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Cardiologists weigh in on ethically challenging issues
Would you tell a patient about a potentially harmful medical mistake? Would you upcode or overstate a patient’s condition so an insurer will cover it? What about reporting a colleague who seems impaired or engages in sexual harassment or bullying?
In a new survey, this news organization asked more than 4,100 U.S. physicians how they would react to these and other ethically challenging scenarios.
For example, a full 80% of cardiologists responding to the survey said they would reveal a potentially harmful medical mistake to their patient.
This aligns with decades of advice from major medical societies such as the American Medical Association and the American College of Physicians, which endorse disclosing to patients and families any error that could jeopardize the patient’s health.
“Disclosure of close calls should also be made. From a health law context, being upfront with the patient is standard practice,” said Eric Mathison, PhD, a clinical ethicist at University of Toronto.
When it comes to upcoding or overstating a patient’s condition so an insurer will cover it, more than three quarters of cardiologists (78%) viewed this as unacceptable, while 9% felt it was okay and 13% said “it depends.”
Many doctors are willing to stretch coding policies to the limit to support patients and their finances, said Arthur L. Caplan, PhD, NYU professor of bioethics and Medscape blogger. “That’s acceptable advocacy. But most doctors will not say they are willing to commit fraud.”
Okay to breach patient confidentiality?
More than half of cardiologists felt it was okay to breach patient confidentiality when someone’s health could be threatened, 14% felt the opposite, and 29% said it depends.
“I teach that if you know someone faces a direct risk from catching a deadly disease, and you know who that person is, then you have a duty to warn,” Dr. Caplan said. “The disease has to be serious for [breaching confidentiality] to be morally defensible, and your disclosure has to be actionable. Telling your mother won’t achieve a lot” in protecting someone’s health.
In a 2020 ethics survey by this news organization, 72% of cardiologists felt that they could accept a meal or speaking gig from a drug company without its creating any issue for them.
Three years later, only 66% of cardiologists said they could accept a meal or speaking engagement without its influencing their prescribing habits; 21% said they couldn’t and 13% said it depends.
Dr. Caplan thinks that many doctors are deceiving themselves. “We know from business school case studies that even little gifts like calendars and flashlights work. Humans get a sense of debt when they receive gifts. Physicians are no exception. If you get a meal or an invitation to do a talk for a small fee, you may still say, ‘This is nothing to me,’ ” but subconscious favoritism can result, he cautioned.
Support for physician-assisted dying?
Ten states and the District of Columbia now allow physicians to help a terminally ill patient with dying. Fifty percent of cardiologists surveyed support it, 36% are against it, and 14% said it depends. These percentages are roughly the same as in 2020.
Dr. Mathison said the public and physicians are “getting more comfortable with physician-assisted dying. Physicians are seeing it used in practice and hearing from other physicians who are participating.”
However, only 31% of cardiologists felt physician-assisted dying should be allowed for patients in intractable pain; 42% said it should not be legal in this case, and 26% said it depends.
As opposed to physician-assisted dying for terminally ill patients, no U.S. state recognizes the legal right to help end the life of a patient in unending pain. However, Belgium, the Netherlands, and Luxembourg do under certain conditions.
Going public about issues with a cardiologist’s hospital or health care organization became a major issue during the COVID-19 pandemic as some medical professionals struggled to get enough personal protective equipment and made it known.
More than half of cardiologists surveyed (53%) endorsed speaking out if employers don’t provide needed resources; 9% didn’t feel this was appropriate, and 28% said it depends.
Dr. Caplan noted that prominent cases of hospitals firing nurses and doctors who complained over social media may influence cardiologists’ willingness. He also thinks some doctors would ask, “Speak out to whom?” Many cardiologists will aggressively push for resources through the internal chain of command “but don’t think talking to the media is ethical or appropriate.”
The vast majority of cardiologists and physicians overall said they have never failed to report or investigate suspected domestic abuse of a patient.
Both male and female physicians strongly support reporting of abuse cases, said Thomas May, PhD, a bioethicist at Washington State University, Spokane.
This reflects the “tremendous strides society has made in recognizing the impact of abuse and the need for required-reporting policies, because victims are often, if not usually, reticent to come forward. Required reporting is necessary and in the patient’s interests,” Dr. May said.
Romancing a patient?
More than half (58%) of cardiologists felt that having a romantic relationship with a current patient is not okay; 3% were okay with it, and 30% felt it would be okay at least 6 months after the patient-doctor relationship ended.
Dr. May said a romantic relationship is “inappropriate while the professional relationship is active and even for some time afterward. There’s a professional dynamic that needs to be maintained, a sense of objectivity.
“Plus, the physician is in a power relationship to the patient where there’s a sense of gratefulness or vulnerability that makes the patient unable to say no to a personal relationship,” Dr. May said.
Dr. May is not sure 6 months after they stop being your patient is long enough. “I’d think something like 2 years as a minimum. If I were your oncologist and helped save your life, it may never be appropriate,” Dr. May said.
In other ethical questions, one-quarter of cardiologists would report a doctor who seems impaired by drugs, alcohol, or illness, and 62% would do so only after speaking to him/her first.
“Our obligation is to do no harm to patients, and the professional standards and integrity of the profession are at stake,” one survey respondent said.
Another said, “A colleague who recognizes the problem and after private discussion enters a treatment program is often better served than by the often excessively harsh management by the state medical board.”
But when it comes to random alcohol and drug tests for cardiologists, 51% are not in favor, 31% are in favor, and 18% said it depends.
Dr. Caplan thinks that physicians face enough responsibility to patients to warrant such testing randomly but infrequently. “Doctors may feel like they’re being treated unprofessionally, like drug addicts, or question the accuracy of testing,” he noted. But he tilts instead toward “the moral fight to protect patient safety and trying to drive down malpractice costs.”
When it comes to reporting a colleague for sexual harassment or bullying, 71% of cardiologists said yes, they would report such behavior; only 7% would not, while 22% said it depends.
“If we ignore bad behavior such as this by our colleagues, then we are hurting our profession,” one physician said.
A version of this article originally appeared on Medscape.com.
Would you tell a patient about a potentially harmful medical mistake? Would you upcode or overstate a patient’s condition so an insurer will cover it? What about reporting a colleague who seems impaired or engages in sexual harassment or bullying?
In a new survey, this news organization asked more than 4,100 U.S. physicians how they would react to these and other ethically challenging scenarios.
For example, a full 80% of cardiologists responding to the survey said they would reveal a potentially harmful medical mistake to their patient.
This aligns with decades of advice from major medical societies such as the American Medical Association and the American College of Physicians, which endorse disclosing to patients and families any error that could jeopardize the patient’s health.
“Disclosure of close calls should also be made. From a health law context, being upfront with the patient is standard practice,” said Eric Mathison, PhD, a clinical ethicist at University of Toronto.
When it comes to upcoding or overstating a patient’s condition so an insurer will cover it, more than three quarters of cardiologists (78%) viewed this as unacceptable, while 9% felt it was okay and 13% said “it depends.”
Many doctors are willing to stretch coding policies to the limit to support patients and their finances, said Arthur L. Caplan, PhD, NYU professor of bioethics and Medscape blogger. “That’s acceptable advocacy. But most doctors will not say they are willing to commit fraud.”
Okay to breach patient confidentiality?
More than half of cardiologists felt it was okay to breach patient confidentiality when someone’s health could be threatened, 14% felt the opposite, and 29% said it depends.
“I teach that if you know someone faces a direct risk from catching a deadly disease, and you know who that person is, then you have a duty to warn,” Dr. Caplan said. “The disease has to be serious for [breaching confidentiality] to be morally defensible, and your disclosure has to be actionable. Telling your mother won’t achieve a lot” in protecting someone’s health.
In a 2020 ethics survey by this news organization, 72% of cardiologists felt that they could accept a meal or speaking gig from a drug company without its creating any issue for them.
Three years later, only 66% of cardiologists said they could accept a meal or speaking engagement without its influencing their prescribing habits; 21% said they couldn’t and 13% said it depends.
Dr. Caplan thinks that many doctors are deceiving themselves. “We know from business school case studies that even little gifts like calendars and flashlights work. Humans get a sense of debt when they receive gifts. Physicians are no exception. If you get a meal or an invitation to do a talk for a small fee, you may still say, ‘This is nothing to me,’ ” but subconscious favoritism can result, he cautioned.
Support for physician-assisted dying?
Ten states and the District of Columbia now allow physicians to help a terminally ill patient with dying. Fifty percent of cardiologists surveyed support it, 36% are against it, and 14% said it depends. These percentages are roughly the same as in 2020.
Dr. Mathison said the public and physicians are “getting more comfortable with physician-assisted dying. Physicians are seeing it used in practice and hearing from other physicians who are participating.”
However, only 31% of cardiologists felt physician-assisted dying should be allowed for patients in intractable pain; 42% said it should not be legal in this case, and 26% said it depends.
As opposed to physician-assisted dying for terminally ill patients, no U.S. state recognizes the legal right to help end the life of a patient in unending pain. However, Belgium, the Netherlands, and Luxembourg do under certain conditions.
Going public about issues with a cardiologist’s hospital or health care organization became a major issue during the COVID-19 pandemic as some medical professionals struggled to get enough personal protective equipment and made it known.
More than half of cardiologists surveyed (53%) endorsed speaking out if employers don’t provide needed resources; 9% didn’t feel this was appropriate, and 28% said it depends.
Dr. Caplan noted that prominent cases of hospitals firing nurses and doctors who complained over social media may influence cardiologists’ willingness. He also thinks some doctors would ask, “Speak out to whom?” Many cardiologists will aggressively push for resources through the internal chain of command “but don’t think talking to the media is ethical or appropriate.”
The vast majority of cardiologists and physicians overall said they have never failed to report or investigate suspected domestic abuse of a patient.
Both male and female physicians strongly support reporting of abuse cases, said Thomas May, PhD, a bioethicist at Washington State University, Spokane.
This reflects the “tremendous strides society has made in recognizing the impact of abuse and the need for required-reporting policies, because victims are often, if not usually, reticent to come forward. Required reporting is necessary and in the patient’s interests,” Dr. May said.
Romancing a patient?
More than half (58%) of cardiologists felt that having a romantic relationship with a current patient is not okay; 3% were okay with it, and 30% felt it would be okay at least 6 months after the patient-doctor relationship ended.
Dr. May said a romantic relationship is “inappropriate while the professional relationship is active and even for some time afterward. There’s a professional dynamic that needs to be maintained, a sense of objectivity.
“Plus, the physician is in a power relationship to the patient where there’s a sense of gratefulness or vulnerability that makes the patient unable to say no to a personal relationship,” Dr. May said.
Dr. May is not sure 6 months after they stop being your patient is long enough. “I’d think something like 2 years as a minimum. If I were your oncologist and helped save your life, it may never be appropriate,” Dr. May said.
In other ethical questions, one-quarter of cardiologists would report a doctor who seems impaired by drugs, alcohol, or illness, and 62% would do so only after speaking to him/her first.
“Our obligation is to do no harm to patients, and the professional standards and integrity of the profession are at stake,” one survey respondent said.
Another said, “A colleague who recognizes the problem and after private discussion enters a treatment program is often better served than by the often excessively harsh management by the state medical board.”
But when it comes to random alcohol and drug tests for cardiologists, 51% are not in favor, 31% are in favor, and 18% said it depends.
Dr. Caplan thinks that physicians face enough responsibility to patients to warrant such testing randomly but infrequently. “Doctors may feel like they’re being treated unprofessionally, like drug addicts, or question the accuracy of testing,” he noted. But he tilts instead toward “the moral fight to protect patient safety and trying to drive down malpractice costs.”
When it comes to reporting a colleague for sexual harassment or bullying, 71% of cardiologists said yes, they would report such behavior; only 7% would not, while 22% said it depends.
“If we ignore bad behavior such as this by our colleagues, then we are hurting our profession,” one physician said.
A version of this article originally appeared on Medscape.com.
Would you tell a patient about a potentially harmful medical mistake? Would you upcode or overstate a patient’s condition so an insurer will cover it? What about reporting a colleague who seems impaired or engages in sexual harassment or bullying?
In a new survey, this news organization asked more than 4,100 U.S. physicians how they would react to these and other ethically challenging scenarios.
For example, a full 80% of cardiologists responding to the survey said they would reveal a potentially harmful medical mistake to their patient.
This aligns with decades of advice from major medical societies such as the American Medical Association and the American College of Physicians, which endorse disclosing to patients and families any error that could jeopardize the patient’s health.
“Disclosure of close calls should also be made. From a health law context, being upfront with the patient is standard practice,” said Eric Mathison, PhD, a clinical ethicist at University of Toronto.
When it comes to upcoding or overstating a patient’s condition so an insurer will cover it, more than three quarters of cardiologists (78%) viewed this as unacceptable, while 9% felt it was okay and 13% said “it depends.”
Many doctors are willing to stretch coding policies to the limit to support patients and their finances, said Arthur L. Caplan, PhD, NYU professor of bioethics and Medscape blogger. “That’s acceptable advocacy. But most doctors will not say they are willing to commit fraud.”
Okay to breach patient confidentiality?
More than half of cardiologists felt it was okay to breach patient confidentiality when someone’s health could be threatened, 14% felt the opposite, and 29% said it depends.
“I teach that if you know someone faces a direct risk from catching a deadly disease, and you know who that person is, then you have a duty to warn,” Dr. Caplan said. “The disease has to be serious for [breaching confidentiality] to be morally defensible, and your disclosure has to be actionable. Telling your mother won’t achieve a lot” in protecting someone’s health.
In a 2020 ethics survey by this news organization, 72% of cardiologists felt that they could accept a meal or speaking gig from a drug company without its creating any issue for them.
Three years later, only 66% of cardiologists said they could accept a meal or speaking engagement without its influencing their prescribing habits; 21% said they couldn’t and 13% said it depends.
Dr. Caplan thinks that many doctors are deceiving themselves. “We know from business school case studies that even little gifts like calendars and flashlights work. Humans get a sense of debt when they receive gifts. Physicians are no exception. If you get a meal or an invitation to do a talk for a small fee, you may still say, ‘This is nothing to me,’ ” but subconscious favoritism can result, he cautioned.
Support for physician-assisted dying?
Ten states and the District of Columbia now allow physicians to help a terminally ill patient with dying. Fifty percent of cardiologists surveyed support it, 36% are against it, and 14% said it depends. These percentages are roughly the same as in 2020.
Dr. Mathison said the public and physicians are “getting more comfortable with physician-assisted dying. Physicians are seeing it used in practice and hearing from other physicians who are participating.”
However, only 31% of cardiologists felt physician-assisted dying should be allowed for patients in intractable pain; 42% said it should not be legal in this case, and 26% said it depends.
As opposed to physician-assisted dying for terminally ill patients, no U.S. state recognizes the legal right to help end the life of a patient in unending pain. However, Belgium, the Netherlands, and Luxembourg do under certain conditions.
Going public about issues with a cardiologist’s hospital or health care organization became a major issue during the COVID-19 pandemic as some medical professionals struggled to get enough personal protective equipment and made it known.
More than half of cardiologists surveyed (53%) endorsed speaking out if employers don’t provide needed resources; 9% didn’t feel this was appropriate, and 28% said it depends.
Dr. Caplan noted that prominent cases of hospitals firing nurses and doctors who complained over social media may influence cardiologists’ willingness. He also thinks some doctors would ask, “Speak out to whom?” Many cardiologists will aggressively push for resources through the internal chain of command “but don’t think talking to the media is ethical or appropriate.”
The vast majority of cardiologists and physicians overall said they have never failed to report or investigate suspected domestic abuse of a patient.
Both male and female physicians strongly support reporting of abuse cases, said Thomas May, PhD, a bioethicist at Washington State University, Spokane.
This reflects the “tremendous strides society has made in recognizing the impact of abuse and the need for required-reporting policies, because victims are often, if not usually, reticent to come forward. Required reporting is necessary and in the patient’s interests,” Dr. May said.
Romancing a patient?
More than half (58%) of cardiologists felt that having a romantic relationship with a current patient is not okay; 3% were okay with it, and 30% felt it would be okay at least 6 months after the patient-doctor relationship ended.
Dr. May said a romantic relationship is “inappropriate while the professional relationship is active and even for some time afterward. There’s a professional dynamic that needs to be maintained, a sense of objectivity.
“Plus, the physician is in a power relationship to the patient where there’s a sense of gratefulness or vulnerability that makes the patient unable to say no to a personal relationship,” Dr. May said.
Dr. May is not sure 6 months after they stop being your patient is long enough. “I’d think something like 2 years as a minimum. If I were your oncologist and helped save your life, it may never be appropriate,” Dr. May said.
In other ethical questions, one-quarter of cardiologists would report a doctor who seems impaired by drugs, alcohol, or illness, and 62% would do so only after speaking to him/her first.
“Our obligation is to do no harm to patients, and the professional standards and integrity of the profession are at stake,” one survey respondent said.
Another said, “A colleague who recognizes the problem and after private discussion enters a treatment program is often better served than by the often excessively harsh management by the state medical board.”
But when it comes to random alcohol and drug tests for cardiologists, 51% are not in favor, 31% are in favor, and 18% said it depends.
Dr. Caplan thinks that physicians face enough responsibility to patients to warrant such testing randomly but infrequently. “Doctors may feel like they’re being treated unprofessionally, like drug addicts, or question the accuracy of testing,” he noted. But he tilts instead toward “the moral fight to protect patient safety and trying to drive down malpractice costs.”
When it comes to reporting a colleague for sexual harassment or bullying, 71% of cardiologists said yes, they would report such behavior; only 7% would not, while 22% said it depends.
“If we ignore bad behavior such as this by our colleagues, then we are hurting our profession,” one physician said.
A version of this article originally appeared on Medscape.com.
Cold snare polypectomy tops hot snare for small polyps
In the Taiwan Cold Polypectomy Study, CSP was not only safer than HSP, with a significantly lower risk for delayed bleeding, it was also more efficient, report Li-Chun Chang, MD, PhD, from the National Taiwan University Hospital, Taipei, and colleagues.
The study was published online in Annals of Internal Medicine.
This large study “strengthens the already significant evidence that CSP is as effective and safer than HSP for polyps 4-10 mm in size,” Rajesh N. Keswani, MD, Northwestern University, Chicago, told this news organization.
“This study evaluated all significant endpoints – safety (decreased bleeding risk with CSP), effectiveness (equivalent complete resection rates between CSP and HSP), and efficiency (CSP faster than HSP),” said Dr. Keswani, who wasn’t involved in the study.
Previous randomized controlled trials have shown that CSP is as effective as HSP but more efficient in removing small polyps. The reduction in delayed bleeding associated with CSP had been shown only in high-risk patients using antiplatelet agents or anticoagulants, however. Less was known about CSP’s effect on delayed bleeding in the general population.
To investigate, Dr. Chang and colleagues randomly assigned 4,270 adults aged 40 and older who were undergoing polypectomy to remove polyps measuring 4-10 mm to CSP or HSP.
Compared with HSP, CSP was associated with a significantly lower risk for all delayed bleeding (within 14 days after polypectomy) and severe delayed bleeding (defined as a decrease in hemoglobin of 20 g/L or more, requiring transfusion or hemostasis).
Eight of 2,137 patients (0.4%) in the CSP group had delayed bleeding versus 31 of 2,133 patients (1.5%) in the HSP group. Severe bleeding occurred in one patient who had CSP (0.05%) and eight who had HSP (0.4%).
The CSP group also had fewer emergency service visits than the HSP group – 4 visits (0.2%) versus 13 visits (0.6%).
CSP was more efficient, with mean polypectomy time reduced 26.9%, compared with HSP, with no difference between groups in successful tissue retrieval, en bloc resection, and complete histologic resection.
“CSP saves time setting up electrosurgical generators or conducting submucosal injection. Moreover, the lower rate of delayed bleeding means fewer emergency service visits or hospital stays, saving medical expenses,” Dr. Chang and colleagues write in their article.
“Given the benefit in safety and cost-effectiveness, CSP may replace HSP for removal of small polyps in the general population,” they add.
Dr. Keswani agreed. “Based on the accumulated evidence over the past decade, CSP is the clear standard of care for polyps 4-10 mm in size,” he said in an interview.
“For polyps less than 4 mm, it remains reasonable to use either large capacity/jumbo forceps or CSP. Cautery should be reserved only for polyps greater than 10 mm, although there is ongoing work regarding cold versus hot EMR [endoscopic mucosal resection],” Dr. Keswani said.
The trial was principal investigator–initiated and partially funded by Boston Scientific, which had no role in the study design, data collection or analysis, data interpretation, manuscript preparation, or decision to submit the manuscript for publication. Dr. Keswani is a consultant for Boston Scientific and Neptune Medical and receives research support from Virgo.
A version of this article first appeared on Medscape.com.
In the Taiwan Cold Polypectomy Study, CSP was not only safer than HSP, with a significantly lower risk for delayed bleeding, it was also more efficient, report Li-Chun Chang, MD, PhD, from the National Taiwan University Hospital, Taipei, and colleagues.
The study was published online in Annals of Internal Medicine.
This large study “strengthens the already significant evidence that CSP is as effective and safer than HSP for polyps 4-10 mm in size,” Rajesh N. Keswani, MD, Northwestern University, Chicago, told this news organization.
“This study evaluated all significant endpoints – safety (decreased bleeding risk with CSP), effectiveness (equivalent complete resection rates between CSP and HSP), and efficiency (CSP faster than HSP),” said Dr. Keswani, who wasn’t involved in the study.
Previous randomized controlled trials have shown that CSP is as effective as HSP but more efficient in removing small polyps. The reduction in delayed bleeding associated with CSP had been shown only in high-risk patients using antiplatelet agents or anticoagulants, however. Less was known about CSP’s effect on delayed bleeding in the general population.
To investigate, Dr. Chang and colleagues randomly assigned 4,270 adults aged 40 and older who were undergoing polypectomy to remove polyps measuring 4-10 mm to CSP or HSP.
Compared with HSP, CSP was associated with a significantly lower risk for all delayed bleeding (within 14 days after polypectomy) and severe delayed bleeding (defined as a decrease in hemoglobin of 20 g/L or more, requiring transfusion or hemostasis).
Eight of 2,137 patients (0.4%) in the CSP group had delayed bleeding versus 31 of 2,133 patients (1.5%) in the HSP group. Severe bleeding occurred in one patient who had CSP (0.05%) and eight who had HSP (0.4%).
The CSP group also had fewer emergency service visits than the HSP group – 4 visits (0.2%) versus 13 visits (0.6%).
CSP was more efficient, with mean polypectomy time reduced 26.9%, compared with HSP, with no difference between groups in successful tissue retrieval, en bloc resection, and complete histologic resection.
“CSP saves time setting up electrosurgical generators or conducting submucosal injection. Moreover, the lower rate of delayed bleeding means fewer emergency service visits or hospital stays, saving medical expenses,” Dr. Chang and colleagues write in their article.
“Given the benefit in safety and cost-effectiveness, CSP may replace HSP for removal of small polyps in the general population,” they add.
Dr. Keswani agreed. “Based on the accumulated evidence over the past decade, CSP is the clear standard of care for polyps 4-10 mm in size,” he said in an interview.
“For polyps less than 4 mm, it remains reasonable to use either large capacity/jumbo forceps or CSP. Cautery should be reserved only for polyps greater than 10 mm, although there is ongoing work regarding cold versus hot EMR [endoscopic mucosal resection],” Dr. Keswani said.
The trial was principal investigator–initiated and partially funded by Boston Scientific, which had no role in the study design, data collection or analysis, data interpretation, manuscript preparation, or decision to submit the manuscript for publication. Dr. Keswani is a consultant for Boston Scientific and Neptune Medical and receives research support from Virgo.
A version of this article first appeared on Medscape.com.
In the Taiwan Cold Polypectomy Study, CSP was not only safer than HSP, with a significantly lower risk for delayed bleeding, it was also more efficient, report Li-Chun Chang, MD, PhD, from the National Taiwan University Hospital, Taipei, and colleagues.
The study was published online in Annals of Internal Medicine.
This large study “strengthens the already significant evidence that CSP is as effective and safer than HSP for polyps 4-10 mm in size,” Rajesh N. Keswani, MD, Northwestern University, Chicago, told this news organization.
“This study evaluated all significant endpoints – safety (decreased bleeding risk with CSP), effectiveness (equivalent complete resection rates between CSP and HSP), and efficiency (CSP faster than HSP),” said Dr. Keswani, who wasn’t involved in the study.
Previous randomized controlled trials have shown that CSP is as effective as HSP but more efficient in removing small polyps. The reduction in delayed bleeding associated with CSP had been shown only in high-risk patients using antiplatelet agents or anticoagulants, however. Less was known about CSP’s effect on delayed bleeding in the general population.
To investigate, Dr. Chang and colleagues randomly assigned 4,270 adults aged 40 and older who were undergoing polypectomy to remove polyps measuring 4-10 mm to CSP or HSP.
Compared with HSP, CSP was associated with a significantly lower risk for all delayed bleeding (within 14 days after polypectomy) and severe delayed bleeding (defined as a decrease in hemoglobin of 20 g/L or more, requiring transfusion or hemostasis).
Eight of 2,137 patients (0.4%) in the CSP group had delayed bleeding versus 31 of 2,133 patients (1.5%) in the HSP group. Severe bleeding occurred in one patient who had CSP (0.05%) and eight who had HSP (0.4%).
The CSP group also had fewer emergency service visits than the HSP group – 4 visits (0.2%) versus 13 visits (0.6%).
CSP was more efficient, with mean polypectomy time reduced 26.9%, compared with HSP, with no difference between groups in successful tissue retrieval, en bloc resection, and complete histologic resection.
“CSP saves time setting up electrosurgical generators or conducting submucosal injection. Moreover, the lower rate of delayed bleeding means fewer emergency service visits or hospital stays, saving medical expenses,” Dr. Chang and colleagues write in their article.
“Given the benefit in safety and cost-effectiveness, CSP may replace HSP for removal of small polyps in the general population,” they add.
Dr. Keswani agreed. “Based on the accumulated evidence over the past decade, CSP is the clear standard of care for polyps 4-10 mm in size,” he said in an interview.
“For polyps less than 4 mm, it remains reasonable to use either large capacity/jumbo forceps or CSP. Cautery should be reserved only for polyps greater than 10 mm, although there is ongoing work regarding cold versus hot EMR [endoscopic mucosal resection],” Dr. Keswani said.
The trial was principal investigator–initiated and partially funded by Boston Scientific, which had no role in the study design, data collection or analysis, data interpretation, manuscript preparation, or decision to submit the manuscript for publication. Dr. Keswani is a consultant for Boston Scientific and Neptune Medical and receives research support from Virgo.
A version of this article first appeared on Medscape.com.
FROM ANNALS OF INTERNAL MEDICINE
‘Quick, affordable’ test helps predict CGRP response for migraine
new research suggests.
The ictal phase refers to “sensitization occurring during a time when central trigeminovascular neurons receive massive nociceptive input from active meningeal nociceptors,” whereas the nonictal phase refers to “sensitization occurring during a time when central trigeminovascular neurons receive no or subliminal nociceptive input from meningeal nociceptors,” investigators noted.
In an observational, open-label cohort study, pretreatment nonictal cephalic allodynia identified galcanezumab responders with nearly 80% accuracy, and it identified nonresponders with nearly 85% accuracy.
“Detection of nonictal allodynia with a simplified paradigm of Quantitative Sensory Testing (QST) may provide a quick, affordable, noninvasive, and patient-friendly way to prospectively distinguish between responders and nonresponders to the prophylactic treatment of chronic and high-frequency episodic migraine with drugs that reduce CGRP signaling,” Sait Ashina, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, and colleagues wrote.
The findings were published online in Cephalalgia.
Immediate clinical relevance
Investigator Rami Burstein, PhD, also with Beth Israel Deaconess Medical Center and Harvard Medical School, developed the concept of predicting response to anti-CGRP treatment by testing for the presence or absence of nonictal cephalic allodynia in collaboration with the company CGRP Diagnostics.
In 43 anti–CGRP-naive patients with migraine, the researchers used a simplified QST algorithm to determine the presence/absence of cephalic or extracephalic allodynia during the nonictal phase of migraine – defined as the period from less than 12 hours after a migraine attack to less than 12 hours before the next attack.
Patients were considered to have allodynia if heat pain thresholds were between 32° C and 40° C, if cold pain thresholds were between 32° C and 20° C, or if the mechanical pain was threshold was less than 60 g.
Using these strict criteria, pretreatment nonictal cephalic allodynia was a statistically significant predictor of response to anti-CGRP therapy. It was present in 84% of the 19 nonresponders and was absent in 79% of the 24 responders, for an overall accuracy rate of 86% (P < .0001).
Nonictal cephalic allodynia was “consistently” predictive of response for patients with chronic migraine as well as for those with high-frequency episodic migraine, the researchers reported.
In contrast, they noted that assessing nonictal extracephalic allodynia with QST missed nearly 50% of the patients with allodynia among the nonresponders (accuracy rate of 42%) and added little to the assessment of allodynia among the responders.
Mark Hasleton, PhD, CEO of CGRP Diagnostics, said in an interview that the study shows it’s possible to determine response to anti-CGRP therapy and to prescribe these medications to patients who are most likely to respond.
Dr. Hasleton, who was not personally involved with the current study, noted that pretreatment testing for nonictal cephalic allodynia may also allow for earlier prescription of anti-CGRP therapy and potentially dispense without the need for the current trial-and-error approach to prescribing. He noted that if one anti-CGRP fails the patient, it is highly likely that others will also fail.
Given the “very high correlation of the presence of nonictal cephalic allodynia in responders to galcanezumab, our recommendation would be to routinely pretest all potential anti-CGRP candidates prior to prescription,” he said.
End of trial-and-error prescribing
In a comment, Shaheen Lakhan, MD, a neurologist and researcher in Boston, said this research is “very noteworthy, moving us one step closer to predictive, precision medicine and away from the practice of trial-and-error prescribing.
“The trial-and-error approach to migraine management is daunting. These are very costly therapies, and when they don’t work, there is continued tremendous suffering and loss of quality of life for patients,” said Dr. Lakhan, who was not involved in the study.
He added that the failure of drugs to benefit individual patients “may lead to distrust of the health care provider” and to the system as a whole, which in turn could lead to less access to care for other conditions or for preventive measures.
“I envision a time when these predictive measures collectively (interictal allodynia, as in this study, plus biobehavioral data) will assist us neurologists in appropriately selecting migraine therapies,” Dr. Lakhan said.
“Beyond that, we will eventually test new therapies not in cells, animals, and even humans but in silico. In the very near future, we will have solutions tailored to not people suffering a disease but to you – an individual with a unique genetic, protein, physical, developmental, psychological, and behavioral makeup,” he added.
The study was funded in part by Eli Lilly, the National Institutes of Health, and the anesthesia department at Beth Israel Deaconess Medical Center. Galcanezumab was provided by Eli Lilly. Dr. Lakhan reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
The ictal phase refers to “sensitization occurring during a time when central trigeminovascular neurons receive massive nociceptive input from active meningeal nociceptors,” whereas the nonictal phase refers to “sensitization occurring during a time when central trigeminovascular neurons receive no or subliminal nociceptive input from meningeal nociceptors,” investigators noted.
In an observational, open-label cohort study, pretreatment nonictal cephalic allodynia identified galcanezumab responders with nearly 80% accuracy, and it identified nonresponders with nearly 85% accuracy.
“Detection of nonictal allodynia with a simplified paradigm of Quantitative Sensory Testing (QST) may provide a quick, affordable, noninvasive, and patient-friendly way to prospectively distinguish between responders and nonresponders to the prophylactic treatment of chronic and high-frequency episodic migraine with drugs that reduce CGRP signaling,” Sait Ashina, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, and colleagues wrote.
The findings were published online in Cephalalgia.
Immediate clinical relevance
Investigator Rami Burstein, PhD, also with Beth Israel Deaconess Medical Center and Harvard Medical School, developed the concept of predicting response to anti-CGRP treatment by testing for the presence or absence of nonictal cephalic allodynia in collaboration with the company CGRP Diagnostics.
In 43 anti–CGRP-naive patients with migraine, the researchers used a simplified QST algorithm to determine the presence/absence of cephalic or extracephalic allodynia during the nonictal phase of migraine – defined as the period from less than 12 hours after a migraine attack to less than 12 hours before the next attack.
Patients were considered to have allodynia if heat pain thresholds were between 32° C and 40° C, if cold pain thresholds were between 32° C and 20° C, or if the mechanical pain was threshold was less than 60 g.
Using these strict criteria, pretreatment nonictal cephalic allodynia was a statistically significant predictor of response to anti-CGRP therapy. It was present in 84% of the 19 nonresponders and was absent in 79% of the 24 responders, for an overall accuracy rate of 86% (P < .0001).
Nonictal cephalic allodynia was “consistently” predictive of response for patients with chronic migraine as well as for those with high-frequency episodic migraine, the researchers reported.
In contrast, they noted that assessing nonictal extracephalic allodynia with QST missed nearly 50% of the patients with allodynia among the nonresponders (accuracy rate of 42%) and added little to the assessment of allodynia among the responders.
Mark Hasleton, PhD, CEO of CGRP Diagnostics, said in an interview that the study shows it’s possible to determine response to anti-CGRP therapy and to prescribe these medications to patients who are most likely to respond.
Dr. Hasleton, who was not personally involved with the current study, noted that pretreatment testing for nonictal cephalic allodynia may also allow for earlier prescription of anti-CGRP therapy and potentially dispense without the need for the current trial-and-error approach to prescribing. He noted that if one anti-CGRP fails the patient, it is highly likely that others will also fail.
Given the “very high correlation of the presence of nonictal cephalic allodynia in responders to galcanezumab, our recommendation would be to routinely pretest all potential anti-CGRP candidates prior to prescription,” he said.
End of trial-and-error prescribing
In a comment, Shaheen Lakhan, MD, a neurologist and researcher in Boston, said this research is “very noteworthy, moving us one step closer to predictive, precision medicine and away from the practice of trial-and-error prescribing.
“The trial-and-error approach to migraine management is daunting. These are very costly therapies, and when they don’t work, there is continued tremendous suffering and loss of quality of life for patients,” said Dr. Lakhan, who was not involved in the study.
He added that the failure of drugs to benefit individual patients “may lead to distrust of the health care provider” and to the system as a whole, which in turn could lead to less access to care for other conditions or for preventive measures.
“I envision a time when these predictive measures collectively (interictal allodynia, as in this study, plus biobehavioral data) will assist us neurologists in appropriately selecting migraine therapies,” Dr. Lakhan said.
“Beyond that, we will eventually test new therapies not in cells, animals, and even humans but in silico. In the very near future, we will have solutions tailored to not people suffering a disease but to you – an individual with a unique genetic, protein, physical, developmental, psychological, and behavioral makeup,” he added.
The study was funded in part by Eli Lilly, the National Institutes of Health, and the anesthesia department at Beth Israel Deaconess Medical Center. Galcanezumab was provided by Eli Lilly. Dr. Lakhan reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
new research suggests.
The ictal phase refers to “sensitization occurring during a time when central trigeminovascular neurons receive massive nociceptive input from active meningeal nociceptors,” whereas the nonictal phase refers to “sensitization occurring during a time when central trigeminovascular neurons receive no or subliminal nociceptive input from meningeal nociceptors,” investigators noted.
In an observational, open-label cohort study, pretreatment nonictal cephalic allodynia identified galcanezumab responders with nearly 80% accuracy, and it identified nonresponders with nearly 85% accuracy.
“Detection of nonictal allodynia with a simplified paradigm of Quantitative Sensory Testing (QST) may provide a quick, affordable, noninvasive, and patient-friendly way to prospectively distinguish between responders and nonresponders to the prophylactic treatment of chronic and high-frequency episodic migraine with drugs that reduce CGRP signaling,” Sait Ashina, MD, of Beth Israel Deaconess Medical Center and Harvard Medical School, both in Boston, and colleagues wrote.
The findings were published online in Cephalalgia.
Immediate clinical relevance
Investigator Rami Burstein, PhD, also with Beth Israel Deaconess Medical Center and Harvard Medical School, developed the concept of predicting response to anti-CGRP treatment by testing for the presence or absence of nonictal cephalic allodynia in collaboration with the company CGRP Diagnostics.
In 43 anti–CGRP-naive patients with migraine, the researchers used a simplified QST algorithm to determine the presence/absence of cephalic or extracephalic allodynia during the nonictal phase of migraine – defined as the period from less than 12 hours after a migraine attack to less than 12 hours before the next attack.
Patients were considered to have allodynia if heat pain thresholds were between 32° C and 40° C, if cold pain thresholds were between 32° C and 20° C, or if the mechanical pain was threshold was less than 60 g.
Using these strict criteria, pretreatment nonictal cephalic allodynia was a statistically significant predictor of response to anti-CGRP therapy. It was present in 84% of the 19 nonresponders and was absent in 79% of the 24 responders, for an overall accuracy rate of 86% (P < .0001).
Nonictal cephalic allodynia was “consistently” predictive of response for patients with chronic migraine as well as for those with high-frequency episodic migraine, the researchers reported.
In contrast, they noted that assessing nonictal extracephalic allodynia with QST missed nearly 50% of the patients with allodynia among the nonresponders (accuracy rate of 42%) and added little to the assessment of allodynia among the responders.
Mark Hasleton, PhD, CEO of CGRP Diagnostics, said in an interview that the study shows it’s possible to determine response to anti-CGRP therapy and to prescribe these medications to patients who are most likely to respond.
Dr. Hasleton, who was not personally involved with the current study, noted that pretreatment testing for nonictal cephalic allodynia may also allow for earlier prescription of anti-CGRP therapy and potentially dispense without the need for the current trial-and-error approach to prescribing. He noted that if one anti-CGRP fails the patient, it is highly likely that others will also fail.
Given the “very high correlation of the presence of nonictal cephalic allodynia in responders to galcanezumab, our recommendation would be to routinely pretest all potential anti-CGRP candidates prior to prescription,” he said.
End of trial-and-error prescribing
In a comment, Shaheen Lakhan, MD, a neurologist and researcher in Boston, said this research is “very noteworthy, moving us one step closer to predictive, precision medicine and away from the practice of trial-and-error prescribing.
“The trial-and-error approach to migraine management is daunting. These are very costly therapies, and when they don’t work, there is continued tremendous suffering and loss of quality of life for patients,” said Dr. Lakhan, who was not involved in the study.
He added that the failure of drugs to benefit individual patients “may lead to distrust of the health care provider” and to the system as a whole, which in turn could lead to less access to care for other conditions or for preventive measures.
“I envision a time when these predictive measures collectively (interictal allodynia, as in this study, plus biobehavioral data) will assist us neurologists in appropriately selecting migraine therapies,” Dr. Lakhan said.
“Beyond that, we will eventually test new therapies not in cells, animals, and even humans but in silico. In the very near future, we will have solutions tailored to not people suffering a disease but to you – an individual with a unique genetic, protein, physical, developmental, psychological, and behavioral makeup,” he added.
The study was funded in part by Eli Lilly, the National Institutes of Health, and the anesthesia department at Beth Israel Deaconess Medical Center. Galcanezumab was provided by Eli Lilly. Dr. Lakhan reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CEPHALALGIA
New ACC, AHA, SCAI interventional cardiology training guidance
The American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI) have jointly issued new guidance outlining competency-based advanced training requirements for interventional cardiology trainees.
It’s the first document of its kind to define the training requirements for the full breadth of interventional cardiology for adults, including coronary interventions, peripheral vascular interventions (PVIs), and structural heart interventions (SHIs), the organizations say.
“With this groundbreaking document, the writing committee provides a roadmap for both program directors and interventional cardiology trainees to help them progress through important training milestones,” Theodore A. Bass, MD, chair of the statement writing committee, says in a news release.
“The document defines the required competencies for the full scope of interventional cardiology, providing trainees for the first time with the information to support training across all these areas,” Dr. Bass adds.
Minimum of 250 procedures
To gain the necessary experience in interventional cardiology, cardiovascular fellows are advised to complete the following:
- A 3-year general cardiovascular disease fellowship (successful completion consists of Level I competency in all aspects of cardiovascular medicine and Level II competency in diagnostic cardiac catheterization to pursue interventional cardiology training);
- A 1-year accredited interventional cardiology fellowship, the focus of which is coronary intervention with the opportunity to gain procedural experience in various aspects of PVI or SHI (Level III competency);
- An option for additional post-fellowship training based on the trainee’s career goals.
The goal of Level III training is to provide the interventional cardiology trainees with a “well-rounded, competency-based education,” including didactic instruction, clinical experience in the diagnosis and care of patients, and hands-on procedural experience, the writing group says.
Competency requirements are defined using the Accreditation Council for Graduate Medical Education’s six “essential” competency domains: medical knowledge; patient care and procedural skills; practice-based learning and improvement; systems-based practice; interpersonal and communication skills; and professionalism.
To support attaining these competencies, the writing committee recommends a minimum of 250 interventional cardiology procedures. Of these, 200 should be coronary procedures, with the remaining 50 specialized in coronary, PVI, or SHI, which allows the fellows to customize training on the basis of their career goals.
Adjunctive procedures related to physiologic assessment and intracoronary imaging are also required (25 of each). “These minimum numbers are meant to provide trainees with exposure to a variety and spectrum of complexity of clinical case material and give supervising faculty sufficient opportunity to evaluate trainees’ competency,” the writing group says.
In addition to their procedural skills, evaluation of interventional cardiology trainee proficiency should include regular assessment of a trainee’s ability to clinically diagnose and manage patients across the broad spectrum of diseases.
Assessment of trainees should involve multiple components, including direct observation by instructors, case logs, chart reviews (including adherence to guideline recommendations, appropriate use criteria, and patient outcomes), simulation training, and assessment of leadership skills.
Trainees must also acquire experience working as part of a multidisciplinary team to provide a holistic approach to patient care. The document also highlights the importance of leadership skills, mentorship and lifelong learning beyond initial training.
The 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions) was published online in the Journal of the American College of Cardiology.
The statement was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American Society of Echocardiography, the Heart Failure Society of America, the Heart Rhythm Society, the Society of Cardiovascular Anesthesiologists, the Society of Cardiovascular Computed Tomography, the Society for Cardiovascular Magnetic Resonance, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.
A version of this article first appeared on Medscape.com.
The American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI) have jointly issued new guidance outlining competency-based advanced training requirements for interventional cardiology trainees.
It’s the first document of its kind to define the training requirements for the full breadth of interventional cardiology for adults, including coronary interventions, peripheral vascular interventions (PVIs), and structural heart interventions (SHIs), the organizations say.
“With this groundbreaking document, the writing committee provides a roadmap for both program directors and interventional cardiology trainees to help them progress through important training milestones,” Theodore A. Bass, MD, chair of the statement writing committee, says in a news release.
“The document defines the required competencies for the full scope of interventional cardiology, providing trainees for the first time with the information to support training across all these areas,” Dr. Bass adds.
Minimum of 250 procedures
To gain the necessary experience in interventional cardiology, cardiovascular fellows are advised to complete the following:
- A 3-year general cardiovascular disease fellowship (successful completion consists of Level I competency in all aspects of cardiovascular medicine and Level II competency in diagnostic cardiac catheterization to pursue interventional cardiology training);
- A 1-year accredited interventional cardiology fellowship, the focus of which is coronary intervention with the opportunity to gain procedural experience in various aspects of PVI or SHI (Level III competency);
- An option for additional post-fellowship training based on the trainee’s career goals.
The goal of Level III training is to provide the interventional cardiology trainees with a “well-rounded, competency-based education,” including didactic instruction, clinical experience in the diagnosis and care of patients, and hands-on procedural experience, the writing group says.
Competency requirements are defined using the Accreditation Council for Graduate Medical Education’s six “essential” competency domains: medical knowledge; patient care and procedural skills; practice-based learning and improvement; systems-based practice; interpersonal and communication skills; and professionalism.
To support attaining these competencies, the writing committee recommends a minimum of 250 interventional cardiology procedures. Of these, 200 should be coronary procedures, with the remaining 50 specialized in coronary, PVI, or SHI, which allows the fellows to customize training on the basis of their career goals.
Adjunctive procedures related to physiologic assessment and intracoronary imaging are also required (25 of each). “These minimum numbers are meant to provide trainees with exposure to a variety and spectrum of complexity of clinical case material and give supervising faculty sufficient opportunity to evaluate trainees’ competency,” the writing group says.
In addition to their procedural skills, evaluation of interventional cardiology trainee proficiency should include regular assessment of a trainee’s ability to clinically diagnose and manage patients across the broad spectrum of diseases.
Assessment of trainees should involve multiple components, including direct observation by instructors, case logs, chart reviews (including adherence to guideline recommendations, appropriate use criteria, and patient outcomes), simulation training, and assessment of leadership skills.
Trainees must also acquire experience working as part of a multidisciplinary team to provide a holistic approach to patient care. The document also highlights the importance of leadership skills, mentorship and lifelong learning beyond initial training.
The 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions) was published online in the Journal of the American College of Cardiology.
The statement was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American Society of Echocardiography, the Heart Failure Society of America, the Heart Rhythm Society, the Society of Cardiovascular Anesthesiologists, the Society of Cardiovascular Computed Tomography, the Society for Cardiovascular Magnetic Resonance, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.
A version of this article first appeared on Medscape.com.
The American College of Cardiology, the American Heart Association, and the Society for Cardiovascular Angiography and Interventions (SCAI) have jointly issued new guidance outlining competency-based advanced training requirements for interventional cardiology trainees.
It’s the first document of its kind to define the training requirements for the full breadth of interventional cardiology for adults, including coronary interventions, peripheral vascular interventions (PVIs), and structural heart interventions (SHIs), the organizations say.
“With this groundbreaking document, the writing committee provides a roadmap for both program directors and interventional cardiology trainees to help them progress through important training milestones,” Theodore A. Bass, MD, chair of the statement writing committee, says in a news release.
“The document defines the required competencies for the full scope of interventional cardiology, providing trainees for the first time with the information to support training across all these areas,” Dr. Bass adds.
Minimum of 250 procedures
To gain the necessary experience in interventional cardiology, cardiovascular fellows are advised to complete the following:
- A 3-year general cardiovascular disease fellowship (successful completion consists of Level I competency in all aspects of cardiovascular medicine and Level II competency in diagnostic cardiac catheterization to pursue interventional cardiology training);
- A 1-year accredited interventional cardiology fellowship, the focus of which is coronary intervention with the opportunity to gain procedural experience in various aspects of PVI or SHI (Level III competency);
- An option for additional post-fellowship training based on the trainee’s career goals.
The goal of Level III training is to provide the interventional cardiology trainees with a “well-rounded, competency-based education,” including didactic instruction, clinical experience in the diagnosis and care of patients, and hands-on procedural experience, the writing group says.
Competency requirements are defined using the Accreditation Council for Graduate Medical Education’s six “essential” competency domains: medical knowledge; patient care and procedural skills; practice-based learning and improvement; systems-based practice; interpersonal and communication skills; and professionalism.
To support attaining these competencies, the writing committee recommends a minimum of 250 interventional cardiology procedures. Of these, 200 should be coronary procedures, with the remaining 50 specialized in coronary, PVI, or SHI, which allows the fellows to customize training on the basis of their career goals.
Adjunctive procedures related to physiologic assessment and intracoronary imaging are also required (25 of each). “These minimum numbers are meant to provide trainees with exposure to a variety and spectrum of complexity of clinical case material and give supervising faculty sufficient opportunity to evaluate trainees’ competency,” the writing group says.
In addition to their procedural skills, evaluation of interventional cardiology trainee proficiency should include regular assessment of a trainee’s ability to clinically diagnose and manage patients across the broad spectrum of diseases.
Assessment of trainees should involve multiple components, including direct observation by instructors, case logs, chart reviews (including adherence to guideline recommendations, appropriate use criteria, and patient outcomes), simulation training, and assessment of leadership skills.
Trainees must also acquire experience working as part of a multidisciplinary team to provide a holistic approach to patient care. The document also highlights the importance of leadership skills, mentorship and lifelong learning beyond initial training.
The 2023 ACC/AHA/SCAI Advanced Training Statement on Interventional Cardiology (Coronary, Peripheral Vascular, and Structural Heart Interventions) was published online in the Journal of the American College of Cardiology.
The statement was developed in collaboration with and endorsed by the American Association for Thoracic Surgery, the American Society of Echocardiography, the Heart Failure Society of America, the Heart Rhythm Society, the Society of Cardiovascular Anesthesiologists, the Society of Cardiovascular Computed Tomography, the Society for Cardiovascular Magnetic Resonance, the Society of Thoracic Surgeons, and the Society for Vascular Medicine.
A version of this article first appeared on Medscape.com.
Factors linked to higher risk for death in young cancer survivors
according to new data from the St. Jude Lifetime Cohort.
Survivors with a greater number and severity of modifiable chronic health conditions as well as those living in the most versus least resource-deprived areas had a significantly higher risk of all-cause and health-related late death.
Finding ways to mitigate these factors “will be important to improving health outcomes and developing risk-stratification strategies to optimize care delivery to survivors at varying risk of adverse health events,” the researchers wrote.
The study indicates that treating chronic health conditions alone may not be enough to increase a cancer survivor’s lifespan; improving local environments matters too.
“It is important for clinicians to ask patients about their specific situation,” first author Matthew J. Ehrhardt, MD, department of oncology, St. Jude Children’s Research Hospital, Memphis, said in a news release. “It’s easy to prescribe medications or to tell people to exercise. It takes more time and more thoughtfulness to sit and understand environments in which they are residing.”
“As clinicians, we may have limited ability to modify some of those factors. But we can work closely with the rest of the health care team, such as social workers, for example, to help survivors to identify and access local resources,” Dr. Ehrhardt added.
The study was published online in JAMA Network Open.
A growing population of childhood cancer survivors faces an increased risk for premature death in the years following their diagnosis. However, associations between social determinants of health, modifiable health conditions, and late mortality in childhood cancer survivors remain unclear.
To assess late mortality, the study team analyzed data on 9,440 participants (median age at assessment, 27.5 years; range, 5.3-71.9 years) who lived at least 5 years after being diagnosed with a childhood cancer between 1962 and 2012.
During a median follow-up of about 18 years, childhood cancer survivors had an increased rate of both all-cause and health-related late mortality (standardized mortality rate, 7.6 for both). Among specific health-related causes of death, SMRs were 16.0 for subsequent neoplasms, 9.0 for pulmonary causes, 4.2 for cardiac causes, and 4.3 for other health-related causes.
To evaluate ties between modifiable chronic health conditions, social determinants, and late mortality, the researchers restricted their analysis to 3,407 adult study participants for whom relevant data were available. Modifiable chronic health conditions included dyslipidemia, hypertension, diabetes, underweight or obesity, bone mineral deficiency, and hypothyroidism.
After adjusting for individual factors, including age at diagnosis and treatment, as well as neighborhood-level factors, the researchers observed a significantly increased risk for death among survivors with one or more modifiable chronic health conditions of grade 2 or higher (relative risk, 2.2), two chronic health conditions of grade 2 or higher (RR, 2.6) or three chronic health conditions of grade 2 or higher (RR, 3.6).
These findings suggest that “increased late mortality experienced by childhood cancer survivors in adulthood may not be predetermined by treatment-related risk factors alone,” the researchers said.
In addition, survivors living in the most disadvantaged areas, as measured by the area deprivation index (ADI), had a five- to eightfold increased risk of late death from any cause compared with those living in the least disadvantaged areas, even after adjusting for modifiable chronic health conditions, cancer treatment, demographics, and individual socioeconomic factors.
The findings have important public health implications, Dr. Ehrhardt and colleagues said. The results can, for instance, help identify and stratify cancer survivors at higher lifetime risk for specific chronic conditions and late death.
This risk-stratified approach to care, however, is “relatively static” and does not account for risk factors acquired after cancer diagnosis and treatment, such as social determinants of health.
That is why also focusing on socioeconomic factors is important, and transitional care services following cancer treatment should consider that survivors in disadvantaged neighborhoods may lack supportive resources to address health issues, potentially leading to increased risk for death, the researchers said.
The knowledge that living in a resource-poor neighborhood may raise the risk for late death in childhood cancer survivors “strengthens support for public health policies that will direct resources to such regions and facilitate a multipronged approach to risk mitigation,” the authors concluded.
This study was supported by grants from the National Institutes of Health and the American Lebanese Syrian Associated Charities. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to new data from the St. Jude Lifetime Cohort.
Survivors with a greater number and severity of modifiable chronic health conditions as well as those living in the most versus least resource-deprived areas had a significantly higher risk of all-cause and health-related late death.
Finding ways to mitigate these factors “will be important to improving health outcomes and developing risk-stratification strategies to optimize care delivery to survivors at varying risk of adverse health events,” the researchers wrote.
The study indicates that treating chronic health conditions alone may not be enough to increase a cancer survivor’s lifespan; improving local environments matters too.
“It is important for clinicians to ask patients about their specific situation,” first author Matthew J. Ehrhardt, MD, department of oncology, St. Jude Children’s Research Hospital, Memphis, said in a news release. “It’s easy to prescribe medications or to tell people to exercise. It takes more time and more thoughtfulness to sit and understand environments in which they are residing.”
“As clinicians, we may have limited ability to modify some of those factors. But we can work closely with the rest of the health care team, such as social workers, for example, to help survivors to identify and access local resources,” Dr. Ehrhardt added.
The study was published online in JAMA Network Open.
A growing population of childhood cancer survivors faces an increased risk for premature death in the years following their diagnosis. However, associations between social determinants of health, modifiable health conditions, and late mortality in childhood cancer survivors remain unclear.
To assess late mortality, the study team analyzed data on 9,440 participants (median age at assessment, 27.5 years; range, 5.3-71.9 years) who lived at least 5 years after being diagnosed with a childhood cancer between 1962 and 2012.
During a median follow-up of about 18 years, childhood cancer survivors had an increased rate of both all-cause and health-related late mortality (standardized mortality rate, 7.6 for both). Among specific health-related causes of death, SMRs were 16.0 for subsequent neoplasms, 9.0 for pulmonary causes, 4.2 for cardiac causes, and 4.3 for other health-related causes.
To evaluate ties between modifiable chronic health conditions, social determinants, and late mortality, the researchers restricted their analysis to 3,407 adult study participants for whom relevant data were available. Modifiable chronic health conditions included dyslipidemia, hypertension, diabetes, underweight or obesity, bone mineral deficiency, and hypothyroidism.
After adjusting for individual factors, including age at diagnosis and treatment, as well as neighborhood-level factors, the researchers observed a significantly increased risk for death among survivors with one or more modifiable chronic health conditions of grade 2 or higher (relative risk, 2.2), two chronic health conditions of grade 2 or higher (RR, 2.6) or three chronic health conditions of grade 2 or higher (RR, 3.6).
These findings suggest that “increased late mortality experienced by childhood cancer survivors in adulthood may not be predetermined by treatment-related risk factors alone,” the researchers said.
In addition, survivors living in the most disadvantaged areas, as measured by the area deprivation index (ADI), had a five- to eightfold increased risk of late death from any cause compared with those living in the least disadvantaged areas, even after adjusting for modifiable chronic health conditions, cancer treatment, demographics, and individual socioeconomic factors.
The findings have important public health implications, Dr. Ehrhardt and colleagues said. The results can, for instance, help identify and stratify cancer survivors at higher lifetime risk for specific chronic conditions and late death.
This risk-stratified approach to care, however, is “relatively static” and does not account for risk factors acquired after cancer diagnosis and treatment, such as social determinants of health.
That is why also focusing on socioeconomic factors is important, and transitional care services following cancer treatment should consider that survivors in disadvantaged neighborhoods may lack supportive resources to address health issues, potentially leading to increased risk for death, the researchers said.
The knowledge that living in a resource-poor neighborhood may raise the risk for late death in childhood cancer survivors “strengthens support for public health policies that will direct resources to such regions and facilitate a multipronged approach to risk mitigation,” the authors concluded.
This study was supported by grants from the National Institutes of Health and the American Lebanese Syrian Associated Charities. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
according to new data from the St. Jude Lifetime Cohort.
Survivors with a greater number and severity of modifiable chronic health conditions as well as those living in the most versus least resource-deprived areas had a significantly higher risk of all-cause and health-related late death.
Finding ways to mitigate these factors “will be important to improving health outcomes and developing risk-stratification strategies to optimize care delivery to survivors at varying risk of adverse health events,” the researchers wrote.
The study indicates that treating chronic health conditions alone may not be enough to increase a cancer survivor’s lifespan; improving local environments matters too.
“It is important for clinicians to ask patients about their specific situation,” first author Matthew J. Ehrhardt, MD, department of oncology, St. Jude Children’s Research Hospital, Memphis, said in a news release. “It’s easy to prescribe medications or to tell people to exercise. It takes more time and more thoughtfulness to sit and understand environments in which they are residing.”
“As clinicians, we may have limited ability to modify some of those factors. But we can work closely with the rest of the health care team, such as social workers, for example, to help survivors to identify and access local resources,” Dr. Ehrhardt added.
The study was published online in JAMA Network Open.
A growing population of childhood cancer survivors faces an increased risk for premature death in the years following their diagnosis. However, associations between social determinants of health, modifiable health conditions, and late mortality in childhood cancer survivors remain unclear.
To assess late mortality, the study team analyzed data on 9,440 participants (median age at assessment, 27.5 years; range, 5.3-71.9 years) who lived at least 5 years after being diagnosed with a childhood cancer between 1962 and 2012.
During a median follow-up of about 18 years, childhood cancer survivors had an increased rate of both all-cause and health-related late mortality (standardized mortality rate, 7.6 for both). Among specific health-related causes of death, SMRs were 16.0 for subsequent neoplasms, 9.0 for pulmonary causes, 4.2 for cardiac causes, and 4.3 for other health-related causes.
To evaluate ties between modifiable chronic health conditions, social determinants, and late mortality, the researchers restricted their analysis to 3,407 adult study participants for whom relevant data were available. Modifiable chronic health conditions included dyslipidemia, hypertension, diabetes, underweight or obesity, bone mineral deficiency, and hypothyroidism.
After adjusting for individual factors, including age at diagnosis and treatment, as well as neighborhood-level factors, the researchers observed a significantly increased risk for death among survivors with one or more modifiable chronic health conditions of grade 2 or higher (relative risk, 2.2), two chronic health conditions of grade 2 or higher (RR, 2.6) or three chronic health conditions of grade 2 or higher (RR, 3.6).
These findings suggest that “increased late mortality experienced by childhood cancer survivors in adulthood may not be predetermined by treatment-related risk factors alone,” the researchers said.
In addition, survivors living in the most disadvantaged areas, as measured by the area deprivation index (ADI), had a five- to eightfold increased risk of late death from any cause compared with those living in the least disadvantaged areas, even after adjusting for modifiable chronic health conditions, cancer treatment, demographics, and individual socioeconomic factors.
The findings have important public health implications, Dr. Ehrhardt and colleagues said. The results can, for instance, help identify and stratify cancer survivors at higher lifetime risk for specific chronic conditions and late death.
This risk-stratified approach to care, however, is “relatively static” and does not account for risk factors acquired after cancer diagnosis and treatment, such as social determinants of health.
That is why also focusing on socioeconomic factors is important, and transitional care services following cancer treatment should consider that survivors in disadvantaged neighborhoods may lack supportive resources to address health issues, potentially leading to increased risk for death, the researchers said.
The knowledge that living in a resource-poor neighborhood may raise the risk for late death in childhood cancer survivors “strengthens support for public health policies that will direct resources to such regions and facilitate a multipronged approach to risk mitigation,” the authors concluded.
This study was supported by grants from the National Institutes of Health and the American Lebanese Syrian Associated Charities. The authors reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA NETWORK OPEN
Diabetes drug tied to lower dementia risk
new research suggests.
Overall, in a large cohort study from South Korea, patients who took pioglitazone were 16% less likely to develop dementia over an average of 10 years than peers who did not take the drug.
However, the dementia risk reduction was 54% among those with ischemic heart disease and 43% among those with a history of stroke.
“Our study was to see the association between pioglitazone use and incidence of dementia, not how (with what mechanisms) this drug can suppress dementia pathology,” coinvestigator Eosu Kim, MD, PhD, Yonsei University, Seoul, South Korea, said in an interview.
However, “as we found this drug is more effective in diabetic patients who have blood circulation problems in the heart or brain than in those without such problems, we speculate that pioglitazone’s antidementia action may be related to improving blood vessel’s health,” Dr. Kim said.
This finding suggests that pioglitazone could be used as a personalized treatment approach for dementia prevention in this subgroup of patients with diabetes, the researchers noted.
The results were published online in Neurology.
Dose-response relationship
Risk for dementia is doubled in adults with T2DM, the investigators wrote. Prior studies have suggested that pioglitazone may protect against dementia, as well as a first or recurrent stroke, in patients with T2DM.
This led Dr. Kim and colleagues to examine the effects of pioglitazone on dementia risk overall and in relation to stroke and ischemic heart disease.
Using the national Korean health database, the researchers identified 91,218 adults aged 50 and older with new-onset T2DM who did not have dementia. A total of 3,467 were treated with pioglitazone.
Pioglitazone exposure was defined as a total cumulative daily dose of 90 or more calculated from all dispensations during 4 years after T2DM diagnosis, with outcomes assessed after this period.
Over an average of 10 years, 8.3% of pioglitazone users developed dementia, compared with 10.0% of nonusers.
There was a statistically significant 16% lower risk for developing all-cause dementia among pioglitazone users than among nonusers (adjusted hazard ratio, 0.84; 95% confidence interval, 0.75-0.95).
A dose-response relationship was evident; pioglitazone users who received the highest cumulative daily dose were at lower risk for dementia (aHR, 0.72; 95% CI, 0.55-0.94).
Several limitations
The reduced risk for dementia was more pronounced among patients who used pioglitazone for 4 years in comparison with patients who did not use the drug (aHR, 0.63; 95% CI, 0.44-0.90).
The apparent protective effect of pioglitazone with regard to dementia was greater among those with a history of ischemic heart disease (aHR, 0.46; 95% CI, 0.24-0.90) or stroke (aHR, 0.57; 95% CI, 0.38-0.86) before diabetes diagnosis.
The incidence of stroke was also reduced with pioglitazone use (aHR, 0.81; 95% CI, 0.66-1.0).
“These results provide valuable information on who could potentially benefit from pioglitazone use for prevention of dementia,” Dr. Kim said in a news release.
However, “the risk and benefit balance of long-term use of this drug to prevent dementia should be prospectively assessed,” he said in an interview.
The researchers cautioned that the study was observational; hence, the reported associations cannot address causal relationships. Also, because of the use of claims data, drug compliance could not be guaranteed, and exposure may have been overestimated.
There is also the potential for selection bias, and no information on apolipoprotein E was available, they noted.
More data needed
In an accompanying editorial, Colleen J. Maxwell, PhD, University of Waterloo (Ont.), and colleagues wrote that the results “not only support previous studies showing the potential cognitive benefit of pioglitazone but also extend our understanding of this benefit through the mediating effect of reducing ischemic stroke.”
However, because of their associated risks, which include fractures, weight gain, heart failure, and bladder cancer, thiazolidinediones are not currently favored in diabetes management guidelines – and their use has significantly declined since the mid to late 2000s, the editorialists noted.
They agreed that it will be important to reassess the risk-benefit profile of pioglitazone in T2DM as additional findings emerge.
They also noted that sodium-glucose cotransporter-2 inhibitors, which have significant cardiovascular and renal benefits and minimal side effects, may also lower the risk for dementia.
“As both pioglitazone and SGLT-2 inhibitors are second-line options for physicians, the current decision would easily be in favor of SGLT-2 inhibitors given their safety profile,” Dr. Maxwell and colleagues wrote.
For now, pioglitazone “should not be used to prevent dementia in patients with T2DM,” they concluded.
The study was supported by grants from the National Research Foundation of Korea funded by the Korean government and the Ministry of Health and Welfare. The investigators and editorialists report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
new research suggests.
Overall, in a large cohort study from South Korea, patients who took pioglitazone were 16% less likely to develop dementia over an average of 10 years than peers who did not take the drug.
However, the dementia risk reduction was 54% among those with ischemic heart disease and 43% among those with a history of stroke.
“Our study was to see the association between pioglitazone use and incidence of dementia, not how (with what mechanisms) this drug can suppress dementia pathology,” coinvestigator Eosu Kim, MD, PhD, Yonsei University, Seoul, South Korea, said in an interview.
However, “as we found this drug is more effective in diabetic patients who have blood circulation problems in the heart or brain than in those without such problems, we speculate that pioglitazone’s antidementia action may be related to improving blood vessel’s health,” Dr. Kim said.
This finding suggests that pioglitazone could be used as a personalized treatment approach for dementia prevention in this subgroup of patients with diabetes, the researchers noted.
The results were published online in Neurology.
Dose-response relationship
Risk for dementia is doubled in adults with T2DM, the investigators wrote. Prior studies have suggested that pioglitazone may protect against dementia, as well as a first or recurrent stroke, in patients with T2DM.
This led Dr. Kim and colleagues to examine the effects of pioglitazone on dementia risk overall and in relation to stroke and ischemic heart disease.
Using the national Korean health database, the researchers identified 91,218 adults aged 50 and older with new-onset T2DM who did not have dementia. A total of 3,467 were treated with pioglitazone.
Pioglitazone exposure was defined as a total cumulative daily dose of 90 or more calculated from all dispensations during 4 years after T2DM diagnosis, with outcomes assessed after this period.
Over an average of 10 years, 8.3% of pioglitazone users developed dementia, compared with 10.0% of nonusers.
There was a statistically significant 16% lower risk for developing all-cause dementia among pioglitazone users than among nonusers (adjusted hazard ratio, 0.84; 95% confidence interval, 0.75-0.95).
A dose-response relationship was evident; pioglitazone users who received the highest cumulative daily dose were at lower risk for dementia (aHR, 0.72; 95% CI, 0.55-0.94).
Several limitations
The reduced risk for dementia was more pronounced among patients who used pioglitazone for 4 years in comparison with patients who did not use the drug (aHR, 0.63; 95% CI, 0.44-0.90).
The apparent protective effect of pioglitazone with regard to dementia was greater among those with a history of ischemic heart disease (aHR, 0.46; 95% CI, 0.24-0.90) or stroke (aHR, 0.57; 95% CI, 0.38-0.86) before diabetes diagnosis.
The incidence of stroke was also reduced with pioglitazone use (aHR, 0.81; 95% CI, 0.66-1.0).
“These results provide valuable information on who could potentially benefit from pioglitazone use for prevention of dementia,” Dr. Kim said in a news release.
However, “the risk and benefit balance of long-term use of this drug to prevent dementia should be prospectively assessed,” he said in an interview.
The researchers cautioned that the study was observational; hence, the reported associations cannot address causal relationships. Also, because of the use of claims data, drug compliance could not be guaranteed, and exposure may have been overestimated.
There is also the potential for selection bias, and no information on apolipoprotein E was available, they noted.
More data needed
In an accompanying editorial, Colleen J. Maxwell, PhD, University of Waterloo (Ont.), and colleagues wrote that the results “not only support previous studies showing the potential cognitive benefit of pioglitazone but also extend our understanding of this benefit through the mediating effect of reducing ischemic stroke.”
However, because of their associated risks, which include fractures, weight gain, heart failure, and bladder cancer, thiazolidinediones are not currently favored in diabetes management guidelines – and their use has significantly declined since the mid to late 2000s, the editorialists noted.
They agreed that it will be important to reassess the risk-benefit profile of pioglitazone in T2DM as additional findings emerge.
They also noted that sodium-glucose cotransporter-2 inhibitors, which have significant cardiovascular and renal benefits and minimal side effects, may also lower the risk for dementia.
“As both pioglitazone and SGLT-2 inhibitors are second-line options for physicians, the current decision would easily be in favor of SGLT-2 inhibitors given their safety profile,” Dr. Maxwell and colleagues wrote.
For now, pioglitazone “should not be used to prevent dementia in patients with T2DM,” they concluded.
The study was supported by grants from the National Research Foundation of Korea funded by the Korean government and the Ministry of Health and Welfare. The investigators and editorialists report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
new research suggests.
Overall, in a large cohort study from South Korea, patients who took pioglitazone were 16% less likely to develop dementia over an average of 10 years than peers who did not take the drug.
However, the dementia risk reduction was 54% among those with ischemic heart disease and 43% among those with a history of stroke.
“Our study was to see the association between pioglitazone use and incidence of dementia, not how (with what mechanisms) this drug can suppress dementia pathology,” coinvestigator Eosu Kim, MD, PhD, Yonsei University, Seoul, South Korea, said in an interview.
However, “as we found this drug is more effective in diabetic patients who have blood circulation problems in the heart or brain than in those without such problems, we speculate that pioglitazone’s antidementia action may be related to improving blood vessel’s health,” Dr. Kim said.
This finding suggests that pioglitazone could be used as a personalized treatment approach for dementia prevention in this subgroup of patients with diabetes, the researchers noted.
The results were published online in Neurology.
Dose-response relationship
Risk for dementia is doubled in adults with T2DM, the investigators wrote. Prior studies have suggested that pioglitazone may protect against dementia, as well as a first or recurrent stroke, in patients with T2DM.
This led Dr. Kim and colleagues to examine the effects of pioglitazone on dementia risk overall and in relation to stroke and ischemic heart disease.
Using the national Korean health database, the researchers identified 91,218 adults aged 50 and older with new-onset T2DM who did not have dementia. A total of 3,467 were treated with pioglitazone.
Pioglitazone exposure was defined as a total cumulative daily dose of 90 or more calculated from all dispensations during 4 years after T2DM diagnosis, with outcomes assessed after this period.
Over an average of 10 years, 8.3% of pioglitazone users developed dementia, compared with 10.0% of nonusers.
There was a statistically significant 16% lower risk for developing all-cause dementia among pioglitazone users than among nonusers (adjusted hazard ratio, 0.84; 95% confidence interval, 0.75-0.95).
A dose-response relationship was evident; pioglitazone users who received the highest cumulative daily dose were at lower risk for dementia (aHR, 0.72; 95% CI, 0.55-0.94).
Several limitations
The reduced risk for dementia was more pronounced among patients who used pioglitazone for 4 years in comparison with patients who did not use the drug (aHR, 0.63; 95% CI, 0.44-0.90).
The apparent protective effect of pioglitazone with regard to dementia was greater among those with a history of ischemic heart disease (aHR, 0.46; 95% CI, 0.24-0.90) or stroke (aHR, 0.57; 95% CI, 0.38-0.86) before diabetes diagnosis.
The incidence of stroke was also reduced with pioglitazone use (aHR, 0.81; 95% CI, 0.66-1.0).
“These results provide valuable information on who could potentially benefit from pioglitazone use for prevention of dementia,” Dr. Kim said in a news release.
However, “the risk and benefit balance of long-term use of this drug to prevent dementia should be prospectively assessed,” he said in an interview.
The researchers cautioned that the study was observational; hence, the reported associations cannot address causal relationships. Also, because of the use of claims data, drug compliance could not be guaranteed, and exposure may have been overestimated.
There is also the potential for selection bias, and no information on apolipoprotein E was available, they noted.
More data needed
In an accompanying editorial, Colleen J. Maxwell, PhD, University of Waterloo (Ont.), and colleagues wrote that the results “not only support previous studies showing the potential cognitive benefit of pioglitazone but also extend our understanding of this benefit through the mediating effect of reducing ischemic stroke.”
However, because of their associated risks, which include fractures, weight gain, heart failure, and bladder cancer, thiazolidinediones are not currently favored in diabetes management guidelines – and their use has significantly declined since the mid to late 2000s, the editorialists noted.
They agreed that it will be important to reassess the risk-benefit profile of pioglitazone in T2DM as additional findings emerge.
They also noted that sodium-glucose cotransporter-2 inhibitors, which have significant cardiovascular and renal benefits and minimal side effects, may also lower the risk for dementia.
“As both pioglitazone and SGLT-2 inhibitors are second-line options for physicians, the current decision would easily be in favor of SGLT-2 inhibitors given their safety profile,” Dr. Maxwell and colleagues wrote.
For now, pioglitazone “should not be used to prevent dementia in patients with T2DM,” they concluded.
The study was supported by grants from the National Research Foundation of Korea funded by the Korean government and the Ministry of Health and Welfare. The investigators and editorialists report no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
FROM NEUROLOGY
Breast cancer exacts high financial toll worldwide
but in low- and middle-income countries as well, a meta-analysis found.
Although the rate of financial toxicity was much higher in low- and middle-income countries – affecting 79% of patients – more than 35% of patients in high-income countries also incurred financial hardship, the study team found.
The findings highlight the need for policies to offset the burden of direct and indirect costs for breast cancer care and improve the financial health of vulnerable patients, said the study authors, led by Kavitha Ranganathan, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston.
The study was published online in JAMA Network Open.
The most expensive malignancy?
Patients with breast cancer may be particularly burdened by costs of care, with one study showing substantially higher out-of-pocket costs for patients with breast cancer than colorectal, lung, and prostate cancer combined.
A Lancet Oncology Commission report revealed that breast cancer was the most expensive cancer in the United States in 2010, accounting for $16.5 billion, or 13% of all cancer-related spending. A separate analysis found that individual direct medical costs of breast cancer care can reach $100,000.
In high-income countries, the financial burden of breast cancer care may be the result of novel and costly cancer therapeutics and interventions, overuse of services, increased willingness to pay, and varying insurance coverage. In low- and middle-income countries, women may experience delayed diagnosis because of limited access to screening and high-quality diagnostic services, leading to more later-stage diagnoses requiring more extensive treatments. Lower baseline income, limited insurance coverage, and greater distance to treatment centers may also be factors.
“Establishing the global extent of financial toxicity and comparing the economic burden of disease in different populations is imperative to help policy makers prioritize funding of breast cancer care infrastructure,” Dr. Ranganathan and colleagues write.
In their meta-analysis of 18 studies – 14 from high-income countries and 4 from low – published from 2008 to 2021, the authors found that the definition of financial toxicity varied widely across studies.
For example, some used specific numerical criteria for defining financial toxicity, such as medical cost exceeding 40% of household capacity to pay or potential income or out-of-pocket costs exceeding 30% of annual household income.
Others used patient-reported outcome measures instruments evaluating subjective statements of financial difficulty, such as an affirmative answer to having financial difficulty or trouble paying medical bills, or paying more for medical care than is affordable.
In other studies, financial toxicity was defined according to a patient’s report of specific, objective financial consequences of care, including losing income or a job; having to borrow money or go into debt; having trouble paying for food, rent, or transportation; or having to forgo any type of medical care because of cost.
In their analysis, the pooled rate of financial toxicity among patients with breast cancer was 35.3% in high-income countries and 78.8% in low/middle-income countries, both demonstrating high heterogeneity or variability (P for heterogeneity < .001). In contrast, typical financial toxicity rates across all health conditions in low-income countries ranged from 6% to 12%, the investigators noted.
One study assessing quality of life measures in Egypt found that 47.5% of patients were food insecure, 66% needed financial assistance, 34% used savings to pay for treatment, and 41.2% lacked savings altogether.
Burden reduction
Given the high rates of financial toxicity associated with breast cancer, what strategies might reduce this cost burden?
When exploring potential factors associated with financial toxicity, the researchers found no clear association between financial toxicity and race, employment status, and age, and could draw no firm conclusions about the impact of comorbidities and urban vs. rural place of residence. In addition, cancer stage and treatments were “extremely” heterogeneous across studies and the authors found no clear association between either factor and financial toxicity.
But the authors noted that the highest-priority patients are typically those who have low education, have low socioeconomic status, lack health insurance, and live in low-resource areas.
To reduce financial toxicity and improve outcomes among patients with breast cancer, the study team recommended four potential strategies:
- Use targeted educational campaigns to raise awareness about the signs and symptoms of breast cancer and the importance of early diagnosis and treatment.
- Expand health care coverage to minimize direct medical out-of-pocket costs.
- Develop programs to assist with direct nonmedical and indirect costs, such as transportation to and lodging near treatment centers and childcare.
- Improve screening, referral, and treatment infrastructure for breast cancer care.
The researchers also noted that their data highlight the value of universal health care coverage as a policy strategy, with evidence of lower financial toxicity rates in countries with universal health coverage.
Support for the study was provided in part by the National Cancer Institute, United Nations Institute for Training and Research and the Global Surgery Foundation, Harvard Global Health Institute, Connors Center for Women’s Health and Gender Biology, the Center for Surgery and Public Health, and the National Endowment for Plastic Surgery. Dr. Ranganathan reports no relevant financial relationships. Several coauthors have disclosures; the full list can be found with the original article.
A version of this article originally appeared on Medscape.com.
but in low- and middle-income countries as well, a meta-analysis found.
Although the rate of financial toxicity was much higher in low- and middle-income countries – affecting 79% of patients – more than 35% of patients in high-income countries also incurred financial hardship, the study team found.
The findings highlight the need for policies to offset the burden of direct and indirect costs for breast cancer care and improve the financial health of vulnerable patients, said the study authors, led by Kavitha Ranganathan, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston.
The study was published online in JAMA Network Open.
The most expensive malignancy?
Patients with breast cancer may be particularly burdened by costs of care, with one study showing substantially higher out-of-pocket costs for patients with breast cancer than colorectal, lung, and prostate cancer combined.
A Lancet Oncology Commission report revealed that breast cancer was the most expensive cancer in the United States in 2010, accounting for $16.5 billion, or 13% of all cancer-related spending. A separate analysis found that individual direct medical costs of breast cancer care can reach $100,000.
In high-income countries, the financial burden of breast cancer care may be the result of novel and costly cancer therapeutics and interventions, overuse of services, increased willingness to pay, and varying insurance coverage. In low- and middle-income countries, women may experience delayed diagnosis because of limited access to screening and high-quality diagnostic services, leading to more later-stage diagnoses requiring more extensive treatments. Lower baseline income, limited insurance coverage, and greater distance to treatment centers may also be factors.
“Establishing the global extent of financial toxicity and comparing the economic burden of disease in different populations is imperative to help policy makers prioritize funding of breast cancer care infrastructure,” Dr. Ranganathan and colleagues write.
In their meta-analysis of 18 studies – 14 from high-income countries and 4 from low – published from 2008 to 2021, the authors found that the definition of financial toxicity varied widely across studies.
For example, some used specific numerical criteria for defining financial toxicity, such as medical cost exceeding 40% of household capacity to pay or potential income or out-of-pocket costs exceeding 30% of annual household income.
Others used patient-reported outcome measures instruments evaluating subjective statements of financial difficulty, such as an affirmative answer to having financial difficulty or trouble paying medical bills, or paying more for medical care than is affordable.
In other studies, financial toxicity was defined according to a patient’s report of specific, objective financial consequences of care, including losing income or a job; having to borrow money or go into debt; having trouble paying for food, rent, or transportation; or having to forgo any type of medical care because of cost.
In their analysis, the pooled rate of financial toxicity among patients with breast cancer was 35.3% in high-income countries and 78.8% in low/middle-income countries, both demonstrating high heterogeneity or variability (P for heterogeneity < .001). In contrast, typical financial toxicity rates across all health conditions in low-income countries ranged from 6% to 12%, the investigators noted.
One study assessing quality of life measures in Egypt found that 47.5% of patients were food insecure, 66% needed financial assistance, 34% used savings to pay for treatment, and 41.2% lacked savings altogether.
Burden reduction
Given the high rates of financial toxicity associated with breast cancer, what strategies might reduce this cost burden?
When exploring potential factors associated with financial toxicity, the researchers found no clear association between financial toxicity and race, employment status, and age, and could draw no firm conclusions about the impact of comorbidities and urban vs. rural place of residence. In addition, cancer stage and treatments were “extremely” heterogeneous across studies and the authors found no clear association between either factor and financial toxicity.
But the authors noted that the highest-priority patients are typically those who have low education, have low socioeconomic status, lack health insurance, and live in low-resource areas.
To reduce financial toxicity and improve outcomes among patients with breast cancer, the study team recommended four potential strategies:
- Use targeted educational campaigns to raise awareness about the signs and symptoms of breast cancer and the importance of early diagnosis and treatment.
- Expand health care coverage to minimize direct medical out-of-pocket costs.
- Develop programs to assist with direct nonmedical and indirect costs, such as transportation to and lodging near treatment centers and childcare.
- Improve screening, referral, and treatment infrastructure for breast cancer care.
The researchers also noted that their data highlight the value of universal health care coverage as a policy strategy, with evidence of lower financial toxicity rates in countries with universal health coverage.
Support for the study was provided in part by the National Cancer Institute, United Nations Institute for Training and Research and the Global Surgery Foundation, Harvard Global Health Institute, Connors Center for Women’s Health and Gender Biology, the Center for Surgery and Public Health, and the National Endowment for Plastic Surgery. Dr. Ranganathan reports no relevant financial relationships. Several coauthors have disclosures; the full list can be found with the original article.
A version of this article originally appeared on Medscape.com.
but in low- and middle-income countries as well, a meta-analysis found.
Although the rate of financial toxicity was much higher in low- and middle-income countries – affecting 79% of patients – more than 35% of patients in high-income countries also incurred financial hardship, the study team found.
The findings highlight the need for policies to offset the burden of direct and indirect costs for breast cancer care and improve the financial health of vulnerable patients, said the study authors, led by Kavitha Ranganathan, MD, of Brigham and Women’s Hospital and Harvard Medical School, Boston.
The study was published online in JAMA Network Open.
The most expensive malignancy?
Patients with breast cancer may be particularly burdened by costs of care, with one study showing substantially higher out-of-pocket costs for patients with breast cancer than colorectal, lung, and prostate cancer combined.
A Lancet Oncology Commission report revealed that breast cancer was the most expensive cancer in the United States in 2010, accounting for $16.5 billion, or 13% of all cancer-related spending. A separate analysis found that individual direct medical costs of breast cancer care can reach $100,000.
In high-income countries, the financial burden of breast cancer care may be the result of novel and costly cancer therapeutics and interventions, overuse of services, increased willingness to pay, and varying insurance coverage. In low- and middle-income countries, women may experience delayed diagnosis because of limited access to screening and high-quality diagnostic services, leading to more later-stage diagnoses requiring more extensive treatments. Lower baseline income, limited insurance coverage, and greater distance to treatment centers may also be factors.
“Establishing the global extent of financial toxicity and comparing the economic burden of disease in different populations is imperative to help policy makers prioritize funding of breast cancer care infrastructure,” Dr. Ranganathan and colleagues write.
In their meta-analysis of 18 studies – 14 from high-income countries and 4 from low – published from 2008 to 2021, the authors found that the definition of financial toxicity varied widely across studies.
For example, some used specific numerical criteria for defining financial toxicity, such as medical cost exceeding 40% of household capacity to pay or potential income or out-of-pocket costs exceeding 30% of annual household income.
Others used patient-reported outcome measures instruments evaluating subjective statements of financial difficulty, such as an affirmative answer to having financial difficulty or trouble paying medical bills, or paying more for medical care than is affordable.
In other studies, financial toxicity was defined according to a patient’s report of specific, objective financial consequences of care, including losing income or a job; having to borrow money or go into debt; having trouble paying for food, rent, or transportation; or having to forgo any type of medical care because of cost.
In their analysis, the pooled rate of financial toxicity among patients with breast cancer was 35.3% in high-income countries and 78.8% in low/middle-income countries, both demonstrating high heterogeneity or variability (P for heterogeneity < .001). In contrast, typical financial toxicity rates across all health conditions in low-income countries ranged from 6% to 12%, the investigators noted.
One study assessing quality of life measures in Egypt found that 47.5% of patients were food insecure, 66% needed financial assistance, 34% used savings to pay for treatment, and 41.2% lacked savings altogether.
Burden reduction
Given the high rates of financial toxicity associated with breast cancer, what strategies might reduce this cost burden?
When exploring potential factors associated with financial toxicity, the researchers found no clear association between financial toxicity and race, employment status, and age, and could draw no firm conclusions about the impact of comorbidities and urban vs. rural place of residence. In addition, cancer stage and treatments were “extremely” heterogeneous across studies and the authors found no clear association between either factor and financial toxicity.
But the authors noted that the highest-priority patients are typically those who have low education, have low socioeconomic status, lack health insurance, and live in low-resource areas.
To reduce financial toxicity and improve outcomes among patients with breast cancer, the study team recommended four potential strategies:
- Use targeted educational campaigns to raise awareness about the signs and symptoms of breast cancer and the importance of early diagnosis and treatment.
- Expand health care coverage to minimize direct medical out-of-pocket costs.
- Develop programs to assist with direct nonmedical and indirect costs, such as transportation to and lodging near treatment centers and childcare.
- Improve screening, referral, and treatment infrastructure for breast cancer care.
The researchers also noted that their data highlight the value of universal health care coverage as a policy strategy, with evidence of lower financial toxicity rates in countries with universal health coverage.
Support for the study was provided in part by the National Cancer Institute, United Nations Institute for Training and Research and the Global Surgery Foundation, Harvard Global Health Institute, Connors Center for Women’s Health and Gender Biology, the Center for Surgery and Public Health, and the National Endowment for Plastic Surgery. Dr. Ranganathan reports no relevant financial relationships. Several coauthors have disclosures; the full list can be found with the original article.
A version of this article originally appeared on Medscape.com.
FROM JAMA NETWORK OPEN
‘Sighing’ tops mindfulness for reduced stress, improved mood
In a randomized controlled study, daily breathwork – especially cyclic breathing, which emphasizes shorter inhalations and prolonged exhalations – was associated with greater improvement in mood and a slower respiratory rate than mindfulness meditation.
“We were pleased that just 5 minutes a day of the breathing exercises positively affected mood and resulted in slower respiratory rate, indicating reduced arousal,” coinvestigator David Spiegel, MD, who directs the Center for Stress and Health at Stanford (Calif.) University, told this news organization.
The findings were published online in Cell Reports Medicine.
Intentional breath control
Controlled breathwork has emerged as a potential tool to manage stress and boost well-being.
In the new study, researchers compared three different daily 5-minute breathwork exercises to an equal amount of mindfulness meditation over 1 month in 108 healthy adults recruited mostly from an undergraduate psychology class at Stanford: 33 participants practiced cyclic hyperventilation, which emphasizes robust inhalation, short retention and rapid exhalation, 30 did exhale-focused cyclic sighing, 21 performed box breathing, which emphasizes equal duration of inhalation, breath retention, and exhalation, and 24 practiced mindfulness meditation (the control group).
The primary endpoints were improvement in mood and anxiety, as well as reduced physiologic arousal (respiratory rate, heart rate, and heart rate variability). Physiological data was collected using a wearable WHOOP strap.
All four groups showed significant daily improvement in mood, as well as reduction in anxiety and negative mood, but there were significant differences between mindfulness meditation and breathwork.
Using a mixed-effects model, the researchers showed that breathwork, especially the exhale-focused cyclic sighing, produced greater improvement in mood (P < .05) and reduction in respiratory rate (P < .05), compared with mindfulness meditation.
Specific patterns vs. passive attention
The finding supports the team’s hypothesis that intentional control over breath with specific breathing patterns produces more benefit to mood than passive attention to one’s breath, as in mindfulness meditation practice.
“It turned out that the cyclic sighing was indeed most soothing,” Dr. Spiegel noted.
“We expected that because of respiratory sinus arrhythmia. Exhaling is accomplished by increasing pressure in the chest, which increases venous return to the heart, triggering parasympathetic slowing of heart rate via the sinoatrial node,” he said.
Dr. Spiegel added that, conversely, inspiration reduces venous return, triggering sympathetic activity and increased heart rate.
“The magnitude of this heart rate variability is associated with better health, including recovery from myocardial infarction and even cancer survival. So self-soothing is a good thing, and we expected an advantage for cyclic sighing,” he said.
“If you’re looking to improve sleep and reduce daytime stress, recover from intense work, life, and/or training, then interventions that facilitate autonomic control (and indeed you can control it), brief (5 minutes) structured breathwork is among the more powerful (and zero cost) tools,” tweeted senior investigator Andrew Huberman, PhD, professor of neurobiology at Stanford.
Immediate application?
Sara Lazar, PhD, Massachusetts General Hospital and Harvard Medical School, Boston, said the findings are “interesting” but cautioned that this is “just one study with a pretty small sample size,” and it only enrolled healthy college students.
Dr. Lazar, who also runs the Lazar Lab for Meditation Research at Mass General, noted that she would want to see a future study “done with working-age adults and with clinical populations.”
“It should also be noted that mindfulness had a bigger effect on negative affect, which could have implications for conditions such as depression or trauma,” said Dr. Lazar, who was not involved with the current research.
Also weighing in, Steven R. Thorp, PhD, professor at California School of Professional Psychology, Alliant International University, San Diego, said in an interview the study is “really interesting and well done.”
“Although breathing exercises and breathing retraining are commonly found in psychosocial interventions, especially for anxiety disorders, there have been few empirical studies comparing different breathing protocols,” Dr. Thorp said.
In this study, the passive observation of breaths (mindfulness) and specific breathwork interventions “all worked to decrease state anxiety; but the breathwork, particularly the cyclic sighing protocol, produced a greater overall reduction in respiratory rate and increase in positive mood,” he noted.
“These techniques can be recommended by all clinicians because all clients have access to their breath at all times – and only 5 minutes of daily practice can yield the benefits. Moreover, as the authors note, the immediate benefits may encourage clients to engage with the breathwork and potentially other aspects of treatment,” Dr. Thorp said.
The study was funded by Victor and Winnie Koo and Tianren Culture and a Stanford School of Medicine Discovery Innovation Award. WHOOP donated the wrist straps used in the study, but was not involved in the study’s design or analysis. Dr. Huberman is an advisor to WHOOP. Dr. Lazar and Dr. Thorp have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a randomized controlled study, daily breathwork – especially cyclic breathing, which emphasizes shorter inhalations and prolonged exhalations – was associated with greater improvement in mood and a slower respiratory rate than mindfulness meditation.
“We were pleased that just 5 minutes a day of the breathing exercises positively affected mood and resulted in slower respiratory rate, indicating reduced arousal,” coinvestigator David Spiegel, MD, who directs the Center for Stress and Health at Stanford (Calif.) University, told this news organization.
The findings were published online in Cell Reports Medicine.
Intentional breath control
Controlled breathwork has emerged as a potential tool to manage stress and boost well-being.
In the new study, researchers compared three different daily 5-minute breathwork exercises to an equal amount of mindfulness meditation over 1 month in 108 healthy adults recruited mostly from an undergraduate psychology class at Stanford: 33 participants practiced cyclic hyperventilation, which emphasizes robust inhalation, short retention and rapid exhalation, 30 did exhale-focused cyclic sighing, 21 performed box breathing, which emphasizes equal duration of inhalation, breath retention, and exhalation, and 24 practiced mindfulness meditation (the control group).
The primary endpoints were improvement in mood and anxiety, as well as reduced physiologic arousal (respiratory rate, heart rate, and heart rate variability). Physiological data was collected using a wearable WHOOP strap.
All four groups showed significant daily improvement in mood, as well as reduction in anxiety and negative mood, but there were significant differences between mindfulness meditation and breathwork.
Using a mixed-effects model, the researchers showed that breathwork, especially the exhale-focused cyclic sighing, produced greater improvement in mood (P < .05) and reduction in respiratory rate (P < .05), compared with mindfulness meditation.
Specific patterns vs. passive attention
The finding supports the team’s hypothesis that intentional control over breath with specific breathing patterns produces more benefit to mood than passive attention to one’s breath, as in mindfulness meditation practice.
“It turned out that the cyclic sighing was indeed most soothing,” Dr. Spiegel noted.
“We expected that because of respiratory sinus arrhythmia. Exhaling is accomplished by increasing pressure in the chest, which increases venous return to the heart, triggering parasympathetic slowing of heart rate via the sinoatrial node,” he said.
Dr. Spiegel added that, conversely, inspiration reduces venous return, triggering sympathetic activity and increased heart rate.
“The magnitude of this heart rate variability is associated with better health, including recovery from myocardial infarction and even cancer survival. So self-soothing is a good thing, and we expected an advantage for cyclic sighing,” he said.
“If you’re looking to improve sleep and reduce daytime stress, recover from intense work, life, and/or training, then interventions that facilitate autonomic control (and indeed you can control it), brief (5 minutes) structured breathwork is among the more powerful (and zero cost) tools,” tweeted senior investigator Andrew Huberman, PhD, professor of neurobiology at Stanford.
Immediate application?
Sara Lazar, PhD, Massachusetts General Hospital and Harvard Medical School, Boston, said the findings are “interesting” but cautioned that this is “just one study with a pretty small sample size,” and it only enrolled healthy college students.
Dr. Lazar, who also runs the Lazar Lab for Meditation Research at Mass General, noted that she would want to see a future study “done with working-age adults and with clinical populations.”
“It should also be noted that mindfulness had a bigger effect on negative affect, which could have implications for conditions such as depression or trauma,” said Dr. Lazar, who was not involved with the current research.
Also weighing in, Steven R. Thorp, PhD, professor at California School of Professional Psychology, Alliant International University, San Diego, said in an interview the study is “really interesting and well done.”
“Although breathing exercises and breathing retraining are commonly found in psychosocial interventions, especially for anxiety disorders, there have been few empirical studies comparing different breathing protocols,” Dr. Thorp said.
In this study, the passive observation of breaths (mindfulness) and specific breathwork interventions “all worked to decrease state anxiety; but the breathwork, particularly the cyclic sighing protocol, produced a greater overall reduction in respiratory rate and increase in positive mood,” he noted.
“These techniques can be recommended by all clinicians because all clients have access to their breath at all times – and only 5 minutes of daily practice can yield the benefits. Moreover, as the authors note, the immediate benefits may encourage clients to engage with the breathwork and potentially other aspects of treatment,” Dr. Thorp said.
The study was funded by Victor and Winnie Koo and Tianren Culture and a Stanford School of Medicine Discovery Innovation Award. WHOOP donated the wrist straps used in the study, but was not involved in the study’s design or analysis. Dr. Huberman is an advisor to WHOOP. Dr. Lazar and Dr. Thorp have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a randomized controlled study, daily breathwork – especially cyclic breathing, which emphasizes shorter inhalations and prolonged exhalations – was associated with greater improvement in mood and a slower respiratory rate than mindfulness meditation.
“We were pleased that just 5 minutes a day of the breathing exercises positively affected mood and resulted in slower respiratory rate, indicating reduced arousal,” coinvestigator David Spiegel, MD, who directs the Center for Stress and Health at Stanford (Calif.) University, told this news organization.
The findings were published online in Cell Reports Medicine.
Intentional breath control
Controlled breathwork has emerged as a potential tool to manage stress and boost well-being.
In the new study, researchers compared three different daily 5-minute breathwork exercises to an equal amount of mindfulness meditation over 1 month in 108 healthy adults recruited mostly from an undergraduate psychology class at Stanford: 33 participants practiced cyclic hyperventilation, which emphasizes robust inhalation, short retention and rapid exhalation, 30 did exhale-focused cyclic sighing, 21 performed box breathing, which emphasizes equal duration of inhalation, breath retention, and exhalation, and 24 practiced mindfulness meditation (the control group).
The primary endpoints were improvement in mood and anxiety, as well as reduced physiologic arousal (respiratory rate, heart rate, and heart rate variability). Physiological data was collected using a wearable WHOOP strap.
All four groups showed significant daily improvement in mood, as well as reduction in anxiety and negative mood, but there were significant differences between mindfulness meditation and breathwork.
Using a mixed-effects model, the researchers showed that breathwork, especially the exhale-focused cyclic sighing, produced greater improvement in mood (P < .05) and reduction in respiratory rate (P < .05), compared with mindfulness meditation.
Specific patterns vs. passive attention
The finding supports the team’s hypothesis that intentional control over breath with specific breathing patterns produces more benefit to mood than passive attention to one’s breath, as in mindfulness meditation practice.
“It turned out that the cyclic sighing was indeed most soothing,” Dr. Spiegel noted.
“We expected that because of respiratory sinus arrhythmia. Exhaling is accomplished by increasing pressure in the chest, which increases venous return to the heart, triggering parasympathetic slowing of heart rate via the sinoatrial node,” he said.
Dr. Spiegel added that, conversely, inspiration reduces venous return, triggering sympathetic activity and increased heart rate.
“The magnitude of this heart rate variability is associated with better health, including recovery from myocardial infarction and even cancer survival. So self-soothing is a good thing, and we expected an advantage for cyclic sighing,” he said.
“If you’re looking to improve sleep and reduce daytime stress, recover from intense work, life, and/or training, then interventions that facilitate autonomic control (and indeed you can control it), brief (5 minutes) structured breathwork is among the more powerful (and zero cost) tools,” tweeted senior investigator Andrew Huberman, PhD, professor of neurobiology at Stanford.
Immediate application?
Sara Lazar, PhD, Massachusetts General Hospital and Harvard Medical School, Boston, said the findings are “interesting” but cautioned that this is “just one study with a pretty small sample size,” and it only enrolled healthy college students.
Dr. Lazar, who also runs the Lazar Lab for Meditation Research at Mass General, noted that she would want to see a future study “done with working-age adults and with clinical populations.”
“It should also be noted that mindfulness had a bigger effect on negative affect, which could have implications for conditions such as depression or trauma,” said Dr. Lazar, who was not involved with the current research.
Also weighing in, Steven R. Thorp, PhD, professor at California School of Professional Psychology, Alliant International University, San Diego, said in an interview the study is “really interesting and well done.”
“Although breathing exercises and breathing retraining are commonly found in psychosocial interventions, especially for anxiety disorders, there have been few empirical studies comparing different breathing protocols,” Dr. Thorp said.
In this study, the passive observation of breaths (mindfulness) and specific breathwork interventions “all worked to decrease state anxiety; but the breathwork, particularly the cyclic sighing protocol, produced a greater overall reduction in respiratory rate and increase in positive mood,” he noted.
“These techniques can be recommended by all clinicians because all clients have access to their breath at all times – and only 5 minutes of daily practice can yield the benefits. Moreover, as the authors note, the immediate benefits may encourage clients to engage with the breathwork and potentially other aspects of treatment,” Dr. Thorp said.
The study was funded by Victor and Winnie Koo and Tianren Culture and a Stanford School of Medicine Discovery Innovation Award. WHOOP donated the wrist straps used in the study, but was not involved in the study’s design or analysis. Dr. Huberman is an advisor to WHOOP. Dr. Lazar and Dr. Thorp have reported no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM CELL REPORTS MEDICINE
FDA puts hold on esophagitis, H. pylori drug, owing to impurity concerns
The Food and Drug Administration
The FDA approved the company’s two vonoprazan-based treatments for H. pylori infection, Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), last May.
The target action date of the company’s NDA for vonoprazan for the treatment of erosive esophagitis was Jan. 11, 2023.
In a news release, Phathom said it has received complete response letters from the FDA related to its erosive esophagitis NDA and H. pylori postapproval supplement.
Both letters address specifications and controls for a nitrosamine drug substance–related impurity, N-nitroso-vonoprazan (NVP), which was detected in the initial commercial launch materials of both products.
The FDA letters ask Phathom to provide “additional stability data to demonstrate that levels of the impurity previously found in vonoprazan drug product will remain at or below the daily acceptable intake throughout the proposed shelf life of the product,” Phathom said.
Phathom said it has conducted “extensive root cause investigations regarding the trace levels of the impurity since it was detected and has implemented mitigation measures to control the levels of NVP below the acceptable intake.”
The company expects to meet with the FDA before the end of March to discuss a resubmission plan and a timeline for the vonoprazan products.
Owing to the regulatory delays, Phathom said it no longer expects product launches for H. pylori or erosive esophagitis in the first quarter of 2023.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration
The FDA approved the company’s two vonoprazan-based treatments for H. pylori infection, Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), last May.
The target action date of the company’s NDA for vonoprazan for the treatment of erosive esophagitis was Jan. 11, 2023.
In a news release, Phathom said it has received complete response letters from the FDA related to its erosive esophagitis NDA and H. pylori postapproval supplement.
Both letters address specifications and controls for a nitrosamine drug substance–related impurity, N-nitroso-vonoprazan (NVP), which was detected in the initial commercial launch materials of both products.
The FDA letters ask Phathom to provide “additional stability data to demonstrate that levels of the impurity previously found in vonoprazan drug product will remain at or below the daily acceptable intake throughout the proposed shelf life of the product,” Phathom said.
Phathom said it has conducted “extensive root cause investigations regarding the trace levels of the impurity since it was detected and has implemented mitigation measures to control the levels of NVP below the acceptable intake.”
The company expects to meet with the FDA before the end of March to discuss a resubmission plan and a timeline for the vonoprazan products.
Owing to the regulatory delays, Phathom said it no longer expects product launches for H. pylori or erosive esophagitis in the first quarter of 2023.
A version of this article first appeared on Medscape.com.
The Food and Drug Administration
The FDA approved the company’s two vonoprazan-based treatments for H. pylori infection, Voquezna Triple Pak (vonoprazan, amoxicillin, clarithromycin) and Voquezna Dual Pak (vonoprazan, amoxicillin), last May.
The target action date of the company’s NDA for vonoprazan for the treatment of erosive esophagitis was Jan. 11, 2023.
In a news release, Phathom said it has received complete response letters from the FDA related to its erosive esophagitis NDA and H. pylori postapproval supplement.
Both letters address specifications and controls for a nitrosamine drug substance–related impurity, N-nitroso-vonoprazan (NVP), which was detected in the initial commercial launch materials of both products.
The FDA letters ask Phathom to provide “additional stability data to demonstrate that levels of the impurity previously found in vonoprazan drug product will remain at or below the daily acceptable intake throughout the proposed shelf life of the product,” Phathom said.
Phathom said it has conducted “extensive root cause investigations regarding the trace levels of the impurity since it was detected and has implemented mitigation measures to control the levels of NVP below the acceptable intake.”
The company expects to meet with the FDA before the end of March to discuss a resubmission plan and a timeline for the vonoprazan products.
Owing to the regulatory delays, Phathom said it no longer expects product launches for H. pylori or erosive esophagitis in the first quarter of 2023.
A version of this article first appeared on Medscape.com.
Room for improvement in Barrett esophagus care
, an analysis of U.S. registry data shows.
“As the GI Quality Improvement Consortium (GIQuIC) registry represents the ‘best-case scenario’ for adherence, since sites and endoscopists enrolled in this quality registry are aware that their practices are being monitored, these results indicate that there is still room for improvement and better consistency,” the researchers write.
The study was published online in The American Journal of Gastroenterology.
Quality care in BE, which is a precursor to esophageal adenocarcinoma (EAC), includes adherence to the Seattle biopsy protocol for sampling the BE segment (four-quadrant biopsies every 2 cm) and to a surveillance interval of 3-5 years for patients with nondysplastic BE (NDBE).
Previous studies have found poor adherence to these two QIs, but those studies only provided overall estimates, and individual endoscopists or different sites were not taken into consideration.
Jennifer Kolb, MD, with the University of California, Los Angeles, and colleagues say their study is the first to highlight variation in adherence to these measures at the center and endoscopist levels.
The study is also the first U.S. population–based study to report the dysplasia detection rate (DDR), which is a proposed quality indicator. The findings on this metric also demonstrate marked variability across endoscopists and sites.
Study details
Using the nationwide GIQuIC registry, the researchers evaluated endoscopist and site-based adherence to the Seattle protocol and surveillance interval advice from January 2018 to May 2021.
Among 255 practices with 1,195 endoscopists who performed 20,155 upper endoscopies for suspected or established BE, overall adherence to the Seattle protocol was 86%, which is considerably higher than the 51% reported in a study conducted from 2002 to 2007, Dr. Kolb and colleagues note.
When researchers looked specifically at 572 endoscopists for whom there were at least 10 endoscopy records in the registry, they found high variability in adherence to the Seattle protocol (median, 93.8%; interquartile range, 18.9%).
Adherence to the Seattle protocol was also variable among 153 practices for which there were at least 20 endoscopy records (median, 90%; IQR, 20.1%).
Of the 12,100 upper endoscopies with documented NDBE, 8,517 (70.4%) had a guideline-concordant–recommended surveillance interval of 3-5 years, with variability at both the endoscopist (median, 82.4%; IQR, 36.3%) and site level (median, 77.2%; IQR, 28.9%).
Endoscopist and site adherence to the Seattle protocol and surveillance guidance generally rose along with volume of upper endoscopies performed.
The overall DDR was 3.1%; it varied among endoscopists and sites (mean, 3.3% for both).
The investigators note that the 95% confidence intervals for each provider for DDR were “highly variable” and ranged from –20% to 119.3%. Notably, increasing upper endoscopy volume had an inconsistent effect on adherence rates and DDR by endoscopists and sites.
The investigators saw no correlation between overall DDR and Seattle protocol adherence among sites and only weak but statistically significant negative correlation between DDR and Seattle protocol adherence among individual endoscopists.
Practical approaches to improvement
The researchers say their observations from the GIQuIC database “most accurately represent the real-world experience in Barrett’s endoscopy.”
The results can serve as a “benchmark for quality initiatives and intervention trials aimed at improving outcomes for patients with BE,” they say.
Improving adherence to key QI measures and ensuring more consistent clinical behavior across practice groups and endoscopists are “critical first steps” to ensure high-quality BE care, Dr. Kolb and colleagues say.
To that end, they encourage professional societies to emphasize these metrics to their members and to streamline the reporting systems for QIs within the electronic health records used across various practice settings.
Avenues to improve examination quality may include educational interventions, such as online learning platforms that teach dysplasia detection or that highlight best practices, they add. These educational tools should be easy to use and should emphasize quality improvement measures.
“Future efforts are warranted to identify and extinguish predictors of this variability and to determine whether these interventions can improve DDR and adherence rates to QIs among endoscopists doing these examinations with the goal to improve EAC outcomes,” they conclude.
The study had no financial support. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, an analysis of U.S. registry data shows.
“As the GI Quality Improvement Consortium (GIQuIC) registry represents the ‘best-case scenario’ for adherence, since sites and endoscopists enrolled in this quality registry are aware that their practices are being monitored, these results indicate that there is still room for improvement and better consistency,” the researchers write.
The study was published online in The American Journal of Gastroenterology.
Quality care in BE, which is a precursor to esophageal adenocarcinoma (EAC), includes adherence to the Seattle biopsy protocol for sampling the BE segment (four-quadrant biopsies every 2 cm) and to a surveillance interval of 3-5 years for patients with nondysplastic BE (NDBE).
Previous studies have found poor adherence to these two QIs, but those studies only provided overall estimates, and individual endoscopists or different sites were not taken into consideration.
Jennifer Kolb, MD, with the University of California, Los Angeles, and colleagues say their study is the first to highlight variation in adherence to these measures at the center and endoscopist levels.
The study is also the first U.S. population–based study to report the dysplasia detection rate (DDR), which is a proposed quality indicator. The findings on this metric also demonstrate marked variability across endoscopists and sites.
Study details
Using the nationwide GIQuIC registry, the researchers evaluated endoscopist and site-based adherence to the Seattle protocol and surveillance interval advice from January 2018 to May 2021.
Among 255 practices with 1,195 endoscopists who performed 20,155 upper endoscopies for suspected or established BE, overall adherence to the Seattle protocol was 86%, which is considerably higher than the 51% reported in a study conducted from 2002 to 2007, Dr. Kolb and colleagues note.
When researchers looked specifically at 572 endoscopists for whom there were at least 10 endoscopy records in the registry, they found high variability in adherence to the Seattle protocol (median, 93.8%; interquartile range, 18.9%).
Adherence to the Seattle protocol was also variable among 153 practices for which there were at least 20 endoscopy records (median, 90%; IQR, 20.1%).
Of the 12,100 upper endoscopies with documented NDBE, 8,517 (70.4%) had a guideline-concordant–recommended surveillance interval of 3-5 years, with variability at both the endoscopist (median, 82.4%; IQR, 36.3%) and site level (median, 77.2%; IQR, 28.9%).
Endoscopist and site adherence to the Seattle protocol and surveillance guidance generally rose along with volume of upper endoscopies performed.
The overall DDR was 3.1%; it varied among endoscopists and sites (mean, 3.3% for both).
The investigators note that the 95% confidence intervals for each provider for DDR were “highly variable” and ranged from –20% to 119.3%. Notably, increasing upper endoscopy volume had an inconsistent effect on adherence rates and DDR by endoscopists and sites.
The investigators saw no correlation between overall DDR and Seattle protocol adherence among sites and only weak but statistically significant negative correlation between DDR and Seattle protocol adherence among individual endoscopists.
Practical approaches to improvement
The researchers say their observations from the GIQuIC database “most accurately represent the real-world experience in Barrett’s endoscopy.”
The results can serve as a “benchmark for quality initiatives and intervention trials aimed at improving outcomes for patients with BE,” they say.
Improving adherence to key QI measures and ensuring more consistent clinical behavior across practice groups and endoscopists are “critical first steps” to ensure high-quality BE care, Dr. Kolb and colleagues say.
To that end, they encourage professional societies to emphasize these metrics to their members and to streamline the reporting systems for QIs within the electronic health records used across various practice settings.
Avenues to improve examination quality may include educational interventions, such as online learning platforms that teach dysplasia detection or that highlight best practices, they add. These educational tools should be easy to use and should emphasize quality improvement measures.
“Future efforts are warranted to identify and extinguish predictors of this variability and to determine whether these interventions can improve DDR and adherence rates to QIs among endoscopists doing these examinations with the goal to improve EAC outcomes,” they conclude.
The study had no financial support. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
, an analysis of U.S. registry data shows.
“As the GI Quality Improvement Consortium (GIQuIC) registry represents the ‘best-case scenario’ for adherence, since sites and endoscopists enrolled in this quality registry are aware that their practices are being monitored, these results indicate that there is still room for improvement and better consistency,” the researchers write.
The study was published online in The American Journal of Gastroenterology.
Quality care in BE, which is a precursor to esophageal adenocarcinoma (EAC), includes adherence to the Seattle biopsy protocol for sampling the BE segment (four-quadrant biopsies every 2 cm) and to a surveillance interval of 3-5 years for patients with nondysplastic BE (NDBE).
Previous studies have found poor adherence to these two QIs, but those studies only provided overall estimates, and individual endoscopists or different sites were not taken into consideration.
Jennifer Kolb, MD, with the University of California, Los Angeles, and colleagues say their study is the first to highlight variation in adherence to these measures at the center and endoscopist levels.
The study is also the first U.S. population–based study to report the dysplasia detection rate (DDR), which is a proposed quality indicator. The findings on this metric also demonstrate marked variability across endoscopists and sites.
Study details
Using the nationwide GIQuIC registry, the researchers evaluated endoscopist and site-based adherence to the Seattle protocol and surveillance interval advice from January 2018 to May 2021.
Among 255 practices with 1,195 endoscopists who performed 20,155 upper endoscopies for suspected or established BE, overall adherence to the Seattle protocol was 86%, which is considerably higher than the 51% reported in a study conducted from 2002 to 2007, Dr. Kolb and colleagues note.
When researchers looked specifically at 572 endoscopists for whom there were at least 10 endoscopy records in the registry, they found high variability in adherence to the Seattle protocol (median, 93.8%; interquartile range, 18.9%).
Adherence to the Seattle protocol was also variable among 153 practices for which there were at least 20 endoscopy records (median, 90%; IQR, 20.1%).
Of the 12,100 upper endoscopies with documented NDBE, 8,517 (70.4%) had a guideline-concordant–recommended surveillance interval of 3-5 years, with variability at both the endoscopist (median, 82.4%; IQR, 36.3%) and site level (median, 77.2%; IQR, 28.9%).
Endoscopist and site adherence to the Seattle protocol and surveillance guidance generally rose along with volume of upper endoscopies performed.
The overall DDR was 3.1%; it varied among endoscopists and sites (mean, 3.3% for both).
The investigators note that the 95% confidence intervals for each provider for DDR were “highly variable” and ranged from –20% to 119.3%. Notably, increasing upper endoscopy volume had an inconsistent effect on adherence rates and DDR by endoscopists and sites.
The investigators saw no correlation between overall DDR and Seattle protocol adherence among sites and only weak but statistically significant negative correlation between DDR and Seattle protocol adherence among individual endoscopists.
Practical approaches to improvement
The researchers say their observations from the GIQuIC database “most accurately represent the real-world experience in Barrett’s endoscopy.”
The results can serve as a “benchmark for quality initiatives and intervention trials aimed at improving outcomes for patients with BE,” they say.
Improving adherence to key QI measures and ensuring more consistent clinical behavior across practice groups and endoscopists are “critical first steps” to ensure high-quality BE care, Dr. Kolb and colleagues say.
To that end, they encourage professional societies to emphasize these metrics to their members and to streamline the reporting systems for QIs within the electronic health records used across various practice settings.
Avenues to improve examination quality may include educational interventions, such as online learning platforms that teach dysplasia detection or that highlight best practices, they add. These educational tools should be easy to use and should emphasize quality improvement measures.
“Future efforts are warranted to identify and extinguish predictors of this variability and to determine whether these interventions can improve DDR and adherence rates to QIs among endoscopists doing these examinations with the goal to improve EAC outcomes,” they conclude.
The study had no financial support. The authors have disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM THE AMERICAN JOURNAL OF GASTROENTEROLOGY