Federal Practitioner

For many Americans – especially those too young to know much about the Cold War or Hiroshima – Russia’s invasion of Ukraine might mark the first time they’ve truly considered the dangers of nuclear weapons. But dozens of hematologists in the United States already know the drill and have placed themselves on the front lines. These physicians stand prepared to treat patients exposed to radiation caused by nuclear accidents or attacks on U.S. soil.

They work nationwide at 74 medical centers that make up the Radiation Injury Treatment Network, ready to manage cases of acute radiation syndrome (ARS) during disasters. While RITN keeps a low profile, it’s been in the news lately amid anxieties about the Ukraine conflict, nuclear plant accidents, and the potential launching of nuclear weapons by foreign adversaries.

Wikimedia Commons

“The Radiation Injury Treatment Network helps plan responses for disaster scenarios where a person’s cells would be damaged after having been exposed to ionizing radiation,” program director Cullen Case Jr., MPA, said in an interview.

A U.S. Army veteran who took part in hurricane response early in his career, Mr. Case now oversees preparedness activities among all RITN hospitals, blood donor centers, and cord blood banks, in readiness for a mass casualty radiological incident. He also serves as a senior manager of the National Marrow Donor Program/Be a Match Marrow Registry.

Intense preparation for nuclear attacks or accidents is necessary, Mr. Case said, despite the doomsday scenarios disseminated on television shows and movies.

“The most frequent misconception we hear is that a nuclear disaster will encompass the whole world and be so complete that preparedness isn’t useful. However, many planning scenarios include smaller-scale incidents where survivors will need prompt and expert care,” he said.

In the wake of 9/11, the National Marrow Donor Program and the American Society for Blood and Marrow Transplantation established the RITN in 2006, with a mission to prepare for nuclear disaster and help manage the response if one occurs.

National Archives/Wikimedia commons

“The widespread availability of radioactive material has made future exposure events, accidental or intentional, nearly inevitable,” RITN leaders warned in a 2008 report. “Hematologists, oncologists, and HSCT [hematopoietic stem cell transplantation] physicians are uniquely suited to care for victims of radiation exposure, creating a collective responsibility to prepare for a variety of contingencies.”

RITN doesn’t just train physicians, Mr. Case noted. All medical centers within the RITN are required to conduct an annual tabletop exercise where a radiation disaster scenario and a set of discussion questions are presented to the team.
 

Hematologists specially equipped to treat radiation injuries

Why are hematologists involved in treating people exposed to dangerously high levels of radiation? The answer has to do with how radiation harms the body, said Dr. Ann A. Jakubowski, a hematologist/oncologist and transplant physician at Memorial Sloan Kettering Cancer Center, New York, who serves as a medical director for RITN.

“One of the most common toxicities from radiation exposure and a major player in acute radiation syndrome is hematologic toxicity– damage to the bone marrow by the radiation, with a resultant decrease in peripheral blood counts,” she said in an interview. “This is similar to what is often seen in the treatment of cancers with radiation and/or chemotherapy.”

In cases of severe and nonreversible radiation damage to the bone marrow, Dr. Jakubowski noted, “patients can be considered for a stem cell transplant to provide new healthy cells to repopulate the bone marrow, which provides recovery of peripheral blood counts. Hematologist/oncologists are the physicians who manage stem cell transplants.”

The crucial role of hematologists in radiation injuries is not new. In fact, these physicians have been closely intertwined with nuclear research since the dawn of the atomic age. The work of developing atomic bombs also led investigators to an understanding of the structure and processes of hematopoiesis and helped them to identify hematopoietic stem cells and prove their existence in humans.
 

Disaster response poses multiple challenges

As noted in a recent article in ASH Clinical News, the challenges of treating radiation injuries would be intense, especially in the event of a nuclear accident or attack that affects a wide area. For starters, how quickly can medical professionals be mobilized, and will there be enough physicians comfortable treating patients? Fortunately, irradiated patients should not pose a direct risk to medical professionals who treat them.

“The expectation is that the patients will all be decontaminated,” said Nelson Chao, MD, MBA, one of the founders of RITN and a hematologist/oncologist and transplant physician at Duke University, Durham, N.C.

Dr. Jakubowski questions whether there will be adequate resources to handle the influx of patients who need more intensive treatment, as well as outpatients who “received lower doses of radiation and may experience a period of low blood counts but are expected to eventually recover blood counts.”

AFP/Getty Images

And if many people are injured, Dr. Chao asks, how will physicians “adopt altered standards of care to treat large numbers of patients?”

There will also be a need for physicians who aren’t hematologists, Dr. Jakubowski said. “There may be many victims who have both radiation exposure and traumatic or burn injuries, which need to be addressed first, before the hematologist can start addressing the consequences of ARS. Traumatic and burn injuries will require surgical resources.”

In addition, ARS affects the gastrointestinal track and central nervous system/cardiovascular, and it has multiple stages, she noted.

“Although we have methods of supporting the hematopoietic system – transfusions and growth factors – and even replacing it with a stem cell transplant, this will not necessarily fix the badly damaged other organs, Dr. Jakubowski said. “Also, not all radioactive isotopes are equal in their effects, nor are the various types of radiation exposure.”
 

Training goes beyond transplants and drugs

RITN offers individual hematologists specialized education about treating radiation injuries through annual exercises, modules, and “just-in-time” training.

For example, the RITN webpage devoted to triage includes guidelines for transferring radiation injury patients, triage guidelines for cytokine administration in cases of ARS, an exposure and symptom triage tool, and more. The treatment page includes details about subjects such as when human leukocyte antigen typing of casualties is appropriate and how to keep yourself safe while treating patients.

Another focus is teaching hematologists to react quickly in disasters, Mr. Case said. “The vast majority of hematologists have little to no experience in responding to disasters and making decisions with imperfect or incomplete information, as emergency medicine practitioners must do regularly.”

“Some of the RITN tabletop exercises present physicians and advanced practitioners with an incomplete set of patient information and ask physicians to then determine and prioritize their care,” Mr. Case said. “The resulting discussions help to lay the groundwork for being able to shift to the crisis standards of care mindset that would be necessary during a radiological disaster.”
 

Here’s how hematologists can get involved

If you want to help improve the nation’s response to radiation injuries, Mr. Case suggests checking RITN’s list of participating hospitals. If your facility is already part of this network, he said, contact its bone marrow transplant unit for more information.

In such cases, Dr. Jakubowski suggests that you “consider periodically giving a presentation to staff on the basics of radiation injury and the center’s role in RITN.” And if you’re not part of RITN, she said, consider contacting the network about becoming a member.

Hematologists, Mr. Case said, can also take advantage of RITN’s free short overview courses, review the RITN Treatment Guidelines, or watch short videos on the RITN’s YouTube channel.

He highlighted the Radiation Emergency Medical Management website administered by the Department of Health & Human Services, the Center for Disease Control’s radiation emergencies webpage, and the Department of Energy’s Radiation Emergency Assistance Center/Training Site.

For many Americans – especially those too young to know much about the Cold War or Hiroshima – Russia’s invasion of Ukraine might mark the first time they’ve truly considered the dangers of nuclear weapons. But dozens of hematologists in the United States already know the drill and have placed themselves on the front lines. These physicians stand prepared to treat patients exposed to radiation caused by nuclear accidents or attacks on U.S. soil.

They work nationwide at 74 medical centers that make up the Radiation Injury Treatment Network, ready to manage cases of acute radiation syndrome (ARS) during disasters. While RITN keeps a low profile, it’s been in the news lately amid anxieties about the Ukraine conflict, nuclear plant accidents, and the potential launching of nuclear weapons by foreign adversaries.

Wikimedia Commons

“The Radiation Injury Treatment Network helps plan responses for disaster scenarios where a person’s cells would be damaged after having been exposed to ionizing radiation,” program director Cullen Case Jr., MPA, said in an interview.

A U.S. Army veteran who took part in hurricane response early in his career, Mr. Case now oversees preparedness activities among all RITN hospitals, blood donor centers, and cord blood banks, in readiness for a mass casualty radiological incident. He also serves as a senior manager of the National Marrow Donor Program/Be a Match Marrow Registry.

Intense preparation for nuclear attacks or accidents is necessary, Mr. Case said, despite the doomsday scenarios disseminated on television shows and movies.

“The most frequent misconception we hear is that a nuclear disaster will encompass the whole world and be so complete that preparedness isn’t useful. However, many planning scenarios include smaller-scale incidents where survivors will need prompt and expert care,” he said.

In the wake of 9/11, the National Marrow Donor Program and the American Society for Blood and Marrow Transplantation established the RITN in 2006, with a mission to prepare for nuclear disaster and help manage the response if one occurs.

National Archives/Wikimedia commons

“The widespread availability of radioactive material has made future exposure events, accidental or intentional, nearly inevitable,” RITN leaders warned in a 2008 report. “Hematologists, oncologists, and HSCT [hematopoietic stem cell transplantation] physicians are uniquely suited to care for victims of radiation exposure, creating a collective responsibility to prepare for a variety of contingencies.”

RITN doesn’t just train physicians, Mr. Case noted. All medical centers within the RITN are required to conduct an annual tabletop exercise where a radiation disaster scenario and a set of discussion questions are presented to the team.
 

Hematologists specially equipped to treat radiation injuries

Why are hematologists involved in treating people exposed to dangerously high levels of radiation? The answer has to do with how radiation harms the body, said Dr. Ann A. Jakubowski, a hematologist/oncologist and transplant physician at Memorial Sloan Kettering Cancer Center, New York, who serves as a medical director for RITN.

“One of the most common toxicities from radiation exposure and a major player in acute radiation syndrome is hematologic toxicity– damage to the bone marrow by the radiation, with a resultant decrease in peripheral blood counts,” she said in an interview. “This is similar to what is often seen in the treatment of cancers with radiation and/or chemotherapy.”

In cases of severe and nonreversible radiation damage to the bone marrow, Dr. Jakubowski noted, “patients can be considered for a stem cell transplant to provide new healthy cells to repopulate the bone marrow, which provides recovery of peripheral blood counts. Hematologist/oncologists are the physicians who manage stem cell transplants.”

The crucial role of hematologists in radiation injuries is not new. In fact, these physicians have been closely intertwined with nuclear research since the dawn of the atomic age. The work of developing atomic bombs also led investigators to an understanding of the structure and processes of hematopoiesis and helped them to identify hematopoietic stem cells and prove their existence in humans.
 

Disaster response poses multiple challenges

As noted in a recent article in ASH Clinical News, the challenges of treating radiation injuries would be intense, especially in the event of a nuclear accident or attack that affects a wide area. For starters, how quickly can medical professionals be mobilized, and will there be enough physicians comfortable treating patients? Fortunately, irradiated patients should not pose a direct risk to medical professionals who treat them.

“The expectation is that the patients will all be decontaminated,” said Nelson Chao, MD, MBA, one of the founders of RITN and a hematologist/oncologist and transplant physician at Duke University, Durham, N.C.

Dr. Jakubowski questions whether there will be adequate resources to handle the influx of patients who need more intensive treatment, as well as outpatients who “received lower doses of radiation and may experience a period of low blood counts but are expected to eventually recover blood counts.”

AFP/Getty Images

And if many people are injured, Dr. Chao asks, how will physicians “adopt altered standards of care to treat large numbers of patients?”

There will also be a need for physicians who aren’t hematologists, Dr. Jakubowski said. “There may be many victims who have both radiation exposure and traumatic or burn injuries, which need to be addressed first, before the hematologist can start addressing the consequences of ARS. Traumatic and burn injuries will require surgical resources.”

In addition, ARS affects the gastrointestinal track and central nervous system/cardiovascular, and it has multiple stages, she noted.

“Although we have methods of supporting the hematopoietic system – transfusions and growth factors – and even replacing it with a stem cell transplant, this will not necessarily fix the badly damaged other organs, Dr. Jakubowski said. “Also, not all radioactive isotopes are equal in their effects, nor are the various types of radiation exposure.”
 

Training goes beyond transplants and drugs

RITN offers individual hematologists specialized education about treating radiation injuries through annual exercises, modules, and “just-in-time” training.

For example, the RITN webpage devoted to triage includes guidelines for transferring radiation injury patients, triage guidelines for cytokine administration in cases of ARS, an exposure and symptom triage tool, and more. The treatment page includes details about subjects such as when human leukocyte antigen typing of casualties is appropriate and how to keep yourself safe while treating patients.

Another focus is teaching hematologists to react quickly in disasters, Mr. Case said. “The vast majority of hematologists have little to no experience in responding to disasters and making decisions with imperfect or incomplete information, as emergency medicine practitioners must do regularly.”

“Some of the RITN tabletop exercises present physicians and advanced practitioners with an incomplete set of patient information and ask physicians to then determine and prioritize their care,” Mr. Case said. “The resulting discussions help to lay the groundwork for being able to shift to the crisis standards of care mindset that would be necessary during a radiological disaster.”
 

Here’s how hematologists can get involved

If you want to help improve the nation’s response to radiation injuries, Mr. Case suggests checking RITN’s list of participating hospitals. If your facility is already part of this network, he said, contact its bone marrow transplant unit for more information.

In such cases, Dr. Jakubowski suggests that you “consider periodically giving a presentation to staff on the basics of radiation injury and the center’s role in RITN.” And if you’re not part of RITN, she said, consider contacting the network about becoming a member.

Hematologists, Mr. Case said, can also take advantage of RITN’s free short overview courses, review the RITN Treatment Guidelines, or watch short videos on the RITN’s YouTube channel.

He highlighted the Radiation Emergency Medical Management website administered by the Department of Health & Human Services, the Center for Disease Control’s radiation emergencies webpage, and the Department of Energy’s Radiation Emergency Assistance Center/Training Site.

For many Americans – especially those too young to know much about the Cold War or Hiroshima – Russia’s invasion of Ukraine might mark the first time they’ve truly considered the dangers of nuclear weapons. But dozens of hematologists in the United States already know the drill and have placed themselves on the front lines. These physicians stand prepared to treat patients exposed to radiation caused by nuclear accidents or attacks on U.S. soil.

They work nationwide at 74 medical centers that make up the Radiation Injury Treatment Network, ready to manage cases of acute radiation syndrome (ARS) during disasters. While RITN keeps a low profile, it’s been in the news lately amid anxieties about the Ukraine conflict, nuclear plant accidents, and the potential launching of nuclear weapons by foreign adversaries.

Wikimedia Commons

“The Radiation Injury Treatment Network helps plan responses for disaster scenarios where a person’s cells would be damaged after having been exposed to ionizing radiation,” program director Cullen Case Jr., MPA, said in an interview.

A U.S. Army veteran who took part in hurricane response early in his career, Mr. Case now oversees preparedness activities among all RITN hospitals, blood donor centers, and cord blood banks, in readiness for a mass casualty radiological incident. He also serves as a senior manager of the National Marrow Donor Program/Be a Match Marrow Registry.

Intense preparation for nuclear attacks or accidents is necessary, Mr. Case said, despite the doomsday scenarios disseminated on television shows and movies.

“The most frequent misconception we hear is that a nuclear disaster will encompass the whole world and be so complete that preparedness isn’t useful. However, many planning scenarios include smaller-scale incidents where survivors will need prompt and expert care,” he said.

In the wake of 9/11, the National Marrow Donor Program and the American Society for Blood and Marrow Transplantation established the RITN in 2006, with a mission to prepare for nuclear disaster and help manage the response if one occurs.

National Archives/Wikimedia commons

“The widespread availability of radioactive material has made future exposure events, accidental or intentional, nearly inevitable,” RITN leaders warned in a 2008 report. “Hematologists, oncologists, and HSCT [hematopoietic stem cell transplantation] physicians are uniquely suited to care for victims of radiation exposure, creating a collective responsibility to prepare for a variety of contingencies.”

RITN doesn’t just train physicians, Mr. Case noted. All medical centers within the RITN are required to conduct an annual tabletop exercise where a radiation disaster scenario and a set of discussion questions are presented to the team.
 

Hematologists specially equipped to treat radiation injuries

Why are hematologists involved in treating people exposed to dangerously high levels of radiation? The answer has to do with how radiation harms the body, said Dr. Ann A. Jakubowski, a hematologist/oncologist and transplant physician at Memorial Sloan Kettering Cancer Center, New York, who serves as a medical director for RITN.

“One of the most common toxicities from radiation exposure and a major player in acute radiation syndrome is hematologic toxicity– damage to the bone marrow by the radiation, with a resultant decrease in peripheral blood counts,” she said in an interview. “This is similar to what is often seen in the treatment of cancers with radiation and/or chemotherapy.”

In cases of severe and nonreversible radiation damage to the bone marrow, Dr. Jakubowski noted, “patients can be considered for a stem cell transplant to provide new healthy cells to repopulate the bone marrow, which provides recovery of peripheral blood counts. Hematologist/oncologists are the physicians who manage stem cell transplants.”

The crucial role of hematologists in radiation injuries is not new. In fact, these physicians have been closely intertwined with nuclear research since the dawn of the atomic age. The work of developing atomic bombs also led investigators to an understanding of the structure and processes of hematopoiesis and helped them to identify hematopoietic stem cells and prove their existence in humans.
 

Disaster response poses multiple challenges

As noted in a recent article in ASH Clinical News, the challenges of treating radiation injuries would be intense, especially in the event of a nuclear accident or attack that affects a wide area. For starters, how quickly can medical professionals be mobilized, and will there be enough physicians comfortable treating patients? Fortunately, irradiated patients should not pose a direct risk to medical professionals who treat them.

“The expectation is that the patients will all be decontaminated,” said Nelson Chao, MD, MBA, one of the founders of RITN and a hematologist/oncologist and transplant physician at Duke University, Durham, N.C.

Dr. Jakubowski questions whether there will be adequate resources to handle the influx of patients who need more intensive treatment, as well as outpatients who “received lower doses of radiation and may experience a period of low blood counts but are expected to eventually recover blood counts.”

AFP/Getty Images

And if many people are injured, Dr. Chao asks, how will physicians “adopt altered standards of care to treat large numbers of patients?”

There will also be a need for physicians who aren’t hematologists, Dr. Jakubowski said. “There may be many victims who have both radiation exposure and traumatic or burn injuries, which need to be addressed first, before the hematologist can start addressing the consequences of ARS. Traumatic and burn injuries will require surgical resources.”

In addition, ARS affects the gastrointestinal track and central nervous system/cardiovascular, and it has multiple stages, she noted.

“Although we have methods of supporting the hematopoietic system – transfusions and growth factors – and even replacing it with a stem cell transplant, this will not necessarily fix the badly damaged other organs, Dr. Jakubowski said. “Also, not all radioactive isotopes are equal in their effects, nor are the various types of radiation exposure.”
 

Training goes beyond transplants and drugs

RITN offers individual hematologists specialized education about treating radiation injuries through annual exercises, modules, and “just-in-time” training.

For example, the RITN webpage devoted to triage includes guidelines for transferring radiation injury patients, triage guidelines for cytokine administration in cases of ARS, an exposure and symptom triage tool, and more. The treatment page includes details about subjects such as when human leukocyte antigen typing of casualties is appropriate and how to keep yourself safe while treating patients.

Another focus is teaching hematologists to react quickly in disasters, Mr. Case said. “The vast majority of hematologists have little to no experience in responding to disasters and making decisions with imperfect or incomplete information, as emergency medicine practitioners must do regularly.”

“Some of the RITN tabletop exercises present physicians and advanced practitioners with an incomplete set of patient information and ask physicians to then determine and prioritize their care,” Mr. Case said. “The resulting discussions help to lay the groundwork for being able to shift to the crisis standards of care mindset that would be necessary during a radiological disaster.”
 

Here’s how hematologists can get involved

If you want to help improve the nation’s response to radiation injuries, Mr. Case suggests checking RITN’s list of participating hospitals. If your facility is already part of this network, he said, contact its bone marrow transplant unit for more information.

In such cases, Dr. Jakubowski suggests that you “consider periodically giving a presentation to staff on the basics of radiation injury and the center’s role in RITN.” And if you’re not part of RITN, she said, consider contacting the network about becoming a member.

Hematologists, Mr. Case said, can also take advantage of RITN’s free short overview courses, review the RITN Treatment Guidelines, or watch short videos on the RITN’s YouTube channel.

He highlighted the Radiation Emergency Medical Management website administered by the Department of Health & Human Services, the Center for Disease Control’s radiation emergencies webpage, and the Department of Energy’s Radiation Emergency Assistance Center/Training Site.

High use of telemental health services by patients with serious mental illness (SMI) who live in nonmetropolitan U.S. counties is associated with improvements in key outcomes, including greater posthospitalization follow-up, new research suggests.

In a nationwide study, researchers drew on Medicare data from nearly 3,000 counties covering the period from 2000 to 2018. Results show that counties in which there was greater use of telemental health services reported higher increases of clinical visits and better follow-up after hospitalization among patients with bipolar 1 disorder and schizophrenia or other psychotic disorders.

In the study, “clinical visits” referred to both in-person and telemental health visits.

Courtesy Gretchen Ertl

“These findings really support the idea that telemental health can be safe and effective and beneficial for in-person care for people with severe mental illness,” coinvestigator Haiden Huskamp, PhD, professor of health care policy at Harvard Medical School, Boston, said in an interview.

The findings were published online in JAMA Network Open.
 

Continuing trend?

Past studies have pointed to a sharp increase in the use of telepsychiatry services for patients with SMI. As reported by this news organization, this is a trend some clinicians say is likely to continue after the pandemic.

Use of telemedicine during the pandemic received a boost by the temporary suspension of certain Medicare rules that restrict telehealth use. Debate continues at the federal and state levels on whether to make that suspension permanent. Dr. Huskamp said more information is needed about the efficacy and accessibility of telemental health.

To investigate, researchers used Medicare fee-for-service data from 118,170 patients in 2,916 counties. More than two-thirds of the patients were aged 65 years or younger.

During the study period, telemental health service increased from 0.03 visits per patient with SMI in 2010 to 0.19 visits per patient in 2018. This increase was broad, with the number of counties reporting high use of telemental health increasing from 2% in 2010 to 17% in 2018.

Compared with counties in which there was no telemental health services, those with high use were less densely populated and had fewer health care professionals and hospital beds.

The number of overall visits with a mental health professional increased slightly in high-use counties compared to no-use counties, from 4.65 visits in 2010 to 4.79 visits in 2018. The number of in-person visits during that period declined from 4.55 visits in 2010 to 3.73 visits in 2018, which suggests that the overall increase was due to higher use of telemental health.

In the high-use group, the number of patients who had at least four mental health care visits increased 8%, and the number of patients who had a follow-up visit within 30 days of a hospitalization increased 20.4%.
 

A ‘helpful option’

“Telemedicine doesn’t address the national shortage of providers, but it definitely helps in underserved areas [and] rural areas,” Dr. Huskamp said.

“We need more mental health providers and need to develop new models of care that can leverage the providers we have in the best way possible. This is at least a helpful option, especially when you’re thinking about the maldistribution of providers across the country,” she added.

The study results showed that there was no difference in medication adherence between low- and high-use counties.

There was greater contact with mental health care providers in counties with high use of telemental health, and patients in the high-use group were 7.6% more likely to be hospitalized within a year compared with their peers in counties that had no telemental health use.

“We did see modest increases in inpatient use in counties that shifted the most to telemental health services, but that’s not typically viewed as a measure of quality because it can mean so many different things,” Dr. Huskamp said.

For example, it could mean that counties with greater telemental health use did a better job of identifying and responding to patients’ need for acute care, she noted. It could also be a reflection of the loss of psychiatric inpatient care in low-use communities.
 

Another tool

Commenting on the findings, Robert Caudill, MD, director of Telemedicine and Information Technology Programs at the University of Louisville (Ky.), called the increase in hospitalization in high-use counties “surprising.” However, he noted it might be a reflection of the need to fine-tune telemental health for patients with SMI.

“I think that more time and experience with telehealth will further normalize the practice and help to narrow, if not close, the gap,” said Dr. Caudill, who was not involved with the research.

“There are so many side benefits to doing things via telehealth,” he added. “It is a simple matter of continuing to learn how to do those things better.”

A multidisciplinary approach that includes psychiatric care and case management is generally considered to be the gold standard in treating patients with the types of mental illness included in this study, Dr. Caudill said.

While some of that care can be delivered effectively via telemedicine, it is possible other aspects, such as case management, are better handled in person, he added.

“I don’t think it is the role of telehealth to make in-person care obsolete. It is simply a tool to be used when appropriate,” said Dr. Caudill, past chair of the American Telemedicine Association’s Telemental Health Special Interest Group.

“Surgeons did not abandon scalpels when laser surgery became possible,” he said.

The study was funded by the National Institutes of Mental Health. Dr. Huskamp and Dr. Caudill report no relevant financial relationships.

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

High use of telemental health services by patients with serious mental illness (SMI) who live in nonmetropolitan U.S. counties is associated with improvements in key outcomes, including greater posthospitalization follow-up, new research suggests.

In a nationwide study, researchers drew on Medicare data from nearly 3,000 counties covering the period from 2000 to 2018. Results show that counties in which there was greater use of telemental health services reported higher increases of clinical visits and better follow-up after hospitalization among patients with bipolar 1 disorder and schizophrenia or other psychotic disorders.

In the study, “clinical visits” referred to both in-person and telemental health visits.

Courtesy Gretchen Ertl

“These findings really support the idea that telemental health can be safe and effective and beneficial for in-person care for people with severe mental illness,” coinvestigator Haiden Huskamp, PhD, professor of health care policy at Harvard Medical School, Boston, said in an interview.

The findings were published online in JAMA Network Open.
 

Continuing trend?

Past studies have pointed to a sharp increase in the use of telepsychiatry services for patients with SMI. As reported by this news organization, this is a trend some clinicians say is likely to continue after the pandemic.

Use of telemedicine during the pandemic received a boost by the temporary suspension of certain Medicare rules that restrict telehealth use. Debate continues at the federal and state levels on whether to make that suspension permanent. Dr. Huskamp said more information is needed about the efficacy and accessibility of telemental health.

To investigate, researchers used Medicare fee-for-service data from 118,170 patients in 2,916 counties. More than two-thirds of the patients were aged 65 years or younger.

During the study period, telemental health service increased from 0.03 visits per patient with SMI in 2010 to 0.19 visits per patient in 2018. This increase was broad, with the number of counties reporting high use of telemental health increasing from 2% in 2010 to 17% in 2018.

Compared with counties in which there was no telemental health services, those with high use were less densely populated and had fewer health care professionals and hospital beds.

The number of overall visits with a mental health professional increased slightly in high-use counties compared to no-use counties, from 4.65 visits in 2010 to 4.79 visits in 2018. The number of in-person visits during that period declined from 4.55 visits in 2010 to 3.73 visits in 2018, which suggests that the overall increase was due to higher use of telemental health.

In the high-use group, the number of patients who had at least four mental health care visits increased 8%, and the number of patients who had a follow-up visit within 30 days of a hospitalization increased 20.4%.
 

A ‘helpful option’

“Telemedicine doesn’t address the national shortage of providers, but it definitely helps in underserved areas [and] rural areas,” Dr. Huskamp said.

“We need more mental health providers and need to develop new models of care that can leverage the providers we have in the best way possible. This is at least a helpful option, especially when you’re thinking about the maldistribution of providers across the country,” she added.

The study results showed that there was no difference in medication adherence between low- and high-use counties.

There was greater contact with mental health care providers in counties with high use of telemental health, and patients in the high-use group were 7.6% more likely to be hospitalized within a year compared with their peers in counties that had no telemental health use.

“We did see modest increases in inpatient use in counties that shifted the most to telemental health services, but that’s not typically viewed as a measure of quality because it can mean so many different things,” Dr. Huskamp said.

For example, it could mean that counties with greater telemental health use did a better job of identifying and responding to patients’ need for acute care, she noted. It could also be a reflection of the loss of psychiatric inpatient care in low-use communities.
 

Another tool

Commenting on the findings, Robert Caudill, MD, director of Telemedicine and Information Technology Programs at the University of Louisville (Ky.), called the increase in hospitalization in high-use counties “surprising.” However, he noted it might be a reflection of the need to fine-tune telemental health for patients with SMI.

“I think that more time and experience with telehealth will further normalize the practice and help to narrow, if not close, the gap,” said Dr. Caudill, who was not involved with the research.

“There are so many side benefits to doing things via telehealth,” he added. “It is a simple matter of continuing to learn how to do those things better.”

A multidisciplinary approach that includes psychiatric care and case management is generally considered to be the gold standard in treating patients with the types of mental illness included in this study, Dr. Caudill said.

While some of that care can be delivered effectively via telemedicine, it is possible other aspects, such as case management, are better handled in person, he added.

“I don’t think it is the role of telehealth to make in-person care obsolete. It is simply a tool to be used when appropriate,” said Dr. Caudill, past chair of the American Telemedicine Association’s Telemental Health Special Interest Group.

“Surgeons did not abandon scalpels when laser surgery became possible,” he said.

The study was funded by the National Institutes of Mental Health. Dr. Huskamp and Dr. Caudill report no relevant financial relationships.

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

High use of telemental health services by patients with serious mental illness (SMI) who live in nonmetropolitan U.S. counties is associated with improvements in key outcomes, including greater posthospitalization follow-up, new research suggests.

In a nationwide study, researchers drew on Medicare data from nearly 3,000 counties covering the period from 2000 to 2018. Results show that counties in which there was greater use of telemental health services reported higher increases of clinical visits and better follow-up after hospitalization among patients with bipolar 1 disorder and schizophrenia or other psychotic disorders.

In the study, “clinical visits” referred to both in-person and telemental health visits.

Courtesy Gretchen Ertl

“These findings really support the idea that telemental health can be safe and effective and beneficial for in-person care for people with severe mental illness,” coinvestigator Haiden Huskamp, PhD, professor of health care policy at Harvard Medical School, Boston, said in an interview.

The findings were published online in JAMA Network Open.
 

Continuing trend?

Past studies have pointed to a sharp increase in the use of telepsychiatry services for patients with SMI. As reported by this news organization, this is a trend some clinicians say is likely to continue after the pandemic.

Use of telemedicine during the pandemic received a boost by the temporary suspension of certain Medicare rules that restrict telehealth use. Debate continues at the federal and state levels on whether to make that suspension permanent. Dr. Huskamp said more information is needed about the efficacy and accessibility of telemental health.

To investigate, researchers used Medicare fee-for-service data from 118,170 patients in 2,916 counties. More than two-thirds of the patients were aged 65 years or younger.

During the study period, telemental health service increased from 0.03 visits per patient with SMI in 2010 to 0.19 visits per patient in 2018. This increase was broad, with the number of counties reporting high use of telemental health increasing from 2% in 2010 to 17% in 2018.

Compared with counties in which there was no telemental health services, those with high use were less densely populated and had fewer health care professionals and hospital beds.

The number of overall visits with a mental health professional increased slightly in high-use counties compared to no-use counties, from 4.65 visits in 2010 to 4.79 visits in 2018. The number of in-person visits during that period declined from 4.55 visits in 2010 to 3.73 visits in 2018, which suggests that the overall increase was due to higher use of telemental health.

In the high-use group, the number of patients who had at least four mental health care visits increased 8%, and the number of patients who had a follow-up visit within 30 days of a hospitalization increased 20.4%.
 

A ‘helpful option’

“Telemedicine doesn’t address the national shortage of providers, but it definitely helps in underserved areas [and] rural areas,” Dr. Huskamp said.

“We need more mental health providers and need to develop new models of care that can leverage the providers we have in the best way possible. This is at least a helpful option, especially when you’re thinking about the maldistribution of providers across the country,” she added.

The study results showed that there was no difference in medication adherence between low- and high-use counties.

There was greater contact with mental health care providers in counties with high use of telemental health, and patients in the high-use group were 7.6% more likely to be hospitalized within a year compared with their peers in counties that had no telemental health use.

“We did see modest increases in inpatient use in counties that shifted the most to telemental health services, but that’s not typically viewed as a measure of quality because it can mean so many different things,” Dr. Huskamp said.

For example, it could mean that counties with greater telemental health use did a better job of identifying and responding to patients’ need for acute care, she noted. It could also be a reflection of the loss of psychiatric inpatient care in low-use communities.
 

Another tool

Commenting on the findings, Robert Caudill, MD, director of Telemedicine and Information Technology Programs at the University of Louisville (Ky.), called the increase in hospitalization in high-use counties “surprising.” However, he noted it might be a reflection of the need to fine-tune telemental health for patients with SMI.

“I think that more time and experience with telehealth will further normalize the practice and help to narrow, if not close, the gap,” said Dr. Caudill, who was not involved with the research.

“There are so many side benefits to doing things via telehealth,” he added. “It is a simple matter of continuing to learn how to do those things better.”

A multidisciplinary approach that includes psychiatric care and case management is generally considered to be the gold standard in treating patients with the types of mental illness included in this study, Dr. Caudill said.

While some of that care can be delivered effectively via telemedicine, it is possible other aspects, such as case management, are better handled in person, he added.

“I don’t think it is the role of telehealth to make in-person care obsolete. It is simply a tool to be used when appropriate,” said Dr. Caudill, past chair of the American Telemedicine Association’s Telemental Health Special Interest Group.

“Surgeons did not abandon scalpels when laser surgery became possible,” he said.

The study was funded by the National Institutes of Mental Health. Dr. Huskamp and Dr. Caudill report no relevant financial relationships.

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

Racial differences in cancer outcomes are widespread. Studies indicate that Black people face higher rates of mortality for most cancers than their White counterparts. To bridge this racial gap, researchers need to investigate the biological effects of structural racism and discrimination on cancer outcomes, experts say.

“As a physician, I always like to think that I can influence care in that if I just find the right drugs, help patients understand what their options are, it will help them,” said Ruth Carlos, MD, a radiologist with the University of Michigan Hospital, Ann Arbor. But these things alone are often not enough, because a large proportion of the variation in cancer outcomes is attributable to neighborhood social conditions and the physical environment. “It is incredibly important for us to start to understand just how the neighborhood exerts this effect.”

In a commentary published in the Journal of Clinical Oncology, Dr. Carlos and colleagues highlighted the limitations of previous studies aimed at identifying the causes of racial differences in cancer outcomes. They call upon researchers to turn instead to the long-underexamined biological effects of structural racism and discrimination that contribute to these differences.

In the past, studies on the role of race in health outcomes largely looked at race as a proxy for genetic predisposition. But such an interpretation is flawed, because no genes are specific for a racial or ethnic group, Dr. Carlos and coauthors wrote. Researchers have shown that the vast majority of genetic variation occurs within, rather than between groups.

In an analysis published in Science, researchers reported that within-group differences account for more than 90% of genetic variation.

“Using race in these analyses was not necessarily wrong, but the inferences may have been flawed or incomplete,” Dr. Carlos said. On one hand, looking at genetic predisposition has led to important insights, such as the link between mutations in the BRCA gene and increased risk for breast and ovarian cancer.

However, genetic variation alone is not enough to explain the disparities in cancer outcomes between racial and ethnic groups. The fact that breast cancer can be more aggressive in Black women raises several questions, Dr. Carlos said. Is the cancer worse because Black women have a specific genetic predisposition? Is it worse because Black women exist in a society that marginalizes them and exposes them to increased stress, which in turn produces bad outcomes? Or, could it be both?

Despite progress in the screening, diagnosis and treatment of breast cancer, Black women are 40% more likely to die from the disease than White women. At the time of diagnosis, Black women are more likely to have high-grade, more aggressive breast cancer molecular subtypes, and to have had their cancer spread to the lymph nodes. They also tend to be diagnosed at more advanced stages of breast cancer while at the same time, experience higher rates of false-positive screening results.

Although researchers have hypothesized that genetic differences related to African or European ancestry might contribute, studies have not turned up any differences in cancer susceptibility genes by race. Other factors, such as racial differences in the stage of presentation, molecular subtypes, and disparities in treatment, have also emerged as potential culprits.

In her commentary, Dr. Carlos and colleagues wrote that disparities in breast cancer outcomes previously attributed to race need to be examined from multiple angles. This means looking at both the complex interactions between social conditions and policies, which encompass racism both at the individual and structural level, and stressors such as the experience of discrimination in addition to potential biological and genetic contributions.

Many studies now provide evidence for the harmful effects of racism on health. For breast cancer, specifically, studies also suggest that factors such as racial segregation can influence the stage at which Black women get diagnosed and their likelihood of dying from the disease.

However, an important question that remains is what biological changes occur in women exposed to the kind of persistent low-level stress that is associated with structural racism and discrimination, Dr. Carlos said. “We don’t know what stress pathways actually manifest in the body and how they eventually produce the disease.” Studies to address this issue are important, “especially if you would like to develop interventions to prevent or mitigate disease.”

To address this issue, Dr. Carlos and colleagues called upon the research community to conduct both studies that delineate the underlying biology as well as those that test potential interventions – particularly those associated with breast cancer screening outcomes – to try to shed light on why Black women receive more false positives and diagnoses of more aggressive cancer.

Interventions that can target these specific biological pathways could potentially reduce the negative effects of structural racism and discrimination as well as the effects of other social factors that contribute to breast cancer outcomes, “to ultimately help enhance clinical outcomes and close persistent disparities gaps,” the authors wrote.

Racial differences in cancer outcomes are widespread. Studies indicate that Black people face higher rates of mortality for most cancers than their White counterparts. To bridge this racial gap, researchers need to investigate the biological effects of structural racism and discrimination on cancer outcomes, experts say.

“As a physician, I always like to think that I can influence care in that if I just find the right drugs, help patients understand what their options are, it will help them,” said Ruth Carlos, MD, a radiologist with the University of Michigan Hospital, Ann Arbor. But these things alone are often not enough, because a large proportion of the variation in cancer outcomes is attributable to neighborhood social conditions and the physical environment. “It is incredibly important for us to start to understand just how the neighborhood exerts this effect.”

In a commentary published in the Journal of Clinical Oncology, Dr. Carlos and colleagues highlighted the limitations of previous studies aimed at identifying the causes of racial differences in cancer outcomes. They call upon researchers to turn instead to the long-underexamined biological effects of structural racism and discrimination that contribute to these differences.

In the past, studies on the role of race in health outcomes largely looked at race as a proxy for genetic predisposition. But such an interpretation is flawed, because no genes are specific for a racial or ethnic group, Dr. Carlos and coauthors wrote. Researchers have shown that the vast majority of genetic variation occurs within, rather than between groups.

In an analysis published in Science, researchers reported that within-group differences account for more than 90% of genetic variation.

“Using race in these analyses was not necessarily wrong, but the inferences may have been flawed or incomplete,” Dr. Carlos said. On one hand, looking at genetic predisposition has led to important insights, such as the link between mutations in the BRCA gene and increased risk for breast and ovarian cancer.

However, genetic variation alone is not enough to explain the disparities in cancer outcomes between racial and ethnic groups. The fact that breast cancer can be more aggressive in Black women raises several questions, Dr. Carlos said. Is the cancer worse because Black women have a specific genetic predisposition? Is it worse because Black women exist in a society that marginalizes them and exposes them to increased stress, which in turn produces bad outcomes? Or, could it be both?

Despite progress in the screening, diagnosis and treatment of breast cancer, Black women are 40% more likely to die from the disease than White women. At the time of diagnosis, Black women are more likely to have high-grade, more aggressive breast cancer molecular subtypes, and to have had their cancer spread to the lymph nodes. They also tend to be diagnosed at more advanced stages of breast cancer while at the same time, experience higher rates of false-positive screening results.

Although researchers have hypothesized that genetic differences related to African or European ancestry might contribute, studies have not turned up any differences in cancer susceptibility genes by race. Other factors, such as racial differences in the stage of presentation, molecular subtypes, and disparities in treatment, have also emerged as potential culprits.

In her commentary, Dr. Carlos and colleagues wrote that disparities in breast cancer outcomes previously attributed to race need to be examined from multiple angles. This means looking at both the complex interactions between social conditions and policies, which encompass racism both at the individual and structural level, and stressors such as the experience of discrimination in addition to potential biological and genetic contributions.

Many studies now provide evidence for the harmful effects of racism on health. For breast cancer, specifically, studies also suggest that factors such as racial segregation can influence the stage at which Black women get diagnosed and their likelihood of dying from the disease.

However, an important question that remains is what biological changes occur in women exposed to the kind of persistent low-level stress that is associated with structural racism and discrimination, Dr. Carlos said. “We don’t know what stress pathways actually manifest in the body and how they eventually produce the disease.” Studies to address this issue are important, “especially if you would like to develop interventions to prevent or mitigate disease.”

To address this issue, Dr. Carlos and colleagues called upon the research community to conduct both studies that delineate the underlying biology as well as those that test potential interventions – particularly those associated with breast cancer screening outcomes – to try to shed light on why Black women receive more false positives and diagnoses of more aggressive cancer.

Interventions that can target these specific biological pathways could potentially reduce the negative effects of structural racism and discrimination as well as the effects of other social factors that contribute to breast cancer outcomes, “to ultimately help enhance clinical outcomes and close persistent disparities gaps,” the authors wrote.

Racial differences in cancer outcomes are widespread. Studies indicate that Black people face higher rates of mortality for most cancers than their White counterparts. To bridge this racial gap, researchers need to investigate the biological effects of structural racism and discrimination on cancer outcomes, experts say.

“As a physician, I always like to think that I can influence care in that if I just find the right drugs, help patients understand what their options are, it will help them,” said Ruth Carlos, MD, a radiologist with the University of Michigan Hospital, Ann Arbor. But these things alone are often not enough, because a large proportion of the variation in cancer outcomes is attributable to neighborhood social conditions and the physical environment. “It is incredibly important for us to start to understand just how the neighborhood exerts this effect.”

In a commentary published in the Journal of Clinical Oncology, Dr. Carlos and colleagues highlighted the limitations of previous studies aimed at identifying the causes of racial differences in cancer outcomes. They call upon researchers to turn instead to the long-underexamined biological effects of structural racism and discrimination that contribute to these differences.

In the past, studies on the role of race in health outcomes largely looked at race as a proxy for genetic predisposition. But such an interpretation is flawed, because no genes are specific for a racial or ethnic group, Dr. Carlos and coauthors wrote. Researchers have shown that the vast majority of genetic variation occurs within, rather than between groups.

In an analysis published in Science, researchers reported that within-group differences account for more than 90% of genetic variation.

“Using race in these analyses was not necessarily wrong, but the inferences may have been flawed or incomplete,” Dr. Carlos said. On one hand, looking at genetic predisposition has led to important insights, such as the link between mutations in the BRCA gene and increased risk for breast and ovarian cancer.

However, genetic variation alone is not enough to explain the disparities in cancer outcomes between racial and ethnic groups. The fact that breast cancer can be more aggressive in Black women raises several questions, Dr. Carlos said. Is the cancer worse because Black women have a specific genetic predisposition? Is it worse because Black women exist in a society that marginalizes them and exposes them to increased stress, which in turn produces bad outcomes? Or, could it be both?

Despite progress in the screening, diagnosis and treatment of breast cancer, Black women are 40% more likely to die from the disease than White women. At the time of diagnosis, Black women are more likely to have high-grade, more aggressive breast cancer molecular subtypes, and to have had their cancer spread to the lymph nodes. They also tend to be diagnosed at more advanced stages of breast cancer while at the same time, experience higher rates of false-positive screening results.

Although researchers have hypothesized that genetic differences related to African or European ancestry might contribute, studies have not turned up any differences in cancer susceptibility genes by race. Other factors, such as racial differences in the stage of presentation, molecular subtypes, and disparities in treatment, have also emerged as potential culprits.

In her commentary, Dr. Carlos and colleagues wrote that disparities in breast cancer outcomes previously attributed to race need to be examined from multiple angles. This means looking at both the complex interactions between social conditions and policies, which encompass racism both at the individual and structural level, and stressors such as the experience of discrimination in addition to potential biological and genetic contributions.

Many studies now provide evidence for the harmful effects of racism on health. For breast cancer, specifically, studies also suggest that factors such as racial segregation can influence the stage at which Black women get diagnosed and their likelihood of dying from the disease.

However, an important question that remains is what biological changes occur in women exposed to the kind of persistent low-level stress that is associated with structural racism and discrimination, Dr. Carlos said. “We don’t know what stress pathways actually manifest in the body and how they eventually produce the disease.” Studies to address this issue are important, “especially if you would like to develop interventions to prevent or mitigate disease.”

To address this issue, Dr. Carlos and colleagues called upon the research community to conduct both studies that delineate the underlying biology as well as those that test potential interventions – particularly those associated with breast cancer screening outcomes – to try to shed light on why Black women receive more false positives and diagnoses of more aggressive cancer.

Interventions that can target these specific biological pathways could potentially reduce the negative effects of structural racism and discrimination as well as the effects of other social factors that contribute to breast cancer outcomes, “to ultimately help enhance clinical outcomes and close persistent disparities gaps,” the authors wrote.

A mother-of-three was killed at her hospital appointment in the United Kingdom by a doctor who botched a routine procedure, a court has heard. On July 5, Dr. Isyaka Mamman was sentenced at Manchester Crown Court to 3 years imprisonment after pleading guilty to the manslaughter by gross negligence of his patient.

Dr. Mamman, 85, had already been suspended once by medical watchdogs for lying about his age and was sacked but then re-employed by the Royal Oldham Hospital, where he was responsible for a series of critical incidents before the fatal appointment, Manchester Crown Court heard.

The Nigerian-born doctor had also used various dates of birth and left his previous job through “poor performance.”

‘Highly dangerous’ procedure

Shahida Parveen, 48, had gone to the hospital with her husband, Khizar Mahmood, for investigations into possible myeloproliferative disorder.

A bone marrow biopsy had been advised and the routine procedure was allocated to Dr. Mamman, who was working as a specialty doctor in hematology, Andrew Thomas QC, prosecuting, told the hearing.

Normally, bone marrow samples are taken from the hip bone but Dr. Mamman failed to obtain a sample at the first attempt.

Instead, he attempted a rare and “highly dangerous” procedure of getting a sample from Ms. Parveen’s sternum – despite objections from the patient and her husband.

Dr. Mamman, using the wrong biopsy needle, missed the bone and pierced her pericardium, the sac containing the heart, causing massive internal bleeding.

Ms. Parveen lost consciousness as soon as the needle was inserted, with her husband running from the room shouting: “He killed her. I told him to stop three times and he did not listen. He killed her.”

A crash team arrived but Ms. Parveen was confirmed dead later the same day, September 3, 2018.
 

Controversy over his ‘true age’

Dr. Mamman qualified as a doctor in Nigeria in 1965 and had worked in the United Kingdom since 1991. From 2004 until the time of the fatal incident he was employed by the Pennine Acute Hospitals NHS Trust.

But his “true age” is a matter of “controversy,” the court heard, as his birthplace in rural Nigeria had no system of birth registration.

During his medical training he gave a date of birth of September 16, 1936, which meant that he was 21 years old when he began his medical training and 81 at the time of the fatal hospital incident.

But he knocked years off his age by adopting a birth date in 1941, provided to the NHS, suggesting he began his medical degree at the age of 16.

However, in about 2001 and approaching what was then the compulsory retirement age of 65, Dr. Mamman adopted an even later birth date – October 1947 – which he relied upon in an application for naturalisation as a British citizen – suggesting he started his degree course at the age of 10.

In 2004 he was found guilty of serious professional misconduct by the General Medical Council and suspended for 12 months for lying about his age.

The Pennine Trust sacked him but then re-employed him in 2006, after he had been restored to the register by the GMC, who accepted his date of birth to be 1943 – which meant he was 14 or 15 when he began his medical degree.

Dr. Mamman had left his previous employment with the Medway Trust because of “poor performance,” and in 2015 a formal complaint was made to the Oldham hospital when a patient complained he used “excessive force” during a bone marrow biopsy.

The patient was told that Dr. Mamman was in his 70s and his colleagues thought he should retire but they could not dismiss him purely because of his age. She was assured he would be put on light duties in future.

However, the same year there was another clinical incident, which resulted in serious injury to another patient, again during a bone marrow biopsy, and again involving a needle being inserted in the wrong place. The patient survived but has been left permanently disabled.

Michael Hayton, mitigating, said it was clear Dr. Mamman was a “failing” doctor and he should not have been allowed to continue treating patients.

He added: “He is not the only person at fault. He should not have been allowed to be in the position he was.

“There’s a grotesque catalogue of failings by the trust from 2015.”



This article contains information from PA Media.

A version of this article first appeared on Medscape.co.uk.

A mother-of-three was killed at her hospital appointment in the United Kingdom by a doctor who botched a routine procedure, a court has heard. On July 5, Dr. Isyaka Mamman was sentenced at Manchester Crown Court to 3 years imprisonment after pleading guilty to the manslaughter by gross negligence of his patient.

Dr. Mamman, 85, had already been suspended once by medical watchdogs for lying about his age and was sacked but then re-employed by the Royal Oldham Hospital, where he was responsible for a series of critical incidents before the fatal appointment, Manchester Crown Court heard.

The Nigerian-born doctor had also used various dates of birth and left his previous job through “poor performance.”

‘Highly dangerous’ procedure

Shahida Parveen, 48, had gone to the hospital with her husband, Khizar Mahmood, for investigations into possible myeloproliferative disorder.

A bone marrow biopsy had been advised and the routine procedure was allocated to Dr. Mamman, who was working as a specialty doctor in hematology, Andrew Thomas QC, prosecuting, told the hearing.

Normally, bone marrow samples are taken from the hip bone but Dr. Mamman failed to obtain a sample at the first attempt.

Instead, he attempted a rare and “highly dangerous” procedure of getting a sample from Ms. Parveen’s sternum – despite objections from the patient and her husband.

Dr. Mamman, using the wrong biopsy needle, missed the bone and pierced her pericardium, the sac containing the heart, causing massive internal bleeding.

Ms. Parveen lost consciousness as soon as the needle was inserted, with her husband running from the room shouting: “He killed her. I told him to stop three times and he did not listen. He killed her.”

A crash team arrived but Ms. Parveen was confirmed dead later the same day, September 3, 2018.
 

Controversy over his ‘true age’

Dr. Mamman qualified as a doctor in Nigeria in 1965 and had worked in the United Kingdom since 1991. From 2004 until the time of the fatal incident he was employed by the Pennine Acute Hospitals NHS Trust.

But his “true age” is a matter of “controversy,” the court heard, as his birthplace in rural Nigeria had no system of birth registration.

During his medical training he gave a date of birth of September 16, 1936, which meant that he was 21 years old when he began his medical training and 81 at the time of the fatal hospital incident.

But he knocked years off his age by adopting a birth date in 1941, provided to the NHS, suggesting he began his medical degree at the age of 16.

However, in about 2001 and approaching what was then the compulsory retirement age of 65, Dr. Mamman adopted an even later birth date – October 1947 – which he relied upon in an application for naturalisation as a British citizen – suggesting he started his degree course at the age of 10.

In 2004 he was found guilty of serious professional misconduct by the General Medical Council and suspended for 12 months for lying about his age.

The Pennine Trust sacked him but then re-employed him in 2006, after he had been restored to the register by the GMC, who accepted his date of birth to be 1943 – which meant he was 14 or 15 when he began his medical degree.

Dr. Mamman had left his previous employment with the Medway Trust because of “poor performance,” and in 2015 a formal complaint was made to the Oldham hospital when a patient complained he used “excessive force” during a bone marrow biopsy.

The patient was told that Dr. Mamman was in his 70s and his colleagues thought he should retire but they could not dismiss him purely because of his age. She was assured he would be put on light duties in future.

However, the same year there was another clinical incident, which resulted in serious injury to another patient, again during a bone marrow biopsy, and again involving a needle being inserted in the wrong place. The patient survived but has been left permanently disabled.

Michael Hayton, mitigating, said it was clear Dr. Mamman was a “failing” doctor and he should not have been allowed to continue treating patients.

He added: “He is not the only person at fault. He should not have been allowed to be in the position he was.

“There’s a grotesque catalogue of failings by the trust from 2015.”



This article contains information from PA Media.

A version of this article first appeared on Medscape.co.uk.

A mother-of-three was killed at her hospital appointment in the United Kingdom by a doctor who botched a routine procedure, a court has heard. On July 5, Dr. Isyaka Mamman was sentenced at Manchester Crown Court to 3 years imprisonment after pleading guilty to the manslaughter by gross negligence of his patient.

Dr. Mamman, 85, had already been suspended once by medical watchdogs for lying about his age and was sacked but then re-employed by the Royal Oldham Hospital, where he was responsible for a series of critical incidents before the fatal appointment, Manchester Crown Court heard.

The Nigerian-born doctor had also used various dates of birth and left his previous job through “poor performance.”

‘Highly dangerous’ procedure

Shahida Parveen, 48, had gone to the hospital with her husband, Khizar Mahmood, for investigations into possible myeloproliferative disorder.

A bone marrow biopsy had been advised and the routine procedure was allocated to Dr. Mamman, who was working as a specialty doctor in hematology, Andrew Thomas QC, prosecuting, told the hearing.

Normally, bone marrow samples are taken from the hip bone but Dr. Mamman failed to obtain a sample at the first attempt.

Instead, he attempted a rare and “highly dangerous” procedure of getting a sample from Ms. Parveen’s sternum – despite objections from the patient and her husband.

Dr. Mamman, using the wrong biopsy needle, missed the bone and pierced her pericardium, the sac containing the heart, causing massive internal bleeding.

Ms. Parveen lost consciousness as soon as the needle was inserted, with her husband running from the room shouting: “He killed her. I told him to stop three times and he did not listen. He killed her.”

A crash team arrived but Ms. Parveen was confirmed dead later the same day, September 3, 2018.
 

Controversy over his ‘true age’

Dr. Mamman qualified as a doctor in Nigeria in 1965 and had worked in the United Kingdom since 1991. From 2004 until the time of the fatal incident he was employed by the Pennine Acute Hospitals NHS Trust.

But his “true age” is a matter of “controversy,” the court heard, as his birthplace in rural Nigeria had no system of birth registration.

During his medical training he gave a date of birth of September 16, 1936, which meant that he was 21 years old when he began his medical training and 81 at the time of the fatal hospital incident.

But he knocked years off his age by adopting a birth date in 1941, provided to the NHS, suggesting he began his medical degree at the age of 16.

However, in about 2001 and approaching what was then the compulsory retirement age of 65, Dr. Mamman adopted an even later birth date – October 1947 – which he relied upon in an application for naturalisation as a British citizen – suggesting he started his degree course at the age of 10.

In 2004 he was found guilty of serious professional misconduct by the General Medical Council and suspended for 12 months for lying about his age.

The Pennine Trust sacked him but then re-employed him in 2006, after he had been restored to the register by the GMC, who accepted his date of birth to be 1943 – which meant he was 14 or 15 when he began his medical degree.

Dr. Mamman had left his previous employment with the Medway Trust because of “poor performance,” and in 2015 a formal complaint was made to the Oldham hospital when a patient complained he used “excessive force” during a bone marrow biopsy.

The patient was told that Dr. Mamman was in his 70s and his colleagues thought he should retire but they could not dismiss him purely because of his age. She was assured he would be put on light duties in future.

However, the same year there was another clinical incident, which resulted in serious injury to another patient, again during a bone marrow biopsy, and again involving a needle being inserted in the wrong place. The patient survived but has been left permanently disabled.

Michael Hayton, mitigating, said it was clear Dr. Mamman was a “failing” doctor and he should not have been allowed to continue treating patients.

He added: “He is not the only person at fault. He should not have been allowed to be in the position he was.

“There’s a grotesque catalogue of failings by the trust from 2015.”



This article contains information from PA Media.

A version of this article first appeared on Medscape.co.uk.

Pharmacists can now prescribe Paxlovid, Pfizer’s COVID-19 antiviral pill, directly to patients.

The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.

Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.

“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.

Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”

“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.

But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”

“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.

After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.

Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.

If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.

In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.

Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.

Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.

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

Pharmacists can now prescribe Paxlovid, Pfizer’s COVID-19 antiviral pill, directly to patients.

The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.

Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.

“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.

Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”

“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.

But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”

“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.

After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.

Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.

If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.

In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.

Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.

Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.

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

Pharmacists can now prescribe Paxlovid, Pfizer’s COVID-19 antiviral pill, directly to patients.

The Food and Drug Administration revised the drug’s emergency use authorization on July 6, letting state-licensed pharmacists screen patients and determine if they are eligible for Paxlovid, according to The Associated Press.

Previously, only doctors could prescribe the antiviral drug, the AP reported. With some limits, pharmacists can now prescribe the medication for patients who face high risks for severe COVID-19.

“The FDA recognizes the important role pharmacists have played and continue to play in combating this pandemic,” Patrizia Cavazzoni, MD, director of the FDA’s Center for Drug Evaluation and Research, said in a statement.

“Since Paxlovid must be taken within 5 days after symptoms begin, authorizing state-licensed pharmacists to prescribe Paxlovid could expand access to timely treatment for some patients who are eligible to receive this drug for the treatment of COVID-19,” she said.

Tom Kraus, the vice president of government relations at the American Society of Health-System Pharmacists, said in a statement that the organization was “pleased to see the FDA remove this barrier to patients’ access to this critical treatment.”

“Pharmacists have played a vital role in our pandemic response efforts and are well-positioned to help patients, particularly those in rural and underserved communities, benefit from this medication,” he said.

But some doctor’s groups questioned the FDA’s move. Jack Resneck Jr., MD, the president of the American Medical Association, said in a statement that prescribing Paxlovid “requires knowledge of a patient’s medical history, as well as clinical monitoring for side effects and follow-up care to determine whether a patient is improving” – requirements that are “far beyond a pharmacist’s scope and training.”

“In the fight against a virus that has killed more than a million people in the United States and is still extremely present and transmissible, patients will get the best, most comprehensive care from physician-led teams – teams that include pharmacists. But, whenever possible, prescribing decisions should be made by a physician with knowledge of a patient’s medical history and the ability to follow up. To ensure the best possible care for COVID-19 patients, we urge people who test positive to discuss treatment options with their physician, if they have one,” he said.

After testing positive for COVID-19, patients should first consider seeking care from their regular health care provider or locating a Test-to-Treat site in their area, the FDA said. Although the latest update allows pharmacists to prescribe Paxlovid, community pharmacies that don’t yet take part in the Test-to-Treat program can decide if they will offer the prescription service to patients.

Paxlovid is authorized to treat mild to moderate COVID-19 in adults and in kids ages 12 and older who weigh at least 88 pounds. Patients who report a positive at-home test are eligible for Paxlovid under the FDA authorization.

If patients want to seek a prescription directly from a pharmacist, they should bring electronic or printed health records from the past year, including their most recent reports of blood work, so the pharmacist can review for kidney or liver problems. Pharmacists can also get this information from the patient’s health care provider.

In addition, patients should bring a list of all medications they are taking, including over-the-counter medications, so the pharmacist can screen for drugs that can have serious interactions with Paxlovid.

Under the limits in the updated FDA authorization, pharmacists should refer patients for more screening if Paxlovid isn’t a good option or if there’s not enough information to find out how well their kidneys or liver works, as well as potential drug interactions.

Paxlovid is intended for people with COVID-19 who face the highest risks for serious disease, the AP reported, including older adults and those with health conditions such as heart disease, obesity, cancer, or diabetes. It isn’t recommended for people with severe kidney or liver problems. A course of treatment requires three pills twice a day for 5 days.

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

World Health Organization officials announced July 6 that they’re tracking a new subvariant of Omicron, which is becoming more common in India.

The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.

“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.

The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.

“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.

The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.

Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.

BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.

Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.

The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.

BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.

“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.

“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.

Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.

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

World Health Organization officials announced July 6 that they’re tracking a new subvariant of Omicron, which is becoming more common in India.

The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.

“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.

The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.

“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.

The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.

Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.

BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.

Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.

The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.

BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.

“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.

“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.

Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.

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

World Health Organization officials announced July 6 that they’re tracking a new subvariant of Omicron, which is becoming more common in India.

The subvariant, a sublineage of BA.2 being called BA.2.75, has been reported in eight countries and hasn’t yet been declared a variant of concern.

“There’s been an emergence of a ‘could be’ subvariant. It’s been not yet officially called, but some people are referring to it as BA.2.75,” Soumya Swaminathan, MD, the WHO’s chief scientist, said in a video posted on Twitter.

The subvariant appears to have mutations similar to other contagious strains, she said, though there are a limited number of sequences available to analyze. How transmissible and severe it is, and how well it can evade our immunity, aren’t yet known.

“We have to wait and see, and of course, we are tracking it,” Dr. Swaminathan said.

The WHO committee responsible for analyzing global coronavirus data will label the subvariant officially and release more information as the situation warrants it, she said.

Public health experts around the world are also talking about the subvariant, which has been nicknamed Centaurus. BA.2.75 was first found in India in May and is now competing with BA.5, which has become dominant in the United States.

BA.2.75 has eight mutations beyond those seen in BA.5, which “could make immune escape worse than what we’re seeing now,” Eric Topol, MD, founder and director of the Scripps Research Translational Institute and editor-in-chief at Medscape, wrote in a Twitter post.

Individually, the extra mutations aren’t too concerning, “but all appearing together at once is another matter,” Tom Peacock, PhD, a virologist at Imperial College London, wrote in a Twitter post.

The “apparent rapid growth and wide geographical spread” are “worth keeping a close eye on,” he said.

BA.2.75 has been found in a handful of cases in the United States, Australia, Canada, Germany, Japan, New Zealand, and the United Kingdom. In India, the sequence accounts for about 23% of recent samples.

“It is really too early to know if BA.2.75 will take over relative to BA.2 or even relative to BA.5,” Ulrich Elling, PhD, a researcher at Australia’s Institute of Molecular Biotechnology, wrote in a Twitter post.

“Just to emphasize it again: While the distribution across Indian regions as well as internationally and the very rapid appearance makes it likely we are dealing with a variant spreading fast and spread widely already, the absolute data points are few,” he said.

Globally, coronavirus cases have increased nearly 30% during the past 2 weeks, the WHO said July 6. Four out of six of the WHO subregions reported an increase in the last week, with BA.4 and BA.5 driving waves in the United States and Europe.

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

Only a small number of research clinical trials for cancer drugs actually show benefit in quality of life, according to a study published in JAMA Oncology.

The study found trials that failed to show improved quality of life often reported their quality of life outcomes more favorably. Non–immunotherapy-targeted drugs were found to lead to worse quality of life outcomes more often than did cytotoxic agents. And, while there is an association between quality of life benefit and overall survival, no such association was found with progression-free survival.

“In this study, we evaluated the outcomes of cancer drug trials with regard to patients’ quality of life and found that only a quarter of phase 3 cancer drug trials in the advanced-disease setting demonstrated improved quality of life,” wrote authors who were led by Bishal Gyawali, MD, PhD, of the Cancer Research Institute, Queen’s University, Kingston, Ont.

“Improved quality of life outcomes were associated with improved overall survival but not with improved progression-free survival. Importantly, almost half of the cancer drugs drug trials that showed improved progression-free survival showed no improved overall survival or quality of life (i.e., PFS-only benefit). Some reports included conclusions regarding quality of life (QOL) findings that were not directly supported by the trial data, particularly for inferior or non–statistically significant QOL outcomes, thereby framing the findings in a favorable light or downplaying detrimental effects of the study intervention on QOL. Furthermore, contrary to common perception, inferior QOL outcomes were more common with targeted drugs than cytotoxic drugs. Taken together, these findings have important policy implications,” the authors wrote.

These findings are based on the results of a cohort study of 45 phase 3 research clinical trials of 24,806 patients. Only a small percentage of patients showed QOL benefits. The study found that industry-funded clinical trial reports often framed QOL findings more favorably than was warranted by the data.

The study found improved QOL with experimental agents in 11 of 45 randomized controlled trials (24.4%). Studies that reported improved QOL were more likely to also show improved overall survival as compared with trials in which quality of life was not improved (7 of 11 [64%] versus 10 of 34 [29%] trials). For improved progression-free survival, however, there was no positive association (6 of 11 [55%] trials versus 17 of 34 [50%] trials without improved QOL). Among six trials reporting worsening QOL, three (50%) were trials of targeted drugs. Among 11 trials reporting improved QOL, 6 (55%) were trials of immunotherapy drugs. Among the 34 trials in which QOL was not improved compared with controls, the findings were framed favorably (versus neutrally or negatively) in the abstract or conclusions in 16 (47%), an observation that was statistically significantly associated with industry funding (chi-squared = 6.35; P = .01).

“It is important to clearly understand and communicate the effects of cancer drugs”

To fulfill the obligation to inform patients about proposed treatments, the authors wrote that it is important to clearly understand and communicate the effects of cancer drugs on patient quality of life alongside their effects on overall survival and intermediate end points such as progression-free survival. “Patients with advanced cancer expect treatment to help them live longer or have better lives,” the authors wrote. In that respect, in clinical trials of cancer medicines, overall survival and quality of life are the most important measures. Toxicity profiles and disease progression delays do not reliably predict quality of life, and studies have shown poor correlations between quality of life, overall survival, and progression-free survival. This raises the question of validity of progression-free survival as a surrogate endpoint. “Progression-free survival is meaningless without overall survival or quality of life gains,” Dr. Gyawali said in an interview.

Writing in The Lancet Oncology in March, Dr. Gyawali stated that, because progression free survival “does not directly measure how a patient feels or functions, or how long a patient lives, progression-free survival was not intended to inform clinical practice or establish whether a new therapy provides clinically meaningful benefits for patients. However, over the past 2 decades, it has become the most common primary endpoint in oncology clinical trials. We are deeply worried about how the term survival in this phrase can influence clinical practice and patient choices. We propose replacing the phrase progression-free survival with a less ambiguous term: progression-free interval.”

In JAMA Oncology, Dr. Gyawali aimed to elucidate relationships between QOL, overall survival, and progression-free survival, and to assess, as well, how QOL results are framed, especially in industry-sponsored research. When drug trials they analyzed showed no change in QOL but reported that QOL did not worsen or QOL was maintained rather than stating that QOL did not improve, or if there was downplaying of worse QOL outcomes, the study had favorable interpretation, Dr. Gyawali and associates wrote. The expectation of patients receiving cancer drugs would be improved QOL rather than “not worse” QOL, Dr. Gyawali said.

Regarding the finding that QOL outcomes were described as favorable in 47% of trials with unimproved QOL outcomes, Dr. Gyawali said, “the bias in reporting should be corrected by the reviewers and editors of journals. Also, quality of life reporting should be made mandatory. Without unbiased quality of life information, informed decision making on whether or not to use a certain drug is impossible. Patients and physicians need to know that information. Regulators can demand that this should be mandatory in all trials in noncurative settings.”

He remarked further on the worsening QOL in some targeted drug trials, “People tout chemo-free regimens as automatically having better quality of life, but that doesn’t seem to be the case. Targeted drugs can have a severe impact on quality of life, probably due to prolonged duration of side effects. Quality of life should be measured and reported for all drugs.”

Dr. Gyawali and associates noted the limitation in that several studies with negative QOL results are not published at all or are published after a considerable delay, so the present observations may understate the issues that have been raised.

Dr. Gyawali declared that he received no funding and disclosed no conflicts of interest for this study.

Only a small number of research clinical trials for cancer drugs actually show benefit in quality of life, according to a study published in JAMA Oncology.

The study found trials that failed to show improved quality of life often reported their quality of life outcomes more favorably. Non–immunotherapy-targeted drugs were found to lead to worse quality of life outcomes more often than did cytotoxic agents. And, while there is an association between quality of life benefit and overall survival, no such association was found with progression-free survival.

“In this study, we evaluated the outcomes of cancer drug trials with regard to patients’ quality of life and found that only a quarter of phase 3 cancer drug trials in the advanced-disease setting demonstrated improved quality of life,” wrote authors who were led by Bishal Gyawali, MD, PhD, of the Cancer Research Institute, Queen’s University, Kingston, Ont.

“Improved quality of life outcomes were associated with improved overall survival but not with improved progression-free survival. Importantly, almost half of the cancer drugs drug trials that showed improved progression-free survival showed no improved overall survival or quality of life (i.e., PFS-only benefit). Some reports included conclusions regarding quality of life (QOL) findings that were not directly supported by the trial data, particularly for inferior or non–statistically significant QOL outcomes, thereby framing the findings in a favorable light or downplaying detrimental effects of the study intervention on QOL. Furthermore, contrary to common perception, inferior QOL outcomes were more common with targeted drugs than cytotoxic drugs. Taken together, these findings have important policy implications,” the authors wrote.

These findings are based on the results of a cohort study of 45 phase 3 research clinical trials of 24,806 patients. Only a small percentage of patients showed QOL benefits. The study found that industry-funded clinical trial reports often framed QOL findings more favorably than was warranted by the data.

The study found improved QOL with experimental agents in 11 of 45 randomized controlled trials (24.4%). Studies that reported improved QOL were more likely to also show improved overall survival as compared with trials in which quality of life was not improved (7 of 11 [64%] versus 10 of 34 [29%] trials). For improved progression-free survival, however, there was no positive association (6 of 11 [55%] trials versus 17 of 34 [50%] trials without improved QOL). Among six trials reporting worsening QOL, three (50%) were trials of targeted drugs. Among 11 trials reporting improved QOL, 6 (55%) were trials of immunotherapy drugs. Among the 34 trials in which QOL was not improved compared with controls, the findings were framed favorably (versus neutrally or negatively) in the abstract or conclusions in 16 (47%), an observation that was statistically significantly associated with industry funding (chi-squared = 6.35; P = .01).

“It is important to clearly understand and communicate the effects of cancer drugs”

To fulfill the obligation to inform patients about proposed treatments, the authors wrote that it is important to clearly understand and communicate the effects of cancer drugs on patient quality of life alongside their effects on overall survival and intermediate end points such as progression-free survival. “Patients with advanced cancer expect treatment to help them live longer or have better lives,” the authors wrote. In that respect, in clinical trials of cancer medicines, overall survival and quality of life are the most important measures. Toxicity profiles and disease progression delays do not reliably predict quality of life, and studies have shown poor correlations between quality of life, overall survival, and progression-free survival. This raises the question of validity of progression-free survival as a surrogate endpoint. “Progression-free survival is meaningless without overall survival or quality of life gains,” Dr. Gyawali said in an interview.

Writing in The Lancet Oncology in March, Dr. Gyawali stated that, because progression free survival “does not directly measure how a patient feels or functions, or how long a patient lives, progression-free survival was not intended to inform clinical practice or establish whether a new therapy provides clinically meaningful benefits for patients. However, over the past 2 decades, it has become the most common primary endpoint in oncology clinical trials. We are deeply worried about how the term survival in this phrase can influence clinical practice and patient choices. We propose replacing the phrase progression-free survival with a less ambiguous term: progression-free interval.”

In JAMA Oncology, Dr. Gyawali aimed to elucidate relationships between QOL, overall survival, and progression-free survival, and to assess, as well, how QOL results are framed, especially in industry-sponsored research. When drug trials they analyzed showed no change in QOL but reported that QOL did not worsen or QOL was maintained rather than stating that QOL did not improve, or if there was downplaying of worse QOL outcomes, the study had favorable interpretation, Dr. Gyawali and associates wrote. The expectation of patients receiving cancer drugs would be improved QOL rather than “not worse” QOL, Dr. Gyawali said.

Regarding the finding that QOL outcomes were described as favorable in 47% of trials with unimproved QOL outcomes, Dr. Gyawali said, “the bias in reporting should be corrected by the reviewers and editors of journals. Also, quality of life reporting should be made mandatory. Without unbiased quality of life information, informed decision making on whether or not to use a certain drug is impossible. Patients and physicians need to know that information. Regulators can demand that this should be mandatory in all trials in noncurative settings.”

He remarked further on the worsening QOL in some targeted drug trials, “People tout chemo-free regimens as automatically having better quality of life, but that doesn’t seem to be the case. Targeted drugs can have a severe impact on quality of life, probably due to prolonged duration of side effects. Quality of life should be measured and reported for all drugs.”

Dr. Gyawali and associates noted the limitation in that several studies with negative QOL results are not published at all or are published after a considerable delay, so the present observations may understate the issues that have been raised.

Dr. Gyawali declared that he received no funding and disclosed no conflicts of interest for this study.

Only a small number of research clinical trials for cancer drugs actually show benefit in quality of life, according to a study published in JAMA Oncology.

The study found trials that failed to show improved quality of life often reported their quality of life outcomes more favorably. Non–immunotherapy-targeted drugs were found to lead to worse quality of life outcomes more often than did cytotoxic agents. And, while there is an association between quality of life benefit and overall survival, no such association was found with progression-free survival.

“In this study, we evaluated the outcomes of cancer drug trials with regard to patients’ quality of life and found that only a quarter of phase 3 cancer drug trials in the advanced-disease setting demonstrated improved quality of life,” wrote authors who were led by Bishal Gyawali, MD, PhD, of the Cancer Research Institute, Queen’s University, Kingston, Ont.

“Improved quality of life outcomes were associated with improved overall survival but not with improved progression-free survival. Importantly, almost half of the cancer drugs drug trials that showed improved progression-free survival showed no improved overall survival or quality of life (i.e., PFS-only benefit). Some reports included conclusions regarding quality of life (QOL) findings that were not directly supported by the trial data, particularly for inferior or non–statistically significant QOL outcomes, thereby framing the findings in a favorable light or downplaying detrimental effects of the study intervention on QOL. Furthermore, contrary to common perception, inferior QOL outcomes were more common with targeted drugs than cytotoxic drugs. Taken together, these findings have important policy implications,” the authors wrote.

These findings are based on the results of a cohort study of 45 phase 3 research clinical trials of 24,806 patients. Only a small percentage of patients showed QOL benefits. The study found that industry-funded clinical trial reports often framed QOL findings more favorably than was warranted by the data.

The study found improved QOL with experimental agents in 11 of 45 randomized controlled trials (24.4%). Studies that reported improved QOL were more likely to also show improved overall survival as compared with trials in which quality of life was not improved (7 of 11 [64%] versus 10 of 34 [29%] trials). For improved progression-free survival, however, there was no positive association (6 of 11 [55%] trials versus 17 of 34 [50%] trials without improved QOL). Among six trials reporting worsening QOL, three (50%) were trials of targeted drugs. Among 11 trials reporting improved QOL, 6 (55%) were trials of immunotherapy drugs. Among the 34 trials in which QOL was not improved compared with controls, the findings were framed favorably (versus neutrally or negatively) in the abstract or conclusions in 16 (47%), an observation that was statistically significantly associated with industry funding (chi-squared = 6.35; P = .01).

“It is important to clearly understand and communicate the effects of cancer drugs”

To fulfill the obligation to inform patients about proposed treatments, the authors wrote that it is important to clearly understand and communicate the effects of cancer drugs on patient quality of life alongside their effects on overall survival and intermediate end points such as progression-free survival. “Patients with advanced cancer expect treatment to help them live longer or have better lives,” the authors wrote. In that respect, in clinical trials of cancer medicines, overall survival and quality of life are the most important measures. Toxicity profiles and disease progression delays do not reliably predict quality of life, and studies have shown poor correlations between quality of life, overall survival, and progression-free survival. This raises the question of validity of progression-free survival as a surrogate endpoint. “Progression-free survival is meaningless without overall survival or quality of life gains,” Dr. Gyawali said in an interview.

Writing in The Lancet Oncology in March, Dr. Gyawali stated that, because progression free survival “does not directly measure how a patient feels or functions, or how long a patient lives, progression-free survival was not intended to inform clinical practice or establish whether a new therapy provides clinically meaningful benefits for patients. However, over the past 2 decades, it has become the most common primary endpoint in oncology clinical trials. We are deeply worried about how the term survival in this phrase can influence clinical practice and patient choices. We propose replacing the phrase progression-free survival with a less ambiguous term: progression-free interval.”

In JAMA Oncology, Dr. Gyawali aimed to elucidate relationships between QOL, overall survival, and progression-free survival, and to assess, as well, how QOL results are framed, especially in industry-sponsored research. When drug trials they analyzed showed no change in QOL but reported that QOL did not worsen or QOL was maintained rather than stating that QOL did not improve, or if there was downplaying of worse QOL outcomes, the study had favorable interpretation, Dr. Gyawali and associates wrote. The expectation of patients receiving cancer drugs would be improved QOL rather than “not worse” QOL, Dr. Gyawali said.

Regarding the finding that QOL outcomes were described as favorable in 47% of trials with unimproved QOL outcomes, Dr. Gyawali said, “the bias in reporting should be corrected by the reviewers and editors of journals. Also, quality of life reporting should be made mandatory. Without unbiased quality of life information, informed decision making on whether or not to use a certain drug is impossible. Patients and physicians need to know that information. Regulators can demand that this should be mandatory in all trials in noncurative settings.”

He remarked further on the worsening QOL in some targeted drug trials, “People tout chemo-free regimens as automatically having better quality of life, but that doesn’t seem to be the case. Targeted drugs can have a severe impact on quality of life, probably due to prolonged duration of side effects. Quality of life should be measured and reported for all drugs.”

Dr. Gyawali and associates noted the limitation in that several studies with negative QOL results are not published at all or are published after a considerable delay, so the present observations may understate the issues that have been raised.

Dr. Gyawali declared that he received no funding and disclosed no conflicts of interest for this study.

Ann Marco, 73, who was diagnosed with ovarian cancer in late 2018, credits her oncology team for saving her life. They treated her with chemotherapy, debulking surgery, and more chemotherapy. But it is her second and current care team that helped restore Ms. Marco’s quality of life, directing her toward such resources as palliative care, physical therapy and counseling for her and her husband.

“I can’t say enough about my palliative care doctor. She helped me manage pain, and the fatigue associated with chemotherapy. When she noticed that my leg was swollen she suspected a blood clot and sent me for an ultrasound,” Ms. Marco said.

The ultrasound revealed that she did indeed have a blood clot, for which she received, and continues to receive, medication. “Because with ovarian cancer, you always have blood clots. So little things like that, though they’re not that little, have really helped me in my journey with this cancer,” Ms. Marco said.

That journey has had its ups and downs. One chemotherapy regimen was so intolerable she decided to discontinue it, with full support of her oncologist. I told her, I just want to live my life, whether that’s only 6 more months or 3 years, but I don’t want to live it like this. And she said, ‘Ann, we’re going to do what you want to do.’”

Nine months later, when her cancer started growing again, Ms. Marco returned to chemotherapy. But this regimen has been much more tolerable, and it also appears to be doing its job. A recent CT scan showed that the tumors are shrinking.

“They’ll never go away. I have metastatic cancer. But they’re smaller, and I was really thrilled about that. It’s the best news I’ve had in more than 3 years,” Ms. Marco said.
 

End-of-life aggressive care still common

Despite clinical guidelines advising against intensive or invasive end-of-life care, more than half of women with terminal ovarian cancer receive at least one aggressive intervention, shows a study published in JCO Oncology Practice.

“We have good evidence that the types of aggressive end-of-life care we looked at in this paper are generally related to a lower quality of life for patients, poorer bereavement outcomes for their families, and even shorter duration survivals,” said lead author Megan A. Mullins, PhD, MPH, a postdoctoral research fellow at the University of Michigan in Ann Arbor. “This suggests there’s a disconnect between what people think aggressive care might do and what it’s doing.”

In their evaluation of variation in end-of-life care, Dr. Mullins and her colleagues analyzed SEER-Medicare data on 6,288 women with ovarian cancer who died between 2016 and 2020. They found that 51% of those women received some form of aggressive cancer care. The most common forms were not being admitted to hospice (28.9%), receiving an invasive procedure (20.7%) and being admitted to an intensive care unit (18.6%).

Dr. Mullins noted that since palliative care was officially recognized as a specialty in 2006, there has been increasing guidance for earlier integration of palliative care and reducing the aggressiveness of end-of-life care; both ASCO and the National Quality Form have standards advising against aggressive end-of-life care.

“But there are a lot of complicated factors that I think make it hard to move the needle in this area,” she said. “For one thing, particularly with ovarian cancer, women tend to have recurrences. I’ve spoken with physicians who got their patients through a difficult patch; they rebounded and they did fine. You don’t know for sure if that’s going to happen again if you try something else. Prognostication is not an exact science.”

Also, end-of-life discussions can be challenging conversations. “Nobody wants to take hope away from their patients. But there’s evidence to show that these conversations don’t actually reduce patients’ hopes – that’s a misconception,” Dr. Mullins said.

“It’s challenging. In the United States, we don’t like to talk about death and dying. But I think having these conversations earlier and more often can help make them a more regular part of care,” she said.

Brittany A. Davidson, MD, a gynecologic oncologist with Duke Health in Durham, N.C., who wrote an accompanying editorial, acknowledges that end-of-life can be fraught with fear, anxiety, and a lot of emotion. But she finds helping patients and their families navigate the ups and downs of their cancer one of the most rewarding aspects of her career as a physician.

“We want to help patients and their family members make these transitions as smoothly as possible,” she said.

A proponent of communications skills training for physicians in general, Dr. Brittany said doctors can learn to identify cues that patients are ready to have conversations about their end-of-life care.

“Those cues will help us facilitate conversations sooner rather than later so we’re not waiting until the very end,” she said.

What these conversations consist of varies depending on where the patient is in her cancer trajectory. In a patient with recurrent ovarian or recurrent uterine cancer, this might start with making sure the patient understands that while their cancer is treatable, it is very unlikely to be curable.

“I have often had patients who have been treated for cancer for several years and didn’t know their cancer wasn’t curable. How many missed opportunities have we overlooked?” Dr. Davidson said.

Then the conversation can turn to the goals of treatment. What’s important to the patient? “Are there events they want to be around for? Symptoms they want to avoid? Some patients really want to know what it’s going to be like to die. I try to take the lead from the patient. Ask what kind of information is helpful to them. Is it numbers? Is it symptoms? It’s really different for everybody,” Dr. Davidson said.

Although Dr. Mullins’s research and Dr. Davidson’s editorial suggest there’s room for improvement toward achieving goal-concordant care in gynecological cancers, Dr. Davidson suspects these patients might be faring a bit better than patients with other types of cancer based on her own anecdotal observations.

“One of the unique things about gynecologic oncology is that we have an amazing longitudinal relationship with our patients – we are not only their surgeons, we’re their oncologists. In other solid tumors, care is fractionated.

“That’s one of the reasons I love gynecologic oncology. I have the opportunity to know my patients through all the stages they experience as part of their cancer. I’d like to think that allows me a better opportunity to get to know them and help them recognize the value of palliative care,” Dr. Mullins said.

Ann Marco, 73, who was diagnosed with ovarian cancer in late 2018, credits her oncology team for saving her life. They treated her with chemotherapy, debulking surgery, and more chemotherapy. But it is her second and current care team that helped restore Ms. Marco’s quality of life, directing her toward such resources as palliative care, physical therapy and counseling for her and her husband.

“I can’t say enough about my palliative care doctor. She helped me manage pain, and the fatigue associated with chemotherapy. When she noticed that my leg was swollen she suspected a blood clot and sent me for an ultrasound,” Ms. Marco said.

The ultrasound revealed that she did indeed have a blood clot, for which she received, and continues to receive, medication. “Because with ovarian cancer, you always have blood clots. So little things like that, though they’re not that little, have really helped me in my journey with this cancer,” Ms. Marco said.

That journey has had its ups and downs. One chemotherapy regimen was so intolerable she decided to discontinue it, with full support of her oncologist. I told her, I just want to live my life, whether that’s only 6 more months or 3 years, but I don’t want to live it like this. And she said, ‘Ann, we’re going to do what you want to do.’”

Nine months later, when her cancer started growing again, Ms. Marco returned to chemotherapy. But this regimen has been much more tolerable, and it also appears to be doing its job. A recent CT scan showed that the tumors are shrinking.

“They’ll never go away. I have metastatic cancer. But they’re smaller, and I was really thrilled about that. It’s the best news I’ve had in more than 3 years,” Ms. Marco said.
 

End-of-life aggressive care still common

Despite clinical guidelines advising against intensive or invasive end-of-life care, more than half of women with terminal ovarian cancer receive at least one aggressive intervention, shows a study published in JCO Oncology Practice.

“We have good evidence that the types of aggressive end-of-life care we looked at in this paper are generally related to a lower quality of life for patients, poorer bereavement outcomes for their families, and even shorter duration survivals,” said lead author Megan A. Mullins, PhD, MPH, a postdoctoral research fellow at the University of Michigan in Ann Arbor. “This suggests there’s a disconnect between what people think aggressive care might do and what it’s doing.”

In their evaluation of variation in end-of-life care, Dr. Mullins and her colleagues analyzed SEER-Medicare data on 6,288 women with ovarian cancer who died between 2016 and 2020. They found that 51% of those women received some form of aggressive cancer care. The most common forms were not being admitted to hospice (28.9%), receiving an invasive procedure (20.7%) and being admitted to an intensive care unit (18.6%).

Dr. Mullins noted that since palliative care was officially recognized as a specialty in 2006, there has been increasing guidance for earlier integration of palliative care and reducing the aggressiveness of end-of-life care; both ASCO and the National Quality Form have standards advising against aggressive end-of-life care.

“But there are a lot of complicated factors that I think make it hard to move the needle in this area,” she said. “For one thing, particularly with ovarian cancer, women tend to have recurrences. I’ve spoken with physicians who got their patients through a difficult patch; they rebounded and they did fine. You don’t know for sure if that’s going to happen again if you try something else. Prognostication is not an exact science.”

Also, end-of-life discussions can be challenging conversations. “Nobody wants to take hope away from their patients. But there’s evidence to show that these conversations don’t actually reduce patients’ hopes – that’s a misconception,” Dr. Mullins said.

“It’s challenging. In the United States, we don’t like to talk about death and dying. But I think having these conversations earlier and more often can help make them a more regular part of care,” she said.

Brittany A. Davidson, MD, a gynecologic oncologist with Duke Health in Durham, N.C., who wrote an accompanying editorial, acknowledges that end-of-life can be fraught with fear, anxiety, and a lot of emotion. But she finds helping patients and their families navigate the ups and downs of their cancer one of the most rewarding aspects of her career as a physician.

“We want to help patients and their family members make these transitions as smoothly as possible,” she said.

A proponent of communications skills training for physicians in general, Dr. Brittany said doctors can learn to identify cues that patients are ready to have conversations about their end-of-life care.

“Those cues will help us facilitate conversations sooner rather than later so we’re not waiting until the very end,” she said.

What these conversations consist of varies depending on where the patient is in her cancer trajectory. In a patient with recurrent ovarian or recurrent uterine cancer, this might start with making sure the patient understands that while their cancer is treatable, it is very unlikely to be curable.

“I have often had patients who have been treated for cancer for several years and didn’t know their cancer wasn’t curable. How many missed opportunities have we overlooked?” Dr. Davidson said.

Then the conversation can turn to the goals of treatment. What’s important to the patient? “Are there events they want to be around for? Symptoms they want to avoid? Some patients really want to know what it’s going to be like to die. I try to take the lead from the patient. Ask what kind of information is helpful to them. Is it numbers? Is it symptoms? It’s really different for everybody,” Dr. Davidson said.

Although Dr. Mullins’s research and Dr. Davidson’s editorial suggest there’s room for improvement toward achieving goal-concordant care in gynecological cancers, Dr. Davidson suspects these patients might be faring a bit better than patients with other types of cancer based on her own anecdotal observations.

“One of the unique things about gynecologic oncology is that we have an amazing longitudinal relationship with our patients – we are not only their surgeons, we’re their oncologists. In other solid tumors, care is fractionated.

“That’s one of the reasons I love gynecologic oncology. I have the opportunity to know my patients through all the stages they experience as part of their cancer. I’d like to think that allows me a better opportunity to get to know them and help them recognize the value of palliative care,” Dr. Mullins said.

Ann Marco, 73, who was diagnosed with ovarian cancer in late 2018, credits her oncology team for saving her life. They treated her with chemotherapy, debulking surgery, and more chemotherapy. But it is her second and current care team that helped restore Ms. Marco’s quality of life, directing her toward such resources as palliative care, physical therapy and counseling for her and her husband.

“I can’t say enough about my palliative care doctor. She helped me manage pain, and the fatigue associated with chemotherapy. When she noticed that my leg was swollen she suspected a blood clot and sent me for an ultrasound,” Ms. Marco said.

The ultrasound revealed that she did indeed have a blood clot, for which she received, and continues to receive, medication. “Because with ovarian cancer, you always have blood clots. So little things like that, though they’re not that little, have really helped me in my journey with this cancer,” Ms. Marco said.

That journey has had its ups and downs. One chemotherapy regimen was so intolerable she decided to discontinue it, with full support of her oncologist. I told her, I just want to live my life, whether that’s only 6 more months or 3 years, but I don’t want to live it like this. And she said, ‘Ann, we’re going to do what you want to do.’”

Nine months later, when her cancer started growing again, Ms. Marco returned to chemotherapy. But this regimen has been much more tolerable, and it also appears to be doing its job. A recent CT scan showed that the tumors are shrinking.

“They’ll never go away. I have metastatic cancer. But they’re smaller, and I was really thrilled about that. It’s the best news I’ve had in more than 3 years,” Ms. Marco said.
 

End-of-life aggressive care still common

Despite clinical guidelines advising against intensive or invasive end-of-life care, more than half of women with terminal ovarian cancer receive at least one aggressive intervention, shows a study published in JCO Oncology Practice.

“We have good evidence that the types of aggressive end-of-life care we looked at in this paper are generally related to a lower quality of life for patients, poorer bereavement outcomes for their families, and even shorter duration survivals,” said lead author Megan A. Mullins, PhD, MPH, a postdoctoral research fellow at the University of Michigan in Ann Arbor. “This suggests there’s a disconnect between what people think aggressive care might do and what it’s doing.”

In their evaluation of variation in end-of-life care, Dr. Mullins and her colleagues analyzed SEER-Medicare data on 6,288 women with ovarian cancer who died between 2016 and 2020. They found that 51% of those women received some form of aggressive cancer care. The most common forms were not being admitted to hospice (28.9%), receiving an invasive procedure (20.7%) and being admitted to an intensive care unit (18.6%).

Dr. Mullins noted that since palliative care was officially recognized as a specialty in 2006, there has been increasing guidance for earlier integration of palliative care and reducing the aggressiveness of end-of-life care; both ASCO and the National Quality Form have standards advising against aggressive end-of-life care.

“But there are a lot of complicated factors that I think make it hard to move the needle in this area,” she said. “For one thing, particularly with ovarian cancer, women tend to have recurrences. I’ve spoken with physicians who got their patients through a difficult patch; they rebounded and they did fine. You don’t know for sure if that’s going to happen again if you try something else. Prognostication is not an exact science.”

Also, end-of-life discussions can be challenging conversations. “Nobody wants to take hope away from their patients. But there’s evidence to show that these conversations don’t actually reduce patients’ hopes – that’s a misconception,” Dr. Mullins said.

“It’s challenging. In the United States, we don’t like to talk about death and dying. But I think having these conversations earlier and more often can help make them a more regular part of care,” she said.

Brittany A. Davidson, MD, a gynecologic oncologist with Duke Health in Durham, N.C., who wrote an accompanying editorial, acknowledges that end-of-life can be fraught with fear, anxiety, and a lot of emotion. But she finds helping patients and their families navigate the ups and downs of their cancer one of the most rewarding aspects of her career as a physician.

“We want to help patients and their family members make these transitions as smoothly as possible,” she said.

A proponent of communications skills training for physicians in general, Dr. Brittany said doctors can learn to identify cues that patients are ready to have conversations about their end-of-life care.

“Those cues will help us facilitate conversations sooner rather than later so we’re not waiting until the very end,” she said.

What these conversations consist of varies depending on where the patient is in her cancer trajectory. In a patient with recurrent ovarian or recurrent uterine cancer, this might start with making sure the patient understands that while their cancer is treatable, it is very unlikely to be curable.

“I have often had patients who have been treated for cancer for several years and didn’t know their cancer wasn’t curable. How many missed opportunities have we overlooked?” Dr. Davidson said.

Then the conversation can turn to the goals of treatment. What’s important to the patient? “Are there events they want to be around for? Symptoms they want to avoid? Some patients really want to know what it’s going to be like to die. I try to take the lead from the patient. Ask what kind of information is helpful to them. Is it numbers? Is it symptoms? It’s really different for everybody,” Dr. Davidson said.

Although Dr. Mullins’s research and Dr. Davidson’s editorial suggest there’s room for improvement toward achieving goal-concordant care in gynecological cancers, Dr. Davidson suspects these patients might be faring a bit better than patients with other types of cancer based on her own anecdotal observations.

“One of the unique things about gynecologic oncology is that we have an amazing longitudinal relationship with our patients – we are not only their surgeons, we’re their oncologists. In other solid tumors, care is fractionated.

“That’s one of the reasons I love gynecologic oncology. I have the opportunity to know my patients through all the stages they experience as part of their cancer. I’d like to think that allows me a better opportunity to get to know them and help them recognize the value of palliative care,” Dr. Mullins said.

Opioids remain a staple in pain management for cancer, but there is little guidance around how to treat patients who have a history of opioid misuse.

Recently, a group of palliative and addiction medicine specialists developed strategies to help frontline clinicians manage patients with advanced cancer-related pain and opioid use disorder.

“There is a tendency to ignore treatment of opioid use disorder in advanced cancer patients because people think: ‘Oh, this person has bigger fish to fry,’ but that’s not a very patient-centric way of looking at things,” senior author Jessica Merlin, MD, PhD, with the University of Pittsburgh, said in a news release.

“We know that opioid use disorder is a really important factor in quality of life, so addressing opioid addiction and prescription opioid misuse in people with advanced cancer is really critical,” Dr. Merlin added.

The study was published online in JAMA Oncology.

To improve care for people with advanced cancer and cancer-related pain, the researchers first assessed how clinicians currently treat patients with opioid complexity.

Using an online Delphi platform, the team invited 120 clinicians with expertise in palliative care, pain management, and addiction medicine to weigh in on three common clinical scenarios – a patient with a recent history of untreated opioid use disorder, a patient taking more opioids than prescribed, and a patient using nonprescribed benzodiazepines.

For a patient with cancer and a recent history of untreated opioid use disorder, regardless of prognosis, the panel deemed it appropriate to begin treatment with buprenorphine/naloxone for pain but inappropriate to refer the patient to a methadone clinic. The panel felt that going to a methadone clinic would be too burdensome for a patient with advanced cancer and not possible for those with limited prognoses.

“This underscores the importance of access to [opioid use disorder] treatment in cancer treatment settings, including non–addiction specialists waivered to prescribe buprenorphine/naloxone and addiction specialists for more complex cases,” the authors wrote.

For a patient with untreated opioid use disorder, the panel deemed split-dose methadone (two to three times daily) appropriate in those with limited prognosis of weeks to months but was uncertain about the suitability of this approach for patients with longer prognoses of a year or longer.

The appropriateness of initiating treatment with a full-agonist opioid was considered uncertain for a patient with limited prognosis and inappropriate for a patient with longer prognosis.

For a patient with cancer pain and no medical history of opioid use disorder but taking more opioids than prescribed, regardless of prognosis, the panel felt it was appropriate to increase monitoring and inappropriate to taper opioids. The panel was not certain about whether to increase opioids based on the patient’s account of what they need or transition to buprenorphine/naloxone.

For a patient with no history of opioid use disorder who was prescribed traditional opioids for pain and had a positive urine drug test for nonprescribed benzodiazepines, regardless of prognosis, the panel felt it was appropriate to continue opioids with close monitoring and inappropriate to taper opioids or transition to buprenorphine/naloxone.

The researchers said that improving education around buprenorphine and cancer pain management in the context of opioid use disorder or misuse is needed.

In a related editorial, two experts noted that the patients considered in this “important article” require considerable time and expertise from an interdisciplinary team.

“It is important that cancer centers establish and fund such teams mainly as a safety measure for these patients and also as a major contribution to the care of all patients with cancer,” wrote Joseph Arthur, MD, and Eduardo Bruera, MD, with the University of Texas MD Anderson Cancer Center, Houston.

In the wider context, Dr. Arthur and Dr. Bruera highlighted how treatments for patients with advanced cancer have evolved over the past 3 decades, yet patients have continued to be given opioids to address cancer-related pain. Developing more sophisticated drugs that relieve pain without significant side effects or addictive properties is imperative.

Dr. Arthur and Dr. Bruera said the study authors “appropriately emphasize the value of delivering compassionate and expert care for these particularly complex cases and the importance of conducting research on the best ways to alleviate the suffering in this rapidly growing patient population.”

This research was supported by Cambia Health Foundation and the National Institute of Nursing Research. Dr. Merlin, Dr. Arthur, and Dr. Bruera reported no relevant disclosures.

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

Opioids remain a staple in pain management for cancer, but there is little guidance around how to treat patients who have a history of opioid misuse.

Recently, a group of palliative and addiction medicine specialists developed strategies to help frontline clinicians manage patients with advanced cancer-related pain and opioid use disorder.

“There is a tendency to ignore treatment of opioid use disorder in advanced cancer patients because people think: ‘Oh, this person has bigger fish to fry,’ but that’s not a very patient-centric way of looking at things,” senior author Jessica Merlin, MD, PhD, with the University of Pittsburgh, said in a news release.

“We know that opioid use disorder is a really important factor in quality of life, so addressing opioid addiction and prescription opioid misuse in people with advanced cancer is really critical,” Dr. Merlin added.

The study was published online in JAMA Oncology.

To improve care for people with advanced cancer and cancer-related pain, the researchers first assessed how clinicians currently treat patients with opioid complexity.

Using an online Delphi platform, the team invited 120 clinicians with expertise in palliative care, pain management, and addiction medicine to weigh in on three common clinical scenarios – a patient with a recent history of untreated opioid use disorder, a patient taking more opioids than prescribed, and a patient using nonprescribed benzodiazepines.

For a patient with cancer and a recent history of untreated opioid use disorder, regardless of prognosis, the panel deemed it appropriate to begin treatment with buprenorphine/naloxone for pain but inappropriate to refer the patient to a methadone clinic. The panel felt that going to a methadone clinic would be too burdensome for a patient with advanced cancer and not possible for those with limited prognoses.

“This underscores the importance of access to [opioid use disorder] treatment in cancer treatment settings, including non–addiction specialists waivered to prescribe buprenorphine/naloxone and addiction specialists for more complex cases,” the authors wrote.

For a patient with untreated opioid use disorder, the panel deemed split-dose methadone (two to three times daily) appropriate in those with limited prognosis of weeks to months but was uncertain about the suitability of this approach for patients with longer prognoses of a year or longer.

The appropriateness of initiating treatment with a full-agonist opioid was considered uncertain for a patient with limited prognosis and inappropriate for a patient with longer prognosis.

For a patient with cancer pain and no medical history of opioid use disorder but taking more opioids than prescribed, regardless of prognosis, the panel felt it was appropriate to increase monitoring and inappropriate to taper opioids. The panel was not certain about whether to increase opioids based on the patient’s account of what they need or transition to buprenorphine/naloxone.

For a patient with no history of opioid use disorder who was prescribed traditional opioids for pain and had a positive urine drug test for nonprescribed benzodiazepines, regardless of prognosis, the panel felt it was appropriate to continue opioids with close monitoring and inappropriate to taper opioids or transition to buprenorphine/naloxone.

The researchers said that improving education around buprenorphine and cancer pain management in the context of opioid use disorder or misuse is needed.

In a related editorial, two experts noted that the patients considered in this “important article” require considerable time and expertise from an interdisciplinary team.

“It is important that cancer centers establish and fund such teams mainly as a safety measure for these patients and also as a major contribution to the care of all patients with cancer,” wrote Joseph Arthur, MD, and Eduardo Bruera, MD, with the University of Texas MD Anderson Cancer Center, Houston.

In the wider context, Dr. Arthur and Dr. Bruera highlighted how treatments for patients with advanced cancer have evolved over the past 3 decades, yet patients have continued to be given opioids to address cancer-related pain. Developing more sophisticated drugs that relieve pain without significant side effects or addictive properties is imperative.

Dr. Arthur and Dr. Bruera said the study authors “appropriately emphasize the value of delivering compassionate and expert care for these particularly complex cases and the importance of conducting research on the best ways to alleviate the suffering in this rapidly growing patient population.”

This research was supported by Cambia Health Foundation and the National Institute of Nursing Research. Dr. Merlin, Dr. Arthur, and Dr. Bruera reported no relevant disclosures.

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

Opioids remain a staple in pain management for cancer, but there is little guidance around how to treat patients who have a history of opioid misuse.

Recently, a group of palliative and addiction medicine specialists developed strategies to help frontline clinicians manage patients with advanced cancer-related pain and opioid use disorder.

“There is a tendency to ignore treatment of opioid use disorder in advanced cancer patients because people think: ‘Oh, this person has bigger fish to fry,’ but that’s not a very patient-centric way of looking at things,” senior author Jessica Merlin, MD, PhD, with the University of Pittsburgh, said in a news release.

“We know that opioid use disorder is a really important factor in quality of life, so addressing opioid addiction and prescription opioid misuse in people with advanced cancer is really critical,” Dr. Merlin added.

The study was published online in JAMA Oncology.

To improve care for people with advanced cancer and cancer-related pain, the researchers first assessed how clinicians currently treat patients with opioid complexity.

Using an online Delphi platform, the team invited 120 clinicians with expertise in palliative care, pain management, and addiction medicine to weigh in on three common clinical scenarios – a patient with a recent history of untreated opioid use disorder, a patient taking more opioids than prescribed, and a patient using nonprescribed benzodiazepines.

For a patient with cancer and a recent history of untreated opioid use disorder, regardless of prognosis, the panel deemed it appropriate to begin treatment with buprenorphine/naloxone for pain but inappropriate to refer the patient to a methadone clinic. The panel felt that going to a methadone clinic would be too burdensome for a patient with advanced cancer and not possible for those with limited prognoses.

“This underscores the importance of access to [opioid use disorder] treatment in cancer treatment settings, including non–addiction specialists waivered to prescribe buprenorphine/naloxone and addiction specialists for more complex cases,” the authors wrote.

For a patient with untreated opioid use disorder, the panel deemed split-dose methadone (two to three times daily) appropriate in those with limited prognosis of weeks to months but was uncertain about the suitability of this approach for patients with longer prognoses of a year or longer.

The appropriateness of initiating treatment with a full-agonist opioid was considered uncertain for a patient with limited prognosis and inappropriate for a patient with longer prognosis.

For a patient with cancer pain and no medical history of opioid use disorder but taking more opioids than prescribed, regardless of prognosis, the panel felt it was appropriate to increase monitoring and inappropriate to taper opioids. The panel was not certain about whether to increase opioids based on the patient’s account of what they need or transition to buprenorphine/naloxone.

For a patient with no history of opioid use disorder who was prescribed traditional opioids for pain and had a positive urine drug test for nonprescribed benzodiazepines, regardless of prognosis, the panel felt it was appropriate to continue opioids with close monitoring and inappropriate to taper opioids or transition to buprenorphine/naloxone.

The researchers said that improving education around buprenorphine and cancer pain management in the context of opioid use disorder or misuse is needed.

In a related editorial, two experts noted that the patients considered in this “important article” require considerable time and expertise from an interdisciplinary team.

“It is important that cancer centers establish and fund such teams mainly as a safety measure for these patients and also as a major contribution to the care of all patients with cancer,” wrote Joseph Arthur, MD, and Eduardo Bruera, MD, with the University of Texas MD Anderson Cancer Center, Houston.

In the wider context, Dr. Arthur and Dr. Bruera highlighted how treatments for patients with advanced cancer have evolved over the past 3 decades, yet patients have continued to be given opioids to address cancer-related pain. Developing more sophisticated drugs that relieve pain without significant side effects or addictive properties is imperative.

Dr. Arthur and Dr. Bruera said the study authors “appropriately emphasize the value of delivering compassionate and expert care for these particularly complex cases and the importance of conducting research on the best ways to alleviate the suffering in this rapidly growing patient population.”

This research was supported by Cambia Health Foundation and the National Institute of Nursing Research. Dr. Merlin, Dr. Arthur, and Dr. Bruera reported no relevant disclosures.

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