds Mr. Sims.

“Having training is key,” he said. “Oftentimes, an employee might think, ‘Well, if I can click on this data and it comes up, obviously, I can look at it.’ They need to understand what information they are and are not allowed to access.”

Keep in mind that settings or controls might change when larger transitions take place, such as moving to a new electronic health record system, Mr. Sims said. It’s essential to reevaluate controls when changes in the practice take place to ensure that everything is functioning correctly.

Mr. Sims also suggests that practices create a type of “If you see something, say something,” policy that encourages fellow physicians and employees to report anything that looks suspicious within electronic logs. If an employee, for instance, is suddenly looking at many more records than usual or at odd times of the day or night, this should raise red flags.

“It’s great to stop it early so that it doesn’t become a bigger issue for the practice to deal with, but also, from a legal standpoint, you want to have a defensible argument that you were doing all you could to stop this as quickly as possible,” he said. “It puts you in a better position to defend yourself.”

The snooping security guards case holds an important lesson for all health providers, Mr. Harlow said.

“This is a message to all of us, that you need to have done the assessment up front,” he said. You need to have the right controls in place up front. This is not a situation where somebody managed to hack into a system for some devious means. This is someone who was given keys. Why were they given the keys?”

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

Women in the United States are dying of alcohol-related causes at a much faster rate than are U.S. men, according to a new study that tracked these deaths for 20 years. The most dramatic rise occurred in the last 3 years covered by the study, published in JAMA Network Open.

“From 2018 to 2020, there was an increase of 14.7% per year” in alcohol-related deaths in women, said study researcher Ibraheem M. Karaye, MD, DrPH, assistant professor of population health, and director of the health science program at Hofstra University in Hempstead, N.Y. While alcohol-related deaths in men also rose greatly during that same 3-year period, the increase was less than in women, at 12.5% per year.

Researchers have known for several years that the sex gap related to alcohol use and complications is narrowing. Women are drinking more, engaging in more high-risk drinking, and increasingly developing alcohol use disorder, Dr. Karaye said. “However, we know very little about the trends in alcohol-related deaths.”

Using a Centers for Disease Control and Prevention database that spanned the years 1999 to 2020, Dr. Karaye and his coresearchers analyzed files that identified underlying causes of death. During those years, more than 605,000 alcohol-attributed deaths were identified. Overall, men were still nearly three times more likely to die from alcohol-related issues than were women. However, the rate of alcohol-related deaths in women increased steadily and, in the latest years studied, more greatly than in men. 

“We found there were three different segments of trends in women,” Dr. Karaye said. The rates increased slowly, then steadily picked up speed. For instance:

• 1999-2007: “We found that mortality rates from alcohol were increasing by 1% per year” in women, he said.
• 2007-2018: “The rate increased 4.3% per year. That was a big one, but not as phenomenal as the most recent, the most concerning,” he said. 
• 2018 to 2020: The rate increased 14.7% per year in women, compared with 12.5% per year for men.

The findings stayed strong, Dr. Karaye said, even when the researchers excluded data from the year 2020, the first pandemic year. 
 

Explaining the increase

“Our study is descriptive; it tells us the ‘what’ but not the ‘why,’” Dr. Karaye said. “However, we can speculate based on what’s known and previous research.” Women are drinking at higher rates than before and tend to develop more alcohol-related complications than men do.

Women have lower concentrations of the enzyme called alcohol dehydrogenase, which helps breaks down and metabolize alcohol. “We know that in women the concentration of fat to water is higher, so that also leads to a possibly higher concentration of alcohol,” Dr. Karaye said.

The study findings point to the need for more research to focus on causes for the rise in women, Dr. Karaye said. Studies on the use of medication for alcohol use disorder need to represent women more equitably, he said.
 

Other findings on women, alcohol

Other recent research has found that the proportion of suicides that involved alcohol has also increased for women of all age groups, but not men. In research published in 2022, researchers analyzed more than 115,000 deaths by suicide from 2003 to 2018 and found the proportion of those deaths involving alcohol at a level above the legal limit increased annually for women in all age groups, but not for men. 

A review by Mayo Clinic researchers found that women are increasingly affected by liver disease linked to alcohol and develop more severe disease at lower levels of drinking than do men. Among other factors, the researchers said that an increase in obesity, which can worsen the liver-damaging effects of alcohol, is a contributor.  
 

Expert perspectives

Overall, recent research is showing that, “not only are women drinking more but potentially are developing more problems later on as a result of the alcohol,” said Mark S. Kaplan, DrPH, professor emeritus of social welfare at the University of California, Los Angeles. He conducted the study finding growing alcohol use involvement in women’s death by suicide.

“I think this new study is strong,” he said. In future research, “we should focus on some of the issues that may have to do with social circumstances.” 

In particular, he said, research should examine the increase in alcohol-involved death found in the new study among American Indian or Alaska Native women. While the overall annual increase was 14.7% for the years 2018-2020, the rate among American Indian or Alaska Native women was 22.8% annually. 

While the new study and others find the gap between the sexes is narrowing for alcohol-related complications, “unfortunately, alcohol use disorder and alcohol-related deaths are increasing in both men and women,” said Camille A. Kezer, MD, a gastroenterology and hepatology fellow at Mayo Clinic, who led the review on sex differences in alcohol-linked liver disease.  

However, she said, “we know that there are risks of alcohol that are unique to women for a variety of reasons, including differences in metabolism and the impact of hormones, as well as the increasing prevalence of obesity and bariatric surgery in women.” 

Bariatric surgery has been linked with an increase in alcohol consumption and disorder in some studies. 

Dr. Kezer’s advice to women: “Limit alcohol intake to one drink per day or less. If you are concerned about your alcohol intake, you should seek help.”  

Health care providers are committed to helping their patients recognize and treat alcohol-related disorders, she said.

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

Women in the United States are dying of alcohol-related causes at a much faster rate than are U.S. men, according to a new study that tracked these deaths for 20 years. The most dramatic rise occurred in the last 3 years covered by the study, published in JAMA Network Open.

“From 2018 to 2020, there was an increase of 14.7% per year” in alcohol-related deaths in women, said study researcher Ibraheem M. Karaye, MD, DrPH, assistant professor of population health, and director of the health science program at Hofstra University in Hempstead, N.Y. While alcohol-related deaths in men also rose greatly during that same 3-year period, the increase was less than in women, at 12.5% per year.

Researchers have known for several years that the sex gap related to alcohol use and complications is narrowing. Women are drinking more, engaging in more high-risk drinking, and increasingly developing alcohol use disorder, Dr. Karaye said. “However, we know very little about the trends in alcohol-related deaths.”

Using a Centers for Disease Control and Prevention database that spanned the years 1999 to 2020, Dr. Karaye and his coresearchers analyzed files that identified underlying causes of death. During those years, more than 605,000 alcohol-attributed deaths were identified. Overall, men were still nearly three times more likely to die from alcohol-related issues than were women. However, the rate of alcohol-related deaths in women increased steadily and, in the latest years studied, more greatly than in men. 

“We found there were three different segments of trends in women,” Dr. Karaye said. The rates increased slowly, then steadily picked up speed. For instance:

• 1999-2007: “We found that mortality rates from alcohol were increasing by 1% per year” in women, he said.
• 2007-2018: “The rate increased 4.3% per year. That was a big one, but not as phenomenal as the most recent, the most concerning,” he said. 
• 2018 to 2020: The rate increased 14.7% per year in women, compared with 12.5% per year for men.

The findings stayed strong, Dr. Karaye said, even when the researchers excluded data from the year 2020, the first pandemic year. 
 

Explaining the increase

“Our study is descriptive; it tells us the ‘what’ but not the ‘why,’” Dr. Karaye said. “However, we can speculate based on what’s known and previous research.” Women are drinking at higher rates than before and tend to develop more alcohol-related complications than men do.

Women have lower concentrations of the enzyme called alcohol dehydrogenase, which helps breaks down and metabolize alcohol. “We know that in women the concentration of fat to water is higher, so that also leads to a possibly higher concentration of alcohol,” Dr. Karaye said.

The study findings point to the need for more research to focus on causes for the rise in women, Dr. Karaye said. Studies on the use of medication for alcohol use disorder need to represent women more equitably, he said.
 

Other findings on women, alcohol

Other recent research has found that the proportion of suicides that involved alcohol has also increased for women of all age groups, but not men. In research published in 2022, researchers analyzed more than 115,000 deaths by suicide from 2003 to 2018 and found the proportion of those deaths involving alcohol at a level above the legal limit increased annually for women in all age groups, but not for men. 

A review by Mayo Clinic researchers found that women are increasingly affected by liver disease linked to alcohol and develop more severe disease at lower levels of drinking than do men. Among other factors, the researchers said that an increase in obesity, which can worsen the liver-damaging effects of alcohol, is a contributor.  
 

Expert perspectives

Overall, recent research is showing that, “not only are women drinking more but potentially are developing more problems later on as a result of the alcohol,” said Mark S. Kaplan, DrPH, professor emeritus of social welfare at the University of California, Los Angeles. He conducted the study finding growing alcohol use involvement in women’s death by suicide.

“I think this new study is strong,” he said. In future research, “we should focus on some of the issues that may have to do with social circumstances.” 

In particular, he said, research should examine the increase in alcohol-involved death found in the new study among American Indian or Alaska Native women. While the overall annual increase was 14.7% for the years 2018-2020, the rate among American Indian or Alaska Native women was 22.8% annually. 

While the new study and others find the gap between the sexes is narrowing for alcohol-related complications, “unfortunately, alcohol use disorder and alcohol-related deaths are increasing in both men and women,” said Camille A. Kezer, MD, a gastroenterology and hepatology fellow at Mayo Clinic, who led the review on sex differences in alcohol-linked liver disease.  

However, she said, “we know that there are risks of alcohol that are unique to women for a variety of reasons, including differences in metabolism and the impact of hormones, as well as the increasing prevalence of obesity and bariatric surgery in women.” 

Bariatric surgery has been linked with an increase in alcohol consumption and disorder in some studies. 

Dr. Kezer’s advice to women: “Limit alcohol intake to one drink per day or less. If you are concerned about your alcohol intake, you should seek help.”  

Health care providers are committed to helping their patients recognize and treat alcohol-related disorders, she said.

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

Women in the United States are dying of alcohol-related causes at a much faster rate than are U.S. men, according to a new study that tracked these deaths for 20 years. The most dramatic rise occurred in the last 3 years covered by the study, published in JAMA Network Open.

“From 2018 to 2020, there was an increase of 14.7% per year” in alcohol-related deaths in women, said study researcher Ibraheem M. Karaye, MD, DrPH, assistant professor of population health, and director of the health science program at Hofstra University in Hempstead, N.Y. While alcohol-related deaths in men also rose greatly during that same 3-year period, the increase was less than in women, at 12.5% per year.

Researchers have known for several years that the sex gap related to alcohol use and complications is narrowing. Women are drinking more, engaging in more high-risk drinking, and increasingly developing alcohol use disorder, Dr. Karaye said. “However, we know very little about the trends in alcohol-related deaths.”

Using a Centers for Disease Control and Prevention database that spanned the years 1999 to 2020, Dr. Karaye and his coresearchers analyzed files that identified underlying causes of death. During those years, more than 605,000 alcohol-attributed deaths were identified. Overall, men were still nearly three times more likely to die from alcohol-related issues than were women. However, the rate of alcohol-related deaths in women increased steadily and, in the latest years studied, more greatly than in men. 

“We found there were three different segments of trends in women,” Dr. Karaye said. The rates increased slowly, then steadily picked up speed. For instance:

• 1999-2007: “We found that mortality rates from alcohol were increasing by 1% per year” in women, he said.
• 2007-2018: “The rate increased 4.3% per year. That was a big one, but not as phenomenal as the most recent, the most concerning,” he said. 
• 2018 to 2020: The rate increased 14.7% per year in women, compared with 12.5% per year for men.

The findings stayed strong, Dr. Karaye said, even when the researchers excluded data from the year 2020, the first pandemic year. 
 

Explaining the increase

“Our study is descriptive; it tells us the ‘what’ but not the ‘why,’” Dr. Karaye said. “However, we can speculate based on what’s known and previous research.” Women are drinking at higher rates than before and tend to develop more alcohol-related complications than men do.

Women have lower concentrations of the enzyme called alcohol dehydrogenase, which helps breaks down and metabolize alcohol. “We know that in women the concentration of fat to water is higher, so that also leads to a possibly higher concentration of alcohol,” Dr. Karaye said.

The study findings point to the need for more research to focus on causes for the rise in women, Dr. Karaye said. Studies on the use of medication for alcohol use disorder need to represent women more equitably, he said.
 

Other findings on women, alcohol

Other recent research has found that the proportion of suicides that involved alcohol has also increased for women of all age groups, but not men. In research published in 2022, researchers analyzed more than 115,000 deaths by suicide from 2003 to 2018 and found the proportion of those deaths involving alcohol at a level above the legal limit increased annually for women in all age groups, but not for men. 

A review by Mayo Clinic researchers found that women are increasingly affected by liver disease linked to alcohol and develop more severe disease at lower levels of drinking than do men. Among other factors, the researchers said that an increase in obesity, which can worsen the liver-damaging effects of alcohol, is a contributor.  
 

Expert perspectives

Overall, recent research is showing that, “not only are women drinking more but potentially are developing more problems later on as a result of the alcohol,” said Mark S. Kaplan, DrPH, professor emeritus of social welfare at the University of California, Los Angeles. He conducted the study finding growing alcohol use involvement in women’s death by suicide.

“I think this new study is strong,” he said. In future research, “we should focus on some of the issues that may have to do with social circumstances.” 

In particular, he said, research should examine the increase in alcohol-involved death found in the new study among American Indian or Alaska Native women. While the overall annual increase was 14.7% for the years 2018-2020, the rate among American Indian or Alaska Native women was 22.8% annually. 

While the new study and others find the gap between the sexes is narrowing for alcohol-related complications, “unfortunately, alcohol use disorder and alcohol-related deaths are increasing in both men and women,” said Camille A. Kezer, MD, a gastroenterology and hepatology fellow at Mayo Clinic, who led the review on sex differences in alcohol-linked liver disease.  

However, she said, “we know that there are risks of alcohol that are unique to women for a variety of reasons, including differences in metabolism and the impact of hormones, as well as the increasing prevalence of obesity and bariatric surgery in women.” 

Bariatric surgery has been linked with an increase in alcohol consumption and disorder in some studies. 

Dr. Kezer’s advice to women: “Limit alcohol intake to one drink per day or less. If you are concerned about your alcohol intake, you should seek help.”  

Health care providers are committed to helping their patients recognize and treat alcohol-related disorders, she said.

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

Daily low-dose aspirin increased the risk of intracranial bleeding, including hemorrhagic stroke, by 38% among healthy older people with no history of cardiovascular events, and did not help prevent ischemic stroke, according to results from a large randomized trial.

The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.

Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
 

ASPEE findings

In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.

The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).

Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).

“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.

The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
 

Patients need to know their risk

In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.

“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”

Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”

A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”

The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.

Daily low-dose aspirin increased the risk of intracranial bleeding, including hemorrhagic stroke, by 38% among healthy older people with no history of cardiovascular events, and did not help prevent ischemic stroke, according to results from a large randomized trial.

The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.

Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
 

ASPEE findings

In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.

The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).

Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).

“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.

The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
 

Patients need to know their risk

In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.

“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”

Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”

A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”

The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.

Daily low-dose aspirin increased the risk of intracranial bleeding, including hemorrhagic stroke, by 38% among healthy older people with no history of cardiovascular events, and did not help prevent ischemic stroke, according to results from a large randomized trial.

The findings, published in JAMA Network Open, bolster recommendations published in 2022 by the U.S. Preventive Services Task Force against daily aspirin for primary prevention of stroke in older adults and add to a mounting consensus that it should be avoided in the healthy elderly, for whom bleeding risks outweigh potential benefits.

Stroke was a preplanned secondary outcome of the Aspirin in Reducing Events in the Elderly (ASPREE) trial, which randomized 19,114 community-living people in Australia and the United States (56% women, 91% White) to 100 mg. daily aspirin or placebo. Participants were aged 70 and older, with the exception of U.S. Black and Hispanic individuals, who could be as young as 65. Participants did not have disability or known cardiovascular disease at baseline, and blood pressure was adequately controlled.
 

ASPEE findings

In 2018 the ASPREE authors, led by John McNeil, PhD, of Monash University, Melbourne, published their findings that aspirin did not reduce mortality or cardiovascular events (including stroke) in the same large cohort.

The new analysis, led by Geoffrey Cloud, MB, BS, of Monash University, focuses on stroke and intracranial bleeding outcomes. At 5 years’ follow up, the ASPREE investigators saw no significant reduction in ischemic stroke incidence associated with aspirin (hazard ratio, 0.89; 95% confidence interval, 0.71-1.11), while incidence of all types of intracranial bleeding, including hemorrhagic stroke, was significantly increased (HR, 1.38; 95% CI, 1.03-1.84).

Altogether 108 of participants taking aspirin (1.1%) experienced some form of intracranial bleeding (subdural, extradural, and/or subarachnoid), compared with 79 (0.8%) in the placebo group. Aspirin-treated patients also saw more hemorrhagic stroke (0.5% vs. 0.4%). As the ASPREE investigators had reported in an earlier paper, upper gastrointestinal bleeding occurred in significantly more aspirin-treated patients than those on placebo (HR, 1.87; 95% CI, 1.32-2.66).

“These outcomes may alter the balance of risks and benefits of an antiplatelet drug, especially if given to individuals at low risk in a primary prevention setting. This concern is relevant given the high stroke risk in older individuals, worldwide increases in populations of older individuals, and the importance of evaluating preventive strategies in this age group,” the investigators wrote.

The investigators cited the study’s large size as a strength while noting among its weaknesses that fewer stroke and bleeding events occurred during follow-up than expected, and that not all ischemic stroke events among older participants were thoroughly investigated.
 

Patients need to know their risk

In an interview, Shlee Song, MD, director of the stroke center at Cedars-Sinai, Los Angeles, said that the new ASPREE findings underscore the importance of careful communication with patients and their families, who may be confused about which risk group they belong to and either cease taking aspirin when it is in fact indicated, or take it when it could harm them.

“We need to be clear for our patients whether these results are relevant to them or not,” Dr. Song said. “People with a history of ischemic stroke need to know aspirin therapy is helpful in reducing risk of another stroke.”

Some patients may come to believe that because their stroke occurred a long time ago, they are in a lower-risk group. “But people need to understand that with a history of a heart attack or stroke, you’re always a separate group,” Dr. Song said. “Our job is also surveillance screening – have you had a fall this past year? Have you had a change in bowel movements? The bleeding events seen in ASPREE include bleeding in the head and bleeding in the gut.”

A key issue to stress with patients, Dr. Song said, is blood pressure management. “Patients might take aspirin because a family member had a stroke, without controlling blood pressure first. That could be the perfect storm for a head bleed: uncontrolled hypertension and an antiplatelet agent.”

The ASPREE study was funded by the National Institutes of Health in the United States and Monash University and the Victorian Cancer Agency in Australia. Three coauthors reported receiving funding or fees from drug manufacturers. Dr. Song disclosed no financial conflicts related to her comments.

People who do 4-5 minutes of vigorous physical activity daily can reduce their cancer risk by up to 32%, a new study published in  JAMA Oncology says.

Researchers at the University of Sydney studied data from wearable fitness devices worn by more than 22,000 “non-exercisers,” then examined their health records for 6 or 7 years. 

The scientists found that people who did 4-5 minutes of “vigorous intermittent lifestyle physical activity” (VILPA) had a “substantially” lower cancer risk than people who did no VILPA. 

Examples of VILPA are vigorous housework, carrying heavy shopping bags around the grocery store, bursts of power walking, and playing high-energy games with children. The activities could occur in 1-minute bursts, instead of all at once.

Getty Images/Kentaroo Tryman

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

People who do 4-5 minutes of vigorous physical activity daily can reduce their cancer risk by up to 32%, a new study published in  JAMA Oncology says.

Researchers at the University of Sydney studied data from wearable fitness devices worn by more than 22,000 “non-exercisers,” then examined their health records for 6 or 7 years. 

The scientists found that people who did 4-5 minutes of “vigorous intermittent lifestyle physical activity” (VILPA) had a “substantially” lower cancer risk than people who did no VILPA. 

Examples of VILPA are vigorous housework, carrying heavy shopping bags around the grocery store, bursts of power walking, and playing high-energy games with children. The activities could occur in 1-minute bursts, instead of all at once.

Getty Images/Kentaroo Tryman

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

People who do 4-5 minutes of vigorous physical activity daily can reduce their cancer risk by up to 32%, a new study published in  JAMA Oncology says.

Researchers at the University of Sydney studied data from wearable fitness devices worn by more than 22,000 “non-exercisers,” then examined their health records for 6 or 7 years. 

The scientists found that people who did 4-5 minutes of “vigorous intermittent lifestyle physical activity” (VILPA) had a “substantially” lower cancer risk than people who did no VILPA. 

Examples of VILPA are vigorous housework, carrying heavy shopping bags around the grocery store, bursts of power walking, and playing high-energy games with children. The activities could occur in 1-minute bursts, instead of all at once.

Getty Images/Kentaroo Tryman

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

Although there are several treatment options for PsA, there have been few head-to-head studies conducted to determine comparative efficacy. Ustekinumab, a biologic agent targeting IL-p40, and therefore both IL-12 and IL-23, has proven efficacy in PsA, but the impression is that this drug is less effective than are TNF inhibitors for the treatment of the peripheral arthritis domain. However, in a prospective, observational study, Gossec and colleagues report that the improvements in patient-reported outcomes were generally comparable between ustekinumab and TNF inhibitor treatments. This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n = 219) or TNF inhibitors (n = 218) and continued the initial treatment for 3 years. At 3 years, ustekinumab and TNF inhibitors were associated with comparable improvements in the EuroQol-5 dimensions health state visual analog scale scores, Psoriatic Arthritis Impact of Disease 12-item scores, and work productivity, although the improvements were generally greater in the TNF inhibitor–treated group. A randomized trial comparing ustekinumab to TNF inhibitors in PsA is warranted to confirm these findings and inform treatment decisions.

Targeted therapies, such as biologics, are proven to be more efficacious than are conventional therapies; however, only about 60% of patients initiating targeted therapies demonstrate treatment response. Identifying the predictors of treatment response is an active area of research. Linde and colleagues looked at data from 13,369 biologic-naive patients registered with a PsA diagnosis from 13 European registries who initiated a first TNF inhibitor treatment. The study demonstrated that sex, disease duration, C-reactive protein level, age at treatment initiation, and fatigue predicted the achievement of the Disease Activity in Psoriatic Arthritis in 28 joints remission at 6 months.

Could biomarkers help predict response beyond clinical predictors? An interesting study indicates that beta–defensin 2 (BD-2) may serve as a predictive biomarker for clinical response to secukinumab in PsA. BD-2 is an antimicrobial peptide and an important protein in innate immune response. Cardner and colleagues analyzed protein expression data in serum samples from the phase 3 FUTURE 1-5 trials that included 1989 patients with PsA who received secukinumab or placebo. Baseline BD-2 levels were associated with early as well as sustained PsA treatment response to secukinumab, independent of psoriasis severity. BD-2 levels did not predict response to adalimumab in PsA nor was it associated with treatment response to secukinumab in RA. The addition of BD-2 to the clinical prediction model significantly improved the prediction of the 16-week American College of Rheumatology 20 response. Thus, BD-2 seems to be a secukinumab treatment response biomarker and requires further evaluation.

Although there are several treatment options for PsA, there have been few head-to-head studies conducted to determine comparative efficacy. Ustekinumab, a biologic agent targeting IL-p40, and therefore both IL-12 and IL-23, has proven efficacy in PsA, but the impression is that this drug is less effective than are TNF inhibitors for the treatment of the peripheral arthritis domain. However, in a prospective, observational study, Gossec and colleagues report that the improvements in patient-reported outcomes were generally comparable between ustekinumab and TNF inhibitor treatments. This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n = 219) or TNF inhibitors (n = 218) and continued the initial treatment for 3 years. At 3 years, ustekinumab and TNF inhibitors were associated with comparable improvements in the EuroQol-5 dimensions health state visual analog scale scores, Psoriatic Arthritis Impact of Disease 12-item scores, and work productivity, although the improvements were generally greater in the TNF inhibitor–treated group. A randomized trial comparing ustekinumab to TNF inhibitors in PsA is warranted to confirm these findings and inform treatment decisions.

Targeted therapies, such as biologics, are proven to be more efficacious than are conventional therapies; however, only about 60% of patients initiating targeted therapies demonstrate treatment response. Identifying the predictors of treatment response is an active area of research. Linde and colleagues looked at data from 13,369 biologic-naive patients registered with a PsA diagnosis from 13 European registries who initiated a first TNF inhibitor treatment. The study demonstrated that sex, disease duration, C-reactive protein level, age at treatment initiation, and fatigue predicted the achievement of the Disease Activity in Psoriatic Arthritis in 28 joints remission at 6 months.

Could biomarkers help predict response beyond clinical predictors? An interesting study indicates that beta–defensin 2 (BD-2) may serve as a predictive biomarker for clinical response to secukinumab in PsA. BD-2 is an antimicrobial peptide and an important protein in innate immune response. Cardner and colleagues analyzed protein expression data in serum samples from the phase 3 FUTURE 1-5 trials that included 1989 patients with PsA who received secukinumab or placebo. Baseline BD-2 levels were associated with early as well as sustained PsA treatment response to secukinumab, independent of psoriasis severity. BD-2 levels did not predict response to adalimumab in PsA nor was it associated with treatment response to secukinumab in RA. The addition of BD-2 to the clinical prediction model significantly improved the prediction of the 16-week American College of Rheumatology 20 response. Thus, BD-2 seems to be a secukinumab treatment response biomarker and requires further evaluation.

Although there are several treatment options for PsA, there have been few head-to-head studies conducted to determine comparative efficacy. Ustekinumab, a biologic agent targeting IL-p40, and therefore both IL-12 and IL-23, has proven efficacy in PsA, but the impression is that this drug is less effective than are TNF inhibitors for the treatment of the peripheral arthritis domain. However, in a prospective, observational study, Gossec and colleagues report that the improvements in patient-reported outcomes were generally comparable between ustekinumab and TNF inhibitor treatments. This study evaluated 437 patients with PsA from the PsABio study who initiated first- to third-line ustekinumab (n = 219) or TNF inhibitors (n = 218) and continued the initial treatment for 3 years. At 3 years, ustekinumab and TNF inhibitors were associated with comparable improvements in the EuroQol-5 dimensions health state visual analog scale scores, Psoriatic Arthritis Impact of Disease 12-item scores, and work productivity, although the improvements were generally greater in the TNF inhibitor–treated group. A randomized trial comparing ustekinumab to TNF inhibitors in PsA is warranted to confirm these findings and inform treatment decisions.

Targeted therapies, such as biologics, are proven to be more efficacious than are conventional therapies; however, only about 60% of patients initiating targeted therapies demonstrate treatment response. Identifying the predictors of treatment response is an active area of research. Linde and colleagues looked at data from 13,369 biologic-naive patients registered with a PsA diagnosis from 13 European registries who initiated a first TNF inhibitor treatment. The study demonstrated that sex, disease duration, C-reactive protein level, age at treatment initiation, and fatigue predicted the achievement of the Disease Activity in Psoriatic Arthritis in 28 joints remission at 6 months.

Could biomarkers help predict response beyond clinical predictors? An interesting study indicates that beta–defensin 2 (BD-2) may serve as a predictive biomarker for clinical response to secukinumab in PsA. BD-2 is an antimicrobial peptide and an important protein in innate immune response. Cardner and colleagues analyzed protein expression data in serum samples from the phase 3 FUTURE 1-5 trials that included 1989 patients with PsA who received secukinumab or placebo. Baseline BD-2 levels were associated with early as well as sustained PsA treatment response to secukinumab, independent of psoriasis severity. BD-2 levels did not predict response to adalimumab in PsA nor was it associated with treatment response to secukinumab in RA. The addition of BD-2 to the clinical prediction model significantly improved the prediction of the 16-week American College of Rheumatology 20 response. Thus, BD-2 seems to be a secukinumab treatment response biomarker and requires further evaluation.

The excellent short-term efficacy of the drug was well maintained up to 48 weeks, with only a slight loss of efficacy over time. Abrocitinib is a small molecule. We wouldn't expect a loss of efficacy due to the anti-drug antibodies that we see for large-molecule biologic drugs. I suspect that the slight loss of efficacy over time is a form of tachyphylaxis that is, to my thinking, probably due to poor adherence. Shocking, I know! Patients may not be fully adherent to treatment, even in a clinical trial. I think we should encourage patients to use 7-day pill boxes to aid better long-term adherence and outcomes.

Long-term safety is a critical issue with any new drug, certainly with a Janus kinase (JAK) inhibitor. Reich and colleagues concluded, "The long-term safety profile was manageable and consistent with previous reports." That conclusion seems reasonable to me. The most common side effects were upper respiratory tract infections. There may be a slight signal for increased risk for oral herpes infection, particularly at the higher dose. If this safety profile endures with longer-term data in larger numbers of people, it will be very reassuring.

The study by Wan and colleagues is another extremely well-done, important study by the premier dermatoepidemiology research team at the University of Pennsylvania. The study used an outstanding database from the United Kingdom that encompassed the clinical care experience of hundreds of thousands of children and adults with atopic dermatitis and millions of control patients without atopic dermatitis. With this many patients, the study has tremendous power to detect risk differences between groups.

With all that power, this study’s findings are very reassuring that there is no meaningful overall increased risk for malignancy in children or adults with atopic dermatitis. And while there was a statistically significant increased risk for lymphoma in children with severe atopic dermatitis, that risk is small … very small. Similarly, adults with severe AD had a twofold higher risk for noncutaneous T-cell lymphoma (CTCL), but since non-CTCL is rare, patients with severe AD shouldn't lose any sleep over it..

Simpson and colleagues' study of the effect of dupilumab on Staphylococcus aureus surprised me. Of course, we could expect that S aureus counts would be reduced with dupilumab; as barrier function is restored, surely S aureus counts would go down too. But, fascinatingly, with dupilumab treatment, S aureus counts decreased almost immediately, at both 3 and 7 days, before there was apparent clinical improvement in the skin rash. Simpson and colleagues suggest that the drop in S aureus counts could be due to improvement in immune function when interleukins 4 and 13 are blocked. Whether or not that is true, it is striking how fast S aureus counts improved, long before normal skin barrier function is restored.

Here's a fun fact: Atopic dermatitis is a little less common, about 10% less common, in people born second or later in the birth order. Lisik and colleagues did a meta-analysis of 114 studies and found this marginally lower rate in those born second or later compared with those born first. I'm not sure that there is any clinically meaningful significance to this, but I found it interesting (even though I was born first, and my younger brother had atopic dermatitis).

The excellent short-term efficacy of the drug was well maintained up to 48 weeks, with only a slight loss of efficacy over time. Abrocitinib is a small molecule. We wouldn't expect a loss of efficacy due to the anti-drug antibodies that we see for large-molecule biologic drugs. I suspect that the slight loss of efficacy over time is a form of tachyphylaxis that is, to my thinking, probably due to poor adherence. Shocking, I know! Patients may not be fully adherent to treatment, even in a clinical trial. I think we should encourage patients to use 7-day pill boxes to aid better long-term adherence and outcomes.

Long-term safety is a critical issue with any new drug, certainly with a Janus kinase (JAK) inhibitor. Reich and colleagues concluded, "The long-term safety profile was manageable and consistent with previous reports." That conclusion seems reasonable to me. The most common side effects were upper respiratory tract infections. There may be a slight signal for increased risk for oral herpes infection, particularly at the higher dose. If this safety profile endures with longer-term data in larger numbers of people, it will be very reassuring.

The study by Wan and colleagues is another extremely well-done, important study by the premier dermatoepidemiology research team at the University of Pennsylvania. The study used an outstanding database from the United Kingdom that encompassed the clinical care experience of hundreds of thousands of children and adults with atopic dermatitis and millions of control patients without atopic dermatitis. With this many patients, the study has tremendous power to detect risk differences between groups.

With all that power, this study’s findings are very reassuring that there is no meaningful overall increased risk for malignancy in children or adults with atopic dermatitis. And while there was a statistically significant increased risk for lymphoma in children with severe atopic dermatitis, that risk is small … very small. Similarly, adults with severe AD had a twofold higher risk for noncutaneous T-cell lymphoma (CTCL), but since non-CTCL is rare, patients with severe AD shouldn't lose any sleep over it..

Simpson and colleagues' study of the effect of dupilumab on Staphylococcus aureus surprised me. Of course, we could expect that S aureus counts would be reduced with dupilumab; as barrier function is restored, surely S aureus counts would go down too. But, fascinatingly, with dupilumab treatment, S aureus counts decreased almost immediately, at both 3 and 7 days, before there was apparent clinical improvement in the skin rash. Simpson and colleagues suggest that the drop in S aureus counts could be due to improvement in immune function when interleukins 4 and 13 are blocked. Whether or not that is true, it is striking how fast S aureus counts improved, long before normal skin barrier function is restored.

Here's a fun fact: Atopic dermatitis is a little less common, about 10% less common, in people born second or later in the birth order. Lisik and colleagues did a meta-analysis of 114 studies and found this marginally lower rate in those born second or later compared with those born first. I'm not sure that there is any clinically meaningful significance to this, but I found it interesting (even though I was born first, and my younger brother had atopic dermatitis).

The excellent short-term efficacy of the drug was well maintained up to 48 weeks, with only a slight loss of efficacy over time. Abrocitinib is a small molecule. We wouldn't expect a loss of efficacy due to the anti-drug antibodies that we see for large-molecule biologic drugs. I suspect that the slight loss of efficacy over time is a form of tachyphylaxis that is, to my thinking, probably due to poor adherence. Shocking, I know! Patients may not be fully adherent to treatment, even in a clinical trial. I think we should encourage patients to use 7-day pill boxes to aid better long-term adherence and outcomes.

Long-term safety is a critical issue with any new drug, certainly with a Janus kinase (JAK) inhibitor. Reich and colleagues concluded, "The long-term safety profile was manageable and consistent with previous reports." That conclusion seems reasonable to me. The most common side effects were upper respiratory tract infections. There may be a slight signal for increased risk for oral herpes infection, particularly at the higher dose. If this safety profile endures with longer-term data in larger numbers of people, it will be very reassuring.

The study by Wan and colleagues is another extremely well-done, important study by the premier dermatoepidemiology research team at the University of Pennsylvania. The study used an outstanding database from the United Kingdom that encompassed the clinical care experience of hundreds of thousands of children and adults with atopic dermatitis and millions of control patients without atopic dermatitis. With this many patients, the study has tremendous power to detect risk differences between groups.

With all that power, this study’s findings are very reassuring that there is no meaningful overall increased risk for malignancy in children or adults with atopic dermatitis. And while there was a statistically significant increased risk for lymphoma in children with severe atopic dermatitis, that risk is small … very small. Similarly, adults with severe AD had a twofold higher risk for noncutaneous T-cell lymphoma (CTCL), but since non-CTCL is rare, patients with severe AD shouldn't lose any sleep over it..

Simpson and colleagues' study of the effect of dupilumab on Staphylococcus aureus surprised me. Of course, we could expect that S aureus counts would be reduced with dupilumab; as barrier function is restored, surely S aureus counts would go down too. But, fascinatingly, with dupilumab treatment, S aureus counts decreased almost immediately, at both 3 and 7 days, before there was apparent clinical improvement in the skin rash. Simpson and colleagues suggest that the drop in S aureus counts could be due to improvement in immune function when interleukins 4 and 13 are blocked. Whether or not that is true, it is striking how fast S aureus counts improved, long before normal skin barrier function is restored.

Here's a fun fact: Atopic dermatitis is a little less common, about 10% less common, in people born second or later in the birth order. Lisik and colleagues did a meta-analysis of 114 studies and found this marginally lower rate in those born second or later compared with those born first. I'm not sure that there is any clinically meaningful significance to this, but I found it interesting (even though I was born first, and my younger brother had atopic dermatitis).

GE HealthCare is recalling 7,559 TruSignal arterial oxygen saturation (SpO₂) sensors because of problems that may reduce defibrillation energy, expose patients to unintended voltage, or give inaccurate readings.

The Food and Drug Administration has identified this as a class I recall, the most serious type. The company has not received any reports of patient injury or deaths as a result of these issues.*

The recall includes the TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor With Datex Connector, TruSignal Integrated Ear Sensor With Datex Connector, and TruSignal Integrated Ear Sensor With Ohmeda Connector.

The sensors were distributed in the United States from Jan. 1, 2021, to March 4, 2023.

According to the recall notice, the malfunctioning sensors “may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation.

“This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO₂, which can impact treatment decisions,” the notice warns.

In an urgent device correction letter sent to health care professionals in May, GE HealthCare recommends that health care professionals do the following:

• Use an alternate method for SpO₂ monitoring, including TruSignal sensors not impacted or an alternate SpO₂ device.
• If alternate methods are not available, use affected TruSignal SpO₂ sensors as long as they have not been saturated with fluids.
• If defibrillation is necessary when affected TruSignal SpO₂ sensors are being used, remove the affected TruSignal SpO₂ sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO₂ sensor after defibrillation is no longer needed.
• For Adult/Pediatric SpO₂ sensors, confirm that material does not cover the emitter or detector before using.
• Discard the sensor and use another sensor if any additional material is present.
• Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.

Customers are also asked to complete and return the acknowledgment form attached to the notice to [email protected].

For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.

Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

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

*Correction, 8/3/23: An earlier version of this article mischaracterized the reports received by the company.

GE HealthCare is recalling 7,559 TruSignal arterial oxygen saturation (SpO₂) sensors because of problems that may reduce defibrillation energy, expose patients to unintended voltage, or give inaccurate readings.

The Food and Drug Administration has identified this as a class I recall, the most serious type. The company has not received any reports of patient injury or deaths as a result of these issues.*

The recall includes the TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor With Datex Connector, TruSignal Integrated Ear Sensor With Datex Connector, and TruSignal Integrated Ear Sensor With Ohmeda Connector.

The sensors were distributed in the United States from Jan. 1, 2021, to March 4, 2023.

According to the recall notice, the malfunctioning sensors “may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation.

“This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO₂, which can impact treatment decisions,” the notice warns.

In an urgent device correction letter sent to health care professionals in May, GE HealthCare recommends that health care professionals do the following:

• Use an alternate method for SpO₂ monitoring, including TruSignal sensors not impacted or an alternate SpO₂ device.
• If alternate methods are not available, use affected TruSignal SpO₂ sensors as long as they have not been saturated with fluids.
• If defibrillation is necessary when affected TruSignal SpO₂ sensors are being used, remove the affected TruSignal SpO₂ sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO₂ sensor after defibrillation is no longer needed.
• For Adult/Pediatric SpO₂ sensors, confirm that material does not cover the emitter or detector before using.
• Discard the sensor and use another sensor if any additional material is present.
• Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.

Customers are also asked to complete and return the acknowledgment form attached to the notice to [email protected].

For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.

Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

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

*Correction, 8/3/23: An earlier version of this article mischaracterized the reports received by the company.

GE HealthCare is recalling 7,559 TruSignal arterial oxygen saturation (SpO₂) sensors because of problems that may reduce defibrillation energy, expose patients to unintended voltage, or give inaccurate readings.

The Food and Drug Administration has identified this as a class I recall, the most serious type. The company has not received any reports of patient injury or deaths as a result of these issues.*

The recall includes the TruSignal Adult Pediatric Sensor, TruSignal AllFit Sensor, TruSignal Sensitive Skin Sensor, TruSignal Wrap Sensor, TruSignal Ear Sensor, TruSignal Integrated Ear Sensor with GE Connector, TruSignal Integrated Ear Sensor With Datex Connector, TruSignal Integrated Ear Sensor With Datex Connector, and TruSignal Integrated Ear Sensor With Ohmeda Connector.

The sensors were distributed in the United States from Jan. 1, 2021, to March 4, 2023.

According to the recall notice, the malfunctioning sensors “may reduce the amount of energy sent to the heart during defibrillation without any notification to the care provider, which could prevent delivery of lifesaving therapy in a critical situation.

“This issue is most hazardous to hospitalized patients who may need defibrillation for cardiac arrest. Affected sensors may also unintentionally expose patients to electrical currents from other sources or may provide inaccurate measurements of SpO₂, which can impact treatment decisions,” the notice warns.

In an urgent device correction letter sent to health care professionals in May, GE HealthCare recommends that health care professionals do the following:

• Use an alternate method for SpO₂ monitoring, including TruSignal sensors not impacted or an alternate SpO₂ device.
• If alternate methods are not available, use affected TruSignal SpO₂ sensors as long as they have not been saturated with fluids.
• If defibrillation is necessary when affected TruSignal SpO₂ sensors are being used, remove the affected TruSignal SpO₂ sensor, defibrillate per hospital protocol, and reattach the affected TruSignal SpO₂ sensor after defibrillation is no longer needed.
• For Adult/Pediatric SpO₂ sensors, confirm that material does not cover the emitter or detector before using.
• Discard the sensor and use another sensor if any additional material is present.
• Make sure all potential users are made aware of this safety notification and the recommended actions, and retain this notice.

Customers are also asked to complete and return the acknowledgment form attached to the notice to [email protected].

For questions or concerns about this recall, contact GE HealthCare Service at 1-800-437-1171 or a local service representative.

Health care professionals can report adverse reactions or quality problems they experience using these devices to the FDA’s MedWatch program.

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

*Correction, 8/3/23: An earlier version of this article mischaracterized the reports received by the company.

Progression-free survival (PFS) is now the dominant endpoint in cancer clinical trials, but simply prolonging time to progression without extending overall survival or quality of life does not justify additional therapy for many patients, new research indicates.
 

“The results of our study demonstrate that more than half of patients with advanced cancer would not want a treatment that delays time to progression on imaging without any improvement in survival or quality of life,” Christopher Booth, MD, an oncologist and professor at Queen’s University, Kingston, Ont., said in an interview.

Even with an overall survival benefit of 6 months, one in five patients said they would decline additional treatment, which indicates the limited value of extra months of life with better quality of life.

“This has very important implications for our field – how we design trials, how we write guidelines, and how we make treatment recommendations to our patients,” said Booth.

The findings highlight the importance of “making sure that we incorporate patient perspectives into what we do and the research around it,” agreed Richard Lee, MD, with City of Hope Comprehensive Cancer Center, Duarte, Calif., who wasn’t involved in the study.

“It’s easy for us to pick outcome measures that are important to us as researchers but really have very little value to the patient,” said Dr. Lee, associate editor (palliative care) for Cancer.Net, the American Society of Clinical Oncology patient information website.

The study was published online in the Journal of the National Cancer Institute.

Although PFS is often used as a primary endpoint in cancer drug trials, evidence indicates that PFS is typically a poor surrogate both for overall survival and quality of life. It’s also unclear how much patients value additional time with no progression, especially if it means extra toxicity with no overall survival or quality of life gains.

In the current study, Dr. Booth and colleagues wanted to better understand patients’ attitudes toward a treatment that offers PFS but does not improve overall survival.

The study involved 100 patients who had received at least 3 months of systemic therapy for incurable solid tumors. Nearly two-thirds of the patients were older than 60. They were asked about their preferences and goals for additional therapy. A variety of primary cancer sites were represented, most commonly gastrointestinal, breast, lung, genitourinary, and brain.

Among the patients interviewed, 80 were currently receiving palliative systemic treatment. Only one patient described the intent as curative; 45% described it as intending to prolong life, and 5% described it as intending to improve quality of life. The remainder had a combination of goals.

Overall, patients expressed a variety of preferences about additional treatment.

More than half (52%) said they would decline additional treatment that only offered PFS gains, while 26% said they would accept more treatment in the absence of an overall survival benefit if it meant delaying disease progression by 3-9 months.

About one in six patients (17%) said they would prefer additional treatment, even without any gain in PFS. These patients expressed “wanting to fight or hoping that they would defy the survival statistics” – an attitude that is “not irrational,” the researchers noted, but rather reflects the “more must be better” line of thinking.

Compared with the 26% of patients willing to undergo additional treatment for a PFS benefit but no overall survival benefit, 71% of patients said they would undergo more treatment for a 6-month gain in overall survival.
 

Weighing the benefits of more treatment

Overall, the findings suggest that while some patients are willing to undergo more toxic treatment regardless of PFS outcomes, most prefer to explicitly weigh the benefits of PFS, overall survival, and quality of life, Dr. Booth and colleagues said.

The findings also make clear the need to design randomized clinical trials that focus on endpoints and the gains that are of greatest value to patients.

“While there are a handful of circumstances in which PFS is a valid surrogate for overall survival, this is the exception and not the rule,” said Dr. Booth, who, along with colleagues, recently launched a global movement called Common Sense Oncology to help make cancer care and clinical trials more patient centered.

Drug companies like the PFS measure because it gives an answer quickly. “They don’t have to wait for the overall survival surrogate,” but in many cases, PFS is not a good primary endpoint, said Dr. Lee.

The exception, he noted, would be for some slow-growing cancers, such as low-grade prostate cancer, in which overall survival takes 10 years to gauge. “But outside of those few cancers, we need to stick to overall survival as the gold standard, and patients are basically telling us the same,” Dr. Lee explained.

What about a treatment that might not extend overall survival but could improve quality of life?

“It is easy to measure a year in life, but what about the life within a year,” Rachel Koven, MSc, author and patient advocate, Queen’s University Cancer Research Institute, said in an interview. “Beyond the potential for an extended number of days, what constitutes a ‘good’ day or a day well lived, and are the treatment decisions impacting that? While this may be different for each person, regardless of the definition used, it will still be of the utmost importance for all.”

Overall, Dr. Lee stressed, it’s important for oncologists to inform patients about what trial results show.

“We have to talk to patients and tell them a drug has shown progression-free improvement but not an overall survival benefit. That absolutely needs to be included in the discussion so that patients can give full, informed consent to what the treatment options are,” he said.

Ms. Koven agreed. “We must continuously strive to improve doctor-patient communication to ensure that patients facing incurable cancer can make evidence-based choices that match their unique goals, preferences, and needs,” she said.

“It is essential that care plans be created with outcomes that matter,” Ms. Koven said. “Treatments with small benefits lead to lost time for patients spent at the cancer center rather than with family and friends.”

The study was supported by the Canadian Institutes of Health Research. Dr. Booth, Ms. Koven, and Dr. Lee reported no relevant disclosures.

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

Progression-free survival (PFS) is now the dominant endpoint in cancer clinical trials, but simply prolonging time to progression without extending overall survival or quality of life does not justify additional therapy for many patients, new research indicates.
 

“The results of our study demonstrate that more than half of patients with advanced cancer would not want a treatment that delays time to progression on imaging without any improvement in survival or quality of life,” Christopher Booth, MD, an oncologist and professor at Queen’s University, Kingston, Ont., said in an interview.

Even with an overall survival benefit of 6 months, one in five patients said they would decline additional treatment, which indicates the limited value of extra months of life with better quality of life.

“This has very important implications for our field – how we design trials, how we write guidelines, and how we make treatment recommendations to our patients,” said Booth.

The findings highlight the importance of “making sure that we incorporate patient perspectives into what we do and the research around it,” agreed Richard Lee, MD, with City of Hope Comprehensive Cancer Center, Duarte, Calif., who wasn’t involved in the study.

“It’s easy for us to pick outcome measures that are important to us as researchers but really have very little value to the patient,” said Dr. Lee, associate editor (palliative care) for Cancer.Net, the American Society of Clinical Oncology patient information website.

The study was published online in the Journal of the National Cancer Institute.

Although PFS is often used as a primary endpoint in cancer drug trials, evidence indicates that PFS is typically a poor surrogate both for overall survival and quality of life. It’s also unclear how much patients value additional time with no progression, especially if it means extra toxicity with no overall survival or quality of life gains.

In the current study, Dr. Booth and colleagues wanted to better understand patients’ attitudes toward a treatment that offers PFS but does not improve overall survival.

The study involved 100 patients who had received at least 3 months of systemic therapy for incurable solid tumors. Nearly two-thirds of the patients were older than 60. They were asked about their preferences and goals for additional therapy. A variety of primary cancer sites were represented, most commonly gastrointestinal, breast, lung, genitourinary, and brain.

Among the patients interviewed, 80 were currently receiving palliative systemic treatment. Only one patient described the intent as curative; 45% described it as intending to prolong life, and 5% described it as intending to improve quality of life. The remainder had a combination of goals.

Overall, patients expressed a variety of preferences about additional treatment.

More than half (52%) said they would decline additional treatment that only offered PFS gains, while 26% said they would accept more treatment in the absence of an overall survival benefit if it meant delaying disease progression by 3-9 months.

About one in six patients (17%) said they would prefer additional treatment, even without any gain in PFS. These patients expressed “wanting to fight or hoping that they would defy the survival statistics” – an attitude that is “not irrational,” the researchers noted, but rather reflects the “more must be better” line of thinking.

Compared with the 26% of patients willing to undergo additional treatment for a PFS benefit but no overall survival benefit, 71% of patients said they would undergo more treatment for a 6-month gain in overall survival.
 

Weighing the benefits of more treatment

Overall, the findings suggest that while some patients are willing to undergo more toxic treatment regardless of PFS outcomes, most prefer to explicitly weigh the benefits of PFS, overall survival, and quality of life, Dr. Booth and colleagues said.

The findings also make clear the need to design randomized clinical trials that focus on endpoints and the gains that are of greatest value to patients.

“While there are a handful of circumstances in which PFS is a valid surrogate for overall survival, this is the exception and not the rule,” said Dr. Booth, who, along with colleagues, recently launched a global movement called Common Sense Oncology to help make cancer care and clinical trials more patient centered.

Drug companies like the PFS measure because it gives an answer quickly. “They don’t have to wait for the overall survival surrogate,” but in many cases, PFS is not a good primary endpoint, said Dr. Lee.

The exception, he noted, would be for some slow-growing cancers, such as low-grade prostate cancer, in which overall survival takes 10 years to gauge. “But outside of those few cancers, we need to stick to overall survival as the gold standard, and patients are basically telling us the same,” Dr. Lee explained.

What about a treatment that might not extend overall survival but could improve quality of life?

“It is easy to measure a year in life, but what about the life within a year,” Rachel Koven, MSc, author and patient advocate, Queen’s University Cancer Research Institute, said in an interview. “Beyond the potential for an extended number of days, what constitutes a ‘good’ day or a day well lived, and are the treatment decisions impacting that? While this may be different for each person, regardless of the definition used, it will still be of the utmost importance for all.”

Overall, Dr. Lee stressed, it’s important for oncologists to inform patients about what trial results show.

“We have to talk to patients and tell them a drug has shown progression-free improvement but not an overall survival benefit. That absolutely needs to be included in the discussion so that patients can give full, informed consent to what the treatment options are,” he said.

Ms. Koven agreed. “We must continuously strive to improve doctor-patient communication to ensure that patients facing incurable cancer can make evidence-based choices that match their unique goals, preferences, and needs,” she said.

“It is essential that care plans be created with outcomes that matter,” Ms. Koven said. “Treatments with small benefits lead to lost time for patients spent at the cancer center rather than with family and friends.”

The study was supported by the Canadian Institutes of Health Research. Dr. Booth, Ms. Koven, and Dr. Lee reported no relevant disclosures.

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

Progression-free survival (PFS) is now the dominant endpoint in cancer clinical trials, but simply prolonging time to progression without extending overall survival or quality of life does not justify additional therapy for many patients, new research indicates.
 

“The results of our study demonstrate that more than half of patients with advanced cancer would not want a treatment that delays time to progression on imaging without any improvement in survival or quality of life,” Christopher Booth, MD, an oncologist and professor at Queen’s University, Kingston, Ont., said in an interview.

Even with an overall survival benefit of 6 months, one in five patients said they would decline additional treatment, which indicates the limited value of extra months of life with better quality of life.

“This has very important implications for our field – how we design trials, how we write guidelines, and how we make treatment recommendations to our patients,” said Booth.

The findings highlight the importance of “making sure that we incorporate patient perspectives into what we do and the research around it,” agreed Richard Lee, MD, with City of Hope Comprehensive Cancer Center, Duarte, Calif., who wasn’t involved in the study.

“It’s easy for us to pick outcome measures that are important to us as researchers but really have very little value to the patient,” said Dr. Lee, associate editor (palliative care) for Cancer.Net, the American Society of Clinical Oncology patient information website.

The study was published online in the Journal of the National Cancer Institute.

Although PFS is often used as a primary endpoint in cancer drug trials, evidence indicates that PFS is typically a poor surrogate both for overall survival and quality of life. It’s also unclear how much patients value additional time with no progression, especially if it means extra toxicity with no overall survival or quality of life gains.

In the current study, Dr. Booth and colleagues wanted to better understand patients’ attitudes toward a treatment that offers PFS but does not improve overall survival.

The study involved 100 patients who had received at least 3 months of systemic therapy for incurable solid tumors. Nearly two-thirds of the patients were older than 60. They were asked about their preferences and goals for additional therapy. A variety of primary cancer sites were represented, most commonly gastrointestinal, breast, lung, genitourinary, and brain.

Among the patients interviewed, 80 were currently receiving palliative systemic treatment. Only one patient described the intent as curative; 45% described it as intending to prolong life, and 5% described it as intending to improve quality of life. The remainder had a combination of goals.

Overall, patients expressed a variety of preferences about additional treatment.

More than half (52%) said they would decline additional treatment that only offered PFS gains, while 26% said they would accept more treatment in the absence of an overall survival benefit if it meant delaying disease progression by 3-9 months.

About one in six patients (17%) said they would prefer additional treatment, even without any gain in PFS. These patients expressed “wanting to fight or hoping that they would defy the survival statistics” – an attitude that is “not irrational,” the researchers noted, but rather reflects the “more must be better” line of thinking.

Compared with the 26% of patients willing to undergo additional treatment for a PFS benefit but no overall survival benefit, 71% of patients said they would undergo more treatment for a 6-month gain in overall survival.
 

Weighing the benefits of more treatment

Overall, the findings suggest that while some patients are willing to undergo more toxic treatment regardless of PFS outcomes, most prefer to explicitly weigh the benefits of PFS, overall survival, and quality of life, Dr. Booth and colleagues said.

The findings also make clear the need to design randomized clinical trials that focus on endpoints and the gains that are of greatest value to patients.

“While there are a handful of circumstances in which PFS is a valid surrogate for overall survival, this is the exception and not the rule,” said Dr. Booth, who, along with colleagues, recently launched a global movement called Common Sense Oncology to help make cancer care and clinical trials more patient centered.

Drug companies like the PFS measure because it gives an answer quickly. “They don’t have to wait for the overall survival surrogate,” but in many cases, PFS is not a good primary endpoint, said Dr. Lee.

The exception, he noted, would be for some slow-growing cancers, such as low-grade prostate cancer, in which overall survival takes 10 years to gauge. “But outside of those few cancers, we need to stick to overall survival as the gold standard, and patients are basically telling us the same,” Dr. Lee explained.

What about a treatment that might not extend overall survival but could improve quality of life?

“It is easy to measure a year in life, but what about the life within a year,” Rachel Koven, MSc, author and patient advocate, Queen’s University Cancer Research Institute, said in an interview. “Beyond the potential for an extended number of days, what constitutes a ‘good’ day or a day well lived, and are the treatment decisions impacting that? While this may be different for each person, regardless of the definition used, it will still be of the utmost importance for all.”

Overall, Dr. Lee stressed, it’s important for oncologists to inform patients about what trial results show.

“We have to talk to patients and tell them a drug has shown progression-free improvement but not an overall survival benefit. That absolutely needs to be included in the discussion so that patients can give full, informed consent to what the treatment options are,” he said.

Ms. Koven agreed. “We must continuously strive to improve doctor-patient communication to ensure that patients facing incurable cancer can make evidence-based choices that match their unique goals, preferences, and needs,” she said.

“It is essential that care plans be created with outcomes that matter,” Ms. Koven said. “Treatments with small benefits lead to lost time for patients spent at the cancer center rather than with family and friends.”

The study was supported by the Canadian Institutes of Health Research. Dr. Booth, Ms. Koven, and Dr. Lee reported no relevant disclosures.

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

The Advisory Committee on Immunization Practices (ACIP) recently issued new recommendations on polio vaccine for adults. The ACIP decided to update its previous recommendations (from 2000) in response to a case in New York that demonstrated the United States is at risk for poliovirus importation as long as the disease has not been eliminated worldwide.¹

What happened in New York? In July 2022, a case of paralytic polio was confirmed in an unvaccinated adult in Rockland County, New York, an area that has low polio vaccine coverage. Subsequent testing of wastewater systems detected poliovirus in a total of 5 New York counties (including 2 in New York City).¹

The Centers for Disease Control and Prevention estimates that this region of the state probably experienced 1000 to 2000 nonparalytic, mostly asymptomatic poliovirus infections. The virus detected in wastewater in New York is genetically linked to polioviruses collected in wastewater in Israel, the United Kingdom, and Canada. No poliovirus has been detected in these wastewater systems since late 2022.^1,2

Why there’s reason for concern. Routine immunization against polio has been part of the immunization schedule for infants and children since the mid-1950s. As a result, endemic polio was eliminated in the United States in 1979 and in the Western Hemisphere in 1994.

However, adult vaccination until now has been recommended only for those at risk for exposure to poliovirus by way of travel or occupation. And while most adults in the United States are immune to polio due to childhood vaccination, unvaccinated adults remain susceptible if exposed to poliovirus—as demonstrated in the New York case.

What does the ACIP now recommend? Two recommendations were adopted by the ACIP this June to address this problem²:

1. Adults who are known or suspected to be unvaccinated or incompletely vaccinated against polio should complete a primary vaccination series with inactivated polio vaccine (IPV).
2. Adults who have received a primary series of oral polio vaccine (OPV) or IPV in any combination and who are at increased risk for poliovirus exposure may receive another dose of IPV. Available data do not indicate a need for > 1 lifetime booster.

A few details: To be considered fully vaccinated, a patient must have received a primary series of ≥ 3 doses of OPV or IPV (in any combination) given at least 4 weeks apart, with the last dose given on or after the 4th birthday and at least 6 months from the previous dose. Most adults who were born and raised in the United States can assume they were vaccinated against polio as children, unless there are specific reasons to suspect otherwise.²

Individuals considered to be at increased risk include: travelers who are going to countries where polio is epidemic or endemic; laboratory and health care workers who handle specimens that might contain polioviruses; and health care workers or other caregivers who have close contact with a person who could be infected with poliovirus.²

Take-home message. Be prepared to discuss and offer IPV (the only form of the vaccine currently in use in the United States) to adults, as either a one-time booster for those at increased risk for exposure to poliovirus or a complete series for those you know or suspect to be unvaccinated or incompletely vaccinated.

The Advisory Committee on Immunization Practices (ACIP) recently issued new recommendations on polio vaccine for adults. The ACIP decided to update its previous recommendations (from 2000) in response to a case in New York that demonstrated the United States is at risk for poliovirus importation as long as the disease has not been eliminated worldwide.¹

What happened in New York? In July 2022, a case of paralytic polio was confirmed in an unvaccinated adult in Rockland County, New York, an area that has low polio vaccine coverage. Subsequent testing of wastewater systems detected poliovirus in a total of 5 New York counties (including 2 in New York City).¹

The Centers for Disease Control and Prevention estimates that this region of the state probably experienced 1000 to 2000 nonparalytic, mostly asymptomatic poliovirus infections. The virus detected in wastewater in New York is genetically linked to polioviruses collected in wastewater in Israel, the United Kingdom, and Canada. No poliovirus has been detected in these wastewater systems since late 2022.^1,2

Why there’s reason for concern. Routine immunization against polio has been part of the immunization schedule for infants and children since the mid-1950s. As a result, endemic polio was eliminated in the United States in 1979 and in the Western Hemisphere in 1994.

However, adult vaccination until now has been recommended only for those at risk for exposure to poliovirus by way of travel or occupation. And while most adults in the United States are immune to polio due to childhood vaccination, unvaccinated adults remain susceptible if exposed to poliovirus—as demonstrated in the New York case.

What does the ACIP now recommend? Two recommendations were adopted by the ACIP this June to address this problem²:

1. Adults who are known or suspected to be unvaccinated or incompletely vaccinated against polio should complete a primary vaccination series with inactivated polio vaccine (IPV).
2. Adults who have received a primary series of oral polio vaccine (OPV) or IPV in any combination and who are at increased risk for poliovirus exposure may receive another dose of IPV. Available data do not indicate a need for > 1 lifetime booster.

A few details: To be considered fully vaccinated, a patient must have received a primary series of ≥ 3 doses of OPV or IPV (in any combination) given at least 4 weeks apart, with the last dose given on or after the 4th birthday and at least 6 months from the previous dose. Most adults who were born and raised in the United States can assume they were vaccinated against polio as children, unless there are specific reasons to suspect otherwise.²

Individuals considered to be at increased risk include: travelers who are going to countries where polio is epidemic or endemic; laboratory and health care workers who handle specimens that might contain polioviruses; and health care workers or other caregivers who have close contact with a person who could be infected with poliovirus.²

Take-home message. Be prepared to discuss and offer IPV (the only form of the vaccine currently in use in the United States) to adults, as either a one-time booster for those at increased risk for exposure to poliovirus or a complete series for those you know or suspect to be unvaccinated or incompletely vaccinated.

The Advisory Committee on Immunization Practices (ACIP) recently issued new recommendations on polio vaccine for adults. The ACIP decided to update its previous recommendations (from 2000) in response to a case in New York that demonstrated the United States is at risk for poliovirus importation as long as the disease has not been eliminated worldwide.¹

What happened in New York? In July 2022, a case of paralytic polio was confirmed in an unvaccinated adult in Rockland County, New York, an area that has low polio vaccine coverage. Subsequent testing of wastewater systems detected poliovirus in a total of 5 New York counties (including 2 in New York City).¹

The Centers for Disease Control and Prevention estimates that this region of the state probably experienced 1000 to 2000 nonparalytic, mostly asymptomatic poliovirus infections. The virus detected in wastewater in New York is genetically linked to polioviruses collected in wastewater in Israel, the United Kingdom, and Canada. No poliovirus has been detected in these wastewater systems since late 2022.^1,2

Why there’s reason for concern. Routine immunization against polio has been part of the immunization schedule for infants and children since the mid-1950s. As a result, endemic polio was eliminated in the United States in 1979 and in the Western Hemisphere in 1994.

However, adult vaccination until now has been recommended only for those at risk for exposure to poliovirus by way of travel or occupation. And while most adults in the United States are immune to polio due to childhood vaccination, unvaccinated adults remain susceptible if exposed to poliovirus—as demonstrated in the New York case.

What does the ACIP now recommend? Two recommendations were adopted by the ACIP this June to address this problem²:

1. Adults who are known or suspected to be unvaccinated or incompletely vaccinated against polio should complete a primary vaccination series with inactivated polio vaccine (IPV).
2. Adults who have received a primary series of oral polio vaccine (OPV) or IPV in any combination and who are at increased risk for poliovirus exposure may receive another dose of IPV. Available data do not indicate a need for > 1 lifetime booster.

A few details: To be considered fully vaccinated, a patient must have received a primary series of ≥ 3 doses of OPV or IPV (in any combination) given at least 4 weeks apart, with the last dose given on or after the 4th birthday and at least 6 months from the previous dose. Most adults who were born and raised in the United States can assume they were vaccinated against polio as children, unless there are specific reasons to suspect otherwise.²

Individuals considered to be at increased risk include: travelers who are going to countries where polio is epidemic or endemic; laboratory and health care workers who handle specimens that might contain polioviruses; and health care workers or other caregivers who have close contact with a person who could be infected with poliovirus.²

Take-home message. Be prepared to discuss and offer IPV (the only form of the vaccine currently in use in the United States) to adults, as either a one-time booster for those at increased risk for exposure to poliovirus or a complete series for those you know or suspect to be unvaccinated or incompletely vaccinated.