Feature

Doctors say a woman in Michigan contracted COVID-19 and died last fall 2 months after receiving a tainted double-lung transplant from a donor who turned out to harbor the virus that causes the disease – despite showing no signs of illness and initially testing negative.

Officials at the University of Michigan Medical School suggested it may be the first proven case of COVID-19 in the U.S. in which the virus was transmitted via an organ transplant. A surgeon who handled the donor lungs was also infected with the virus and fell ill but later recovered.

The incident appears to be isolated – the only confirmed case among nearly 40,000 transplants in 2020. But it has led to calls for more thorough testing of lung transplant donors, with samples taken from deep within the donor lungs as well as the nose and throat, said Dr. Daniel Kaul, director of Michigan Medicine’s transplant infectious disease service.

“We would absolutely not have used the lungs if we’d had a positive COVID-19 test,” said Dr. Kaul, who coauthored a report about the case in the American Journal of Transplantation.

The virus was transmitted when lungs from a woman from the Upper Midwest, who died after suffering a severe brain injury in a car accident, were transplanted into a woman with chronic obstructive lung disease at University Hospital in Ann Arbor. The nose and throat samples routinely collected from both organ donors and recipients tested negative for SARS-CoV-2, the virus that causes covid.

“All the screening that we normally do and are able to do, we did,” Dr. Kaul said.

Three days after the operation, however, the recipient spiked a fever; her blood pressure fell and her breathing became labored. Imaging showed signs of lung infection.

As her condition worsened, the patient developed septic shock and heart function problems. Doctors decided to test for SARS-CoV-2, Dr. Kaul said. Samples from her new lungs came back positive.

Suspicious about the origin of the infection, doctors returned to samples from the transplant donor. A molecular test of a swab from the donor’s nose and throat, taken 48 hours after her lungs were procured, had been negative for SARS-Cov-2. The donor’s family told doctors she had no history of recent travel or COVID-19 symptoms and no known exposure to anyone with the disease.

But doctors had kept a sample of fluid washed from deep within the donor lungs. When they tested that fluid, it was positive for the virus. Four days after the transplant, the surgeon who handled the donor lungs and performed the surgery tested positive, too. Genetic screening revealed that the transplant recipient and the surgeon had been infected by the donor. Ten other members of the transplant team tested negative for the virus.

The transplant recipient deteriorated rapidly, developing multisystem organ failure. Doctors tried known treatments for COVID-19, including remdesivir, a newly approved drug, and convalescent blood plasma from people previously infected with the disease. Eventually, she was placed on the last-resort option of ECMO, or extracorporeal membrane oxygenation, to no avail. Life support was withdrawn, and she died 61 days after the transplant.

Dr. Kaul called the incident “a tragic case.”

While the Michigan case marks the first confirmed incident in the U.S. of transmission through a transplant, others have been suspected. A recent Centers for Disease Control and Prevention report reviewed eight possible cases of what’s known as donor-derived infection that occurred last spring, but concluded the most likely source of transmission of the COVID-19 virus in those cases was in a community or health care setting.

Before this incident, it was not clear whether the COVID-19 virus could be transmitted through solid organ transplants, though it’s well documented with other respiratory viruses. Donor transmission of H1N1 2009 pandemic influenza has been detected almost exclusively in lung transplant recipients, Dr. Kaul noted.

While it’s not surprising that SARS-CoV-2 can be transmitted through infected lungs, it remains uncertain whether other organs affected by COVID-19 – hearts, livers and kidneys, for instance – can transmit the virus, too.

“It seems for non-lung donors that it may be very difficult to transmit COVID-19, even if the donor has COVID-19,” Dr. Kaul said.

Organ donors have been tested routinely for SARS-CoV-2 during the pandemic, though it’s not required by the Organ Procurement and Transplantation Network, or OPTN, which oversees transplants in the U.S. But the Michigan case underscores the need for more extensive sampling before transplant, especially in areas with high rates of covid transmission, Dr. Kaul said.

When it comes to lungs, that means making sure to test samples from the donor’s lower respiratory tract, as well as from the nose and throat. Obtaining and testing such samples from donors can be difficult to carry out in a timely fashion. There’s also the risk of introducing infection into the donated lungs, Dr. Kaul said.

Because no organs other than lungs were used, the Michigan case doesn’t provide insight into testing protocols for other organs.

Overall, viral transmissions from organ donors to recipients remain rare, occurring in fewer than 1% of transplant recipients, research shows. The medical risks facing ailing patients who reject a donor organ are generally far higher, said Dr. David Klassen, chief medical officer with the United Network for Organ Sharing, the federal contractor that runs the OPTN.

“The risks of turning down transplants are catastrophic,” he said. “I don’t think patients should be afraid of the transplant process.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Doctors say a woman in Michigan contracted COVID-19 and died last fall 2 months after receiving a tainted double-lung transplant from a donor who turned out to harbor the virus that causes the disease – despite showing no signs of illness and initially testing negative.

Officials at the University of Michigan Medical School suggested it may be the first proven case of COVID-19 in the U.S. in which the virus was transmitted via an organ transplant. A surgeon who handled the donor lungs was also infected with the virus and fell ill but later recovered.

The incident appears to be isolated – the only confirmed case among nearly 40,000 transplants in 2020. But it has led to calls for more thorough testing of lung transplant donors, with samples taken from deep within the donor lungs as well as the nose and throat, said Dr. Daniel Kaul, director of Michigan Medicine’s transplant infectious disease service.

“We would absolutely not have used the lungs if we’d had a positive COVID-19 test,” said Dr. Kaul, who coauthored a report about the case in the American Journal of Transplantation.

The virus was transmitted when lungs from a woman from the Upper Midwest, who died after suffering a severe brain injury in a car accident, were transplanted into a woman with chronic obstructive lung disease at University Hospital in Ann Arbor. The nose and throat samples routinely collected from both organ donors and recipients tested negative for SARS-CoV-2, the virus that causes covid.

“All the screening that we normally do and are able to do, we did,” Dr. Kaul said.

Three days after the operation, however, the recipient spiked a fever; her blood pressure fell and her breathing became labored. Imaging showed signs of lung infection.

As her condition worsened, the patient developed septic shock and heart function problems. Doctors decided to test for SARS-CoV-2, Dr. Kaul said. Samples from her new lungs came back positive.

Suspicious about the origin of the infection, doctors returned to samples from the transplant donor. A molecular test of a swab from the donor’s nose and throat, taken 48 hours after her lungs were procured, had been negative for SARS-Cov-2. The donor’s family told doctors she had no history of recent travel or COVID-19 symptoms and no known exposure to anyone with the disease.

But doctors had kept a sample of fluid washed from deep within the donor lungs. When they tested that fluid, it was positive for the virus. Four days after the transplant, the surgeon who handled the donor lungs and performed the surgery tested positive, too. Genetic screening revealed that the transplant recipient and the surgeon had been infected by the donor. Ten other members of the transplant team tested negative for the virus.

The transplant recipient deteriorated rapidly, developing multisystem organ failure. Doctors tried known treatments for COVID-19, including remdesivir, a newly approved drug, and convalescent blood plasma from people previously infected with the disease. Eventually, she was placed on the last-resort option of ECMO, or extracorporeal membrane oxygenation, to no avail. Life support was withdrawn, and she died 61 days after the transplant.

Dr. Kaul called the incident “a tragic case.”

While the Michigan case marks the first confirmed incident in the U.S. of transmission through a transplant, others have been suspected. A recent Centers for Disease Control and Prevention report reviewed eight possible cases of what’s known as donor-derived infection that occurred last spring, but concluded the most likely source of transmission of the COVID-19 virus in those cases was in a community or health care setting.

Before this incident, it was not clear whether the COVID-19 virus could be transmitted through solid organ transplants, though it’s well documented with other respiratory viruses. Donor transmission of H1N1 2009 pandemic influenza has been detected almost exclusively in lung transplant recipients, Dr. Kaul noted.

While it’s not surprising that SARS-CoV-2 can be transmitted through infected lungs, it remains uncertain whether other organs affected by COVID-19 – hearts, livers and kidneys, for instance – can transmit the virus, too.

“It seems for non-lung donors that it may be very difficult to transmit COVID-19, even if the donor has COVID-19,” Dr. Kaul said.

Organ donors have been tested routinely for SARS-CoV-2 during the pandemic, though it’s not required by the Organ Procurement and Transplantation Network, or OPTN, which oversees transplants in the U.S. But the Michigan case underscores the need for more extensive sampling before transplant, especially in areas with high rates of covid transmission, Dr. Kaul said.

When it comes to lungs, that means making sure to test samples from the donor’s lower respiratory tract, as well as from the nose and throat. Obtaining and testing such samples from donors can be difficult to carry out in a timely fashion. There’s also the risk of introducing infection into the donated lungs, Dr. Kaul said.

Because no organs other than lungs were used, the Michigan case doesn’t provide insight into testing protocols for other organs.

Overall, viral transmissions from organ donors to recipients remain rare, occurring in fewer than 1% of transplant recipients, research shows. The medical risks facing ailing patients who reject a donor organ are generally far higher, said Dr. David Klassen, chief medical officer with the United Network for Organ Sharing, the federal contractor that runs the OPTN.

“The risks of turning down transplants are catastrophic,” he said. “I don’t think patients should be afraid of the transplant process.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Doctors say a woman in Michigan contracted COVID-19 and died last fall 2 months after receiving a tainted double-lung transplant from a donor who turned out to harbor the virus that causes the disease – despite showing no signs of illness and initially testing negative.

Officials at the University of Michigan Medical School suggested it may be the first proven case of COVID-19 in the U.S. in which the virus was transmitted via an organ transplant. A surgeon who handled the donor lungs was also infected with the virus and fell ill but later recovered.

The incident appears to be isolated – the only confirmed case among nearly 40,000 transplants in 2020. But it has led to calls for more thorough testing of lung transplant donors, with samples taken from deep within the donor lungs as well as the nose and throat, said Dr. Daniel Kaul, director of Michigan Medicine’s transplant infectious disease service.

“We would absolutely not have used the lungs if we’d had a positive COVID-19 test,” said Dr. Kaul, who coauthored a report about the case in the American Journal of Transplantation.

The virus was transmitted when lungs from a woman from the Upper Midwest, who died after suffering a severe brain injury in a car accident, were transplanted into a woman with chronic obstructive lung disease at University Hospital in Ann Arbor. The nose and throat samples routinely collected from both organ donors and recipients tested negative for SARS-CoV-2, the virus that causes covid.

“All the screening that we normally do and are able to do, we did,” Dr. Kaul said.

Three days after the operation, however, the recipient spiked a fever; her blood pressure fell and her breathing became labored. Imaging showed signs of lung infection.

As her condition worsened, the patient developed septic shock and heart function problems. Doctors decided to test for SARS-CoV-2, Dr. Kaul said. Samples from her new lungs came back positive.

Suspicious about the origin of the infection, doctors returned to samples from the transplant donor. A molecular test of a swab from the donor’s nose and throat, taken 48 hours after her lungs were procured, had been negative for SARS-Cov-2. The donor’s family told doctors she had no history of recent travel or COVID-19 symptoms and no known exposure to anyone with the disease.

But doctors had kept a sample of fluid washed from deep within the donor lungs. When they tested that fluid, it was positive for the virus. Four days after the transplant, the surgeon who handled the donor lungs and performed the surgery tested positive, too. Genetic screening revealed that the transplant recipient and the surgeon had been infected by the donor. Ten other members of the transplant team tested negative for the virus.

The transplant recipient deteriorated rapidly, developing multisystem organ failure. Doctors tried known treatments for COVID-19, including remdesivir, a newly approved drug, and convalescent blood plasma from people previously infected with the disease. Eventually, she was placed on the last-resort option of ECMO, or extracorporeal membrane oxygenation, to no avail. Life support was withdrawn, and she died 61 days after the transplant.

Dr. Kaul called the incident “a tragic case.”

While the Michigan case marks the first confirmed incident in the U.S. of transmission through a transplant, others have been suspected. A recent Centers for Disease Control and Prevention report reviewed eight possible cases of what’s known as donor-derived infection that occurred last spring, but concluded the most likely source of transmission of the COVID-19 virus in those cases was in a community or health care setting.

Before this incident, it was not clear whether the COVID-19 virus could be transmitted through solid organ transplants, though it’s well documented with other respiratory viruses. Donor transmission of H1N1 2009 pandemic influenza has been detected almost exclusively in lung transplant recipients, Dr. Kaul noted.

While it’s not surprising that SARS-CoV-2 can be transmitted through infected lungs, it remains uncertain whether other organs affected by COVID-19 – hearts, livers and kidneys, for instance – can transmit the virus, too.

“It seems for non-lung donors that it may be very difficult to transmit COVID-19, even if the donor has COVID-19,” Dr. Kaul said.

Organ donors have been tested routinely for SARS-CoV-2 during the pandemic, though it’s not required by the Organ Procurement and Transplantation Network, or OPTN, which oversees transplants in the U.S. But the Michigan case underscores the need for more extensive sampling before transplant, especially in areas with high rates of covid transmission, Dr. Kaul said.

When it comes to lungs, that means making sure to test samples from the donor’s lower respiratory tract, as well as from the nose and throat. Obtaining and testing such samples from donors can be difficult to carry out in a timely fashion. There’s also the risk of introducing infection into the donated lungs, Dr. Kaul said.

Because no organs other than lungs were used, the Michigan case doesn’t provide insight into testing protocols for other organs.

Overall, viral transmissions from organ donors to recipients remain rare, occurring in fewer than 1% of transplant recipients, research shows. The medical risks facing ailing patients who reject a donor organ are generally far higher, said Dr. David Klassen, chief medical officer with the United Network for Organ Sharing, the federal contractor that runs the OPTN.

“The risks of turning down transplants are catastrophic,” he said. “I don’t think patients should be afraid of the transplant process.”
 

Kaiser Health News is a nonprofit news service covering health issues. It is an editorially independent program of KFF (Kaiser Family Foundation), which is not affiliated with Kaiser Permanente.

Pretty much everything connected with family medicine has undergone a great deal of change in the 50 years since Family Practice News published its first issue, and the men and women who practice it are no exception.

The family medicine workforce of 2021 is not the workforce of 1971. Not even close. Although we would like to give a huge shout-out to anyone who can claim to be a member of both.

Today’s FP workforce is, first of all, much larger than it was in 1971, although we can’t actually prove it because the American Medical Association’s data for that year are “only available in books that are locked away at the empty AMA headquarters,” according to a member of the AMA media relations staff who is, like so many people these days, working at home because of the pandemic.
 

The face of family medicine in 1975 vs. today

Today’s workforce is much larger than it was in 1975, when there were just over 12,000 family physicians in the United States. As of January 2021, the total was approaching 137,000, including all “physicians and residents in patient care, research, administration, teaching, retired, inactive, etc.,” the AMA explained.

Family physicians as a group are much more diverse than they were in 1975. That year, 8.3% of FPs were international medical graduates (IMGs). By 2010, IMGs made up almost 23% of the workforce, and in the 2020 resident match, 37% of the 4,662 available family medicine slots were filled by IMGs.

Women have made even greater inroads into the family physician ranks over the last 5 decades. In 1975, less than 5% of all FPs were females, but by 2021 the proportion of females in the specialty was just over 40%.

In the first 5 years of the family practice era, 1969-1973, only 12 women and 31 IMGs graduated from FP residency programs, those numbers representing 3.2% and 8.3%, respectively, of the total of 372, according to a 1996 study in JAMA. By 1990-1993, women made up 33% and IMGs 14% of the 9,400 graduates.

Another group that increased its presence in family medicine is doctors of osteopathy, who went from zero residency graduates in 1969-1973 to over 1,100 (11.8%) in 1990-1993, the JAMA report noted. By 2020, almost 1,400 osteopathic physicians entered family medicine residencies, filling 30% of all slots available, according to the National Resident Matching Program.

The medical schools producing all these new residents have raised their games since 1971: the number of full-time faculty in family medicine departments rose from 323 to 5,929 in 2020, based on data from the Association of American Medical Colleges (Faculty Roster, Dec. 31 snapshots, as of Dec. 31, 2020).

A shortage or a surplus of FPs?

It has been suggested, however, that all is not well in primary care land. A study conducted by the American Academy of Family Physicians in 2016 – a year after 2,463 graduates of MD- and DO-granting medical schools entered family medicine residencies – concluded “that the current medical school system is failing, collectively, to produce the primary care workforce that is needed to achieve optimal health.”

Warnings about physician shortages are nothing new, but how about the other side of the coin? The Jan. 15, 1981, issue of Family Practice News covered a somewhat controversial report from the Graduate Medical Education National Advisory Committee, which projected a surplus of 3,000 FPs, and as many as 70,000 physicians overall, by the year 1990.

Just a few months later, in the June 15, 1981, issue of FPN, an AAFP officer predicted that “the flood of new physicians in the next decade may affect family practice more than any other specialty.”

Mostly, though, the issue is shortages. In 2002, a status report on family practice from the Robert Graham Center acknowledged that “many centers of academic medicine continue to resist the development of family practice and primary care. ... Family medicine remains a true counterculture in these environments, and students may continue to face significant discouragement in response to interest they may express in becoming a family physician.”

rfranki@mdedge.com

Pretty much everything connected with family medicine has undergone a great deal of change in the 50 years since Family Practice News published its first issue, and the men and women who practice it are no exception.

The family medicine workforce of 2021 is not the workforce of 1971. Not even close. Although we would like to give a huge shout-out to anyone who can claim to be a member of both.

Today’s FP workforce is, first of all, much larger than it was in 1971, although we can’t actually prove it because the American Medical Association’s data for that year are “only available in books that are locked away at the empty AMA headquarters,” according to a member of the AMA media relations staff who is, like so many people these days, working at home because of the pandemic.
 

The face of family medicine in 1975 vs. today

Today’s workforce is much larger than it was in 1975, when there were just over 12,000 family physicians in the United States. As of January 2021, the total was approaching 137,000, including all “physicians and residents in patient care, research, administration, teaching, retired, inactive, etc.,” the AMA explained.

Family physicians as a group are much more diverse than they were in 1975. That year, 8.3% of FPs were international medical graduates (IMGs). By 2010, IMGs made up almost 23% of the workforce, and in the 2020 resident match, 37% of the 4,662 available family medicine slots were filled by IMGs.

Women have made even greater inroads into the family physician ranks over the last 5 decades. In 1975, less than 5% of all FPs were females, but by 2021 the proportion of females in the specialty was just over 40%.

In the first 5 years of the family practice era, 1969-1973, only 12 women and 31 IMGs graduated from FP residency programs, those numbers representing 3.2% and 8.3%, respectively, of the total of 372, according to a 1996 study in JAMA. By 1990-1993, women made up 33% and IMGs 14% of the 9,400 graduates.

Another group that increased its presence in family medicine is doctors of osteopathy, who went from zero residency graduates in 1969-1973 to over 1,100 (11.8%) in 1990-1993, the JAMA report noted. By 2020, almost 1,400 osteopathic physicians entered family medicine residencies, filling 30% of all slots available, according to the National Resident Matching Program.

The medical schools producing all these new residents have raised their games since 1971: the number of full-time faculty in family medicine departments rose from 323 to 5,929 in 2020, based on data from the Association of American Medical Colleges (Faculty Roster, Dec. 31 snapshots, as of Dec. 31, 2020).

A shortage or a surplus of FPs?

It has been suggested, however, that all is not well in primary care land. A study conducted by the American Academy of Family Physicians in 2016 – a year after 2,463 graduates of MD- and DO-granting medical schools entered family medicine residencies – concluded “that the current medical school system is failing, collectively, to produce the primary care workforce that is needed to achieve optimal health.”

Warnings about physician shortages are nothing new, but how about the other side of the coin? The Jan. 15, 1981, issue of Family Practice News covered a somewhat controversial report from the Graduate Medical Education National Advisory Committee, which projected a surplus of 3,000 FPs, and as many as 70,000 physicians overall, by the year 1990.

Just a few months later, in the June 15, 1981, issue of FPN, an AAFP officer predicted that “the flood of new physicians in the next decade may affect family practice more than any other specialty.”

Mostly, though, the issue is shortages. In 2002, a status report on family practice from the Robert Graham Center acknowledged that “many centers of academic medicine continue to resist the development of family practice and primary care. ... Family medicine remains a true counterculture in these environments, and students may continue to face significant discouragement in response to interest they may express in becoming a family physician.”

rfranki@mdedge.com

Pretty much everything connected with family medicine has undergone a great deal of change in the 50 years since Family Practice News published its first issue, and the men and women who practice it are no exception.

The family medicine workforce of 2021 is not the workforce of 1971. Not even close. Although we would like to give a huge shout-out to anyone who can claim to be a member of both.

Today’s FP workforce is, first of all, much larger than it was in 1971, although we can’t actually prove it because the American Medical Association’s data for that year are “only available in books that are locked away at the empty AMA headquarters,” according to a member of the AMA media relations staff who is, like so many people these days, working at home because of the pandemic.
 

The face of family medicine in 1975 vs. today

Today’s workforce is much larger than it was in 1975, when there were just over 12,000 family physicians in the United States. As of January 2021, the total was approaching 137,000, including all “physicians and residents in patient care, research, administration, teaching, retired, inactive, etc.,” the AMA explained.

Family physicians as a group are much more diverse than they were in 1975. That year, 8.3% of FPs were international medical graduates (IMGs). By 2010, IMGs made up almost 23% of the workforce, and in the 2020 resident match, 37% of the 4,662 available family medicine slots were filled by IMGs.

Women have made even greater inroads into the family physician ranks over the last 5 decades. In 1975, less than 5% of all FPs were females, but by 2021 the proportion of females in the specialty was just over 40%.

In the first 5 years of the family practice era, 1969-1973, only 12 women and 31 IMGs graduated from FP residency programs, those numbers representing 3.2% and 8.3%, respectively, of the total of 372, according to a 1996 study in JAMA. By 1990-1993, women made up 33% and IMGs 14% of the 9,400 graduates.

Another group that increased its presence in family medicine is doctors of osteopathy, who went from zero residency graduates in 1969-1973 to over 1,100 (11.8%) in 1990-1993, the JAMA report noted. By 2020, almost 1,400 osteopathic physicians entered family medicine residencies, filling 30% of all slots available, according to the National Resident Matching Program.

The medical schools producing all these new residents have raised their games since 1971: the number of full-time faculty in family medicine departments rose from 323 to 5,929 in 2020, based on data from the Association of American Medical Colleges (Faculty Roster, Dec. 31 snapshots, as of Dec. 31, 2020).

A shortage or a surplus of FPs?

It has been suggested, however, that all is not well in primary care land. A study conducted by the American Academy of Family Physicians in 2016 – a year after 2,463 graduates of MD- and DO-granting medical schools entered family medicine residencies – concluded “that the current medical school system is failing, collectively, to produce the primary care workforce that is needed to achieve optimal health.”

Warnings about physician shortages are nothing new, but how about the other side of the coin? The Jan. 15, 1981, issue of Family Practice News covered a somewhat controversial report from the Graduate Medical Education National Advisory Committee, which projected a surplus of 3,000 FPs, and as many as 70,000 physicians overall, by the year 1990.

Just a few months later, in the June 15, 1981, issue of FPN, an AAFP officer predicted that “the flood of new physicians in the next decade may affect family practice more than any other specialty.”

Mostly, though, the issue is shortages. In 2002, a status report on family practice from the Robert Graham Center acknowledged that “many centers of academic medicine continue to resist the development of family practice and primary care. ... Family medicine remains a true counterculture in these environments, and students may continue to face significant discouragement in response to interest they may express in becoming a family physician.”

rfranki@mdedge.com

The Food and Drug Administration has approved the first device to help reduce snoring and mild obstructive sleep apnea (OSA) that is used during the day while the patient is awake.

eXciteOSA (Signifier Medical Technologies) is a prescription-only, neuromuscular stimulation device designed to improve tongue muscle function, which, over time, can help prevent the tongue from collapsing backwards and obstructing the airway during sleep, the FDA said.

The eXciteOSA mouthpiece has four electrodes that deliver a series of electrical pulses with rest periods in between. Two electrodes are located above the tongue and two are located below the tongue.

The patient uses the device for 20 minutes once a day while awake for 6 weeks, and once a week thereafter. It is indicated for adults aged 18 and older with snoring and mild OSA.

OSA is marked by the recurring collapse of the upper airways during sleep, intermittently reducing or completely blocking airflow. Common symptoms include snoring, restless sleep and daytime sleepiness. Untreated OSA can lead to serious complications such as cardiovascular disease and cognitive and behavioral disorders.

Continuous positive airway pressure therapy, administered through a face mask that is worn while asleep, is a first-line treatment for OSA.

The eXciteOSA device “offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” Malvina Eydelman, MD, director, FDA Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices, said in a news release.

The FDA reviewed data on the safety and effectiveness of the eXciteOSA device in 115 patients with snoring, including 48 patients with snoring and mild OSA. All patients used the device for 20 minutes once a day for 6 weeks, then stopped using it for 2 weeks before they were reassessed.

Overall, the percentage of time spent snoring at levels louder than 40 decibels was reduced by more than 20% in 87 out of the 115 patients.

In the subset of patients with snoring and mild OSA, the average apnea-hypopnea index score was reduced by 48%, from 10.21 to 5.27, in 41 of 48 patients. Mild OSA is defined as an AHI score greater than 5 but less than 15.

The most common adverse events were excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging, and tight jaw.

Before using the eXciteOSA device, patients should receive a comprehensive dental examination, the FDA said. 

The device should not be used in patients with pacemakers or implanted pacing leads, or women who are pregnant. The device is also contraindicated in patients with temporary or permanent implants, dental braces, intraoral metal prosthesis/restorations, or ulcerations in or around the mouth.

The eXciteOSA device was approved under the de novo premarket review pathway for new low- to moderate-risk devices. More information on the device is available online.

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

The Food and Drug Administration has approved the first device to help reduce snoring and mild obstructive sleep apnea (OSA) that is used during the day while the patient is awake.

eXciteOSA (Signifier Medical Technologies) is a prescription-only, neuromuscular stimulation device designed to improve tongue muscle function, which, over time, can help prevent the tongue from collapsing backwards and obstructing the airway during sleep, the FDA said.

The eXciteOSA mouthpiece has four electrodes that deliver a series of electrical pulses with rest periods in between. Two electrodes are located above the tongue and two are located below the tongue.

The patient uses the device for 20 minutes once a day while awake for 6 weeks, and once a week thereafter. It is indicated for adults aged 18 and older with snoring and mild OSA.

OSA is marked by the recurring collapse of the upper airways during sleep, intermittently reducing or completely blocking airflow. Common symptoms include snoring, restless sleep and daytime sleepiness. Untreated OSA can lead to serious complications such as cardiovascular disease and cognitive and behavioral disorders.

Continuous positive airway pressure therapy, administered through a face mask that is worn while asleep, is a first-line treatment for OSA.

The eXciteOSA device “offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” Malvina Eydelman, MD, director, FDA Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices, said in a news release.

The FDA reviewed data on the safety and effectiveness of the eXciteOSA device in 115 patients with snoring, including 48 patients with snoring and mild OSA. All patients used the device for 20 minutes once a day for 6 weeks, then stopped using it for 2 weeks before they were reassessed.

Overall, the percentage of time spent snoring at levels louder than 40 decibels was reduced by more than 20% in 87 out of the 115 patients.

In the subset of patients with snoring and mild OSA, the average apnea-hypopnea index score was reduced by 48%, from 10.21 to 5.27, in 41 of 48 patients. Mild OSA is defined as an AHI score greater than 5 but less than 15.

The most common adverse events were excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging, and tight jaw.

Before using the eXciteOSA device, patients should receive a comprehensive dental examination, the FDA said. 

The device should not be used in patients with pacemakers or implanted pacing leads, or women who are pregnant. The device is also contraindicated in patients with temporary or permanent implants, dental braces, intraoral metal prosthesis/restorations, or ulcerations in or around the mouth.

The eXciteOSA device was approved under the de novo premarket review pathway for new low- to moderate-risk devices. More information on the device is available online.

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

The Food and Drug Administration has approved the first device to help reduce snoring and mild obstructive sleep apnea (OSA) that is used during the day while the patient is awake.

eXciteOSA (Signifier Medical Technologies) is a prescription-only, neuromuscular stimulation device designed to improve tongue muscle function, which, over time, can help prevent the tongue from collapsing backwards and obstructing the airway during sleep, the FDA said.

The eXciteOSA mouthpiece has four electrodes that deliver a series of electrical pulses with rest periods in between. Two electrodes are located above the tongue and two are located below the tongue.

The patient uses the device for 20 minutes once a day while awake for 6 weeks, and once a week thereafter. It is indicated for adults aged 18 and older with snoring and mild OSA.

OSA is marked by the recurring collapse of the upper airways during sleep, intermittently reducing or completely blocking airflow. Common symptoms include snoring, restless sleep and daytime sleepiness. Untreated OSA can lead to serious complications such as cardiovascular disease and cognitive and behavioral disorders.

Continuous positive airway pressure therapy, administered through a face mask that is worn while asleep, is a first-line treatment for OSA.

The eXciteOSA device “offers a new option for the thousands of individuals who experience snoring or mild sleep apnea,” Malvina Eydelman, MD, director, FDA Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices, said in a news release.

The FDA reviewed data on the safety and effectiveness of the eXciteOSA device in 115 patients with snoring, including 48 patients with snoring and mild OSA. All patients used the device for 20 minutes once a day for 6 weeks, then stopped using it for 2 weeks before they were reassessed.

Overall, the percentage of time spent snoring at levels louder than 40 decibels was reduced by more than 20% in 87 out of the 115 patients.

In the subset of patients with snoring and mild OSA, the average apnea-hypopnea index score was reduced by 48%, from 10.21 to 5.27, in 41 of 48 patients. Mild OSA is defined as an AHI score greater than 5 but less than 15.

The most common adverse events were excessive salivation, tongue or tooth discomfort, tongue tingling, dental filling sensitivity, metallic taste, gagging, and tight jaw.

Before using the eXciteOSA device, patients should receive a comprehensive dental examination, the FDA said. 

The device should not be used in patients with pacemakers or implanted pacing leads, or women who are pregnant. The device is also contraindicated in patients with temporary or permanent implants, dental braces, intraoral metal prosthesis/restorations, or ulcerations in or around the mouth.

The eXciteOSA device was approved under the de novo premarket review pathway for new low- to moderate-risk devices. More information on the device is available online.

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

New COVID-19 cases in children continue to drop each week, but the total number of cases has now surpassed 3 million since the start of the pandemic, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

There were just over 99,000 new cases reported during the week of Feb. 5-11, the lowest number since early November and the fourth consecutive week with a decline. It was still enough, though, to bring the total to 3.03 million children infected with SARS-CoV-19 in the United States, the AAP and the CHA said in their weekly report.

The nation also hit a couple of other ignominious milestones. The cumulative rate of COVID-19 infection now stands at 4,030 per 100,000, so 4% of all children have been infected. Also, children represented 16.9% of all new cases for the week, which equals the highest proportion seen throughout the pandemic, based on data from health departments in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

There have been 241 COVID-19–related deaths in children so far, with 14 reported during the week of Feb. 5-11. Kansas just recorded its first pediatric death, which leaves 10 states that have had no fatalities. Texas, with 39 deaths, has had more than any other state, among the 43 that are reporting mortality by age, the AAP/CHA report showed.

rfranki@mdedge.com

New COVID-19 cases in children continue to drop each week, but the total number of cases has now surpassed 3 million since the start of the pandemic, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

There were just over 99,000 new cases reported during the week of Feb. 5-11, the lowest number since early November and the fourth consecutive week with a decline. It was still enough, though, to bring the total to 3.03 million children infected with SARS-CoV-19 in the United States, the AAP and the CHA said in their weekly report.

The nation also hit a couple of other ignominious milestones. The cumulative rate of COVID-19 infection now stands at 4,030 per 100,000, so 4% of all children have been infected. Also, children represented 16.9% of all new cases for the week, which equals the highest proportion seen throughout the pandemic, based on data from health departments in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

There have been 241 COVID-19–related deaths in children so far, with 14 reported during the week of Feb. 5-11. Kansas just recorded its first pediatric death, which leaves 10 states that have had no fatalities. Texas, with 39 deaths, has had more than any other state, among the 43 that are reporting mortality by age, the AAP/CHA report showed.

rfranki@mdedge.com

New COVID-19 cases in children continue to drop each week, but the total number of cases has now surpassed 3 million since the start of the pandemic, according to a report from the American Academy of Pediatrics and the Children’s Hospital Association.

There were just over 99,000 new cases reported during the week of Feb. 5-11, the lowest number since early November and the fourth consecutive week with a decline. It was still enough, though, to bring the total to 3.03 million children infected with SARS-CoV-19 in the United States, the AAP and the CHA said in their weekly report.

The nation also hit a couple of other ignominious milestones. The cumulative rate of COVID-19 infection now stands at 4,030 per 100,000, so 4% of all children have been infected. Also, children represented 16.9% of all new cases for the week, which equals the highest proportion seen throughout the pandemic, based on data from health departments in 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam.

There have been 241 COVID-19–related deaths in children so far, with 14 reported during the week of Feb. 5-11. Kansas just recorded its first pediatric death, which leaves 10 states that have had no fatalities. Texas, with 39 deaths, has had more than any other state, among the 43 that are reporting mortality by age, the AAP/CHA report showed.

rfranki@mdedge.com

Doctors are learning about new rules coming this April that encourage open and transparent communication among patients, families, and clinicians. The rules, putting into effect the bipartisan 21st Century Cures Act, mandate offering patients access to notes (“open notes”) written by clinicians in electronic medical records.

A recent article from this news organization noted that for many doctors this represents both a sudden and troubling change in practice. For others, the rules codify what they have been doing as a matter of routine for a decade. Spurred by the OpenNotes movement, at least 55 million Americans are already offered access to their clinical notes, including, since 2013, more than 9 million veterans with access to the Blue Button function in Veterans Affairs practices and hospitals.

The practice is spreading beyond the United States to other countries, including Canada, Sweden, Norway, Estonia, and the United Kingdom.

In this commentary, we review what patients, clinicians, and policymakers have been learning about open notes.
 

The patient experience

What do patients experience? In a survey of more than 22,000 patients who read notes in three diverse health systems, more than 90% reported having a good grasp of what their doctors and other clinicians had written, and very few (3%) reported being very confused by what they read. About two-thirds described reading their notes as very important for taking care of their health, remembering details of their visits and their care plans, and understanding why a medication was prescribed.

Indeed, in a clinically exciting finding, 14% of survey respondents reported that reading their notes made them more likely to take their medications as their doctors wished. With about half of Americans with chronic illness failing to take their medicines as prescribed, which sometimes leads to compromised outcomes and associated unnecessary costs (estimated at $300 billion annually), these reports of increased adherence should be taken very seriously.

Some doctors anticipate that open notes will erode patient communication. A growing body of research reveals just the opposite. In multiple surveys, patients describe open notes as “extending the visit,” strengthening collaboration and teamwork with their doctor. Quite possibly, the invitation to read notes may in itself increase trust. Such benefits appear especially pronounced among patients who are older, less educated, are persons of color or Hispanic, or who do not speak English at home.

And in several studies, more than a third of patients also report sharing their notes with others, with older and chronically ill patients in particular sharing access with family and friends who are their care partners.

On the other hand, a small minority of patients (5%) do report being more worried by what they read. It’s unknown whether this is because they are better informed about their care or because baseline anxiety levels increase. Doctors expect also that some patients, particularly those with cancer or serious mental illness, will be upset by their notes. So far, evidence does not support that specific concern.

Conversely, withholding, delaying, or blocking notes may be a source of anxiety or even stigmatization. When clinicians find themselves worried about sharing notes, we suggest that they discuss with their patients the benefits and risks. Recall also that transparency facilitates freedom of choice; patients make their own decision, and quite a few choose to leave notes unread.

Finding mistakes early and preventing harm are important goals for health care, and open notes can make care safer. Inevitably, medical records contain errors, omissions, and inaccuracies. In a large patient survey, 21% reported finding an error in their notes, and 42% perceived the error to be serious.

Moreover, 25% of doctors with more than a year’s experience with open notes reported patients finding errors that they (the doctors) considered “serious.” In 2015, the National Academy of Medicine cited open notes as a mechanism for improving diagnostic accuracy. In regard to possible legal action from patients, most attorneys, patients, and doctors agree that more transparent communication will build trust overall and, if anything, diminish litigation. We know of no instances so far of lawsuits deriving from open notes.
 

The physician experience

Doctors may worry that open notes will impede workflow, that they will be compelled to “dumb down” their documentation to avoid causing offense or anxiety, and that patients will demand changes to what is written. Here, extensive survey research should allay such fears and expectations. In a survey of more than 1,600 clinicians with at least 1 year of experience with open notes, reports of disruption to workflow were uncommon.

Most doctors (84%) reported that patients contacted them with questions about their notes “less than monthly or never.” Approximately two-thirds (62%) reported spending the same amount of time writing visit notes.

After implementing open notes, many doctors do report being more mindful about their documentation. For example, 41% reported changing how they used language such as “patient denies” or “noncompliant,” and 18% reported changing their use of medical jargon or abbreviations. Might these changes undermine the utility of medical notes? A majority of doctors surveyed (78%) said no, reporting that, after implementing open notes, the value of their documentation was the same or better.

Innovations spotlight difficult and often longstanding challenges. Open notes highlight the complex role of medical records in preserving privacy, especially in the spectrum of abuse, whether domestic or involving elders, children or sexual transgressions. For families with adolescents, issues concerning confidentiality can become a two-way street, and federal and state rules at times provide conflicting and idiosyncratic guidance. It is important to emphasize that the new rules permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties.

Perhaps think of open notes as a new medicine designed to help the vast majority of those who use it but with side effects and even contraindications for a few. Doctors can step in to minimize risks to vulnerable individuals, and imaginative and creative solutions to complex issues may emerge. In a growing number of practices serving adolescents, clinicians can now create two notes, with some elements of care visible on a patient portal and others held privately or visible only to the adolescent.
 

The shared experience

Overall, when it comes to documenting sensitive social information, open notes may act as a useful catalyst prompting deeper discussion about personal details clinically important to record, as opposed to those perhaps best left unwritten.

The implementation of open notes nationwide calls for exciting explorations. How can transparent systems maximize benefits for targeted populations in diverse settings? For patients with mental illness, can notes become part of the therapy? Given that care partners often report more benefit from reading notes than do patients themselves, how can they be mobilized to maximize their contributions to those acutely ill on hospital floors, or to family members with Alzheimer’s or in long-term care facilities?

How can we harness emerging technologies to translate notes and medical records into other languages or support lower literacy levels, while preserving the clinical detail in the notes? Should patients contribute to their own notes, cogenerating them with their clinicians? Experiments for “OurNotes” interventions are underway, and early reports from both patients and doctors hold considerable promise.

Ownership of medical records is evolving. Once firmly held by clinicians, electronic technologies have rapidly led to what may best be viewed currently as joint ownership by clinicians and patients. As apps evolve further and issues with interoperability of records diminish, it is likely that patients will eventually take control. Then it will be up to patients what to carry in their records. Clinicians will advise, but patients will decide.

The new rules herald clear changes in the fabric of care, and after a decade of study we anticipate that the benefits well outweigh the harms. But in the short run, it’s wrong to predict an avalanche. Two decades ago, when patient portals first revealed laboratory test findings to patients, doctors expected cataclysmic change in their practices. It did not occur. The vast majority of patients who registered on portals benefited and few disturbed their doctors.

Similarly, after notes were first unblinded by the OpenNotes research teams, the question we were asked most commonly by the primary care doctors who volunteered was whether the computers were actually displaying their notes. Even though many patients read them carefully, the doctors heard little from them. Clinicians have now reported the same experience in several subsequent studies.

Patients are resourceful, turning quickly to friends or the Internet for answers to their questions. They know how busy doctors are and don’t want to bother them if at all possible. When notes do trigger questions, the time taken to respond is probably offset by silence from other patients finding answers to their own questions in notes they read.

We believe that clinicians should embrace the spirit of the rules and also view them as HIPAA catching up with a computerized universe. As the new practice takes hold, ambiguities will diminish as further experience and research evolve. Warner V. Slack, MD, the first doctor to ask patients to talk to computers, opined that patients are the “largest and least utilized resource in health care.” Open and transparent communication through electronic medical records may mobilize patients (and their families) far more effectively. Patients will almost certainly benefit. Remembering Dr. Slack’s prophecy, we believe that clinicians will too.

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

Doctors are learning about new rules coming this April that encourage open and transparent communication among patients, families, and clinicians. The rules, putting into effect the bipartisan 21st Century Cures Act, mandate offering patients access to notes (“open notes”) written by clinicians in electronic medical records.

A recent article from this news organization noted that for many doctors this represents both a sudden and troubling change in practice. For others, the rules codify what they have been doing as a matter of routine for a decade. Spurred by the OpenNotes movement, at least 55 million Americans are already offered access to their clinical notes, including, since 2013, more than 9 million veterans with access to the Blue Button function in Veterans Affairs practices and hospitals.

The practice is spreading beyond the United States to other countries, including Canada, Sweden, Norway, Estonia, and the United Kingdom.

In this commentary, we review what patients, clinicians, and policymakers have been learning about open notes.
 

The patient experience

What do patients experience? In a survey of more than 22,000 patients who read notes in three diverse health systems, more than 90% reported having a good grasp of what their doctors and other clinicians had written, and very few (3%) reported being very confused by what they read. About two-thirds described reading their notes as very important for taking care of their health, remembering details of their visits and their care plans, and understanding why a medication was prescribed.

Indeed, in a clinically exciting finding, 14% of survey respondents reported that reading their notes made them more likely to take their medications as their doctors wished. With about half of Americans with chronic illness failing to take their medicines as prescribed, which sometimes leads to compromised outcomes and associated unnecessary costs (estimated at $300 billion annually), these reports of increased adherence should be taken very seriously.

Some doctors anticipate that open notes will erode patient communication. A growing body of research reveals just the opposite. In multiple surveys, patients describe open notes as “extending the visit,” strengthening collaboration and teamwork with their doctor. Quite possibly, the invitation to read notes may in itself increase trust. Such benefits appear especially pronounced among patients who are older, less educated, are persons of color or Hispanic, or who do not speak English at home.

And in several studies, more than a third of patients also report sharing their notes with others, with older and chronically ill patients in particular sharing access with family and friends who are their care partners.

On the other hand, a small minority of patients (5%) do report being more worried by what they read. It’s unknown whether this is because they are better informed about their care or because baseline anxiety levels increase. Doctors expect also that some patients, particularly those with cancer or serious mental illness, will be upset by their notes. So far, evidence does not support that specific concern.

Conversely, withholding, delaying, or blocking notes may be a source of anxiety or even stigmatization. When clinicians find themselves worried about sharing notes, we suggest that they discuss with their patients the benefits and risks. Recall also that transparency facilitates freedom of choice; patients make their own decision, and quite a few choose to leave notes unread.

Finding mistakes early and preventing harm are important goals for health care, and open notes can make care safer. Inevitably, medical records contain errors, omissions, and inaccuracies. In a large patient survey, 21% reported finding an error in their notes, and 42% perceived the error to be serious.

Moreover, 25% of doctors with more than a year’s experience with open notes reported patients finding errors that they (the doctors) considered “serious.” In 2015, the National Academy of Medicine cited open notes as a mechanism for improving diagnostic accuracy. In regard to possible legal action from patients, most attorneys, patients, and doctors agree that more transparent communication will build trust overall and, if anything, diminish litigation. We know of no instances so far of lawsuits deriving from open notes.
 

The physician experience

Doctors may worry that open notes will impede workflow, that they will be compelled to “dumb down” their documentation to avoid causing offense or anxiety, and that patients will demand changes to what is written. Here, extensive survey research should allay such fears and expectations. In a survey of more than 1,600 clinicians with at least 1 year of experience with open notes, reports of disruption to workflow were uncommon.

Most doctors (84%) reported that patients contacted them with questions about their notes “less than monthly or never.” Approximately two-thirds (62%) reported spending the same amount of time writing visit notes.

After implementing open notes, many doctors do report being more mindful about their documentation. For example, 41% reported changing how they used language such as “patient denies” or “noncompliant,” and 18% reported changing their use of medical jargon or abbreviations. Might these changes undermine the utility of medical notes? A majority of doctors surveyed (78%) said no, reporting that, after implementing open notes, the value of their documentation was the same or better.

Innovations spotlight difficult and often longstanding challenges. Open notes highlight the complex role of medical records in preserving privacy, especially in the spectrum of abuse, whether domestic or involving elders, children or sexual transgressions. For families with adolescents, issues concerning confidentiality can become a two-way street, and federal and state rules at times provide conflicting and idiosyncratic guidance. It is important to emphasize that the new rules permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties.

Perhaps think of open notes as a new medicine designed to help the vast majority of those who use it but with side effects and even contraindications for a few. Doctors can step in to minimize risks to vulnerable individuals, and imaginative and creative solutions to complex issues may emerge. In a growing number of practices serving adolescents, clinicians can now create two notes, with some elements of care visible on a patient portal and others held privately or visible only to the adolescent.
 

The shared experience

Overall, when it comes to documenting sensitive social information, open notes may act as a useful catalyst prompting deeper discussion about personal details clinically important to record, as opposed to those perhaps best left unwritten.

The implementation of open notes nationwide calls for exciting explorations. How can transparent systems maximize benefits for targeted populations in diverse settings? For patients with mental illness, can notes become part of the therapy? Given that care partners often report more benefit from reading notes than do patients themselves, how can they be mobilized to maximize their contributions to those acutely ill on hospital floors, or to family members with Alzheimer’s or in long-term care facilities?

How can we harness emerging technologies to translate notes and medical records into other languages or support lower literacy levels, while preserving the clinical detail in the notes? Should patients contribute to their own notes, cogenerating them with their clinicians? Experiments for “OurNotes” interventions are underway, and early reports from both patients and doctors hold considerable promise.

Ownership of medical records is evolving. Once firmly held by clinicians, electronic technologies have rapidly led to what may best be viewed currently as joint ownership by clinicians and patients. As apps evolve further and issues with interoperability of records diminish, it is likely that patients will eventually take control. Then it will be up to patients what to carry in their records. Clinicians will advise, but patients will decide.

The new rules herald clear changes in the fabric of care, and after a decade of study we anticipate that the benefits well outweigh the harms. But in the short run, it’s wrong to predict an avalanche. Two decades ago, when patient portals first revealed laboratory test findings to patients, doctors expected cataclysmic change in their practices. It did not occur. The vast majority of patients who registered on portals benefited and few disturbed their doctors.

Similarly, after notes were first unblinded by the OpenNotes research teams, the question we were asked most commonly by the primary care doctors who volunteered was whether the computers were actually displaying their notes. Even though many patients read them carefully, the doctors heard little from them. Clinicians have now reported the same experience in several subsequent studies.

Patients are resourceful, turning quickly to friends or the Internet for answers to their questions. They know how busy doctors are and don’t want to bother them if at all possible. When notes do trigger questions, the time taken to respond is probably offset by silence from other patients finding answers to their own questions in notes they read.

We believe that clinicians should embrace the spirit of the rules and also view them as HIPAA catching up with a computerized universe. As the new practice takes hold, ambiguities will diminish as further experience and research evolve. Warner V. Slack, MD, the first doctor to ask patients to talk to computers, opined that patients are the “largest and least utilized resource in health care.” Open and transparent communication through electronic medical records may mobilize patients (and their families) far more effectively. Patients will almost certainly benefit. Remembering Dr. Slack’s prophecy, we believe that clinicians will too.

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

Doctors are learning about new rules coming this April that encourage open and transparent communication among patients, families, and clinicians. The rules, putting into effect the bipartisan 21st Century Cures Act, mandate offering patients access to notes (“open notes”) written by clinicians in electronic medical records.

A recent article from this news organization noted that for many doctors this represents both a sudden and troubling change in practice. For others, the rules codify what they have been doing as a matter of routine for a decade. Spurred by the OpenNotes movement, at least 55 million Americans are already offered access to their clinical notes, including, since 2013, more than 9 million veterans with access to the Blue Button function in Veterans Affairs practices and hospitals.

The practice is spreading beyond the United States to other countries, including Canada, Sweden, Norway, Estonia, and the United Kingdom.

In this commentary, we review what patients, clinicians, and policymakers have been learning about open notes.
 

The patient experience

What do patients experience? In a survey of more than 22,000 patients who read notes in three diverse health systems, more than 90% reported having a good grasp of what their doctors and other clinicians had written, and very few (3%) reported being very confused by what they read. About two-thirds described reading their notes as very important for taking care of their health, remembering details of their visits and their care plans, and understanding why a medication was prescribed.

Indeed, in a clinically exciting finding, 14% of survey respondents reported that reading their notes made them more likely to take their medications as their doctors wished. With about half of Americans with chronic illness failing to take their medicines as prescribed, which sometimes leads to compromised outcomes and associated unnecessary costs (estimated at $300 billion annually), these reports of increased adherence should be taken very seriously.

Some doctors anticipate that open notes will erode patient communication. A growing body of research reveals just the opposite. In multiple surveys, patients describe open notes as “extending the visit,” strengthening collaboration and teamwork with their doctor. Quite possibly, the invitation to read notes may in itself increase trust. Such benefits appear especially pronounced among patients who are older, less educated, are persons of color or Hispanic, or who do not speak English at home.

And in several studies, more than a third of patients also report sharing their notes with others, with older and chronically ill patients in particular sharing access with family and friends who are their care partners.

On the other hand, a small minority of patients (5%) do report being more worried by what they read. It’s unknown whether this is because they are better informed about their care or because baseline anxiety levels increase. Doctors expect also that some patients, particularly those with cancer or serious mental illness, will be upset by their notes. So far, evidence does not support that specific concern.

Conversely, withholding, delaying, or blocking notes may be a source of anxiety or even stigmatization. When clinicians find themselves worried about sharing notes, we suggest that they discuss with their patients the benefits and risks. Recall also that transparency facilitates freedom of choice; patients make their own decision, and quite a few choose to leave notes unread.

Finding mistakes early and preventing harm are important goals for health care, and open notes can make care safer. Inevitably, medical records contain errors, omissions, and inaccuracies. In a large patient survey, 21% reported finding an error in their notes, and 42% perceived the error to be serious.

Moreover, 25% of doctors with more than a year’s experience with open notes reported patients finding errors that they (the doctors) considered “serious.” In 2015, the National Academy of Medicine cited open notes as a mechanism for improving diagnostic accuracy. In regard to possible legal action from patients, most attorneys, patients, and doctors agree that more transparent communication will build trust overall and, if anything, diminish litigation. We know of no instances so far of lawsuits deriving from open notes.
 

The physician experience

Doctors may worry that open notes will impede workflow, that they will be compelled to “dumb down” their documentation to avoid causing offense or anxiety, and that patients will demand changes to what is written. Here, extensive survey research should allay such fears and expectations. In a survey of more than 1,600 clinicians with at least 1 year of experience with open notes, reports of disruption to workflow were uncommon.

Most doctors (84%) reported that patients contacted them with questions about their notes “less than monthly or never.” Approximately two-thirds (62%) reported spending the same amount of time writing visit notes.

After implementing open notes, many doctors do report being more mindful about their documentation. For example, 41% reported changing how they used language such as “patient denies” or “noncompliant,” and 18% reported changing their use of medical jargon or abbreviations. Might these changes undermine the utility of medical notes? A majority of doctors surveyed (78%) said no, reporting that, after implementing open notes, the value of their documentation was the same or better.

Innovations spotlight difficult and often longstanding challenges. Open notes highlight the complex role of medical records in preserving privacy, especially in the spectrum of abuse, whether domestic or involving elders, children or sexual transgressions. For families with adolescents, issues concerning confidentiality can become a two-way street, and federal and state rules at times provide conflicting and idiosyncratic guidance. It is important to emphasize that the new rules permit information blocking if there is clear evidence that doing so “will substantially reduce the risk of harm” to patients or to other third parties.

Perhaps think of open notes as a new medicine designed to help the vast majority of those who use it but with side effects and even contraindications for a few. Doctors can step in to minimize risks to vulnerable individuals, and imaginative and creative solutions to complex issues may emerge. In a growing number of practices serving adolescents, clinicians can now create two notes, with some elements of care visible on a patient portal and others held privately or visible only to the adolescent.
 

The shared experience

Overall, when it comes to documenting sensitive social information, open notes may act as a useful catalyst prompting deeper discussion about personal details clinically important to record, as opposed to those perhaps best left unwritten.

The implementation of open notes nationwide calls for exciting explorations. How can transparent systems maximize benefits for targeted populations in diverse settings? For patients with mental illness, can notes become part of the therapy? Given that care partners often report more benefit from reading notes than do patients themselves, how can they be mobilized to maximize their contributions to those acutely ill on hospital floors, or to family members with Alzheimer’s or in long-term care facilities?

How can we harness emerging technologies to translate notes and medical records into other languages or support lower literacy levels, while preserving the clinical detail in the notes? Should patients contribute to their own notes, cogenerating them with their clinicians? Experiments for “OurNotes” interventions are underway, and early reports from both patients and doctors hold considerable promise.

Ownership of medical records is evolving. Once firmly held by clinicians, electronic technologies have rapidly led to what may best be viewed currently as joint ownership by clinicians and patients. As apps evolve further and issues with interoperability of records diminish, it is likely that patients will eventually take control. Then it will be up to patients what to carry in their records. Clinicians will advise, but patients will decide.

The new rules herald clear changes in the fabric of care, and after a decade of study we anticipate that the benefits well outweigh the harms. But in the short run, it’s wrong to predict an avalanche. Two decades ago, when patient portals first revealed laboratory test findings to patients, doctors expected cataclysmic change in their practices. It did not occur. The vast majority of patients who registered on portals benefited and few disturbed their doctors.

Similarly, after notes were first unblinded by the OpenNotes research teams, the question we were asked most commonly by the primary care doctors who volunteered was whether the computers were actually displaying their notes. Even though many patients read them carefully, the doctors heard little from them. Clinicians have now reported the same experience in several subsequent studies.

Patients are resourceful, turning quickly to friends or the Internet for answers to their questions. They know how busy doctors are and don’t want to bother them if at all possible. When notes do trigger questions, the time taken to respond is probably offset by silence from other patients finding answers to their own questions in notes they read.

We believe that clinicians should embrace the spirit of the rules and also view them as HIPAA catching up with a computerized universe. As the new practice takes hold, ambiguities will diminish as further experience and research evolve. Warner V. Slack, MD, the first doctor to ask patients to talk to computers, opined that patients are the “largest and least utilized resource in health care.” Open and transparent communication through electronic medical records may mobilize patients (and their families) far more effectively. Patients will almost certainly benefit. Remembering Dr. Slack’s prophecy, we believe that clinicians will too.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

Nearly 60% of those working in a large health care system expressed their intent to roll up their sleeves to receive the COVID-19 vaccine, but about one-third were unsure of doing so.

Moreover, 54% of direct care providers indicated that they would take the vaccine if offered, compared with 60% of noncare providers.

The findings come from what is believed to be the largest survey of health care provider attitudes toward COVID-19 vaccination, published online Jan. 25 in Clinical Infectious Diseases.

“We have shown that self-reported willingness to receive vaccination against COVID-19 differs by age, gender, race and hospital role, with physicians and research scientists showing the highest acceptance,” Jana Shaw, MD, MPH, State University of New York, Syracuse, N.Y, the study’s corresponding author, told this news organization. “Building trust in authorities and confidence in vaccines is a complex and time-consuming process that requires commitment and resources. We have to make those investments as hesitancy can severely undermine vaccination coverage. Because health care providers are members of our communities, it is possible that their views are shared by the public at large. Our findings can assist public health professionals as a starting point of discussion and engagement with communities to ensure that we vaccinate at least 80% of the public to end the pandemic.”

For the study, Dr. Shaw and her colleagues emailed an anonymous survey to 9,565 employees of State University of New York Upstate Medical University, Syracuse, an academic medical center that cares for an estimated 1.8 million people. The survey, which contained questions intended to evaluate attitudes, belief, and willingness to get vaccinated, took place between Nov. 23 and Dec. 5, about a week before the U.S. Food and Drug Administration granted the first emergency use authorization for the Pfizer-BioNTech BNT162b2 mRNA vaccine.

Survey recipients included physicians, nurse practitioners, physician assistants, nurses, pharmacists, medical and nursing students, allied health professionals, and nonclinical ancillary staff.

Of the 9,565 surveys sent, 5,287 responses were collected and used in the final analysis, for a response rate of 55%. The mean age of respondents was 43, 73% were female, 85% were White, 6% were Asian, 5% were Black/African American, and the rest were Native American, Native Hawaiian/Pacific Islander, or from other races. More than half of respondents (59%) reported that they provided direct patient care, and 32% said they provided care for patients with COVID-19.

Of all survey respondents, 58% expressed their intent to receive a COVID-19 vaccine, but this varied by their role in the health care system. For example, in response to the statement, “If a vaccine were offered free of charge, I would take it,” 80% of scientists and physicians agreed that they would, while colleagues in other roles were unsure whether they would take the vaccine, including 34% of registered nurses, 32% of allied health professionals, and 32% of master’s-level clinicians. These differences across roles were significant (P less than .001).

The researchers also found that direct patient care or care for COVID-19 patients was associated with lower vaccination intent. For example, 54% of direct care providers and 62% of non-care providers indicated they would take the vaccine if offered, compared with 52% of those who had provided care for COVID-19 patients vs. 61% of those who had not (P less than .001).

“This was a really surprising finding,” said Dr. Shaw, who is a pediatric infectious diseases physician at SUNY Upstate. “In general, one would expect that perceived severity of disease would lead to a greater desire to get vaccinated. Because our question did not address severity of disease, it is possible that we oversampled respondents who took care of patients with mild disease (i.e., in an outpatient setting). This could have led to an underestimation of disease severity and resulted in lower vaccination intent.”
 

A focus on rebuilding trust

Survey respondents who agreed or strongly agreed that they would accept a vaccine were older (a mean age of 44 years), compared with those who were not sure or who disagreed (a mean age of 42 vs. 38 years, respectively; P less than .001). In addition, fewer females agreed or strongly agreed that they would accept a vaccine (54% vs. 73% of males), whereas those who self-identified as Black/African American were least likely to want to get vaccinated, compared with those from other ethnic groups (31%, compared with 74% of Asians, 58% of Whites, and 39% of American Indians or Alaska Natives).

“We are deeply aware of the poor decisions scientists made in the past, which led to a prevailing skepticism and ‘feeling like guinea pigs’ among people of color, especially Black adults,” Dr. Shaw said. “Black adults are less likely, compared [with] White adults, to have confidence that scientists act in the public interest. Rebuilding trust will take time and has to start with addressing health care disparities. In addition, we need to acknowledge contributions of Black researchers to science. For example, until recently very few knew that the Moderna vaccine was developed [with the help of] Dr. Kizzmekia Corbett, who is Black.”

The top five main areas of unease that all respondents expressed about a COVID-19 vaccine were concern about adverse events/side effects (47%), efficacy (15%), rushed release (11%), safety (11%), and the research and authorization process (3%).

“I think it is important that fellow clinicians recognize that, in order to boost vaccine confidence we will need careful, individually tailored communication strategies,” Dr. Shaw said. “A consideration should be given to those [strategies] that utilize interpersonal channels that deliver leadership by example and leverage influencers in the institution to encourage wider adoption of vaccination.”

Aaron M. Milstone, MD, MHS, asked to comment on the research, recommended that health care workers advocate for the vaccine and encourage their patients, friends, and loved ones to get vaccinated. “Soon, COVID-19 will have taken more than half a million lives in the U.S.,” said Dr. Milstone, a pediatric epidemiologist at Johns Hopkins University, Baltimore. “Although vaccines can have side effects like fever and muscle aches, and very, very rare more serious side effects, the risks of dying from COVID are much greater than the risk of a serious vaccine reaction. The study’s authors shed light on the ongoing need for leaders of all communities to support the COVID vaccines, not just the scientific community, but religious leaders, political leaders, and community leaders.”
 

Addressing vaccine hesitancy

Informed by their own survey, Dr. Shaw and her colleagues have developed a plan to address vaccine hesitancy to ensure high vaccine uptake at SUNY Upstate. Those strategies include, but aren’t limited to, institution-wide forums for all employees on COVID-19 vaccine safety, risks, and benefits followed by Q&A sessions, grand rounds for providers summarizing clinical trial data on mRNA vaccines, development of an Ask COVID email line for staff to ask vaccine-related questions, and a detailed vaccine-specific FAQ document.

In addition, SUNY Upstate experts have engaged in numerous media interviews to provide education and updates on the benefits of vaccination to public and staff, stationary vaccine locations, and mobile COVID-19 vaccine carts. “To date, the COVID-19 vaccination process has been well received, and we anticipate strong vaccine uptake,” she said.

Dr. Shaw acknowledged certain limitations of the survey, including its cross-sectional design and the fact that it was conducted in a single health care system in the northeastern United States. “Thus, generalizability to other regions of the U.S. and other countries may be limited,” Dr. Shaw said. “The study was also conducted before EUA [emergency use authorization] was granted to either the Moderna or Pfizer-BioNTech vaccines. It is therefore likely that vaccine acceptance will change over time as more people get vaccinated.”

The authors have disclosed no relevant financial relationships. Dr. Milstone disclosed that he has received a research grant from Merck, but it is not related to vaccines.

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

A Zika virus vaccine candidate prompted antibody responses in 80% of individuals who received two doses in a phase 1 study.

©Aunt_Spray/Thinkstock

Although Zika cases have declined in recent years, “geographic expansion of the Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” wrote Nadine C. Salisch, PhD, of Janssen Vaccines and Prevention, Leiden, the Netherlands, and colleagues in a paper published in Annals of Internal Medicine.

No vaccine against Zika is yet available, although more than 10 candidates have been studied in preclinical trials to date, they said.

The researchers randomized 100 healthy adult volunteers to an experimental Zika vaccine candidate known as Ad26.ZIKV.001 in either one-dose or two-dose regimens of 5x10¹⁰ viral particles (low dose) or 1x10¹¹ viral particles (high dose) or placebo. Approximately half (55%) of the participants were women, and 72% were White.

Approximately 80% of patients in both two-dose groups showed antibody responses for a year after vaccination. Geometric mean titers (GMTs) reached peak of 823.4 in the low-dose/low-dose group and 961.5 in the high-dose/high-dose group. At day 365, the GMTs for these groups were 68.7 and 87.0, respectively.

A single high-dose vaccine achieved a similar level of neutralizing antibody titers, but lower peak neutralizing responses than the two-dose strategies, the researchers noted.

Most of the reported adverse events were mild to moderate, and short lived; the most common were injection site pain or tenderness, headache, and fatigue, the researchers said. After the first vaccination, 75% of participants in the low-dose groups, 88% of participants in high-dose groups, and 45% of participants receiving placebo reported local adverse events. In addition, 73%, 83%, and 40% of the participants in the low-dose, high-dose, and placebo groups, respectively, reported systemic adverse events. Reports were similar after the second vaccination. Two serious adverse events not related to vaccination were reported; one case of right lower lobe pneumonia and one case of incomplete spontaneous abortion.

The researchers also explored protective efficacy through a nonlethal mouse challenge model. “Transfer of 6 mg of IgG from Ad26.ZIKV.001 vaccines conferred complete protection from viremia in most recipient animals, with statistically significantly decreased breakthrough rates and cumulative viral loads per group compared with placebo,” they said.

The study findings were limited by the inability to assess safety and immunogenicity in an endemic area, the researchers noted. However, “Ad26.ZIKV.001 induces potent ZIKV-specific neutralizing responses with durability of at least 1 year, which supports further clinical development if an unmet medical need reemerges,” they said. “In addition, these data underscore the performance of the Ad26 vaccine platform, which Janssen is using for different infectious diseases, including COVID-19,” they noted.
 

Ad26 vector platform shows consistency

“Development of the investigational Janssen Zika vaccine candidate was initiated in 2015, and while the incidence of Zika virus has declined since the 2015-2016 outbreak, spread of the ‘carrier’ Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” lead author Dr. Salisch said in an interview. For this reason, researchers say the vaccine warrants further development should the need reemerge, she said.

“Our research has found that while a single higher-dose regimen had lower peak neutralizing responses than a two-dose regimen, it achieved a similar level of neutralizing antibody responses at 1 year, an encouraging finding that shows our vaccine may be a useful tool to curb Zika epidemics,” Dr. Salisch noted. “Previous experience with the Ad26 vector platform across our investigational vaccine programs have yielded similarly promising results, most recently with our investigational Janssen COVID-19 vaccine program, for which phase 3 data show a single-dose vaccine met all primary and key secondary endpoints,” she said.

“The biggest barrier [to further development of the candidate vaccine] is one that we actually consider ourselves fortunate to have: The very low incidence of reported Zika cases currently reported worldwide,” Dr. Salisch said. “However, the current Zika case rate can change at any time, and in the event the situation demands it, we are open to alternative regulatory pathways to help us glean the necessary insights on vaccine safety and efficacy to further advance the development of this candidate,” she emphasized.

As for additional research, “there are still questions surrounding Zika transmission and the pathomechanism of congenital Zika syndrome,” said Dr. Salisch. “Our hope is that a correlate of protection against Zika disease, and in particular against congenital Zika syndrome, can be identified,” she said.  

Consider pregnant women in next phase of research

“A major hurdle in ZIKV vaccine development is the inability to conduct large efficacy studies in the absence of a current outbreak,” Ann Chahroudi, MD, of Emory University, Atlanta, and Sallie Permar, MD, of Weill Cornell Medicine, New York, wrote in an accompanying editorial.

The current study provided some efficacy data using a mouse model, but “these data are obviously not conclusive for human protection,” they said.

“A further challenge for ZIKV vaccine efficacy trials will be to demonstrate fetal protection from [congenital Zika syndrome] after adult immunization. There should be a clear plan to readily deploy phase 3 trials for the most promising vaccines to emerge from phase 1 and 2 in the event of an outbreak, as was implemented for Ebola, including infant follow-up,” they emphasized.

The editorialists noted that the study did not include pregnant women, who represent a major target for immunization, but they said that vaccination of pregnant women against other neonatal pathogens such as influenza and tetanus has been effective. “Candidate ZIKV vaccines proven safe in phase 1 trials should immediately be assessed for safety and efficacy in pregnant women,” they said. Although Zika infections are not at epidemic levels currently, resurgence remains a possibility and the coronavirus pandemic “has taught us that preparedness for emerging infections is crucial,” they said.
 

Zika vaccine research is a challenge worth pursuing

“It is important to continue Zika vaccine research because of the unpredictable nature of that infection,” Kevin Ault, MD, of the University of Kansas, Kansas City, said in an interview. “Several times Zika has gained a foothold in unexposed and vulnerable populations,” Dr. Ault said.  “Additionally, there are some data about using this vector during pregnancy, and eventually this vaccine may prevent the birth defects associated with Zika infections during pregnancy, he noted.

Dr. Ault said he was not surprised by the study findings. “This is a promising early phase vaccine candidate, and this adenovirus vector has been used in other similar trials,” he said. Potential barriers to vaccine development include the challenge of conducting late phase clinical trials in pregnant women, he noted. “The relevant endpoint is going to be clinical disease, and one of the most critical populations is pregnant women,” he said. In addition, “later phase 3 trials would be conducted in a population where there is an ongoing Zika outbreak,” Dr. Ault emphasized.   

The study was supported by Janssen Vaccines and Infectious Diseases.

Dr. Chahroudi had no financial conflicts to disclose. Dr. Permar disclosed grants from Merck and Moderna unrelated to the current study. Dr. Ault had no relevant financial conflicts to disclose; he has served as an adviser to the Centers for Disease Control and Prevention, the World Medical Association, the National Vaccine Program Office, and the National Institute for Allergy and Infectious Diseases. He is a fellow of the Infectious Disease Society of American and a fellow of ACOG. 

A Zika virus vaccine candidate prompted antibody responses in 80% of individuals who received two doses in a phase 1 study.

©Aunt_Spray/Thinkstock

Although Zika cases have declined in recent years, “geographic expansion of the Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” wrote Nadine C. Salisch, PhD, of Janssen Vaccines and Prevention, Leiden, the Netherlands, and colleagues in a paper published in Annals of Internal Medicine.

No vaccine against Zika is yet available, although more than 10 candidates have been studied in preclinical trials to date, they said.

The researchers randomized 100 healthy adult volunteers to an experimental Zika vaccine candidate known as Ad26.ZIKV.001 in either one-dose or two-dose regimens of 5x10¹⁰ viral particles (low dose) or 1x10¹¹ viral particles (high dose) or placebo. Approximately half (55%) of the participants were women, and 72% were White.

Approximately 80% of patients in both two-dose groups showed antibody responses for a year after vaccination. Geometric mean titers (GMTs) reached peak of 823.4 in the low-dose/low-dose group and 961.5 in the high-dose/high-dose group. At day 365, the GMTs for these groups were 68.7 and 87.0, respectively.

A single high-dose vaccine achieved a similar level of neutralizing antibody titers, but lower peak neutralizing responses than the two-dose strategies, the researchers noted.

Most of the reported adverse events were mild to moderate, and short lived; the most common were injection site pain or tenderness, headache, and fatigue, the researchers said. After the first vaccination, 75% of participants in the low-dose groups, 88% of participants in high-dose groups, and 45% of participants receiving placebo reported local adverse events. In addition, 73%, 83%, and 40% of the participants in the low-dose, high-dose, and placebo groups, respectively, reported systemic adverse events. Reports were similar after the second vaccination. Two serious adverse events not related to vaccination were reported; one case of right lower lobe pneumonia and one case of incomplete spontaneous abortion.

The researchers also explored protective efficacy through a nonlethal mouse challenge model. “Transfer of 6 mg of IgG from Ad26.ZIKV.001 vaccines conferred complete protection from viremia in most recipient animals, with statistically significantly decreased breakthrough rates and cumulative viral loads per group compared with placebo,” they said.

The study findings were limited by the inability to assess safety and immunogenicity in an endemic area, the researchers noted. However, “Ad26.ZIKV.001 induces potent ZIKV-specific neutralizing responses with durability of at least 1 year, which supports further clinical development if an unmet medical need reemerges,” they said. “In addition, these data underscore the performance of the Ad26 vaccine platform, which Janssen is using for different infectious diseases, including COVID-19,” they noted.
 

Ad26 vector platform shows consistency

“Development of the investigational Janssen Zika vaccine candidate was initiated in 2015, and while the incidence of Zika virus has declined since the 2015-2016 outbreak, spread of the ‘carrier’ Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” lead author Dr. Salisch said in an interview. For this reason, researchers say the vaccine warrants further development should the need reemerge, she said.

“Our research has found that while a single higher-dose regimen had lower peak neutralizing responses than a two-dose regimen, it achieved a similar level of neutralizing antibody responses at 1 year, an encouraging finding that shows our vaccine may be a useful tool to curb Zika epidemics,” Dr. Salisch noted. “Previous experience with the Ad26 vector platform across our investigational vaccine programs have yielded similarly promising results, most recently with our investigational Janssen COVID-19 vaccine program, for which phase 3 data show a single-dose vaccine met all primary and key secondary endpoints,” she said.

“The biggest barrier [to further development of the candidate vaccine] is one that we actually consider ourselves fortunate to have: The very low incidence of reported Zika cases currently reported worldwide,” Dr. Salisch said. “However, the current Zika case rate can change at any time, and in the event the situation demands it, we are open to alternative regulatory pathways to help us glean the necessary insights on vaccine safety and efficacy to further advance the development of this candidate,” she emphasized.

As for additional research, “there are still questions surrounding Zika transmission and the pathomechanism of congenital Zika syndrome,” said Dr. Salisch. “Our hope is that a correlate of protection against Zika disease, and in particular against congenital Zika syndrome, can be identified,” she said.  

Consider pregnant women in next phase of research

“A major hurdle in ZIKV vaccine development is the inability to conduct large efficacy studies in the absence of a current outbreak,” Ann Chahroudi, MD, of Emory University, Atlanta, and Sallie Permar, MD, of Weill Cornell Medicine, New York, wrote in an accompanying editorial.

The current study provided some efficacy data using a mouse model, but “these data are obviously not conclusive for human protection,” they said.

“A further challenge for ZIKV vaccine efficacy trials will be to demonstrate fetal protection from [congenital Zika syndrome] after adult immunization. There should be a clear plan to readily deploy phase 3 trials for the most promising vaccines to emerge from phase 1 and 2 in the event of an outbreak, as was implemented for Ebola, including infant follow-up,” they emphasized.

The editorialists noted that the study did not include pregnant women, who represent a major target for immunization, but they said that vaccination of pregnant women against other neonatal pathogens such as influenza and tetanus has been effective. “Candidate ZIKV vaccines proven safe in phase 1 trials should immediately be assessed for safety and efficacy in pregnant women,” they said. Although Zika infections are not at epidemic levels currently, resurgence remains a possibility and the coronavirus pandemic “has taught us that preparedness for emerging infections is crucial,” they said.
 

Zika vaccine research is a challenge worth pursuing

“It is important to continue Zika vaccine research because of the unpredictable nature of that infection,” Kevin Ault, MD, of the University of Kansas, Kansas City, said in an interview. “Several times Zika has gained a foothold in unexposed and vulnerable populations,” Dr. Ault said.  “Additionally, there are some data about using this vector during pregnancy, and eventually this vaccine may prevent the birth defects associated with Zika infections during pregnancy, he noted.

Dr. Ault said he was not surprised by the study findings. “This is a promising early phase vaccine candidate, and this adenovirus vector has been used in other similar trials,” he said. Potential barriers to vaccine development include the challenge of conducting late phase clinical trials in pregnant women, he noted. “The relevant endpoint is going to be clinical disease, and one of the most critical populations is pregnant women,” he said. In addition, “later phase 3 trials would be conducted in a population where there is an ongoing Zika outbreak,” Dr. Ault emphasized.   

The study was supported by Janssen Vaccines and Infectious Diseases.

Dr. Chahroudi had no financial conflicts to disclose. Dr. Permar disclosed grants from Merck and Moderna unrelated to the current study. Dr. Ault had no relevant financial conflicts to disclose; he has served as an adviser to the Centers for Disease Control and Prevention, the World Medical Association, the National Vaccine Program Office, and the National Institute for Allergy and Infectious Diseases. He is a fellow of the Infectious Disease Society of American and a fellow of ACOG. 

A Zika virus vaccine candidate prompted antibody responses in 80% of individuals who received two doses in a phase 1 study.

©Aunt_Spray/Thinkstock

Although Zika cases have declined in recent years, “geographic expansion of the Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” wrote Nadine C. Salisch, PhD, of Janssen Vaccines and Prevention, Leiden, the Netherlands, and colleagues in a paper published in Annals of Internal Medicine.

No vaccine against Zika is yet available, although more than 10 candidates have been studied in preclinical trials to date, they said.

The researchers randomized 100 healthy adult volunteers to an experimental Zika vaccine candidate known as Ad26.ZIKV.001 in either one-dose or two-dose regimens of 5x10¹⁰ viral particles (low dose) or 1x10¹¹ viral particles (high dose) or placebo. Approximately half (55%) of the participants were women, and 72% were White.

Approximately 80% of patients in both two-dose groups showed antibody responses for a year after vaccination. Geometric mean titers (GMTs) reached peak of 823.4 in the low-dose/low-dose group and 961.5 in the high-dose/high-dose group. At day 365, the GMTs for these groups were 68.7 and 87.0, respectively.

A single high-dose vaccine achieved a similar level of neutralizing antibody titers, but lower peak neutralizing responses than the two-dose strategies, the researchers noted.

Most of the reported adverse events were mild to moderate, and short lived; the most common were injection site pain or tenderness, headache, and fatigue, the researchers said. After the first vaccination, 75% of participants in the low-dose groups, 88% of participants in high-dose groups, and 45% of participants receiving placebo reported local adverse events. In addition, 73%, 83%, and 40% of the participants in the low-dose, high-dose, and placebo groups, respectively, reported systemic adverse events. Reports were similar after the second vaccination. Two serious adverse events not related to vaccination were reported; one case of right lower lobe pneumonia and one case of incomplete spontaneous abortion.

The researchers also explored protective efficacy through a nonlethal mouse challenge model. “Transfer of 6 mg of IgG from Ad26.ZIKV.001 vaccines conferred complete protection from viremia in most recipient animals, with statistically significantly decreased breakthrough rates and cumulative viral loads per group compared with placebo,” they said.

The study findings were limited by the inability to assess safety and immunogenicity in an endemic area, the researchers noted. However, “Ad26.ZIKV.001 induces potent ZIKV-specific neutralizing responses with durability of at least 1 year, which supports further clinical development if an unmet medical need reemerges,” they said. “In addition, these data underscore the performance of the Ad26 vaccine platform, which Janssen is using for different infectious diseases, including COVID-19,” they noted.
 

Ad26 vector platform shows consistency

“Development of the investigational Janssen Zika vaccine candidate was initiated in 2015, and while the incidence of Zika virus has declined since the 2015-2016 outbreak, spread of the ‘carrier’ Aedes aegypti mosquito to areas where population-level immunity is low poses a substantial risk for future epidemics,” lead author Dr. Salisch said in an interview. For this reason, researchers say the vaccine warrants further development should the need reemerge, she said.

“Our research has found that while a single higher-dose regimen had lower peak neutralizing responses than a two-dose regimen, it achieved a similar level of neutralizing antibody responses at 1 year, an encouraging finding that shows our vaccine may be a useful tool to curb Zika epidemics,” Dr. Salisch noted. “Previous experience with the Ad26 vector platform across our investigational vaccine programs have yielded similarly promising results, most recently with our investigational Janssen COVID-19 vaccine program, for which phase 3 data show a single-dose vaccine met all primary and key secondary endpoints,” she said.

“The biggest barrier [to further development of the candidate vaccine] is one that we actually consider ourselves fortunate to have: The very low incidence of reported Zika cases currently reported worldwide,” Dr. Salisch said. “However, the current Zika case rate can change at any time, and in the event the situation demands it, we are open to alternative regulatory pathways to help us glean the necessary insights on vaccine safety and efficacy to further advance the development of this candidate,” she emphasized.

As for additional research, “there are still questions surrounding Zika transmission and the pathomechanism of congenital Zika syndrome,” said Dr. Salisch. “Our hope is that a correlate of protection against Zika disease, and in particular against congenital Zika syndrome, can be identified,” she said.  

Consider pregnant women in next phase of research

“A major hurdle in ZIKV vaccine development is the inability to conduct large efficacy studies in the absence of a current outbreak,” Ann Chahroudi, MD, of Emory University, Atlanta, and Sallie Permar, MD, of Weill Cornell Medicine, New York, wrote in an accompanying editorial.

The current study provided some efficacy data using a mouse model, but “these data are obviously not conclusive for human protection,” they said.

“A further challenge for ZIKV vaccine efficacy trials will be to demonstrate fetal protection from [congenital Zika syndrome] after adult immunization. There should be a clear plan to readily deploy phase 3 trials for the most promising vaccines to emerge from phase 1 and 2 in the event of an outbreak, as was implemented for Ebola, including infant follow-up,” they emphasized.

The editorialists noted that the study did not include pregnant women, who represent a major target for immunization, but they said that vaccination of pregnant women against other neonatal pathogens such as influenza and tetanus has been effective. “Candidate ZIKV vaccines proven safe in phase 1 trials should immediately be assessed for safety and efficacy in pregnant women,” they said. Although Zika infections are not at epidemic levels currently, resurgence remains a possibility and the coronavirus pandemic “has taught us that preparedness for emerging infections is crucial,” they said.
 

Zika vaccine research is a challenge worth pursuing

“It is important to continue Zika vaccine research because of the unpredictable nature of that infection,” Kevin Ault, MD, of the University of Kansas, Kansas City, said in an interview. “Several times Zika has gained a foothold in unexposed and vulnerable populations,” Dr. Ault said.  “Additionally, there are some data about using this vector during pregnancy, and eventually this vaccine may prevent the birth defects associated with Zika infections during pregnancy, he noted.

Dr. Ault said he was not surprised by the study findings. “This is a promising early phase vaccine candidate, and this adenovirus vector has been used in other similar trials,” he said. Potential barriers to vaccine development include the challenge of conducting late phase clinical trials in pregnant women, he noted. “The relevant endpoint is going to be clinical disease, and one of the most critical populations is pregnant women,” he said. In addition, “later phase 3 trials would be conducted in a population where there is an ongoing Zika outbreak,” Dr. Ault emphasized.   

The study was supported by Janssen Vaccines and Infectious Diseases.

Dr. Chahroudi had no financial conflicts to disclose. Dr. Permar disclosed grants from Merck and Moderna unrelated to the current study. Dr. Ault had no relevant financial conflicts to disclose; he has served as an adviser to the Centers for Disease Control and Prevention, the World Medical Association, the National Vaccine Program Office, and the National Institute for Allergy and Infectious Diseases. He is a fellow of the Infectious Disease Society of American and a fellow of ACOG. 

John G. Bartlett, MD, professor emeritus at Johns Hopkins University School of Medicine, Baltimore, and a prominent leader and instructor in infectious disease medicine, died Jan. 19 at age 83. The cause of death was not immediately disclosed.

Dr. Bartlett is remembered by colleagues for his wide range of infectious disease expertise, an ability to repeatedly predict emerging issues in the field, and for inspiring students and trainees to choose the same specialty. 

“What I consistently found so extraordinary about John was his excitement for ID – the whole field. He had a wonderful sixth sense about what was going to be the next ‘big thing,’” Paul Edward Sax, MD, clinical director of the Infectious Disease Clinic at Brigham and Women’s Hospital in Boston, told this news organization.

“He thoroughly absorbed the emerging research on the topic and then provided the most wonderful clinical summaries,” Dr. Sax said. “His range of expert content areas was unbelievably broad.” Dr. Bartlett was “a true ID polymath.”

Dr. Bartlett was “a giant in the field of infectious diseases,” David Lee Thomas, MD, MPH, said in an interview. He agreed that Dr. Bartlett was a visionary who could anticipate the most exciting developments in the specialty.

Dr. Bartlett also “led the efforts to combat the foes, from HIV to antimicrobial resistance,” said Dr. Thomas, director of the division of infectious diseases and professor of medicine at Johns Hopkins University.
 

A pioneer in HIV research and care

Dr. Bartlett’s early research focused on anaerobic pulmonary and other infections, Bacteroides fragilis pathogenesis, and colitis caused by Clostridioides difficile.

Shortly after joining Johns Hopkins in 1980, he focused on HIV/AIDS research and caring for people with HIV. Dr. Bartlett led clinical trials of new treatments and developed years of HIV clinical treatment guidelines.

“Back when most hospitals, university medical centers, and ID divisions were running away from the AIDS epidemic, John took it on, both as a scientific priority and a moral imperative,” Dr. Sax writes in a blog post for NEJM Journal Watch. “With the help of Frank Polk and the Hopkins president, he established an outpatient AIDS clinic and an inpatient AIDS ward – both of which were way ahead of their time.”

In the same post, Dr. Sax points out that Dr. Bartlett was an expert in multiple areas – any one of which could be a sole career focus. “How many ID doctors are true experts in all of the following distinct topics? HIV, Clostridium difficile, respiratory tract infections, antimicrobial resistance, and anaerobic pulmonary infections.” Dr. Sax writes.
 

Expertise that defined an era

In a piece reviewing the long history of infectious disease medicine at Johns Hopkins published in Clinical Infectious Diseases in 2014, Paul Auwaerter, MD, and colleagues describe his tenure at the institution from 1980 to 2006 as “The Bartlett Era,” notable for the many advances he spearheaded.

“It is nearly impossible to find someone trained in infectious diseases in the past 30 years who has not been impacted by John Bartlett,” Dr. Auwaerter and colleagues note. “His tireless devotion to scholarship, teaching, and patient care remains an inspiration to his faculty members at Johns Hopkins, his colleagues, and coworkers around the world.”

Dr. Bartlett was not only a faculty member in the division of infectious diseases, he also helped establish it. When he joined Johns Hopkins, the infectious disease department featured just three faculty members with a research budget of less than $285,000. By the time he left 26 years later, the division had 44 faculty members on tenure track and a research budget exceeding $40 million.
 

Sharing memories via social media

Reactions to Dr. Bartlett’s passing on Twitter were swift.

“We have lost one of the greatest physicians I have ever met or had the privilege to learn from. Saddened to hear of Dr. John G. Bartlett’s passing. He inspired so many, including me, to choose the field of infectious diseases,” David Fisk, MD, infectious disease specialist in Santa Barbara, Calif., wrote on Twitter.

“John Bartlett just died – a true visionary and the classic ‘Renaissance’ person in clinical ID. Such a nice guy, too! His IDSA/IDWeek literature summaries (among other things) were amazing. We’ll miss him!” Dr. Sax tweeted on Jan. 19.

A colleague at Johns Hopkins, transplant infectious disease specialist Shmuel Shoham, MD, shared an anecdote about Dr. Bartlett on Twitter: “Year ago. My office is across from his. I ask him what he is doing. He tells me he is reviewing a file from the Vatican to adjudicate whether a miracle happened. True story.”

Infectious disease specialist Graeme Forrest, MBBS, also shared a story about Dr. Bartlett via Twitter. “He described to me in 2001 how the U.S. model of health care would not cope with a pandemic or serious bioterror attack as it’s not connected to disseminate information. How prescient from 20 years ago.”

Dr. Bartlett shared his expertise at many national and international infectious disease conferences over the years. He also authored 470 articles, 282 book chapters, and 61 editions of 14 books.

Dr. Bartlett was also a regular contributor to this news organization. For example, he shared his expertise in perspective pieces that addressed priorities in antibiotic stewardship, upcoming infectious disease predictions, and critical infectious disease topics in a three-part series.

Dr. Bartlett’s education includes a bachelor’s degree from Dartmouth College in Hanover, N.H., in 1959 and an MD from Upstate Medical Center in Syracuse, N.Y., in 1963. He did his first 2 years of residency at Brigham and Women’s Hospital.

He also served as an Army captain from 1965 to 1967, treating patients in fever wards in Vietnam. He then returned to the United States to finish his internal medicine training at the University of Alabama in 1968.

Dr. Bartlett completed his fellowship in infectious diseases at the University of California, Los Angeles. In 1975, he joined the faculty at Tufts University, Boston.
 

Leaving a legacy

Dr. Bartlett’s influence will likely live on in many ways at Johns Hopkins.

“John is a larger-than-life legend whose impact will endure and after whom we are so proud to have named our clinical service, The Bartlett Specialty Practice,” Dr. Thomas said.

The specialty practice clinic named for him has 23 exam rooms and features multidisciplinary care for people with HIV, hepatitis, bone infections, general infectious diseases, and more. Furthermore, friends, family, and colleagues joined forces to create the “Dr. John G. Bartlett HIV/AIDS Fund.”

They note that it is “only appropriate that we honor him by creating an endowment that will provide support for young trainees and junior faculty in the division, helping them transition to their independent careers.”

In addition to all his professional accomplishments, “He was also a genuinely nice person, approachable and humble,” Dr. Sax said. “We really lost a great one!”

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

John G. Bartlett, MD, professor emeritus at Johns Hopkins University School of Medicine, Baltimore, and a prominent leader and instructor in infectious disease medicine, died Jan. 19 at age 83. The cause of death was not immediately disclosed.

Dr. Bartlett is remembered by colleagues for his wide range of infectious disease expertise, an ability to repeatedly predict emerging issues in the field, and for inspiring students and trainees to choose the same specialty. 

“What I consistently found so extraordinary about John was his excitement for ID – the whole field. He had a wonderful sixth sense about what was going to be the next ‘big thing,’” Paul Edward Sax, MD, clinical director of the Infectious Disease Clinic at Brigham and Women’s Hospital in Boston, told this news organization.

“He thoroughly absorbed the emerging research on the topic and then provided the most wonderful clinical summaries,” Dr. Sax said. “His range of expert content areas was unbelievably broad.” Dr. Bartlett was “a true ID polymath.”

Dr. Bartlett was “a giant in the field of infectious diseases,” David Lee Thomas, MD, MPH, said in an interview. He agreed that Dr. Bartlett was a visionary who could anticipate the most exciting developments in the specialty.

Dr. Bartlett also “led the efforts to combat the foes, from HIV to antimicrobial resistance,” said Dr. Thomas, director of the division of infectious diseases and professor of medicine at Johns Hopkins University.
 

A pioneer in HIV research and care

Dr. Bartlett’s early research focused on anaerobic pulmonary and other infections, Bacteroides fragilis pathogenesis, and colitis caused by Clostridioides difficile.

Shortly after joining Johns Hopkins in 1980, he focused on HIV/AIDS research and caring for people with HIV. Dr. Bartlett led clinical trials of new treatments and developed years of HIV clinical treatment guidelines.

“Back when most hospitals, university medical centers, and ID divisions were running away from the AIDS epidemic, John took it on, both as a scientific priority and a moral imperative,” Dr. Sax writes in a blog post for NEJM Journal Watch. “With the help of Frank Polk and the Hopkins president, he established an outpatient AIDS clinic and an inpatient AIDS ward – both of which were way ahead of their time.”

In the same post, Dr. Sax points out that Dr. Bartlett was an expert in multiple areas – any one of which could be a sole career focus. “How many ID doctors are true experts in all of the following distinct topics? HIV, Clostridium difficile, respiratory tract infections, antimicrobial resistance, and anaerobic pulmonary infections.” Dr. Sax writes.
 

Expertise that defined an era

In a piece reviewing the long history of infectious disease medicine at Johns Hopkins published in Clinical Infectious Diseases in 2014, Paul Auwaerter, MD, and colleagues describe his tenure at the institution from 1980 to 2006 as “The Bartlett Era,” notable for the many advances he spearheaded.

“It is nearly impossible to find someone trained in infectious diseases in the past 30 years who has not been impacted by John Bartlett,” Dr. Auwaerter and colleagues note. “His tireless devotion to scholarship, teaching, and patient care remains an inspiration to his faculty members at Johns Hopkins, his colleagues, and coworkers around the world.”

Dr. Bartlett was not only a faculty member in the division of infectious diseases, he also helped establish it. When he joined Johns Hopkins, the infectious disease department featured just three faculty members with a research budget of less than $285,000. By the time he left 26 years later, the division had 44 faculty members on tenure track and a research budget exceeding $40 million.
 

Sharing memories via social media

Reactions to Dr. Bartlett’s passing on Twitter were swift.

“We have lost one of the greatest physicians I have ever met or had the privilege to learn from. Saddened to hear of Dr. John G. Bartlett’s passing. He inspired so many, including me, to choose the field of infectious diseases,” David Fisk, MD, infectious disease specialist in Santa Barbara, Calif., wrote on Twitter.

“John Bartlett just died – a true visionary and the classic ‘Renaissance’ person in clinical ID. Such a nice guy, too! His IDSA/IDWeek literature summaries (among other things) were amazing. We’ll miss him!” Dr. Sax tweeted on Jan. 19.

A colleague at Johns Hopkins, transplant infectious disease specialist Shmuel Shoham, MD, shared an anecdote about Dr. Bartlett on Twitter: “Year ago. My office is across from his. I ask him what he is doing. He tells me he is reviewing a file from the Vatican to adjudicate whether a miracle happened. True story.”

Infectious disease specialist Graeme Forrest, MBBS, also shared a story about Dr. Bartlett via Twitter. “He described to me in 2001 how the U.S. model of health care would not cope with a pandemic or serious bioterror attack as it’s not connected to disseminate information. How prescient from 20 years ago.”

Dr. Bartlett shared his expertise at many national and international infectious disease conferences over the years. He also authored 470 articles, 282 book chapters, and 61 editions of 14 books.

Dr. Bartlett was also a regular contributor to this news organization. For example, he shared his expertise in perspective pieces that addressed priorities in antibiotic stewardship, upcoming infectious disease predictions, and critical infectious disease topics in a three-part series.

Dr. Bartlett’s education includes a bachelor’s degree from Dartmouth College in Hanover, N.H., in 1959 and an MD from Upstate Medical Center in Syracuse, N.Y., in 1963. He did his first 2 years of residency at Brigham and Women’s Hospital.

He also served as an Army captain from 1965 to 1967, treating patients in fever wards in Vietnam. He then returned to the United States to finish his internal medicine training at the University of Alabama in 1968.

Dr. Bartlett completed his fellowship in infectious diseases at the University of California, Los Angeles. In 1975, he joined the faculty at Tufts University, Boston.
 

Leaving a legacy

Dr. Bartlett’s influence will likely live on in many ways at Johns Hopkins.

“John is a larger-than-life legend whose impact will endure and after whom we are so proud to have named our clinical service, The Bartlett Specialty Practice,” Dr. Thomas said.

The specialty practice clinic named for him has 23 exam rooms and features multidisciplinary care for people with HIV, hepatitis, bone infections, general infectious diseases, and more. Furthermore, friends, family, and colleagues joined forces to create the “Dr. John G. Bartlett HIV/AIDS Fund.”

They note that it is “only appropriate that we honor him by creating an endowment that will provide support for young trainees and junior faculty in the division, helping them transition to their independent careers.”

In addition to all his professional accomplishments, “He was also a genuinely nice person, approachable and humble,” Dr. Sax said. “We really lost a great one!”

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

John G. Bartlett, MD, professor emeritus at Johns Hopkins University School of Medicine, Baltimore, and a prominent leader and instructor in infectious disease medicine, died Jan. 19 at age 83. The cause of death was not immediately disclosed.

Dr. Bartlett is remembered by colleagues for his wide range of infectious disease expertise, an ability to repeatedly predict emerging issues in the field, and for inspiring students and trainees to choose the same specialty. 

“What I consistently found so extraordinary about John was his excitement for ID – the whole field. He had a wonderful sixth sense about what was going to be the next ‘big thing,’” Paul Edward Sax, MD, clinical director of the Infectious Disease Clinic at Brigham and Women’s Hospital in Boston, told this news organization.

“He thoroughly absorbed the emerging research on the topic and then provided the most wonderful clinical summaries,” Dr. Sax said. “His range of expert content areas was unbelievably broad.” Dr. Bartlett was “a true ID polymath.”

Dr. Bartlett was “a giant in the field of infectious diseases,” David Lee Thomas, MD, MPH, said in an interview. He agreed that Dr. Bartlett was a visionary who could anticipate the most exciting developments in the specialty.

Dr. Bartlett also “led the efforts to combat the foes, from HIV to antimicrobial resistance,” said Dr. Thomas, director of the division of infectious diseases and professor of medicine at Johns Hopkins University.
 

A pioneer in HIV research and care

Dr. Bartlett’s early research focused on anaerobic pulmonary and other infections, Bacteroides fragilis pathogenesis, and colitis caused by Clostridioides difficile.

Shortly after joining Johns Hopkins in 1980, he focused on HIV/AIDS research and caring for people with HIV. Dr. Bartlett led clinical trials of new treatments and developed years of HIV clinical treatment guidelines.

“Back when most hospitals, university medical centers, and ID divisions were running away from the AIDS epidemic, John took it on, both as a scientific priority and a moral imperative,” Dr. Sax writes in a blog post for NEJM Journal Watch. “With the help of Frank Polk and the Hopkins president, he established an outpatient AIDS clinic and an inpatient AIDS ward – both of which were way ahead of their time.”

In the same post, Dr. Sax points out that Dr. Bartlett was an expert in multiple areas – any one of which could be a sole career focus. “How many ID doctors are true experts in all of the following distinct topics? HIV, Clostridium difficile, respiratory tract infections, antimicrobial resistance, and anaerobic pulmonary infections.” Dr. Sax writes.
 

Expertise that defined an era

In a piece reviewing the long history of infectious disease medicine at Johns Hopkins published in Clinical Infectious Diseases in 2014, Paul Auwaerter, MD, and colleagues describe his tenure at the institution from 1980 to 2006 as “The Bartlett Era,” notable for the many advances he spearheaded.

“It is nearly impossible to find someone trained in infectious diseases in the past 30 years who has not been impacted by John Bartlett,” Dr. Auwaerter and colleagues note. “His tireless devotion to scholarship, teaching, and patient care remains an inspiration to his faculty members at Johns Hopkins, his colleagues, and coworkers around the world.”

Dr. Bartlett was not only a faculty member in the division of infectious diseases, he also helped establish it. When he joined Johns Hopkins, the infectious disease department featured just three faculty members with a research budget of less than $285,000. By the time he left 26 years later, the division had 44 faculty members on tenure track and a research budget exceeding $40 million.
 

Sharing memories via social media

Reactions to Dr. Bartlett’s passing on Twitter were swift.

“We have lost one of the greatest physicians I have ever met or had the privilege to learn from. Saddened to hear of Dr. John G. Bartlett’s passing. He inspired so many, including me, to choose the field of infectious diseases,” David Fisk, MD, infectious disease specialist in Santa Barbara, Calif., wrote on Twitter.

“John Bartlett just died – a true visionary and the classic ‘Renaissance’ person in clinical ID. Such a nice guy, too! His IDSA/IDWeek literature summaries (among other things) were amazing. We’ll miss him!” Dr. Sax tweeted on Jan. 19.

A colleague at Johns Hopkins, transplant infectious disease specialist Shmuel Shoham, MD, shared an anecdote about Dr. Bartlett on Twitter: “Year ago. My office is across from his. I ask him what he is doing. He tells me he is reviewing a file from the Vatican to adjudicate whether a miracle happened. True story.”

Infectious disease specialist Graeme Forrest, MBBS, also shared a story about Dr. Bartlett via Twitter. “He described to me in 2001 how the U.S. model of health care would not cope with a pandemic or serious bioterror attack as it’s not connected to disseminate information. How prescient from 20 years ago.”

Dr. Bartlett shared his expertise at many national and international infectious disease conferences over the years. He also authored 470 articles, 282 book chapters, and 61 editions of 14 books.

Dr. Bartlett was also a regular contributor to this news organization. For example, he shared his expertise in perspective pieces that addressed priorities in antibiotic stewardship, upcoming infectious disease predictions, and critical infectious disease topics in a three-part series.

Dr. Bartlett’s education includes a bachelor’s degree from Dartmouth College in Hanover, N.H., in 1959 and an MD from Upstate Medical Center in Syracuse, N.Y., in 1963. He did his first 2 years of residency at Brigham and Women’s Hospital.

He also served as an Army captain from 1965 to 1967, treating patients in fever wards in Vietnam. He then returned to the United States to finish his internal medicine training at the University of Alabama in 1968.

Dr. Bartlett completed his fellowship in infectious diseases at the University of California, Los Angeles. In 1975, he joined the faculty at Tufts University, Boston.
 

Leaving a legacy

Dr. Bartlett’s influence will likely live on in many ways at Johns Hopkins.

“John is a larger-than-life legend whose impact will endure and after whom we are so proud to have named our clinical service, The Bartlett Specialty Practice,” Dr. Thomas said.

The specialty practice clinic named for him has 23 exam rooms and features multidisciplinary care for people with HIV, hepatitis, bone infections, general infectious diseases, and more. Furthermore, friends, family, and colleagues joined forces to create the “Dr. John G. Bartlett HIV/AIDS Fund.”

They note that it is “only appropriate that we honor him by creating an endowment that will provide support for young trainees and junior faculty in the division, helping them transition to their independent careers.”

In addition to all his professional accomplishments, “He was also a genuinely nice person, approachable and humble,” Dr. Sax said. “We really lost a great one!”

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

Exposure to antibiotics in mid- to late pregnancy was associated with childhood asthma in vaginally born children, in a Danish birth cohort study.

The reason behind the correlation is unclear. Maternal infections, rather than antibiotics, “could explain the observed association,” said study author Cecilie Skaarup Uldbjerg, a researcher in the department of public health at Aarhus University in Denmark.

Still, the “results are in keeping with the hypothesis that effects of antibiotics impact the maternally derived microbiome in vaginally born children and that this may increase the odds of childhood asthma,” Ms. Uldbjerg and coauthors wrote in their study, which was published online Feb. 9 in Archives of Disease in Childhood . “However, this observational study did not address underlying mechanisms, and this interpretation, while plausible, remains speculative.”
 

Antibiotic use in pregnancy likely to continue

Patrick Duff, MD, who was not involved in the research, does not expect the findings will alter clinical practice.

The association was relatively weak, and the study does not account for factors such as antibiotic exposure during early childhood or tobacco smoke in the house, said Dr. Duff, professor of maternal-fetal medicine at University of Florida, Gainesville.

“Although I agree that we should not use antibiotics indiscriminately during pregnancy, we definitely need to treat certain infections,” Dr. Duff said. “Thus we cannot avoid some degree of antibiotic exposure.”

Although prior research has indicated that antibiotic use in pregnancy may increase the risk of asthma in children, results have been inconsistent.

To study whether antibiotic exposure during pregnancy is associated with childhood asthma and whether the timing of antibiotic exposure or mode of delivery influence the relationship, the investigators analyzed data from more than 32,000 children in the Danish National Birth Cohort, which was established in 1996.
 

Children of mothers who took and did not take antibiotics compared

In all, 17% of the children were born to mothers who used antibiotics during pregnancy. Compared with mothers who did not take antibiotics, those who did reported more maternal asthma, smoking during pregnancy, and having overweight or obesity. In addition, they were less likely to have been in their first pregnancy.

During follow-up at age 11 years, 4,238 children (13%) had asthma, including 12.7% of those whose mothers had not been exposed to antibiotics, and 14.6% of those whose mothers had used antibiotics during pregnancy.

In adjusted analyses, children born to mothers who received antibiotics were more likely to have asthma (OR, 1.14).

Antibiotic exposure in the second to third trimester, but not in the first trimester, was associated with asthma. The association was observed in vaginally born children, but not in children born by cesarean section.

The study is limited by its reliance on maternal reporting for data about antibiotics and asthma diagnoses, the authors noted. Mothers completed telephone interviews twice during pregnancy and once at 6 months postpartum. They completed online questionnaires to provide follow-up information at 11 years.
 

Mode of delivery may matter

The researchers said their analysis indicates that mode of delivery may modify the association between antibiotic exposure during pregnancy and childhood asthma.

Fourteen percent of the children in the study were delivered by cesarean section. Further research may clarify the relationship between antibiotics in pregnancy, mode of delivery, and asthma risk, another doctor who was not involved the study added.

“I do not think that the evidence indicates that mode of delivery clearly has an impact,” said Santina J. G. Wheat, MD, MPH, associate professor of family and community medicine at Northwestern University in Chicago, “as the number of cesarean deliveries was not large enough to fully support such a statement.

“It will be interesting to see if an association holds in future studies with increased cesarean deliveries,” Dr. Wheat said.

How and why antibiotics were used may be other important factors to investigate, Dr. Duff suggested.

“The authors did not provide any specific information about which antibiotics were used by the mothers, duration of use, and indication for use. Those are very important confounders,” Dr. Duff said. “Perhaps the key exposure is to a particular maternal infection rather than to the antibiotic per se.”

The Danish National Birth Cohort was established with a grant from the Danish National Research Foundation and support from regional committees and other organizations. Its biobank has been supported by the Novo Nordisk Foundation and the Lundbeck Foundation, and follow-up of mothers and children has been supported by the Danish Medical Research Council, the Lundbeck Foundation, Innovation Fund Denmark, the Nordea Foundation, Aarhus Ideas, a University of Copenhagen strategic grant, and the Danish Council for Independent Research. The study was partially funded by the Health Research Fund of Central Denmark Region, which supported one of the authors. Other authors were supported by the DHB Foundation and the Australian National Health and Medical Research Council. One author is affiliated with Murdoch Children’s Research Institute in Australia, where the Victorian Government’s Operational Infrastructure Support Program supports research.

The authors had no competing interests. Dr. Wheat serves on the editorial advisory board of Family Practice News. Dr. Duff had no relevant financial disclosures.

jremaly@mdedge.com

Exposure to antibiotics in mid- to late pregnancy was associated with childhood asthma in vaginally born children, in a Danish birth cohort study.

The reason behind the correlation is unclear. Maternal infections, rather than antibiotics, “could explain the observed association,” said study author Cecilie Skaarup Uldbjerg, a researcher in the department of public health at Aarhus University in Denmark.

Still, the “results are in keeping with the hypothesis that effects of antibiotics impact the maternally derived microbiome in vaginally born children and that this may increase the odds of childhood asthma,” Ms. Uldbjerg and coauthors wrote in their study, which was published online Feb. 9 in Archives of Disease in Childhood . “However, this observational study did not address underlying mechanisms, and this interpretation, while plausible, remains speculative.”
 

Antibiotic use in pregnancy likely to continue

Patrick Duff, MD, who was not involved in the research, does not expect the findings will alter clinical practice.

The association was relatively weak, and the study does not account for factors such as antibiotic exposure during early childhood or tobacco smoke in the house, said Dr. Duff, professor of maternal-fetal medicine at University of Florida, Gainesville.

“Although I agree that we should not use antibiotics indiscriminately during pregnancy, we definitely need to treat certain infections,” Dr. Duff said. “Thus we cannot avoid some degree of antibiotic exposure.”

Although prior research has indicated that antibiotic use in pregnancy may increase the risk of asthma in children, results have been inconsistent.

To study whether antibiotic exposure during pregnancy is associated with childhood asthma and whether the timing of antibiotic exposure or mode of delivery influence the relationship, the investigators analyzed data from more than 32,000 children in the Danish National Birth Cohort, which was established in 1996.
 

Children of mothers who took and did not take antibiotics compared

In all, 17% of the children were born to mothers who used antibiotics during pregnancy. Compared with mothers who did not take antibiotics, those who did reported more maternal asthma, smoking during pregnancy, and having overweight or obesity. In addition, they were less likely to have been in their first pregnancy.

During follow-up at age 11 years, 4,238 children (13%) had asthma, including 12.7% of those whose mothers had not been exposed to antibiotics, and 14.6% of those whose mothers had used antibiotics during pregnancy.

In adjusted analyses, children born to mothers who received antibiotics were more likely to have asthma (OR, 1.14).

Antibiotic exposure in the second to third trimester, but not in the first trimester, was associated with asthma. The association was observed in vaginally born children, but not in children born by cesarean section.

The study is limited by its reliance on maternal reporting for data about antibiotics and asthma diagnoses, the authors noted. Mothers completed telephone interviews twice during pregnancy and once at 6 months postpartum. They completed online questionnaires to provide follow-up information at 11 years.
 

Mode of delivery may matter

The researchers said their analysis indicates that mode of delivery may modify the association between antibiotic exposure during pregnancy and childhood asthma.

Fourteen percent of the children in the study were delivered by cesarean section. Further research may clarify the relationship between antibiotics in pregnancy, mode of delivery, and asthma risk, another doctor who was not involved the study added.

“I do not think that the evidence indicates that mode of delivery clearly has an impact,” said Santina J. G. Wheat, MD, MPH, associate professor of family and community medicine at Northwestern University in Chicago, “as the number of cesarean deliveries was not large enough to fully support such a statement.

“It will be interesting to see if an association holds in future studies with increased cesarean deliveries,” Dr. Wheat said.

How and why antibiotics were used may be other important factors to investigate, Dr. Duff suggested.

“The authors did not provide any specific information about which antibiotics were used by the mothers, duration of use, and indication for use. Those are very important confounders,” Dr. Duff said. “Perhaps the key exposure is to a particular maternal infection rather than to the antibiotic per se.”

The Danish National Birth Cohort was established with a grant from the Danish National Research Foundation and support from regional committees and other organizations. Its biobank has been supported by the Novo Nordisk Foundation and the Lundbeck Foundation, and follow-up of mothers and children has been supported by the Danish Medical Research Council, the Lundbeck Foundation, Innovation Fund Denmark, the Nordea Foundation, Aarhus Ideas, a University of Copenhagen strategic grant, and the Danish Council for Independent Research. The study was partially funded by the Health Research Fund of Central Denmark Region, which supported one of the authors. Other authors were supported by the DHB Foundation and the Australian National Health and Medical Research Council. One author is affiliated with Murdoch Children’s Research Institute in Australia, where the Victorian Government’s Operational Infrastructure Support Program supports research.

The authors had no competing interests. Dr. Wheat serves on the editorial advisory board of Family Practice News. Dr. Duff had no relevant financial disclosures.

jremaly@mdedge.com

Exposure to antibiotics in mid- to late pregnancy was associated with childhood asthma in vaginally born children, in a Danish birth cohort study.

The reason behind the correlation is unclear. Maternal infections, rather than antibiotics, “could explain the observed association,” said study author Cecilie Skaarup Uldbjerg, a researcher in the department of public health at Aarhus University in Denmark.

Still, the “results are in keeping with the hypothesis that effects of antibiotics impact the maternally derived microbiome in vaginally born children and that this may increase the odds of childhood asthma,” Ms. Uldbjerg and coauthors wrote in their study, which was published online Feb. 9 in Archives of Disease in Childhood . “However, this observational study did not address underlying mechanisms, and this interpretation, while plausible, remains speculative.”
 

Antibiotic use in pregnancy likely to continue

Patrick Duff, MD, who was not involved in the research, does not expect the findings will alter clinical practice.

The association was relatively weak, and the study does not account for factors such as antibiotic exposure during early childhood or tobacco smoke in the house, said Dr. Duff, professor of maternal-fetal medicine at University of Florida, Gainesville.

“Although I agree that we should not use antibiotics indiscriminately during pregnancy, we definitely need to treat certain infections,” Dr. Duff said. “Thus we cannot avoid some degree of antibiotic exposure.”

Although prior research has indicated that antibiotic use in pregnancy may increase the risk of asthma in children, results have been inconsistent.

To study whether antibiotic exposure during pregnancy is associated with childhood asthma and whether the timing of antibiotic exposure or mode of delivery influence the relationship, the investigators analyzed data from more than 32,000 children in the Danish National Birth Cohort, which was established in 1996.
 

Children of mothers who took and did not take antibiotics compared

In all, 17% of the children were born to mothers who used antibiotics during pregnancy. Compared with mothers who did not take antibiotics, those who did reported more maternal asthma, smoking during pregnancy, and having overweight or obesity. In addition, they were less likely to have been in their first pregnancy.

During follow-up at age 11 years, 4,238 children (13%) had asthma, including 12.7% of those whose mothers had not been exposed to antibiotics, and 14.6% of those whose mothers had used antibiotics during pregnancy.

In adjusted analyses, children born to mothers who received antibiotics were more likely to have asthma (OR, 1.14).

Antibiotic exposure in the second to third trimester, but not in the first trimester, was associated with asthma. The association was observed in vaginally born children, but not in children born by cesarean section.

The study is limited by its reliance on maternal reporting for data about antibiotics and asthma diagnoses, the authors noted. Mothers completed telephone interviews twice during pregnancy and once at 6 months postpartum. They completed online questionnaires to provide follow-up information at 11 years.
 

Mode of delivery may matter

The researchers said their analysis indicates that mode of delivery may modify the association between antibiotic exposure during pregnancy and childhood asthma.

Fourteen percent of the children in the study were delivered by cesarean section. Further research may clarify the relationship between antibiotics in pregnancy, mode of delivery, and asthma risk, another doctor who was not involved the study added.

“I do not think that the evidence indicates that mode of delivery clearly has an impact,” said Santina J. G. Wheat, MD, MPH, associate professor of family and community medicine at Northwestern University in Chicago, “as the number of cesarean deliveries was not large enough to fully support such a statement.

“It will be interesting to see if an association holds in future studies with increased cesarean deliveries,” Dr. Wheat said.

How and why antibiotics were used may be other important factors to investigate, Dr. Duff suggested.

“The authors did not provide any specific information about which antibiotics were used by the mothers, duration of use, and indication for use. Those are very important confounders,” Dr. Duff said. “Perhaps the key exposure is to a particular maternal infection rather than to the antibiotic per se.”

The Danish National Birth Cohort was established with a grant from the Danish National Research Foundation and support from regional committees and other organizations. Its biobank has been supported by the Novo Nordisk Foundation and the Lundbeck Foundation, and follow-up of mothers and children has been supported by the Danish Medical Research Council, the Lundbeck Foundation, Innovation Fund Denmark, the Nordea Foundation, Aarhus Ideas, a University of Copenhagen strategic grant, and the Danish Council for Independent Research. The study was partially funded by the Health Research Fund of Central Denmark Region, which supported one of the authors. Other authors were supported by the DHB Foundation and the Australian National Health and Medical Research Council. One author is affiliated with Murdoch Children’s Research Institute in Australia, where the Victorian Government’s Operational Infrastructure Support Program supports research.

The authors had no competing interests. Dr. Wheat serves on the editorial advisory board of Family Practice News. Dr. Duff had no relevant financial disclosures.

jremaly@mdedge.com

A commercial for the continuous glucose monitor (CGM) Dexcom G6 shown during the Super Bowl has provoked strong reactions in the diabetes community, both positive and negative.

The 30-second ad, which aired between the first two quarters of the American football game yesterday, features singer-songwriter-actor Nick Jonas, who has type 1 diabetes. During the ad, Mr. Jonas asks – with so much technology available today, including drones that deliver packages and self-driving cars – why are people with diabetes still pricking their fingers to test their blood sugar?

Mr. Jonas goes on to demonstrate the Dexcom G6 smartphone glucose app as it displays three different glucose levels including two trending upward, explaining: “It shows your glucose right in your phone, and where it’s heading, without fingersticks. Finally, technology that makes it easier to manage our diabetes.”

Diabetes type or insulin treatment are not mentioned in the ad, despite the fact that most insurance plans typically only cover CGMs for people with type 1 diabetes and sometimes for those with type 2 diabetes who take multiple daily insulin doses (given the risk for hypoglycemia).
 

Ad prompts mixed reaction on social media

Reactions rolled in on Twitter after the ad debuted Feb. 2, and then again after it aired during the game.

Some people who have type 1 diabetes themselves or have children with the disease who use the product were thrilled.

“Thanks to @NickJonas for his advocacy on T1. My 11-year old has been on the Dexcom for 3 weeks. For a newly diagnosed kid, it removes a lot of anxiety (and for his parents, too!) Plus, he is thrilled his meter has a Super Bowl commercial!” tweeted @KatisJewell.

Another positive tweet, from @rturnerroy, read: “@nickjonas Thank you for bringing representation to #type1diabetes. And hey #Dexcom, you’re the best.”

But many others were critical, both of Jonas and Dexcom. @hb_herrick tweeted: “Diabetes awareness is fantastic. Dexcom being able to afford Nick Jonas for a #SuperBowl commercial is not. This is a health care product. Make it more affordable for those who need it.”

Another Twitter user, @universeofdust, tweeted: “Feeling ambivalent about the #Dexcom ad tbh. I love the awareness & representation. But also not a big fan of dexcom spending $5.5 mill+ to make the CGM seem like this ~cool & trendy~ thing when many type 1s can’t afford their insulin, let alone a CGM.”

And @andricheli wrote: “Only people lucky enough to have excellent insurance and be able to afford the out-of-pocket costs have access. Many others do not.”

And in another tweet the same user said, “The #Dexcom is an amazing device. It’s literally lifesaving and life extending. But it’s also very expensive and not available to everyone. Maybe instead of spending $5 mil on a Super Bowl ad, @dexcom should spend that on getting Dex into the handle of people who need it.”

Others, including @1hitwonderdate, criticized Mr. Jonas directly, asking him: “As someone who has struggled with diabetes and is trying to support themselves along with millions of others, why not use this platform to help those who can’t afford their supplies or are rationing them?!”


 

Dexcom and Jonas’ organization respond

This news organization reached out to both Dexcom and to Beyond Type 1, a nonprofit organization cofounded by Mr. Jonas, for comment. Both emailed responses.

Regarding the intended audience for the ad, Dexcom acknowledged that it hoped to reach a much wider group than just people with type 1 diabetes or even just insulin users.

“We believe our CGM technology has the ability to empower any person with diabetes and significantly improve their treatment and quality of life, whether they are using insulin or not,” the company said, adding that the ad was also aimed at “loved ones, caregivers, and even health care professionals who need to know about this technology.”

According to Dexcom, the G6 is covered by 99% of commercial insurance in the United States, in addition to Medicare, and by Medicaid in more than 40 states. Over 70% of Dexcom patients with pharmacy coverage in the United States pay under $60 per month for CGM, and a third pay $0 out-of-pocket.

“That said, we know there’s more to be done to improve access, and we are working with several partners to broaden access to Dexcom CGM, especially for people with type 2 diabetes not on mealtime insulin,” the company noted.

Beyond Type 1 responded to the criticisms about Mr. Jonas personally, noting that the celebrity is, in fact, heavily involved in advocacy.

“Nick was involved in the launch of GetInsulin.org this past October,” they said. “GetInsulin.org is a tool created by Beyond Type 1 to connect people with diabetes in the United States to the insulin access and affordability options that match their unique circumstances. ... Beyond Type 1 will continue driving awareness of short-term solutions related to insulin access and affordability while fighting for systemic change.”

The organization “is also advocating for systemic payment policies that will make devices less expensive and avoid the same pitfalls (and rising prices) as the drug pricing system in the U.S.”

Mr. Jonas himself appears aware of the concerns.

Is 2021’s most expensive Super Bowl ad justified?

Meanwhile, in a piece in Esquire, Dave Holmes, who has type 1 diabetes, weighs up the pros and cons of the ad.

He writes: “While Jonas makes it look fun and easy to use a Dexcom G6 – a program to just get with like you would a drone or LED eyelashes – the process of acquiring one is complicated and often very expensive, even for people with good insurance. Which makes the year’s most expensive ad buy, for a product that only a small percentage of the U.S. population needs, confusing to me and others.”

Mr. Holmes also spoke with Craig Stubing, founder of the Beta Cell Foundation, a nonprofit that aims to educate and empower those with type 1 diabetes.

“Spending all this money on an ad, when people’s lives are at stake. I don’t know if offensive is the right word, but it seems out of touch with the reality that their patients are facing,” Mr. Stubing told Mr. Holmes.

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

A commercial for the continuous glucose monitor (CGM) Dexcom G6 shown during the Super Bowl has provoked strong reactions in the diabetes community, both positive and negative.

The 30-second ad, which aired between the first two quarters of the American football game yesterday, features singer-songwriter-actor Nick Jonas, who has type 1 diabetes. During the ad, Mr. Jonas asks – with so much technology available today, including drones that deliver packages and self-driving cars – why are people with diabetes still pricking their fingers to test their blood sugar?

Mr. Jonas goes on to demonstrate the Dexcom G6 smartphone glucose app as it displays three different glucose levels including two trending upward, explaining: “It shows your glucose right in your phone, and where it’s heading, without fingersticks. Finally, technology that makes it easier to manage our diabetes.”

Diabetes type or insulin treatment are not mentioned in the ad, despite the fact that most insurance plans typically only cover CGMs for people with type 1 diabetes and sometimes for those with type 2 diabetes who take multiple daily insulin doses (given the risk for hypoglycemia).
 

Ad prompts mixed reaction on social media

Reactions rolled in on Twitter after the ad debuted Feb. 2, and then again after it aired during the game.

Some people who have type 1 diabetes themselves or have children with the disease who use the product were thrilled.

“Thanks to @NickJonas for his advocacy on T1. My 11-year old has been on the Dexcom for 3 weeks. For a newly diagnosed kid, it removes a lot of anxiety (and for his parents, too!) Plus, he is thrilled his meter has a Super Bowl commercial!” tweeted @KatisJewell.

Another positive tweet, from @rturnerroy, read: “@nickjonas Thank you for bringing representation to #type1diabetes. And hey #Dexcom, you’re the best.”

But many others were critical, both of Jonas and Dexcom. @hb_herrick tweeted: “Diabetes awareness is fantastic. Dexcom being able to afford Nick Jonas for a #SuperBowl commercial is not. This is a health care product. Make it more affordable for those who need it.”

Another Twitter user, @universeofdust, tweeted: “Feeling ambivalent about the #Dexcom ad tbh. I love the awareness & representation. But also not a big fan of dexcom spending $5.5 mill+ to make the CGM seem like this ~cool & trendy~ thing when many type 1s can’t afford their insulin, let alone a CGM.”

And @andricheli wrote: “Only people lucky enough to have excellent insurance and be able to afford the out-of-pocket costs have access. Many others do not.”

And in another tweet the same user said, “The #Dexcom is an amazing device. It’s literally lifesaving and life extending. But it’s also very expensive and not available to everyone. Maybe instead of spending $5 mil on a Super Bowl ad, @dexcom should spend that on getting Dex into the handle of people who need it.”

Others, including @1hitwonderdate, criticized Mr. Jonas directly, asking him: “As someone who has struggled with diabetes and is trying to support themselves along with millions of others, why not use this platform to help those who can’t afford their supplies or are rationing them?!”


 

Dexcom and Jonas’ organization respond

This news organization reached out to both Dexcom and to Beyond Type 1, a nonprofit organization cofounded by Mr. Jonas, for comment. Both emailed responses.

Regarding the intended audience for the ad, Dexcom acknowledged that it hoped to reach a much wider group than just people with type 1 diabetes or even just insulin users.

“We believe our CGM technology has the ability to empower any person with diabetes and significantly improve their treatment and quality of life, whether they are using insulin or not,” the company said, adding that the ad was also aimed at “loved ones, caregivers, and even health care professionals who need to know about this technology.”

According to Dexcom, the G6 is covered by 99% of commercial insurance in the United States, in addition to Medicare, and by Medicaid in more than 40 states. Over 70% of Dexcom patients with pharmacy coverage in the United States pay under $60 per month for CGM, and a third pay $0 out-of-pocket.

“That said, we know there’s more to be done to improve access, and we are working with several partners to broaden access to Dexcom CGM, especially for people with type 2 diabetes not on mealtime insulin,” the company noted.

Beyond Type 1 responded to the criticisms about Mr. Jonas personally, noting that the celebrity is, in fact, heavily involved in advocacy.

“Nick was involved in the launch of GetInsulin.org this past October,” they said. “GetInsulin.org is a tool created by Beyond Type 1 to connect people with diabetes in the United States to the insulin access and affordability options that match their unique circumstances. ... Beyond Type 1 will continue driving awareness of short-term solutions related to insulin access and affordability while fighting for systemic change.”

The organization “is also advocating for systemic payment policies that will make devices less expensive and avoid the same pitfalls (and rising prices) as the drug pricing system in the U.S.”

Mr. Jonas himself appears aware of the concerns.

Is 2021’s most expensive Super Bowl ad justified?

Meanwhile, in a piece in Esquire, Dave Holmes, who has type 1 diabetes, weighs up the pros and cons of the ad.

He writes: “While Jonas makes it look fun and easy to use a Dexcom G6 – a program to just get with like you would a drone or LED eyelashes – the process of acquiring one is complicated and often very expensive, even for people with good insurance. Which makes the year’s most expensive ad buy, for a product that only a small percentage of the U.S. population needs, confusing to me and others.”

Mr. Holmes also spoke with Craig Stubing, founder of the Beta Cell Foundation, a nonprofit that aims to educate and empower those with type 1 diabetes.

“Spending all this money on an ad, when people’s lives are at stake. I don’t know if offensive is the right word, but it seems out of touch with the reality that their patients are facing,” Mr. Stubing told Mr. Holmes.

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

A commercial for the continuous glucose monitor (CGM) Dexcom G6 shown during the Super Bowl has provoked strong reactions in the diabetes community, both positive and negative.

The 30-second ad, which aired between the first two quarters of the American football game yesterday, features singer-songwriter-actor Nick Jonas, who has type 1 diabetes. During the ad, Mr. Jonas asks – with so much technology available today, including drones that deliver packages and self-driving cars – why are people with diabetes still pricking their fingers to test their blood sugar?

Mr. Jonas goes on to demonstrate the Dexcom G6 smartphone glucose app as it displays three different glucose levels including two trending upward, explaining: “It shows your glucose right in your phone, and where it’s heading, without fingersticks. Finally, technology that makes it easier to manage our diabetes.”

Diabetes type or insulin treatment are not mentioned in the ad, despite the fact that most insurance plans typically only cover CGMs for people with type 1 diabetes and sometimes for those with type 2 diabetes who take multiple daily insulin doses (given the risk for hypoglycemia).
 

Ad prompts mixed reaction on social media

Reactions rolled in on Twitter after the ad debuted Feb. 2, and then again after it aired during the game.

Some people who have type 1 diabetes themselves or have children with the disease who use the product were thrilled.

“Thanks to @NickJonas for his advocacy on T1. My 11-year old has been on the Dexcom for 3 weeks. For a newly diagnosed kid, it removes a lot of anxiety (and for his parents, too!) Plus, he is thrilled his meter has a Super Bowl commercial!” tweeted @KatisJewell.

Another positive tweet, from @rturnerroy, read: “@nickjonas Thank you for bringing representation to #type1diabetes. And hey #Dexcom, you’re the best.”

But many others were critical, both of Jonas and Dexcom. @hb_herrick tweeted: “Diabetes awareness is fantastic. Dexcom being able to afford Nick Jonas for a #SuperBowl commercial is not. This is a health care product. Make it more affordable for those who need it.”

Another Twitter user, @universeofdust, tweeted: “Feeling ambivalent about the #Dexcom ad tbh. I love the awareness & representation. But also not a big fan of dexcom spending $5.5 mill+ to make the CGM seem like this ~cool & trendy~ thing when many type 1s can’t afford their insulin, let alone a CGM.”

And @andricheli wrote: “Only people lucky enough to have excellent insurance and be able to afford the out-of-pocket costs have access. Many others do not.”

And in another tweet the same user said, “The #Dexcom is an amazing device. It’s literally lifesaving and life extending. But it’s also very expensive and not available to everyone. Maybe instead of spending $5 mil on a Super Bowl ad, @dexcom should spend that on getting Dex into the handle of people who need it.”

Others, including @1hitwonderdate, criticized Mr. Jonas directly, asking him: “As someone who has struggled with diabetes and is trying to support themselves along with millions of others, why not use this platform to help those who can’t afford their supplies or are rationing them?!”


 

Dexcom and Jonas’ organization respond

This news organization reached out to both Dexcom and to Beyond Type 1, a nonprofit organization cofounded by Mr. Jonas, for comment. Both emailed responses.

Regarding the intended audience for the ad, Dexcom acknowledged that it hoped to reach a much wider group than just people with type 1 diabetes or even just insulin users.

“We believe our CGM technology has the ability to empower any person with diabetes and significantly improve their treatment and quality of life, whether they are using insulin or not,” the company said, adding that the ad was also aimed at “loved ones, caregivers, and even health care professionals who need to know about this technology.”

According to Dexcom, the G6 is covered by 99% of commercial insurance in the United States, in addition to Medicare, and by Medicaid in more than 40 states. Over 70% of Dexcom patients with pharmacy coverage in the United States pay under $60 per month for CGM, and a third pay $0 out-of-pocket.

“That said, we know there’s more to be done to improve access, and we are working with several partners to broaden access to Dexcom CGM, especially for people with type 2 diabetes not on mealtime insulin,” the company noted.

Beyond Type 1 responded to the criticisms about Mr. Jonas personally, noting that the celebrity is, in fact, heavily involved in advocacy.

“Nick was involved in the launch of GetInsulin.org this past October,” they said. “GetInsulin.org is a tool created by Beyond Type 1 to connect people with diabetes in the United States to the insulin access and affordability options that match their unique circumstances. ... Beyond Type 1 will continue driving awareness of short-term solutions related to insulin access and affordability while fighting for systemic change.”

The organization “is also advocating for systemic payment policies that will make devices less expensive and avoid the same pitfalls (and rising prices) as the drug pricing system in the U.S.”

Mr. Jonas himself appears aware of the concerns.

Is 2021’s most expensive Super Bowl ad justified?

Meanwhile, in a piece in Esquire, Dave Holmes, who has type 1 diabetes, weighs up the pros and cons of the ad.

He writes: “While Jonas makes it look fun and easy to use a Dexcom G6 – a program to just get with like you would a drone or LED eyelashes – the process of acquiring one is complicated and often very expensive, even for people with good insurance. Which makes the year’s most expensive ad buy, for a product that only a small percentage of the U.S. population needs, confusing to me and others.”

Mr. Holmes also spoke with Craig Stubing, founder of the Beta Cell Foundation, a nonprofit that aims to educate and empower those with type 1 diabetes.

“Spending all this money on an ad, when people’s lives are at stake. I don’t know if offensive is the right word, but it seems out of touch with the reality that their patients are facing,” Mr. Stubing told Mr. Holmes.

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