A scoring system that predicts risk for new heart failure over 5 years that is based solely on a few familiar, readily available biomarkers could potentially help steer patients with diabetes or even prediabetes toward HF-preventive therapies, researchers proposed based on a new study.

They foresee the risk-stratification tool, based on data pooled from three major community-based cohort studies but not independently validated, as a way to select patients with diabetes and prediabetes for treatment with SGLT2 inhibitors.

Several members of that drug class, conceived as antidiabetic agents, have been shown to help in prevention or treatment of HF in patients with diabetes and those without diabetes but at increased cardiovascular (CV) risk. Yet their uptake in practice has been lagging, the group noted.

Most HF benefits in the SGLT2 inhibitor trials “were seen in patients who have established cardiovascular disease – basically a history of heart attack or stroke,” Ambarish Pandey, MD, MSCS, University of Texas Southwestern Medical Center, Dallas, said in an interview.

“So we wanted to see how we can identify high-risk patients without a history of cardiovascular disease using these biomarkers, as an approach to targeting SGLT2 inhibitors, which are fairly expensive therapies,” he said. Without such risk stratification, “you end up treating so many more patients to get very modest returns.”

The group developed a scoring system based on four biomarkers that are “easily measured with inexpensive tests,” Dr. Pandey said: high-sensitivity-assay cardiac troponin T (hs-cTnT) and C-reactive protein (hs-CRP) levels, N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) levels, and electrocardiography for evidence of left-ventricular hypertrophy (ECG-LVH).

The derivation cohort consisted of participants in the Atherosclerosis Risk in Communities RIC, Dallas Heart Study, and Multi-Ethnic Study of Atherosclerosis Multi-Ethnic Study of Atherosclerosis epidemiologic studies who were free of coronary heart disease, stroke, or HF for whom there were sufficient data on CV risk factors and the four biomarkers. None were taking SGLT2 inhibitors at enrollment in their respective studies, the researchers noted.

Members of the pooled cohorts who had diabetes or prediabetes were assigned 1 point for each abnormal biomarker. The 5-year risk for incident HF went up continuously along with the score in people with diabetes and in those with prediabetes, the latter defined as a fasting plasma glucose level from 100 mg/dL to less than 126 mg/dL.

For those with a score of 1, compared with 0, for example, the risk for HF went up 82% with diabetes and 40% with prediabetes. But for those with a score of 3 or 4, the risk went up more than four and a half times with diabetes and more than three and a half times for those with prediabetes. Risk increases were independent of other likely HF risk factors and consistently significant.

The analysis was published Jan. 6 in JACC: Heart Failure.

The biomarker score should be especially useful in patients considered at low to intermediate risk, based on clinical characteristics, as a means to identify residual HF risk and, potentially, select candidates for SGLT2-inhibitor therapy, Dr. Pandey said.

“The other purpose of the study was to broaden the scope of heart failure prevention in dysglycemia by looking also at prediabetes, not just diabetes,” he said. There isn’t much high-quality evidence supporting SGLT2-inhibitor therapy in prediabetes, but it follows that the drugs may be helpful in prediabetes because they are protective in patients with and without diabetes.

“Our work suggests that prediabetes patients who have elevated biomarkers are at a higher risk of heart failure,” Dr. Pandey said, suggesting that the HF risk score could potentially help select their drug therapy as well.

The current study seems “to provide a proof of concept that one can use circulating biomarkers to more precisely identify patients in whom therapies might be expected to exert greatest benefit,” which is especially important for potentially expensive agents like the SGLT2 inhibitors, James L. Januzzi, MD, Massachusetts General Hospital, Boston, said in an interview.

Importantly in the analysis, a greater number of biomarker abnormalities not only corresponded to rising levels of risk, the risk increases were “dramatic,” and therefore so was the supposed potential benefit of SGLT2-inhibitor therapy, said Dr. Januzzi, who isn’t a coauthor but was an editor for its publication in JACC: Heart Failure.

The uptake of SGLT2 inhibitors for heart failure in practice has been less rapid than hoped, he observed, so if “this hypothetical construct holds up” for the drug class, “it might actually help kick-start focusing on who might optimally receive the drugs.”

Elevated levels of hs-cTnT, hs-CRP, and NT-proBNP, as well as presence of ECG-LVH, were each independently associated with a significantly increased 5-year risk for HF in unadjusted and adjusted analyses of the 6,799 people in the pooled cohort, 33.2% of whom had diabetes and 66.8% of whom had prediabetes, the group writes.

The scoring system would require validation in other cohorts before it could be used, Dr. Pandey observed; once there is “robust validation,” it might be applied first to patients with dysglycemia at intermediate CV risk by standard clinical measures.

Certainly the HF risk-stratification scoring system requires validation in other studies, Dr. Januzzi agreed. But it is intuitively appealing, and the study’s results are consistent with “data that we’re submitting for publication imminently” based on the CANVAS CV-outcomes trial of the SGLT2 inhibitor canagliflozin (Invokana) in patients with diabetes.

Dr. Pandey disclosed receiving support from the Gilead Sciences Research Scholar Program and serving on an advisory board of Roche Diagnostics. Dr. Januzzi disclosed receiving grant support from Novartis, Applied Therapeutics, and Innolife; consulting for Abbott Diagnostics, Janssen, Novartis, Quidel, and Roche Diagnostics; and serving on end-point committees or data safety monitoring boards for trials supported by Abbott, AbbVie, Amgen, CVRx, Janssen, MyoKardia, and Takeda.

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

A scoring system that predicts risk for new heart failure over 5 years that is based solely on a few familiar, readily available biomarkers could potentially help steer patients with diabetes or even prediabetes toward HF-preventive therapies, researchers proposed based on a new study.

They foresee the risk-stratification tool, based on data pooled from three major community-based cohort studies but not independently validated, as a way to select patients with diabetes and prediabetes for treatment with SGLT2 inhibitors.

Several members of that drug class, conceived as antidiabetic agents, have been shown to help in prevention or treatment of HF in patients with diabetes and those without diabetes but at increased cardiovascular (CV) risk. Yet their uptake in practice has been lagging, the group noted.

Most HF benefits in the SGLT2 inhibitor trials “were seen in patients who have established cardiovascular disease – basically a history of heart attack or stroke,” Ambarish Pandey, MD, MSCS, University of Texas Southwestern Medical Center, Dallas, said in an interview.

“So we wanted to see how we can identify high-risk patients without a history of cardiovascular disease using these biomarkers, as an approach to targeting SGLT2 inhibitors, which are fairly expensive therapies,” he said. Without such risk stratification, “you end up treating so many more patients to get very modest returns.”

The group developed a scoring system based on four biomarkers that are “easily measured with inexpensive tests,” Dr. Pandey said: high-sensitivity-assay cardiac troponin T (hs-cTnT) and C-reactive protein (hs-CRP) levels, N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) levels, and electrocardiography for evidence of left-ventricular hypertrophy (ECG-LVH).

The derivation cohort consisted of participants in the Atherosclerosis Risk in Communities RIC, Dallas Heart Study, and Multi-Ethnic Study of Atherosclerosis Multi-Ethnic Study of Atherosclerosis epidemiologic studies who were free of coronary heart disease, stroke, or HF for whom there were sufficient data on CV risk factors and the four biomarkers. None were taking SGLT2 inhibitors at enrollment in their respective studies, the researchers noted.

Members of the pooled cohorts who had diabetes or prediabetes were assigned 1 point for each abnormal biomarker. The 5-year risk for incident HF went up continuously along with the score in people with diabetes and in those with prediabetes, the latter defined as a fasting plasma glucose level from 100 mg/dL to less than 126 mg/dL.

For those with a score of 1, compared with 0, for example, the risk for HF went up 82% with diabetes and 40% with prediabetes. But for those with a score of 3 or 4, the risk went up more than four and a half times with diabetes and more than three and a half times for those with prediabetes. Risk increases were independent of other likely HF risk factors and consistently significant.

The analysis was published Jan. 6 in JACC: Heart Failure.

The biomarker score should be especially useful in patients considered at low to intermediate risk, based on clinical characteristics, as a means to identify residual HF risk and, potentially, select candidates for SGLT2-inhibitor therapy, Dr. Pandey said.

“The other purpose of the study was to broaden the scope of heart failure prevention in dysglycemia by looking also at prediabetes, not just diabetes,” he said. There isn’t much high-quality evidence supporting SGLT2-inhibitor therapy in prediabetes, but it follows that the drugs may be helpful in prediabetes because they are protective in patients with and without diabetes.

“Our work suggests that prediabetes patients who have elevated biomarkers are at a higher risk of heart failure,” Dr. Pandey said, suggesting that the HF risk score could potentially help select their drug therapy as well.

The current study seems “to provide a proof of concept that one can use circulating biomarkers to more precisely identify patients in whom therapies might be expected to exert greatest benefit,” which is especially important for potentially expensive agents like the SGLT2 inhibitors, James L. Januzzi, MD, Massachusetts General Hospital, Boston, said in an interview.

Importantly in the analysis, a greater number of biomarker abnormalities not only corresponded to rising levels of risk, the risk increases were “dramatic,” and therefore so was the supposed potential benefit of SGLT2-inhibitor therapy, said Dr. Januzzi, who isn’t a coauthor but was an editor for its publication in JACC: Heart Failure.

The uptake of SGLT2 inhibitors for heart failure in practice has been less rapid than hoped, he observed, so if “this hypothetical construct holds up” for the drug class, “it might actually help kick-start focusing on who might optimally receive the drugs.”

Elevated levels of hs-cTnT, hs-CRP, and NT-proBNP, as well as presence of ECG-LVH, were each independently associated with a significantly increased 5-year risk for HF in unadjusted and adjusted analyses of the 6,799 people in the pooled cohort, 33.2% of whom had diabetes and 66.8% of whom had prediabetes, the group writes.

The scoring system would require validation in other cohorts before it could be used, Dr. Pandey observed; once there is “robust validation,” it might be applied first to patients with dysglycemia at intermediate CV risk by standard clinical measures.

Certainly the HF risk-stratification scoring system requires validation in other studies, Dr. Januzzi agreed. But it is intuitively appealing, and the study’s results are consistent with “data that we’re submitting for publication imminently” based on the CANVAS CV-outcomes trial of the SGLT2 inhibitor canagliflozin (Invokana) in patients with diabetes.

Dr. Pandey disclosed receiving support from the Gilead Sciences Research Scholar Program and serving on an advisory board of Roche Diagnostics. Dr. Januzzi disclosed receiving grant support from Novartis, Applied Therapeutics, and Innolife; consulting for Abbott Diagnostics, Janssen, Novartis, Quidel, and Roche Diagnostics; and serving on end-point committees or data safety monitoring boards for trials supported by Abbott, AbbVie, Amgen, CVRx, Janssen, MyoKardia, and Takeda.

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

A scoring system that predicts risk for new heart failure over 5 years that is based solely on a few familiar, readily available biomarkers could potentially help steer patients with diabetes or even prediabetes toward HF-preventive therapies, researchers proposed based on a new study.

They foresee the risk-stratification tool, based on data pooled from three major community-based cohort studies but not independently validated, as a way to select patients with diabetes and prediabetes for treatment with SGLT2 inhibitors.

Several members of that drug class, conceived as antidiabetic agents, have been shown to help in prevention or treatment of HF in patients with diabetes and those without diabetes but at increased cardiovascular (CV) risk. Yet their uptake in practice has been lagging, the group noted.

Most HF benefits in the SGLT2 inhibitor trials “were seen in patients who have established cardiovascular disease – basically a history of heart attack or stroke,” Ambarish Pandey, MD, MSCS, University of Texas Southwestern Medical Center, Dallas, said in an interview.

“So we wanted to see how we can identify high-risk patients without a history of cardiovascular disease using these biomarkers, as an approach to targeting SGLT2 inhibitors, which are fairly expensive therapies,” he said. Without such risk stratification, “you end up treating so many more patients to get very modest returns.”

The group developed a scoring system based on four biomarkers that are “easily measured with inexpensive tests,” Dr. Pandey said: high-sensitivity-assay cardiac troponin T (hs-cTnT) and C-reactive protein (hs-CRP) levels, N-terminal of the prohormone brain natriuretic peptide (NT-proBNP) levels, and electrocardiography for evidence of left-ventricular hypertrophy (ECG-LVH).

The derivation cohort consisted of participants in the Atherosclerosis Risk in Communities RIC, Dallas Heart Study, and Multi-Ethnic Study of Atherosclerosis Multi-Ethnic Study of Atherosclerosis epidemiologic studies who were free of coronary heart disease, stroke, or HF for whom there were sufficient data on CV risk factors and the four biomarkers. None were taking SGLT2 inhibitors at enrollment in their respective studies, the researchers noted.

Members of the pooled cohorts who had diabetes or prediabetes were assigned 1 point for each abnormal biomarker. The 5-year risk for incident HF went up continuously along with the score in people with diabetes and in those with prediabetes, the latter defined as a fasting plasma glucose level from 100 mg/dL to less than 126 mg/dL.

For those with a score of 1, compared with 0, for example, the risk for HF went up 82% with diabetes and 40% with prediabetes. But for those with a score of 3 or 4, the risk went up more than four and a half times with diabetes and more than three and a half times for those with prediabetes. Risk increases were independent of other likely HF risk factors and consistently significant.

The analysis was published Jan. 6 in JACC: Heart Failure.

The biomarker score should be especially useful in patients considered at low to intermediate risk, based on clinical characteristics, as a means to identify residual HF risk and, potentially, select candidates for SGLT2-inhibitor therapy, Dr. Pandey said.

“The other purpose of the study was to broaden the scope of heart failure prevention in dysglycemia by looking also at prediabetes, not just diabetes,” he said. There isn’t much high-quality evidence supporting SGLT2-inhibitor therapy in prediabetes, but it follows that the drugs may be helpful in prediabetes because they are protective in patients with and without diabetes.

“Our work suggests that prediabetes patients who have elevated biomarkers are at a higher risk of heart failure,” Dr. Pandey said, suggesting that the HF risk score could potentially help select their drug therapy as well.

The current study seems “to provide a proof of concept that one can use circulating biomarkers to more precisely identify patients in whom therapies might be expected to exert greatest benefit,” which is especially important for potentially expensive agents like the SGLT2 inhibitors, James L. Januzzi, MD, Massachusetts General Hospital, Boston, said in an interview.

Importantly in the analysis, a greater number of biomarker abnormalities not only corresponded to rising levels of risk, the risk increases were “dramatic,” and therefore so was the supposed potential benefit of SGLT2-inhibitor therapy, said Dr. Januzzi, who isn’t a coauthor but was an editor for its publication in JACC: Heart Failure.

The uptake of SGLT2 inhibitors for heart failure in practice has been less rapid than hoped, he observed, so if “this hypothetical construct holds up” for the drug class, “it might actually help kick-start focusing on who might optimally receive the drugs.”

Elevated levels of hs-cTnT, hs-CRP, and NT-proBNP, as well as presence of ECG-LVH, were each independently associated with a significantly increased 5-year risk for HF in unadjusted and adjusted analyses of the 6,799 people in the pooled cohort, 33.2% of whom had diabetes and 66.8% of whom had prediabetes, the group writes.

The scoring system would require validation in other cohorts before it could be used, Dr. Pandey observed; once there is “robust validation,” it might be applied first to patients with dysglycemia at intermediate CV risk by standard clinical measures.

Certainly the HF risk-stratification scoring system requires validation in other studies, Dr. Januzzi agreed. But it is intuitively appealing, and the study’s results are consistent with “data that we’re submitting for publication imminently” based on the CANVAS CV-outcomes trial of the SGLT2 inhibitor canagliflozin (Invokana) in patients with diabetes.

Dr. Pandey disclosed receiving support from the Gilead Sciences Research Scholar Program and serving on an advisory board of Roche Diagnostics. Dr. Januzzi disclosed receiving grant support from Novartis, Applied Therapeutics, and Innolife; consulting for Abbott Diagnostics, Janssen, Novartis, Quidel, and Roche Diagnostics; and serving on end-point committees or data safety monitoring boards for trials supported by Abbott, AbbVie, Amgen, CVRx, Janssen, MyoKardia, and Takeda.

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

Federal officials on Thursday announced a plan to largely drop the so-called X-waiver requirement for buprenorphine prescriptions for physicians in a bid to remove an administrative procedure widely seen as a barrier to opioid use disorder (OUD) treatment.

The Department of Health & Human Services unveiled new practice guidelines that include an exemption from current certification requirements. The exemption applies to physicians already registered with the Drug Enforcement Administration.

A restriction included in the new HHS policy is a limit of treating no more than 30 patients with buprenorphine for OUD at any one time. There is an exception to this limit for hospital-based physicians, such as those working in emergency departments, HHS said.

The policy change applies only to the prescription of drugs or formulations covered under the so-called X-waiver of the Controlled Substance Act, such as buprenorphine, and does not apply to methadone. The new guidelines say the date on which they will take effect will be added after publication in the Federal Register. HHS did not immediately answer a request from this news organization for a more specific timeline.
 

Welcomed change

The change in prescribing rule was widely welcomed, with the American Medical Association issuing a statement endorsing the revision. The AMA and many prescribers and researchers had seen the X-waiver as a hurdle to address the nation’s opioid epidemic.

There were more than 83,000 deaths attributed to drug overdoses in the United States in the 12 months ending in June 2020. This is the highest number of overdose deaths ever recorded in a 12-month period, HHS said in a press release, which cited data from the Centers for Disease Control and Prevention.

In a tweet about the new policy, Peter Grinspoon, MD, a Boston internist and author of the memoir “Free Refills: A Doctor Confronts His Addiction,” contrasted the relative ease with which clinicians can give medicines that carry a risk for abuse with the challenge that has existed in trying to provide patients with buprenorphine.

“Absolutely insane that we need a special waiver for buprenorphine to TREAT opioid addiction, but not to prescribe oxycodone, Vicodin, etc., which can get people in trouble in the first place!!” Dr. Grinspoon tweeted.

Patrice Harris, MD, chair of the AMA’s Opioid Task Force and the organization’s immediate past president, said removing the X-waiver requirement can help lessen the stigma associated with this OUD treatment. The AMA had urged HHS to change the regulation.

“With this change, office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to a separate and burdensome regulatory regime,” Dr. Harris said in the AMA statement.

Researchers have in recent years sought to highlight what they described as missed opportunities for OUD treatment because of the need for the X-waiver. 

Buprenorphine is a cost-effective treatment for opioid use disorder, which reduces the risk of injection-related infections and mortality risk, notes a study published online last month in JAMA Network Open.  

However, results showed that fewer than 2% of obstetrician-gynecologists who examined women enrolled in Medicaid were trained to prescribe buprenorphine. The study, which was based on data from 31, 211 ob.gyns. who accepted Medicaid insurance, was created to quantify how many were on the list of Drug Addiction Treatment Act buprenorphine-waived clinicians.

The Drug Addiction Treatment Act has required 8 hours of training for physicians and 24 hours for nurse practitioners and physician assistants for the X-waiver needed to prescribe buprenorphine, the investigators report.
 

‘X the X-waiver’

Only 10% of recent family residency graduates reported being adequately trained to prescribe buprenorphine and only 7% reported actually prescribing the drug, write Kevin Fiscella, MD, University of Rochester (N.Y.) Medical Center and colleagues in a 2018 Viewpoint article published in JAMA Psychiatry.

In the article, which was subtitled “X the X Waiver,” they called for deregulation of buprenorphine as a way of mainstreaming treatment for OUD.

“The DATA 2000 has failed – too few physicians have obtained X-waivers,” the authors write. “Regulations reinforce the stigma surrounding buprenorphine prescribers and patients who receive it while constraining access and discouraging patient engagement and retention in treatment.”

The change, announced Jan. 14, leaves in place restrictions on prescribing for clinicians other than physicians. On a call with reporters, Adm. Brett P. Giroir, MD, assistant secretary for health, suggested that federal officials should take further steps to remove hurdles to buprenorphine prescriptions.

“Many people will say this has gone too far,” Dr. Giroir said of the drive to end the X-waiver for clinicians. “But I believe more people will say this has not gone far enough.”

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

Federal officials on Thursday announced a plan to largely drop the so-called X-waiver requirement for buprenorphine prescriptions for physicians in a bid to remove an administrative procedure widely seen as a barrier to opioid use disorder (OUD) treatment.

The Department of Health & Human Services unveiled new practice guidelines that include an exemption from current certification requirements. The exemption applies to physicians already registered with the Drug Enforcement Administration.

A restriction included in the new HHS policy is a limit of treating no more than 30 patients with buprenorphine for OUD at any one time. There is an exception to this limit for hospital-based physicians, such as those working in emergency departments, HHS said.

The policy change applies only to the prescription of drugs or formulations covered under the so-called X-waiver of the Controlled Substance Act, such as buprenorphine, and does not apply to methadone. The new guidelines say the date on which they will take effect will be added after publication in the Federal Register. HHS did not immediately answer a request from this news organization for a more specific timeline.
 

Welcomed change

The change in prescribing rule was widely welcomed, with the American Medical Association issuing a statement endorsing the revision. The AMA and many prescribers and researchers had seen the X-waiver as a hurdle to address the nation’s opioid epidemic.

There were more than 83,000 deaths attributed to drug overdoses in the United States in the 12 months ending in June 2020. This is the highest number of overdose deaths ever recorded in a 12-month period, HHS said in a press release, which cited data from the Centers for Disease Control and Prevention.

In a tweet about the new policy, Peter Grinspoon, MD, a Boston internist and author of the memoir “Free Refills: A Doctor Confronts His Addiction,” contrasted the relative ease with which clinicians can give medicines that carry a risk for abuse with the challenge that has existed in trying to provide patients with buprenorphine.

“Absolutely insane that we need a special waiver for buprenorphine to TREAT opioid addiction, but not to prescribe oxycodone, Vicodin, etc., which can get people in trouble in the first place!!” Dr. Grinspoon tweeted.

Patrice Harris, MD, chair of the AMA’s Opioid Task Force and the organization’s immediate past president, said removing the X-waiver requirement can help lessen the stigma associated with this OUD treatment. The AMA had urged HHS to change the regulation.

“With this change, office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to a separate and burdensome regulatory regime,” Dr. Harris said in the AMA statement.

Researchers have in recent years sought to highlight what they described as missed opportunities for OUD treatment because of the need for the X-waiver. 

Buprenorphine is a cost-effective treatment for opioid use disorder, which reduces the risk of injection-related infections and mortality risk, notes a study published online last month in JAMA Network Open.  

However, results showed that fewer than 2% of obstetrician-gynecologists who examined women enrolled in Medicaid were trained to prescribe buprenorphine. The study, which was based on data from 31, 211 ob.gyns. who accepted Medicaid insurance, was created to quantify how many were on the list of Drug Addiction Treatment Act buprenorphine-waived clinicians.

The Drug Addiction Treatment Act has required 8 hours of training for physicians and 24 hours for nurse practitioners and physician assistants for the X-waiver needed to prescribe buprenorphine, the investigators report.
 

‘X the X-waiver’

Only 10% of recent family residency graduates reported being adequately trained to prescribe buprenorphine and only 7% reported actually prescribing the drug, write Kevin Fiscella, MD, University of Rochester (N.Y.) Medical Center and colleagues in a 2018 Viewpoint article published in JAMA Psychiatry.

In the article, which was subtitled “X the X Waiver,” they called for deregulation of buprenorphine as a way of mainstreaming treatment for OUD.

“The DATA 2000 has failed – too few physicians have obtained X-waivers,” the authors write. “Regulations reinforce the stigma surrounding buprenorphine prescribers and patients who receive it while constraining access and discouraging patient engagement and retention in treatment.”

The change, announced Jan. 14, leaves in place restrictions on prescribing for clinicians other than physicians. On a call with reporters, Adm. Brett P. Giroir, MD, assistant secretary for health, suggested that federal officials should take further steps to remove hurdles to buprenorphine prescriptions.

“Many people will say this has gone too far,” Dr. Giroir said of the drive to end the X-waiver for clinicians. “But I believe more people will say this has not gone far enough.”

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

Federal officials on Thursday announced a plan to largely drop the so-called X-waiver requirement for buprenorphine prescriptions for physicians in a bid to remove an administrative procedure widely seen as a barrier to opioid use disorder (OUD) treatment.

The Department of Health & Human Services unveiled new practice guidelines that include an exemption from current certification requirements. The exemption applies to physicians already registered with the Drug Enforcement Administration.

A restriction included in the new HHS policy is a limit of treating no more than 30 patients with buprenorphine for OUD at any one time. There is an exception to this limit for hospital-based physicians, such as those working in emergency departments, HHS said.

The policy change applies only to the prescription of drugs or formulations covered under the so-called X-waiver of the Controlled Substance Act, such as buprenorphine, and does not apply to methadone. The new guidelines say the date on which they will take effect will be added after publication in the Federal Register. HHS did not immediately answer a request from this news organization for a more specific timeline.
 

Welcomed change

The change in prescribing rule was widely welcomed, with the American Medical Association issuing a statement endorsing the revision. The AMA and many prescribers and researchers had seen the X-waiver as a hurdle to address the nation’s opioid epidemic.

There were more than 83,000 deaths attributed to drug overdoses in the United States in the 12 months ending in June 2020. This is the highest number of overdose deaths ever recorded in a 12-month period, HHS said in a press release, which cited data from the Centers for Disease Control and Prevention.

In a tweet about the new policy, Peter Grinspoon, MD, a Boston internist and author of the memoir “Free Refills: A Doctor Confronts His Addiction,” contrasted the relative ease with which clinicians can give medicines that carry a risk for abuse with the challenge that has existed in trying to provide patients with buprenorphine.

“Absolutely insane that we need a special waiver for buprenorphine to TREAT opioid addiction, but not to prescribe oxycodone, Vicodin, etc., which can get people in trouble in the first place!!” Dr. Grinspoon tweeted.

Patrice Harris, MD, chair of the AMA’s Opioid Task Force and the organization’s immediate past president, said removing the X-waiver requirement can help lessen the stigma associated with this OUD treatment. The AMA had urged HHS to change the regulation.

“With this change, office-based physicians and physician-led teams working with patients to manage their other medical conditions can also treat them for their opioid use disorder without being subjected to a separate and burdensome regulatory regime,” Dr. Harris said in the AMA statement.

Researchers have in recent years sought to highlight what they described as missed opportunities for OUD treatment because of the need for the X-waiver. 

Buprenorphine is a cost-effective treatment for opioid use disorder, which reduces the risk of injection-related infections and mortality risk, notes a study published online last month in JAMA Network Open.  

However, results showed that fewer than 2% of obstetrician-gynecologists who examined women enrolled in Medicaid were trained to prescribe buprenorphine. The study, which was based on data from 31, 211 ob.gyns. who accepted Medicaid insurance, was created to quantify how many were on the list of Drug Addiction Treatment Act buprenorphine-waived clinicians.

The Drug Addiction Treatment Act has required 8 hours of training for physicians and 24 hours for nurse practitioners and physician assistants for the X-waiver needed to prescribe buprenorphine, the investigators report.
 

‘X the X-waiver’

Only 10% of recent family residency graduates reported being adequately trained to prescribe buprenorphine and only 7% reported actually prescribing the drug, write Kevin Fiscella, MD, University of Rochester (N.Y.) Medical Center and colleagues in a 2018 Viewpoint article published in JAMA Psychiatry.

In the article, which was subtitled “X the X Waiver,” they called for deregulation of buprenorphine as a way of mainstreaming treatment for OUD.

“The DATA 2000 has failed – too few physicians have obtained X-waivers,” the authors write. “Regulations reinforce the stigma surrounding buprenorphine prescribers and patients who receive it while constraining access and discouraging patient engagement and retention in treatment.”

The change, announced Jan. 14, leaves in place restrictions on prescribing for clinicians other than physicians. On a call with reporters, Adm. Brett P. Giroir, MD, assistant secretary for health, suggested that federal officials should take further steps to remove hurdles to buprenorphine prescriptions.

“Many people will say this has gone too far,” Dr. Giroir said of the drive to end the X-waiver for clinicians. “But I believe more people will say this has not gone far enough.”

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

Background: Prior studies have established an increased risk of overt stroke after noncardiac surgery, with significant associated morbidity and mortality. Similarly, covert stroke in the nonsurgical population is well described and has been shown to be associated with cognitive decline.

Covert stroke was detected in 78 (7%) of the study participants. Those with covert stroke had a higher incidence of cognitive decline at 1 year (adjusted odds ratio, 1.98; 95% confidence interval, 1.22-3.2) with an absolute risk increase of 13%. Patients with covert stroke also had a higher rate of delirium within 3 days of surgery (hazard ratio, 2.24; 95% CI, 1.06-4.73) and a higher rate of overt stroke and transient ischemic attack at 1 year (HR, 4.13; 95% CI, 1.14-14.99).

This study helps to establish the incidence of covert stroke after noncardiac surgery and provides support for covert stroke as a risk factor for cognitive impairment.

Bottom line: Covert stroke following noncardiac surgery is common, affecting 1 in 14 patients in this study, and it is associated with an increased risk of cognitive decline, perioperative delirium, and subsequent overt stroke.

Citation: The NeuroVISION Investigators (Mrkobrada M et al.). Perioperative covert stroke in patients undergoing noncardiac surgery (NeuroVISION): a prospective cohort study. Lancet. 2019;394(10203):1022-9.

Dr. Herrle is a hospitalist at Maine Medical Center in Portland and at Stephens Memorial Hospital in Norway, Maine.

Background: Prior studies have established an increased risk of overt stroke after noncardiac surgery, with significant associated morbidity and mortality. Similarly, covert stroke in the nonsurgical population is well described and has been shown to be associated with cognitive decline.

Covert stroke was detected in 78 (7%) of the study participants. Those with covert stroke had a higher incidence of cognitive decline at 1 year (adjusted odds ratio, 1.98; 95% confidence interval, 1.22-3.2) with an absolute risk increase of 13%. Patients with covert stroke also had a higher rate of delirium within 3 days of surgery (hazard ratio, 2.24; 95% CI, 1.06-4.73) and a higher rate of overt stroke and transient ischemic attack at 1 year (HR, 4.13; 95% CI, 1.14-14.99).

This study helps to establish the incidence of covert stroke after noncardiac surgery and provides support for covert stroke as a risk factor for cognitive impairment.

Bottom line: Covert stroke following noncardiac surgery is common, affecting 1 in 14 patients in this study, and it is associated with an increased risk of cognitive decline, perioperative delirium, and subsequent overt stroke.

Citation: The NeuroVISION Investigators (Mrkobrada M et al.). Perioperative covert stroke in patients undergoing noncardiac surgery (NeuroVISION): a prospective cohort study. Lancet. 2019;394(10203):1022-9.

Dr. Herrle is a hospitalist at Maine Medical Center in Portland and at Stephens Memorial Hospital in Norway, Maine.

Background: Prior studies have established an increased risk of overt stroke after noncardiac surgery, with significant associated morbidity and mortality. Similarly, covert stroke in the nonsurgical population is well described and has been shown to be associated with cognitive decline.

Covert stroke was detected in 78 (7%) of the study participants. Those with covert stroke had a higher incidence of cognitive decline at 1 year (adjusted odds ratio, 1.98; 95% confidence interval, 1.22-3.2) with an absolute risk increase of 13%. Patients with covert stroke also had a higher rate of delirium within 3 days of surgery (hazard ratio, 2.24; 95% CI, 1.06-4.73) and a higher rate of overt stroke and transient ischemic attack at 1 year (HR, 4.13; 95% CI, 1.14-14.99).

This study helps to establish the incidence of covert stroke after noncardiac surgery and provides support for covert stroke as a risk factor for cognitive impairment.

Bottom line: Covert stroke following noncardiac surgery is common, affecting 1 in 14 patients in this study, and it is associated with an increased risk of cognitive decline, perioperative delirium, and subsequent overt stroke.

Citation: The NeuroVISION Investigators (Mrkobrada M et al.). Perioperative covert stroke in patients undergoing noncardiac surgery (NeuroVISION): a prospective cohort study. Lancet. 2019;394(10203):1022-9.

Dr. Herrle is a hospitalist at Maine Medical Center in Portland and at Stephens Memorial Hospital in Norway, Maine.

Birth rates for women who underwent assisted reproduction using fresh donor oocytes were significantly higher than for women who used cryopreserved-thawed embryos, based on data from more than 33,000 women.

Cryopreserved-thawed embryo transfers in donor oocyte cycles have gained in popularity in recent years for reasons including “convenience, elimination of the need for synchronization between donor and recipient cycles, and/or increasing utilization of preimplantation genetic testing for aneuploidy,” wrote Iris G. Insogna, MD, of Brigham and Women’s Hospital, Boston, and colleagues.“ However, to date, no comparison of pregnancy outcomes has been made between transfers of fresh embryos and cryopreserved-thawed embryos derived exclusively from fresh donor oocytes,” they said.

In a retrospective cohort study published in JAMA, the researchers identified 33,863 women who underwent IVF cycles using freshly retrieved oocytes with a total of 51,942 embryo transfer cycles; 15,308 fresh embryo transfer cycles, and 36,634 cryopreserved-thawed embryo transfer cycles.

Overall, the live birth rate was 56.6% for cycles involving fresh donor oocytes compared to 44.0% for cycles with cryopreserved-thawed embryos, with an adjusted relative risk of 1.42 after the researchers controlled for donor age, day of embryo transfer, use of gestational carrier, and assisted hatching. Demographics were similar between women who received fresh vs. cryopreserved-thawed embryos including median age (42 years for both), gravidity (1 for both), parity (0 vs. 1), and body mass index (24.5 vs. 24.4 kg/m²).

Clinical pregnancy rates for women with fresh vs. cryopreserved-thawed embryo transfers were 66.7% and 54.2%, respectively, and miscarriage rates were approximately 9% for both groups.

The average number of embryos transferred was similar between the groups, and blastocysts were transferred in 92.4% and 96.5% of fresh embryo and cryopreserved-thawed embryo transfer cycles, respectively.

The finding that, in cycles using fresh donor oocytes, fresh embryo transfer yielded higher birth rates than transfer of cryopreserved-thawed embryo transfer “was in contrast to previous investigations of cycles using autologous oocytes that demonstrated higher live birth rates following cryopreserved-thawed embryo transfers,” the researchers noted.

Live birth rates remained higher in cases of fresh embryo transfer when preimplantation genetic testing for aneuploidy (PGT-A) was performed, they added.

The study findings were limited by several factors, including the retrospective design and lack of data on potential confounding factors in the donor population, such as age, ethnicity, BMI, and smoking status, the researchers said. However, the results have implications for clinical practice by providing informed counseling information, given the significantly greater complexity of preparing a fresh transfer of an embryo from a fresh donor oocyte, the researchers noted. In addition, “given the considerable financial investment, these data may influence patient decision-making regarding transferring a fresh embryo derived from a fresh donor oocyte vs. cryopreserving all embryos a priori for convenience,” they said. More data on the cost-effectiveness of fresh vs. cryopreserved-thawed embryo transfer in the study population also would help guide clinical practice, they said.
 

Prospective studies needed to confirm potential

“For women who use autologous oocytes, there is increasing evidence for improved pregnancy rates by frozen embryo transfer (FET) rather than fresh, particularly in women with good ovarian response to gonadotropins,” Mark P. Trolice, MD, of the University of Central Florida, Orlando, said in an interview. The current study was important because it examined “whether the same concept applies with the use of embryos from donor oocytes,” he said.

Dr. Trolice, director of Fertility CARE: The IVF Center, in Orlando, said he was surprised by the study findings. The study “contradicts the experience in cycles using autologous oocytes,” he said. “Fresh embryo superiority remained after a subgroup analysis of first embryo transfers for fresh and frozen cycles as well as for embryos that underwent PGT-A (preimplantation genetic testing for aneuploidy, typically resulting in FET cycles, although a small percentage of cycles underwent fresh embryo transfer), yielding no difference to non-PGT-A fresh cycles. This reinforces the prior evidence for lack of improvement following PGT-A in women less than age 35 years,” he noted.

“Coincidentally, the same findings were discovered using the same SART [Society for Assisted Reproductive Technology] database (from 2013 to 2015), namely fresh embryo transfer from donor oocytes was more likely to result in a live birth – 55.7% versus 39.5%,” said Dr. Trolice. “An abstract presented at the 2017 ASRM annual meeting also used the SART data base (from 2003 to 2014) and demonstrated live birth rates from fresh transfer of embryos using donor oocytes were 15%-20% higher than those from frozen embryo transfers,” he noted.

“In summary, the use of fresh embryos from donor oocytes consistently appears to have superior pregnancy outcomes compared with frozen embryos; a nearly 13% absolute difference in this recent study,” said Dr. Trolice. The strengths of the study included the primary outcome of live births and the heterogeneity, with cycles taken from all participating U.S. SART clinics, Dr. Trolice noted. Limitations included the “retrospective design with the inherent risk of selection bias and the lack of information on the embryo freezing method, i.e., the older ‘slow-freeze’ or the more advanced and popular method of vitrification,” he added. “Randomized, prospective studies are needed to more accurately address this important issue,” he emphasized.

The study received no outside funding. Lead author Dr. Insogna disclosed part-time work as an assistant physician for Teladoc Health. Dr. Trolice had no relevant financial conflicts to disclose.

Birth rates for women who underwent assisted reproduction using fresh donor oocytes were significantly higher than for women who used cryopreserved-thawed embryos, based on data from more than 33,000 women.

Cryopreserved-thawed embryo transfers in donor oocyte cycles have gained in popularity in recent years for reasons including “convenience, elimination of the need for synchronization between donor and recipient cycles, and/or increasing utilization of preimplantation genetic testing for aneuploidy,” wrote Iris G. Insogna, MD, of Brigham and Women’s Hospital, Boston, and colleagues.“ However, to date, no comparison of pregnancy outcomes has been made between transfers of fresh embryos and cryopreserved-thawed embryos derived exclusively from fresh donor oocytes,” they said.

In a retrospective cohort study published in JAMA, the researchers identified 33,863 women who underwent IVF cycles using freshly retrieved oocytes with a total of 51,942 embryo transfer cycles; 15,308 fresh embryo transfer cycles, and 36,634 cryopreserved-thawed embryo transfer cycles.

Overall, the live birth rate was 56.6% for cycles involving fresh donor oocytes compared to 44.0% for cycles with cryopreserved-thawed embryos, with an adjusted relative risk of 1.42 after the researchers controlled for donor age, day of embryo transfer, use of gestational carrier, and assisted hatching. Demographics were similar between women who received fresh vs. cryopreserved-thawed embryos including median age (42 years for both), gravidity (1 for both), parity (0 vs. 1), and body mass index (24.5 vs. 24.4 kg/m²).

Clinical pregnancy rates for women with fresh vs. cryopreserved-thawed embryo transfers were 66.7% and 54.2%, respectively, and miscarriage rates were approximately 9% for both groups.

The average number of embryos transferred was similar between the groups, and blastocysts were transferred in 92.4% and 96.5% of fresh embryo and cryopreserved-thawed embryo transfer cycles, respectively.

The finding that, in cycles using fresh donor oocytes, fresh embryo transfer yielded higher birth rates than transfer of cryopreserved-thawed embryo transfer “was in contrast to previous investigations of cycles using autologous oocytes that demonstrated higher live birth rates following cryopreserved-thawed embryo transfers,” the researchers noted.

Live birth rates remained higher in cases of fresh embryo transfer when preimplantation genetic testing for aneuploidy (PGT-A) was performed, they added.

The study findings were limited by several factors, including the retrospective design and lack of data on potential confounding factors in the donor population, such as age, ethnicity, BMI, and smoking status, the researchers said. However, the results have implications for clinical practice by providing informed counseling information, given the significantly greater complexity of preparing a fresh transfer of an embryo from a fresh donor oocyte, the researchers noted. In addition, “given the considerable financial investment, these data may influence patient decision-making regarding transferring a fresh embryo derived from a fresh donor oocyte vs. cryopreserving all embryos a priori for convenience,” they said. More data on the cost-effectiveness of fresh vs. cryopreserved-thawed embryo transfer in the study population also would help guide clinical practice, they said.
 

Prospective studies needed to confirm potential

“For women who use autologous oocytes, there is increasing evidence for improved pregnancy rates by frozen embryo transfer (FET) rather than fresh, particularly in women with good ovarian response to gonadotropins,” Mark P. Trolice, MD, of the University of Central Florida, Orlando, said in an interview. The current study was important because it examined “whether the same concept applies with the use of embryos from donor oocytes,” he said.

Dr. Trolice, director of Fertility CARE: The IVF Center, in Orlando, said he was surprised by the study findings. The study “contradicts the experience in cycles using autologous oocytes,” he said. “Fresh embryo superiority remained after a subgroup analysis of first embryo transfers for fresh and frozen cycles as well as for embryos that underwent PGT-A (preimplantation genetic testing for aneuploidy, typically resulting in FET cycles, although a small percentage of cycles underwent fresh embryo transfer), yielding no difference to non-PGT-A fresh cycles. This reinforces the prior evidence for lack of improvement following PGT-A in women less than age 35 years,” he noted.

“Coincidentally, the same findings were discovered using the same SART [Society for Assisted Reproductive Technology] database (from 2013 to 2015), namely fresh embryo transfer from donor oocytes was more likely to result in a live birth – 55.7% versus 39.5%,” said Dr. Trolice. “An abstract presented at the 2017 ASRM annual meeting also used the SART data base (from 2003 to 2014) and demonstrated live birth rates from fresh transfer of embryos using donor oocytes were 15%-20% higher than those from frozen embryo transfers,” he noted.

“In summary, the use of fresh embryos from donor oocytes consistently appears to have superior pregnancy outcomes compared with frozen embryos; a nearly 13% absolute difference in this recent study,” said Dr. Trolice. The strengths of the study included the primary outcome of live births and the heterogeneity, with cycles taken from all participating U.S. SART clinics, Dr. Trolice noted. Limitations included the “retrospective design with the inherent risk of selection bias and the lack of information on the embryo freezing method, i.e., the older ‘slow-freeze’ or the more advanced and popular method of vitrification,” he added. “Randomized, prospective studies are needed to more accurately address this important issue,” he emphasized.

The study received no outside funding. Lead author Dr. Insogna disclosed part-time work as an assistant physician for Teladoc Health. Dr. Trolice had no relevant financial conflicts to disclose.

Birth rates for women who underwent assisted reproduction using fresh donor oocytes were significantly higher than for women who used cryopreserved-thawed embryos, based on data from more than 33,000 women.

Cryopreserved-thawed embryo transfers in donor oocyte cycles have gained in popularity in recent years for reasons including “convenience, elimination of the need for synchronization between donor and recipient cycles, and/or increasing utilization of preimplantation genetic testing for aneuploidy,” wrote Iris G. Insogna, MD, of Brigham and Women’s Hospital, Boston, and colleagues.“ However, to date, no comparison of pregnancy outcomes has been made between transfers of fresh embryos and cryopreserved-thawed embryos derived exclusively from fresh donor oocytes,” they said.

In a retrospective cohort study published in JAMA, the researchers identified 33,863 women who underwent IVF cycles using freshly retrieved oocytes with a total of 51,942 embryo transfer cycles; 15,308 fresh embryo transfer cycles, and 36,634 cryopreserved-thawed embryo transfer cycles.

Overall, the live birth rate was 56.6% for cycles involving fresh donor oocytes compared to 44.0% for cycles with cryopreserved-thawed embryos, with an adjusted relative risk of 1.42 after the researchers controlled for donor age, day of embryo transfer, use of gestational carrier, and assisted hatching. Demographics were similar between women who received fresh vs. cryopreserved-thawed embryos including median age (42 years for both), gravidity (1 for both), parity (0 vs. 1), and body mass index (24.5 vs. 24.4 kg/m²).

Clinical pregnancy rates for women with fresh vs. cryopreserved-thawed embryo transfers were 66.7% and 54.2%, respectively, and miscarriage rates were approximately 9% for both groups.

The average number of embryos transferred was similar between the groups, and blastocysts were transferred in 92.4% and 96.5% of fresh embryo and cryopreserved-thawed embryo transfer cycles, respectively.

The finding that, in cycles using fresh donor oocytes, fresh embryo transfer yielded higher birth rates than transfer of cryopreserved-thawed embryo transfer “was in contrast to previous investigations of cycles using autologous oocytes that demonstrated higher live birth rates following cryopreserved-thawed embryo transfers,” the researchers noted.

Live birth rates remained higher in cases of fresh embryo transfer when preimplantation genetic testing for aneuploidy (PGT-A) was performed, they added.

The study findings were limited by several factors, including the retrospective design and lack of data on potential confounding factors in the donor population, such as age, ethnicity, BMI, and smoking status, the researchers said. However, the results have implications for clinical practice by providing informed counseling information, given the significantly greater complexity of preparing a fresh transfer of an embryo from a fresh donor oocyte, the researchers noted. In addition, “given the considerable financial investment, these data may influence patient decision-making regarding transferring a fresh embryo derived from a fresh donor oocyte vs. cryopreserving all embryos a priori for convenience,” they said. More data on the cost-effectiveness of fresh vs. cryopreserved-thawed embryo transfer in the study population also would help guide clinical practice, they said.
 

Prospective studies needed to confirm potential

“For women who use autologous oocytes, there is increasing evidence for improved pregnancy rates by frozen embryo transfer (FET) rather than fresh, particularly in women with good ovarian response to gonadotropins,” Mark P. Trolice, MD, of the University of Central Florida, Orlando, said in an interview. The current study was important because it examined “whether the same concept applies with the use of embryos from donor oocytes,” he said.

Dr. Trolice, director of Fertility CARE: The IVF Center, in Orlando, said he was surprised by the study findings. The study “contradicts the experience in cycles using autologous oocytes,” he said. “Fresh embryo superiority remained after a subgroup analysis of first embryo transfers for fresh and frozen cycles as well as for embryos that underwent PGT-A (preimplantation genetic testing for aneuploidy, typically resulting in FET cycles, although a small percentage of cycles underwent fresh embryo transfer), yielding no difference to non-PGT-A fresh cycles. This reinforces the prior evidence for lack of improvement following PGT-A in women less than age 35 years,” he noted.

“Coincidentally, the same findings were discovered using the same SART [Society for Assisted Reproductive Technology] database (from 2013 to 2015), namely fresh embryo transfer from donor oocytes was more likely to result in a live birth – 55.7% versus 39.5%,” said Dr. Trolice. “An abstract presented at the 2017 ASRM annual meeting also used the SART data base (from 2003 to 2014) and demonstrated live birth rates from fresh transfer of embryos using donor oocytes were 15%-20% higher than those from frozen embryo transfers,” he noted.

“In summary, the use of fresh embryos from donor oocytes consistently appears to have superior pregnancy outcomes compared with frozen embryos; a nearly 13% absolute difference in this recent study,” said Dr. Trolice. The strengths of the study included the primary outcome of live births and the heterogeneity, with cycles taken from all participating U.S. SART clinics, Dr. Trolice noted. Limitations included the “retrospective design with the inherent risk of selection bias and the lack of information on the embryo freezing method, i.e., the older ‘slow-freeze’ or the more advanced and popular method of vitrification,” he added. “Randomized, prospective studies are needed to more accurately address this important issue,” he emphasized.

The study received no outside funding. Lead author Dr. Insogna disclosed part-time work as an assistant physician for Teladoc Health. Dr. Trolice had no relevant financial conflicts to disclose.

Adding bemarituzumab to chemotherapy as first-line treatment for advanced gastric and gastroesophageal junction (GEJ) cancers improved survival over chemotherapy alone in the phase 2 FIGHT trial.

Among 155 patients followed for a median of 10.9 months, the combination of bemarituzumab and modified FOLFOX chemotherapy (leucovorin, fluorouracil, and oxaliplatin) resulted in a median progression-free survival (PFS) of 9.5 months, compared with 7.4 months with chemotherapy alone.

The median overall survival (OS) was not reached in the combination arm but was 12.9 months for patients treated with modified FOLFOX plus placebo

Zev A. Wainberg, MD, of the University of California, Los Angeles, presented these results at the 2021 Gastrointestinal Cancers Symposium.

Dr. Wainberg explained that bemarituzumab is an IgG1 antibody targeted specifically to the FGFR2b receptor to block growth factor signaling. The findings from FIGHT suggest FGFR2b is a new biomarker and therapeutic target for advanced gastric and GEJ cancers.

“The FIGHT trial results support a prospective, randomized, phase 3 study in gastric and gastroesophageal adenocarcinoma and the evaluation of bemarituzumab in other FGFR2b tumor types,” Dr. Wainberg said.

FGFR2b is a splice isoform of FGFR2 that is thought to be overexpressed in anywhere from 3% to 61% of gastric cancers, depending on the tumor stage and assay used, he explained at the meeting sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
 

Study downgrading and design

The FIGHT trial was originally designed as a phase 3, randomized trial with the primary endpoint of OS, but it was converted to a phase 2 trial with a PFS primary endpoint and OS secondary endpoint.

In the question-and-answer phase following his presentation, Dr. Wainberg explained that the trial was downgraded because “we wanted to get a little more comfortable with the biomarker,” and because the prevalence of FGFR2b, which was unknown during the planning phase, played a large role in the statistical assumptions.

Patients were eligible for FIGHT if they had received no prior therapy for unresectable, locally advanced or metastatic gastric or GEJ cancers. They also had to have FGFR2b overexpression on immunohistochemistry and/or FGFR2 gene amplification by circulating tumor DNA. They had to have good Eastern Cooperative Oncology Group performance status (0 or 1) and could not have tumors positive for HER2.

Patients were allowed to have one cycle of FOLFOX while their FGFR2b status was being determined, prior to randomization.

After stratification for geographic region, FOLFOX use during screenings, and prior adjuvant or neoadjuvant chemotherapy, the patients were randomized to receive FOLFOX with either placebo or 15 mg/kg of bemarituzumab every 2 weeks, plus an additional 7.5-mg/kg dose on day 8 of cycle 1.

A total of 77 patients were randomized to the bemarituzumab arm, and 78 were randomized to the placebo arm.
 

Patient status at cutoff

As of the September 2020 cutoff, 14 patients continued on bemarituzumab, and 63 were off the assigned drug: 26 because of radiographic progression, 3 for consent withdrawal, 5 because of death, 20 because of adverse events, and 9 for other unspecified causes.

There were 42 patients in the bemarituzumab arm who were still being followed at the cutoff, and 35 were off study. Of this latter group, 28 died, 6 withdrew consent, and 1 was off study for an unspecified cause.

In the placebo arm, 8 patients were still receiving the assigned therapy, and 70 were off that treatment. Of the patients who discontinued study treatment, 4 died, 39 had radiographic progression, 7 withdrew consent, 3 had adverse events, and 17 discontinued for other unspecified reasons.

A total of 27 patients assigned to placebo were still on follow-up at the data cutoff. Of the remaining 51 patients, 40 died, 10 withdrew consent, and 1 had other, unspecified causes for going off study.
 

Primary endpoint met

The PFS rate at 9 months was 52.5% in the experimental arm and 33.8% in the control arm. The median PFS was 9.5 months with bemarituzumab and 7.4 months with placebo, which translated to a hazard ratio of 0.68 (P = .0727). This met the prespecified level of statistical significance for the phase 2 version of the trial, which required a two-sided alpha of 0.2

­OS at 12 months was also superior in the experimental arm, at 65.3% with bemarituzumab and 56.9% with placebo (HR, 0.58; P = .0268).

The benefit of bemarituzumab for both PFS and OS was greatest among patients whose tumors had the highest levels of FGFR2b expression.

Overall response rates were 47% in the experimental arm and 33% in the placebo arm. Among patients with measurable disease at baseline, the respective response rates were 53% and 40%. The median duration of response was 12.2 months in the bemarituzumab arm and 7.1 months in the placebo arm.
 

Corneal toxicities, stomatitis

The incidence of grade 3 or greater adverse events was 82.9% in the experimental arm and 74% in the placebo arm. Five patients in the bemarituzumab arm and four in the placebo arm died from treatment-related causes.

Grade 3 or greater stomatitis occurred in seven patients in the experimental arm, compared with just one patient in the placebo arm. Grade 3 or greater dry eye occurred in two patients in the experimental arm but none in the placebo arm.

Corneal adverse events occurred in 67.1% of patients treated with bemarituzumab and 10.4% of patients on placebo. Respective rates of grade 3 or greater corneal events were 23.7% and 0%.

Twenty patients assigned to bemarituzumab had to discontinue the drug because of corneal problems, compared with no patients on placebo.

At last follow-up, corneal adverse events had resolved in 60% of patients, while 40% had continuing problems. The median time to resolution of corneal adverse events was 27 weeks.
 

New biomarker

“FIGHT study is the first study to demonstrate that biomarker selection exists beyond HER2,” commented invited discussant Rutika Mehta, MD, of the Moffitt Cancer Center and University of South Florida, both in Tampa.

“These are promising results, with toxicities that need to be watched out for. It calls for a larger phase 3 study with special attention to the toxicity profile for bema[rituzumab],” she added.

The trial was supported by Five Prime Therapeutics. Dr. Wainberg disclosed relationships with Five Prime and other companies. Dr. Mehta disclosed relationships with several companies, not including Five Prime.

Adding bemarituzumab to chemotherapy as first-line treatment for advanced gastric and gastroesophageal junction (GEJ) cancers improved survival over chemotherapy alone in the phase 2 FIGHT trial.

Among 155 patients followed for a median of 10.9 months, the combination of bemarituzumab and modified FOLFOX chemotherapy (leucovorin, fluorouracil, and oxaliplatin) resulted in a median progression-free survival (PFS) of 9.5 months, compared with 7.4 months with chemotherapy alone.

The median overall survival (OS) was not reached in the combination arm but was 12.9 months for patients treated with modified FOLFOX plus placebo

Zev A. Wainberg, MD, of the University of California, Los Angeles, presented these results at the 2021 Gastrointestinal Cancers Symposium.

Dr. Wainberg explained that bemarituzumab is an IgG1 antibody targeted specifically to the FGFR2b receptor to block growth factor signaling. The findings from FIGHT suggest FGFR2b is a new biomarker and therapeutic target for advanced gastric and GEJ cancers.

“The FIGHT trial results support a prospective, randomized, phase 3 study in gastric and gastroesophageal adenocarcinoma and the evaluation of bemarituzumab in other FGFR2b tumor types,” Dr. Wainberg said.

FGFR2b is a splice isoform of FGFR2 that is thought to be overexpressed in anywhere from 3% to 61% of gastric cancers, depending on the tumor stage and assay used, he explained at the meeting sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
 

Study downgrading and design

The FIGHT trial was originally designed as a phase 3, randomized trial with the primary endpoint of OS, but it was converted to a phase 2 trial with a PFS primary endpoint and OS secondary endpoint.

In the question-and-answer phase following his presentation, Dr. Wainberg explained that the trial was downgraded because “we wanted to get a little more comfortable with the biomarker,” and because the prevalence of FGFR2b, which was unknown during the planning phase, played a large role in the statistical assumptions.

Patients were eligible for FIGHT if they had received no prior therapy for unresectable, locally advanced or metastatic gastric or GEJ cancers. They also had to have FGFR2b overexpression on immunohistochemistry and/or FGFR2 gene amplification by circulating tumor DNA. They had to have good Eastern Cooperative Oncology Group performance status (0 or 1) and could not have tumors positive for HER2.

Patients were allowed to have one cycle of FOLFOX while their FGFR2b status was being determined, prior to randomization.

After stratification for geographic region, FOLFOX use during screenings, and prior adjuvant or neoadjuvant chemotherapy, the patients were randomized to receive FOLFOX with either placebo or 15 mg/kg of bemarituzumab every 2 weeks, plus an additional 7.5-mg/kg dose on day 8 of cycle 1.

A total of 77 patients were randomized to the bemarituzumab arm, and 78 were randomized to the placebo arm.
 

Patient status at cutoff

As of the September 2020 cutoff, 14 patients continued on bemarituzumab, and 63 were off the assigned drug: 26 because of radiographic progression, 3 for consent withdrawal, 5 because of death, 20 because of adverse events, and 9 for other unspecified causes.

There were 42 patients in the bemarituzumab arm who were still being followed at the cutoff, and 35 were off study. Of this latter group, 28 died, 6 withdrew consent, and 1 was off study for an unspecified cause.

In the placebo arm, 8 patients were still receiving the assigned therapy, and 70 were off that treatment. Of the patients who discontinued study treatment, 4 died, 39 had radiographic progression, 7 withdrew consent, 3 had adverse events, and 17 discontinued for other unspecified reasons.

A total of 27 patients assigned to placebo were still on follow-up at the data cutoff. Of the remaining 51 patients, 40 died, 10 withdrew consent, and 1 had other, unspecified causes for going off study.
 

Primary endpoint met

The PFS rate at 9 months was 52.5% in the experimental arm and 33.8% in the control arm. The median PFS was 9.5 months with bemarituzumab and 7.4 months with placebo, which translated to a hazard ratio of 0.68 (P = .0727). This met the prespecified level of statistical significance for the phase 2 version of the trial, which required a two-sided alpha of 0.2

­OS at 12 months was also superior in the experimental arm, at 65.3% with bemarituzumab and 56.9% with placebo (HR, 0.58; P = .0268).

The benefit of bemarituzumab for both PFS and OS was greatest among patients whose tumors had the highest levels of FGFR2b expression.

Overall response rates were 47% in the experimental arm and 33% in the placebo arm. Among patients with measurable disease at baseline, the respective response rates were 53% and 40%. The median duration of response was 12.2 months in the bemarituzumab arm and 7.1 months in the placebo arm.
 

Corneal toxicities, stomatitis

The incidence of grade 3 or greater adverse events was 82.9% in the experimental arm and 74% in the placebo arm. Five patients in the bemarituzumab arm and four in the placebo arm died from treatment-related causes.

Grade 3 or greater stomatitis occurred in seven patients in the experimental arm, compared with just one patient in the placebo arm. Grade 3 or greater dry eye occurred in two patients in the experimental arm but none in the placebo arm.

Corneal adverse events occurred in 67.1% of patients treated with bemarituzumab and 10.4% of patients on placebo. Respective rates of grade 3 or greater corneal events were 23.7% and 0%.

Twenty patients assigned to bemarituzumab had to discontinue the drug because of corneal problems, compared with no patients on placebo.

At last follow-up, corneal adverse events had resolved in 60% of patients, while 40% had continuing problems. The median time to resolution of corneal adverse events was 27 weeks.
 

New biomarker

“FIGHT study is the first study to demonstrate that biomarker selection exists beyond HER2,” commented invited discussant Rutika Mehta, MD, of the Moffitt Cancer Center and University of South Florida, both in Tampa.

“These are promising results, with toxicities that need to be watched out for. It calls for a larger phase 3 study with special attention to the toxicity profile for bema[rituzumab],” she added.

The trial was supported by Five Prime Therapeutics. Dr. Wainberg disclosed relationships with Five Prime and other companies. Dr. Mehta disclosed relationships with several companies, not including Five Prime.

Adding bemarituzumab to chemotherapy as first-line treatment for advanced gastric and gastroesophageal junction (GEJ) cancers improved survival over chemotherapy alone in the phase 2 FIGHT trial.

Among 155 patients followed for a median of 10.9 months, the combination of bemarituzumab and modified FOLFOX chemotherapy (leucovorin, fluorouracil, and oxaliplatin) resulted in a median progression-free survival (PFS) of 9.5 months, compared with 7.4 months with chemotherapy alone.

The median overall survival (OS) was not reached in the combination arm but was 12.9 months for patients treated with modified FOLFOX plus placebo

Zev A. Wainberg, MD, of the University of California, Los Angeles, presented these results at the 2021 Gastrointestinal Cancers Symposium.

Dr. Wainberg explained that bemarituzumab is an IgG1 antibody targeted specifically to the FGFR2b receptor to block growth factor signaling. The findings from FIGHT suggest FGFR2b is a new biomarker and therapeutic target for advanced gastric and GEJ cancers.

“The FIGHT trial results support a prospective, randomized, phase 3 study in gastric and gastroesophageal adenocarcinoma and the evaluation of bemarituzumab in other FGFR2b tumor types,” Dr. Wainberg said.

FGFR2b is a splice isoform of FGFR2 that is thought to be overexpressed in anywhere from 3% to 61% of gastric cancers, depending on the tumor stage and assay used, he explained at the meeting sponsored by the American Gastroenterological Association, the American Society for Clinical Oncology, the American Society for Radiation Oncology, and the Society of Surgical Oncology.
 

Study downgrading and design

The FIGHT trial was originally designed as a phase 3, randomized trial with the primary endpoint of OS, but it was converted to a phase 2 trial with a PFS primary endpoint and OS secondary endpoint.

In the question-and-answer phase following his presentation, Dr. Wainberg explained that the trial was downgraded because “we wanted to get a little more comfortable with the biomarker,” and because the prevalence of FGFR2b, which was unknown during the planning phase, played a large role in the statistical assumptions.

Patients were eligible for FIGHT if they had received no prior therapy for unresectable, locally advanced or metastatic gastric or GEJ cancers. They also had to have FGFR2b overexpression on immunohistochemistry and/or FGFR2 gene amplification by circulating tumor DNA. They had to have good Eastern Cooperative Oncology Group performance status (0 or 1) and could not have tumors positive for HER2.

Patients were allowed to have one cycle of FOLFOX while their FGFR2b status was being determined, prior to randomization.

After stratification for geographic region, FOLFOX use during screenings, and prior adjuvant or neoadjuvant chemotherapy, the patients were randomized to receive FOLFOX with either placebo or 15 mg/kg of bemarituzumab every 2 weeks, plus an additional 7.5-mg/kg dose on day 8 of cycle 1.

A total of 77 patients were randomized to the bemarituzumab arm, and 78 were randomized to the placebo arm.
 

Patient status at cutoff

As of the September 2020 cutoff, 14 patients continued on bemarituzumab, and 63 were off the assigned drug: 26 because of radiographic progression, 3 for consent withdrawal, 5 because of death, 20 because of adverse events, and 9 for other unspecified causes.

There were 42 patients in the bemarituzumab arm who were still being followed at the cutoff, and 35 were off study. Of this latter group, 28 died, 6 withdrew consent, and 1 was off study for an unspecified cause.

In the placebo arm, 8 patients were still receiving the assigned therapy, and 70 were off that treatment. Of the patients who discontinued study treatment, 4 died, 39 had radiographic progression, 7 withdrew consent, 3 had adverse events, and 17 discontinued for other unspecified reasons.

A total of 27 patients assigned to placebo were still on follow-up at the data cutoff. Of the remaining 51 patients, 40 died, 10 withdrew consent, and 1 had other, unspecified causes for going off study.
 

Primary endpoint met

The PFS rate at 9 months was 52.5% in the experimental arm and 33.8% in the control arm. The median PFS was 9.5 months with bemarituzumab and 7.4 months with placebo, which translated to a hazard ratio of 0.68 (P = .0727). This met the prespecified level of statistical significance for the phase 2 version of the trial, which required a two-sided alpha of 0.2

­OS at 12 months was also superior in the experimental arm, at 65.3% with bemarituzumab and 56.9% with placebo (HR, 0.58; P = .0268).

The benefit of bemarituzumab for both PFS and OS was greatest among patients whose tumors had the highest levels of FGFR2b expression.

Overall response rates were 47% in the experimental arm and 33% in the placebo arm. Among patients with measurable disease at baseline, the respective response rates were 53% and 40%. The median duration of response was 12.2 months in the bemarituzumab arm and 7.1 months in the placebo arm.
 

Corneal toxicities, stomatitis

The incidence of grade 3 or greater adverse events was 82.9% in the experimental arm and 74% in the placebo arm. Five patients in the bemarituzumab arm and four in the placebo arm died from treatment-related causes.

Grade 3 or greater stomatitis occurred in seven patients in the experimental arm, compared with just one patient in the placebo arm. Grade 3 or greater dry eye occurred in two patients in the experimental arm but none in the placebo arm.

Corneal adverse events occurred in 67.1% of patients treated with bemarituzumab and 10.4% of patients on placebo. Respective rates of grade 3 or greater corneal events were 23.7% and 0%.

Twenty patients assigned to bemarituzumab had to discontinue the drug because of corneal problems, compared with no patients on placebo.

At last follow-up, corneal adverse events had resolved in 60% of patients, while 40% had continuing problems. The median time to resolution of corneal adverse events was 27 weeks.
 

New biomarker

“FIGHT study is the first study to demonstrate that biomarker selection exists beyond HER2,” commented invited discussant Rutika Mehta, MD, of the Moffitt Cancer Center and University of South Florida, both in Tampa.

“These are promising results, with toxicities that need to be watched out for. It calls for a larger phase 3 study with special attention to the toxicity profile for bema[rituzumab],” she added.

The trial was supported by Five Prime Therapeutics. Dr. Wainberg disclosed relationships with Five Prime and other companies. Dr. Mehta disclosed relationships with several companies, not including Five Prime.

Nearly a quarter of ED visits were deemed preventable in a single-center study of patients with non–small cell lung cancer.

The leading cause of ED visits in the study was the cancer itself, although many visits were unrelated to non–small cell lung cancer (NSCLC) or cancer therapy.

Less than 10% of ED visits were related to cancer therapy, but visits were much more common among patients receiving chemotherapy than among those receiving immunotherapy or tyrosine kinase inhibitors (TKIs).

Manan P. Shah, MD, and Joel W. Neal, MD, PhD, both of Stanford (Calif. ) University, reported these results in JCO Oncology Practice.

The authors noted that, in the United States, care of patients with cancer, among all diseases, leads to the highest per-person cost. Unplanned hospital visits are among the largest drivers of increased spending in advanced cancer care, accounting for 48% of spending. However, that spending may not be indicative of better quality care, but rather of inefficiency, according to the authors.

One registry spanning 2009-2012 and including more than 400,000 newly diagnosed cancer patients found lung cancer to have the third-highest rate of unplanned hospitalizations (after hepatobiliary and pancreatic cancer). Those findings were published in JCO Oncology Practice in 2018.

While the reason for presentation to the ED is often the cancer or its therapy in this population, there is a paucity of research on the relative contribution of factors leading to unplanned hospital visits.

Common precipitants of medical emergencies in advanced stages of lung cancer include pulmonary embolism, obstructive pneumonia, spinal cord compression caused by metastasis, and tumor progression or pleural effusion leading to respiratory failure.

Lung cancer therapies, such as TKIs, immunotherapy, and cytotoxic chemotherapy, can also cause various medical emergencies arising out of skin reactions, gastrointestinal dysfunction, organ inflammatory processes, and bone marrow suppression.
 

Identifying drivers of unplanned ED visits

The primary goals of Dr. Shah and Dr. Neal’s study were to understand the drivers of unplanned ED visits and identify potential strategies to prevent them.

Drawing from the Stanford Medicine Research Data Repository, the authors identified 97 NSCLC patients with 173 ED visits at Stanford.

Patients were sorted according to which of the three therapies they had been receiving in the 3 months prior to the unplanned visit – TKIs (n = 47), immunotherapy (n = 24), or chemotherapy (n = 26). Patients receiving a combination of chemotherapy and immunotherapy were classified under the immunotherapy category.

ED visits were divided into four categories: cancer related, therapy related, unrelated to cancer or therapy, and rule-out (when an outpatient provider sent the patient to rule out medico-oncologic emergencies such as pulmonary embolism or cord compression).

If the patient’s main complaint(s) began 2 or more days before presentation, the diagnostics or therapeutics could have been provided in an outpatient setting (e.g., in clinic or urgent care), and the patient was discharged directly from the ED, the encounter was classified as potentially preventable. Among these preventable encounters, those made during business hours were also labeled unnecessary because they could have been managed through the Stanford sick call system for same-day urgent visits.
 

Leading cause is cancer

Overall, the leading cause of ED visits was NSCLC itself (54%). The patient’s cancer contributed to 61% of ED visits in the TKI group, 49% in the immunotherapy group, and 42% in the chemotherapy group.

Many ED visits were deemed unrelated to cancer or its therapies – 30% in the TKI group, 26% in the immunotherapy group, and 32% in the chemotherapy group.

Rule-out cases contributed to 7% of ED visits in the TKI group, 14% in the immunotherapy group, and 5% in the chemotherapy group.

Overall, 9% of ED visits were therapy related. The smallest proportion of these was observed in the TKI group (2%), which was significantly smaller than in the immunotherapy group (12%), a rate also significantly smaller than in the chemotherapy group (21%, P < .001).

Most unplanned ED visits did not lead to admissions (55%), were for complaints that began 2 or more days prior to presentation (53%), led to diagnostics or therapeutics that could have been administered in an outpatient setting (48%), and were during business hours (52%).

As a result, 24% of visits were classified as preventable, and 10% were deemed unnecessary.
 

Preventive strategies

“Our study suggests that TKIs lead to fewer emergency room visits than immunotherapy and chemotherapy,” Dr. Shah said in an interview.

“Overall, this may not necessarily change which therapy we prescribe,” he added, “as TKI therapy is often first line for patients with targeted mutations. However, recognizing that those on chemotherapy or immunotherapy are at higher risk for emergency room visits, we may target preventative strategies, for example, nursing phone calls, telemonitoring of symptoms, and frequent video visits toward this high-risk population.”

Dr. Shah and Dr. Neal said it’s “reassuring” that TKIs and immunotherapy are small drivers of unplanned hospital care. However, they also said efforts aimed at reducing chemotherapy-related ED visits are warranted.

The authors speculated that early intervention, extension of ambulatory care, and patient education about outpatient avenues of care could eliminate a significant proportion (at least 20%) of unplanned ED visits by NSCLC patients.

There was no specific funding for this study. Dr. Shah disclosed no conflicts of interest. Dr. Neal disclosed relationships with many companies, including this news organization.

Nearly a quarter of ED visits were deemed preventable in a single-center study of patients with non–small cell lung cancer.

The leading cause of ED visits in the study was the cancer itself, although many visits were unrelated to non–small cell lung cancer (NSCLC) or cancer therapy.

Less than 10% of ED visits were related to cancer therapy, but visits were much more common among patients receiving chemotherapy than among those receiving immunotherapy or tyrosine kinase inhibitors (TKIs).

Manan P. Shah, MD, and Joel W. Neal, MD, PhD, both of Stanford (Calif. ) University, reported these results in JCO Oncology Practice.

The authors noted that, in the United States, care of patients with cancer, among all diseases, leads to the highest per-person cost. Unplanned hospital visits are among the largest drivers of increased spending in advanced cancer care, accounting for 48% of spending. However, that spending may not be indicative of better quality care, but rather of inefficiency, according to the authors.

One registry spanning 2009-2012 and including more than 400,000 newly diagnosed cancer patients found lung cancer to have the third-highest rate of unplanned hospitalizations (after hepatobiliary and pancreatic cancer). Those findings were published in JCO Oncology Practice in 2018.

While the reason for presentation to the ED is often the cancer or its therapy in this population, there is a paucity of research on the relative contribution of factors leading to unplanned hospital visits.

Common precipitants of medical emergencies in advanced stages of lung cancer include pulmonary embolism, obstructive pneumonia, spinal cord compression caused by metastasis, and tumor progression or pleural effusion leading to respiratory failure.

Lung cancer therapies, such as TKIs, immunotherapy, and cytotoxic chemotherapy, can also cause various medical emergencies arising out of skin reactions, gastrointestinal dysfunction, organ inflammatory processes, and bone marrow suppression.
 

Identifying drivers of unplanned ED visits

The primary goals of Dr. Shah and Dr. Neal’s study were to understand the drivers of unplanned ED visits and identify potential strategies to prevent them.

Drawing from the Stanford Medicine Research Data Repository, the authors identified 97 NSCLC patients with 173 ED visits at Stanford.

Patients were sorted according to which of the three therapies they had been receiving in the 3 months prior to the unplanned visit – TKIs (n = 47), immunotherapy (n = 24), or chemotherapy (n = 26). Patients receiving a combination of chemotherapy and immunotherapy were classified under the immunotherapy category.

ED visits were divided into four categories: cancer related, therapy related, unrelated to cancer or therapy, and rule-out (when an outpatient provider sent the patient to rule out medico-oncologic emergencies such as pulmonary embolism or cord compression).

If the patient’s main complaint(s) began 2 or more days before presentation, the diagnostics or therapeutics could have been provided in an outpatient setting (e.g., in clinic or urgent care), and the patient was discharged directly from the ED, the encounter was classified as potentially preventable. Among these preventable encounters, those made during business hours were also labeled unnecessary because they could have been managed through the Stanford sick call system for same-day urgent visits.
 

Leading cause is cancer

Overall, the leading cause of ED visits was NSCLC itself (54%). The patient’s cancer contributed to 61% of ED visits in the TKI group, 49% in the immunotherapy group, and 42% in the chemotherapy group.

Many ED visits were deemed unrelated to cancer or its therapies – 30% in the TKI group, 26% in the immunotherapy group, and 32% in the chemotherapy group.

Rule-out cases contributed to 7% of ED visits in the TKI group, 14% in the immunotherapy group, and 5% in the chemotherapy group.

Overall, 9% of ED visits were therapy related. The smallest proportion of these was observed in the TKI group (2%), which was significantly smaller than in the immunotherapy group (12%), a rate also significantly smaller than in the chemotherapy group (21%, P < .001).

Most unplanned ED visits did not lead to admissions (55%), were for complaints that began 2 or more days prior to presentation (53%), led to diagnostics or therapeutics that could have been administered in an outpatient setting (48%), and were during business hours (52%).

As a result, 24% of visits were classified as preventable, and 10% were deemed unnecessary.
 

Preventive strategies

“Our study suggests that TKIs lead to fewer emergency room visits than immunotherapy and chemotherapy,” Dr. Shah said in an interview.

“Overall, this may not necessarily change which therapy we prescribe,” he added, “as TKI therapy is often first line for patients with targeted mutations. However, recognizing that those on chemotherapy or immunotherapy are at higher risk for emergency room visits, we may target preventative strategies, for example, nursing phone calls, telemonitoring of symptoms, and frequent video visits toward this high-risk population.”

Dr. Shah and Dr. Neal said it’s “reassuring” that TKIs and immunotherapy are small drivers of unplanned hospital care. However, they also said efforts aimed at reducing chemotherapy-related ED visits are warranted.

The authors speculated that early intervention, extension of ambulatory care, and patient education about outpatient avenues of care could eliminate a significant proportion (at least 20%) of unplanned ED visits by NSCLC patients.

There was no specific funding for this study. Dr. Shah disclosed no conflicts of interest. Dr. Neal disclosed relationships with many companies, including this news organization.

Nearly a quarter of ED visits were deemed preventable in a single-center study of patients with non–small cell lung cancer.

The leading cause of ED visits in the study was the cancer itself, although many visits were unrelated to non–small cell lung cancer (NSCLC) or cancer therapy.

Less than 10% of ED visits were related to cancer therapy, but visits were much more common among patients receiving chemotherapy than among those receiving immunotherapy or tyrosine kinase inhibitors (TKIs).

Manan P. Shah, MD, and Joel W. Neal, MD, PhD, both of Stanford (Calif. ) University, reported these results in JCO Oncology Practice.

The authors noted that, in the United States, care of patients with cancer, among all diseases, leads to the highest per-person cost. Unplanned hospital visits are among the largest drivers of increased spending in advanced cancer care, accounting for 48% of spending. However, that spending may not be indicative of better quality care, but rather of inefficiency, according to the authors.

One registry spanning 2009-2012 and including more than 400,000 newly diagnosed cancer patients found lung cancer to have the third-highest rate of unplanned hospitalizations (after hepatobiliary and pancreatic cancer). Those findings were published in JCO Oncology Practice in 2018.

While the reason for presentation to the ED is often the cancer or its therapy in this population, there is a paucity of research on the relative contribution of factors leading to unplanned hospital visits.

Common precipitants of medical emergencies in advanced stages of lung cancer include pulmonary embolism, obstructive pneumonia, spinal cord compression caused by metastasis, and tumor progression or pleural effusion leading to respiratory failure.

Lung cancer therapies, such as TKIs, immunotherapy, and cytotoxic chemotherapy, can also cause various medical emergencies arising out of skin reactions, gastrointestinal dysfunction, organ inflammatory processes, and bone marrow suppression.
 

Identifying drivers of unplanned ED visits

The primary goals of Dr. Shah and Dr. Neal’s study were to understand the drivers of unplanned ED visits and identify potential strategies to prevent them.

Drawing from the Stanford Medicine Research Data Repository, the authors identified 97 NSCLC patients with 173 ED visits at Stanford.

Patients were sorted according to which of the three therapies they had been receiving in the 3 months prior to the unplanned visit – TKIs (n = 47), immunotherapy (n = 24), or chemotherapy (n = 26). Patients receiving a combination of chemotherapy and immunotherapy were classified under the immunotherapy category.

ED visits were divided into four categories: cancer related, therapy related, unrelated to cancer or therapy, and rule-out (when an outpatient provider sent the patient to rule out medico-oncologic emergencies such as pulmonary embolism or cord compression).

If the patient’s main complaint(s) began 2 or more days before presentation, the diagnostics or therapeutics could have been provided in an outpatient setting (e.g., in clinic or urgent care), and the patient was discharged directly from the ED, the encounter was classified as potentially preventable. Among these preventable encounters, those made during business hours were also labeled unnecessary because they could have been managed through the Stanford sick call system for same-day urgent visits.
 

Leading cause is cancer

Overall, the leading cause of ED visits was NSCLC itself (54%). The patient’s cancer contributed to 61% of ED visits in the TKI group, 49% in the immunotherapy group, and 42% in the chemotherapy group.

Many ED visits were deemed unrelated to cancer or its therapies – 30% in the TKI group, 26% in the immunotherapy group, and 32% in the chemotherapy group.

Rule-out cases contributed to 7% of ED visits in the TKI group, 14% in the immunotherapy group, and 5% in the chemotherapy group.

Overall, 9% of ED visits were therapy related. The smallest proportion of these was observed in the TKI group (2%), which was significantly smaller than in the immunotherapy group (12%), a rate also significantly smaller than in the chemotherapy group (21%, P < .001).

Most unplanned ED visits did not lead to admissions (55%), were for complaints that began 2 or more days prior to presentation (53%), led to diagnostics or therapeutics that could have been administered in an outpatient setting (48%), and were during business hours (52%).

As a result, 24% of visits were classified as preventable, and 10% were deemed unnecessary.
 

Preventive strategies

“Our study suggests that TKIs lead to fewer emergency room visits than immunotherapy and chemotherapy,” Dr. Shah said in an interview.

“Overall, this may not necessarily change which therapy we prescribe,” he added, “as TKI therapy is often first line for patients with targeted mutations. However, recognizing that those on chemotherapy or immunotherapy are at higher risk for emergency room visits, we may target preventative strategies, for example, nursing phone calls, telemonitoring of symptoms, and frequent video visits toward this high-risk population.”

Dr. Shah and Dr. Neal said it’s “reassuring” that TKIs and immunotherapy are small drivers of unplanned hospital care. However, they also said efforts aimed at reducing chemotherapy-related ED visits are warranted.

The authors speculated that early intervention, extension of ambulatory care, and patient education about outpatient avenues of care could eliminate a significant proportion (at least 20%) of unplanned ED visits by NSCLC patients.

There was no specific funding for this study. Dr. Shah disclosed no conflicts of interest. Dr. Neal disclosed relationships with many companies, including this news organization.

Moderna probably will not have clinical trial results anytime soon on how its COVID-19 vaccine affects children and adolescents, according to the company CEO and a federal official.

The Moderna vaccine was authorized for use in December and is now being given to people 18 and over. But children would receive lower doses, so new clinical trials must be done, Moderna CEO Stephane Bancel said at the JPMorgan virtual Health Care Conference on Monday.

Clinical trials on children 11 and younger “will take much longer, because we have to age deescalate and start at a lower dose. So we should not anticipate clinical data in 2021, but more in 2022,” Ms. Bancel said, according to Business Insider.

Moderna’s clinical trials for 12- to 17-year-olds started 4 weeks ago, but the company is having trouble getting enough participants, said Moncef Slaoui, PhD, the scientific head of Operation Warp Speed, the U.S. government’s vaccine effort. That could delay Food and Drug Administration approval, he said.

“It’s really very important for all of us, for all the population in America, to realize that we can’t have that indication unless adolescents aged 12-18 decide to participate,” Dr. Slaoui said, according to USA Today.

He said the adolescent trials are getting only about 800 volunteers a month, but need at least 3,000 volunteers to complete the study, USA Today reported. Parents interested in having their child participate can check eligibility and sign at this website.

The Pfizer/BioNTech vaccine won authorization for use in 16- to 17-year-olds as well as adults.

The coronavirus doesn’t appear to have as serious complications for children as for adults.

“At this time, it appears that severe illness due to COVID-19 is rare among children,” the American Association of Pediatrics says. “However, there is an urgent need to collect more data on longer-term impacts of the pandemic on children, including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects.”

The association says 179 children had died of COVID-related reasons in 43 states and New York City as of Dec. 31, 2020. That’s about 0.06% of total COVID deaths, it says.

But children do get sick. As of Jan. 7, 2021, nearly 2.3 million children had tested positive for COVID-19 since the start of the pandemic, the association says.

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

Moderna probably will not have clinical trial results anytime soon on how its COVID-19 vaccine affects children and adolescents, according to the company CEO and a federal official.

The Moderna vaccine was authorized for use in December and is now being given to people 18 and over. But children would receive lower doses, so new clinical trials must be done, Moderna CEO Stephane Bancel said at the JPMorgan virtual Health Care Conference on Monday.

Clinical trials on children 11 and younger “will take much longer, because we have to age deescalate and start at a lower dose. So we should not anticipate clinical data in 2021, but more in 2022,” Ms. Bancel said, according to Business Insider.

Moderna’s clinical trials for 12- to 17-year-olds started 4 weeks ago, but the company is having trouble getting enough participants, said Moncef Slaoui, PhD, the scientific head of Operation Warp Speed, the U.S. government’s vaccine effort. That could delay Food and Drug Administration approval, he said.

“It’s really very important for all of us, for all the population in America, to realize that we can’t have that indication unless adolescents aged 12-18 decide to participate,” Dr. Slaoui said, according to USA Today.

He said the adolescent trials are getting only about 800 volunteers a month, but need at least 3,000 volunteers to complete the study, USA Today reported. Parents interested in having their child participate can check eligibility and sign at this website.

The Pfizer/BioNTech vaccine won authorization for use in 16- to 17-year-olds as well as adults.

The coronavirus doesn’t appear to have as serious complications for children as for adults.

“At this time, it appears that severe illness due to COVID-19 is rare among children,” the American Association of Pediatrics says. “However, there is an urgent need to collect more data on longer-term impacts of the pandemic on children, including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects.”

The association says 179 children had died of COVID-related reasons in 43 states and New York City as of Dec. 31, 2020. That’s about 0.06% of total COVID deaths, it says.

But children do get sick. As of Jan. 7, 2021, nearly 2.3 million children had tested positive for COVID-19 since the start of the pandemic, the association says.

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

Moderna probably will not have clinical trial results anytime soon on how its COVID-19 vaccine affects children and adolescents, according to the company CEO and a federal official.

The Moderna vaccine was authorized for use in December and is now being given to people 18 and over. But children would receive lower doses, so new clinical trials must be done, Moderna CEO Stephane Bancel said at the JPMorgan virtual Health Care Conference on Monday.

Clinical trials on children 11 and younger “will take much longer, because we have to age deescalate and start at a lower dose. So we should not anticipate clinical data in 2021, but more in 2022,” Ms. Bancel said, according to Business Insider.

Moderna’s clinical trials for 12- to 17-year-olds started 4 weeks ago, but the company is having trouble getting enough participants, said Moncef Slaoui, PhD, the scientific head of Operation Warp Speed, the U.S. government’s vaccine effort. That could delay Food and Drug Administration approval, he said.

“It’s really very important for all of us, for all the population in America, to realize that we can’t have that indication unless adolescents aged 12-18 decide to participate,” Dr. Slaoui said, according to USA Today.

He said the adolescent trials are getting only about 800 volunteers a month, but need at least 3,000 volunteers to complete the study, USA Today reported. Parents interested in having their child participate can check eligibility and sign at this website.

The Pfizer/BioNTech vaccine won authorization for use in 16- to 17-year-olds as well as adults.

The coronavirus doesn’t appear to have as serious complications for children as for adults.

“At this time, it appears that severe illness due to COVID-19 is rare among children,” the American Association of Pediatrics says. “However, there is an urgent need to collect more data on longer-term impacts of the pandemic on children, including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects.”

The association says 179 children had died of COVID-related reasons in 43 states and New York City as of Dec. 31, 2020. That’s about 0.06% of total COVID deaths, it says.

But children do get sick. As of Jan. 7, 2021, nearly 2.3 million children had tested positive for COVID-19 since the start of the pandemic, the association says.

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

Women who receive ovarian stimulation for assisted reproductive technology (ART) procedures don’t have an increased risk of developing ovarian cancer when compared to subfertile women who don’t undergo ART, according to a new study.

The results suggest that nulliparity is likely responsible for the increased risk of ovarian cancer observed in patients treated with ART, the researchers said.

Earlier, shorter studies had only compared ART-treated women with women from the general population.

“Subfertile women differ from women in the general population according to several ovarian cancer risk factors. Therefore, to estimate the risk of ovarian cancer associated with ART, it was important to include a comparison group of women who were subfertile and not treated with ART,” said senior study author Flora E. van Leeuwen, PhD, of Netherlands Cancer Institute in Amsterdam.

She and her colleagues conducted a nationwide cohort study of 30,625 women who received ovarian stimulation for ART during 1983-2000 and 9,988 women who received fertility treatments other than ART.

Incident invasive and borderline ovarian tumors were ascertained through linkage with the Netherlands Cancer Registry and the Dutch Pathology Registry. Ovarian tumor risk in ART-treated women was compared with risks in the general population and the subfertile non-ART group.

The researchers reported the results in the Journal of the National Cancer Institute.
 

Risk of ovarian cancer

Women treated with ART were no more likely to develop ovarian cancer than subfertile women not treated with ART (adjusted hazard ratio, 1.02), but the ART group did have an increased risk of ovarian cancer when compared to the general population (standardized incidence ratio, 1.43).

“This, however, turned out to be due to the fact that the women who had received ART were less likely to have children. Not having children is a known risk factor for ovarian cancer,” Dr. van Leeuwen said.

Women with more ART procedures that resulted in the birth of a child were at lower risk of developing ovarian cancer, compared with women without any successful cycle (Ptrend = .001). However, women who had only cycles not resulting in a birth were not at higher risk of ovarian cancer when they had a greater number of cycles.

“These results indicate that parity decreases the risk of ovarian cancer, also in ART-treated women. But more unsuccessful ART cycles do not increase the risk of ovarian cancer,” Dr. van Leeuwen said.
 

Risk of borderline ovarian tumors

The risk of developing borderline ovarian tumors was roughly twice as high in women who had received ART, both compared with women who had received other fertility treatments (hazard ratio, 1.84) and women from the general population (standardized incidence ratio, 2.20).

However, the risk of developing borderline ovarian tumors did not increase in women who had received multiple ART procedures.

“If there was a causal association between ART and increased risk of borderline ovarian tumors, we would expect to see this risk increase with a greater number of ART procedures from more hormones and more stimulation of the ovaries. This makes the direct link between ART and increased risk of borderline tumors a bit uncertain. It might be caused by other factors, such as the severity of infertility,” Dr. van Leeuwen said.

Borderline ovarian tumors are rare in the general population in the Netherlands, and women who develop these tumors generally have a good prognosis, she said.

The risk of developing a borderline tumor before the age of 55 for women in the Netherlands is approximately 0.2%. After ART, the study found a risk of approximately 0.3%.

Causal associations with ART 'unlikely'

“Women who develop cancer and have undergone ART procedures in the past may wonder whether their cancer may be caused by ART. Based on the results from our study, that seems unlikely, and that is a very reassuring message from practicing oncologists to women diagnosed with ovarian cancer. Another important message is that, in ART-treated women, increasing parity reduces the risk of ovarian cancer,” Dr. van Leeuwen said.

She added that the risk of borderline ovarian tumors did not increase in women who received multiple ART procedures, “which makes it somewhat less likely that ART would have caused their borderline ovarian tumor.”

The study does not exclude the possibility that ART might increase the risk of ovarian tumors after age 60.

“Despite our long follow-up, the age of the women at the end of our study was still relatively young [average 56 years]. Because the incidence of ovarian cancer increases with older age, it is vital to continue to follow these women. Only then can we be sure that ART does not increase the risk of ovarian tumors in the very long run,” Dr. van Leeuwen said.

“This study offers confirmation of several previous studies and provides reassurance about the risk of ovarian cancer after ART procedures,” said Daniel Kenigsberg, MD, of RMA Long Island IVF in New York. Dr. Kenigsberg was not involved in this study but has performed more than 30,000 ART procedures over the past 32 years.

“Researchers have looked at whether fertility drugs cause ovarian cancer in different ways and in different countries, and there is no cause-and-effect relationship. There was no dose-response relationship between ART and ovarian tumors in this study. It’s more likely there is something wrong with the women’s ovaries that lead to borderline tumors and infertility more than any treatment,” Dr. Kenigsberg added.

“Perhaps both fertility and cancer relate to an underlying ovarian issue, but this would not explain the increased cancer incidence in those who never attempted pregnancy, that is, women who are voluntarily childless. Pregnancy is statistically protective: more pregnancies lead to less ovarian cancer, but this is far from absolute,” he explained.

Dr. Kenigsberg suggested that oncologists should be aware of a patient’s obstetrical history and fertility history as well as any related medical interventions.

“Borderline tumors look like cancer and have histologic features of cancer but do not meet the criteria for a cancer diagnosis,” he said. “They require close surveillance because their relationship to the development of full-fledged cancer is uncertain.”

This research was supported by grants from the Dutch Cancer Society. The authors and Dr. Kenigsberg have no conflicts of interest.

Women who receive ovarian stimulation for assisted reproductive technology (ART) procedures don’t have an increased risk of developing ovarian cancer when compared to subfertile women who don’t undergo ART, according to a new study.

The results suggest that nulliparity is likely responsible for the increased risk of ovarian cancer observed in patients treated with ART, the researchers said.

Earlier, shorter studies had only compared ART-treated women with women from the general population.

“Subfertile women differ from women in the general population according to several ovarian cancer risk factors. Therefore, to estimate the risk of ovarian cancer associated with ART, it was important to include a comparison group of women who were subfertile and not treated with ART,” said senior study author Flora E. van Leeuwen, PhD, of Netherlands Cancer Institute in Amsterdam.

She and her colleagues conducted a nationwide cohort study of 30,625 women who received ovarian stimulation for ART during 1983-2000 and 9,988 women who received fertility treatments other than ART.

Incident invasive and borderline ovarian tumors were ascertained through linkage with the Netherlands Cancer Registry and the Dutch Pathology Registry. Ovarian tumor risk in ART-treated women was compared with risks in the general population and the subfertile non-ART group.

The researchers reported the results in the Journal of the National Cancer Institute.
 

Risk of ovarian cancer

Women treated with ART were no more likely to develop ovarian cancer than subfertile women not treated with ART (adjusted hazard ratio, 1.02), but the ART group did have an increased risk of ovarian cancer when compared to the general population (standardized incidence ratio, 1.43).

“This, however, turned out to be due to the fact that the women who had received ART were less likely to have children. Not having children is a known risk factor for ovarian cancer,” Dr. van Leeuwen said.

Women with more ART procedures that resulted in the birth of a child were at lower risk of developing ovarian cancer, compared with women without any successful cycle (Ptrend = .001). However, women who had only cycles not resulting in a birth were not at higher risk of ovarian cancer when they had a greater number of cycles.

“These results indicate that parity decreases the risk of ovarian cancer, also in ART-treated women. But more unsuccessful ART cycles do not increase the risk of ovarian cancer,” Dr. van Leeuwen said.
 

Risk of borderline ovarian tumors

The risk of developing borderline ovarian tumors was roughly twice as high in women who had received ART, both compared with women who had received other fertility treatments (hazard ratio, 1.84) and women from the general population (standardized incidence ratio, 2.20).

However, the risk of developing borderline ovarian tumors did not increase in women who had received multiple ART procedures.

“If there was a causal association between ART and increased risk of borderline ovarian tumors, we would expect to see this risk increase with a greater number of ART procedures from more hormones and more stimulation of the ovaries. This makes the direct link between ART and increased risk of borderline tumors a bit uncertain. It might be caused by other factors, such as the severity of infertility,” Dr. van Leeuwen said.

Borderline ovarian tumors are rare in the general population in the Netherlands, and women who develop these tumors generally have a good prognosis, she said.

The risk of developing a borderline tumor before the age of 55 for women in the Netherlands is approximately 0.2%. After ART, the study found a risk of approximately 0.3%.

Causal associations with ART 'unlikely'

“Women who develop cancer and have undergone ART procedures in the past may wonder whether their cancer may be caused by ART. Based on the results from our study, that seems unlikely, and that is a very reassuring message from practicing oncologists to women diagnosed with ovarian cancer. Another important message is that, in ART-treated women, increasing parity reduces the risk of ovarian cancer,” Dr. van Leeuwen said.

She added that the risk of borderline ovarian tumors did not increase in women who received multiple ART procedures, “which makes it somewhat less likely that ART would have caused their borderline ovarian tumor.”

The study does not exclude the possibility that ART might increase the risk of ovarian tumors after age 60.

“Despite our long follow-up, the age of the women at the end of our study was still relatively young [average 56 years]. Because the incidence of ovarian cancer increases with older age, it is vital to continue to follow these women. Only then can we be sure that ART does not increase the risk of ovarian tumors in the very long run,” Dr. van Leeuwen said.

“This study offers confirmation of several previous studies and provides reassurance about the risk of ovarian cancer after ART procedures,” said Daniel Kenigsberg, MD, of RMA Long Island IVF in New York. Dr. Kenigsberg was not involved in this study but has performed more than 30,000 ART procedures over the past 32 years.

“Researchers have looked at whether fertility drugs cause ovarian cancer in different ways and in different countries, and there is no cause-and-effect relationship. There was no dose-response relationship between ART and ovarian tumors in this study. It’s more likely there is something wrong with the women’s ovaries that lead to borderline tumors and infertility more than any treatment,” Dr. Kenigsberg added.

“Perhaps both fertility and cancer relate to an underlying ovarian issue, but this would not explain the increased cancer incidence in those who never attempted pregnancy, that is, women who are voluntarily childless. Pregnancy is statistically protective: more pregnancies lead to less ovarian cancer, but this is far from absolute,” he explained.

Dr. Kenigsberg suggested that oncologists should be aware of a patient’s obstetrical history and fertility history as well as any related medical interventions.

“Borderline tumors look like cancer and have histologic features of cancer but do not meet the criteria for a cancer diagnosis,” he said. “They require close surveillance because their relationship to the development of full-fledged cancer is uncertain.”

This research was supported by grants from the Dutch Cancer Society. The authors and Dr. Kenigsberg have no conflicts of interest.

Women who receive ovarian stimulation for assisted reproductive technology (ART) procedures don’t have an increased risk of developing ovarian cancer when compared to subfertile women who don’t undergo ART, according to a new study.

The results suggest that nulliparity is likely responsible for the increased risk of ovarian cancer observed in patients treated with ART, the researchers said.

Earlier, shorter studies had only compared ART-treated women with women from the general population.

“Subfertile women differ from women in the general population according to several ovarian cancer risk factors. Therefore, to estimate the risk of ovarian cancer associated with ART, it was important to include a comparison group of women who were subfertile and not treated with ART,” said senior study author Flora E. van Leeuwen, PhD, of Netherlands Cancer Institute in Amsterdam.

She and her colleagues conducted a nationwide cohort study of 30,625 women who received ovarian stimulation for ART during 1983-2000 and 9,988 women who received fertility treatments other than ART.

Incident invasive and borderline ovarian tumors were ascertained through linkage with the Netherlands Cancer Registry and the Dutch Pathology Registry. Ovarian tumor risk in ART-treated women was compared with risks in the general population and the subfertile non-ART group.

The researchers reported the results in the Journal of the National Cancer Institute.
 

Risk of ovarian cancer

Women treated with ART were no more likely to develop ovarian cancer than subfertile women not treated with ART (adjusted hazard ratio, 1.02), but the ART group did have an increased risk of ovarian cancer when compared to the general population (standardized incidence ratio, 1.43).

“This, however, turned out to be due to the fact that the women who had received ART were less likely to have children. Not having children is a known risk factor for ovarian cancer,” Dr. van Leeuwen said.

Women with more ART procedures that resulted in the birth of a child were at lower risk of developing ovarian cancer, compared with women without any successful cycle (Ptrend = .001). However, women who had only cycles not resulting in a birth were not at higher risk of ovarian cancer when they had a greater number of cycles.

“These results indicate that parity decreases the risk of ovarian cancer, also in ART-treated women. But more unsuccessful ART cycles do not increase the risk of ovarian cancer,” Dr. van Leeuwen said.
 

Risk of borderline ovarian tumors

The risk of developing borderline ovarian tumors was roughly twice as high in women who had received ART, both compared with women who had received other fertility treatments (hazard ratio, 1.84) and women from the general population (standardized incidence ratio, 2.20).

However, the risk of developing borderline ovarian tumors did not increase in women who had received multiple ART procedures.

“If there was a causal association between ART and increased risk of borderline ovarian tumors, we would expect to see this risk increase with a greater number of ART procedures from more hormones and more stimulation of the ovaries. This makes the direct link between ART and increased risk of borderline tumors a bit uncertain. It might be caused by other factors, such as the severity of infertility,” Dr. van Leeuwen said.

Borderline ovarian tumors are rare in the general population in the Netherlands, and women who develop these tumors generally have a good prognosis, she said.

The risk of developing a borderline tumor before the age of 55 for women in the Netherlands is approximately 0.2%. After ART, the study found a risk of approximately 0.3%.

Causal associations with ART 'unlikely'

“Women who develop cancer and have undergone ART procedures in the past may wonder whether their cancer may be caused by ART. Based on the results from our study, that seems unlikely, and that is a very reassuring message from practicing oncologists to women diagnosed with ovarian cancer. Another important message is that, in ART-treated women, increasing parity reduces the risk of ovarian cancer,” Dr. van Leeuwen said.

She added that the risk of borderline ovarian tumors did not increase in women who received multiple ART procedures, “which makes it somewhat less likely that ART would have caused their borderline ovarian tumor.”

The study does not exclude the possibility that ART might increase the risk of ovarian tumors after age 60.

“Despite our long follow-up, the age of the women at the end of our study was still relatively young [average 56 years]. Because the incidence of ovarian cancer increases with older age, it is vital to continue to follow these women. Only then can we be sure that ART does not increase the risk of ovarian tumors in the very long run,” Dr. van Leeuwen said.

“This study offers confirmation of several previous studies and provides reassurance about the risk of ovarian cancer after ART procedures,” said Daniel Kenigsberg, MD, of RMA Long Island IVF in New York. Dr. Kenigsberg was not involved in this study but has performed more than 30,000 ART procedures over the past 32 years.

“Researchers have looked at whether fertility drugs cause ovarian cancer in different ways and in different countries, and there is no cause-and-effect relationship. There was no dose-response relationship between ART and ovarian tumors in this study. It’s more likely there is something wrong with the women’s ovaries that lead to borderline tumors and infertility more than any treatment,” Dr. Kenigsberg added.

“Perhaps both fertility and cancer relate to an underlying ovarian issue, but this would not explain the increased cancer incidence in those who never attempted pregnancy, that is, women who are voluntarily childless. Pregnancy is statistically protective: more pregnancies lead to less ovarian cancer, but this is far from absolute,” he explained.

Dr. Kenigsberg suggested that oncologists should be aware of a patient’s obstetrical history and fertility history as well as any related medical interventions.

“Borderline tumors look like cancer and have histologic features of cancer but do not meet the criteria for a cancer diagnosis,” he said. “They require close surveillance because their relationship to the development of full-fledged cancer is uncertain.”

This research was supported by grants from the Dutch Cancer Society. The authors and Dr. Kenigsberg have no conflicts of interest.

Although the United States has observed daylight saving time (DST) continuously, in some form, for the last 5 decades (Table), the twice a year switches have never been less popular. In 2019, an American Academy of Sleep Medicine (AASM) survey of more than 2,000 US adults found that 63% support the elimination of seasonal time changes in favor of a national, fixed, year-round time, and only 11% oppose it. Indeed, multiple states have pending legislations to adopt year-round daylight saving time or year-round standard time (Updated September 30, 2020, Congressional Research Service. https://crsreports.congress.gov. R45208 Daylight Saving Time. Accessed Dec 14, 2020). Adjacent states, to limit confusion to interstate travel and commerce, tend to lobby for similar changes together. Most importantly, because of the scientific evidence of detrimental health effects to the public and safety concerns, the American Academy of Sleep Medicine has issued a position statement for year-round standard time (Rishi MA, et al. Daylight saving time: an American Academy of Sleep Medicine position statement. J Clin Sleep Med. 2020;16(10):1781).

Railroad industry successfully lobbied the US government for consistent time in the United States to keep transportation schedules uniform in 1883; standard time was implemented. When war efforts were over, DST was dropped. Some regions, such as New York and Chicago, maintained DST, but no national standard was applied. Retailers and the recreational activity industry advocated for DST to increase business after work in the afternoon and evenings. In 1966, Congress passed the Uniform Time Act of 1966 to implement 6 months of DST and 6 months of standard time (Waxman OB. The real reason why daylight saving time is a thing. https://time.com/4549397/daylight-saving-time-history-politics/; November 1, 2017. Accessed Dec 14, 2020). Local jurisdictions can opt out of DST, but it requires an act of congress to enforce perennial DST.

When the OPEC embargo occurred, the Emergency Daylight Saving Time Energy Conservation Act was enacted in 1973, but it was quickly ended in October 1974 due to its unpopularity. The dairy industry was opposed to earlier rise time that disrupted the animals’ feeding schedules and their farm operations (Feldman R. Five myths about daylight saving time. https://www.washingtonpost.com/opinions/five-myths-about-daylight-saving-time/2015/03/06/970092d4-c2c1-11e4-9271-610273846239_story.html. Accessed Dec 14, 2020.). Public safety was raised as a concern as early as 1975. The Department of Transportation found increased fatalities of school-aged children in the mornings from January to April of 1974 as compared with 1973. However, the National Bureau of Standards, that performed a review subsequently, stated that other factors might also be at play. Further extension of DST from 6 months of the year to the subsequent 7, and then 8 months per year were enacted in 1986 and 2005, respectively (The reasoning behind changing daylight saving. https://www.npr.org/templates/story/story.php?storyId=7779869. NPR. Accessed Nov 1, 2020.)

An exemption of a state from DST is allowable under existing law, but to establish permanent DST will require an act of Congress. Since then, Arizona and Hawaii, as well as US territories, such as Puerto Rico, Guam, American Samoa and Northern Mariana Islands, and US Virgin Islands, have all opted out of DST by state exemption. Because of Hawaii’s proximity to the equator, the timing of sunrise and sunset were fairly constant throughout the year that made DST unnecessary. The Navajo Nation in Arizona, because of its extension into adjacent New Mexico and Utah, participates in DST. Most of the countries along the tropics, parts of Australia, China, Japan, South Korea, India, and majority of African countries do not observe DST. The European Union has voted to abolish twice yearly change in time in 2021; and individual member states will be able to decide whether they wish to remain on permanent standard time or DST. Since 2015, more than 45 states have proposed legislation to change their observance of DST.

The human biological rhythm is most consistent with standard time (Antle M. Circadian rhythm expert argues against permanent daylight saving time. https://www.ucalgary.ca/news/circadian-rhythm-expert-argues-against-permanent-daylight-saving-time. Accessed Dec 14, 2020.). Since the biological clock for most individuals is not exactly 24 hours long, zeitgebers such as sunlight, exercise, and feeding behaviors are important time cues to foster a regular rhythm. Acutely, the adjustment to 1 hour’s sleep loss at the spring switch from standard time to DST generally requires several days to adapt (Kalidindi A. Daylight saving time is bad for your health. https://massivesci.com/articles/daylight-saving-savings-time-dst-november-standard-time. Accessed Dec 14, 2020.). During this adjustment period, the internal bodily functions are disrupted. The sense of sleepiness and fatigue are increased with earlier morning awakenings, and the inability to fall asleep earlier leads to symptoms of insomnia and poor sleep quality.

Timeline for DST
 

1784 Benjamin Franklin advocated to rise earlier so as to burn fewer candles in the evenings.

1883 Railroads need standard time for operations.

1890 Merchants and retailers (clothing, cigars) advocated for longer shopping hours.

1916 Germany conserves energy.

1918 DST: fuel conservation during World War I.

1942 DST during World War II.

1963 “Chaos of clocks” needs uniform time for commerce.

1966 Uniform Time Act: DST 6 months per year.

1973 Emergency DST Energy Conservation Act: Arab oil embargo to extend DST to 8 months; ended prematurely in October 1974.

1986 Extended start date from last Sunday of April to first Sunday of November.

2005 Energy Act of 2005: 2nd week of March.
 

Dr. Yuen is Assistant Professor, UCSF Department of Internal Medicine-Pulmonary Department, and Adjunct Clinical Assistant Professor at Department of Psychiatry & Behavioral Sciences at Stanford (Calif.) University. Dr. Rishi is Consultant – Pulmonary, Critical Care and Sleep Medicine, Mayo Clinic Health System, Eau Claire, WI; and Assistant Professor of Medicine, Alix School of Medicine, Mayo Clinic, Rochester, MN.

Correction 3/16/21: A photo caption in an earlier version of this article misstated Dr. Kin Yuen's name.






 

Although the United States has observed daylight saving time (DST) continuously, in some form, for the last 5 decades (Table), the twice a year switches have never been less popular. In 2019, an American Academy of Sleep Medicine (AASM) survey of more than 2,000 US adults found that 63% support the elimination of seasonal time changes in favor of a national, fixed, year-round time, and only 11% oppose it. Indeed, multiple states have pending legislations to adopt year-round daylight saving time or year-round standard time (Updated September 30, 2020, Congressional Research Service. https://crsreports.congress.gov. R45208 Daylight Saving Time. Accessed Dec 14, 2020). Adjacent states, to limit confusion to interstate travel and commerce, tend to lobby for similar changes together. Most importantly, because of the scientific evidence of detrimental health effects to the public and safety concerns, the American Academy of Sleep Medicine has issued a position statement for year-round standard time (Rishi MA, et al. Daylight saving time: an American Academy of Sleep Medicine position statement. J Clin Sleep Med. 2020;16(10):1781).

Railroad industry successfully lobbied the US government for consistent time in the United States to keep transportation schedules uniform in 1883; standard time was implemented. When war efforts were over, DST was dropped. Some regions, such as New York and Chicago, maintained DST, but no national standard was applied. Retailers and the recreational activity industry advocated for DST to increase business after work in the afternoon and evenings. In 1966, Congress passed the Uniform Time Act of 1966 to implement 6 months of DST and 6 months of standard time (Waxman OB. The real reason why daylight saving time is a thing. https://time.com/4549397/daylight-saving-time-history-politics/; November 1, 2017. Accessed Dec 14, 2020). Local jurisdictions can opt out of DST, but it requires an act of congress to enforce perennial DST.

When the OPEC embargo occurred, the Emergency Daylight Saving Time Energy Conservation Act was enacted in 1973, but it was quickly ended in October 1974 due to its unpopularity. The dairy industry was opposed to earlier rise time that disrupted the animals’ feeding schedules and their farm operations (Feldman R. Five myths about daylight saving time. https://www.washingtonpost.com/opinions/five-myths-about-daylight-saving-time/2015/03/06/970092d4-c2c1-11e4-9271-610273846239_story.html. Accessed Dec 14, 2020.). Public safety was raised as a concern as early as 1975. The Department of Transportation found increased fatalities of school-aged children in the mornings from January to April of 1974 as compared with 1973. However, the National Bureau of Standards, that performed a review subsequently, stated that other factors might also be at play. Further extension of DST from 6 months of the year to the subsequent 7, and then 8 months per year were enacted in 1986 and 2005, respectively (The reasoning behind changing daylight saving. https://www.npr.org/templates/story/story.php?storyId=7779869. NPR. Accessed Nov 1, 2020.)

An exemption of a state from DST is allowable under existing law, but to establish permanent DST will require an act of Congress. Since then, Arizona and Hawaii, as well as US territories, such as Puerto Rico, Guam, American Samoa and Northern Mariana Islands, and US Virgin Islands, have all opted out of DST by state exemption. Because of Hawaii’s proximity to the equator, the timing of sunrise and sunset were fairly constant throughout the year that made DST unnecessary. The Navajo Nation in Arizona, because of its extension into adjacent New Mexico and Utah, participates in DST. Most of the countries along the tropics, parts of Australia, China, Japan, South Korea, India, and majority of African countries do not observe DST. The European Union has voted to abolish twice yearly change in time in 2021; and individual member states will be able to decide whether they wish to remain on permanent standard time or DST. Since 2015, more than 45 states have proposed legislation to change their observance of DST.

The human biological rhythm is most consistent with standard time (Antle M. Circadian rhythm expert argues against permanent daylight saving time. https://www.ucalgary.ca/news/circadian-rhythm-expert-argues-against-permanent-daylight-saving-time. Accessed Dec 14, 2020.). Since the biological clock for most individuals is not exactly 24 hours long, zeitgebers such as sunlight, exercise, and feeding behaviors are important time cues to foster a regular rhythm. Acutely, the adjustment to 1 hour’s sleep loss at the spring switch from standard time to DST generally requires several days to adapt (Kalidindi A. Daylight saving time is bad for your health. https://massivesci.com/articles/daylight-saving-savings-time-dst-november-standard-time. Accessed Dec 14, 2020.). During this adjustment period, the internal bodily functions are disrupted. The sense of sleepiness and fatigue are increased with earlier morning awakenings, and the inability to fall asleep earlier leads to symptoms of insomnia and poor sleep quality.

Timeline for DST
 

1784 Benjamin Franklin advocated to rise earlier so as to burn fewer candles in the evenings.

1883 Railroads need standard time for operations.

1890 Merchants and retailers (clothing, cigars) advocated for longer shopping hours.

1916 Germany conserves energy.

1918 DST: fuel conservation during World War I.

1942 DST during World War II.

1963 “Chaos of clocks” needs uniform time for commerce.

1966 Uniform Time Act: DST 6 months per year.

1973 Emergency DST Energy Conservation Act: Arab oil embargo to extend DST to 8 months; ended prematurely in October 1974.

1986 Extended start date from last Sunday of April to first Sunday of November.

2005 Energy Act of 2005: 2nd week of March.
 

Dr. Yuen is Assistant Professor, UCSF Department of Internal Medicine-Pulmonary Department, and Adjunct Clinical Assistant Professor at Department of Psychiatry & Behavioral Sciences at Stanford (Calif.) University. Dr. Rishi is Consultant – Pulmonary, Critical Care and Sleep Medicine, Mayo Clinic Health System, Eau Claire, WI; and Assistant Professor of Medicine, Alix School of Medicine, Mayo Clinic, Rochester, MN.

Correction 3/16/21: A photo caption in an earlier version of this article misstated Dr. Kin Yuen's name.






 

Although the United States has observed daylight saving time (DST) continuously, in some form, for the last 5 decades (Table), the twice a year switches have never been less popular. In 2019, an American Academy of Sleep Medicine (AASM) survey of more than 2,000 US adults found that 63% support the elimination of seasonal time changes in favor of a national, fixed, year-round time, and only 11% oppose it. Indeed, multiple states have pending legislations to adopt year-round daylight saving time or year-round standard time (Updated September 30, 2020, Congressional Research Service. https://crsreports.congress.gov. R45208 Daylight Saving Time. Accessed Dec 14, 2020). Adjacent states, to limit confusion to interstate travel and commerce, tend to lobby for similar changes together. Most importantly, because of the scientific evidence of detrimental health effects to the public and safety concerns, the American Academy of Sleep Medicine has issued a position statement for year-round standard time (Rishi MA, et al. Daylight saving time: an American Academy of Sleep Medicine position statement. J Clin Sleep Med. 2020;16(10):1781).

Railroad industry successfully lobbied the US government for consistent time in the United States to keep transportation schedules uniform in 1883; standard time was implemented. When war efforts were over, DST was dropped. Some regions, such as New York and Chicago, maintained DST, but no national standard was applied. Retailers and the recreational activity industry advocated for DST to increase business after work in the afternoon and evenings. In 1966, Congress passed the Uniform Time Act of 1966 to implement 6 months of DST and 6 months of standard time (Waxman OB. The real reason why daylight saving time is a thing. https://time.com/4549397/daylight-saving-time-history-politics/; November 1, 2017. Accessed Dec 14, 2020). Local jurisdictions can opt out of DST, but it requires an act of congress to enforce perennial DST.

When the OPEC embargo occurred, the Emergency Daylight Saving Time Energy Conservation Act was enacted in 1973, but it was quickly ended in October 1974 due to its unpopularity. The dairy industry was opposed to earlier rise time that disrupted the animals’ feeding schedules and their farm operations (Feldman R. Five myths about daylight saving time. https://www.washingtonpost.com/opinions/five-myths-about-daylight-saving-time/2015/03/06/970092d4-c2c1-11e4-9271-610273846239_story.html. Accessed Dec 14, 2020.). Public safety was raised as a concern as early as 1975. The Department of Transportation found increased fatalities of school-aged children in the mornings from January to April of 1974 as compared with 1973. However, the National Bureau of Standards, that performed a review subsequently, stated that other factors might also be at play. Further extension of DST from 6 months of the year to the subsequent 7, and then 8 months per year were enacted in 1986 and 2005, respectively (The reasoning behind changing daylight saving. https://www.npr.org/templates/story/story.php?storyId=7779869. NPR. Accessed Nov 1, 2020.)

An exemption of a state from DST is allowable under existing law, but to establish permanent DST will require an act of Congress. Since then, Arizona and Hawaii, as well as US territories, such as Puerto Rico, Guam, American Samoa and Northern Mariana Islands, and US Virgin Islands, have all opted out of DST by state exemption. Because of Hawaii’s proximity to the equator, the timing of sunrise and sunset were fairly constant throughout the year that made DST unnecessary. The Navajo Nation in Arizona, because of its extension into adjacent New Mexico and Utah, participates in DST. Most of the countries along the tropics, parts of Australia, China, Japan, South Korea, India, and majority of African countries do not observe DST. The European Union has voted to abolish twice yearly change in time in 2021; and individual member states will be able to decide whether they wish to remain on permanent standard time or DST. Since 2015, more than 45 states have proposed legislation to change their observance of DST.

The human biological rhythm is most consistent with standard time (Antle M. Circadian rhythm expert argues against permanent daylight saving time. https://www.ucalgary.ca/news/circadian-rhythm-expert-argues-against-permanent-daylight-saving-time. Accessed Dec 14, 2020.). Since the biological clock for most individuals is not exactly 24 hours long, zeitgebers such as sunlight, exercise, and feeding behaviors are important time cues to foster a regular rhythm. Acutely, the adjustment to 1 hour’s sleep loss at the spring switch from standard time to DST generally requires several days to adapt (Kalidindi A. Daylight saving time is bad for your health. https://massivesci.com/articles/daylight-saving-savings-time-dst-november-standard-time. Accessed Dec 14, 2020.). During this adjustment period, the internal bodily functions are disrupted. The sense of sleepiness and fatigue are increased with earlier morning awakenings, and the inability to fall asleep earlier leads to symptoms of insomnia and poor sleep quality.

Timeline for DST
 

1784 Benjamin Franklin advocated to rise earlier so as to burn fewer candles in the evenings.

1883 Railroads need standard time for operations.

1890 Merchants and retailers (clothing, cigars) advocated for longer shopping hours.

1916 Germany conserves energy.

1918 DST: fuel conservation during World War I.

1942 DST during World War II.

1963 “Chaos of clocks” needs uniform time for commerce.

1966 Uniform Time Act: DST 6 months per year.

1973 Emergency DST Energy Conservation Act: Arab oil embargo to extend DST to 8 months; ended prematurely in October 1974.

1986 Extended start date from last Sunday of April to first Sunday of November.

2005 Energy Act of 2005: 2nd week of March.
 

Dr. Yuen is Assistant Professor, UCSF Department of Internal Medicine-Pulmonary Department, and Adjunct Clinical Assistant Professor at Department of Psychiatry & Behavioral Sciences at Stanford (Calif.) University. Dr. Rishi is Consultant – Pulmonary, Critical Care and Sleep Medicine, Mayo Clinic Health System, Eau Claire, WI; and Assistant Professor of Medicine, Alix School of Medicine, Mayo Clinic, Rochester, MN.

Correction 3/16/21: A photo caption in an earlier version of this article misstated Dr. Kin Yuen's name.






 

The American Medical Association (AMA) had its November 2020 AMA Special Meeting of the AMA House of Delegates (HOD) from November 13-17.

Delegates from over 170 societies (state societies, specialties, subspecialties, and uniformed services), including physicians, residents, and students, gathered virtually for the meeting(https://tinyurl.com/y7494mwa) to consider a wide array of proposals to help fulfill the AMA’s core mission of promoting medicine and improving public health. The AMA House of Delegates, also known as the “House” or the “HOD,” is the principal policy-making body of the AMA. This democratic forum represents the views and interests of a diverse group of member physicians from more than 170 societies. These delegates meet twice per year to establish policies on health; medical, professional, and governance matters; and the principles within which the AMA’s business activities are conducted.

During the COVID-19 pandemic, the AMA has been the leading physician and patient ally—voicing recommendations to key Congressional leaders and agency staff, state policymakers, and private sector stakeholders. Acting on both federal and state levels, examples of AMA’s recent efforts include actions in financial relief, telehealth, testing and vaccine development, health equity, and more.

CHEST is an active member, and through the HOD and Specialty and Service Society (SSS), CHEST can partner with AMA other societies to support each other on important regulatory issues. CHEST/Allergy Section Council (participants at this meeting were from the AAAAI, AAOA, AASM, ACAAI, ATS, CHEST, and SCCM) met before voting in the House to discuss pending business. The meeting was hosted by the current CHEST/Allergy council chair Dr. Wesley Vander Ark (AMA Delegate AAOA) and Jami Lucas, CEO AAOA.
 

Policy and resolutions

Overview of the process

Policies originate via resolutions submitted by individuals or societies. These resolutions then go to one of several Reference Committees for open discussion. These committees then report their recommendations back to the HOD, which then discusses and votes on the recommendations. In some instances, the question is referred for further studies by one of several Councils, which reports go to the Board of Trustees or back to the House. Details can be found in the April 2018 CHEST Physician® article on the process. (https://tinyurl.com/yacysxar).

This year, due to the virtual nature, prioritization matrix was utilized and based on urgency. Resolutions were divided into top priority, priority, medium priority, low priority, and not a priority.

The following reference committees convened at this Special Meeting Constitution & Bylaws, Medical Service, Legislation Medical Education, Public Health, Science and Technology, Finance and Medical Practice.

Some of the issues discussed at the House of Delegates are as follows:


 

Medical education

Continuing board certification (Adapted as a new policy)

The policy states that American Medical Association (AMA), through its Council on Medical Education, continue to work with the American Board of Medical Specialties (ABMS) and ABMS member boards to implement key recommendations outlined by the Continuing Board Certification: Vision for the Future Commission in its final report, including the development of new, integrated standards for continuing certification programs by 2020 that will address the Commission’s recommendations for flexibility in knowledge assessment and advancing practice, feedback to diplomates, and consistency.

Graduate medical education and the corporate practice of medicine (modified existing policy)

The existing policy was amended to urge AMA to continue to monitor issues, including waiver of due process requirements, created by corporate-owned graduate medical education sites.
 

Public health

Bullying in the Practice of Medicine

Health-care organizations, including academic medical centers, should establish policies to prevent and address bullying in their workplaces. An effective workplace policy should:

• Describe the management’s commitment to providing a safe and healthy workplace.

• Show the staff that their leaders are concerned about bullying and unprofessional behavior and that they take it seriously.

• Clearly define workplace violence, harassment, and bullying, specifically including intimidation, threats, and other forms of aggressive behavior.

• Specify to whom the policy applies (ie, medical staff, students, administration, patients, employees, contractors, vendors, etc).

• Define both expected and prohibited behaviors.

• Outline steps for individuals to take when they feel they are a victim of workplace bullying.

• Provide contact information for a confidential means for documenting and reporting incidents.

• Prohibit retaliation and ensure privacy and confidentiality.

• Document training requirements and establish clear expectations about the training objectives.



Availability of personal protective equipment (PPE)

That our American Medical Association actively support that physicians and health-care professionals are empowered to use workplace modifications to continue professional patient care when they determine such action to be appropriate and in the best interest of patient and physician wellbeing. Physicians and health-care professionals must be permitted to use their professional judgment and augment institution-provided PPE with additional, appropriately decontaminated, personally provided personal protective equipment (PPE) without penalty (Directive to Take Action); and be it further that AMA affirm that the medical staff of each healt-care institution should integrally be involved in disaster planning, strategy, and tactical management of ongoing crises (New HOD Policy).


 

AMA governance and finance

The establishment of private practice physicians’ section was approved.
 

Medical practice

Merit-based incentive payment system (MIPS)

That our American Medical Association (AMA) support legislation that ensures Medicare physician payment is sufficient to safeguard beneficiary access to care, replaces or supplements budget neutrality in MIPS with incentive payments, or implements positive annual physician payment updates. (Directive to Take Action).

Establishing professional services claims-based payment enhancement for activities associated with the COVID-19 pandemic

American Medical Association work with other interested parties to advocate for regulatory action on the part of the Centers for Medicare & Medicaid Services to implement a professional services claims-based payment enhancement to help recognize the enhanced, nonseparately reimbursable work performed by physicians during the COVID-19 Public Health Emergency. (Directive to Take Action).

This is just a small sampling of the activities and more information, including reports from the various Councils, are available on the AMA website, http://ama-assn.org.

CHEST members interested in the AMA policy-making process may observe any AMA-HOD meeting or participate in the AMA’s democratic processes. Attendees will also be able to increase their knowledge and skills at no cost. They will also be able to connect with more than 1,500 peers and other meeting attendees from across the country. CHEST members with the time (there are two 5-day meetings each year) and interest are invited to apply to be an official CHEST delegate to the AMA. Contact Jennifer Nemkovich at [email protected] for details.
 

Dr. Desai is with the Chicago Chest Center and AMITA Health Suburban Lung Associates; and the Division of Pulmonary, Critical Care, Sleep and Allergy, University of Illinois at Chicago. He is also the CHEST Delegate to the AMA House of Delegates.

The American Medical Association (AMA) had its November 2020 AMA Special Meeting of the AMA House of Delegates (HOD) from November 13-17.

Delegates from over 170 societies (state societies, specialties, subspecialties, and uniformed services), including physicians, residents, and students, gathered virtually for the meeting(https://tinyurl.com/y7494mwa) to consider a wide array of proposals to help fulfill the AMA’s core mission of promoting medicine and improving public health. The AMA House of Delegates, also known as the “House” or the “HOD,” is the principal policy-making body of the AMA. This democratic forum represents the views and interests of a diverse group of member physicians from more than 170 societies. These delegates meet twice per year to establish policies on health; medical, professional, and governance matters; and the principles within which the AMA’s business activities are conducted.

During the COVID-19 pandemic, the AMA has been the leading physician and patient ally—voicing recommendations to key Congressional leaders and agency staff, state policymakers, and private sector stakeholders. Acting on both federal and state levels, examples of AMA’s recent efforts include actions in financial relief, telehealth, testing and vaccine development, health equity, and more.

CHEST is an active member, and through the HOD and Specialty and Service Society (SSS), CHEST can partner with AMA other societies to support each other on important regulatory issues. CHEST/Allergy Section Council (participants at this meeting were from the AAAAI, AAOA, AASM, ACAAI, ATS, CHEST, and SCCM) met before voting in the House to discuss pending business. The meeting was hosted by the current CHEST/Allergy council chair Dr. Wesley Vander Ark (AMA Delegate AAOA) and Jami Lucas, CEO AAOA.
 

Policy and resolutions

Overview of the process

Policies originate via resolutions submitted by individuals or societies. These resolutions then go to one of several Reference Committees for open discussion. These committees then report their recommendations back to the HOD, which then discusses and votes on the recommendations. In some instances, the question is referred for further studies by one of several Councils, which reports go to the Board of Trustees or back to the House. Details can be found in the April 2018 CHEST Physician® article on the process. (https://tinyurl.com/yacysxar).

This year, due to the virtual nature, prioritization matrix was utilized and based on urgency. Resolutions were divided into top priority, priority, medium priority, low priority, and not a priority.

The following reference committees convened at this Special Meeting Constitution & Bylaws, Medical Service, Legislation Medical Education, Public Health, Science and Technology, Finance and Medical Practice.

Some of the issues discussed at the House of Delegates are as follows:


 

Medical education

Continuing board certification (Adapted as a new policy)

The policy states that American Medical Association (AMA), through its Council on Medical Education, continue to work with the American Board of Medical Specialties (ABMS) and ABMS member boards to implement key recommendations outlined by the Continuing Board Certification: Vision for the Future Commission in its final report, including the development of new, integrated standards for continuing certification programs by 2020 that will address the Commission’s recommendations for flexibility in knowledge assessment and advancing practice, feedback to diplomates, and consistency.

Graduate medical education and the corporate practice of medicine (modified existing policy)

The existing policy was amended to urge AMA to continue to monitor issues, including waiver of due process requirements, created by corporate-owned graduate medical education sites.
 

Public health

Bullying in the Practice of Medicine

Health-care organizations, including academic medical centers, should establish policies to prevent and address bullying in their workplaces. An effective workplace policy should:

• Describe the management’s commitment to providing a safe and healthy workplace.

• Show the staff that their leaders are concerned about bullying and unprofessional behavior and that they take it seriously.

• Clearly define workplace violence, harassment, and bullying, specifically including intimidation, threats, and other forms of aggressive behavior.

• Specify to whom the policy applies (ie, medical staff, students, administration, patients, employees, contractors, vendors, etc).

• Define both expected and prohibited behaviors.

• Outline steps for individuals to take when they feel they are a victim of workplace bullying.

• Provide contact information for a confidential means for documenting and reporting incidents.

• Prohibit retaliation and ensure privacy and confidentiality.

• Document training requirements and establish clear expectations about the training objectives.



Availability of personal protective equipment (PPE)

That our American Medical Association actively support that physicians and health-care professionals are empowered to use workplace modifications to continue professional patient care when they determine such action to be appropriate and in the best interest of patient and physician wellbeing. Physicians and health-care professionals must be permitted to use their professional judgment and augment institution-provided PPE with additional, appropriately decontaminated, personally provided personal protective equipment (PPE) without penalty (Directive to Take Action); and be it further that AMA affirm that the medical staff of each healt-care institution should integrally be involved in disaster planning, strategy, and tactical management of ongoing crises (New HOD Policy).


 

AMA governance and finance

The establishment of private practice physicians’ section was approved.
 

Medical practice

Merit-based incentive payment system (MIPS)

That our American Medical Association (AMA) support legislation that ensures Medicare physician payment is sufficient to safeguard beneficiary access to care, replaces or supplements budget neutrality in MIPS with incentive payments, or implements positive annual physician payment updates. (Directive to Take Action).

Establishing professional services claims-based payment enhancement for activities associated with the COVID-19 pandemic

American Medical Association work with other interested parties to advocate for regulatory action on the part of the Centers for Medicare & Medicaid Services to implement a professional services claims-based payment enhancement to help recognize the enhanced, nonseparately reimbursable work performed by physicians during the COVID-19 Public Health Emergency. (Directive to Take Action).

This is just a small sampling of the activities and more information, including reports from the various Councils, are available on the AMA website, http://ama-assn.org.

CHEST members interested in the AMA policy-making process may observe any AMA-HOD meeting or participate in the AMA’s democratic processes. Attendees will also be able to increase their knowledge and skills at no cost. They will also be able to connect with more than 1,500 peers and other meeting attendees from across the country. CHEST members with the time (there are two 5-day meetings each year) and interest are invited to apply to be an official CHEST delegate to the AMA. Contact Jennifer Nemkovich at [email protected] for details.
 

Dr. Desai is with the Chicago Chest Center and AMITA Health Suburban Lung Associates; and the Division of Pulmonary, Critical Care, Sleep and Allergy, University of Illinois at Chicago. He is also the CHEST Delegate to the AMA House of Delegates.

The American Medical Association (AMA) had its November 2020 AMA Special Meeting of the AMA House of Delegates (HOD) from November 13-17.

Delegates from over 170 societies (state societies, specialties, subspecialties, and uniformed services), including physicians, residents, and students, gathered virtually for the meeting(https://tinyurl.com/y7494mwa) to consider a wide array of proposals to help fulfill the AMA’s core mission of promoting medicine and improving public health. The AMA House of Delegates, also known as the “House” or the “HOD,” is the principal policy-making body of the AMA. This democratic forum represents the views and interests of a diverse group of member physicians from more than 170 societies. These delegates meet twice per year to establish policies on health; medical, professional, and governance matters; and the principles within which the AMA’s business activities are conducted.

During the COVID-19 pandemic, the AMA has been the leading physician and patient ally—voicing recommendations to key Congressional leaders and agency staff, state policymakers, and private sector stakeholders. Acting on both federal and state levels, examples of AMA’s recent efforts include actions in financial relief, telehealth, testing and vaccine development, health equity, and more.

CHEST is an active member, and through the HOD and Specialty and Service Society (SSS), CHEST can partner with AMA other societies to support each other on important regulatory issues. CHEST/Allergy Section Council (participants at this meeting were from the AAAAI, AAOA, AASM, ACAAI, ATS, CHEST, and SCCM) met before voting in the House to discuss pending business. The meeting was hosted by the current CHEST/Allergy council chair Dr. Wesley Vander Ark (AMA Delegate AAOA) and Jami Lucas, CEO AAOA.
 

Policy and resolutions

Overview of the process

Policies originate via resolutions submitted by individuals or societies. These resolutions then go to one of several Reference Committees for open discussion. These committees then report their recommendations back to the HOD, which then discusses and votes on the recommendations. In some instances, the question is referred for further studies by one of several Councils, which reports go to the Board of Trustees or back to the House. Details can be found in the April 2018 CHEST Physician® article on the process. (https://tinyurl.com/yacysxar).

This year, due to the virtual nature, prioritization matrix was utilized and based on urgency. Resolutions were divided into top priority, priority, medium priority, low priority, and not a priority.

The following reference committees convened at this Special Meeting Constitution & Bylaws, Medical Service, Legislation Medical Education, Public Health, Science and Technology, Finance and Medical Practice.

Some of the issues discussed at the House of Delegates are as follows:


 

Medical education

Continuing board certification (Adapted as a new policy)

The policy states that American Medical Association (AMA), through its Council on Medical Education, continue to work with the American Board of Medical Specialties (ABMS) and ABMS member boards to implement key recommendations outlined by the Continuing Board Certification: Vision for the Future Commission in its final report, including the development of new, integrated standards for continuing certification programs by 2020 that will address the Commission’s recommendations for flexibility in knowledge assessment and advancing practice, feedback to diplomates, and consistency.

Graduate medical education and the corporate practice of medicine (modified existing policy)

The existing policy was amended to urge AMA to continue to monitor issues, including waiver of due process requirements, created by corporate-owned graduate medical education sites.
 

Public health

Bullying in the Practice of Medicine

Health-care organizations, including academic medical centers, should establish policies to prevent and address bullying in their workplaces. An effective workplace policy should:

• Describe the management’s commitment to providing a safe and healthy workplace.

• Show the staff that their leaders are concerned about bullying and unprofessional behavior and that they take it seriously.

• Clearly define workplace violence, harassment, and bullying, specifically including intimidation, threats, and other forms of aggressive behavior.

• Specify to whom the policy applies (ie, medical staff, students, administration, patients, employees, contractors, vendors, etc).

• Define both expected and prohibited behaviors.

• Outline steps for individuals to take when they feel they are a victim of workplace bullying.

• Provide contact information for a confidential means for documenting and reporting incidents.

• Prohibit retaliation and ensure privacy and confidentiality.

• Document training requirements and establish clear expectations about the training objectives.



Availability of personal protective equipment (PPE)

That our American Medical Association actively support that physicians and health-care professionals are empowered to use workplace modifications to continue professional patient care when they determine such action to be appropriate and in the best interest of patient and physician wellbeing. Physicians and health-care professionals must be permitted to use their professional judgment and augment institution-provided PPE with additional, appropriately decontaminated, personally provided personal protective equipment (PPE) without penalty (Directive to Take Action); and be it further that AMA affirm that the medical staff of each healt-care institution should integrally be involved in disaster planning, strategy, and tactical management of ongoing crises (New HOD Policy).


 

AMA governance and finance

The establishment of private practice physicians’ section was approved.
 

Medical practice

Merit-based incentive payment system (MIPS)

That our American Medical Association (AMA) support legislation that ensures Medicare physician payment is sufficient to safeguard beneficiary access to care, replaces or supplements budget neutrality in MIPS with incentive payments, or implements positive annual physician payment updates. (Directive to Take Action).

Establishing professional services claims-based payment enhancement for activities associated with the COVID-19 pandemic

American Medical Association work with other interested parties to advocate for regulatory action on the part of the Centers for Medicare & Medicaid Services to implement a professional services claims-based payment enhancement to help recognize the enhanced, nonseparately reimbursable work performed by physicians during the COVID-19 Public Health Emergency. (Directive to Take Action).

This is just a small sampling of the activities and more information, including reports from the various Councils, are available on the AMA website, http://ama-assn.org.

CHEST members interested in the AMA policy-making process may observe any AMA-HOD meeting or participate in the AMA’s democratic processes. Attendees will also be able to increase their knowledge and skills at no cost. They will also be able to connect with more than 1,500 peers and other meeting attendees from across the country. CHEST members with the time (there are two 5-day meetings each year) and interest are invited to apply to be an official CHEST delegate to the AMA. Contact Jennifer Nemkovich at [email protected] for details.
 

Dr. Desai is with the Chicago Chest Center and AMITA Health Suburban Lung Associates; and the Division of Pulmonary, Critical Care, Sleep and Allergy, University of Illinois at Chicago. He is also the CHEST Delegate to the AMA House of Delegates.