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Sleep disorders and cancer: It’s complicated

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Sleep apnea and other types of sleep disorders appear to elevate the risk for some types of cancer, specifically prostate cancer, more so than others. But the overall risk can be highly variable, and some sleep problems were found to be associated with a lower risk for cancer and cancer-related death, an analysis of a large observational cohort study of cardiovascular patients found.

Results of the analysis were published online in the journal Cancer Epidemiology. Investigators analyzed the presence of sleep apnea and insomnia and cancer risk in more than 8,500 patients in the Cardiovascular Health Study (CHS). “The fact that we observed certain sleep problems, like apneas, to be associated with elevated risk of some cancers but not others reflects the fact that cancer is a heterogeneous disease,” senior author Amanda Phipps, PhD, said in an interview. Dr. Phipps is an associate professor of epidemiology at the University of Washington and the Fred Hutchinson Cancer Research Center, both in Seattle.
 

Variable cancer links

The researchers assessed sleep problems in two groups in the CHS: an incident cancer group of 3,930 patients and a cancer mortality group of 4,580 patients. Within those respective groups, the investigators identified 885 first-incident cancers and 804 cancer deaths with a median follow-up of 12 and 14 years. The average age of the study population was 73 years, and 57% were women.

Sleep apnea symptoms (SAS) were associated with a lower risk for incident cancers – a 16% lower baseline risk and a 24% lower time-dependent risk. The study showed no association between cancer incidence and daytime sleepiness and apneas.

However, there was a significantly elevated risk relationship between sleep problems and prostate cancer. A time-dependent analysis of apnea showed more than double the risk (hazard ratio, 2.34), and baseline snoring carried a 69% greater risk. There was also a dose-response relationship for baseline cumulative SAS, compared with not having symptoms: an HR of 1.30 for one symptom, and 2.22 for two or more symptoms.

Risks for lymphatic or hematopoietic cancers were also associated with baseline daytime sleepiness (HR, 1.81), but not with insomnia (HR, 0.54).

With regard to cancer mortality, the study found no relationship between sleep problems and cancer death. In fact, it found an overall inverse relationship with snoring (time-dependent HR, 0.73; cumulative average HR, 0.67) and baseline apnea (HR, 0.69). Likewise, patients reporting SAS had lower risks than those having no SAS: an HR of 0.90 for one symptom and 0.75 for multiple symptoms. No relationships were found between any insomnia symptom and cancer death.

“We know the pathways that lead to prostate cancer can be very different than the pathways that lead to colorectal cancer,” Dr. Phipps said. “What we don’t yet understand is why these associations differ or what mechanisms are responsible for these cancer site-specific associations.”
 

Need for sleep assessment

The findings don’t change much for how clinicians should evaluate cancer risks in patients with sleep problems, Dr. Phipps said. “Other studies have clearly demonstrated the implications that sleep apnea has for a variety of other important health conditions – such as cardiovascular disease – so there are already plenty of good reasons for clinicians to ask their patients about their sleep and to connect patients with resources for the diagnosis and treatment of sleep apnea,” she added. “This study provides another possible reason.”

These findings provide context for future studies of the relationship between sleep problems and cancer. “But, given that sleep is something we all do and given that sleep problems are so pervasive, it’s important that we keep trying to better understand this relationship,” Dr. Phipps said.

“My hope is that future cancer studies will build in more detailed, longitudinal information on sleep patterns to help us fill current gaps in knowledge.”

Dr. Phipps has disclosed no relevant financial relationships.

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

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Sleep apnea and other types of sleep disorders appear to elevate the risk for some types of cancer, specifically prostate cancer, more so than others. But the overall risk can be highly variable, and some sleep problems were found to be associated with a lower risk for cancer and cancer-related death, an analysis of a large observational cohort study of cardiovascular patients found.

Results of the analysis were published online in the journal Cancer Epidemiology. Investigators analyzed the presence of sleep apnea and insomnia and cancer risk in more than 8,500 patients in the Cardiovascular Health Study (CHS). “The fact that we observed certain sleep problems, like apneas, to be associated with elevated risk of some cancers but not others reflects the fact that cancer is a heterogeneous disease,” senior author Amanda Phipps, PhD, said in an interview. Dr. Phipps is an associate professor of epidemiology at the University of Washington and the Fred Hutchinson Cancer Research Center, both in Seattle.
 

Variable cancer links

The researchers assessed sleep problems in two groups in the CHS: an incident cancer group of 3,930 patients and a cancer mortality group of 4,580 patients. Within those respective groups, the investigators identified 885 first-incident cancers and 804 cancer deaths with a median follow-up of 12 and 14 years. The average age of the study population was 73 years, and 57% were women.

Sleep apnea symptoms (SAS) were associated with a lower risk for incident cancers – a 16% lower baseline risk and a 24% lower time-dependent risk. The study showed no association between cancer incidence and daytime sleepiness and apneas.

However, there was a significantly elevated risk relationship between sleep problems and prostate cancer. A time-dependent analysis of apnea showed more than double the risk (hazard ratio, 2.34), and baseline snoring carried a 69% greater risk. There was also a dose-response relationship for baseline cumulative SAS, compared with not having symptoms: an HR of 1.30 for one symptom, and 2.22 for two or more symptoms.

Risks for lymphatic or hematopoietic cancers were also associated with baseline daytime sleepiness (HR, 1.81), but not with insomnia (HR, 0.54).

With regard to cancer mortality, the study found no relationship between sleep problems and cancer death. In fact, it found an overall inverse relationship with snoring (time-dependent HR, 0.73; cumulative average HR, 0.67) and baseline apnea (HR, 0.69). Likewise, patients reporting SAS had lower risks than those having no SAS: an HR of 0.90 for one symptom and 0.75 for multiple symptoms. No relationships were found between any insomnia symptom and cancer death.

“We know the pathways that lead to prostate cancer can be very different than the pathways that lead to colorectal cancer,” Dr. Phipps said. “What we don’t yet understand is why these associations differ or what mechanisms are responsible for these cancer site-specific associations.”
 

Need for sleep assessment

The findings don’t change much for how clinicians should evaluate cancer risks in patients with sleep problems, Dr. Phipps said. “Other studies have clearly demonstrated the implications that sleep apnea has for a variety of other important health conditions – such as cardiovascular disease – so there are already plenty of good reasons for clinicians to ask their patients about their sleep and to connect patients with resources for the diagnosis and treatment of sleep apnea,” she added. “This study provides another possible reason.”

These findings provide context for future studies of the relationship between sleep problems and cancer. “But, given that sleep is something we all do and given that sleep problems are so pervasive, it’s important that we keep trying to better understand this relationship,” Dr. Phipps said.

“My hope is that future cancer studies will build in more detailed, longitudinal information on sleep patterns to help us fill current gaps in knowledge.”

Dr. Phipps has disclosed no relevant financial relationships.

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

Sleep apnea and other types of sleep disorders appear to elevate the risk for some types of cancer, specifically prostate cancer, more so than others. But the overall risk can be highly variable, and some sleep problems were found to be associated with a lower risk for cancer and cancer-related death, an analysis of a large observational cohort study of cardiovascular patients found.

Results of the analysis were published online in the journal Cancer Epidemiology. Investigators analyzed the presence of sleep apnea and insomnia and cancer risk in more than 8,500 patients in the Cardiovascular Health Study (CHS). “The fact that we observed certain sleep problems, like apneas, to be associated with elevated risk of some cancers but not others reflects the fact that cancer is a heterogeneous disease,” senior author Amanda Phipps, PhD, said in an interview. Dr. Phipps is an associate professor of epidemiology at the University of Washington and the Fred Hutchinson Cancer Research Center, both in Seattle.
 

Variable cancer links

The researchers assessed sleep problems in two groups in the CHS: an incident cancer group of 3,930 patients and a cancer mortality group of 4,580 patients. Within those respective groups, the investigators identified 885 first-incident cancers and 804 cancer deaths with a median follow-up of 12 and 14 years. The average age of the study population was 73 years, and 57% were women.

Sleep apnea symptoms (SAS) were associated with a lower risk for incident cancers – a 16% lower baseline risk and a 24% lower time-dependent risk. The study showed no association between cancer incidence and daytime sleepiness and apneas.

However, there was a significantly elevated risk relationship between sleep problems and prostate cancer. A time-dependent analysis of apnea showed more than double the risk (hazard ratio, 2.34), and baseline snoring carried a 69% greater risk. There was also a dose-response relationship for baseline cumulative SAS, compared with not having symptoms: an HR of 1.30 for one symptom, and 2.22 for two or more symptoms.

Risks for lymphatic or hematopoietic cancers were also associated with baseline daytime sleepiness (HR, 1.81), but not with insomnia (HR, 0.54).

With regard to cancer mortality, the study found no relationship between sleep problems and cancer death. In fact, it found an overall inverse relationship with snoring (time-dependent HR, 0.73; cumulative average HR, 0.67) and baseline apnea (HR, 0.69). Likewise, patients reporting SAS had lower risks than those having no SAS: an HR of 0.90 for one symptom and 0.75 for multiple symptoms. No relationships were found between any insomnia symptom and cancer death.

“We know the pathways that lead to prostate cancer can be very different than the pathways that lead to colorectal cancer,” Dr. Phipps said. “What we don’t yet understand is why these associations differ or what mechanisms are responsible for these cancer site-specific associations.”
 

Need for sleep assessment

The findings don’t change much for how clinicians should evaluate cancer risks in patients with sleep problems, Dr. Phipps said. “Other studies have clearly demonstrated the implications that sleep apnea has for a variety of other important health conditions – such as cardiovascular disease – so there are already plenty of good reasons for clinicians to ask their patients about their sleep and to connect patients with resources for the diagnosis and treatment of sleep apnea,” she added. “This study provides another possible reason.”

These findings provide context for future studies of the relationship between sleep problems and cancer. “But, given that sleep is something we all do and given that sleep problems are so pervasive, it’s important that we keep trying to better understand this relationship,” Dr. Phipps said.

“My hope is that future cancer studies will build in more detailed, longitudinal information on sleep patterns to help us fill current gaps in knowledge.”

Dr. Phipps has disclosed no relevant financial relationships.

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

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Cardiologist positive for Omicron after London conference

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A cardiologist from Israel has tested positive for the Omicron variant of COVID-19 after attending a medical conference in London.

Elad Maor, MD, an interventional cardiologist at Sheba Medical Centre near Tel Aviv, posted on Twitter on Nov. 30: “What a mess! Came back from a conference in London. With a mask and 3 Pfizer vaccines I managed to get Omicron.”

Dr. Maor traveled to London on November 19 to attend the PCR London Valves 2021 conference held at the ExCeL Centre Nov. 21-23. He stayed four nights at a hotel in north London and took public transport to and from the ExCeL Centre in East London each day of the meeting. He returned to Israel on the evening of Nov. 23.

Dr. Maor, 45, who has received three doses of the Pfizer COVID-19 vaccine, had two PCR tests in the United Kingdom – on November 20 and 21 in line with travel requirements – and another PCR test upon arriving back in Israel in the early hours of Nov. 24. All three tests were negative.

He began experiencing symptoms within days and tested positive on Nov. 27. His symptoms have been mild so far, and he said he was feeling “better” at the time of his tweet on Nov. 30.

Dr. Maor believes he was infected during his trip to London. “The only reasonable explanation is that I got infected on the last day of the meeting – maybe at the airport, maybe at the meeting,” he told The Guardian newspaper.

Although his wife accompanied him to London, neither she nor any of his 3 children have experienced symptoms or tested positive for COVID-19. But Dr. Maor believes he has passed the infection to a 69-year-old colleague in Israel who has since tested positive for the Omicron variant. The colleague, who has also received three vaccine doses, is understood to have mild symptoms at present.

The case suggests that the Omicron variant of COVID-19 may have been circulating in the United Kingdom earlier than previously thought.
 

Implications for in-person conferences

It will also inevitably lead to questions about the safety of face-to-face conferences, which are only just starting to get underway again.

The PCR Valves 2021 meeting had more than 1,250 on-site attendees as well as 2,400 or more joining online, according to figures on its website. Dr. Maor said he did not have any issues with the conference organizers, who required proof of vaccination before entry. But he posted a photograph on his Twitter account of a crowded auditorium with many delegates not wearing masks.

The conference subsequently posted an announcement on its website alerting delegates that one of the attendees had tested positive for COVID-19 after returning to their home country. It reads: “Since the reported case comes less than a week after the end of PCR London Valves, we want to inform you so that you may decide the best course of action, for yourself, if any.” It does not mention that the case was the Omicron variant. 

Patrick Jolly, strategic and market development director of the conference, commented: “As you may imagine, the health, safety and well-being of everyone who visited PCR London Valves was our number-one priority. All protocols mandated by the U.K. government were put in place. Anyone entering the congress center had to present a valid health pass and were requested to wear a mask. Hydro-alcoholic gel and masks were made readily available for all participants and disposal bins for used protective equipment were provided.”

Mr. Jolly also noted: “To date – more than 9 days after the end of PCR London Valves – we have had no report of any other case of participants testing positive who attended PCR London Valves.”

He said the EuroPCR organization believes that medical conferences are safe to be held in person.

“With the above sanitary requirements and protocols, and no complacency in their enforcement, we believe strongly that medical conferences can take place, as the benefits of in-person medical conferences are obvious for the concerned medical communities,” Mr. Jolly added.  

But what about other meetings happening imminently and planning in-person attendance?

Eileen Murray, executive director of the American Epilepsy Society (AES), whose annual 5-day meeting starts today at Chicago’s McCormick Place Convention Center, said in an interview that the health, safety, and well-being of everyone attending is a priority.

“Vaccinations are required, with no exceptions, to anyone attending the in-person event,” Ms. Murray said. “AES is using the CLEAR HealthPass to verify identity and vaccination status for our attendees. No one who cannot verify identity and vaccination requirement will be permitted to attend the in-person event.”

She noted that masks will also be required except in limited circumstances when actively eating or drinking, or for a faculty member when actively presenting at a lecture or panel. “Anyone not adhering to the mask policy will be asked to leave the meeting and will be denied readmission to the meeting with no refund,” she said.

“These guidelines were developed in accordance with the latest public health guidance and AES will continue to follow that guidance as any updates are made with the emergence of the Omicron variant,” Ms. Murray added.

Also commenting on this issue, a spokesperson for the American Heart Association, which has its large annual international stroke meeting planned for in-person attendance in New Orleans in February, said: “As we have throughout the pandemic, the American Heart Association is closely monitoring conditions and following the guidance of the CDC as well as state and local health departments related to all in-person meetings.”

“Our upcoming International Stroke Conference, February 9-11, is planned as an in-person and digital experience which allows us the ultimate flexibility to address changing pandemic conditions. The health, safety, and well-being of our volunteers, members, and attendees from around the world remains our number-one priority,” the AHA spokesperson added.

But some COVID-19 experts are taking a more cautious view.  

Rowland Kao, PhD, an expert in infectious disease dynamics at the University of Edinburgh, United Kingdom, expressed concern about such large in-person conferences.  

“We know that the Omicron variant appears to be spreading rapidly, with a recent preprint also telling us that the reinfection rate appears to be higher in South Africa. Should this be borne out, then the evidence would support that our reliance on a combination of vaccine-induced and natural immunity may be compromised by the Omicron variant,” he commented.

“We already know that extended contact indoors provides an additional risk, and so large meetings of this type have the potential to create extended risks. Until we know the extent to which Omicron causes severe illness, we should be extra cautious about these high-risk settings,” Dr. Kao commented.

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

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A cardiologist from Israel has tested positive for the Omicron variant of COVID-19 after attending a medical conference in London.

Elad Maor, MD, an interventional cardiologist at Sheba Medical Centre near Tel Aviv, posted on Twitter on Nov. 30: “What a mess! Came back from a conference in London. With a mask and 3 Pfizer vaccines I managed to get Omicron.”

Dr. Maor traveled to London on November 19 to attend the PCR London Valves 2021 conference held at the ExCeL Centre Nov. 21-23. He stayed four nights at a hotel in north London and took public transport to and from the ExCeL Centre in East London each day of the meeting. He returned to Israel on the evening of Nov. 23.

Dr. Maor, 45, who has received three doses of the Pfizer COVID-19 vaccine, had two PCR tests in the United Kingdom – on November 20 and 21 in line with travel requirements – and another PCR test upon arriving back in Israel in the early hours of Nov. 24. All three tests were negative.

He began experiencing symptoms within days and tested positive on Nov. 27. His symptoms have been mild so far, and he said he was feeling “better” at the time of his tweet on Nov. 30.

Dr. Maor believes he was infected during his trip to London. “The only reasonable explanation is that I got infected on the last day of the meeting – maybe at the airport, maybe at the meeting,” he told The Guardian newspaper.

Although his wife accompanied him to London, neither she nor any of his 3 children have experienced symptoms or tested positive for COVID-19. But Dr. Maor believes he has passed the infection to a 69-year-old colleague in Israel who has since tested positive for the Omicron variant. The colleague, who has also received three vaccine doses, is understood to have mild symptoms at present.

The case suggests that the Omicron variant of COVID-19 may have been circulating in the United Kingdom earlier than previously thought.
 

Implications for in-person conferences

It will also inevitably lead to questions about the safety of face-to-face conferences, which are only just starting to get underway again.

The PCR Valves 2021 meeting had more than 1,250 on-site attendees as well as 2,400 or more joining online, according to figures on its website. Dr. Maor said he did not have any issues with the conference organizers, who required proof of vaccination before entry. But he posted a photograph on his Twitter account of a crowded auditorium with many delegates not wearing masks.

The conference subsequently posted an announcement on its website alerting delegates that one of the attendees had tested positive for COVID-19 after returning to their home country. It reads: “Since the reported case comes less than a week after the end of PCR London Valves, we want to inform you so that you may decide the best course of action, for yourself, if any.” It does not mention that the case was the Omicron variant. 

Patrick Jolly, strategic and market development director of the conference, commented: “As you may imagine, the health, safety and well-being of everyone who visited PCR London Valves was our number-one priority. All protocols mandated by the U.K. government were put in place. Anyone entering the congress center had to present a valid health pass and were requested to wear a mask. Hydro-alcoholic gel and masks were made readily available for all participants and disposal bins for used protective equipment were provided.”

Mr. Jolly also noted: “To date – more than 9 days after the end of PCR London Valves – we have had no report of any other case of participants testing positive who attended PCR London Valves.”

He said the EuroPCR organization believes that medical conferences are safe to be held in person.

“With the above sanitary requirements and protocols, and no complacency in their enforcement, we believe strongly that medical conferences can take place, as the benefits of in-person medical conferences are obvious for the concerned medical communities,” Mr. Jolly added.  

But what about other meetings happening imminently and planning in-person attendance?

Eileen Murray, executive director of the American Epilepsy Society (AES), whose annual 5-day meeting starts today at Chicago’s McCormick Place Convention Center, said in an interview that the health, safety, and well-being of everyone attending is a priority.

“Vaccinations are required, with no exceptions, to anyone attending the in-person event,” Ms. Murray said. “AES is using the CLEAR HealthPass to verify identity and vaccination status for our attendees. No one who cannot verify identity and vaccination requirement will be permitted to attend the in-person event.”

She noted that masks will also be required except in limited circumstances when actively eating or drinking, or for a faculty member when actively presenting at a lecture or panel. “Anyone not adhering to the mask policy will be asked to leave the meeting and will be denied readmission to the meeting with no refund,” she said.

“These guidelines were developed in accordance with the latest public health guidance and AES will continue to follow that guidance as any updates are made with the emergence of the Omicron variant,” Ms. Murray added.

Also commenting on this issue, a spokesperson for the American Heart Association, which has its large annual international stroke meeting planned for in-person attendance in New Orleans in February, said: “As we have throughout the pandemic, the American Heart Association is closely monitoring conditions and following the guidance of the CDC as well as state and local health departments related to all in-person meetings.”

“Our upcoming International Stroke Conference, February 9-11, is planned as an in-person and digital experience which allows us the ultimate flexibility to address changing pandemic conditions. The health, safety, and well-being of our volunteers, members, and attendees from around the world remains our number-one priority,” the AHA spokesperson added.

But some COVID-19 experts are taking a more cautious view.  

Rowland Kao, PhD, an expert in infectious disease dynamics at the University of Edinburgh, United Kingdom, expressed concern about such large in-person conferences.  

“We know that the Omicron variant appears to be spreading rapidly, with a recent preprint also telling us that the reinfection rate appears to be higher in South Africa. Should this be borne out, then the evidence would support that our reliance on a combination of vaccine-induced and natural immunity may be compromised by the Omicron variant,” he commented.

“We already know that extended contact indoors provides an additional risk, and so large meetings of this type have the potential to create extended risks. Until we know the extent to which Omicron causes severe illness, we should be extra cautious about these high-risk settings,” Dr. Kao commented.

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

A cardiologist from Israel has tested positive for the Omicron variant of COVID-19 after attending a medical conference in London.

Elad Maor, MD, an interventional cardiologist at Sheba Medical Centre near Tel Aviv, posted on Twitter on Nov. 30: “What a mess! Came back from a conference in London. With a mask and 3 Pfizer vaccines I managed to get Omicron.”

Dr. Maor traveled to London on November 19 to attend the PCR London Valves 2021 conference held at the ExCeL Centre Nov. 21-23. He stayed four nights at a hotel in north London and took public transport to and from the ExCeL Centre in East London each day of the meeting. He returned to Israel on the evening of Nov. 23.

Dr. Maor, 45, who has received three doses of the Pfizer COVID-19 vaccine, had two PCR tests in the United Kingdom – on November 20 and 21 in line with travel requirements – and another PCR test upon arriving back in Israel in the early hours of Nov. 24. All three tests were negative.

He began experiencing symptoms within days and tested positive on Nov. 27. His symptoms have been mild so far, and he said he was feeling “better” at the time of his tweet on Nov. 30.

Dr. Maor believes he was infected during his trip to London. “The only reasonable explanation is that I got infected on the last day of the meeting – maybe at the airport, maybe at the meeting,” he told The Guardian newspaper.

Although his wife accompanied him to London, neither she nor any of his 3 children have experienced symptoms or tested positive for COVID-19. But Dr. Maor believes he has passed the infection to a 69-year-old colleague in Israel who has since tested positive for the Omicron variant. The colleague, who has also received three vaccine doses, is understood to have mild symptoms at present.

The case suggests that the Omicron variant of COVID-19 may have been circulating in the United Kingdom earlier than previously thought.
 

Implications for in-person conferences

It will also inevitably lead to questions about the safety of face-to-face conferences, which are only just starting to get underway again.

The PCR Valves 2021 meeting had more than 1,250 on-site attendees as well as 2,400 or more joining online, according to figures on its website. Dr. Maor said he did not have any issues with the conference organizers, who required proof of vaccination before entry. But he posted a photograph on his Twitter account of a crowded auditorium with many delegates not wearing masks.

The conference subsequently posted an announcement on its website alerting delegates that one of the attendees had tested positive for COVID-19 after returning to their home country. It reads: “Since the reported case comes less than a week after the end of PCR London Valves, we want to inform you so that you may decide the best course of action, for yourself, if any.” It does not mention that the case was the Omicron variant. 

Patrick Jolly, strategic and market development director of the conference, commented: “As you may imagine, the health, safety and well-being of everyone who visited PCR London Valves was our number-one priority. All protocols mandated by the U.K. government were put in place. Anyone entering the congress center had to present a valid health pass and were requested to wear a mask. Hydro-alcoholic gel and masks were made readily available for all participants and disposal bins for used protective equipment were provided.”

Mr. Jolly also noted: “To date – more than 9 days after the end of PCR London Valves – we have had no report of any other case of participants testing positive who attended PCR London Valves.”

He said the EuroPCR organization believes that medical conferences are safe to be held in person.

“With the above sanitary requirements and protocols, and no complacency in their enforcement, we believe strongly that medical conferences can take place, as the benefits of in-person medical conferences are obvious for the concerned medical communities,” Mr. Jolly added.  

But what about other meetings happening imminently and planning in-person attendance?

Eileen Murray, executive director of the American Epilepsy Society (AES), whose annual 5-day meeting starts today at Chicago’s McCormick Place Convention Center, said in an interview that the health, safety, and well-being of everyone attending is a priority.

“Vaccinations are required, with no exceptions, to anyone attending the in-person event,” Ms. Murray said. “AES is using the CLEAR HealthPass to verify identity and vaccination status for our attendees. No one who cannot verify identity and vaccination requirement will be permitted to attend the in-person event.”

She noted that masks will also be required except in limited circumstances when actively eating or drinking, or for a faculty member when actively presenting at a lecture or panel. “Anyone not adhering to the mask policy will be asked to leave the meeting and will be denied readmission to the meeting with no refund,” she said.

“These guidelines were developed in accordance with the latest public health guidance and AES will continue to follow that guidance as any updates are made with the emergence of the Omicron variant,” Ms. Murray added.

Also commenting on this issue, a spokesperson for the American Heart Association, which has its large annual international stroke meeting planned for in-person attendance in New Orleans in February, said: “As we have throughout the pandemic, the American Heart Association is closely monitoring conditions and following the guidance of the CDC as well as state and local health departments related to all in-person meetings.”

“Our upcoming International Stroke Conference, February 9-11, is planned as an in-person and digital experience which allows us the ultimate flexibility to address changing pandemic conditions. The health, safety, and well-being of our volunteers, members, and attendees from around the world remains our number-one priority,” the AHA spokesperson added.

But some COVID-19 experts are taking a more cautious view.  

Rowland Kao, PhD, an expert in infectious disease dynamics at the University of Edinburgh, United Kingdom, expressed concern about such large in-person conferences.  

“We know that the Omicron variant appears to be spreading rapidly, with a recent preprint also telling us that the reinfection rate appears to be higher in South Africa. Should this be borne out, then the evidence would support that our reliance on a combination of vaccine-induced and natural immunity may be compromised by the Omicron variant,” he commented.

“We already know that extended contact indoors provides an additional risk, and so large meetings of this type have the potential to create extended risks. Until we know the extent to which Omicron causes severe illness, we should be extra cautious about these high-risk settings,” Dr. Kao commented.

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

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Large analysis confirms safety of nipple-sparing mastectomy

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A new analysis of over 22,000 mastectomy patients confirms what smaller studies have indicated: Patients who undergo nipple-sparing mastectomy have overall and disease-free survival similar to that of those who receive a total mastectomy.

When nipple-sparing mastectomy was introduced, many experts felt uneasy about opting for the less invasive procedure, recalled Rosa Hwang, MD, associate medical director for breast surgery at MD Anderson Cancer Center in Houston. “The concern was leaving all this skin,” said Dr. Hwang. “Are you going to leave cancer behind” and increase the risk of local recurrence?

Over the past 2 decades, the number of patients undergoing nipple-sparing mastectomy increased and, in turn, studies began to demonstrate the safety of the procedure.

However, large analyses evaluating long-term outcomes – namely, overall survival and breast cancer-specific survival – of nipple-sparing mastectomy were still lacking.

The latest study, published online Nov. 20 in Annals of Surgical Oncology, compared the long-term prognosis and survival benefits of nipple-sparing to total mastectomy in thousands of women. The analysis, which pulled data from the SEER cancer database, included 5,765 patients who underwent the nipple-sparing procedure and 17,289 patients who had a total mastectomy.

The authors found that overall survival and breast cancer–specific survival were similar for women undergoing nipple-sparing mastectomy and those receiving a total mastectomy. In fact, over the long-term, the nipple-sparing group slightly edged out the total mastectomy group in overall survival (94.61% vs. 93% at 5 years and 86.34% vs. 83.48% at 10 years, respectively) and in breast cancer-specific survival rates (96.16% vs. 95.74% at 5 years, and 92.2% vs. 91.37% at 10 years). The differences, however, were not significant.

The study also found that certain subgroups – including White women, women over age 46, those with a median household income of $70,000 or more, hormone receptor-positive, and HER2 negative – had significantly better overall survival rate with the nipple-sparing procedure (P < .05). However, the authors noted, the survival advantage in the nipple-sparing group did not extend to breast cancer–specific survival.

Dr. Hwang, who was not involved in the current analysis, said the significant overall survival result in the subgroup analysis was surprising because “there’s no biological reason why one would expect that to be true.”  

Given that the subgroups did not demonstrate better breast cancer–specific survival, Dr. Hwang believes the overall survival finding may have more to do with comorbidities, which the study did not account for, than type of mastectomy.

When choosing who is eligible for a nipple-sparing mastectomy, “We’re more selective,” Dr. Hwang said. For instance, patients with uncontrolled diabetes or who smoke are unlikely to be candidates. “So, I think it’s possible that medical comorbidities and medical conditions between these groups [were] different.”

According to the authors, coding inconsistencies represent another possible weakness of the study. From 1998 to 2010, “the term ‘nipple-sparing mastectomy’ was coded as a [total mastectomy] with the ‘subcutaneous mastectomy’ code.” It’s possible that some patients receiving the nipple-sparing procedure before 2011 were not appropriately coded in the current study.

Moving forward, a large prospective study that includes comorbidities would be helpful, but overall the study helps validate that “nipple-sparing mastectomy is a safe operation for selected patients,” Dr. Hwang said. 

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

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A new analysis of over 22,000 mastectomy patients confirms what smaller studies have indicated: Patients who undergo nipple-sparing mastectomy have overall and disease-free survival similar to that of those who receive a total mastectomy.

When nipple-sparing mastectomy was introduced, many experts felt uneasy about opting for the less invasive procedure, recalled Rosa Hwang, MD, associate medical director for breast surgery at MD Anderson Cancer Center in Houston. “The concern was leaving all this skin,” said Dr. Hwang. “Are you going to leave cancer behind” and increase the risk of local recurrence?

Over the past 2 decades, the number of patients undergoing nipple-sparing mastectomy increased and, in turn, studies began to demonstrate the safety of the procedure.

However, large analyses evaluating long-term outcomes – namely, overall survival and breast cancer-specific survival – of nipple-sparing mastectomy were still lacking.

The latest study, published online Nov. 20 in Annals of Surgical Oncology, compared the long-term prognosis and survival benefits of nipple-sparing to total mastectomy in thousands of women. The analysis, which pulled data from the SEER cancer database, included 5,765 patients who underwent the nipple-sparing procedure and 17,289 patients who had a total mastectomy.

The authors found that overall survival and breast cancer–specific survival were similar for women undergoing nipple-sparing mastectomy and those receiving a total mastectomy. In fact, over the long-term, the nipple-sparing group slightly edged out the total mastectomy group in overall survival (94.61% vs. 93% at 5 years and 86.34% vs. 83.48% at 10 years, respectively) and in breast cancer-specific survival rates (96.16% vs. 95.74% at 5 years, and 92.2% vs. 91.37% at 10 years). The differences, however, were not significant.

The study also found that certain subgroups – including White women, women over age 46, those with a median household income of $70,000 or more, hormone receptor-positive, and HER2 negative – had significantly better overall survival rate with the nipple-sparing procedure (P < .05). However, the authors noted, the survival advantage in the nipple-sparing group did not extend to breast cancer–specific survival.

Dr. Hwang, who was not involved in the current analysis, said the significant overall survival result in the subgroup analysis was surprising because “there’s no biological reason why one would expect that to be true.”  

Given that the subgroups did not demonstrate better breast cancer–specific survival, Dr. Hwang believes the overall survival finding may have more to do with comorbidities, which the study did not account for, than type of mastectomy.

When choosing who is eligible for a nipple-sparing mastectomy, “We’re more selective,” Dr. Hwang said. For instance, patients with uncontrolled diabetes or who smoke are unlikely to be candidates. “So, I think it’s possible that medical comorbidities and medical conditions between these groups [were] different.”

According to the authors, coding inconsistencies represent another possible weakness of the study. From 1998 to 2010, “the term ‘nipple-sparing mastectomy’ was coded as a [total mastectomy] with the ‘subcutaneous mastectomy’ code.” It’s possible that some patients receiving the nipple-sparing procedure before 2011 were not appropriately coded in the current study.

Moving forward, a large prospective study that includes comorbidities would be helpful, but overall the study helps validate that “nipple-sparing mastectomy is a safe operation for selected patients,” Dr. Hwang said. 

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

A new analysis of over 22,000 mastectomy patients confirms what smaller studies have indicated: Patients who undergo nipple-sparing mastectomy have overall and disease-free survival similar to that of those who receive a total mastectomy.

When nipple-sparing mastectomy was introduced, many experts felt uneasy about opting for the less invasive procedure, recalled Rosa Hwang, MD, associate medical director for breast surgery at MD Anderson Cancer Center in Houston. “The concern was leaving all this skin,” said Dr. Hwang. “Are you going to leave cancer behind” and increase the risk of local recurrence?

Over the past 2 decades, the number of patients undergoing nipple-sparing mastectomy increased and, in turn, studies began to demonstrate the safety of the procedure.

However, large analyses evaluating long-term outcomes – namely, overall survival and breast cancer-specific survival – of nipple-sparing mastectomy were still lacking.

The latest study, published online Nov. 20 in Annals of Surgical Oncology, compared the long-term prognosis and survival benefits of nipple-sparing to total mastectomy in thousands of women. The analysis, which pulled data from the SEER cancer database, included 5,765 patients who underwent the nipple-sparing procedure and 17,289 patients who had a total mastectomy.

The authors found that overall survival and breast cancer–specific survival were similar for women undergoing nipple-sparing mastectomy and those receiving a total mastectomy. In fact, over the long-term, the nipple-sparing group slightly edged out the total mastectomy group in overall survival (94.61% vs. 93% at 5 years and 86.34% vs. 83.48% at 10 years, respectively) and in breast cancer-specific survival rates (96.16% vs. 95.74% at 5 years, and 92.2% vs. 91.37% at 10 years). The differences, however, were not significant.

The study also found that certain subgroups – including White women, women over age 46, those with a median household income of $70,000 or more, hormone receptor-positive, and HER2 negative – had significantly better overall survival rate with the nipple-sparing procedure (P < .05). However, the authors noted, the survival advantage in the nipple-sparing group did not extend to breast cancer–specific survival.

Dr. Hwang, who was not involved in the current analysis, said the significant overall survival result in the subgroup analysis was surprising because “there’s no biological reason why one would expect that to be true.”  

Given that the subgroups did not demonstrate better breast cancer–specific survival, Dr. Hwang believes the overall survival finding may have more to do with comorbidities, which the study did not account for, than type of mastectomy.

When choosing who is eligible for a nipple-sparing mastectomy, “We’re more selective,” Dr. Hwang said. For instance, patients with uncontrolled diabetes or who smoke are unlikely to be candidates. “So, I think it’s possible that medical comorbidities and medical conditions between these groups [were] different.”

According to the authors, coding inconsistencies represent another possible weakness of the study. From 1998 to 2010, “the term ‘nipple-sparing mastectomy’ was coded as a [total mastectomy] with the ‘subcutaneous mastectomy’ code.” It’s possible that some patients receiving the nipple-sparing procedure before 2011 were not appropriately coded in the current study.

Moving forward, a large prospective study that includes comorbidities would be helpful, but overall the study helps validate that “nipple-sparing mastectomy is a safe operation for selected patients,” Dr. Hwang said. 

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

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No serious CV risks for elderly after Pfizer COVID-19 vaccine

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A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.

The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.

“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.

Ridofranz/Getty Images


The study was published as a research letter online Nov. 22 in JAMA.

The Pfizer-BioNTech mRNA vaccine was the first SARS-CoV-2 vaccine authorized in France and has been widely used in older people. The phase 3 trials of the vaccine showed no increase in cardiovascular events, but older people were underrepresented in the trials.

As of April 30, 2021, nearly 3.9 million French adults aged 75 or older had received at least one dose of the Pfizer COVID-19 vaccine and 3.2 million had received two doses.

Using the French National Health Data System linked to the national COVID-19 vaccination database, Dr. Jabagi and her colleagues identified all unvaccinated or vaccinated adults aged 75 and older who were hospitalized between Dec. 15, 2020, and April 30, 2021, for acute MI, hemorrhagic or ischemic stroke, or PE.

During the 4.5-month study period, 11,113 elderly were hospitalized for acute MI, 17,014 for ischemic stroke, 4,804 for hemorrhagic stroke, and 7,221 for PE. Of these, 58.6%, 54.0%, 42.7%, and 55.3%, respectively, had received at least one dose of vaccine.

In the 14 days following receipt of either dose, no significant increased risk was found for any outcome, the investigators report.

The relative incidence (RI) for MI after the first and second dose was 0.97 (95% CI, 0.88-1.06) and 1.04 (95% CI, 0.93-1.16), respectively.

For ischemic stroke, the RI was 0.90 after the first dose (95% CI, 0.84-0.98) and 0.92 (95% CI, 0.84-1.02) after the second; for hemorrhagic stroke, the RI was 0.90 (95% CI, 0.78-1.04) and 0.97 (95% CI, 0.81-1.15), respectively.

For PE, the RI was 0.85 (95% CI, 0.75-0.96) after the first dose and 1.10 (95% CI, 0.95-1.26) after the second dose.

There was also no significant increase for any of the cardiovascular events when the exposure risk window was subdivided into 1 to 7 days and 8 to 14 days.

“Evaluating the short-term risk of hospitalization for severe cardiovascular events after the BNT162b2 mRNA vaccine in older people was a priority, especially after signals for hypertension and cardiovascular, thromboembolic, and hemorrhagic events have been issued from spontaneous notification data,” Dr. Jabagi said in an interview.

“The results of this nationwide study provide further solid evidence regarding the lack of increase of serious cardiovascular adverse events in older people in the 14 days following both doses of the vaccine,” Dr. Jabagi said.

The French study supports a recent U.S. study of more than 6 million people demonstrating that serious health risks were no more common in the first 3 weeks after Pfizer/BioNTech or Moderna COVID-19 vaccination compared with 22 to 42 days later.

As previously reported by this news organization, mRNA vaccination was not associated with greater risks for Guillain-Barré syndrome, myocarditis/pericarditis, stroke, or 20 other serious outcomes.

The current study had no specific funding. Dr. Jabagi and colleagues have declared no relevant conflicts of interest.

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

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A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.

The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.

“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.

Ridofranz/Getty Images


The study was published as a research letter online Nov. 22 in JAMA.

The Pfizer-BioNTech mRNA vaccine was the first SARS-CoV-2 vaccine authorized in France and has been widely used in older people. The phase 3 trials of the vaccine showed no increase in cardiovascular events, but older people were underrepresented in the trials.

As of April 30, 2021, nearly 3.9 million French adults aged 75 or older had received at least one dose of the Pfizer COVID-19 vaccine and 3.2 million had received two doses.

Using the French National Health Data System linked to the national COVID-19 vaccination database, Dr. Jabagi and her colleagues identified all unvaccinated or vaccinated adults aged 75 and older who were hospitalized between Dec. 15, 2020, and April 30, 2021, for acute MI, hemorrhagic or ischemic stroke, or PE.

During the 4.5-month study period, 11,113 elderly were hospitalized for acute MI, 17,014 for ischemic stroke, 4,804 for hemorrhagic stroke, and 7,221 for PE. Of these, 58.6%, 54.0%, 42.7%, and 55.3%, respectively, had received at least one dose of vaccine.

In the 14 days following receipt of either dose, no significant increased risk was found for any outcome, the investigators report.

The relative incidence (RI) for MI after the first and second dose was 0.97 (95% CI, 0.88-1.06) and 1.04 (95% CI, 0.93-1.16), respectively.

For ischemic stroke, the RI was 0.90 after the first dose (95% CI, 0.84-0.98) and 0.92 (95% CI, 0.84-1.02) after the second; for hemorrhagic stroke, the RI was 0.90 (95% CI, 0.78-1.04) and 0.97 (95% CI, 0.81-1.15), respectively.

For PE, the RI was 0.85 (95% CI, 0.75-0.96) after the first dose and 1.10 (95% CI, 0.95-1.26) after the second dose.

There was also no significant increase for any of the cardiovascular events when the exposure risk window was subdivided into 1 to 7 days and 8 to 14 days.

“Evaluating the short-term risk of hospitalization for severe cardiovascular events after the BNT162b2 mRNA vaccine in older people was a priority, especially after signals for hypertension and cardiovascular, thromboembolic, and hemorrhagic events have been issued from spontaneous notification data,” Dr. Jabagi said in an interview.

“The results of this nationwide study provide further solid evidence regarding the lack of increase of serious cardiovascular adverse events in older people in the 14 days following both doses of the vaccine,” Dr. Jabagi said.

The French study supports a recent U.S. study of more than 6 million people demonstrating that serious health risks were no more common in the first 3 weeks after Pfizer/BioNTech or Moderna COVID-19 vaccination compared with 22 to 42 days later.

As previously reported by this news organization, mRNA vaccination was not associated with greater risks for Guillain-Barré syndrome, myocarditis/pericarditis, stroke, or 20 other serious outcomes.

The current study had no specific funding. Dr. Jabagi and colleagues have declared no relevant conflicts of interest.

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

A French population-based study provides further evidence that the BNT162b2 Pfizer-BioNTech mRNA COVID-19 vaccine does not increase the short-term risk for serious cardiovascular adverse events in older people.

The study showed no increased risk of myocardial infarction (MI), stroke, or pulmonary embolism (PE) following vaccination in adults aged 75 years or older in the 14 days following vaccination.

“These findings regarding the BNT162b2 vaccine’s short-term cardiovascular safety profile in older people are reassuring. They should be taken into account by doctors when considering implementing a third dose of the vaccine in older people,” Marie Joelle Jabagi, PharmD, PhD, with the French National Agency for Medicines and Health Products Safety, Saint-Denis, France, said in an interview.

Ridofranz/Getty Images


The study was published as a research letter online Nov. 22 in JAMA.

The Pfizer-BioNTech mRNA vaccine was the first SARS-CoV-2 vaccine authorized in France and has been widely used in older people. The phase 3 trials of the vaccine showed no increase in cardiovascular events, but older people were underrepresented in the trials.

As of April 30, 2021, nearly 3.9 million French adults aged 75 or older had received at least one dose of the Pfizer COVID-19 vaccine and 3.2 million had received two doses.

Using the French National Health Data System linked to the national COVID-19 vaccination database, Dr. Jabagi and her colleagues identified all unvaccinated or vaccinated adults aged 75 and older who were hospitalized between Dec. 15, 2020, and April 30, 2021, for acute MI, hemorrhagic or ischemic stroke, or PE.

During the 4.5-month study period, 11,113 elderly were hospitalized for acute MI, 17,014 for ischemic stroke, 4,804 for hemorrhagic stroke, and 7,221 for PE. Of these, 58.6%, 54.0%, 42.7%, and 55.3%, respectively, had received at least one dose of vaccine.

In the 14 days following receipt of either dose, no significant increased risk was found for any outcome, the investigators report.

The relative incidence (RI) for MI after the first and second dose was 0.97 (95% CI, 0.88-1.06) and 1.04 (95% CI, 0.93-1.16), respectively.

For ischemic stroke, the RI was 0.90 after the first dose (95% CI, 0.84-0.98) and 0.92 (95% CI, 0.84-1.02) after the second; for hemorrhagic stroke, the RI was 0.90 (95% CI, 0.78-1.04) and 0.97 (95% CI, 0.81-1.15), respectively.

For PE, the RI was 0.85 (95% CI, 0.75-0.96) after the first dose and 1.10 (95% CI, 0.95-1.26) after the second dose.

There was also no significant increase for any of the cardiovascular events when the exposure risk window was subdivided into 1 to 7 days and 8 to 14 days.

“Evaluating the short-term risk of hospitalization for severe cardiovascular events after the BNT162b2 mRNA vaccine in older people was a priority, especially after signals for hypertension and cardiovascular, thromboembolic, and hemorrhagic events have been issued from spontaneous notification data,” Dr. Jabagi said in an interview.

“The results of this nationwide study provide further solid evidence regarding the lack of increase of serious cardiovascular adverse events in older people in the 14 days following both doses of the vaccine,” Dr. Jabagi said.

The French study supports a recent U.S. study of more than 6 million people demonstrating that serious health risks were no more common in the first 3 weeks after Pfizer/BioNTech or Moderna COVID-19 vaccination compared with 22 to 42 days later.

As previously reported by this news organization, mRNA vaccination was not associated with greater risks for Guillain-Barré syndrome, myocarditis/pericarditis, stroke, or 20 other serious outcomes.

The current study had no specific funding. Dr. Jabagi and colleagues have declared no relevant conflicts of interest.

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

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After doc uproar, NCCN reverses prostate cancer guidance

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After making a controversial change in September to a long-standing recommendation about the use of active surveillance in men with prostate cancer, the National Comprehensive Cancer Network (NCCN) has reversed course and reinstated its original advice, with a slight tweak.

The influential cancer organization, which is best known for its guidelines, now recommends that “most” men with low-risk prostate cancer be offered active surveillance as the lone “preferred” initial treatment option. This advice aligns closely with the group’s initial recommendation, published over a decade ago.

But controversy erupted in late September when the NCCN suddenly changed its tune on active surveillance, recommending that men with low-risk disease be managed with either active surveillance, radiation therapy, or surgery, with equal weight given to all three.

The new advice angered physicians who support the concept of active surveillance, which aims to avoid or delay treatment — and potentially life-changing side effects — until signs of disease progression.

The NCCN listened to the complaints.

On Nov. 30, the group largely reverted back to the original recommendation. In updated guidelines, active surveillance returned to its place as the sole “preferred” management option, but for “most” men with low-risk disease, not all.

In an email sent to this news organization, Edward Schaeffer, MD, PhD, chair of the prostate cancer treatment panel, said that “the NCCN Prostate Cancer Panel recently convened” and “extensively revised the Principles of Active Surveillance and Observation.”

Dr. Schaeffer, who is from the Lurie Comprehensive Cancer Center of Northwestern University in Chicago, cited the heterogeneity across the low-risk disease group. Factors associated with an increased probability of near-term grade reclassification from low risk to higher risk include high PSA density, a high number of positive cores (≥ 3), high genomic risk (from tissue-based molecular tumor analysis), and/or a known BRCA2 germline mutation, he added.

Urologists cheered the NCCN’s reversal on Twitter.

“Big news! NCCN guidelines updated again — active surveillance is ‘preferred for most patients’ with low risk prostate cancer and life expectancy >=10 years,” tweeted Stacy Loeb of NYU Langone in New York City.

“Very exciting if true,” tweeted Matthew Cooperberg, MD, of University of California San Francisco, who was one of the most vocal critics of the NCCN’s change in September, calling that move a “step backward” that would likely lead to overtreatment.

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

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After making a controversial change in September to a long-standing recommendation about the use of active surveillance in men with prostate cancer, the National Comprehensive Cancer Network (NCCN) has reversed course and reinstated its original advice, with a slight tweak.

The influential cancer organization, which is best known for its guidelines, now recommends that “most” men with low-risk prostate cancer be offered active surveillance as the lone “preferred” initial treatment option. This advice aligns closely with the group’s initial recommendation, published over a decade ago.

But controversy erupted in late September when the NCCN suddenly changed its tune on active surveillance, recommending that men with low-risk disease be managed with either active surveillance, radiation therapy, or surgery, with equal weight given to all three.

The new advice angered physicians who support the concept of active surveillance, which aims to avoid or delay treatment — and potentially life-changing side effects — until signs of disease progression.

The NCCN listened to the complaints.

On Nov. 30, the group largely reverted back to the original recommendation. In updated guidelines, active surveillance returned to its place as the sole “preferred” management option, but for “most” men with low-risk disease, not all.

In an email sent to this news organization, Edward Schaeffer, MD, PhD, chair of the prostate cancer treatment panel, said that “the NCCN Prostate Cancer Panel recently convened” and “extensively revised the Principles of Active Surveillance and Observation.”

Dr. Schaeffer, who is from the Lurie Comprehensive Cancer Center of Northwestern University in Chicago, cited the heterogeneity across the low-risk disease group. Factors associated with an increased probability of near-term grade reclassification from low risk to higher risk include high PSA density, a high number of positive cores (≥ 3), high genomic risk (from tissue-based molecular tumor analysis), and/or a known BRCA2 germline mutation, he added.

Urologists cheered the NCCN’s reversal on Twitter.

“Big news! NCCN guidelines updated again — active surveillance is ‘preferred for most patients’ with low risk prostate cancer and life expectancy >=10 years,” tweeted Stacy Loeb of NYU Langone in New York City.

“Very exciting if true,” tweeted Matthew Cooperberg, MD, of University of California San Francisco, who was one of the most vocal critics of the NCCN’s change in September, calling that move a “step backward” that would likely lead to overtreatment.

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

After making a controversial change in September to a long-standing recommendation about the use of active surveillance in men with prostate cancer, the National Comprehensive Cancer Network (NCCN) has reversed course and reinstated its original advice, with a slight tweak.

The influential cancer organization, which is best known for its guidelines, now recommends that “most” men with low-risk prostate cancer be offered active surveillance as the lone “preferred” initial treatment option. This advice aligns closely with the group’s initial recommendation, published over a decade ago.

But controversy erupted in late September when the NCCN suddenly changed its tune on active surveillance, recommending that men with low-risk disease be managed with either active surveillance, radiation therapy, or surgery, with equal weight given to all three.

The new advice angered physicians who support the concept of active surveillance, which aims to avoid or delay treatment — and potentially life-changing side effects — until signs of disease progression.

The NCCN listened to the complaints.

On Nov. 30, the group largely reverted back to the original recommendation. In updated guidelines, active surveillance returned to its place as the sole “preferred” management option, but for “most” men with low-risk disease, not all.

In an email sent to this news organization, Edward Schaeffer, MD, PhD, chair of the prostate cancer treatment panel, said that “the NCCN Prostate Cancer Panel recently convened” and “extensively revised the Principles of Active Surveillance and Observation.”

Dr. Schaeffer, who is from the Lurie Comprehensive Cancer Center of Northwestern University in Chicago, cited the heterogeneity across the low-risk disease group. Factors associated with an increased probability of near-term grade reclassification from low risk to higher risk include high PSA density, a high number of positive cores (≥ 3), high genomic risk (from tissue-based molecular tumor analysis), and/or a known BRCA2 germline mutation, he added.

Urologists cheered the NCCN’s reversal on Twitter.

“Big news! NCCN guidelines updated again — active surveillance is ‘preferred for most patients’ with low risk prostate cancer and life expectancy >=10 years,” tweeted Stacy Loeb of NYU Langone in New York City.

“Very exciting if true,” tweeted Matthew Cooperberg, MD, of University of California San Francisco, who was one of the most vocal critics of the NCCN’s change in September, calling that move a “step backward” that would likely lead to overtreatment.

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

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‘I Can Go Anywhere’: How Service Dogs Help Veterans With PTSD

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It was supper time in the Whittier, California, home of Air Force veteran Danyelle Clark-Gutierrez, and eagerly awaiting a bowl of kibble and canned dog food was Lisa, a 3-year-old yellow Labrador retriever.

Her nails clicking on the kitchen floor as she danced about, Lisa looked more like an exuberant puppy than the highly trained service animal that helps Clark-Gutierrez manage the symptoms of post-traumatic stress disorder.

“Having her now, it’s like I can go anywhere,” Clark-Gutierrez said. “And, yes, if somebody did come at me, I’d have warning — I could run.”

A growing body of research into PTSD and service animals paved the way for President Joe Biden to sign into law the Puppies Assisting Wounded Servicemembers (PAWS) for Veterans Therapy Act. The legislation, enacted in August, requires the Department of Veterans Affairs to open its service dog referral program to veterans with PTSD and to launch a five-year pilot program in which veterans with PTSD train service dogs for other veterans.

Clark-Gutierrez, 33, is among the 25 percent of female veterans who have reported experiencing military sexual trauma while serving in the U.S. armed services.

Military sexual trauma, combat violence and brain injuries are some of the experiences that increase the risk that service members will develop PTSD. Symptoms include flashbacks to the traumatic event, severe anxiety, nightmares and hypervigilance — all normal reactions to experiencing or witnessing violence, according to psychologists. Someone receives a PTSD diagnosis when symptoms worsen or remain for months or years.

That’s what Clark-Gutierrez said happened to her after ongoing sexual harassment by a fellow airman escalated to a physical attack about a decade ago. A lawyer with three children, she said that to feel safe leaving her home she needed her husband by her side. After diagnosing Clark-Gutierrez with PTSD, doctors at VA hospitals prescribed a cascade of medications for her. At one point, Clark-Gutierrez said, her prescriptions added up to more than a dozen pills a day.

“I had medication, and then I had medication for the two or three side effects for each medication,” she said. “And every time they gave me a new med, they had to give me three more. I just couldn’t do it anymore. I was just getting so tired. So we started looking at other therapies.”

And that’s how she got her service dog, Lisa. Clark-Gutierrez’s husband, also an Air Force veteran, discovered the nonprofit group K9s for Warriors, which rescues dogs — many from kill shelters — and trains them to be service animals for veterans with PTSD. Lisa is one of about 700 dogs the group has paired with veterans dealing with symptoms caused by traumatic experiences.

“Now with Lisa we take bike rides, we go down to the park, we go to Home Depot,” said Clark-Gutierrez. “I go grocery shopping — normal-people things that I get to do that I didn’t get to do before Lisa.”

That comes as no surprise to Maggie O’Haire, an associate professor of human-animal interaction at Purdue University. Her research suggests that while service dogs aren’t necessarily a cure for PTSD, they do ease its symptoms. Among her published studies is one showing that veterans partnered with these dogs experience less anger and anxiety and get better sleep than those without a service dog. Another of her studies suggests that service dogs lower cortisol levels in veterans who have been traumatized.

“We actually saw patterns of that stress hormone that were more similar to healthy adults who don’t have post-traumatic stress disorder,” O’Haire said.

A congressionally mandated VA study that focuses on service dogs’ impact on veterans with PTSD and was published this year suggests that those partnered with the animals experience less suicidal ideation and more improvement to their symptoms than those without them.

Until now, the federal dog referral program — which relies on nonprofit service dog organizations to pay for the dogs and to provide them to veterans for free — required that participating veterans have a physical mobility issue, such as a lost limb, paralysis or blindness. Veterans like Clark-Gutierrez who have PTSD but no physical disability were on their own in arranging for a service dog.

The pilot program created by the new federal law will give veterans with PTSD the chance to train mental health service dogs for other veterans. It’s modeled on a program at the VA hospital in Palo Alto, California, and will be offered at five VA medical centers nationwide in partnership with accredited service dog training organizations.

“This bill is really about therapeutic, on-the-job training, or ‘training the trainer,’” said Adam Webb, a spokesperson for Sen. Thom Tillis (R-N.C.), who introduced the legislation in the Senate. “We don’t anticipate VA will start prescribing PTSD service dogs, but the data we generate from this pilot program will likely be useful in making that case in the future.”

The Congressional Budget Office estimates the pilot program will cost the VA about $19 million. The law stops short of requiring the VA to pay for the dogs. Instead, the agency will partner with accredited service dog organizations that use private money to cover the cost of adopting, training and pairing the dogs with veterans.

Still, the law represents a welcome about-face in VA policy, said Rory Diamond, CEO of K9s for Warriors.

“For the last 10 years, the VA has essentially told us that they don’t recognize service dogs as helping a veteran with post-traumatic stress,” Diamond said.

PTSD service dogs are often confused with emotional support dogs, Diamond said. The latter provide companionship and are not trained to support someone with a disability. PTSD service dogs cost about $25,000 to adopt and train, he said.

Diamond explained that the command “cover” means “the dog will sit next to the warrior, look behind them and alert them if someone comes up from behind.” The command “block” means the dog will “stand perpendicular and give them some space from whatever’s in front of them.”

Retired Army Master Sgt. David Crenshaw of Kearny, New Jersey, said his service dog, Doc, has changed his life.

“We teach in the military to have a battle buddy,” Crenshaw said. “And these service animals act as a battle buddy.”

A few months ago, Crenshaw experienced this firsthand. He had generally avoided large gatherings because persistent hypervigilance is one symptom of his combat-caused PTSD. But this summer, Doc, a pointer and Labrador mix, helped Crenshaw navigate the crowds at Disney World — a significant first for Crenshaw and his family of five.

“I was not agitated. I was not anxious. I was not upset,” said Crenshaw, 39. “It was truly, truly amazing and so much so that I didn’t even have to even stop to think about it in the moment. It just happened naturally.”

Thanks to Doc, Crenshaw said, he no longer takes PTSD drugs or self-medicates with alcohol. Clark-Gutierrez said Lisa, too, has helped her quit using alcohol and stop taking VA-prescribed medications for panic attacks, nightmares and periods of disassociation.

The dogs actually save the VA money over time, Diamond said. “Our warriors are far less likely to be on expensive prescription drugs, are far less likely to use other VA services and far more likely to go to school or go to work. So it’s a win-win-win across the board.

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It was supper time in the Whittier, California, home of Air Force veteran Danyelle Clark-Gutierrez, and eagerly awaiting a bowl of kibble and canned dog food was Lisa, a 3-year-old yellow Labrador retriever.

Her nails clicking on the kitchen floor as she danced about, Lisa looked more like an exuberant puppy than the highly trained service animal that helps Clark-Gutierrez manage the symptoms of post-traumatic stress disorder.

“Having her now, it’s like I can go anywhere,” Clark-Gutierrez said. “And, yes, if somebody did come at me, I’d have warning — I could run.”

A growing body of research into PTSD and service animals paved the way for President Joe Biden to sign into law the Puppies Assisting Wounded Servicemembers (PAWS) for Veterans Therapy Act. The legislation, enacted in August, requires the Department of Veterans Affairs to open its service dog referral program to veterans with PTSD and to launch a five-year pilot program in which veterans with PTSD train service dogs for other veterans.

Clark-Gutierrez, 33, is among the 25 percent of female veterans who have reported experiencing military sexual trauma while serving in the U.S. armed services.

Military sexual trauma, combat violence and brain injuries are some of the experiences that increase the risk that service members will develop PTSD. Symptoms include flashbacks to the traumatic event, severe anxiety, nightmares and hypervigilance — all normal reactions to experiencing or witnessing violence, according to psychologists. Someone receives a PTSD diagnosis when symptoms worsen or remain for months or years.

That’s what Clark-Gutierrez said happened to her after ongoing sexual harassment by a fellow airman escalated to a physical attack about a decade ago. A lawyer with three children, she said that to feel safe leaving her home she needed her husband by her side. After diagnosing Clark-Gutierrez with PTSD, doctors at VA hospitals prescribed a cascade of medications for her. At one point, Clark-Gutierrez said, her prescriptions added up to more than a dozen pills a day.

“I had medication, and then I had medication for the two or three side effects for each medication,” she said. “And every time they gave me a new med, they had to give me three more. I just couldn’t do it anymore. I was just getting so tired. So we started looking at other therapies.”

And that’s how she got her service dog, Lisa. Clark-Gutierrez’s husband, also an Air Force veteran, discovered the nonprofit group K9s for Warriors, which rescues dogs — many from kill shelters — and trains them to be service animals for veterans with PTSD. Lisa is one of about 700 dogs the group has paired with veterans dealing with symptoms caused by traumatic experiences.

“Now with Lisa we take bike rides, we go down to the park, we go to Home Depot,” said Clark-Gutierrez. “I go grocery shopping — normal-people things that I get to do that I didn’t get to do before Lisa.”

That comes as no surprise to Maggie O’Haire, an associate professor of human-animal interaction at Purdue University. Her research suggests that while service dogs aren’t necessarily a cure for PTSD, they do ease its symptoms. Among her published studies is one showing that veterans partnered with these dogs experience less anger and anxiety and get better sleep than those without a service dog. Another of her studies suggests that service dogs lower cortisol levels in veterans who have been traumatized.

“We actually saw patterns of that stress hormone that were more similar to healthy adults who don’t have post-traumatic stress disorder,” O’Haire said.

A congressionally mandated VA study that focuses on service dogs’ impact on veterans with PTSD and was published this year suggests that those partnered with the animals experience less suicidal ideation and more improvement to their symptoms than those without them.

Until now, the federal dog referral program — which relies on nonprofit service dog organizations to pay for the dogs and to provide them to veterans for free — required that participating veterans have a physical mobility issue, such as a lost limb, paralysis or blindness. Veterans like Clark-Gutierrez who have PTSD but no physical disability were on their own in arranging for a service dog.

The pilot program created by the new federal law will give veterans with PTSD the chance to train mental health service dogs for other veterans. It’s modeled on a program at the VA hospital in Palo Alto, California, and will be offered at five VA medical centers nationwide in partnership with accredited service dog training organizations.

“This bill is really about therapeutic, on-the-job training, or ‘training the trainer,’” said Adam Webb, a spokesperson for Sen. Thom Tillis (R-N.C.), who introduced the legislation in the Senate. “We don’t anticipate VA will start prescribing PTSD service dogs, but the data we generate from this pilot program will likely be useful in making that case in the future.”

The Congressional Budget Office estimates the pilot program will cost the VA about $19 million. The law stops short of requiring the VA to pay for the dogs. Instead, the agency will partner with accredited service dog organizations that use private money to cover the cost of adopting, training and pairing the dogs with veterans.

Still, the law represents a welcome about-face in VA policy, said Rory Diamond, CEO of K9s for Warriors.

“For the last 10 years, the VA has essentially told us that they don’t recognize service dogs as helping a veteran with post-traumatic stress,” Diamond said.

PTSD service dogs are often confused with emotional support dogs, Diamond said. The latter provide companionship and are not trained to support someone with a disability. PTSD service dogs cost about $25,000 to adopt and train, he said.

Diamond explained that the command “cover” means “the dog will sit next to the warrior, look behind them and alert them if someone comes up from behind.” The command “block” means the dog will “stand perpendicular and give them some space from whatever’s in front of them.”

Retired Army Master Sgt. David Crenshaw of Kearny, New Jersey, said his service dog, Doc, has changed his life.

“We teach in the military to have a battle buddy,” Crenshaw said. “And these service animals act as a battle buddy.”

A few months ago, Crenshaw experienced this firsthand. He had generally avoided large gatherings because persistent hypervigilance is one symptom of his combat-caused PTSD. But this summer, Doc, a pointer and Labrador mix, helped Crenshaw navigate the crowds at Disney World — a significant first for Crenshaw and his family of five.

“I was not agitated. I was not anxious. I was not upset,” said Crenshaw, 39. “It was truly, truly amazing and so much so that I didn’t even have to even stop to think about it in the moment. It just happened naturally.”

Thanks to Doc, Crenshaw said, he no longer takes PTSD drugs or self-medicates with alcohol. Clark-Gutierrez said Lisa, too, has helped her quit using alcohol and stop taking VA-prescribed medications for panic attacks, nightmares and periods of disassociation.

The dogs actually save the VA money over time, Diamond said. “Our warriors are far less likely to be on expensive prescription drugs, are far less likely to use other VA services and far more likely to go to school or go to work. So it’s a win-win-win across the board.

It was supper time in the Whittier, California, home of Air Force veteran Danyelle Clark-Gutierrez, and eagerly awaiting a bowl of kibble and canned dog food was Lisa, a 3-year-old yellow Labrador retriever.

Her nails clicking on the kitchen floor as she danced about, Lisa looked more like an exuberant puppy than the highly trained service animal that helps Clark-Gutierrez manage the symptoms of post-traumatic stress disorder.

“Having her now, it’s like I can go anywhere,” Clark-Gutierrez said. “And, yes, if somebody did come at me, I’d have warning — I could run.”

A growing body of research into PTSD and service animals paved the way for President Joe Biden to sign into law the Puppies Assisting Wounded Servicemembers (PAWS) for Veterans Therapy Act. The legislation, enacted in August, requires the Department of Veterans Affairs to open its service dog referral program to veterans with PTSD and to launch a five-year pilot program in which veterans with PTSD train service dogs for other veterans.

Clark-Gutierrez, 33, is among the 25 percent of female veterans who have reported experiencing military sexual trauma while serving in the U.S. armed services.

Military sexual trauma, combat violence and brain injuries are some of the experiences that increase the risk that service members will develop PTSD. Symptoms include flashbacks to the traumatic event, severe anxiety, nightmares and hypervigilance — all normal reactions to experiencing or witnessing violence, according to psychologists. Someone receives a PTSD diagnosis when symptoms worsen or remain for months or years.

That’s what Clark-Gutierrez said happened to her after ongoing sexual harassment by a fellow airman escalated to a physical attack about a decade ago. A lawyer with three children, she said that to feel safe leaving her home she needed her husband by her side. After diagnosing Clark-Gutierrez with PTSD, doctors at VA hospitals prescribed a cascade of medications for her. At one point, Clark-Gutierrez said, her prescriptions added up to more than a dozen pills a day.

“I had medication, and then I had medication for the two or three side effects for each medication,” she said. “And every time they gave me a new med, they had to give me three more. I just couldn’t do it anymore. I was just getting so tired. So we started looking at other therapies.”

And that’s how she got her service dog, Lisa. Clark-Gutierrez’s husband, also an Air Force veteran, discovered the nonprofit group K9s for Warriors, which rescues dogs — many from kill shelters — and trains them to be service animals for veterans with PTSD. Lisa is one of about 700 dogs the group has paired with veterans dealing with symptoms caused by traumatic experiences.

“Now with Lisa we take bike rides, we go down to the park, we go to Home Depot,” said Clark-Gutierrez. “I go grocery shopping — normal-people things that I get to do that I didn’t get to do before Lisa.”

That comes as no surprise to Maggie O’Haire, an associate professor of human-animal interaction at Purdue University. Her research suggests that while service dogs aren’t necessarily a cure for PTSD, they do ease its symptoms. Among her published studies is one showing that veterans partnered with these dogs experience less anger and anxiety and get better sleep than those without a service dog. Another of her studies suggests that service dogs lower cortisol levels in veterans who have been traumatized.

“We actually saw patterns of that stress hormone that were more similar to healthy adults who don’t have post-traumatic stress disorder,” O’Haire said.

A congressionally mandated VA study that focuses on service dogs’ impact on veterans with PTSD and was published this year suggests that those partnered with the animals experience less suicidal ideation and more improvement to their symptoms than those without them.

Until now, the federal dog referral program — which relies on nonprofit service dog organizations to pay for the dogs and to provide them to veterans for free — required that participating veterans have a physical mobility issue, such as a lost limb, paralysis or blindness. Veterans like Clark-Gutierrez who have PTSD but no physical disability were on their own in arranging for a service dog.

The pilot program created by the new federal law will give veterans with PTSD the chance to train mental health service dogs for other veterans. It’s modeled on a program at the VA hospital in Palo Alto, California, and will be offered at five VA medical centers nationwide in partnership with accredited service dog training organizations.

“This bill is really about therapeutic, on-the-job training, or ‘training the trainer,’” said Adam Webb, a spokesperson for Sen. Thom Tillis (R-N.C.), who introduced the legislation in the Senate. “We don’t anticipate VA will start prescribing PTSD service dogs, but the data we generate from this pilot program will likely be useful in making that case in the future.”

The Congressional Budget Office estimates the pilot program will cost the VA about $19 million. The law stops short of requiring the VA to pay for the dogs. Instead, the agency will partner with accredited service dog organizations that use private money to cover the cost of adopting, training and pairing the dogs with veterans.

Still, the law represents a welcome about-face in VA policy, said Rory Diamond, CEO of K9s for Warriors.

“For the last 10 years, the VA has essentially told us that they don’t recognize service dogs as helping a veteran with post-traumatic stress,” Diamond said.

PTSD service dogs are often confused with emotional support dogs, Diamond said. The latter provide companionship and are not trained to support someone with a disability. PTSD service dogs cost about $25,000 to adopt and train, he said.

Diamond explained that the command “cover” means “the dog will sit next to the warrior, look behind them and alert them if someone comes up from behind.” The command “block” means the dog will “stand perpendicular and give them some space from whatever’s in front of them.”

Retired Army Master Sgt. David Crenshaw of Kearny, New Jersey, said his service dog, Doc, has changed his life.

“We teach in the military to have a battle buddy,” Crenshaw said. “And these service animals act as a battle buddy.”

A few months ago, Crenshaw experienced this firsthand. He had generally avoided large gatherings because persistent hypervigilance is one symptom of his combat-caused PTSD. But this summer, Doc, a pointer and Labrador mix, helped Crenshaw navigate the crowds at Disney World — a significant first for Crenshaw and his family of five.

“I was not agitated. I was not anxious. I was not upset,” said Crenshaw, 39. “It was truly, truly amazing and so much so that I didn’t even have to even stop to think about it in the moment. It just happened naturally.”

Thanks to Doc, Crenshaw said, he no longer takes PTSD drugs or self-medicates with alcohol. Clark-Gutierrez said Lisa, too, has helped her quit using alcohol and stop taking VA-prescribed medications for panic attacks, nightmares and periods of disassociation.

The dogs actually save the VA money over time, Diamond said. “Our warriors are far less likely to be on expensive prescription drugs, are far less likely to use other VA services and far more likely to go to school or go to work. So it’s a win-win-win across the board.

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Congress OKs Veterans Affairs Expansive New Maternal Care Program

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“Momnibus” bill focused on the maternal health crisis for Black women includes $15 million for veteran mothers.

It’s called the Momnibus—the Black Maternal Health Momnibus Act of 2021 (HR 959) with 12 bills addressing “every dimension of the maternal health crisis in America.” The first bill in the Momnibus to pass Congress is the Protecting Moms Who Served act, which sets up a $15 million maternal care program within the US Department of Veterans Affairs (VA). “There has never been a comprehensive evaluation of how our nation’s growing maternal mortality crisis is impacting our women veterans, even though they may be at higher risk due to their service,” said Sen. Tammy Duckworth (D-IL), a co-sponsor of the Momnibus. The bill has passed Congress and awaits President Biden’s signature.

Rep. Lauren Underwood (D-IL) along with Rep. Alma Adams (D- NC-12), Sen. Cory Booker D-NJ), and members of the Black Maternal Health Caucus reintroduced the bill (first introduced last year). According to Rep. Underwood, the act would codify and strengthen the VA maternity care coordination programs. It also will require the US Government Accountability Office to report the deaths of pregnant and postpartum veterans and to focus on any racial or ethnic disparities. The bill passed overwhelmingly, 414 to 9 and awaits President Biden’s signature.

The Momnibus’s cute name represents a very serious purpose. “Maternal mortality has historically been used as a key indicator of the health of a population,” say researchers from National Vital Statistics Reports. But American mothers are dying at the highest rate in the developed world, and the numbers have been rising dramatically. Between 1987, when the Centers for Disease Control and Prevention (CDC) launched the Pregnancy Mortality Surveillance System in 2017, the latest year for available data, the number of reported pregnancy-related deaths in the United States rose steadily from 7.2 deaths per 100,000 live births to 17.3 per 100,000.

The maternal morbidity crisis is particularly stark among certain groups of women. Black women are acutely at risk, dying at 3 to 4 times the rate of White women (41.7 deaths per 100,000 live births), and one-third higher than the next highest risk group, Native American women (28.3 deaths per 100,000 live births).

But just how accurate have the data been? The study published in National Vital Statistics Report found that using a checkbox for “cause of death” specifying maternal death identified more than triple the number of maternal deaths. Without the checkbox item, maternal mortality rates in 2015 and 2016 would have been reported as 8.7 deaths per 100,000 live births, compared with 8.9 in 2002. With the checkbox, the rate would be reported as 20.9 per 100,000 live births in 2015 and 21.8/100,000 in 2016.

The CDC states that the reasons for the rising numbers are unclear; advances in identification have improved over time, for one. But by and large, the women are dying of preventable causes, such as hypertension, diabetes mellitus, and chronic heart disease. Nearly 60% of maternal deaths are deemed preventable.

Black and other minority women, though, may be dying of biases. Researchers from Beth Israel and Harvard cite studies that have found racial and ethnic disparities in obstetric care delivery. Non-Hispanic Blacks women, Hispanic women, and Asian women, for instance, have lower odds of labor induction when compared with that of White women. The odds of receiving an episiotomy are lower in non-Hispanic Black and Hispanic women. The Listening to Mothers survey III found that 24% of participants perceived discrimination during birth hospitalization, predominantly among Black or Hispanic women and uninsured women.

A maternal health equity advocacy group, 4Kira4Moms, was founded by the husband of Kira Johnson who died of hemorrhage following a routine scheduled cesarean section. In the recovery room, her catheter began turning pink with blood. For 10 hours, her husband said, he and her family begged the medical staff for help but were told his wife was not a priority. Thus, the Momnibus also contains the Kira Johnson Act, which will establish funding for community-based groups to provide Black pregnant women with more support.

Among other changes, the Momnibus will:

  • Make critical investments in social determinants of health that influence maternal health outcomes, such as housing, transportation, and nutrition;
  • Provide funding to community-based organizations that are working to improve maternal health outcomes and promote equity;
  • Comprehensively study the unique maternal health risks facing pregnant and postpartum veterans and support VA maternity care coordination programs;
  • Support mothers with mental health conditions and substance use disorders; and
  • Promote innovative payment models to incentivize high-quality maternity care and nonclinical perinatal support

 

A variety of recent bills in Congress address maternal health. The Mothers and Offspring Mortality and Morbidity Awareness (MOMMA) Act, for instance, also would specifically address maternal health disparities by improving data collection and reporting, improving maternal care, and advancing respectful, equitable care. It also would extend Medicaid and the Children’s Health Insurance Program coverage. Katie Shea Barrett, MPH, executive director of March for Moms, a coalition of families, health care practitioners, policy makers, and partners advocating for mothers’ and families’ health, notes in an essay for thehill.com that Medicaid coverage ends about 60 days postpartum, although half of the maternal deaths happen between 42 days and 1 year postpartum. 

She writes: “[W]e have to directly address the disproportionate impact of maternal mortality on women of color by training providers in offering care that is culturally competent and free of implicit bias. Health systems must be aware and respectful of cultural norms when providing care and be mindful of buying into stereotypes based on race, ethnicity, and even underlying medical conditions like diabetes, which often lead to perceived discrimination and perpetuate systems of injustice.”

In April, Vice President Kamala Harris called for sweeping action to curb racial inequities in pregnancy and childbirth. In an email Q&A with STAT, she said, “With every day that goes by and every woman who dies, the need for action grows more urgent.”

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“Momnibus” bill focused on the maternal health crisis for Black women includes $15 million for veteran mothers.
“Momnibus” bill focused on the maternal health crisis for Black women includes $15 million for veteran mothers.

It’s called the Momnibus—the Black Maternal Health Momnibus Act of 2021 (HR 959) with 12 bills addressing “every dimension of the maternal health crisis in America.” The first bill in the Momnibus to pass Congress is the Protecting Moms Who Served act, which sets up a $15 million maternal care program within the US Department of Veterans Affairs (VA). “There has never been a comprehensive evaluation of how our nation’s growing maternal mortality crisis is impacting our women veterans, even though they may be at higher risk due to their service,” said Sen. Tammy Duckworth (D-IL), a co-sponsor of the Momnibus. The bill has passed Congress and awaits President Biden’s signature.

Rep. Lauren Underwood (D-IL) along with Rep. Alma Adams (D- NC-12), Sen. Cory Booker D-NJ), and members of the Black Maternal Health Caucus reintroduced the bill (first introduced last year). According to Rep. Underwood, the act would codify and strengthen the VA maternity care coordination programs. It also will require the US Government Accountability Office to report the deaths of pregnant and postpartum veterans and to focus on any racial or ethnic disparities. The bill passed overwhelmingly, 414 to 9 and awaits President Biden’s signature.

The Momnibus’s cute name represents a very serious purpose. “Maternal mortality has historically been used as a key indicator of the health of a population,” say researchers from National Vital Statistics Reports. But American mothers are dying at the highest rate in the developed world, and the numbers have been rising dramatically. Between 1987, when the Centers for Disease Control and Prevention (CDC) launched the Pregnancy Mortality Surveillance System in 2017, the latest year for available data, the number of reported pregnancy-related deaths in the United States rose steadily from 7.2 deaths per 100,000 live births to 17.3 per 100,000.

The maternal morbidity crisis is particularly stark among certain groups of women. Black women are acutely at risk, dying at 3 to 4 times the rate of White women (41.7 deaths per 100,000 live births), and one-third higher than the next highest risk group, Native American women (28.3 deaths per 100,000 live births).

But just how accurate have the data been? The study published in National Vital Statistics Report found that using a checkbox for “cause of death” specifying maternal death identified more than triple the number of maternal deaths. Without the checkbox item, maternal mortality rates in 2015 and 2016 would have been reported as 8.7 deaths per 100,000 live births, compared with 8.9 in 2002. With the checkbox, the rate would be reported as 20.9 per 100,000 live births in 2015 and 21.8/100,000 in 2016.

The CDC states that the reasons for the rising numbers are unclear; advances in identification have improved over time, for one. But by and large, the women are dying of preventable causes, such as hypertension, diabetes mellitus, and chronic heart disease. Nearly 60% of maternal deaths are deemed preventable.

Black and other minority women, though, may be dying of biases. Researchers from Beth Israel and Harvard cite studies that have found racial and ethnic disparities in obstetric care delivery. Non-Hispanic Blacks women, Hispanic women, and Asian women, for instance, have lower odds of labor induction when compared with that of White women. The odds of receiving an episiotomy are lower in non-Hispanic Black and Hispanic women. The Listening to Mothers survey III found that 24% of participants perceived discrimination during birth hospitalization, predominantly among Black or Hispanic women and uninsured women.

A maternal health equity advocacy group, 4Kira4Moms, was founded by the husband of Kira Johnson who died of hemorrhage following a routine scheduled cesarean section. In the recovery room, her catheter began turning pink with blood. For 10 hours, her husband said, he and her family begged the medical staff for help but were told his wife was not a priority. Thus, the Momnibus also contains the Kira Johnson Act, which will establish funding for community-based groups to provide Black pregnant women with more support.

Among other changes, the Momnibus will:

  • Make critical investments in social determinants of health that influence maternal health outcomes, such as housing, transportation, and nutrition;
  • Provide funding to community-based organizations that are working to improve maternal health outcomes and promote equity;
  • Comprehensively study the unique maternal health risks facing pregnant and postpartum veterans and support VA maternity care coordination programs;
  • Support mothers with mental health conditions and substance use disorders; and
  • Promote innovative payment models to incentivize high-quality maternity care and nonclinical perinatal support

 

A variety of recent bills in Congress address maternal health. The Mothers and Offspring Mortality and Morbidity Awareness (MOMMA) Act, for instance, also would specifically address maternal health disparities by improving data collection and reporting, improving maternal care, and advancing respectful, equitable care. It also would extend Medicaid and the Children’s Health Insurance Program coverage. Katie Shea Barrett, MPH, executive director of March for Moms, a coalition of families, health care practitioners, policy makers, and partners advocating for mothers’ and families’ health, notes in an essay for thehill.com that Medicaid coverage ends about 60 days postpartum, although half of the maternal deaths happen between 42 days and 1 year postpartum. 

She writes: “[W]e have to directly address the disproportionate impact of maternal mortality on women of color by training providers in offering care that is culturally competent and free of implicit bias. Health systems must be aware and respectful of cultural norms when providing care and be mindful of buying into stereotypes based on race, ethnicity, and even underlying medical conditions like diabetes, which often lead to perceived discrimination and perpetuate systems of injustice.”

In April, Vice President Kamala Harris called for sweeping action to curb racial inequities in pregnancy and childbirth. In an email Q&A with STAT, she said, “With every day that goes by and every woman who dies, the need for action grows more urgent.”

It’s called the Momnibus—the Black Maternal Health Momnibus Act of 2021 (HR 959) with 12 bills addressing “every dimension of the maternal health crisis in America.” The first bill in the Momnibus to pass Congress is the Protecting Moms Who Served act, which sets up a $15 million maternal care program within the US Department of Veterans Affairs (VA). “There has never been a comprehensive evaluation of how our nation’s growing maternal mortality crisis is impacting our women veterans, even though they may be at higher risk due to their service,” said Sen. Tammy Duckworth (D-IL), a co-sponsor of the Momnibus. The bill has passed Congress and awaits President Biden’s signature.

Rep. Lauren Underwood (D-IL) along with Rep. Alma Adams (D- NC-12), Sen. Cory Booker D-NJ), and members of the Black Maternal Health Caucus reintroduced the bill (first introduced last year). According to Rep. Underwood, the act would codify and strengthen the VA maternity care coordination programs. It also will require the US Government Accountability Office to report the deaths of pregnant and postpartum veterans and to focus on any racial or ethnic disparities. The bill passed overwhelmingly, 414 to 9 and awaits President Biden’s signature.

The Momnibus’s cute name represents a very serious purpose. “Maternal mortality has historically been used as a key indicator of the health of a population,” say researchers from National Vital Statistics Reports. But American mothers are dying at the highest rate in the developed world, and the numbers have been rising dramatically. Between 1987, when the Centers for Disease Control and Prevention (CDC) launched the Pregnancy Mortality Surveillance System in 2017, the latest year for available data, the number of reported pregnancy-related deaths in the United States rose steadily from 7.2 deaths per 100,000 live births to 17.3 per 100,000.

The maternal morbidity crisis is particularly stark among certain groups of women. Black women are acutely at risk, dying at 3 to 4 times the rate of White women (41.7 deaths per 100,000 live births), and one-third higher than the next highest risk group, Native American women (28.3 deaths per 100,000 live births).

But just how accurate have the data been? The study published in National Vital Statistics Report found that using a checkbox for “cause of death” specifying maternal death identified more than triple the number of maternal deaths. Without the checkbox item, maternal mortality rates in 2015 and 2016 would have been reported as 8.7 deaths per 100,000 live births, compared with 8.9 in 2002. With the checkbox, the rate would be reported as 20.9 per 100,000 live births in 2015 and 21.8/100,000 in 2016.

The CDC states that the reasons for the rising numbers are unclear; advances in identification have improved over time, for one. But by and large, the women are dying of preventable causes, such as hypertension, diabetes mellitus, and chronic heart disease. Nearly 60% of maternal deaths are deemed preventable.

Black and other minority women, though, may be dying of biases. Researchers from Beth Israel and Harvard cite studies that have found racial and ethnic disparities in obstetric care delivery. Non-Hispanic Blacks women, Hispanic women, and Asian women, for instance, have lower odds of labor induction when compared with that of White women. The odds of receiving an episiotomy are lower in non-Hispanic Black and Hispanic women. The Listening to Mothers survey III found that 24% of participants perceived discrimination during birth hospitalization, predominantly among Black or Hispanic women and uninsured women.

A maternal health equity advocacy group, 4Kira4Moms, was founded by the husband of Kira Johnson who died of hemorrhage following a routine scheduled cesarean section. In the recovery room, her catheter began turning pink with blood. For 10 hours, her husband said, he and her family begged the medical staff for help but were told his wife was not a priority. Thus, the Momnibus also contains the Kira Johnson Act, which will establish funding for community-based groups to provide Black pregnant women with more support.

Among other changes, the Momnibus will:

  • Make critical investments in social determinants of health that influence maternal health outcomes, such as housing, transportation, and nutrition;
  • Provide funding to community-based organizations that are working to improve maternal health outcomes and promote equity;
  • Comprehensively study the unique maternal health risks facing pregnant and postpartum veterans and support VA maternity care coordination programs;
  • Support mothers with mental health conditions and substance use disorders; and
  • Promote innovative payment models to incentivize high-quality maternity care and nonclinical perinatal support

 

A variety of recent bills in Congress address maternal health. The Mothers and Offspring Mortality and Morbidity Awareness (MOMMA) Act, for instance, also would specifically address maternal health disparities by improving data collection and reporting, improving maternal care, and advancing respectful, equitable care. It also would extend Medicaid and the Children’s Health Insurance Program coverage. Katie Shea Barrett, MPH, executive director of March for Moms, a coalition of families, health care practitioners, policy makers, and partners advocating for mothers’ and families’ health, notes in an essay for thehill.com that Medicaid coverage ends about 60 days postpartum, although half of the maternal deaths happen between 42 days and 1 year postpartum. 

She writes: “[W]e have to directly address the disproportionate impact of maternal mortality on women of color by training providers in offering care that is culturally competent and free of implicit bias. Health systems must be aware and respectful of cultural norms when providing care and be mindful of buying into stereotypes based on race, ethnicity, and even underlying medical conditions like diabetes, which often lead to perceived discrimination and perpetuate systems of injustice.”

In April, Vice President Kamala Harris called for sweeping action to curb racial inequities in pregnancy and childbirth. In an email Q&A with STAT, she said, “With every day that goes by and every woman who dies, the need for action grows more urgent.”

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Short-acting opioids needed for withdrawal in U.S. hospitals, say experts

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Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

Dr. Elisabeth Poorman

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

 

 

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

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Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

Dr. Elisabeth Poorman

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

 

 

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

 

Short-acting opioids may complement methadone and buprenorphine for opioid withdrawal symptoms in U.S. hospitals, say authors of an opinion piece calling for rethinking current strategies for opioid withdrawal in this country.

The commentary by Robert A. Kleinman, MD, with the Centre for Addiction and Mental Health, and department of psychiatry, University of Toronto, and Sarah E. Wakeman, MD, with the division of general internal medicine at Massachusetts General Hospital, and Harvard Medical School, Boston, was published in Annals of Internal Medicine.

Currently, short-acting opioids are not recommended in the United States for opioid withdrawal symptoms (OWS) management in the hospital, the authors wrote. Instead, withdrawal symptoms are typically treated, followed by methadone or buprenorphine or nonopioid medications, but many patients don’t get enough relief. Undertreated withdrawal can result in patients leaving the hospital against medical advice, which is linked with higher risk of death.

Addiction specialist Elisabeth Poorman, MD, of the University of Illinois Chicago, said in an interview that she agrees it’s time to start shifting the thinking on using short-acting opioids for OWS in hospitals. Use varies greatly by hospital and by clinician, she said.

Dr. Elisabeth Poorman

“It’s time to let evidence guide us and to be flexible,” Dr. Poorman said.

The commentary authors noted that with methadone, patients must wait several hours for maximal symptom reduction, and the full benefits of methadone treatment are not realized until days after initiation.

Rapid initiation of methadone may be feasible in hospitals and has been proposed as an option, but further study is necessary before widespread use, the authors wrote.
 

Short-acting opioids may address limitations of other opioids

Lofexidine, an alpha-2-adrenergic agonist, is the only drug approved by the Food and Drug Administration specifically for OWS.

“However,” the authors said, “more than half of patients with OWS treated with lofexidine in phase 3 efficacy trials dropped out by day five. Clonidine, another alpha-2-agonist used off label to treat OWS, has similar effects to those of lofexidine. “

Therefore, short-acting opioids may complement methadone and buprenorphine in treating OWS in the hospital by addressing their limitations, the authors wrote.

Dr. Kleinman and Dr. Wakeman also say short-acting opioids may help with starting buprenorphine for patients exposed to fentanyl, because short-acting opioids can relieve withdrawal symptoms while fentanyl is metabolized and excreted.

Supplementation with short-acting opioids within the hospital can relieve withdrawal symptoms and help keep patients comfortable while methadone is titrated to more effective doses for long-term treatment, they wrote.

With short-acting opioids, patients may become more engaged in their care with, for example, a tamper-proof, patient-controlled analgesia pump, which would allow them to have more autonomy in administration of opioids to relieve pain and withdrawal symptoms, the authors wrote.

Dr. Kleinman and Dr. Wakeman noted that many patients who inject drugs already consume short-acting illicit drugs in the hospital, typically in washrooms and smoking areas, so supervised use of short-acting opioids helps eliminate the risk for unwitnessed overdoses.

 

 

Barriers to short-acting opioid use

Despite use of short-acting opioids internationally, barriers in the United States include limited prospective, randomized, controlled research on their benefits. There is limited institutional support for such approaches, and concerns and stigma around providing opioids to patients with OUD.

“[M]any institutions have insufficient numbers of providers who are both confident and competent with standard buprenorphine and methadone initiation approaches, a prerequisite before adopting more complex regimens,” the authors wrote.

Short-acting, full-agonist opioids, as a complement to methadone or buprenorphine, is already recommended for inpatients with OUD who are experiencing acute pain.

But the authors argue it should be an option when pain is not present, but methadone or buprenorphine have not provided enough OWS relief.
 

When short-acting opioids are helpful, according to outside expert

Dr. Poorman agrees and says she has found short-acting opioids simple to use in the hospital and very helpful in two situations.

One is when patients are very clear that they don’t want any medication for opioid use disorder, but they do want to be treated for their acute medical issue.

“I thought that was a fantastic tool to have to demonstrate we’re listening to them and weren’t trying to impose something on them and left the door open to come back when they did want treatment, which many of them did,” Dr. Poorman said.

The second situation is when the patient is uncertain about options but very afraid of precipitated withdrawal from buprenorphine.

She said she then found it easy to switch from those medications to buprenorphine and methadone.

Dr. Poorman described a situation she encountered previously where the patient was injecting heroin several times a day for 30-40 years. He was very clear he wasn’t going to stop injecting heroin, but he needed medical attention. He was willing to get medical attention, but he told his doctor he didn’t want to be uncomfortable while in the hospital.

It was very hard for his doctor to accept relieving his symptoms of withdrawal as part of her job, because she felt as though she was condoning his drug use, Dr. Poorman explained.

But Dr. Poorman said it’s not realistic to think that someone who clearly does not want to stop using is going to stop using because a doctor made that person go through painful withdrawal “that they’ve structured their whole life around avoiding.”
 

Take-home message

“We need to understand that addiction is very complex. A lot of times people come to us distressed, and it’s a great time to engage them in care but engaging them in care doesn’t mean imposing discomfort or pain on them,” Dr. Poorman noted. Instead, it means “listening to them, helping them be comfortable in a really stressful situation and then letting them know we are always there for them wherever they are on their disease process or recovery journey so that they can come back to us.”

Dr. Wakeman previously served on clinical advisory board for Celero Systems and receives textbook royalties from Springer and author payment from UpToDate. Dr. Kleinman and Dr. Poorman declared no relevant financial relationships.

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CDC unveils mental health protection plan for health care workers

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Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.

Dr. Vivek H. Murthy

“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.

“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
 

Burnout is not selective

There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.

He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.

Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.

Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. In the fall of 2020, 69% reported depression and “a very alarming figure” of 13% reported having thoughts of suicide, Dr. Howard said.

Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data. 

“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.

Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.

“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
 

Primary prevention approach

To tackle the burnout crisis, NIOSH plans to:

  • Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
  • Assimilate the evidence and create a repository of best practices, resources, and interventions.
  • Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
  • Identify and adapt tools for the health care workplace that emphasize stress reduction.

NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.

This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.

Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.

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

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Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.

Dr. Vivek H. Murthy

“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.

“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
 

Burnout is not selective

There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.

He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.

Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.

Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. In the fall of 2020, 69% reported depression and “a very alarming figure” of 13% reported having thoughts of suicide, Dr. Howard said.

Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data. 

“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.

Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.

“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
 

Primary prevention approach

To tackle the burnout crisis, NIOSH plans to:

  • Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
  • Assimilate the evidence and create a repository of best practices, resources, and interventions.
  • Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
  • Identify and adapt tools for the health care workplace that emphasize stress reduction.

NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.

This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.

Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.

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

Federal health officials have outlined a five-part plan to improve and protect the mental health and well-being of America’s health care workers (HCWs) and create sustainable change for the next generation of HCWs.

Dr. Vivek H. Murthy

“It’s long past time for us to care for the people who care for all of us and address burnout in our health care workers,” U.S. Surgeon General Vivek H. Murthy, MD, MBA, said during a webinar hosted by the National Institute for Occupational Safety and Health, part of the U.S. Centers for Disease Control and Prevention.

“My hope is that, going forward, we will be able to embark on this journey together to create a health care system, a health care environment, a country where we can not only provide extraordinary care to all those who need it, but where we can take good care of those who have sacrificed so much and make sure that they are well,” Dr. Murthy said.
 

Burnout is not selective

There are 20 million HCWs in the United States, and no one is immune from burnout, said NIOSH Director John Howard, MD.

He noted that from June through Sept. of 2020 – the height of the COVID-19 pandemic – 93% of HCWs experienced some degree of stress, with 22% reporting moderate depression and post-traumatic stress disorder.

Looking at subsets of HCWs, a recent survey showed that one in five nurses contemplated leaving the profession because of insufficient staffing, intensity of workload, emotional and physical toll of the job, and lack of support, Dr. Howard noted.

Physician burnout was a significant issue even before the pandemic, with about 79% of physicians reporting burnout. In the fall of 2020, 69% reported depression and “a very alarming figure” of 13% reported having thoughts of suicide, Dr. Howard said.

Women in health care jobs are especially vulnerable to burnout; 76% of health care jobs are held by women and 64% of physicians that feel burned-out are women, according to federal data. 

“We have significant work to do in shoring up the safety and health of women in health care,” Dr. Howard said.

Mental health is also suffering among local and state public health workers. In a recent CDC survey of 26,000 of these workers, 53% reported symptoms of at least one mental health condition in the past 2 weeks.

“That is really an alarming proportion of public health workers who are as vital and essential as nurses and doctors are in our health care system,” Dr. Howard said.
 

Primary prevention approach

To tackle the burnout crisis, NIOSH plans to:

  • Take a deep dive into understanding the personal, social, and economic burdens HCWs face on a daily basis.
  • Assimilate the evidence and create a repository of best practices, resources, and interventions.
  • Partner with key stakeholders, including the American Hospital Association, the American Nurses Association, National Nurses United, the Joint Commission.
  • Identify and adapt tools for the health care workplace that emphasize stress reduction.

NIOSH also plans to “generate awareness through a national, multidimensional social marketing campaign to get the word out about stress so health care workers don’t feel so alone,” Dr. Howard said.

This five-part plan takes a primary prevention approach to identifying and eliminating risk factors for burnout and stress, he added.

Secondary prevention, “when damage has already been done and you’re trying to save a health care worker who is suffering from a mental health issue, that’s a lot harder than taking a good look at what you can do to organizational practices that lead to health care workers’ stress and burnout,” Dr. Howard said.

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

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Risk for breast cancer recurrence persists past 30 years

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For the first time, new data show that risk for breast cancer recurrence extends past 30 years.

The data come from a Danish study involving 20,315 women who were treated for early operable breast cancer between 1987 and 2004, all of whom were disease-free at 10 years.

Further follow-up showed that 2,595 women had a breast cancer recurrence more than 10 years after their primary diagnosis.

The cumulative incidence of recurrence was 8.5% at 15 years; 12.5% at 20 years; 15.2% at 25 years, and 16.6% at 32 years.

Recurrence risk was greatest early in the study period.

Women who had primary tumors larger than 20 mm, lymph node-positive disease, and estrogen receptor-positive tumors were at higher risk for late recurrence.

“Such patients may warrant extended surveillance, more aggressive treatment, or new therapy approaches,” said the investigators, led by Rikke Pedersen, MD, a PhD candidate in epidemiology at Aarhus University Hospital, Denmark.

“Our observed high cumulative incidence of late breast cancer recurrence is a concern given the increasing prevalence of long-term survivors.” Among other things, a new model to better select women for prolonged surveillance is needed, they said.

The new findings were published online Nov. 8 in the Journal of the National Cancer Institute (NCI).

This study confirms previous investigations, but it is the first to report that breast cancer can recur more than 30 years after diagnosis, note the authors of an accompanying editorialSerban Negoita, MD, DrPH, and Esmeralda Ramirez-Peña, PhD, MPH, both from the National Cancer Institute.

The caveat is that treatment has evolved considerably since the women in the study were diagnosed, so the prognostic value of the findings with current treatment regimens is uncertain, they note. Some studies haven’t found a recurrence benefit for aggressive upfront treatment, but those studies had shorter follow-ups.

Research into the issue is “increasingly important” to guide clinical management and counsel women who are living longer after their primary diagnosis, they comment.  
 

Further details from the study

Data for the study came from the Danish Breast Cancer Group clinical database and other national databases. The researchers focused on women who were disease-free at 10 years after their primary diagnosis, which was stage I or II disease. Median age was 55 years.

Cumulative incidence for breast cancer recurrence was highest for grade 1 tumors with four or more positive lymph nodes (37.9% 10-25 years after the primary diagnosis) and was lowest for patients with grade 3 disease and no involved lymph nodes (7.5%).

The finding of higher recurrence incidence with lower grade tumors goes against some previous reports, the researchers commented. It may be that some tumors considered lower risk decades ago, and treated accordingly, would be considered higher risk in more recent times.

The cumulative incidence of late recurrence was also higher in younger patients and those treated with breast-conserving surgery instead of mastectomy, the team reported.

Adjusted hazard ratios followed the incidence trends, with higher hazards of recurrence for women diagnosed before age 40 as well as those who had breast-conserving surgery, four or more positive lymph nodes, and primary tumors 20 mm or more across.

The work was funded by the Danish Cancer Society and Aarhus University. Lead author Dr. Pedersen reports no disclosures, but coauthors report ties to Amgen, Novo Nordisk, Roche, and other companies. The editorialists have disclosed no relevant financial relationships.

 

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

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For the first time, new data show that risk for breast cancer recurrence extends past 30 years.

The data come from a Danish study involving 20,315 women who were treated for early operable breast cancer between 1987 and 2004, all of whom were disease-free at 10 years.

Further follow-up showed that 2,595 women had a breast cancer recurrence more than 10 years after their primary diagnosis.

The cumulative incidence of recurrence was 8.5% at 15 years; 12.5% at 20 years; 15.2% at 25 years, and 16.6% at 32 years.

Recurrence risk was greatest early in the study period.

Women who had primary tumors larger than 20 mm, lymph node-positive disease, and estrogen receptor-positive tumors were at higher risk for late recurrence.

“Such patients may warrant extended surveillance, more aggressive treatment, or new therapy approaches,” said the investigators, led by Rikke Pedersen, MD, a PhD candidate in epidemiology at Aarhus University Hospital, Denmark.

“Our observed high cumulative incidence of late breast cancer recurrence is a concern given the increasing prevalence of long-term survivors.” Among other things, a new model to better select women for prolonged surveillance is needed, they said.

The new findings were published online Nov. 8 in the Journal of the National Cancer Institute (NCI).

This study confirms previous investigations, but it is the first to report that breast cancer can recur more than 30 years after diagnosis, note the authors of an accompanying editorialSerban Negoita, MD, DrPH, and Esmeralda Ramirez-Peña, PhD, MPH, both from the National Cancer Institute.

The caveat is that treatment has evolved considerably since the women in the study were diagnosed, so the prognostic value of the findings with current treatment regimens is uncertain, they note. Some studies haven’t found a recurrence benefit for aggressive upfront treatment, but those studies had shorter follow-ups.

Research into the issue is “increasingly important” to guide clinical management and counsel women who are living longer after their primary diagnosis, they comment.  
 

Further details from the study

Data for the study came from the Danish Breast Cancer Group clinical database and other national databases. The researchers focused on women who were disease-free at 10 years after their primary diagnosis, which was stage I or II disease. Median age was 55 years.

Cumulative incidence for breast cancer recurrence was highest for grade 1 tumors with four or more positive lymph nodes (37.9% 10-25 years after the primary diagnosis) and was lowest for patients with grade 3 disease and no involved lymph nodes (7.5%).

The finding of higher recurrence incidence with lower grade tumors goes against some previous reports, the researchers commented. It may be that some tumors considered lower risk decades ago, and treated accordingly, would be considered higher risk in more recent times.

The cumulative incidence of late recurrence was also higher in younger patients and those treated with breast-conserving surgery instead of mastectomy, the team reported.

Adjusted hazard ratios followed the incidence trends, with higher hazards of recurrence for women diagnosed before age 40 as well as those who had breast-conserving surgery, four or more positive lymph nodes, and primary tumors 20 mm or more across.

The work was funded by the Danish Cancer Society and Aarhus University. Lead author Dr. Pedersen reports no disclosures, but coauthors report ties to Amgen, Novo Nordisk, Roche, and other companies. The editorialists have disclosed no relevant financial relationships.

 

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

For the first time, new data show that risk for breast cancer recurrence extends past 30 years.

The data come from a Danish study involving 20,315 women who were treated for early operable breast cancer between 1987 and 2004, all of whom were disease-free at 10 years.

Further follow-up showed that 2,595 women had a breast cancer recurrence more than 10 years after their primary diagnosis.

The cumulative incidence of recurrence was 8.5% at 15 years; 12.5% at 20 years; 15.2% at 25 years, and 16.6% at 32 years.

Recurrence risk was greatest early in the study period.

Women who had primary tumors larger than 20 mm, lymph node-positive disease, and estrogen receptor-positive tumors were at higher risk for late recurrence.

“Such patients may warrant extended surveillance, more aggressive treatment, or new therapy approaches,” said the investigators, led by Rikke Pedersen, MD, a PhD candidate in epidemiology at Aarhus University Hospital, Denmark.

“Our observed high cumulative incidence of late breast cancer recurrence is a concern given the increasing prevalence of long-term survivors.” Among other things, a new model to better select women for prolonged surveillance is needed, they said.

The new findings were published online Nov. 8 in the Journal of the National Cancer Institute (NCI).

This study confirms previous investigations, but it is the first to report that breast cancer can recur more than 30 years after diagnosis, note the authors of an accompanying editorialSerban Negoita, MD, DrPH, and Esmeralda Ramirez-Peña, PhD, MPH, both from the National Cancer Institute.

The caveat is that treatment has evolved considerably since the women in the study were diagnosed, so the prognostic value of the findings with current treatment regimens is uncertain, they note. Some studies haven’t found a recurrence benefit for aggressive upfront treatment, but those studies had shorter follow-ups.

Research into the issue is “increasingly important” to guide clinical management and counsel women who are living longer after their primary diagnosis, they comment.  
 

Further details from the study

Data for the study came from the Danish Breast Cancer Group clinical database and other national databases. The researchers focused on women who were disease-free at 10 years after their primary diagnosis, which was stage I or II disease. Median age was 55 years.

Cumulative incidence for breast cancer recurrence was highest for grade 1 tumors with four or more positive lymph nodes (37.9% 10-25 years after the primary diagnosis) and was lowest for patients with grade 3 disease and no involved lymph nodes (7.5%).

The finding of higher recurrence incidence with lower grade tumors goes against some previous reports, the researchers commented. It may be that some tumors considered lower risk decades ago, and treated accordingly, would be considered higher risk in more recent times.

The cumulative incidence of late recurrence was also higher in younger patients and those treated with breast-conserving surgery instead of mastectomy, the team reported.

Adjusted hazard ratios followed the incidence trends, with higher hazards of recurrence for women diagnosed before age 40 as well as those who had breast-conserving surgery, four or more positive lymph nodes, and primary tumors 20 mm or more across.

The work was funded by the Danish Cancer Society and Aarhus University. Lead author Dr. Pedersen reports no disclosures, but coauthors report ties to Amgen, Novo Nordisk, Roche, and other companies. The editorialists have disclosed no relevant financial relationships.

 

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

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