Ob.Gyn. News

The early cancellation of a trial in southern India suggests that the use of antenatal steroids to prevent respiratory complications after late-preterm birth — a recommended practice in the United States — may not be effective in the developing world.

As reported in Obstetrics & Gynecology, researchers led by Hilda Yenuberi, MD, of Christian Medical College, Vellore, Tamil Nadu, India, stopped the randomized, triple-blinded, placebo-controlled CLAP (Corticosteroids in Late Pregnancy) study at 70% enrollment. An interim analysis found no benefit from prescribing betamethasone vs placebo to women at risk of late-preterm delivery between 34 and 36 and 6/7 weeks of gestation (primary outcome of respiratory distress: 4.9% vs 4.8%, respectively, relative risk [RR], 1.03; 95% CI, 0.57-1.84; number needed to treat = 786).

“These findings may suggest differing efficacy of antenatal corticosteroids in developing countries compared with developed countries ... that should be considered when late-preterm antenatal corticosteroids are administered,” the researchers wrote.

The use of steroids in patients at risk of delivery before 34 weeks is widely accepted as a way to prevent neonatal respiratory distress, a common and potentially deadly condition in premature infants whose lungs are not fully developed. However, there’s debate over steroid treatment in women who are expected to deliver later than 34 weeks but still preterm.

As the study notes, “the American College of Obstetricians and Gynecologists recommends a single course of betamethasone for pregnant individuals at risk of delivering between 34 and 36 6/7 weeks of gestation on the basis of the ALPS (Antenatal Late Preterm Steroid) trial.”

But other randomized trials have reached different conclusions, and steroids are not without risks. Studies have linked prenatal steroids to neurosensory disorders in babies, meaning they’re more likely to need hearing aids and eyeglasses, said Kellie Murphy, MD, MSc, professor of obstetrics and gynecology, University of Toronto, Toronto, Ontario, Canada, in an interview. Dr. Murphy, who was not involved in the new trial, added that there are links between steroids and greater likelihood of poorer performance in school,

For the new study, conducted from 2020 to 2022 at Christian Medical College and Hospital in Vellore, India, researchers randomly assigned 423 patients to betamethasone (410 in the interim analysis; average age, 26.8 years) and 424 to placebo (415 in the interim analysis; average age, 26.2 years).

The average age of participants was 26.8 years. All were between 34 and 36 6/7 weeks of gestation and expected to give birth within the next week. A quarter of participants delivered at term, which the authors wrote “may have influenced the primary outcome.” The total number of neonates was 883, including 58 twin pregnancies.

There was no significant difference in respiratory distress between groups, “defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life.” There also were no significant differences in maternal outcomes such as chorioamnionitis or length of hospitalization or neonatal secondary outcomes such as transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, stillbirth, and early neonatal death.

Serious adverse events occurred in four neonates but none were linked to the intervention.

The study doesn’t discuss cost, but a 2019 report suggests that use of betamethasone to prevent neonatal respiratory distress is cost-effective.

“Our findings are contradictory to those of a systematic review, the major contributor of which was the ALPS trial,” the authors of the new study reported. “The primary outcome of the ALPS trial, the composite of neonatal treatment in the first 72 hours, was significantly less in the group who received betamethasone (11.6%), compared with the placebo group (14.4%; relative risk [RR], 0.80; 95% CI, 0.66-0.97).”

The study authors, who didn’t respond to requests for comment, noted that their trial included twin pregnancies and patients with gestational diabetes; the ALPS trial did not.

Perinatologist Cynthia Gyamfi-Bannerman, MD, MS, chair and professor of Obstetrics, Gynecology, and Reproductive Sciences at the University of California,San Diego, and principal investigator of the ALPS study, said in an interview that the inclusion of twins in the new trial is “a fundamental flaw.”

“Because antenatal corticosteroids have not been shown to be useful in twins at any gestational age, it is not surprising that including twins likely moved the findings to the null in this study,” she said. “Twins were purposefully excluded from the ALPS trial for this reason.”

According to the new study, “the primary outcome among singleton neonates occurred in 4.8% (18/374) who received betamethasone and 5.1% (20/393) who received placebo (RR, 0.94; 95% CI, 0.51-1.75)

What should clinicians take from the study findings? In an accompanying commentary, Blair J. Wylie, MD, MPH, of Columbia University Medical Center, New York, NY, and Syed Asad Ali, MBBS, MPH, of Aga Khan University, Karachi, Pakistan, wrote that, “in settings similar to the US-based ALPS trial, the practice of administering a course of late-preterm antenatal corticosteroids should be continued, as espoused by our professional organizations.”

However, the new study suggests that “research in high-resource environments may not be generalizable to low-resource settings,” they write.

Neonatologist Elizabeth Asztalos, MD, MSc, an associate scientist with Sunnybrook Health Sciences Center in Toronto, Canada, said in an interview that she doesn’t worry about pregnant mothers not getting steroids later than 34 weeks. “We have tools in our armamentarium in the NICU setting to help babies if they need it,” said Dr. Asztalos, who didn’t take part in the new trial. “We can put them on CPAP if they have wet lung. If they have an element of respiratory distress, we can give them surfactants. These bigger babies have more ability to recover from all this compared to a baby who was born at 24, 25, 26 weeks.”

For her part, the University of Toronto’s Dr. Murphy said decision-making about late-preterm steroids is complicated. “You don’t want to miss the opportunity to give to provide benefits for the patients” via steroids, she said. “But on the flip side, it’s a double-edged sword. It’s not easy. It’s not straightforward.”

In the big picture, she said, “people need to be really clear why they’re giving an intervention and what they hope to achieve.”

Christian Medical College supported the study. The authors, Dr. Murphy, Dr. Asztalos, and commentary co-author Dr. Ali have no disclosures. Dr. Gyamfi-Bannerman discloses being principal investigator of the ALPS trial. Commentary co-author Dr. Wylie serves on the ultrasound quality assurance committee of a trial discussed in the commentary.

The early cancellation of a trial in southern India suggests that the use of antenatal steroids to prevent respiratory complications after late-preterm birth — a recommended practice in the United States — may not be effective in the developing world.

As reported in Obstetrics & Gynecology, researchers led by Hilda Yenuberi, MD, of Christian Medical College, Vellore, Tamil Nadu, India, stopped the randomized, triple-blinded, placebo-controlled CLAP (Corticosteroids in Late Pregnancy) study at 70% enrollment. An interim analysis found no benefit from prescribing betamethasone vs placebo to women at risk of late-preterm delivery between 34 and 36 and 6/7 weeks of gestation (primary outcome of respiratory distress: 4.9% vs 4.8%, respectively, relative risk [RR], 1.03; 95% CI, 0.57-1.84; number needed to treat = 786).

“These findings may suggest differing efficacy of antenatal corticosteroids in developing countries compared with developed countries ... that should be considered when late-preterm antenatal corticosteroids are administered,” the researchers wrote.

The use of steroids in patients at risk of delivery before 34 weeks is widely accepted as a way to prevent neonatal respiratory distress, a common and potentially deadly condition in premature infants whose lungs are not fully developed. However, there’s debate over steroid treatment in women who are expected to deliver later than 34 weeks but still preterm.

As the study notes, “the American College of Obstetricians and Gynecologists recommends a single course of betamethasone for pregnant individuals at risk of delivering between 34 and 36 6/7 weeks of gestation on the basis of the ALPS (Antenatal Late Preterm Steroid) trial.”

But other randomized trials have reached different conclusions, and steroids are not without risks. Studies have linked prenatal steroids to neurosensory disorders in babies, meaning they’re more likely to need hearing aids and eyeglasses, said Kellie Murphy, MD, MSc, professor of obstetrics and gynecology, University of Toronto, Toronto, Ontario, Canada, in an interview. Dr. Murphy, who was not involved in the new trial, added that there are links between steroids and greater likelihood of poorer performance in school,

For the new study, conducted from 2020 to 2022 at Christian Medical College and Hospital in Vellore, India, researchers randomly assigned 423 patients to betamethasone (410 in the interim analysis; average age, 26.8 years) and 424 to placebo (415 in the interim analysis; average age, 26.2 years).

The average age of participants was 26.8 years. All were between 34 and 36 6/7 weeks of gestation and expected to give birth within the next week. A quarter of participants delivered at term, which the authors wrote “may have influenced the primary outcome.” The total number of neonates was 883, including 58 twin pregnancies.

There was no significant difference in respiratory distress between groups, “defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life.” There also were no significant differences in maternal outcomes such as chorioamnionitis or length of hospitalization or neonatal secondary outcomes such as transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, stillbirth, and early neonatal death.

Serious adverse events occurred in four neonates but none were linked to the intervention.

The study doesn’t discuss cost, but a 2019 report suggests that use of betamethasone to prevent neonatal respiratory distress is cost-effective.

“Our findings are contradictory to those of a systematic review, the major contributor of which was the ALPS trial,” the authors of the new study reported. “The primary outcome of the ALPS trial, the composite of neonatal treatment in the first 72 hours, was significantly less in the group who received betamethasone (11.6%), compared with the placebo group (14.4%; relative risk [RR], 0.80; 95% CI, 0.66-0.97).”

The study authors, who didn’t respond to requests for comment, noted that their trial included twin pregnancies and patients with gestational diabetes; the ALPS trial did not.

Perinatologist Cynthia Gyamfi-Bannerman, MD, MS, chair and professor of Obstetrics, Gynecology, and Reproductive Sciences at the University of California,San Diego, and principal investigator of the ALPS study, said in an interview that the inclusion of twins in the new trial is “a fundamental flaw.”

“Because antenatal corticosteroids have not been shown to be useful in twins at any gestational age, it is not surprising that including twins likely moved the findings to the null in this study,” she said. “Twins were purposefully excluded from the ALPS trial for this reason.”

According to the new study, “the primary outcome among singleton neonates occurred in 4.8% (18/374) who received betamethasone and 5.1% (20/393) who received placebo (RR, 0.94; 95% CI, 0.51-1.75)

What should clinicians take from the study findings? In an accompanying commentary, Blair J. Wylie, MD, MPH, of Columbia University Medical Center, New York, NY, and Syed Asad Ali, MBBS, MPH, of Aga Khan University, Karachi, Pakistan, wrote that, “in settings similar to the US-based ALPS trial, the practice of administering a course of late-preterm antenatal corticosteroids should be continued, as espoused by our professional organizations.”

However, the new study suggests that “research in high-resource environments may not be generalizable to low-resource settings,” they write.

Neonatologist Elizabeth Asztalos, MD, MSc, an associate scientist with Sunnybrook Health Sciences Center in Toronto, Canada, said in an interview that she doesn’t worry about pregnant mothers not getting steroids later than 34 weeks. “We have tools in our armamentarium in the NICU setting to help babies if they need it,” said Dr. Asztalos, who didn’t take part in the new trial. “We can put them on CPAP if they have wet lung. If they have an element of respiratory distress, we can give them surfactants. These bigger babies have more ability to recover from all this compared to a baby who was born at 24, 25, 26 weeks.”

For her part, the University of Toronto’s Dr. Murphy said decision-making about late-preterm steroids is complicated. “You don’t want to miss the opportunity to give to provide benefits for the patients” via steroids, she said. “But on the flip side, it’s a double-edged sword. It’s not easy. It’s not straightforward.”

In the big picture, she said, “people need to be really clear why they’re giving an intervention and what they hope to achieve.”

Christian Medical College supported the study. The authors, Dr. Murphy, Dr. Asztalos, and commentary co-author Dr. Ali have no disclosures. Dr. Gyamfi-Bannerman discloses being principal investigator of the ALPS trial. Commentary co-author Dr. Wylie serves on the ultrasound quality assurance committee of a trial discussed in the commentary.

The early cancellation of a trial in southern India suggests that the use of antenatal steroids to prevent respiratory complications after late-preterm birth — a recommended practice in the United States — may not be effective in the developing world.

As reported in Obstetrics & Gynecology, researchers led by Hilda Yenuberi, MD, of Christian Medical College, Vellore, Tamil Nadu, India, stopped the randomized, triple-blinded, placebo-controlled CLAP (Corticosteroids in Late Pregnancy) study at 70% enrollment. An interim analysis found no benefit from prescribing betamethasone vs placebo to women at risk of late-preterm delivery between 34 and 36 and 6/7 weeks of gestation (primary outcome of respiratory distress: 4.9% vs 4.8%, respectively, relative risk [RR], 1.03; 95% CI, 0.57-1.84; number needed to treat = 786).

“These findings may suggest differing efficacy of antenatal corticosteroids in developing countries compared with developed countries ... that should be considered when late-preterm antenatal corticosteroids are administered,” the researchers wrote.

The use of steroids in patients at risk of delivery before 34 weeks is widely accepted as a way to prevent neonatal respiratory distress, a common and potentially deadly condition in premature infants whose lungs are not fully developed. However, there’s debate over steroid treatment in women who are expected to deliver later than 34 weeks but still preterm.

As the study notes, “the American College of Obstetricians and Gynecologists recommends a single course of betamethasone for pregnant individuals at risk of delivering between 34 and 36 6/7 weeks of gestation on the basis of the ALPS (Antenatal Late Preterm Steroid) trial.”

But other randomized trials have reached different conclusions, and steroids are not without risks. Studies have linked prenatal steroids to neurosensory disorders in babies, meaning they’re more likely to need hearing aids and eyeglasses, said Kellie Murphy, MD, MSc, professor of obstetrics and gynecology, University of Toronto, Toronto, Ontario, Canada, in an interview. Dr. Murphy, who was not involved in the new trial, added that there are links between steroids and greater likelihood of poorer performance in school,

For the new study, conducted from 2020 to 2022 at Christian Medical College and Hospital in Vellore, India, researchers randomly assigned 423 patients to betamethasone (410 in the interim analysis; average age, 26.8 years) and 424 to placebo (415 in the interim analysis; average age, 26.2 years).

The average age of participants was 26.8 years. All were between 34 and 36 6/7 weeks of gestation and expected to give birth within the next week. A quarter of participants delivered at term, which the authors wrote “may have influenced the primary outcome.” The total number of neonates was 883, including 58 twin pregnancies.

There was no significant difference in respiratory distress between groups, “defined as need for oxygen or continuous positive airway pressure or mechanical ventilation for at least 2 hours in the first 72 hours of life.” There also were no significant differences in maternal outcomes such as chorioamnionitis or length of hospitalization or neonatal secondary outcomes such as transient tachypnea of the newborn, respiratory distress syndrome, necrotizing enterocolitis, sepsis, hyperbilirubinemia, stillbirth, and early neonatal death.

Serious adverse events occurred in four neonates but none were linked to the intervention.

The study doesn’t discuss cost, but a 2019 report suggests that use of betamethasone to prevent neonatal respiratory distress is cost-effective.

“Our findings are contradictory to those of a systematic review, the major contributor of which was the ALPS trial,” the authors of the new study reported. “The primary outcome of the ALPS trial, the composite of neonatal treatment in the first 72 hours, was significantly less in the group who received betamethasone (11.6%), compared with the placebo group (14.4%; relative risk [RR], 0.80; 95% CI, 0.66-0.97).”

The study authors, who didn’t respond to requests for comment, noted that their trial included twin pregnancies and patients with gestational diabetes; the ALPS trial did not.

Perinatologist Cynthia Gyamfi-Bannerman, MD, MS, chair and professor of Obstetrics, Gynecology, and Reproductive Sciences at the University of California,San Diego, and principal investigator of the ALPS study, said in an interview that the inclusion of twins in the new trial is “a fundamental flaw.”

“Because antenatal corticosteroids have not been shown to be useful in twins at any gestational age, it is not surprising that including twins likely moved the findings to the null in this study,” she said. “Twins were purposefully excluded from the ALPS trial for this reason.”

According to the new study, “the primary outcome among singleton neonates occurred in 4.8% (18/374) who received betamethasone and 5.1% (20/393) who received placebo (RR, 0.94; 95% CI, 0.51-1.75)

What should clinicians take from the study findings? In an accompanying commentary, Blair J. Wylie, MD, MPH, of Columbia University Medical Center, New York, NY, and Syed Asad Ali, MBBS, MPH, of Aga Khan University, Karachi, Pakistan, wrote that, “in settings similar to the US-based ALPS trial, the practice of administering a course of late-preterm antenatal corticosteroids should be continued, as espoused by our professional organizations.”

However, the new study suggests that “research in high-resource environments may not be generalizable to low-resource settings,” they write.

Neonatologist Elizabeth Asztalos, MD, MSc, an associate scientist with Sunnybrook Health Sciences Center in Toronto, Canada, said in an interview that she doesn’t worry about pregnant mothers not getting steroids later than 34 weeks. “We have tools in our armamentarium in the NICU setting to help babies if they need it,” said Dr. Asztalos, who didn’t take part in the new trial. “We can put them on CPAP if they have wet lung. If they have an element of respiratory distress, we can give them surfactants. These bigger babies have more ability to recover from all this compared to a baby who was born at 24, 25, 26 weeks.”

For her part, the University of Toronto’s Dr. Murphy said decision-making about late-preterm steroids is complicated. “You don’t want to miss the opportunity to give to provide benefits for the patients” via steroids, she said. “But on the flip side, it’s a double-edged sword. It’s not easy. It’s not straightforward.”

In the big picture, she said, “people need to be really clear why they’re giving an intervention and what they hope to achieve.”

Christian Medical College supported the study. The authors, Dr. Murphy, Dr. Asztalos, and commentary co-author Dr. Ali have no disclosures. Dr. Gyamfi-Bannerman discloses being principal investigator of the ALPS trial. Commentary co-author Dr. Wylie serves on the ultrasound quality assurance committee of a trial discussed in the commentary.

Medicare reimbursement for common breast cancer surgeries decreased significantly over the past two decades, and the resulting shortage of funds could affect quality of care and access to services, especially for vulnerable patient populations.

These were findings of new research presented by Terry P. Gao, MD, at the American Society of Breast Surgeons annual meeting.

Medicare reimbursements often set a benchmark that is followed by private insurers, and the impact of changes on various breast surgeries have not been examined, Dr. Gao, a research resident at Temple University Hospital, Philadelphia, said during a press briefing in advance of the meeting.

“This study is important because it is the first to analyze trends in Medicare reimbursement for breast cancer surgery over a long period,” Dr. Gao said during an interview. The findings highlight a critical issue that could impact access to quality care, especially for vulnerable populations, she said.
 

How Were the Data Analyzed?

Dr. Gao and colleagues reviewed percent changes in reimbursement procedures over a 20-year period and compared them to changes in the consumer price index (CPI) to show the real-life impact of inflation.

The study examined reimbursements based on the Medicare Physician Fee Schedule Look-Up Tool from 2003 to 2023 for 10 procedures. The procedures were core needle biopsy, open incisional breast biopsy, open excisional breast biopsy, lumpectomy, lumpectomy with axillary lymph node dissection (ALND), simple mastectomy, radical mastectomy, modified radical mastectomy, biopsy/removal of lymph nodes, and sentinel lymph node biopsy.
 

What Does the New Study Show?

“Reimbursements did not keep pace with the price of goods and services,” Dr. Gao said during the press briefing.

After the researchers corrected data for inflation, the overall mean Medicare reimbursement for breast cancer surgeries decreased by approximately 21%, based in part on the 69% increase in the CPI over the study period, Dr. Gao said. The greatest change was in core needle biopsy, for which reimbursement decreased by 36%.

After inflation adjustment, reimbursement increases were seen for only two procedures, lumpectomy and simple mastectomy, of 0.37% and 3.58%, respectively, but these do not represent meaningful gains, Dr. Gao said.

The researchers also used a model to estimate the real-life impact of decreased reimbursement on clinicians. They subtracted the actual 2023 compensation from expected 2023 compensation based on inflation for a breast cancer case incidence of 297,790 patients who underwent axillary surgery, breast lumpectomy, or simple mastectomy. The calculated potential real-world compensation loss for that year was $107,604,444.
 

What are the Clinical Implications? 

The current study is the first to put specific numbers on the trend in declining breast cancer payments, and the findings should encourage physicians to advocate for equitable policies, Dr. Gao noted during the briefing.

The substantial decrease in inflation-adjusted reimbursement rates was significant, she said during the interview. Although the decrease reflects similar trends seen in other specialties, the magnitude is a potential cause for concern, she said.

Declining reimbursements could disproportionately hurt safety-net hospitals serving vulnerable populations by limiting their ability to invest in better care and potentially worsening existing racial disparities, Dr. Gao told this publication. “Additionally, surgeons may opt out of Medicare networks due to low rates, leading to access issues and longer wait times. Finally, these trends could discourage future generations from specializing in breast cancer surgery.”

The study findings should be considered in the context of the complex and rapidly changing clinical landscape in which breast cancer care is evolving, Mediget Teshome, MD, chief of breast surgery at UCLA Health, said during an interview.

“Surgery remains a critically important aspect to curative treatment,” Dr. Teshome said.

Surgical decision-making tailored to each patient’s goals involves coordination from a multidisciplinary team as well as skill and attention from surgeons, she added.

“This degree of specialization and nuance is not always captured in reimbursement models for breast surgery,” Dr. Teshome emphasized. The policy implications of any changes in Medicare reimbursement will be important given the American Cancer Society reports breast cancer as the most commonly diagnosed cancer in women in the United States, and as the second leading cause of cancer death in US women, she noted.
 

What Additional Research Is Needed?

Research is needed to understand how declining reimbursements affect patients’ access to care, treatment choices, and long-term outcomes, Dr. Gao said in the interview. Future studies also are needed to examine provider overhead costs, staffing structures, and profit margins to offer a more comprehensive understanding of financial sustainability.

Dr. Gao and Dr. Teshome had no financial conflicts to disclose.

Medicare reimbursement for common breast cancer surgeries decreased significantly over the past two decades, and the resulting shortage of funds could affect quality of care and access to services, especially for vulnerable patient populations.

These were findings of new research presented by Terry P. Gao, MD, at the American Society of Breast Surgeons annual meeting.

Medicare reimbursements often set a benchmark that is followed by private insurers, and the impact of changes on various breast surgeries have not been examined, Dr. Gao, a research resident at Temple University Hospital, Philadelphia, said during a press briefing in advance of the meeting.

“This study is important because it is the first to analyze trends in Medicare reimbursement for breast cancer surgery over a long period,” Dr. Gao said during an interview. The findings highlight a critical issue that could impact access to quality care, especially for vulnerable populations, she said.
 

How Were the Data Analyzed?

Dr. Gao and colleagues reviewed percent changes in reimbursement procedures over a 20-year period and compared them to changes in the consumer price index (CPI) to show the real-life impact of inflation.

The study examined reimbursements based on the Medicare Physician Fee Schedule Look-Up Tool from 2003 to 2023 for 10 procedures. The procedures were core needle biopsy, open incisional breast biopsy, open excisional breast biopsy, lumpectomy, lumpectomy with axillary lymph node dissection (ALND), simple mastectomy, radical mastectomy, modified radical mastectomy, biopsy/removal of lymph nodes, and sentinel lymph node biopsy.
 

What Does the New Study Show?

“Reimbursements did not keep pace with the price of goods and services,” Dr. Gao said during the press briefing.

After the researchers corrected data for inflation, the overall mean Medicare reimbursement for breast cancer surgeries decreased by approximately 21%, based in part on the 69% increase in the CPI over the study period, Dr. Gao said. The greatest change was in core needle biopsy, for which reimbursement decreased by 36%.

After inflation adjustment, reimbursement increases were seen for only two procedures, lumpectomy and simple mastectomy, of 0.37% and 3.58%, respectively, but these do not represent meaningful gains, Dr. Gao said.

The researchers also used a model to estimate the real-life impact of decreased reimbursement on clinicians. They subtracted the actual 2023 compensation from expected 2023 compensation based on inflation for a breast cancer case incidence of 297,790 patients who underwent axillary surgery, breast lumpectomy, or simple mastectomy. The calculated potential real-world compensation loss for that year was $107,604,444.
 

What are the Clinical Implications? 

The current study is the first to put specific numbers on the trend in declining breast cancer payments, and the findings should encourage physicians to advocate for equitable policies, Dr. Gao noted during the briefing.

The substantial decrease in inflation-adjusted reimbursement rates was significant, she said during the interview. Although the decrease reflects similar trends seen in other specialties, the magnitude is a potential cause for concern, she said.

Declining reimbursements could disproportionately hurt safety-net hospitals serving vulnerable populations by limiting their ability to invest in better care and potentially worsening existing racial disparities, Dr. Gao told this publication. “Additionally, surgeons may opt out of Medicare networks due to low rates, leading to access issues and longer wait times. Finally, these trends could discourage future generations from specializing in breast cancer surgery.”

The study findings should be considered in the context of the complex and rapidly changing clinical landscape in which breast cancer care is evolving, Mediget Teshome, MD, chief of breast surgery at UCLA Health, said during an interview.

“Surgery remains a critically important aspect to curative treatment,” Dr. Teshome said.

Surgical decision-making tailored to each patient’s goals involves coordination from a multidisciplinary team as well as skill and attention from surgeons, she added.

“This degree of specialization and nuance is not always captured in reimbursement models for breast surgery,” Dr. Teshome emphasized. The policy implications of any changes in Medicare reimbursement will be important given the American Cancer Society reports breast cancer as the most commonly diagnosed cancer in women in the United States, and as the second leading cause of cancer death in US women, she noted.
 

What Additional Research Is Needed?

Research is needed to understand how declining reimbursements affect patients’ access to care, treatment choices, and long-term outcomes, Dr. Gao said in the interview. Future studies also are needed to examine provider overhead costs, staffing structures, and profit margins to offer a more comprehensive understanding of financial sustainability.

Dr. Gao and Dr. Teshome had no financial conflicts to disclose.

Medicare reimbursement for common breast cancer surgeries decreased significantly over the past two decades, and the resulting shortage of funds could affect quality of care and access to services, especially for vulnerable patient populations.

These were findings of new research presented by Terry P. Gao, MD, at the American Society of Breast Surgeons annual meeting.

Medicare reimbursements often set a benchmark that is followed by private insurers, and the impact of changes on various breast surgeries have not been examined, Dr. Gao, a research resident at Temple University Hospital, Philadelphia, said during a press briefing in advance of the meeting.

“This study is important because it is the first to analyze trends in Medicare reimbursement for breast cancer surgery over a long period,” Dr. Gao said during an interview. The findings highlight a critical issue that could impact access to quality care, especially for vulnerable populations, she said.
 

How Were the Data Analyzed?

Dr. Gao and colleagues reviewed percent changes in reimbursement procedures over a 20-year period and compared them to changes in the consumer price index (CPI) to show the real-life impact of inflation.

The study examined reimbursements based on the Medicare Physician Fee Schedule Look-Up Tool from 2003 to 2023 for 10 procedures. The procedures were core needle biopsy, open incisional breast biopsy, open excisional breast biopsy, lumpectomy, lumpectomy with axillary lymph node dissection (ALND), simple mastectomy, radical mastectomy, modified radical mastectomy, biopsy/removal of lymph nodes, and sentinel lymph node biopsy.
 

What Does the New Study Show?

“Reimbursements did not keep pace with the price of goods and services,” Dr. Gao said during the press briefing.

After the researchers corrected data for inflation, the overall mean Medicare reimbursement for breast cancer surgeries decreased by approximately 21%, based in part on the 69% increase in the CPI over the study period, Dr. Gao said. The greatest change was in core needle biopsy, for which reimbursement decreased by 36%.

After inflation adjustment, reimbursement increases were seen for only two procedures, lumpectomy and simple mastectomy, of 0.37% and 3.58%, respectively, but these do not represent meaningful gains, Dr. Gao said.

The researchers also used a model to estimate the real-life impact of decreased reimbursement on clinicians. They subtracted the actual 2023 compensation from expected 2023 compensation based on inflation for a breast cancer case incidence of 297,790 patients who underwent axillary surgery, breast lumpectomy, or simple mastectomy. The calculated potential real-world compensation loss for that year was $107,604,444.
 

What are the Clinical Implications? 

The current study is the first to put specific numbers on the trend in declining breast cancer payments, and the findings should encourage physicians to advocate for equitable policies, Dr. Gao noted during the briefing.

The substantial decrease in inflation-adjusted reimbursement rates was significant, she said during the interview. Although the decrease reflects similar trends seen in other specialties, the magnitude is a potential cause for concern, she said.

Declining reimbursements could disproportionately hurt safety-net hospitals serving vulnerable populations by limiting their ability to invest in better care and potentially worsening existing racial disparities, Dr. Gao told this publication. “Additionally, surgeons may opt out of Medicare networks due to low rates, leading to access issues and longer wait times. Finally, these trends could discourage future generations from specializing in breast cancer surgery.”

The study findings should be considered in the context of the complex and rapidly changing clinical landscape in which breast cancer care is evolving, Mediget Teshome, MD, chief of breast surgery at UCLA Health, said during an interview.

“Surgery remains a critically important aspect to curative treatment,” Dr. Teshome said.

Surgical decision-making tailored to each patient’s goals involves coordination from a multidisciplinary team as well as skill and attention from surgeons, she added.

“This degree of specialization and nuance is not always captured in reimbursement models for breast surgery,” Dr. Teshome emphasized. The policy implications of any changes in Medicare reimbursement will be important given the American Cancer Society reports breast cancer as the most commonly diagnosed cancer in women in the United States, and as the second leading cause of cancer death in US women, she noted.
 

What Additional Research Is Needed?

Research is needed to understand how declining reimbursements affect patients’ access to care, treatment choices, and long-term outcomes, Dr. Gao said in the interview. Future studies also are needed to examine provider overhead costs, staffing structures, and profit margins to offer a more comprehensive understanding of financial sustainability.

Dr. Gao and Dr. Teshome had no financial conflicts to disclose.

Early data suggested that several new multicancer early detection (MCED) tests in development show promise for identifying cancers that lack routine screening options.

Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower-income countries.

The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.

That being said, “the clinical utility of multicancer detection tests has not been established and we’re concerned about issues of overdiagnosis and overtreatment,” she noted.

The Early Data 

One new MCED test called CanScan, developed by Geneseeq Technology, uses plasma cell-free DNA fragment patterns to detect cancer signals as well as identify the tissue of origin across 13 cancer types.

Overall, the CanScan test covers cancer types that contribute to two thirds of new cancer cases and 74% of morality globally, said presenter Shanshan Yang, of Geneseeq Research Institute, in Nanjing, China.

However, only five of these cancer types have screening recommendations issued by the US Preventive Services Task Force (USPSTF), Dr. Yang added.

The interim data comes from an ongoing large-scale prospective study evaluating the MCED test in a cohort of asymptomatic individuals between ages 45 and 75 years with an average risk for cancer and no cancer-related symptoms on enrollment.

Patients at baseline had their blood collected for the CanScan test and subsequently received annual routine physical exams once a year for 3 consecutive years, with an additional 2 years of follow-up. 

The analysis included 3724 participants with analyzable samples at the data cutoff in September 2023. Among the 3724 participants, 29 had confirmed cancer diagnoses. Among these cases, 14 patients had their cancer confirmed through USPSTF recommended screening and 15 were detected through outside of standard USPSTF screening, such as a thyroid ultrasound, Dr. Yang explained.

Almost 90% of the cancers (26 of 29) were detected in the stage I or II, and eight (27.5%) were not one of the test’s 13 targeted cancer types.

The CanScan test had a sensitivity of 55.2%, identifying 16 of 29 of the patients with cancer, including 10 of 21 individuals with stage I (47.6%), and two of three with stage II (66.7%). 

The test had a high specificity of 97.9%, meaning out of 100 people screened, only two had false negative findings.

Among the 15 patients who had their cancer detected outside of USPSTF screening recommendations, eight (53.3%) were found using a CanScan test, including patients with liver and endometrial cancers.

Compared with a positive predictive value of (PPV) of 1.6% with screening or physical exam methods alone, the CanScan test had a PPV of 17.4%, Dr. Yang reported. 

“The MCED test holds significant potential for early cancer screening in asymptomatic populations,” Dr. Yang and colleagues concluded.

Another new MCED test called MERCURY, also developed by Geneseeq Technology and presented during the session, used a similar method to detect cancer signals and predict the tissue of origin across 13 cancer types.

The researchers initially validated the test using 3076 patients with cancer and 3477 healthy controls with a target specificity of 99%. In this group, researchers reported a sensitivity of 0.865 and a specificity of 0.989.

The team then performed an independent validation analysis with 1465 participants, 732 with cancer and 733 with no cancer, and confirmed a high sensitivity and specificity of 0.874 and 0.978, respectively. The sensitivity increased incrementally by cancer stage — 0.768 for stage I, 0.840 for stage II, 0.923 for stage III, and 0.971 for stage IV.

The test identified the tissue of origin with high accuracy, the researchers noted, but cautioned that the test needs “to be further validated in a prospective cohort study.”

MCED in Low-Income Settings

The session also featured findings on a new affordable MCED test called OncoSeek, which could provide greater access to cancer testing in low- and middle-income countries.

The OncoSeek algorithm identifies the presence of cancer using seven protein tumor markers alongside clinical information, such as gender and age. Like other tests, the test also predicts the possible tissue of origin.

The test can be run on clinical protein assay instruments that are already widely available, such as Roche cobas analyzer, Mao Mao, MD, PhD, the founder and CEO of SeekIn, of Shenzhen, China, told this news organization.

This “feature makes the test accessible worldwide, even in low- and middle-income countries,” he said. “These instruments are fully-automated and part of today’s clinical practice. Therefore, the test does not require additional infrastructure building and lab personal training.”

Another notable advantage: the OncoSeek test only costs about $20, compared with other MCED tests, which can cost anywhere from $200 to $1000.

To validate the technology in a large, diverse cohort, Dr. Mao and colleagues enrolled approximately 10,000 participants, including 2003 cancer cases and 7888 non-cancer cases.

Peripheral blood was collected from each participant and analyzed using a panel of the seven protein tumor markers — AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA 21-1.

To reduce the risk for false positive findings, the team designed the OncoSeek algorithm to achieve a specificity of 93%. Dr. Mao and colleagues found a sensitivity of 51.7%, resulting in an overall accuracy of 84.6%.

The performance was consistent in additional validation cohorts in Brazil, China, and the United States, with sensitivities ranging from 39.0% to 77.6% for detecting nine common cancer types, including breast, colorectal, liver, lung, lymphoma, esophagus, ovary, pancreas, and stomach. The sensitivity for pancreatic cancer was at the high end of 77.6%.

The test could predict the tissue of origin in about two thirds of cases. 

Given its low cost, OncoSeek represents an affordable and accessible option for cancer screening, the authors concluded. 

Overall, “I think MCEDs have the potential to enhance cancer screening,” Dr. Wood told this news organization.

Still, questions remain about the optimal use of these tests, such as whether they are best for average-risk or higher risk populations, and how to integrate them into standard screening, she said. 

Dr. Wood also cautioned that the studies presented in the session represent early data, and it is likely that the numbers, such as sensitivity and specificity, will change with further prospective analyses.

And ultimately, these tests should complement, not replace, standard screening. “A negative testing should not be taken as a sign to avoid standard screening,” Dr. Wood said.

Dr. Yang is an employee of Geneseeq Technology, Inc., and Dr. Mao is an employee of SeekIn. Dr. Wood had no disclosures to report.

A version of this article appeared on Medscape.com.

Early data suggested that several new multicancer early detection (MCED) tests in development show promise for identifying cancers that lack routine screening options.

Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower-income countries.

The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.

That being said, “the clinical utility of multicancer detection tests has not been established and we’re concerned about issues of overdiagnosis and overtreatment,” she noted.

The Early Data 

One new MCED test called CanScan, developed by Geneseeq Technology, uses plasma cell-free DNA fragment patterns to detect cancer signals as well as identify the tissue of origin across 13 cancer types.

Overall, the CanScan test covers cancer types that contribute to two thirds of new cancer cases and 74% of morality globally, said presenter Shanshan Yang, of Geneseeq Research Institute, in Nanjing, China.

However, only five of these cancer types have screening recommendations issued by the US Preventive Services Task Force (USPSTF), Dr. Yang added.

The interim data comes from an ongoing large-scale prospective study evaluating the MCED test in a cohort of asymptomatic individuals between ages 45 and 75 years with an average risk for cancer and no cancer-related symptoms on enrollment.

Patients at baseline had their blood collected for the CanScan test and subsequently received annual routine physical exams once a year for 3 consecutive years, with an additional 2 years of follow-up. 

The analysis included 3724 participants with analyzable samples at the data cutoff in September 2023. Among the 3724 participants, 29 had confirmed cancer diagnoses. Among these cases, 14 patients had their cancer confirmed through USPSTF recommended screening and 15 were detected through outside of standard USPSTF screening, such as a thyroid ultrasound, Dr. Yang explained.

Almost 90% of the cancers (26 of 29) were detected in the stage I or II, and eight (27.5%) were not one of the test’s 13 targeted cancer types.

The CanScan test had a sensitivity of 55.2%, identifying 16 of 29 of the patients with cancer, including 10 of 21 individuals with stage I (47.6%), and two of three with stage II (66.7%). 

The test had a high specificity of 97.9%, meaning out of 100 people screened, only two had false negative findings.

Among the 15 patients who had their cancer detected outside of USPSTF screening recommendations, eight (53.3%) were found using a CanScan test, including patients with liver and endometrial cancers.

Compared with a positive predictive value of (PPV) of 1.6% with screening or physical exam methods alone, the CanScan test had a PPV of 17.4%, Dr. Yang reported. 

“The MCED test holds significant potential for early cancer screening in asymptomatic populations,” Dr. Yang and colleagues concluded.

Another new MCED test called MERCURY, also developed by Geneseeq Technology and presented during the session, used a similar method to detect cancer signals and predict the tissue of origin across 13 cancer types.

The researchers initially validated the test using 3076 patients with cancer and 3477 healthy controls with a target specificity of 99%. In this group, researchers reported a sensitivity of 0.865 and a specificity of 0.989.

The team then performed an independent validation analysis with 1465 participants, 732 with cancer and 733 with no cancer, and confirmed a high sensitivity and specificity of 0.874 and 0.978, respectively. The sensitivity increased incrementally by cancer stage — 0.768 for stage I, 0.840 for stage II, 0.923 for stage III, and 0.971 for stage IV.

The test identified the tissue of origin with high accuracy, the researchers noted, but cautioned that the test needs “to be further validated in a prospective cohort study.”

MCED in Low-Income Settings

The session also featured findings on a new affordable MCED test called OncoSeek, which could provide greater access to cancer testing in low- and middle-income countries.

The OncoSeek algorithm identifies the presence of cancer using seven protein tumor markers alongside clinical information, such as gender and age. Like other tests, the test also predicts the possible tissue of origin.

The test can be run on clinical protein assay instruments that are already widely available, such as Roche cobas analyzer, Mao Mao, MD, PhD, the founder and CEO of SeekIn, of Shenzhen, China, told this news organization.

This “feature makes the test accessible worldwide, even in low- and middle-income countries,” he said. “These instruments are fully-automated and part of today’s clinical practice. Therefore, the test does not require additional infrastructure building and lab personal training.”

Another notable advantage: the OncoSeek test only costs about $20, compared with other MCED tests, which can cost anywhere from $200 to $1000.

To validate the technology in a large, diverse cohort, Dr. Mao and colleagues enrolled approximately 10,000 participants, including 2003 cancer cases and 7888 non-cancer cases.

Peripheral blood was collected from each participant and analyzed using a panel of the seven protein tumor markers — AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA 21-1.

To reduce the risk for false positive findings, the team designed the OncoSeek algorithm to achieve a specificity of 93%. Dr. Mao and colleagues found a sensitivity of 51.7%, resulting in an overall accuracy of 84.6%.

The performance was consistent in additional validation cohorts in Brazil, China, and the United States, with sensitivities ranging from 39.0% to 77.6% for detecting nine common cancer types, including breast, colorectal, liver, lung, lymphoma, esophagus, ovary, pancreas, and stomach. The sensitivity for pancreatic cancer was at the high end of 77.6%.

The test could predict the tissue of origin in about two thirds of cases. 

Given its low cost, OncoSeek represents an affordable and accessible option for cancer screening, the authors concluded. 

Overall, “I think MCEDs have the potential to enhance cancer screening,” Dr. Wood told this news organization.

Still, questions remain about the optimal use of these tests, such as whether they are best for average-risk or higher risk populations, and how to integrate them into standard screening, she said. 

Dr. Wood also cautioned that the studies presented in the session represent early data, and it is likely that the numbers, such as sensitivity and specificity, will change with further prospective analyses.

And ultimately, these tests should complement, not replace, standard screening. “A negative testing should not be taken as a sign to avoid standard screening,” Dr. Wood said.

Dr. Yang is an employee of Geneseeq Technology, Inc., and Dr. Mao is an employee of SeekIn. Dr. Wood had no disclosures to report.

A version of this article appeared on Medscape.com.

Early data suggested that several new multicancer early detection (MCED) tests in development show promise for identifying cancers that lack routine screening options.

Analyses presented during a session at the American Association for Cancer Research annual meeting, revealed that three new MCED tests — CanScan, MERCURY, and OncoSeek — could detect a range of cancers and recognize the tissue of origin with high accuracy. One — OncoSeek — could also provide an affordable cancer screening option for individuals living in lower-income countries.

The need for these noninvasive liquid biopsy tests that can accurately identify multiple cancer types with a single blood draw, especially cancers without routine screening strategies, is pressing. “We know that the current cancer standard of care screening will identify less than 50% of all cancers, while more than 50% of all cancer deaths occur in types of cancer with no recommended screening,” said co-moderator Marie E. Wood, MD, of the University of Colorado Anschutz Medical Campus, in Aurora, Colorado.

That being said, “the clinical utility of multicancer detection tests has not been established and we’re concerned about issues of overdiagnosis and overtreatment,” she noted.

The Early Data 

One new MCED test called CanScan, developed by Geneseeq Technology, uses plasma cell-free DNA fragment patterns to detect cancer signals as well as identify the tissue of origin across 13 cancer types.

Overall, the CanScan test covers cancer types that contribute to two thirds of new cancer cases and 74% of morality globally, said presenter Shanshan Yang, of Geneseeq Research Institute, in Nanjing, China.

However, only five of these cancer types have screening recommendations issued by the US Preventive Services Task Force (USPSTF), Dr. Yang added.

The interim data comes from an ongoing large-scale prospective study evaluating the MCED test in a cohort of asymptomatic individuals between ages 45 and 75 years with an average risk for cancer and no cancer-related symptoms on enrollment.

Patients at baseline had their blood collected for the CanScan test and subsequently received annual routine physical exams once a year for 3 consecutive years, with an additional 2 years of follow-up. 

The analysis included 3724 participants with analyzable samples at the data cutoff in September 2023. Among the 3724 participants, 29 had confirmed cancer diagnoses. Among these cases, 14 patients had their cancer confirmed through USPSTF recommended screening and 15 were detected through outside of standard USPSTF screening, such as a thyroid ultrasound, Dr. Yang explained.

Almost 90% of the cancers (26 of 29) were detected in the stage I or II, and eight (27.5%) were not one of the test’s 13 targeted cancer types.

The CanScan test had a sensitivity of 55.2%, identifying 16 of 29 of the patients with cancer, including 10 of 21 individuals with stage I (47.6%), and two of three with stage II (66.7%). 

The test had a high specificity of 97.9%, meaning out of 100 people screened, only two had false negative findings.

Among the 15 patients who had their cancer detected outside of USPSTF screening recommendations, eight (53.3%) were found using a CanScan test, including patients with liver and endometrial cancers.

Compared with a positive predictive value of (PPV) of 1.6% with screening or physical exam methods alone, the CanScan test had a PPV of 17.4%, Dr. Yang reported. 

“The MCED test holds significant potential for early cancer screening in asymptomatic populations,” Dr. Yang and colleagues concluded.

Another new MCED test called MERCURY, also developed by Geneseeq Technology and presented during the session, used a similar method to detect cancer signals and predict the tissue of origin across 13 cancer types.

The researchers initially validated the test using 3076 patients with cancer and 3477 healthy controls with a target specificity of 99%. In this group, researchers reported a sensitivity of 0.865 and a specificity of 0.989.

The team then performed an independent validation analysis with 1465 participants, 732 with cancer and 733 with no cancer, and confirmed a high sensitivity and specificity of 0.874 and 0.978, respectively. The sensitivity increased incrementally by cancer stage — 0.768 for stage I, 0.840 for stage II, 0.923 for stage III, and 0.971 for stage IV.

The test identified the tissue of origin with high accuracy, the researchers noted, but cautioned that the test needs “to be further validated in a prospective cohort study.”

MCED in Low-Income Settings

The session also featured findings on a new affordable MCED test called OncoSeek, which could provide greater access to cancer testing in low- and middle-income countries.

The OncoSeek algorithm identifies the presence of cancer using seven protein tumor markers alongside clinical information, such as gender and age. Like other tests, the test also predicts the possible tissue of origin.

The test can be run on clinical protein assay instruments that are already widely available, such as Roche cobas analyzer, Mao Mao, MD, PhD, the founder and CEO of SeekIn, of Shenzhen, China, told this news organization.

This “feature makes the test accessible worldwide, even in low- and middle-income countries,” he said. “These instruments are fully-automated and part of today’s clinical practice. Therefore, the test does not require additional infrastructure building and lab personal training.”

Another notable advantage: the OncoSeek test only costs about $20, compared with other MCED tests, which can cost anywhere from $200 to $1000.

To validate the technology in a large, diverse cohort, Dr. Mao and colleagues enrolled approximately 10,000 participants, including 2003 cancer cases and 7888 non-cancer cases.

Peripheral blood was collected from each participant and analyzed using a panel of the seven protein tumor markers — AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA 21-1.

To reduce the risk for false positive findings, the team designed the OncoSeek algorithm to achieve a specificity of 93%. Dr. Mao and colleagues found a sensitivity of 51.7%, resulting in an overall accuracy of 84.6%.

The performance was consistent in additional validation cohorts in Brazil, China, and the United States, with sensitivities ranging from 39.0% to 77.6% for detecting nine common cancer types, including breast, colorectal, liver, lung, lymphoma, esophagus, ovary, pancreas, and stomach. The sensitivity for pancreatic cancer was at the high end of 77.6%.

The test could predict the tissue of origin in about two thirds of cases. 

Given its low cost, OncoSeek represents an affordable and accessible option for cancer screening, the authors concluded. 

Overall, “I think MCEDs have the potential to enhance cancer screening,” Dr. Wood told this news organization.

Still, questions remain about the optimal use of these tests, such as whether they are best for average-risk or higher risk populations, and how to integrate them into standard screening, she said. 

Dr. Wood also cautioned that the studies presented in the session represent early data, and it is likely that the numbers, such as sensitivity and specificity, will change with further prospective analyses.

And ultimately, these tests should complement, not replace, standard screening. “A negative testing should not be taken as a sign to avoid standard screening,” Dr. Wood said.

Dr. Yang is an employee of Geneseeq Technology, Inc., and Dr. Mao is an employee of SeekIn. Dr. Wood had no disclosures to report.

A version of this article appeared on Medscape.com.

In a 2023 study published in the Annals of Emergency Medicine, European researchers fed the AI system ChatGPT information on 30 ER patients. Details included physician notes on the patients’ symptoms, physical exams, and lab results. ChatGPT made the correct diagnosis in 97% of patients compared to 87% for human doctors.

AI 1, Physicians 0

JAMA Cardiology reported in 2021 that an AI trained on nearly a million ECGs performed comparably to or exceeded cardiologist clinical diagnoses and the MUSE (GE Healthcare) system›s automated ECG analysis for most diagnostic classes.

AI 2, Physicians 0

Google’s medically focused AI model (Med-PaLM2) scored 85%+ when answering US Medical Licensing Examination–style questions. That›s an «expert» physician level and far beyond the accuracy threshold needed to pass the actual exam.

AI 3, Physicians 0

A new AI tool that uses an online finger-tapping test outperformed primary care physicians when assessing the severity of Parkinson’s disease.

AI 4, Physicians 0

JAMA Ophthalmology reported in 2024 that a chatbot outperformed glaucoma specialists and matched retina specialists in diagnostic and treatment accuracy.

AI 5, Physicians 0

Should we stop? Because we could go on. In the last few years, these AI vs Physician studies have proliferated, and guess who’s winning?

65% of Doctors are Concerned

Now, the standard answer with anything AI-and-Medicine goes something like this: AI is coming, and it will be a transformative tool for physicians and improve patient care.

But the underlying unanswered question is: Physicians spend many years and a lot of money to become really good at what they do. How, exactly, should a doctor feel about a machine that can suddenly do the job better and faster?

The Medscape 2023 Physician and AI Report surveyed 1043 US physicians about their views on AI. In total, 65% are concerned about AI making diagnosis and treatment decisions, but 56% are enthusiastic about having it as an adjunct.

Cardiologists, anesthesiologists, and radiologists are most enthusiastic about AI, whereas family physicians and pediatricians are the least enthusiastic.

To get a more personal view of how physicians and other healthcare professionals are feeling about this transformative tech, I spoke with a variety of practicing doctors, a psychotherapist, and a third-year Harvard Medical School student.

‘Abysmally Poor Understanding’

Alfredo A. Sadun, MD, PhD, has been a neuro-ophthalmologist for nearly 50 years. A graduate of MIT and vice-chair of ophthalmology at UCLA, he’s long been fascinated by AI’s march into medicine. He’s watched it accomplish things that no ophthalmologist can do, such as identify gender, age, and risk for heart attack and stroke from retinal scans. But he doesn›t see the same level of interest and comprehension among the medical community.

“There’s still an abysmally poor understanding of AI among physicians in general,” he said. “It’s striking because these are intelligent, well-educated people. But we tend to draw conclusions based on what we’re familiar with, and most doctors’ experience with computers involves EHRs [electronic health records] and administrative garbage. It’s the reason they’re burning out.”

Easing the Burden

Anthony Philippakis, MD, PhD, left his cardiology practice in 2015 to become the chief data officer at the Broad Institute of MIT and Harvard. While there, he helped develop an AI-based method for identifying patients at risk for atrial fibrillation. Now, he’s a general partner at Google Ventures with the goal of bridging the gap between data sciences and medicine. His perspective on AI is unique, given that he’s seen the issue from both sides.

“I am not a bitter physician, but to be honest, when I was practicing, way too much of my time was spent staring at screens and not enough laying hands on patients,” he said. “Can you imagine what it would be like to speak to the EHR naturally and say, ‘Please order the following labs for this patient and notify me when the results come in.’ Boy, would that improve healthcare and physician satisfaction. Every physician I know is excited and optimistic about that. Almost everyone I’ve talked to feels like AI could take a lot of the stuff they don’t like doing off their plates.”

Indeed, the dividing line between physician support for AI and physician suspicion or skepticism of AI is just that. In our survey, more than three quarters of physicians said they would consider using AI for office administrative tasks, scheduling, EHRs, researching medical conditions, and even summarizing a patient’s record before a visit. But far fewer are supportive of it delivering diagnoses and treatments. This, despite an estimated 800,000 Americans dying or becoming permanently disabled each year because of diagnostic error.

Could AI Have Diagnosed This?

John D. Nuschke, MD, has been a primary care physician in Allentown, Pennsylvania, for 40 years. He’s a jovial general physician who insists his patients call him Jack. He’s recently started using an AI medical scribe called Freed. With the patient’s permission, it listens in on the visit and generates notes, saving Dr. Nuschke time and helping him focus on the person. He likes that type of assistance, but when it comes to AI replacing him, he’s skeptical.

“I had this patient I diagnosed with prostate cancer,” he explained. “He got treated and was fine for 5 years. Then, he started losing weight and feeling awful — got weak as a kitten. He went back to his urologist and oncologist who thought he had metastatic prostate cancer. He went through PET scans and blood work, but there was no sign his cancer had returned. So the specialists sent him back to me, and the second he walked in, I saw he was floridly hyperthyroid. I could tell across the room just by looking at him. Would AI have been able to make that diagnosis? Does AI do physical exams?”

Dr. Nuschke said he’s also had several instances where patients received their cancer diagnosis from the lab through an automated patient-portal system rather than from him. “That’s an AI of sorts, and I found it distressing,” he said.

Empathy From a Robot

All the doctors I spoke to were hopeful that by freeing them from the burden of administrative work, they would be able to return to the reason they got into this business in the first place — to spend more time with patients in need and support them with grace and compassion.

But suppose AI could do that too?

In a 2023 study conducted at the University of California San Diego and published in JAMA Internal Medicine, three licensed healthcare professionals compared the responses of ChatGPT and physicians to real-world health questions. The panel rated the AI’s answers nearly four times higher in quality and almost 10 times more empathetic than physicians’ replies.

A similar 2024 study in Nature found that Google’s large-language model AI matched or surpassed physician diagnostic accuracy in all six of the medical specialties considered. Plus, it outperformed doctors in 24 of 26 criteria for conversation quality, including politeness, explanation, honesty, and expressing care and commitment.

Nathaniel Chin, MD, is a gerontologist at the University of Wisconsin and advisory board member for the Alzheimer’s Foundation of America. Although he admits that studies like these “sadden me,” he’s also a realist. “There was hesitation among physicians at the beginning of the pandemic to virtual care because we missed the human connection,” he explained, “but we worked our way around that. We need to remember that what makes a chatbot strong is that it’s nothuman. It doesn’t burn out, it doesn’t get tired, it can look at data very quickly, and it doesn’t have to go home to a family and try to balance work with other aspects of life. A human being is very complex, whereas a chatbot has one single purpose.”

“Even if you don’t have AI in your space now or don’t like the idea of it, that doesn’t matter,” he added. “It’s coming. But it needs to be done right. If AI is implemented by clinicians for clinicians, it has great potential. But if it’s implemented by businesspeople for business reasons, perhaps not.”

‘The Ones Who Use the Tools the Best Will Be the Best’

One branch of medicine that stands to be dramatically affected by AI is mental health. Because bots are natural data-crunchers, they are becoming adept at analyzing the many subtle clues (phrasing in social media posts and text messages, smartwatch biometrics, therapy session videos…) that could indicate depression or other psychological disorders. In fact, its availability via smartphone apps could help democratize and destigmatize the practice.

“There is a day ahead — probably within 5 years — when a patient won’t be able to tell the difference between a real therapist and an AI therapist,” said Ken Mallon, MS, LMFT, a clinical psychotherapist and data scientist in San Jose, California. “That doesn’t worry me, though. It’s hard on therapists’ egos, but new technologies get developed. Things change. People who embrace these tools will benefit from them. The ones who use the tools the best will be the best.”

Time to Restructure Med School

Aditya Jain is in his third year at Harvard Medical School. At age 24, he’s heading into this brave new medical world with excitement and anxiety. Excitement because he sees AI revolutionizing healthcare on every level. Although the current generations of physicians and patients may grumble about its onset, he believes younger ones will feel comfortable with “DocGPT.” He’s excited that his generation of physicians will be the “translators and managers of this transition” and redefine “what it means to be a doctor.”

His anxiety, however, stems from the fact that AI has come on so fast that “it has not yet crossed the threshold of medical education,” he said. “Medical schools still largely prepare students to work as solo clinical decision makers. Most of my first 2 years were spent on pattern recognition and rote memorization, skills that AI can and will master.”

Indeed, Mr. Jain said AI was not a part of his first- or second-year curriculum. “I talk to students who are a year older than me, graduating, heading to residency, and they tell me they wish they had gotten a better grasp of how to use these technologies in medicine and in their practice. They were surprised to hear that people in my year hadn’t started using ChatGPT. We need to expend a lot more effort within the field, within academia, within practicing physicians, to figure out what our role will be in a world where AI is matching or even exceeding human intelligence. And then we need to restructure the medical education to better accomplish these goals.”

So Are You Ready for AI to Be a Better Doctor Than You?

“Yes, I am,” said Dr. Philippakis without hesitation. “When I was going through my medical training, I was continually confronted with the reality that I personally was not smart enough to keep all the information in my head that could be used to make a good decision for a patient. We have now reached a point where the amount of information that is important and useful in the practice of medicine outstrips what a human being can know. The opportunity to enable physicians with AI to remedy that situation is a good thing for doctors and, most importantly, a good thing for patients. I believe the future of medicine belongs not so much to the AI practitioner but to the AI-enabled practitioner.”

“Quick story,” added Dr. Chin. “I asked ChatGPT two questions. The first was ‘Explain the difference between Alzheimer’s and dementia’ because that’s the most common misconception in my field. And it gave me a pretty darn good answer — one I would use in a presentation with some tweaking. Then I asked it, ‘Are you a better doctor than me?’ And it replied, ‘My purpose is not to replace you, my purpose is to be supportive of you and enhance your ability.’ ”

A version of this article appeared on Medscape.com.

In a 2023 study published in the Annals of Emergency Medicine, European researchers fed the AI system ChatGPT information on 30 ER patients. Details included physician notes on the patients’ symptoms, physical exams, and lab results. ChatGPT made the correct diagnosis in 97% of patients compared to 87% for human doctors.

AI 1, Physicians 0

JAMA Cardiology reported in 2021 that an AI trained on nearly a million ECGs performed comparably to or exceeded cardiologist clinical diagnoses and the MUSE (GE Healthcare) system›s automated ECG analysis for most diagnostic classes.

AI 2, Physicians 0

Google’s medically focused AI model (Med-PaLM2) scored 85%+ when answering US Medical Licensing Examination–style questions. That›s an «expert» physician level and far beyond the accuracy threshold needed to pass the actual exam.

AI 3, Physicians 0

A new AI tool that uses an online finger-tapping test outperformed primary care physicians when assessing the severity of Parkinson’s disease.

AI 4, Physicians 0

JAMA Ophthalmology reported in 2024 that a chatbot outperformed glaucoma specialists and matched retina specialists in diagnostic and treatment accuracy.

AI 5, Physicians 0

Should we stop? Because we could go on. In the last few years, these AI vs Physician studies have proliferated, and guess who’s winning?

65% of Doctors are Concerned

Now, the standard answer with anything AI-and-Medicine goes something like this: AI is coming, and it will be a transformative tool for physicians and improve patient care.

But the underlying unanswered question is: Physicians spend many years and a lot of money to become really good at what they do. How, exactly, should a doctor feel about a machine that can suddenly do the job better and faster?

The Medscape 2023 Physician and AI Report surveyed 1043 US physicians about their views on AI. In total, 65% are concerned about AI making diagnosis and treatment decisions, but 56% are enthusiastic about having it as an adjunct.

Cardiologists, anesthesiologists, and radiologists are most enthusiastic about AI, whereas family physicians and pediatricians are the least enthusiastic.

To get a more personal view of how physicians and other healthcare professionals are feeling about this transformative tech, I spoke with a variety of practicing doctors, a psychotherapist, and a third-year Harvard Medical School student.

‘Abysmally Poor Understanding’

Alfredo A. Sadun, MD, PhD, has been a neuro-ophthalmologist for nearly 50 years. A graduate of MIT and vice-chair of ophthalmology at UCLA, he’s long been fascinated by AI’s march into medicine. He’s watched it accomplish things that no ophthalmologist can do, such as identify gender, age, and risk for heart attack and stroke from retinal scans. But he doesn›t see the same level of interest and comprehension among the medical community.

“There’s still an abysmally poor understanding of AI among physicians in general,” he said. “It’s striking because these are intelligent, well-educated people. But we tend to draw conclusions based on what we’re familiar with, and most doctors’ experience with computers involves EHRs [electronic health records] and administrative garbage. It’s the reason they’re burning out.”

Easing the Burden

Anthony Philippakis, MD, PhD, left his cardiology practice in 2015 to become the chief data officer at the Broad Institute of MIT and Harvard. While there, he helped develop an AI-based method for identifying patients at risk for atrial fibrillation. Now, he’s a general partner at Google Ventures with the goal of bridging the gap between data sciences and medicine. His perspective on AI is unique, given that he’s seen the issue from both sides.

“I am not a bitter physician, but to be honest, when I was practicing, way too much of my time was spent staring at screens and not enough laying hands on patients,” he said. “Can you imagine what it would be like to speak to the EHR naturally and say, ‘Please order the following labs for this patient and notify me when the results come in.’ Boy, would that improve healthcare and physician satisfaction. Every physician I know is excited and optimistic about that. Almost everyone I’ve talked to feels like AI could take a lot of the stuff they don’t like doing off their plates.”

Indeed, the dividing line between physician support for AI and physician suspicion or skepticism of AI is just that. In our survey, more than three quarters of physicians said they would consider using AI for office administrative tasks, scheduling, EHRs, researching medical conditions, and even summarizing a patient’s record before a visit. But far fewer are supportive of it delivering diagnoses and treatments. This, despite an estimated 800,000 Americans dying or becoming permanently disabled each year because of diagnostic error.

Could AI Have Diagnosed This?

John D. Nuschke, MD, has been a primary care physician in Allentown, Pennsylvania, for 40 years. He’s a jovial general physician who insists his patients call him Jack. He’s recently started using an AI medical scribe called Freed. With the patient’s permission, it listens in on the visit and generates notes, saving Dr. Nuschke time and helping him focus on the person. He likes that type of assistance, but when it comes to AI replacing him, he’s skeptical.

“I had this patient I diagnosed with prostate cancer,” he explained. “He got treated and was fine for 5 years. Then, he started losing weight and feeling awful — got weak as a kitten. He went back to his urologist and oncologist who thought he had metastatic prostate cancer. He went through PET scans and blood work, but there was no sign his cancer had returned. So the specialists sent him back to me, and the second he walked in, I saw he was floridly hyperthyroid. I could tell across the room just by looking at him. Would AI have been able to make that diagnosis? Does AI do physical exams?”

Dr. Nuschke said he’s also had several instances where patients received their cancer diagnosis from the lab through an automated patient-portal system rather than from him. “That’s an AI of sorts, and I found it distressing,” he said.

Empathy From a Robot

All the doctors I spoke to were hopeful that by freeing them from the burden of administrative work, they would be able to return to the reason they got into this business in the first place — to spend more time with patients in need and support them with grace and compassion.

But suppose AI could do that too?

In a 2023 study conducted at the University of California San Diego and published in JAMA Internal Medicine, three licensed healthcare professionals compared the responses of ChatGPT and physicians to real-world health questions. The panel rated the AI’s answers nearly four times higher in quality and almost 10 times more empathetic than physicians’ replies.

A similar 2024 study in Nature found that Google’s large-language model AI matched or surpassed physician diagnostic accuracy in all six of the medical specialties considered. Plus, it outperformed doctors in 24 of 26 criteria for conversation quality, including politeness, explanation, honesty, and expressing care and commitment.

Nathaniel Chin, MD, is a gerontologist at the University of Wisconsin and advisory board member for the Alzheimer’s Foundation of America. Although he admits that studies like these “sadden me,” he’s also a realist. “There was hesitation among physicians at the beginning of the pandemic to virtual care because we missed the human connection,” he explained, “but we worked our way around that. We need to remember that what makes a chatbot strong is that it’s nothuman. It doesn’t burn out, it doesn’t get tired, it can look at data very quickly, and it doesn’t have to go home to a family and try to balance work with other aspects of life. A human being is very complex, whereas a chatbot has one single purpose.”

“Even if you don’t have AI in your space now or don’t like the idea of it, that doesn’t matter,” he added. “It’s coming. But it needs to be done right. If AI is implemented by clinicians for clinicians, it has great potential. But if it’s implemented by businesspeople for business reasons, perhaps not.”

‘The Ones Who Use the Tools the Best Will Be the Best’

One branch of medicine that stands to be dramatically affected by AI is mental health. Because bots are natural data-crunchers, they are becoming adept at analyzing the many subtle clues (phrasing in social media posts and text messages, smartwatch biometrics, therapy session videos…) that could indicate depression or other psychological disorders. In fact, its availability via smartphone apps could help democratize and destigmatize the practice.

“There is a day ahead — probably within 5 years — when a patient won’t be able to tell the difference between a real therapist and an AI therapist,” said Ken Mallon, MS, LMFT, a clinical psychotherapist and data scientist in San Jose, California. “That doesn’t worry me, though. It’s hard on therapists’ egos, but new technologies get developed. Things change. People who embrace these tools will benefit from them. The ones who use the tools the best will be the best.”

Time to Restructure Med School

Aditya Jain is in his third year at Harvard Medical School. At age 24, he’s heading into this brave new medical world with excitement and anxiety. Excitement because he sees AI revolutionizing healthcare on every level. Although the current generations of physicians and patients may grumble about its onset, he believes younger ones will feel comfortable with “DocGPT.” He’s excited that his generation of physicians will be the “translators and managers of this transition” and redefine “what it means to be a doctor.”

His anxiety, however, stems from the fact that AI has come on so fast that “it has not yet crossed the threshold of medical education,” he said. “Medical schools still largely prepare students to work as solo clinical decision makers. Most of my first 2 years were spent on pattern recognition and rote memorization, skills that AI can and will master.”

Indeed, Mr. Jain said AI was not a part of his first- or second-year curriculum. “I talk to students who are a year older than me, graduating, heading to residency, and they tell me they wish they had gotten a better grasp of how to use these technologies in medicine and in their practice. They were surprised to hear that people in my year hadn’t started using ChatGPT. We need to expend a lot more effort within the field, within academia, within practicing physicians, to figure out what our role will be in a world where AI is matching or even exceeding human intelligence. And then we need to restructure the medical education to better accomplish these goals.”

So Are You Ready for AI to Be a Better Doctor Than You?

“Yes, I am,” said Dr. Philippakis without hesitation. “When I was going through my medical training, I was continually confronted with the reality that I personally was not smart enough to keep all the information in my head that could be used to make a good decision for a patient. We have now reached a point where the amount of information that is important and useful in the practice of medicine outstrips what a human being can know. The opportunity to enable physicians with AI to remedy that situation is a good thing for doctors and, most importantly, a good thing for patients. I believe the future of medicine belongs not so much to the AI practitioner but to the AI-enabled practitioner.”

“Quick story,” added Dr. Chin. “I asked ChatGPT two questions. The first was ‘Explain the difference between Alzheimer’s and dementia’ because that’s the most common misconception in my field. And it gave me a pretty darn good answer — one I would use in a presentation with some tweaking. Then I asked it, ‘Are you a better doctor than me?’ And it replied, ‘My purpose is not to replace you, my purpose is to be supportive of you and enhance your ability.’ ”

A version of this article appeared on Medscape.com.

In a 2023 study published in the Annals of Emergency Medicine, European researchers fed the AI system ChatGPT information on 30 ER patients. Details included physician notes on the patients’ symptoms, physical exams, and lab results. ChatGPT made the correct diagnosis in 97% of patients compared to 87% for human doctors.

AI 1, Physicians 0

JAMA Cardiology reported in 2021 that an AI trained on nearly a million ECGs performed comparably to or exceeded cardiologist clinical diagnoses and the MUSE (GE Healthcare) system›s automated ECG analysis for most diagnostic classes.

AI 2, Physicians 0

Google’s medically focused AI model (Med-PaLM2) scored 85%+ when answering US Medical Licensing Examination–style questions. That›s an «expert» physician level and far beyond the accuracy threshold needed to pass the actual exam.

AI 3, Physicians 0

A new AI tool that uses an online finger-tapping test outperformed primary care physicians when assessing the severity of Parkinson’s disease.

AI 4, Physicians 0

JAMA Ophthalmology reported in 2024 that a chatbot outperformed glaucoma specialists and matched retina specialists in diagnostic and treatment accuracy.

AI 5, Physicians 0

Should we stop? Because we could go on. In the last few years, these AI vs Physician studies have proliferated, and guess who’s winning?

65% of Doctors are Concerned

Now, the standard answer with anything AI-and-Medicine goes something like this: AI is coming, and it will be a transformative tool for physicians and improve patient care.

But the underlying unanswered question is: Physicians spend many years and a lot of money to become really good at what they do. How, exactly, should a doctor feel about a machine that can suddenly do the job better and faster?

The Medscape 2023 Physician and AI Report surveyed 1043 US physicians about their views on AI. In total, 65% are concerned about AI making diagnosis and treatment decisions, but 56% are enthusiastic about having it as an adjunct.

Cardiologists, anesthesiologists, and radiologists are most enthusiastic about AI, whereas family physicians and pediatricians are the least enthusiastic.

To get a more personal view of how physicians and other healthcare professionals are feeling about this transformative tech, I spoke with a variety of practicing doctors, a psychotherapist, and a third-year Harvard Medical School student.

‘Abysmally Poor Understanding’

Alfredo A. Sadun, MD, PhD, has been a neuro-ophthalmologist for nearly 50 years. A graduate of MIT and vice-chair of ophthalmology at UCLA, he’s long been fascinated by AI’s march into medicine. He’s watched it accomplish things that no ophthalmologist can do, such as identify gender, age, and risk for heart attack and stroke from retinal scans. But he doesn›t see the same level of interest and comprehension among the medical community.

“There’s still an abysmally poor understanding of AI among physicians in general,” he said. “It’s striking because these are intelligent, well-educated people. But we tend to draw conclusions based on what we’re familiar with, and most doctors’ experience with computers involves EHRs [electronic health records] and administrative garbage. It’s the reason they’re burning out.”

Easing the Burden

Anthony Philippakis, MD, PhD, left his cardiology practice in 2015 to become the chief data officer at the Broad Institute of MIT and Harvard. While there, he helped develop an AI-based method for identifying patients at risk for atrial fibrillation. Now, he’s a general partner at Google Ventures with the goal of bridging the gap between data sciences and medicine. His perspective on AI is unique, given that he’s seen the issue from both sides.

“I am not a bitter physician, but to be honest, when I was practicing, way too much of my time was spent staring at screens and not enough laying hands on patients,” he said. “Can you imagine what it would be like to speak to the EHR naturally and say, ‘Please order the following labs for this patient and notify me when the results come in.’ Boy, would that improve healthcare and physician satisfaction. Every physician I know is excited and optimistic about that. Almost everyone I’ve talked to feels like AI could take a lot of the stuff they don’t like doing off their plates.”

Indeed, the dividing line between physician support for AI and physician suspicion or skepticism of AI is just that. In our survey, more than three quarters of physicians said they would consider using AI for office administrative tasks, scheduling, EHRs, researching medical conditions, and even summarizing a patient’s record before a visit. But far fewer are supportive of it delivering diagnoses and treatments. This, despite an estimated 800,000 Americans dying or becoming permanently disabled each year because of diagnostic error.

Could AI Have Diagnosed This?

John D. Nuschke, MD, has been a primary care physician in Allentown, Pennsylvania, for 40 years. He’s a jovial general physician who insists his patients call him Jack. He’s recently started using an AI medical scribe called Freed. With the patient’s permission, it listens in on the visit and generates notes, saving Dr. Nuschke time and helping him focus on the person. He likes that type of assistance, but when it comes to AI replacing him, he’s skeptical.

“I had this patient I diagnosed with prostate cancer,” he explained. “He got treated and was fine for 5 years. Then, he started losing weight and feeling awful — got weak as a kitten. He went back to his urologist and oncologist who thought he had metastatic prostate cancer. He went through PET scans and blood work, but there was no sign his cancer had returned. So the specialists sent him back to me, and the second he walked in, I saw he was floridly hyperthyroid. I could tell across the room just by looking at him. Would AI have been able to make that diagnosis? Does AI do physical exams?”

Dr. Nuschke said he’s also had several instances where patients received their cancer diagnosis from the lab through an automated patient-portal system rather than from him. “That’s an AI of sorts, and I found it distressing,” he said.

Empathy From a Robot

All the doctors I spoke to were hopeful that by freeing them from the burden of administrative work, they would be able to return to the reason they got into this business in the first place — to spend more time with patients in need and support them with grace and compassion.

But suppose AI could do that too?

In a 2023 study conducted at the University of California San Diego and published in JAMA Internal Medicine, three licensed healthcare professionals compared the responses of ChatGPT and physicians to real-world health questions. The panel rated the AI’s answers nearly four times higher in quality and almost 10 times more empathetic than physicians’ replies.

A similar 2024 study in Nature found that Google’s large-language model AI matched or surpassed physician diagnostic accuracy in all six of the medical specialties considered. Plus, it outperformed doctors in 24 of 26 criteria for conversation quality, including politeness, explanation, honesty, and expressing care and commitment.

Nathaniel Chin, MD, is a gerontologist at the University of Wisconsin and advisory board member for the Alzheimer’s Foundation of America. Although he admits that studies like these “sadden me,” he’s also a realist. “There was hesitation among physicians at the beginning of the pandemic to virtual care because we missed the human connection,” he explained, “but we worked our way around that. We need to remember that what makes a chatbot strong is that it’s nothuman. It doesn’t burn out, it doesn’t get tired, it can look at data very quickly, and it doesn’t have to go home to a family and try to balance work with other aspects of life. A human being is very complex, whereas a chatbot has one single purpose.”

“Even if you don’t have AI in your space now or don’t like the idea of it, that doesn’t matter,” he added. “It’s coming. But it needs to be done right. If AI is implemented by clinicians for clinicians, it has great potential. But if it’s implemented by businesspeople for business reasons, perhaps not.”

‘The Ones Who Use the Tools the Best Will Be the Best’

One branch of medicine that stands to be dramatically affected by AI is mental health. Because bots are natural data-crunchers, they are becoming adept at analyzing the many subtle clues (phrasing in social media posts and text messages, smartwatch biometrics, therapy session videos…) that could indicate depression or other psychological disorders. In fact, its availability via smartphone apps could help democratize and destigmatize the practice.

“There is a day ahead — probably within 5 years — when a patient won’t be able to tell the difference between a real therapist and an AI therapist,” said Ken Mallon, MS, LMFT, a clinical psychotherapist and data scientist in San Jose, California. “That doesn’t worry me, though. It’s hard on therapists’ egos, but new technologies get developed. Things change. People who embrace these tools will benefit from them. The ones who use the tools the best will be the best.”

Time to Restructure Med School

Aditya Jain is in his third year at Harvard Medical School. At age 24, he’s heading into this brave new medical world with excitement and anxiety. Excitement because he sees AI revolutionizing healthcare on every level. Although the current generations of physicians and patients may grumble about its onset, he believes younger ones will feel comfortable with “DocGPT.” He’s excited that his generation of physicians will be the “translators and managers of this transition” and redefine “what it means to be a doctor.”

His anxiety, however, stems from the fact that AI has come on so fast that “it has not yet crossed the threshold of medical education,” he said. “Medical schools still largely prepare students to work as solo clinical decision makers. Most of my first 2 years were spent on pattern recognition and rote memorization, skills that AI can and will master.”

Indeed, Mr. Jain said AI was not a part of his first- or second-year curriculum. “I talk to students who are a year older than me, graduating, heading to residency, and they tell me they wish they had gotten a better grasp of how to use these technologies in medicine and in their practice. They were surprised to hear that people in my year hadn’t started using ChatGPT. We need to expend a lot more effort within the field, within academia, within practicing physicians, to figure out what our role will be in a world where AI is matching or even exceeding human intelligence. And then we need to restructure the medical education to better accomplish these goals.”

So Are You Ready for AI to Be a Better Doctor Than You?

“Yes, I am,” said Dr. Philippakis without hesitation. “When I was going through my medical training, I was continually confronted with the reality that I personally was not smart enough to keep all the information in my head that could be used to make a good decision for a patient. We have now reached a point where the amount of information that is important and useful in the practice of medicine outstrips what a human being can know. The opportunity to enable physicians with AI to remedy that situation is a good thing for doctors and, most importantly, a good thing for patients. I believe the future of medicine belongs not so much to the AI practitioner but to the AI-enabled practitioner.”

“Quick story,” added Dr. Chin. “I asked ChatGPT two questions. The first was ‘Explain the difference between Alzheimer’s and dementia’ because that’s the most common misconception in my field. And it gave me a pretty darn good answer — one I would use in a presentation with some tweaking. Then I asked it, ‘Are you a better doctor than me?’ And it replied, ‘My purpose is not to replace you, my purpose is to be supportive of you and enhance your ability.’ ”

A version of this article appeared on Medscape.com.

SAN DIEGO — A new blood test that combines cell-free DNA fragmentomes and protein biomarkers to screen for ovarian cancer shows promising results, according to an initial analysis. 

The test, under development by Delfi Diagnostics, “looks very sensitive for detecting ovarian cancer early,” said company founder and board member Victor E. Velculescu, MD, PhD, codirector of Cancer Genetics and Epigenetics at Johns Hopkins University, Baltimore. 

The assay uses machine learning to integrate cell-free DNA fragment patterns with concentrations of two ovarian cancer biomarkers — CA125 and HE4 — to detect tumors. 

While fragmentation patterns are organized in healthy people, they are chaotic in cancer and reveal both its presence and location, said Velculescu who presented the findings at the American Association for Cancer Research annual meeting.

The researchers tested the assay in 134 women with ovarian cancer, 204 women without cancer, and 203 women with benign adnexal masses. The approach identified 69% of stage 1 cancers, 76% of stage 2, 85% of stage 3, and 100% of stage 4 at a specificity of over 99% and an area under the curve (AUC) of 0.97.

The test identified 91% of high-grade serous ovarian cancers — the most common type of ovarian cancer.

The AUC for distinguishing benign masses from cancer was 0.87, with 60% of ovarian cancers detected at a specificity of 95%. 

“In the preoperative setting where lower specificity is acceptable, this approach may improve management of adnexal masses,” the investigators said in their abstract.

Dr. Velculescu cautioned that the report “is an initial analysis” and that his team is working on validating the finding on a larger scale in both average and high-risk women.

If validated, the test “could enable population-wide ovarian cancer screening,” he added.

Delfi recently launched a lung cancer screening blood test — FirstLook Lung— that also uses a “fragmentomics” approach to detect tumors. The company is hopeful it will reach the market with a similar test for ovarian cancer, but it’s not a certainty. 

With lung cancer, we know screening helps. For ovarian cancer, however, it’s unclear whether this will help or not, said Dr. Velculescu. But based on the study findings, but “we are now optimistic that this could make an impact. We have more work to do.” 

This presentation was one of many at the meeting about liquid biopsies using DNA, RNA, and proteins to detect cancer, including a new assay for pancreatic cancer, another cancer that like ovarian cancer is difficult to detect in the early stages. 

“This is the future,” said study moderator Roy S. Herbst, MD, PhD, chief of medical oncology at Yale University in New Haven, Connecticut. 

He called liquid biopsy “a great advance” in many oncology settings, including cancer screening because finding tumors early offers the best chance at cure. 

However, one of the main concerns about rolling out liquid biopsies for wide-scale cancer screening is the possibility that a test will come back positive, but no tumor will be seen on diagnostic imaging, said Herbst. It won’t be clear if the test was a false positive or if the patient has a brewing tumor that can’t be located and treated, a difficult situation for both patients and doctors. 

What to do in that situation is “a policy question that the entire country is asking now as liquid biopsies are moving forward,” he said. We are going to have to come together to figure it out and learn how to use these tests.

The work was funded by Delfi Diagnostics, the National Institutes of Health, and others. Dr. Velculescu, in addition to founding Delfi, holds patents on the technology. Dr. Herbst is a consultant, researcher, and/or holds stock in many companies, including AstraZeneca, Pfizer, and Checkpoint Therapeutics. 
 

A version of this article appeared on Medscape.com .

SAN DIEGO — A new blood test that combines cell-free DNA fragmentomes and protein biomarkers to screen for ovarian cancer shows promising results, according to an initial analysis. 

The test, under development by Delfi Diagnostics, “looks very sensitive for detecting ovarian cancer early,” said company founder and board member Victor E. Velculescu, MD, PhD, codirector of Cancer Genetics and Epigenetics at Johns Hopkins University, Baltimore. 

The assay uses machine learning to integrate cell-free DNA fragment patterns with concentrations of two ovarian cancer biomarkers — CA125 and HE4 — to detect tumors. 

While fragmentation patterns are organized in healthy people, they are chaotic in cancer and reveal both its presence and location, said Velculescu who presented the findings at the American Association for Cancer Research annual meeting.

The researchers tested the assay in 134 women with ovarian cancer, 204 women without cancer, and 203 women with benign adnexal masses. The approach identified 69% of stage 1 cancers, 76% of stage 2, 85% of stage 3, and 100% of stage 4 at a specificity of over 99% and an area under the curve (AUC) of 0.97.

The test identified 91% of high-grade serous ovarian cancers — the most common type of ovarian cancer.

The AUC for distinguishing benign masses from cancer was 0.87, with 60% of ovarian cancers detected at a specificity of 95%. 

“In the preoperative setting where lower specificity is acceptable, this approach may improve management of adnexal masses,” the investigators said in their abstract.

Dr. Velculescu cautioned that the report “is an initial analysis” and that his team is working on validating the finding on a larger scale in both average and high-risk women.

If validated, the test “could enable population-wide ovarian cancer screening,” he added.

Delfi recently launched a lung cancer screening blood test — FirstLook Lung— that also uses a “fragmentomics” approach to detect tumors. The company is hopeful it will reach the market with a similar test for ovarian cancer, but it’s not a certainty. 

With lung cancer, we know screening helps. For ovarian cancer, however, it’s unclear whether this will help or not, said Dr. Velculescu. But based on the study findings, but “we are now optimistic that this could make an impact. We have more work to do.” 

This presentation was one of many at the meeting about liquid biopsies using DNA, RNA, and proteins to detect cancer, including a new assay for pancreatic cancer, another cancer that like ovarian cancer is difficult to detect in the early stages. 

“This is the future,” said study moderator Roy S. Herbst, MD, PhD, chief of medical oncology at Yale University in New Haven, Connecticut. 

He called liquid biopsy “a great advance” in many oncology settings, including cancer screening because finding tumors early offers the best chance at cure. 

However, one of the main concerns about rolling out liquid biopsies for wide-scale cancer screening is the possibility that a test will come back positive, but no tumor will be seen on diagnostic imaging, said Herbst. It won’t be clear if the test was a false positive or if the patient has a brewing tumor that can’t be located and treated, a difficult situation for both patients and doctors. 

What to do in that situation is “a policy question that the entire country is asking now as liquid biopsies are moving forward,” he said. We are going to have to come together to figure it out and learn how to use these tests.

The work was funded by Delfi Diagnostics, the National Institutes of Health, and others. Dr. Velculescu, in addition to founding Delfi, holds patents on the technology. Dr. Herbst is a consultant, researcher, and/or holds stock in many companies, including AstraZeneca, Pfizer, and Checkpoint Therapeutics. 
 

A version of this article appeared on Medscape.com .

SAN DIEGO — A new blood test that combines cell-free DNA fragmentomes and protein biomarkers to screen for ovarian cancer shows promising results, according to an initial analysis. 

The test, under development by Delfi Diagnostics, “looks very sensitive for detecting ovarian cancer early,” said company founder and board member Victor E. Velculescu, MD, PhD, codirector of Cancer Genetics and Epigenetics at Johns Hopkins University, Baltimore. 

The assay uses machine learning to integrate cell-free DNA fragment patterns with concentrations of two ovarian cancer biomarkers — CA125 and HE4 — to detect tumors. 

While fragmentation patterns are organized in healthy people, they are chaotic in cancer and reveal both its presence and location, said Velculescu who presented the findings at the American Association for Cancer Research annual meeting.

The researchers tested the assay in 134 women with ovarian cancer, 204 women without cancer, and 203 women with benign adnexal masses. The approach identified 69% of stage 1 cancers, 76% of stage 2, 85% of stage 3, and 100% of stage 4 at a specificity of over 99% and an area under the curve (AUC) of 0.97.

The test identified 91% of high-grade serous ovarian cancers — the most common type of ovarian cancer.

The AUC for distinguishing benign masses from cancer was 0.87, with 60% of ovarian cancers detected at a specificity of 95%. 

“In the preoperative setting where lower specificity is acceptable, this approach may improve management of adnexal masses,” the investigators said in their abstract.

Dr. Velculescu cautioned that the report “is an initial analysis” and that his team is working on validating the finding on a larger scale in both average and high-risk women.

If validated, the test “could enable population-wide ovarian cancer screening,” he added.

Delfi recently launched a lung cancer screening blood test — FirstLook Lung— that also uses a “fragmentomics” approach to detect tumors. The company is hopeful it will reach the market with a similar test for ovarian cancer, but it’s not a certainty. 

With lung cancer, we know screening helps. For ovarian cancer, however, it’s unclear whether this will help or not, said Dr. Velculescu. But based on the study findings, but “we are now optimistic that this could make an impact. We have more work to do.” 

This presentation was one of many at the meeting about liquid biopsies using DNA, RNA, and proteins to detect cancer, including a new assay for pancreatic cancer, another cancer that like ovarian cancer is difficult to detect in the early stages. 

“This is the future,” said study moderator Roy S. Herbst, MD, PhD, chief of medical oncology at Yale University in New Haven, Connecticut. 

He called liquid biopsy “a great advance” in many oncology settings, including cancer screening because finding tumors early offers the best chance at cure. 

However, one of the main concerns about rolling out liquid biopsies for wide-scale cancer screening is the possibility that a test will come back positive, but no tumor will be seen on diagnostic imaging, said Herbst. It won’t be clear if the test was a false positive or if the patient has a brewing tumor that can’t be located and treated, a difficult situation for both patients and doctors. 

What to do in that situation is “a policy question that the entire country is asking now as liquid biopsies are moving forward,” he said. We are going to have to come together to figure it out and learn how to use these tests.

The work was funded by Delfi Diagnostics, the National Institutes of Health, and others. Dr. Velculescu, in addition to founding Delfi, holds patents on the technology. Dr. Herbst is a consultant, researcher, and/or holds stock in many companies, including AstraZeneca, Pfizer, and Checkpoint Therapeutics. 
 

A version of this article appeared on Medscape.com .

Ultrasound for assessing lymph nodal involvement may be substituted for sentinel lymph node biopsy with no change in outcomes in patients with early breast cancer, a new study finds.

This was the conclusion of research on the agenda at the American Society of Breast Surgeons annual meeting.

Sentinel lymph node biopsy (SLNB) is the standard of care for individuals with early-stage HR+HER2- breast cancer to assess nodal involvement, but SLNB can bring complications including postoperative arm problems and lasting lymphedema, according to Andreas Giannakou, MD, of Brigham and Women’s Hospital and the Dana-Farber Cancer Institute, Boston, the presenter of this new research.

The SOUND (Sentinel Node vs. Observation After Axillary Ultra-Sound) trial, published in JAMA Oncology in 2023, showed that ultrasound nodal imaging was a safe and effective alternative to SLNB in certain patients with early-stage breast cancers, but real-world validation was needed, Dr. Giannakou said during a press briefing in advance of the meeting.

Why Was the SOUND Trial Important?

The SOUND trial randomized 1,463 individuals with early stage (cT1NO) breast cancer (tumors less than 2 cm) and negative findings on axillary ultrasound to either SLNB or no axillary surgical staging.

The 5-year rate of distant disease-free survival was 97.7% in the SLNB group vs. 98% in the no axillary surgery group, suggesting that omission of staging was noninferior to SLNB in these patients and a safe and effective option.

In current practice, nodal status remains a key factor in decision-making for adjuvant systemic therapy in premenopausal patients and in patients with HER2+ and triple-negative breast cancer, Dr. Giannakou said during the press briefing.

“The SOUND trial is a potentially practice-changing study that can spare a specific patient population from axillary surgical staging,” Dr. Giannakou said in an interview. “Before broadly applying clinical trial results to practice, it is important to ensure that the trial population is representative of the population being treated in real world practice,” he said.

What Did the New Study Show? 

In the new study, the researchers identified 312 patients meeting the SOUND trial eligibility criteria in a large database from a single center, and compared disease characteristics and outcomes with the 708 patients in the SLNB arm of the SOUND trial.

The researchers found a similarly high rate of negative SLNB results and very low recurrence in the study population. Notably, only 11.3% of the patients in the current study and 13.1% of patients in the SOUND trial had 1-3 positive lymph nodes, and less than 1% of patients in both cohorts had 4 or more positive nodes, Dr. Giannakou said.

The population of the current study was similar to that of the SOUND trial population with respect to treatment characteristics and nodal disease burden,” Dr. Giannakou said during the interview. These findings suggest that omission of sentinel lymph node in the new study cohort would have also likely been oncologically safe.

“These results are confirmatory but not surprising,” he said. Previous studies have shown that the sensitivity and accuracy of axillary ultrasound is comparable to the sentinel lymph node biopsy in patients with early breast cancer and only one abnormal lymph node on the ultrasound. 
 

What Are the Clinical Implications?

The current study findings make an important contribution to the effort to de-escalate axillary surgery in early breast cancer, Dr. Giannakou said during the interview. Although SLNB is less morbid than axillary lymph node dissection, the lymphedema risk still exists, and identifying which patients actually benefit from SLNB is critical, he said.

“In our multidisciplinary team, we are working to define selection criteria for postmenopausal patients with HR+HER2- breast cancer who would have met eligibility criteria for the SOUND trial and for whom omission of SLNB would not change adjuvant treatment considerations,” he said.

“Breast surgeons have been moving towards less aggressive axillary surgery based on evidence showing its safety in specific patient cohorts, particularly those with low-risk factors such as older age (70 years and above) and early-stage hormone receptor-positive breast cancer,” Sarah Blair, MD, professor and vice chair in the department of surgery at UC San Diego Health, said in an interview.

“The Choosing Wisely recommendations, issued by the Society of Surgical Oncology, advise against routine use of sentinel lymph node biopsy in women aged 70 and older with early-stage hormone receptor–positive breast cancer; these recommendations are based on clinical trials demonstrating oncologic safety in this population,” said Dr. Blair, who was not involved in the SOUND trial or the current study.

The data from the new study are encouraging and highlight the generalizability of the SOUND results, Mediget Teshome, MD, chief of breast surgery at UCLA Health, said in an interview. The results help to define a low-risk group of patients for which sentinel node staging may be omitted, after multidisciplinary discussion to ensure that nodal staging will not impact adjuvant systemic therapy or radiation decision-making, said Dr. Teshome, who was not involved in the SOUND trial or the current study.
 

What Are the Limitations of the SOUND trial and the New Study?

The current study limitations included its design having been a retrospective review of a prospective database with selection bias, lack of standard criteria for preoperative axillary ultrasound, and the lack of SLNB for many patients older than 70 years based on the Choosing Wisely criteria, Dr. Giannakou said in the press briefing.

“Despite the evidence supporting axillary surgery de-escalation, it can be challenging for surgeons to change their practice based on a single study,” Dr. Blair said an interview. However, the SOUND trial findings support current evidence, giving surgeons more confidence to discuss multidisciplinary treatment options, she said.
 

What Additional Research is Needed?

“Longer follow-up is needed to make definitive conclusions about the oncologic outcomes of axillary surgery de-escalation in this patient population,” said Dr. Blair. “Given that slow-growing tumors are involved, the time to recurrence may extend beyond the typical follow-up period of three years.

“Ongoing research and collaboration among multidisciplinary teams are essential to ensure optimal treatment decisions and patient outcomes,” she emphasized.

Dr. Giannakou, Dr. Blair, and Dr. Teshome had no financial conflicts to disclose.

Ultrasound for assessing lymph nodal involvement may be substituted for sentinel lymph node biopsy with no change in outcomes in patients with early breast cancer, a new study finds.

This was the conclusion of research on the agenda at the American Society of Breast Surgeons annual meeting.

Sentinel lymph node biopsy (SLNB) is the standard of care for individuals with early-stage HR+HER2- breast cancer to assess nodal involvement, but SLNB can bring complications including postoperative arm problems and lasting lymphedema, according to Andreas Giannakou, MD, of Brigham and Women’s Hospital and the Dana-Farber Cancer Institute, Boston, the presenter of this new research.

The SOUND (Sentinel Node vs. Observation After Axillary Ultra-Sound) trial, published in JAMA Oncology in 2023, showed that ultrasound nodal imaging was a safe and effective alternative to SLNB in certain patients with early-stage breast cancers, but real-world validation was needed, Dr. Giannakou said during a press briefing in advance of the meeting.

Why Was the SOUND Trial Important?

The SOUND trial randomized 1,463 individuals with early stage (cT1NO) breast cancer (tumors less than 2 cm) and negative findings on axillary ultrasound to either SLNB or no axillary surgical staging.

The 5-year rate of distant disease-free survival was 97.7% in the SLNB group vs. 98% in the no axillary surgery group, suggesting that omission of staging was noninferior to SLNB in these patients and a safe and effective option.

In current practice, nodal status remains a key factor in decision-making for adjuvant systemic therapy in premenopausal patients and in patients with HER2+ and triple-negative breast cancer, Dr. Giannakou said during the press briefing.

“The SOUND trial is a potentially practice-changing study that can spare a specific patient population from axillary surgical staging,” Dr. Giannakou said in an interview. “Before broadly applying clinical trial results to practice, it is important to ensure that the trial population is representative of the population being treated in real world practice,” he said.

What Did the New Study Show? 

In the new study, the researchers identified 312 patients meeting the SOUND trial eligibility criteria in a large database from a single center, and compared disease characteristics and outcomes with the 708 patients in the SLNB arm of the SOUND trial.

The researchers found a similarly high rate of negative SLNB results and very low recurrence in the study population. Notably, only 11.3% of the patients in the current study and 13.1% of patients in the SOUND trial had 1-3 positive lymph nodes, and less than 1% of patients in both cohorts had 4 or more positive nodes, Dr. Giannakou said.

The population of the current study was similar to that of the SOUND trial population with respect to treatment characteristics and nodal disease burden,” Dr. Giannakou said during the interview. These findings suggest that omission of sentinel lymph node in the new study cohort would have also likely been oncologically safe.

“These results are confirmatory but not surprising,” he said. Previous studies have shown that the sensitivity and accuracy of axillary ultrasound is comparable to the sentinel lymph node biopsy in patients with early breast cancer and only one abnormal lymph node on the ultrasound. 
 

What Are the Clinical Implications?

The current study findings make an important contribution to the effort to de-escalate axillary surgery in early breast cancer, Dr. Giannakou said during the interview. Although SLNB is less morbid than axillary lymph node dissection, the lymphedema risk still exists, and identifying which patients actually benefit from SLNB is critical, he said.

“In our multidisciplinary team, we are working to define selection criteria for postmenopausal patients with HR+HER2- breast cancer who would have met eligibility criteria for the SOUND trial and for whom omission of SLNB would not change adjuvant treatment considerations,” he said.

“Breast surgeons have been moving towards less aggressive axillary surgery based on evidence showing its safety in specific patient cohorts, particularly those with low-risk factors such as older age (70 years and above) and early-stage hormone receptor-positive breast cancer,” Sarah Blair, MD, professor and vice chair in the department of surgery at UC San Diego Health, said in an interview.

“The Choosing Wisely recommendations, issued by the Society of Surgical Oncology, advise against routine use of sentinel lymph node biopsy in women aged 70 and older with early-stage hormone receptor–positive breast cancer; these recommendations are based on clinical trials demonstrating oncologic safety in this population,” said Dr. Blair, who was not involved in the SOUND trial or the current study.

The data from the new study are encouraging and highlight the generalizability of the SOUND results, Mediget Teshome, MD, chief of breast surgery at UCLA Health, said in an interview. The results help to define a low-risk group of patients for which sentinel node staging may be omitted, after multidisciplinary discussion to ensure that nodal staging will not impact adjuvant systemic therapy or radiation decision-making, said Dr. Teshome, who was not involved in the SOUND trial or the current study.
 

What Are the Limitations of the SOUND trial and the New Study?

The current study limitations included its design having been a retrospective review of a prospective database with selection bias, lack of standard criteria for preoperative axillary ultrasound, and the lack of SLNB for many patients older than 70 years based on the Choosing Wisely criteria, Dr. Giannakou said in the press briefing.

“Despite the evidence supporting axillary surgery de-escalation, it can be challenging for surgeons to change their practice based on a single study,” Dr. Blair said an interview. However, the SOUND trial findings support current evidence, giving surgeons more confidence to discuss multidisciplinary treatment options, she said.
 

What Additional Research is Needed?

“Longer follow-up is needed to make definitive conclusions about the oncologic outcomes of axillary surgery de-escalation in this patient population,” said Dr. Blair. “Given that slow-growing tumors are involved, the time to recurrence may extend beyond the typical follow-up period of three years.

“Ongoing research and collaboration among multidisciplinary teams are essential to ensure optimal treatment decisions and patient outcomes,” she emphasized.

Dr. Giannakou, Dr. Blair, and Dr. Teshome had no financial conflicts to disclose.

Ultrasound for assessing lymph nodal involvement may be substituted for sentinel lymph node biopsy with no change in outcomes in patients with early breast cancer, a new study finds.

This was the conclusion of research on the agenda at the American Society of Breast Surgeons annual meeting.

Sentinel lymph node biopsy (SLNB) is the standard of care for individuals with early-stage HR+HER2- breast cancer to assess nodal involvement, but SLNB can bring complications including postoperative arm problems and lasting lymphedema, according to Andreas Giannakou, MD, of Brigham and Women’s Hospital and the Dana-Farber Cancer Institute, Boston, the presenter of this new research.

The SOUND (Sentinel Node vs. Observation After Axillary Ultra-Sound) trial, published in JAMA Oncology in 2023, showed that ultrasound nodal imaging was a safe and effective alternative to SLNB in certain patients with early-stage breast cancers, but real-world validation was needed, Dr. Giannakou said during a press briefing in advance of the meeting.

Why Was the SOUND Trial Important?

The SOUND trial randomized 1,463 individuals with early stage (cT1NO) breast cancer (tumors less than 2 cm) and negative findings on axillary ultrasound to either SLNB or no axillary surgical staging.

The 5-year rate of distant disease-free survival was 97.7% in the SLNB group vs. 98% in the no axillary surgery group, suggesting that omission of staging was noninferior to SLNB in these patients and a safe and effective option.

In current practice, nodal status remains a key factor in decision-making for adjuvant systemic therapy in premenopausal patients and in patients with HER2+ and triple-negative breast cancer, Dr. Giannakou said during the press briefing.

“The SOUND trial is a potentially practice-changing study that can spare a specific patient population from axillary surgical staging,” Dr. Giannakou said in an interview. “Before broadly applying clinical trial results to practice, it is important to ensure that the trial population is representative of the population being treated in real world practice,” he said.

What Did the New Study Show? 

In the new study, the researchers identified 312 patients meeting the SOUND trial eligibility criteria in a large database from a single center, and compared disease characteristics and outcomes with the 708 patients in the SLNB arm of the SOUND trial.

The researchers found a similarly high rate of negative SLNB results and very low recurrence in the study population. Notably, only 11.3% of the patients in the current study and 13.1% of patients in the SOUND trial had 1-3 positive lymph nodes, and less than 1% of patients in both cohorts had 4 or more positive nodes, Dr. Giannakou said.

The population of the current study was similar to that of the SOUND trial population with respect to treatment characteristics and nodal disease burden,” Dr. Giannakou said during the interview. These findings suggest that omission of sentinel lymph node in the new study cohort would have also likely been oncologically safe.

“These results are confirmatory but not surprising,” he said. Previous studies have shown that the sensitivity and accuracy of axillary ultrasound is comparable to the sentinel lymph node biopsy in patients with early breast cancer and only one abnormal lymph node on the ultrasound. 
 

What Are the Clinical Implications?

The current study findings make an important contribution to the effort to de-escalate axillary surgery in early breast cancer, Dr. Giannakou said during the interview. Although SLNB is less morbid than axillary lymph node dissection, the lymphedema risk still exists, and identifying which patients actually benefit from SLNB is critical, he said.

“In our multidisciplinary team, we are working to define selection criteria for postmenopausal patients with HR+HER2- breast cancer who would have met eligibility criteria for the SOUND trial and for whom omission of SLNB would not change adjuvant treatment considerations,” he said.

“Breast surgeons have been moving towards less aggressive axillary surgery based on evidence showing its safety in specific patient cohorts, particularly those with low-risk factors such as older age (70 years and above) and early-stage hormone receptor-positive breast cancer,” Sarah Blair, MD, professor and vice chair in the department of surgery at UC San Diego Health, said in an interview.

“The Choosing Wisely recommendations, issued by the Society of Surgical Oncology, advise against routine use of sentinel lymph node biopsy in women aged 70 and older with early-stage hormone receptor–positive breast cancer; these recommendations are based on clinical trials demonstrating oncologic safety in this population,” said Dr. Blair, who was not involved in the SOUND trial or the current study.

The data from the new study are encouraging and highlight the generalizability of the SOUND results, Mediget Teshome, MD, chief of breast surgery at UCLA Health, said in an interview. The results help to define a low-risk group of patients for which sentinel node staging may be omitted, after multidisciplinary discussion to ensure that nodal staging will not impact adjuvant systemic therapy or radiation decision-making, said Dr. Teshome, who was not involved in the SOUND trial or the current study.
 

What Are the Limitations of the SOUND trial and the New Study?

The current study limitations included its design having been a retrospective review of a prospective database with selection bias, lack of standard criteria for preoperative axillary ultrasound, and the lack of SLNB for many patients older than 70 years based on the Choosing Wisely criteria, Dr. Giannakou said in the press briefing.

“Despite the evidence supporting axillary surgery de-escalation, it can be challenging for surgeons to change their practice based on a single study,” Dr. Blair said an interview. However, the SOUND trial findings support current evidence, giving surgeons more confidence to discuss multidisciplinary treatment options, she said.
 

What Additional Research is Needed?

“Longer follow-up is needed to make definitive conclusions about the oncologic outcomes of axillary surgery de-escalation in this patient population,” said Dr. Blair. “Given that slow-growing tumors are involved, the time to recurrence may extend beyond the typical follow-up period of three years.

“Ongoing research and collaboration among multidisciplinary teams are essential to ensure optimal treatment decisions and patient outcomes,” she emphasized.

Dr. Giannakou, Dr. Blair, and Dr. Teshome had no financial conflicts to disclose.

Safety concerns persist for out-of-hospital births in the United States with multiple potential risk factors and few safety requirements, according to a paper published in the American Journal of Obstetrics and Gynecology.

In 2022, the Centers for Disease Control and Prevention (CDC) reported the highest number of planned home births in 30 years. The numbers rose 12% from 2020 to 2021, the latest period for which complete data are available. Home births rose from 45,646 (1.26% of births) in 2020 to 51,642 (1.41% of births).

Amos Grünebaum, MD, and Frank A. Chervenak, MD, with Northwell Health, and the Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine in New Hyde Park, New York, reviewed the latest safety data surrounding community births in the United States along with well-known perinatal risks and safety requirements for safe out-of-hospital births.

“Most planned home births continue to have one or more risk factors that are associated with an increase in adverse pregnancy outcomes,” they wrote.
 

Birth Certificate Data Analyzed

The researchers used the CDC birth certificate database and analyzed deliveries between 2016 and 2022 regarding the incidence of perinatal risks in community births. The risks included were prior cesarean, first baby, mother older than 35 years, twins, breech presentation, gestational age of less than 37 weeks or more than 41 weeks, newborn weight over 4,000 grams, adequacy of prenatal care, grand multiparity (5 or more prior pregnancies), and a prepregnancy body mass index of at least 35.

The incidence of perinatal risks for out-of-hospital births ranged individually from 0.2% to 28.54% among birthing center births and 0.32% to 24.4% for planned home births.

“The ACOG committee opinion on home births states that for every 1000 home births, 3.9 babies will die,” the authors noted, or about twice the risk of hospital births. The deaths are “potentially avoidable with easy access to an operating room,” they wrote.

Among the safety concerns for perinatal morbidity and mortality in community births, the authors cited the lack of:

• Appropriate patient selection for out-of-hospital births through standardized guidelines.
• Availability of a Certified Nurse Midwife, a Certified Midwife, or midwife whose education and licensure meet International Confederation of Midwives’ (ICM) Global Standards for Midwifery Education.
• Providers practicing obstetrics within an integrated and regulated health system with ready access and availability of board-certified obstetricians to provide consultation for qualified midwives.
• Standardized guidelines on when transport to a hospital is necessary.

“While prerequisites for a safe out-of-hospital delivery may be in place in other high-income countries, these prerequisites have not been actualized in the United States,” the authors wrote.

Incorporating Patient Preferences Into Delivery Models

Yalda Afshar, MD, PhD, maternal-fetal medicine subspecialist and a physician-scientist at UCLA Health in California, said obstetricians are responsible for offering the most evidence-based care to pregnant people.

“What this birth certificate data demonstrates,” she said, “is a tendency among birthing people to opt for out-of-hospital births, despite documented risks to both the pregnant person and the neonate. This underscores the need to persist in educating on risk stratification, risk reduction, and safe birthing practices, while also fostering innovation. Innovation should stem from our commitment to incorporate the preferences of pregnant people into our healthcare delivery model.”

Dr. Afshar, who was not part of the study, said clinicians should develop innovative ways to effectively meet the needs of pregnant patients while ensuring their safety and well-being.

“Ideally, we would establish safe environments within hospital systems and centers that emulate home-like birthing experiences, thereby mitigating risks for these families,” she said.

Though not explicitly stated in the data, she added, it is crucial to emphasize the need for continuous risk assessment throughout pregnancy and childbirth, “with a paramount focus on the safety of the pregnant individual.”

The authors and Dr. Afshar have no relevant financial disclosures.

Safety concerns persist for out-of-hospital births in the United States with multiple potential risk factors and few safety requirements, according to a paper published in the American Journal of Obstetrics and Gynecology.

In 2022, the Centers for Disease Control and Prevention (CDC) reported the highest number of planned home births in 30 years. The numbers rose 12% from 2020 to 2021, the latest period for which complete data are available. Home births rose from 45,646 (1.26% of births) in 2020 to 51,642 (1.41% of births).

Amos Grünebaum, MD, and Frank A. Chervenak, MD, with Northwell Health, and the Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine in New Hyde Park, New York, reviewed the latest safety data surrounding community births in the United States along with well-known perinatal risks and safety requirements for safe out-of-hospital births.

“Most planned home births continue to have one or more risk factors that are associated with an increase in adverse pregnancy outcomes,” they wrote.
 

Birth Certificate Data Analyzed

The researchers used the CDC birth certificate database and analyzed deliveries between 2016 and 2022 regarding the incidence of perinatal risks in community births. The risks included were prior cesarean, first baby, mother older than 35 years, twins, breech presentation, gestational age of less than 37 weeks or more than 41 weeks, newborn weight over 4,000 grams, adequacy of prenatal care, grand multiparity (5 or more prior pregnancies), and a prepregnancy body mass index of at least 35.

The incidence of perinatal risks for out-of-hospital births ranged individually from 0.2% to 28.54% among birthing center births and 0.32% to 24.4% for planned home births.

“The ACOG committee opinion on home births states that for every 1000 home births, 3.9 babies will die,” the authors noted, or about twice the risk of hospital births. The deaths are “potentially avoidable with easy access to an operating room,” they wrote.

Among the safety concerns for perinatal morbidity and mortality in community births, the authors cited the lack of:

• Appropriate patient selection for out-of-hospital births through standardized guidelines.
• Availability of a Certified Nurse Midwife, a Certified Midwife, or midwife whose education and licensure meet International Confederation of Midwives’ (ICM) Global Standards for Midwifery Education.
• Providers practicing obstetrics within an integrated and regulated health system with ready access and availability of board-certified obstetricians to provide consultation for qualified midwives.
• Standardized guidelines on when transport to a hospital is necessary.

“While prerequisites for a safe out-of-hospital delivery may be in place in other high-income countries, these prerequisites have not been actualized in the United States,” the authors wrote.

Incorporating Patient Preferences Into Delivery Models

Yalda Afshar, MD, PhD, maternal-fetal medicine subspecialist and a physician-scientist at UCLA Health in California, said obstetricians are responsible for offering the most evidence-based care to pregnant people.

“What this birth certificate data demonstrates,” she said, “is a tendency among birthing people to opt for out-of-hospital births, despite documented risks to both the pregnant person and the neonate. This underscores the need to persist in educating on risk stratification, risk reduction, and safe birthing practices, while also fostering innovation. Innovation should stem from our commitment to incorporate the preferences of pregnant people into our healthcare delivery model.”

Dr. Afshar, who was not part of the study, said clinicians should develop innovative ways to effectively meet the needs of pregnant patients while ensuring their safety and well-being.

“Ideally, we would establish safe environments within hospital systems and centers that emulate home-like birthing experiences, thereby mitigating risks for these families,” she said.

Though not explicitly stated in the data, she added, it is crucial to emphasize the need for continuous risk assessment throughout pregnancy and childbirth, “with a paramount focus on the safety of the pregnant individual.”

The authors and Dr. Afshar have no relevant financial disclosures.

Safety concerns persist for out-of-hospital births in the United States with multiple potential risk factors and few safety requirements, according to a paper published in the American Journal of Obstetrics and Gynecology.

In 2022, the Centers for Disease Control and Prevention (CDC) reported the highest number of planned home births in 30 years. The numbers rose 12% from 2020 to 2021, the latest period for which complete data are available. Home births rose from 45,646 (1.26% of births) in 2020 to 51,642 (1.41% of births).

Amos Grünebaum, MD, and Frank A. Chervenak, MD, with Northwell Health, and the Department of Obstetrics and Gynecology, Lenox Hill Hospital, Zucker School of Medicine in New Hyde Park, New York, reviewed the latest safety data surrounding community births in the United States along with well-known perinatal risks and safety requirements for safe out-of-hospital births.

“Most planned home births continue to have one or more risk factors that are associated with an increase in adverse pregnancy outcomes,” they wrote.
 

Birth Certificate Data Analyzed

The researchers used the CDC birth certificate database and analyzed deliveries between 2016 and 2022 regarding the incidence of perinatal risks in community births. The risks included were prior cesarean, first baby, mother older than 35 years, twins, breech presentation, gestational age of less than 37 weeks or more than 41 weeks, newborn weight over 4,000 grams, adequacy of prenatal care, grand multiparity (5 or more prior pregnancies), and a prepregnancy body mass index of at least 35.

The incidence of perinatal risks for out-of-hospital births ranged individually from 0.2% to 28.54% among birthing center births and 0.32% to 24.4% for planned home births.

“The ACOG committee opinion on home births states that for every 1000 home births, 3.9 babies will die,” the authors noted, or about twice the risk of hospital births. The deaths are “potentially avoidable with easy access to an operating room,” they wrote.

Among the safety concerns for perinatal morbidity and mortality in community births, the authors cited the lack of:

• Appropriate patient selection for out-of-hospital births through standardized guidelines.
• Availability of a Certified Nurse Midwife, a Certified Midwife, or midwife whose education and licensure meet International Confederation of Midwives’ (ICM) Global Standards for Midwifery Education.
• Providers practicing obstetrics within an integrated and regulated health system with ready access and availability of board-certified obstetricians to provide consultation for qualified midwives.
• Standardized guidelines on when transport to a hospital is necessary.

“While prerequisites for a safe out-of-hospital delivery may be in place in other high-income countries, these prerequisites have not been actualized in the United States,” the authors wrote.

Incorporating Patient Preferences Into Delivery Models

Yalda Afshar, MD, PhD, maternal-fetal medicine subspecialist and a physician-scientist at UCLA Health in California, said obstetricians are responsible for offering the most evidence-based care to pregnant people.

“What this birth certificate data demonstrates,” she said, “is a tendency among birthing people to opt for out-of-hospital births, despite documented risks to both the pregnant person and the neonate. This underscores the need to persist in educating on risk stratification, risk reduction, and safe birthing practices, while also fostering innovation. Innovation should stem from our commitment to incorporate the preferences of pregnant people into our healthcare delivery model.”

Dr. Afshar, who was not part of the study, said clinicians should develop innovative ways to effectively meet the needs of pregnant patients while ensuring their safety and well-being.

“Ideally, we would establish safe environments within hospital systems and centers that emulate home-like birthing experiences, thereby mitigating risks for these families,” she said.

Though not explicitly stated in the data, she added, it is crucial to emphasize the need for continuous risk assessment throughout pregnancy and childbirth, “with a paramount focus on the safety of the pregnant individual.”

The authors and Dr. Afshar have no relevant financial disclosures.

Physicians who misuse the “copy-and-paste” feature in patients’ electronic health records (EHRs) can face serious consequences, including lost hospital privileges, fines, and malpractice lawsuits.

In California, a locum tenens physician lost her hospital privileges after repeatedly violating the copy-and-paste policy developed at Santa Rosa Memorial Hospital, Santa Rosa, California.

“Her use of copy and paste impaired continuity of care,” said Alvin Gore, MD, who was involved in the case as the hospital’s director of utilization management.

Dr. Gore said the hospital warned the doctor, but she did not change her behavior. He did not identify the physician, citing confidentiality. The case occurred more than 5 years ago. Since then, several physicians have been called onto the carpet for violations of the policy, but no one else has lost privileges, Dr. Gore said.

Copy-paste practices can save doctors’ time when dealing with cumbersome EHR systems, but they also can lead to redundant, outdated, or inconsistent information that can compromise patient care, experts said.

“EHRs are imperfect, time consuming, and somewhat rigid,” said Robert A. Dowling, MD, a practice management consultant for large medical groups. “If physicians can’t easily figure out a complex system, they’re likely to use a workaround like copy and paste.”

Copy-and-paste abuse has also led to fines. A six-member cardiology group in Somerville, New Jersey, paid a $422,000 fine to the federal government to settle copy-and-paste charges, following an investigation by the Office of the Inspector General of the Department of Health and Human Services, according to the Report on Medicare Compliance.

This big settlement, announced in 2016, is a rare case in which physicians were charged with copy-and-paste fraud — intentionally using it to enhance reimbursement.

More commonly, Medicare contractors identify physicians who unintentionally received overpayments through sloppy copy-and-paste practices, according to a coding and documentation auditor who worked for 10 years at a Medicare contractor in Pennsylvania.

Such cases are frequent and are handled confidentially, said the auditor, who asked not to be identified. Practices must return the overpayment, and the physicians involved are “contacted and educated,” she said.

Copy and paste can also show up in malpractice lawsuits. In a 2012 survey, 53% of professional liability carriers said they had handled an EHR-related malpractice claim, and 71% of those claims included copy-and-paste use.

One such case, described by CRICO, a malpractice carrier based in Massachusetts, took place in 2012-2013. “A patient developed amiodarone toxicity because the patient›s history and medications were copied from a previous note that did not document that the patient was already on the medication,» CRICO stated.

“If you do face a malpractice claim, copying and pasting the same note repeatedly makes you look clinically inattentive, even if the copy/pasted material is unrelated to the adverse event,” CRICO officials noted in a report.
 

The Push to Use Copy and Paste

Copy and paste is a great time-saver. One study linked its use to lower burnout rates. However, it can easily introduce errors into the medical record. “This can be a huge problem,” Dr. Dowling said. “If, for example, you copy forward a previous note that said the patient had blood in their urine ‘6 days ago,’ it is immediately inaccurate.”

Practices can control use of copy and paste through coding clerks who read the medical records and then educate doctors when problems crop up.

The Pennsylvania auditor, who now works for a large group practice, said the group has very few copy-and-paste problems because of her role. “Not charting responsibly rarely happens because I work very closely with the doctors,” she said.

Dr. Dowling, however, reports that many physicians continue to overuse copy and paste. He points to a 2022 study which found that, on average, half the clinical note at one health system had been copied and pasted.

One solution might be to sanction physicians for overusing copy and paste, just as they’re sometimes penalized for not completing their notes on time with a reduction in income or possible termination.

Practices could periodically audit medical records for excessive copy-paste use. EHR systems like Epic’s can indicate how much of a doctor’s note has been copied. But Dr. Dowling doesn’t know of any practices that do this.

“There is little appetite to introduce a new enforcement activity for physicians,” he said. “Physicians would see it just as a way to make their lives more difficult than they already are.”
 

Monitoring in Hospitals and Health Systems

Some hospitals and health systems have gone as far as disabling copy-and-paste function in their EHR systems. However, enterprising physicians have found ways around these blocks.

Some institutions have also introduced formal policies, directing doctors on how they can copy and paste, including Banner Health in Arizona, Northwell Health in New York, UConn Health in Connecticut, University of Maryland Medical System, and University of Toledo in Ohio.

Definitions of what is not acceptable vary, but most of these policies oppose copying someone else’s notes and direct physicians to indicate the origin of pasted material.

Santa Rosa Memorial’s policy is quite specific. It still allows some copy and paste but stipulates that it cannot be used for the chief complaint, the review of systems, the physical examination, and the assessment and plan in the medical record, except when the information can’t be obtained directly from the patient. Also, physicians must summarize test results and provide references to other providers’ notes.

Dr. Gore said he and a physician educator who works with physicians on clinical documentation proposed the policy about a decade ago. When physicians on staff were asked to comment, some said they would be opposed to a complete ban, but they generally agreed that copy and paste was a serious problem that needed to be addressed, he said.

The hospital could have simply adopted guidelines, as opposed to rules with consequences, but “we wanted our policy to have teeth,” Dr. Gore said.

When violators are identified, Dr. Gore says he meets with them confidentially and educates them on proper use of copy and paste. Sometimes, the department head is brought in. Some physicians go on to violate the policy again and have to attend another meeting, he said, but aside from the one case, no one else has been disciplined.

It’s unclear how many physicians have faced consequences for misusing copy-paste features — such data aren’t tracked, and sanctions are likely to be handled confidentially, as a personnel matter.

Geisinger Health in Pennsylvania regularly monitors copy-and-paste usage and makes it part of physicians’ professional evaluations, according to a 2022 presentation by a Geisinger official.

Meanwhile, even when systems don’t have specific policies, they may still discipline physicians when copy and paste leads to errors. Scott MacDonald, MD, chief medical information officer at UC Davis Health in Sacramento, California, told this news organization that copy-and-paste abuse has come up a few times over the years in investigations of clinical errors.
 

Holding Physicians Accountable

Physicians can be held accountable for copy and paste by Medicare contractors and in malpractice lawsuits, but the most obvious way is at their place of work: A practice, hospital, or health system.

One physician has lost staff privileges, but more typically, coding clerks or colleagues talk to offending physicians and try to educate them on proper use of copy and paste.

Educational outreach, however, is often ineffective, said Robert Hirschtick, MD, a retired teaching physician at Northwestern University Feinberg School of Medicine, Chicago, Illinois. “The physician may be directed to take an online course,” he said. “When they take the course, the goal is to get it done with, rather than to learn something new.”

Dr. Hirschtick’s articles on copy and paste, including one titled, “Sloppy and Paste,” have put him at the front lines of the debate. “This is an ethical issue,” he said in an interview. He agrees that some forms of copy and paste are permissible, but in many cases, “it is intellectually dishonest and potentially even plagiarism,” he said.

Dr. Hirschtick argues that copy-and-paste policies need more teeth. “Tying violations to compensation would be quite effective,” he said. “Even if physicians were rarely penalized, just knowing that it could happen to you might be enough. But I haven’t heard of anyone doing this.”

A version of this article appeared on Medscape.com.

Physicians who misuse the “copy-and-paste” feature in patients’ electronic health records (EHRs) can face serious consequences, including lost hospital privileges, fines, and malpractice lawsuits.

In California, a locum tenens physician lost her hospital privileges after repeatedly violating the copy-and-paste policy developed at Santa Rosa Memorial Hospital, Santa Rosa, California.

“Her use of copy and paste impaired continuity of care,” said Alvin Gore, MD, who was involved in the case as the hospital’s director of utilization management.

Dr. Gore said the hospital warned the doctor, but she did not change her behavior. He did not identify the physician, citing confidentiality. The case occurred more than 5 years ago. Since then, several physicians have been called onto the carpet for violations of the policy, but no one else has lost privileges, Dr. Gore said.

Copy-paste practices can save doctors’ time when dealing with cumbersome EHR systems, but they also can lead to redundant, outdated, or inconsistent information that can compromise patient care, experts said.

“EHRs are imperfect, time consuming, and somewhat rigid,” said Robert A. Dowling, MD, a practice management consultant for large medical groups. “If physicians can’t easily figure out a complex system, they’re likely to use a workaround like copy and paste.”

Copy-and-paste abuse has also led to fines. A six-member cardiology group in Somerville, New Jersey, paid a $422,000 fine to the federal government to settle copy-and-paste charges, following an investigation by the Office of the Inspector General of the Department of Health and Human Services, according to the Report on Medicare Compliance.

This big settlement, announced in 2016, is a rare case in which physicians were charged with copy-and-paste fraud — intentionally using it to enhance reimbursement.

More commonly, Medicare contractors identify physicians who unintentionally received overpayments through sloppy copy-and-paste practices, according to a coding and documentation auditor who worked for 10 years at a Medicare contractor in Pennsylvania.

Such cases are frequent and are handled confidentially, said the auditor, who asked not to be identified. Practices must return the overpayment, and the physicians involved are “contacted and educated,” she said.

Copy and paste can also show up in malpractice lawsuits. In a 2012 survey, 53% of professional liability carriers said they had handled an EHR-related malpractice claim, and 71% of those claims included copy-and-paste use.

One such case, described by CRICO, a malpractice carrier based in Massachusetts, took place in 2012-2013. “A patient developed amiodarone toxicity because the patient›s history and medications were copied from a previous note that did not document that the patient was already on the medication,» CRICO stated.

“If you do face a malpractice claim, copying and pasting the same note repeatedly makes you look clinically inattentive, even if the copy/pasted material is unrelated to the adverse event,” CRICO officials noted in a report.
 

The Push to Use Copy and Paste

Copy and paste is a great time-saver. One study linked its use to lower burnout rates. However, it can easily introduce errors into the medical record. “This can be a huge problem,” Dr. Dowling said. “If, for example, you copy forward a previous note that said the patient had blood in their urine ‘6 days ago,’ it is immediately inaccurate.”

Practices can control use of copy and paste through coding clerks who read the medical records and then educate doctors when problems crop up.

The Pennsylvania auditor, who now works for a large group practice, said the group has very few copy-and-paste problems because of her role. “Not charting responsibly rarely happens because I work very closely with the doctors,” she said.

Dr. Dowling, however, reports that many physicians continue to overuse copy and paste. He points to a 2022 study which found that, on average, half the clinical note at one health system had been copied and pasted.

One solution might be to sanction physicians for overusing copy and paste, just as they’re sometimes penalized for not completing their notes on time with a reduction in income or possible termination.

Practices could periodically audit medical records for excessive copy-paste use. EHR systems like Epic’s can indicate how much of a doctor’s note has been copied. But Dr. Dowling doesn’t know of any practices that do this.

“There is little appetite to introduce a new enforcement activity for physicians,” he said. “Physicians would see it just as a way to make their lives more difficult than they already are.”
 

Monitoring in Hospitals and Health Systems

Some hospitals and health systems have gone as far as disabling copy-and-paste function in their EHR systems. However, enterprising physicians have found ways around these blocks.

Some institutions have also introduced formal policies, directing doctors on how they can copy and paste, including Banner Health in Arizona, Northwell Health in New York, UConn Health in Connecticut, University of Maryland Medical System, and University of Toledo in Ohio.

Definitions of what is not acceptable vary, but most of these policies oppose copying someone else’s notes and direct physicians to indicate the origin of pasted material.

Santa Rosa Memorial’s policy is quite specific. It still allows some copy and paste but stipulates that it cannot be used for the chief complaint, the review of systems, the physical examination, and the assessment and plan in the medical record, except when the information can’t be obtained directly from the patient. Also, physicians must summarize test results and provide references to other providers’ notes.

Dr. Gore said he and a physician educator who works with physicians on clinical documentation proposed the policy about a decade ago. When physicians on staff were asked to comment, some said they would be opposed to a complete ban, but they generally agreed that copy and paste was a serious problem that needed to be addressed, he said.

The hospital could have simply adopted guidelines, as opposed to rules with consequences, but “we wanted our policy to have teeth,” Dr. Gore said.

When violators are identified, Dr. Gore says he meets with them confidentially and educates them on proper use of copy and paste. Sometimes, the department head is brought in. Some physicians go on to violate the policy again and have to attend another meeting, he said, but aside from the one case, no one else has been disciplined.

It’s unclear how many physicians have faced consequences for misusing copy-paste features — such data aren’t tracked, and sanctions are likely to be handled confidentially, as a personnel matter.

Geisinger Health in Pennsylvania regularly monitors copy-and-paste usage and makes it part of physicians’ professional evaluations, according to a 2022 presentation by a Geisinger official.

Meanwhile, even when systems don’t have specific policies, they may still discipline physicians when copy and paste leads to errors. Scott MacDonald, MD, chief medical information officer at UC Davis Health in Sacramento, California, told this news organization that copy-and-paste abuse has come up a few times over the years in investigations of clinical errors.
 

Holding Physicians Accountable

Physicians can be held accountable for copy and paste by Medicare contractors and in malpractice lawsuits, but the most obvious way is at their place of work: A practice, hospital, or health system.

One physician has lost staff privileges, but more typically, coding clerks or colleagues talk to offending physicians and try to educate them on proper use of copy and paste.

Educational outreach, however, is often ineffective, said Robert Hirschtick, MD, a retired teaching physician at Northwestern University Feinberg School of Medicine, Chicago, Illinois. “The physician may be directed to take an online course,” he said. “When they take the course, the goal is to get it done with, rather than to learn something new.”

Dr. Hirschtick’s articles on copy and paste, including one titled, “Sloppy and Paste,” have put him at the front lines of the debate. “This is an ethical issue,” he said in an interview. He agrees that some forms of copy and paste are permissible, but in many cases, “it is intellectually dishonest and potentially even plagiarism,” he said.

Dr. Hirschtick argues that copy-and-paste policies need more teeth. “Tying violations to compensation would be quite effective,” he said. “Even if physicians were rarely penalized, just knowing that it could happen to you might be enough. But I haven’t heard of anyone doing this.”

A version of this article appeared on Medscape.com.

Physicians who misuse the “copy-and-paste” feature in patients’ electronic health records (EHRs) can face serious consequences, including lost hospital privileges, fines, and malpractice lawsuits.

In California, a locum tenens physician lost her hospital privileges after repeatedly violating the copy-and-paste policy developed at Santa Rosa Memorial Hospital, Santa Rosa, California.

“Her use of copy and paste impaired continuity of care,” said Alvin Gore, MD, who was involved in the case as the hospital’s director of utilization management.

Dr. Gore said the hospital warned the doctor, but she did not change her behavior. He did not identify the physician, citing confidentiality. The case occurred more than 5 years ago. Since then, several physicians have been called onto the carpet for violations of the policy, but no one else has lost privileges, Dr. Gore said.

Copy-paste practices can save doctors’ time when dealing with cumbersome EHR systems, but they also can lead to redundant, outdated, or inconsistent information that can compromise patient care, experts said.

“EHRs are imperfect, time consuming, and somewhat rigid,” said Robert A. Dowling, MD, a practice management consultant for large medical groups. “If physicians can’t easily figure out a complex system, they’re likely to use a workaround like copy and paste.”

Copy-and-paste abuse has also led to fines. A six-member cardiology group in Somerville, New Jersey, paid a $422,000 fine to the federal government to settle copy-and-paste charges, following an investigation by the Office of the Inspector General of the Department of Health and Human Services, according to the Report on Medicare Compliance.

This big settlement, announced in 2016, is a rare case in which physicians were charged with copy-and-paste fraud — intentionally using it to enhance reimbursement.

More commonly, Medicare contractors identify physicians who unintentionally received overpayments through sloppy copy-and-paste practices, according to a coding and documentation auditor who worked for 10 years at a Medicare contractor in Pennsylvania.

Such cases are frequent and are handled confidentially, said the auditor, who asked not to be identified. Practices must return the overpayment, and the physicians involved are “contacted and educated,” she said.

Copy and paste can also show up in malpractice lawsuits. In a 2012 survey, 53% of professional liability carriers said they had handled an EHR-related malpractice claim, and 71% of those claims included copy-and-paste use.

One such case, described by CRICO, a malpractice carrier based in Massachusetts, took place in 2012-2013. “A patient developed amiodarone toxicity because the patient›s history and medications were copied from a previous note that did not document that the patient was already on the medication,» CRICO stated.

“If you do face a malpractice claim, copying and pasting the same note repeatedly makes you look clinically inattentive, even if the copy/pasted material is unrelated to the adverse event,” CRICO officials noted in a report.
 

The Push to Use Copy and Paste

Copy and paste is a great time-saver. One study linked its use to lower burnout rates. However, it can easily introduce errors into the medical record. “This can be a huge problem,” Dr. Dowling said. “If, for example, you copy forward a previous note that said the patient had blood in their urine ‘6 days ago,’ it is immediately inaccurate.”

Practices can control use of copy and paste through coding clerks who read the medical records and then educate doctors when problems crop up.

The Pennsylvania auditor, who now works for a large group practice, said the group has very few copy-and-paste problems because of her role. “Not charting responsibly rarely happens because I work very closely with the doctors,” she said.

Dr. Dowling, however, reports that many physicians continue to overuse copy and paste. He points to a 2022 study which found that, on average, half the clinical note at one health system had been copied and pasted.

One solution might be to sanction physicians for overusing copy and paste, just as they’re sometimes penalized for not completing their notes on time with a reduction in income or possible termination.

Practices could periodically audit medical records for excessive copy-paste use. EHR systems like Epic’s can indicate how much of a doctor’s note has been copied. But Dr. Dowling doesn’t know of any practices that do this.

“There is little appetite to introduce a new enforcement activity for physicians,” he said. “Physicians would see it just as a way to make their lives more difficult than they already are.”
 

Monitoring in Hospitals and Health Systems

Some hospitals and health systems have gone as far as disabling copy-and-paste function in their EHR systems. However, enterprising physicians have found ways around these blocks.

Some institutions have also introduced formal policies, directing doctors on how they can copy and paste, including Banner Health in Arizona, Northwell Health in New York, UConn Health in Connecticut, University of Maryland Medical System, and University of Toledo in Ohio.

Definitions of what is not acceptable vary, but most of these policies oppose copying someone else’s notes and direct physicians to indicate the origin of pasted material.

Santa Rosa Memorial’s policy is quite specific. It still allows some copy and paste but stipulates that it cannot be used for the chief complaint, the review of systems, the physical examination, and the assessment and plan in the medical record, except when the information can’t be obtained directly from the patient. Also, physicians must summarize test results and provide references to other providers’ notes.

Dr. Gore said he and a physician educator who works with physicians on clinical documentation proposed the policy about a decade ago. When physicians on staff were asked to comment, some said they would be opposed to a complete ban, but they generally agreed that copy and paste was a serious problem that needed to be addressed, he said.

The hospital could have simply adopted guidelines, as opposed to rules with consequences, but “we wanted our policy to have teeth,” Dr. Gore said.

When violators are identified, Dr. Gore says he meets with them confidentially and educates them on proper use of copy and paste. Sometimes, the department head is brought in. Some physicians go on to violate the policy again and have to attend another meeting, he said, but aside from the one case, no one else has been disciplined.

It’s unclear how many physicians have faced consequences for misusing copy-paste features — such data aren’t tracked, and sanctions are likely to be handled confidentially, as a personnel matter.

Geisinger Health in Pennsylvania regularly monitors copy-and-paste usage and makes it part of physicians’ professional evaluations, according to a 2022 presentation by a Geisinger official.

Meanwhile, even when systems don’t have specific policies, they may still discipline physicians when copy and paste leads to errors. Scott MacDonald, MD, chief medical information officer at UC Davis Health in Sacramento, California, told this news organization that copy-and-paste abuse has come up a few times over the years in investigations of clinical errors.
 

Holding Physicians Accountable

Physicians can be held accountable for copy and paste by Medicare contractors and in malpractice lawsuits, but the most obvious way is at their place of work: A practice, hospital, or health system.

One physician has lost staff privileges, but more typically, coding clerks or colleagues talk to offending physicians and try to educate them on proper use of copy and paste.

Educational outreach, however, is often ineffective, said Robert Hirschtick, MD, a retired teaching physician at Northwestern University Feinberg School of Medicine, Chicago, Illinois. “The physician may be directed to take an online course,” he said. “When they take the course, the goal is to get it done with, rather than to learn something new.”

Dr. Hirschtick’s articles on copy and paste, including one titled, “Sloppy and Paste,” have put him at the front lines of the debate. “This is an ethical issue,” he said in an interview. He agrees that some forms of copy and paste are permissible, but in many cases, “it is intellectually dishonest and potentially even plagiarism,” he said.

Dr. Hirschtick argues that copy-and-paste policies need more teeth. “Tying violations to compensation would be quite effective,” he said. “Even if physicians were rarely penalized, just knowing that it could happen to you might be enough. But I haven’t heard of anyone doing this.”

A version of this article appeared on Medscape.com.

Hormone Therapy (HT) is a good option for most women over age 65, despite entrenched fears about HT safety, according to findings from a new study published in Menopause.

The study, led by Seo H. Baik, PhD, of Lister Hill National Center for Biomedical Communications, National Library of Medicine, in Bethesda, Maryland, and colleagues is based on the health records of 10 million senior women on Medicare from 2007 to 2020. It concludes there are important health benefits with HT beyond age 65 and the effects of using HT after age 65 vary by type of therapy, route of administration, and dose.
 

Controversial Since Women’s Health Initiative

Use of HT after age 65 has been controversial in light of the findings of the Women’s Health Initiative (WHI) study in 2002. Since that study, many women have decided against HT, especially after age 65, because of fears of increased risks for cancers and heart disease.

Baik et al. concluded that, compared with never using or stopping use of HT before the age of 65 years, the use of estrogen alone beyond age 65 years was associated with the following significant risk reductions: mortality (19%); breast cancer (16%); lung cancer (13%); colorectal cancer (12%); congestive heart failure (5%); venous thromboembolism (5%); atrial fibrillation (4%); acute myocardial infarction (11%); and dementia (2%).

The authors further found that estrogen plus progestin was associated with significant risk reductions in endometrial cancer (45%); ovarian cancer (21%); ischemic heart disease (5%); congestive heart failure (5%); and venous thromboembolism (5%).

Estrogen plus progesterone, however, was linked with risk reduction only in congestive heart failure (4%).

Reassuring Results

“These results should provide additional reassurance to women about hormone therapy,” said Lisa C, Larkin, MD, president of The Menopause Society. “This data is largely consistent with the WHI data as we understand it today — that for the majority of women with symptoms transitioning through menopause, hormone therapy is the most effective treatment and has benefits that outweigh risks.”

There may be some exceptions, she noted, particularly in older women with high risk for cardiovascular disease and stroke. Among those women, she explained, the risks of HT may outweigh the benefits and it may be appropriate to stop hormone therapy.

“In these older women with specific risk factors, the discussion of continuing or stopping HT is nuanced and complex and must involve shared decision-making,” she said.

Elevated Breast Cancer Risk Can be Mitigated

With a therapy combining estrogen and progestogen, both estrogen plus progestin and estrogen plus progesterone were associated with a 10%-19% increased risk of breast cancer, but the authors say that risk can be mitigated using low doses of transdermal or vaginal estrogen plus progestin.

“In general, risk reductions appear to be greater with low rather than medium or high doses, vaginal or transdermal rather than oral preparations, and with E2 (estradiol) rather than conjugated estrogen,” the authors write.

The authors report that over 14 years of follow-up (from 2007 to 2020), the proportion of senior women taking any HT-containing estrogen dropped by half, from 11.4% to 5.5%. E2 has largely replaced conjugated estrogen (CEE); and vaginal administration largely replaced oral.

Controversy Remains

Even with these results, hormone use will remain controversial, Dr. Larkin said, without enormous efforts to educate. Menopausal HT therapy in young 50-year-old women having symptoms is still controversial — despite the large body of evidence supporting safety and benefit in the majority of women, she said.

“For the last 25 years we have completely neglected education of clinicians about menopause and the data on hormone therapy,” she said. “As a result, most of the clinicians practicing do not understand the data and remain very negative about hormones even in younger women. The decades of lack of education of clinicians about menopause is one of the major reasons far too many young, healthy, 50-year-old women with symptoms are not getting the care they need [hormone therapy] at menopause.” Instead, she says, women are told to take supplements because some providers think hormone therapy is too dangerous.

Lauren Streicher, MD, a clinical professor of obstetrics and gynecology at Northwestern University’s Feinberg School of Medicine, and founding director of the Northwestern Medical Center for Sexual Medicine and Menopause, both in Chicago, says, “In the WHI, 70% of the women were over the age of 65 when they initiated therapy, which partially accounts for the negative outcomes. In addition, in WHI, everyone was taking oral [HT]. This (current) data is very reassuring — and validating — for women who would like to continue taking HT.”

Dr. Streicher says women who would like to start HT after 65 should be counseled on individual risks and after cardiac health is evaluated. But, she notes, this study did not address that.

‘Best Time to Stop HT is When You Die’

She says in her practice she will counsel women who are on HT and would like to continue after age 65 the way she always has: “If someone is taking HT and has no specific reason to stop, there is no reason to stop at some arbitrary age or time and that if they do, they will lose many of the benefits,” particularly bone, cognitive, cardiovascular, and vulvovaginal benefits, she explained. “The best time to stop HT is when you die,” Dr. Streicher said, “And, given the reduction in mortality in women who take HT, that will be at a much older age than women who don’t take HT.”

So will these new data be convincing?

“It will convince the already convinced — menopause experts who follow the data. It is the rare menopause expert that tells women to stop HT,” Dr. Streicher said.

However, she said, “The overwhelming majority of clinicians in the US currently do not prescribe HT. Sadly, I don’t think this will change much.”

The authors report no relevant financial relationships. Dr. Larkin consults for several women’s health companies including Mayne Pharma, Astellas, Johnson & Johnson, Grail, Pfizer, and Solv Wellness. Dr. Streicher reports no relevant financial relationships.