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News and Views that Matter to Pediatricians
The leading independent newspaper covering news and commentary in pediatrics.
Family medicine has grown; its composition has evolved
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.”
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.”
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.”
Dried blood spot tests show sensitivity as cCMV screen
Dried blood spot testing showed sensitivity comparable to saliva as a screening method for congenital cytomegalovirus infection in newborns, based on data from more than 12,000 newborns.
Congenital cytomegalovirus (cCMV) is a common congenital virus in the United States, but remains underrecognized, wrote Sheila C. Dollard, PhD, of the Centers for Disease Control and Prevention in Atlanta, and colleagues.
“Given the burden associated with cCMV and the proven benefits of treatment and early intervention for some affected infants, there has been growing interest in universal newborn screening,” but an ideal screening strategy has yet to be determined, they said.
In a population-based cohort study published in JAMA Pediatrics, the researchers screened 12,554 newborns in Minnesota, including 56 with confirmed CMV infection. The newborns were screened for cCMV via dried blood spots (DBS) and saliva collected 1-2 days after birth. The DBS were tested for CMV DNA via polymerase chain reaction (PCR) at the University of Minnesota (UMN) and the CDC.
The overall sensitivity rate was 85.7% for a combination of laboratory results from the UMN and the CDC, which had separate sensitivities of 73.2% and 76.8%, respectively.
The specificity of the combined results was 100.0% (100% from both UMN and CDC), the combined positive predictive value was 98.0% (100.0% from UMN, 97.7% from CDC), and the combined negative predictive value was 99.9% (99.9% from both UMN and CDC).
By comparison, saliva swab test results showed sensitivity of 92.9%, specificity of 99.9%, positive predictive value of 86.7%, and negative predictive value of 100.0%.
The study findings were limited by several factors including the false-positive and false-negative results from saliva screening. Overall, the false-positive rate was 0.06%, which is comparable to rates from other screening techniques, the researchers said. “The recent Food and Drug Administration approval of a point-of-care neonatal saliva CMV test (Meridian Bioscience), underscores the importance of further clarifying the role of false-positive saliva CMV test results and underscores the requirement for urine confirmation for diagnosis of cCMV,” they added.
However, the study findings support the acceptability and feasibility of cCMV screening, as parents reported generally positive attitudes about the process, the researchers said.
The study is ongoing, and designed to follow infants with confirmed cCMV for up to age 4 years to assess clinical outcomes, they added. “Diagnostic methods are always improving, and therefore, our results show the potential of DBS to provide low-cost CMV screening with smooth integration of sample collection, laboratory testing, and follow-up,” they concluded.
Findings lay foundation for widespread use
“By using enhanced PCR methods, Dollard et al. have rekindled the hope that NBDBS [newborn dried blood spots] testing may be a viable method for large-scale, universal newborn screening for congenital CMV,” Gail J. Demmler-Harrison, MD, of Texas Children’s Hospital, Houston, wrote in an accompanying editorial. Congenital CMV is a common infection, but accurate prevalence remains uncertain because not all newborns are tested, she noted. Detection of CMV currently may involve urine, saliva, and blood, but challenges to the use of these methods include “a variety of constantly evolving DNA detection methods,” she said.
Although urine and saliva samples have been proposed for universal screening, they would require the creation of new sample collection and testing programs. “The routine of collecting the NBDBS samples on all newborns and the logistics of routing them to central laboratories and then reporting results to caregivers is already in place and are strengths of NBDBS samples for universal newborn screening,” but had been limited by a less sensitive platform than urine or saliva, said Dr. Demmler-Harrison.
“The results in the study by Dollard et al. may be a total game changer for the NBDBS proponents,” she emphasized. “Furthermore, scientists who have adapted even more sensitive DNA detection assays, such as the loop-mediated isothermal assay for detection of DNA in clinical samples from newborns, may be able to adapt loop-mediated isothermal assay methodology to detect CMV DNA in NBDBS,” she added.
“By adapting the collection methods, by using optimal filter paper to enhance DNA adherence, by improving DNA elution procedures, and by developing novel amplification and detection methods, NBDBS may soon meet the challenge and reach the sensitivity and specificity necessary for universal screening for congenital CMV,” she concluded.
The study was supported by the CDC, the Minnesota Department of Health, the National Vaccine Program Office (U.S. federal government), and the University of South Carolina Disability Research and Dissemination Center.
Dr. Dollard and Dr. Demmler-Harrison had no financial conflicts to disclose.
Dried blood spot testing showed sensitivity comparable to saliva as a screening method for congenital cytomegalovirus infection in newborns, based on data from more than 12,000 newborns.
Congenital cytomegalovirus (cCMV) is a common congenital virus in the United States, but remains underrecognized, wrote Sheila C. Dollard, PhD, of the Centers for Disease Control and Prevention in Atlanta, and colleagues.
“Given the burden associated with cCMV and the proven benefits of treatment and early intervention for some affected infants, there has been growing interest in universal newborn screening,” but an ideal screening strategy has yet to be determined, they said.
In a population-based cohort study published in JAMA Pediatrics, the researchers screened 12,554 newborns in Minnesota, including 56 with confirmed CMV infection. The newborns were screened for cCMV via dried blood spots (DBS) and saliva collected 1-2 days after birth. The DBS were tested for CMV DNA via polymerase chain reaction (PCR) at the University of Minnesota (UMN) and the CDC.
The overall sensitivity rate was 85.7% for a combination of laboratory results from the UMN and the CDC, which had separate sensitivities of 73.2% and 76.8%, respectively.
The specificity of the combined results was 100.0% (100% from both UMN and CDC), the combined positive predictive value was 98.0% (100.0% from UMN, 97.7% from CDC), and the combined negative predictive value was 99.9% (99.9% from both UMN and CDC).
By comparison, saliva swab test results showed sensitivity of 92.9%, specificity of 99.9%, positive predictive value of 86.7%, and negative predictive value of 100.0%.
The study findings were limited by several factors including the false-positive and false-negative results from saliva screening. Overall, the false-positive rate was 0.06%, which is comparable to rates from other screening techniques, the researchers said. “The recent Food and Drug Administration approval of a point-of-care neonatal saliva CMV test (Meridian Bioscience), underscores the importance of further clarifying the role of false-positive saliva CMV test results and underscores the requirement for urine confirmation for diagnosis of cCMV,” they added.
However, the study findings support the acceptability and feasibility of cCMV screening, as parents reported generally positive attitudes about the process, the researchers said.
The study is ongoing, and designed to follow infants with confirmed cCMV for up to age 4 years to assess clinical outcomes, they added. “Diagnostic methods are always improving, and therefore, our results show the potential of DBS to provide low-cost CMV screening with smooth integration of sample collection, laboratory testing, and follow-up,” they concluded.
Findings lay foundation for widespread use
“By using enhanced PCR methods, Dollard et al. have rekindled the hope that NBDBS [newborn dried blood spots] testing may be a viable method for large-scale, universal newborn screening for congenital CMV,” Gail J. Demmler-Harrison, MD, of Texas Children’s Hospital, Houston, wrote in an accompanying editorial. Congenital CMV is a common infection, but accurate prevalence remains uncertain because not all newborns are tested, she noted. Detection of CMV currently may involve urine, saliva, and blood, but challenges to the use of these methods include “a variety of constantly evolving DNA detection methods,” she said.
Although urine and saliva samples have been proposed for universal screening, they would require the creation of new sample collection and testing programs. “The routine of collecting the NBDBS samples on all newborns and the logistics of routing them to central laboratories and then reporting results to caregivers is already in place and are strengths of NBDBS samples for universal newborn screening,” but had been limited by a less sensitive platform than urine or saliva, said Dr. Demmler-Harrison.
“The results in the study by Dollard et al. may be a total game changer for the NBDBS proponents,” she emphasized. “Furthermore, scientists who have adapted even more sensitive DNA detection assays, such as the loop-mediated isothermal assay for detection of DNA in clinical samples from newborns, may be able to adapt loop-mediated isothermal assay methodology to detect CMV DNA in NBDBS,” she added.
“By adapting the collection methods, by using optimal filter paper to enhance DNA adherence, by improving DNA elution procedures, and by developing novel amplification and detection methods, NBDBS may soon meet the challenge and reach the sensitivity and specificity necessary for universal screening for congenital CMV,” she concluded.
The study was supported by the CDC, the Minnesota Department of Health, the National Vaccine Program Office (U.S. federal government), and the University of South Carolina Disability Research and Dissemination Center.
Dr. Dollard and Dr. Demmler-Harrison had no financial conflicts to disclose.
Dried blood spot testing showed sensitivity comparable to saliva as a screening method for congenital cytomegalovirus infection in newborns, based on data from more than 12,000 newborns.
Congenital cytomegalovirus (cCMV) is a common congenital virus in the United States, but remains underrecognized, wrote Sheila C. Dollard, PhD, of the Centers for Disease Control and Prevention in Atlanta, and colleagues.
“Given the burden associated with cCMV and the proven benefits of treatment and early intervention for some affected infants, there has been growing interest in universal newborn screening,” but an ideal screening strategy has yet to be determined, they said.
In a population-based cohort study published in JAMA Pediatrics, the researchers screened 12,554 newborns in Minnesota, including 56 with confirmed CMV infection. The newborns were screened for cCMV via dried blood spots (DBS) and saliva collected 1-2 days after birth. The DBS were tested for CMV DNA via polymerase chain reaction (PCR) at the University of Minnesota (UMN) and the CDC.
The overall sensitivity rate was 85.7% for a combination of laboratory results from the UMN and the CDC, which had separate sensitivities of 73.2% and 76.8%, respectively.
The specificity of the combined results was 100.0% (100% from both UMN and CDC), the combined positive predictive value was 98.0% (100.0% from UMN, 97.7% from CDC), and the combined negative predictive value was 99.9% (99.9% from both UMN and CDC).
By comparison, saliva swab test results showed sensitivity of 92.9%, specificity of 99.9%, positive predictive value of 86.7%, and negative predictive value of 100.0%.
The study findings were limited by several factors including the false-positive and false-negative results from saliva screening. Overall, the false-positive rate was 0.06%, which is comparable to rates from other screening techniques, the researchers said. “The recent Food and Drug Administration approval of a point-of-care neonatal saliva CMV test (Meridian Bioscience), underscores the importance of further clarifying the role of false-positive saliva CMV test results and underscores the requirement for urine confirmation for diagnosis of cCMV,” they added.
However, the study findings support the acceptability and feasibility of cCMV screening, as parents reported generally positive attitudes about the process, the researchers said.
The study is ongoing, and designed to follow infants with confirmed cCMV for up to age 4 years to assess clinical outcomes, they added. “Diagnostic methods are always improving, and therefore, our results show the potential of DBS to provide low-cost CMV screening with smooth integration of sample collection, laboratory testing, and follow-up,” they concluded.
Findings lay foundation for widespread use
“By using enhanced PCR methods, Dollard et al. have rekindled the hope that NBDBS [newborn dried blood spots] testing may be a viable method for large-scale, universal newborn screening for congenital CMV,” Gail J. Demmler-Harrison, MD, of Texas Children’s Hospital, Houston, wrote in an accompanying editorial. Congenital CMV is a common infection, but accurate prevalence remains uncertain because not all newborns are tested, she noted. Detection of CMV currently may involve urine, saliva, and blood, but challenges to the use of these methods include “a variety of constantly evolving DNA detection methods,” she said.
Although urine and saliva samples have been proposed for universal screening, they would require the creation of new sample collection and testing programs. “The routine of collecting the NBDBS samples on all newborns and the logistics of routing them to central laboratories and then reporting results to caregivers is already in place and are strengths of NBDBS samples for universal newborn screening,” but had been limited by a less sensitive platform than urine or saliva, said Dr. Demmler-Harrison.
“The results in the study by Dollard et al. may be a total game changer for the NBDBS proponents,” she emphasized. “Furthermore, scientists who have adapted even more sensitive DNA detection assays, such as the loop-mediated isothermal assay for detection of DNA in clinical samples from newborns, may be able to adapt loop-mediated isothermal assay methodology to detect CMV DNA in NBDBS,” she added.
“By adapting the collection methods, by using optimal filter paper to enhance DNA adherence, by improving DNA elution procedures, and by developing novel amplification and detection methods, NBDBS may soon meet the challenge and reach the sensitivity and specificity necessary for universal screening for congenital CMV,” she concluded.
The study was supported by the CDC, the Minnesota Department of Health, the National Vaccine Program Office (U.S. federal government), and the University of South Carolina Disability Research and Dissemination Center.
Dr. Dollard and Dr. Demmler-Harrison had no financial conflicts to disclose.
FROM JAMA PEDIATRICS
FDA clears novel daytime device for obstructive sleep apnea
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.
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.
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.
Family medicine: Who cares for the children?
according to new research.
This the latest sign of a long-term decline, and it “poses a broader concern for a specialty that defines itself by its comprehensive scope of practice,” said the study investigators of the Robert Graham Center in Washington, D.C., in a written statement. “This is consistent with previous Robert Graham Center research that reported a similar steady decline from 1992 to 2002.”
Self-reported data from family physicians indicate that 84.3% cared for children aged 18 years and under in 2017, compared with 83.0% in 2018, based on a cross-sectional analysis of data gathered from 11,674 family physicians who completed the practice demographic questionnaire attached to the American Board of Family Medicine’s certification exam in 2017 and 2018.
“This current trend is unsettling, because family physicians provide the majority of pediatric care in rural and pediatrically underserved areas of the United States,” study author Anuradha Jetty, MPH, and coauthors said in the statement.
The analysis also offers a snapshot of the current state of pediatric care offered by family physicians. In 2017 and 2018, FPs were more likely to see patients aged 5-18 years than those under age 5 (83.0% vs. 67.0%), with variation by age, location, and race/ethnicity, said Ms. Jetty and colleagues, in their new paper.
FPs aged 60 years and older were much less likely to see pediatric patients, compared with those under age 40: odds ratios were 0.52 for children under 5 and 0.56 for children 5-18. Regional variation was even more pronounced: Compared with their colleagues in the Southern states, Midwestern FPs were 1.52 times as likely to treat children aged 5-18 and 2.52 times as likely to treat children under age 5, the investigators reported.
Non-Hispanic Asian and Hispanic family physicians had significantly lower odds of seeing pediatric patients, relative to non-Hispanic White family physicians, as did FPs who were international medical graduates (OR, 0.74), compared with those who trained in the United States, they said.
“Female gender was associated with seeing pediatric patients in a prior study using 2006-2009 [American Board of Family Medicine] data; however, we found no such association in 2017-2018,” Ms. Jetty and associates noted.
“Many diverse drivers likely influence the findings we observed, including organizational, personal, social, and economic factors,” they wrote, suggesting that the policies of some HMOs “may limit scope of practice for employed physicians,” while those who practice in areas of low pediatrician density might “capitalize on a market opportunity ... more than physicians in pediatrician-saturated areas with greater competition for young patients.”
The overall shortage of primary pediatric care may be a matter of debate, the investigators said, but “there is undoubtedly significant variability in the regional supply of pediatric primary care physicians and thus areas where family physicians are needed to meet current pediatric workforce demand.”
The authors reported no conflicts.
according to new research.
This the latest sign of a long-term decline, and it “poses a broader concern for a specialty that defines itself by its comprehensive scope of practice,” said the study investigators of the Robert Graham Center in Washington, D.C., in a written statement. “This is consistent with previous Robert Graham Center research that reported a similar steady decline from 1992 to 2002.”
Self-reported data from family physicians indicate that 84.3% cared for children aged 18 years and under in 2017, compared with 83.0% in 2018, based on a cross-sectional analysis of data gathered from 11,674 family physicians who completed the practice demographic questionnaire attached to the American Board of Family Medicine’s certification exam in 2017 and 2018.
“This current trend is unsettling, because family physicians provide the majority of pediatric care in rural and pediatrically underserved areas of the United States,” study author Anuradha Jetty, MPH, and coauthors said in the statement.
The analysis also offers a snapshot of the current state of pediatric care offered by family physicians. In 2017 and 2018, FPs were more likely to see patients aged 5-18 years than those under age 5 (83.0% vs. 67.0%), with variation by age, location, and race/ethnicity, said Ms. Jetty and colleagues, in their new paper.
FPs aged 60 years and older were much less likely to see pediatric patients, compared with those under age 40: odds ratios were 0.52 for children under 5 and 0.56 for children 5-18. Regional variation was even more pronounced: Compared with their colleagues in the Southern states, Midwestern FPs were 1.52 times as likely to treat children aged 5-18 and 2.52 times as likely to treat children under age 5, the investigators reported.
Non-Hispanic Asian and Hispanic family physicians had significantly lower odds of seeing pediatric patients, relative to non-Hispanic White family physicians, as did FPs who were international medical graduates (OR, 0.74), compared with those who trained in the United States, they said.
“Female gender was associated with seeing pediatric patients in a prior study using 2006-2009 [American Board of Family Medicine] data; however, we found no such association in 2017-2018,” Ms. Jetty and associates noted.
“Many diverse drivers likely influence the findings we observed, including organizational, personal, social, and economic factors,” they wrote, suggesting that the policies of some HMOs “may limit scope of practice for employed physicians,” while those who practice in areas of low pediatrician density might “capitalize on a market opportunity ... more than physicians in pediatrician-saturated areas with greater competition for young patients.”
The overall shortage of primary pediatric care may be a matter of debate, the investigators said, but “there is undoubtedly significant variability in the regional supply of pediatric primary care physicians and thus areas where family physicians are needed to meet current pediatric workforce demand.”
The authors reported no conflicts.
according to new research.
This the latest sign of a long-term decline, and it “poses a broader concern for a specialty that defines itself by its comprehensive scope of practice,” said the study investigators of the Robert Graham Center in Washington, D.C., in a written statement. “This is consistent with previous Robert Graham Center research that reported a similar steady decline from 1992 to 2002.”
Self-reported data from family physicians indicate that 84.3% cared for children aged 18 years and under in 2017, compared with 83.0% in 2018, based on a cross-sectional analysis of data gathered from 11,674 family physicians who completed the practice demographic questionnaire attached to the American Board of Family Medicine’s certification exam in 2017 and 2018.
“This current trend is unsettling, because family physicians provide the majority of pediatric care in rural and pediatrically underserved areas of the United States,” study author Anuradha Jetty, MPH, and coauthors said in the statement.
The analysis also offers a snapshot of the current state of pediatric care offered by family physicians. In 2017 and 2018, FPs were more likely to see patients aged 5-18 years than those under age 5 (83.0% vs. 67.0%), with variation by age, location, and race/ethnicity, said Ms. Jetty and colleagues, in their new paper.
FPs aged 60 years and older were much less likely to see pediatric patients, compared with those under age 40: odds ratios were 0.52 for children under 5 and 0.56 for children 5-18. Regional variation was even more pronounced: Compared with their colleagues in the Southern states, Midwestern FPs were 1.52 times as likely to treat children aged 5-18 and 2.52 times as likely to treat children under age 5, the investigators reported.
Non-Hispanic Asian and Hispanic family physicians had significantly lower odds of seeing pediatric patients, relative to non-Hispanic White family physicians, as did FPs who were international medical graduates (OR, 0.74), compared with those who trained in the United States, they said.
“Female gender was associated with seeing pediatric patients in a prior study using 2006-2009 [American Board of Family Medicine] data; however, we found no such association in 2017-2018,” Ms. Jetty and associates noted.
“Many diverse drivers likely influence the findings we observed, including organizational, personal, social, and economic factors,” they wrote, suggesting that the policies of some HMOs “may limit scope of practice for employed physicians,” while those who practice in areas of low pediatrician density might “capitalize on a market opportunity ... more than physicians in pediatrician-saturated areas with greater competition for young patients.”
The overall shortage of primary pediatric care may be a matter of debate, the investigators said, but “there is undoubtedly significant variability in the regional supply of pediatric primary care physicians and thus areas where family physicians are needed to meet current pediatric workforce demand.”
The authors reported no conflicts.
FROM THE JOURNAL OF THE AMERICAN BOARD OF FAMILY MEDICINE
New child COVID-19 cases decline as total passes 3 million
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.
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.
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.
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.
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.
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.
Don’t fear patients reading their clinical notes: Opinion
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.
What to do if an employee tests positive for COVID-19
An increasingly common question I’m receiving is:
As always, it depends, but here is some general advice: The specifics will vary depending on state/local laws, or your particular situation.
First, you need to determine the level of exposure, and whether it requires action. According to the Centers for Disease Control and Prevention, actionable exposure occurs 2 days prior to the onset of illness, and lasts 10 days after onset.
If action is required, you’ll need to determine who needs to quarantine and who needs to be tested. Vaccinated employees who have been exposed to suspected or confirmed COVID-19 are not required to quarantine or be tested if they are fully vaccinated and have remained asymptomatic since the exposure. Those employees should, however, follow all the usual precautions (masks, social distancing, handwashing, etc.) with increased diligence. Remind them that no vaccine is 100% effective, and suggest they self-monitor for symptoms (fever, cough, shortness of breath, etc.)
All other exposed employees should be tested. A negative test means an individual was not infected at the time the sample was collected, but that does not mean an individual will not get sick later. Some providers are retesting on days 5 and 7 post exposure.
Some experts advise that you monitor exposed employees (vaccinated or not) yourself, with daily temperature readings and inquiries regarding symptoms, and perhaps a daily pulse oximetry check, for 14 days following exposure. Document these screenings in writing. Anyone testing positive or developing a fever or other symptoms should, of course, be sent home and seek medical treatment as necessary.
Employees who develop symptoms or test positive for COVID-19 should remain out of work until all CDC “return-to-work” criteria are met. At this writing, the basic criteria include:
- At least 10 days pass after symptoms first appeared
- At least 24 hours pass after last fever without the use of fever-reducing medications
- Cough, shortness of breath, and any other symptoms improve
Anyone who is significantly immunocompromised may need more time at home, and probably consultation with an infectious disease specialist.
Your facility should be thoroughly cleaned after the exposure. Close off all areas used by the sick individual, and clean and disinfect all areas such as offices, doorknobs, bathrooms, common areas, and shared electronic equipment. Of course, the cleaners should wear gowns, gloves, masks, and goggles. Some practices are hiring cleaning crews to professionally disinfect their offices. Once the area has been disinfected, it can be reopened for use. Workers without close contact with the person who is sick can return to work immediately after disinfection.
If the potential infected area is widespread and cannot be isolated to a room or rooms where doors can be shut, it may be prudent to temporarily close your office, send staff home, and divert patients to other locations if they cannot be rescheduled. Once your facility is cleaned and disinfected and staff have been cleared, your office may reopen.
Use enhanced precautions for any staff or patients who are immunocompromised, or otherwise fall into the high-risk category, to keep them out of the path of potential exposure areas and allow them to self-quarantine if they desire.
You should continue following existing leave policies (paid time off, vacation, sick, short-term disability, leave of absence, Family and Medical Leave Act, and Americans with Disabilities Act). If the employee was exposed at work, contact your workers’ compensation carrier regarding lost wages. Unless your state laws specify otherwise, you are under no obligation to pay beyond your policies, but you may do so if you choose.
Of course, you can take proactive steps to prevent unnecessary exposure and avoid closures in the first place; for example:
- Call patients prior to their visit, or question them upon arrival, regarding fever, shortness of breath, and other COVID-19 symptoms.
- Check employees’ temperatures every morning.
- Check patients’ temperatures as they enter the office.
- Require everyone, patients and employees alike, to wear face coverings.
- Ask patients to leave friends and family members at home.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
An increasingly common question I’m receiving is:
As always, it depends, but here is some general advice: The specifics will vary depending on state/local laws, or your particular situation.
First, you need to determine the level of exposure, and whether it requires action. According to the Centers for Disease Control and Prevention, actionable exposure occurs 2 days prior to the onset of illness, and lasts 10 days after onset.
If action is required, you’ll need to determine who needs to quarantine and who needs to be tested. Vaccinated employees who have been exposed to suspected or confirmed COVID-19 are not required to quarantine or be tested if they are fully vaccinated and have remained asymptomatic since the exposure. Those employees should, however, follow all the usual precautions (masks, social distancing, handwashing, etc.) with increased diligence. Remind them that no vaccine is 100% effective, and suggest they self-monitor for symptoms (fever, cough, shortness of breath, etc.)
All other exposed employees should be tested. A negative test means an individual was not infected at the time the sample was collected, but that does not mean an individual will not get sick later. Some providers are retesting on days 5 and 7 post exposure.
Some experts advise that you monitor exposed employees (vaccinated or not) yourself, with daily temperature readings and inquiries regarding symptoms, and perhaps a daily pulse oximetry check, for 14 days following exposure. Document these screenings in writing. Anyone testing positive or developing a fever or other symptoms should, of course, be sent home and seek medical treatment as necessary.
Employees who develop symptoms or test positive for COVID-19 should remain out of work until all CDC “return-to-work” criteria are met. At this writing, the basic criteria include:
- At least 10 days pass after symptoms first appeared
- At least 24 hours pass after last fever without the use of fever-reducing medications
- Cough, shortness of breath, and any other symptoms improve
Anyone who is significantly immunocompromised may need more time at home, and probably consultation with an infectious disease specialist.
Your facility should be thoroughly cleaned after the exposure. Close off all areas used by the sick individual, and clean and disinfect all areas such as offices, doorknobs, bathrooms, common areas, and shared electronic equipment. Of course, the cleaners should wear gowns, gloves, masks, and goggles. Some practices are hiring cleaning crews to professionally disinfect their offices. Once the area has been disinfected, it can be reopened for use. Workers without close contact with the person who is sick can return to work immediately after disinfection.
If the potential infected area is widespread and cannot be isolated to a room or rooms where doors can be shut, it may be prudent to temporarily close your office, send staff home, and divert patients to other locations if they cannot be rescheduled. Once your facility is cleaned and disinfected and staff have been cleared, your office may reopen.
Use enhanced precautions for any staff or patients who are immunocompromised, or otherwise fall into the high-risk category, to keep them out of the path of potential exposure areas and allow them to self-quarantine if they desire.
You should continue following existing leave policies (paid time off, vacation, sick, short-term disability, leave of absence, Family and Medical Leave Act, and Americans with Disabilities Act). If the employee was exposed at work, contact your workers’ compensation carrier regarding lost wages. Unless your state laws specify otherwise, you are under no obligation to pay beyond your policies, but you may do so if you choose.
Of course, you can take proactive steps to prevent unnecessary exposure and avoid closures in the first place; for example:
- Call patients prior to their visit, or question them upon arrival, regarding fever, shortness of breath, and other COVID-19 symptoms.
- Check employees’ temperatures every morning.
- Check patients’ temperatures as they enter the office.
- Require everyone, patients and employees alike, to wear face coverings.
- Ask patients to leave friends and family members at home.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
An increasingly common question I’m receiving is:
As always, it depends, but here is some general advice: The specifics will vary depending on state/local laws, or your particular situation.
First, you need to determine the level of exposure, and whether it requires action. According to the Centers for Disease Control and Prevention, actionable exposure occurs 2 days prior to the onset of illness, and lasts 10 days after onset.
If action is required, you’ll need to determine who needs to quarantine and who needs to be tested. Vaccinated employees who have been exposed to suspected or confirmed COVID-19 are not required to quarantine or be tested if they are fully vaccinated and have remained asymptomatic since the exposure. Those employees should, however, follow all the usual precautions (masks, social distancing, handwashing, etc.) with increased diligence. Remind them that no vaccine is 100% effective, and suggest they self-monitor for symptoms (fever, cough, shortness of breath, etc.)
All other exposed employees should be tested. A negative test means an individual was not infected at the time the sample was collected, but that does not mean an individual will not get sick later. Some providers are retesting on days 5 and 7 post exposure.
Some experts advise that you monitor exposed employees (vaccinated or not) yourself, with daily temperature readings and inquiries regarding symptoms, and perhaps a daily pulse oximetry check, for 14 days following exposure. Document these screenings in writing. Anyone testing positive or developing a fever or other symptoms should, of course, be sent home and seek medical treatment as necessary.
Employees who develop symptoms or test positive for COVID-19 should remain out of work until all CDC “return-to-work” criteria are met. At this writing, the basic criteria include:
- At least 10 days pass after symptoms first appeared
- At least 24 hours pass after last fever without the use of fever-reducing medications
- Cough, shortness of breath, and any other symptoms improve
Anyone who is significantly immunocompromised may need more time at home, and probably consultation with an infectious disease specialist.
Your facility should be thoroughly cleaned after the exposure. Close off all areas used by the sick individual, and clean and disinfect all areas such as offices, doorknobs, bathrooms, common areas, and shared electronic equipment. Of course, the cleaners should wear gowns, gloves, masks, and goggles. Some practices are hiring cleaning crews to professionally disinfect their offices. Once the area has been disinfected, it can be reopened for use. Workers without close contact with the person who is sick can return to work immediately after disinfection.
If the potential infected area is widespread and cannot be isolated to a room or rooms where doors can be shut, it may be prudent to temporarily close your office, send staff home, and divert patients to other locations if they cannot be rescheduled. Once your facility is cleaned and disinfected and staff have been cleared, your office may reopen.
Use enhanced precautions for any staff or patients who are immunocompromised, or otherwise fall into the high-risk category, to keep them out of the path of potential exposure areas and allow them to self-quarantine if they desire.
You should continue following existing leave policies (paid time off, vacation, sick, short-term disability, leave of absence, Family and Medical Leave Act, and Americans with Disabilities Act). If the employee was exposed at work, contact your workers’ compensation carrier regarding lost wages. Unless your state laws specify otherwise, you are under no obligation to pay beyond your policies, but you may do so if you choose.
Of course, you can take proactive steps to prevent unnecessary exposure and avoid closures in the first place; for example:
- Call patients prior to their visit, or question them upon arrival, regarding fever, shortness of breath, and other COVID-19 symptoms.
- Check employees’ temperatures every morning.
- Check patients’ temperatures as they enter the office.
- Require everyone, patients and employees alike, to wear face coverings.
- Ask patients to leave friends and family members at home.
Dr. Eastern practices dermatology and dermatologic surgery in Belleville, N.J. He is the author of numerous articles and textbook chapters, and is a long-time monthly columnist for Dermatology News. Write to him at dermnews@mdedge.com.
One-third of health care workers leery of getting COVID-19 vaccine, survey shows
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.
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.
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.
Prospective data support delaying antibiotics for pediatric respiratory infections
For pediatric patients with respiratory tract infections (RTIs), immediately prescribing antibiotics may do more harm than good, based on prospective data from 436 children treated by primary care pediatricians in Spain.
In the largest trial of its kind to date, children who were immediately prescribed antibiotics showed no significant difference in symptom severity or duration from those who received a delayed prescription for antibiotics, or no prescription at all; yet those in the immediate-prescription group had a higher rate of gastrointestinal adverse events, reported lead author Gemma Mas-Dalmau, MD, of the Sant Pau Institute for Biomedical Research, Barcelona, and colleagues.
“Most RTIs are self-limiting, and antibiotics hardly alter the course of the condition, yet antibiotics are frequently prescribed for these conditions,” the investigators wrote in Pediatrics. “Antibiotic prescription for RTIs in children is especially considered to be inappropriately high.”
This clinical behavior is driven by several factors, according to Dr. Mas-Dalmau and colleagues, including limited diagnostics in primary care, pressure to meet parental expectations, and concern for possible complications if antibiotics are withheld or delayed.
In an accompanying editorial, Jeffrey S. Gerber, MD, PhD and Bonnie F. Offit, MD, of Children’s Hospital of Philadelphia, noted that “children in the United States receive more than one antibiotic prescription per year, driven largely by acute RTIs.”
Dr. Gerber and Dr. Offit noted that some RTIs are indeed caused by bacteria, and therefore benefit from antibiotics, but it’s “not always easy” to identify these cases.
“Primary care, urgent care, and emergency medicine clinicians have a hard job,” they wrote.
According to the Centers for Disease Control and Prevention, delayed prescription of antibiotics, in which a prescription is filled upon persistence or worsening of symptoms, can balance clinical caution and antibiotic stewardship.
“An example of this approach is acute otitis media, in which delayed prescribing has been shown to safely reduce antibiotic exposure,” wrote Dr. Gerber and Dr. Offit.
In a 2017 Cochrane systematic review of both adults and children with RTIs, antibiotic prescriptions, whether immediate, delayed, or not given at all, had no significant effect on most symptoms or complications. Although several randomized trials have evaluated delayed antibiotic prescriptions in children, Dr. Mas-Dalmau and colleagues described the current body of evidence as “scant.”
The present study built upon this knowledge base by prospectively following 436 children treated at 39 primary care centers in Spain from 2012 to 2016. Patients were between 2 and 14 years of age and presented for rhinosinusitis, pharyngitis, acute otitis media, or acute bronchitis. Inclusion in the study required the pediatrician to have “reasonable doubts about the need to prescribe an antibiotic.” Clinics with access to rapid streptococcal testing did not enroll patients with pharyngitis.
Patients were randomized in approximately equal groups to receive either immediate prescription of antibiotics, delayed prescription, or no prescription. In the delayed group, caregivers were advised to fill prescriptions if any of following three events occurred:
- No symptom improvement after a certain amount of days, depending on presenting complaint (acute otitis media, 4 days; pharyngitis, 7 days; acute rhinosinusitis, 15 days; acute bronchitis, 20 days).
- Temperature of at least 39° C after 24 hours, or at least 38° C but less than 39° C after 48 hours.
- Patient feeling “much worse.”
Primary outcomes were severity and duration of symptoms over 30 days, while secondary outcomes included antibiotic use over 30 days, additional unscheduled visits to primary care over 30 days, and parental satisfaction and beliefs regarding antibiotic efficacy.
In the final dataset, 148 patients received immediate antibiotic prescriptions, while 146 received delayed prescriptions, and 142 received no prescription. Rate of antibiotic use was highest in the immediate prescription group, at 96%, versus 25.3% in the delayed group and 12% among those who received no prescription upon first presentation (P < .001).
Although the mean duration of severe symptoms was longest in the delayed-prescription group, at 12.4 days, versus 10.9 days in the no-prescription group and 10.1 days in the immediate-prescription group, these differences were not statistically significant (P = .539). Median score for greatest severity of any symptom was also similar across groups. Secondary outcomes echoed this pattern, in which reconsultation rates and caregiver satisfaction were statistically similar regardless of treatment type.
In contrast, patients who received immediate antibiotic prescriptions had a significantly higher rate of gastrointestinal adverse events (8.8%) than those who received a delayed prescription (3.4%) or no prescription (2.8%; P = .037).
“Delayed antibiotic prescription is an efficacious and safe strategy for reducing inappropriate antibiotic treatment of uncomplicated RTIs in children when the doctor has reasonable doubts regarding the indication,” the investigators concluded. “[It] is therefore a useful tool for addressing the public health issue of bacterial resistance. However, no antibiotic prescription remains the recommended strategy when it is clear that antibiotics are not indicated, like in most cases of acute bronchitis.”
“These data are reassuring,” wrote Dr. Gerber and Dr. Offit; however, they went on to suggest that the data “might not substantially move the needle.”
“With rare exceptions, children with acute pharyngitis should first receive a group A streptococcal test,” they wrote. “If results are positive, all patients should get antibiotics; if results are negative, no one gets them. Acute bronchitis (whatever that is in children) is viral. Acute sinusitis with persistent symptoms (the most commonly diagnosed variety) already has a delayed option, and the current study ... was not powered for this outcome. We are left with acute otitis media, which dominated enrollment but already has an evidence-based guideline.”
Still, Dr. Gerber and Dr. Offit suggested that the findings should further encourage pediatricians to prescribe antibiotics judiciously, and when elected, to choose the shortest duration and narrowest spectrum possible.
In a joint comment, Rana El Feghaly, MD, MSCI, director of outpatient antibiotic stewardship at Children’s Mercy, Kansas City, and her colleague, Mary Anne Jackson, MD, noted that the findings are “in accordance” with the 2017 Cochrane review.
Dr. Feghaly and Dr. Jackson said that these new data provide greater support for conservative use of antibiotics, which is badly needed, considering approximately 50% of outpatient prescriptions are unnecessary or inappropriate .
Delayed antibiotic prescription is part of a multifaceted approach to the issue, they said, joining “communication skills training, antibiotic justification documentation, audit and feedback reporting with peer comparison, diagnostic stewardship, [and] the use of clinician education on practice-based guidelines.”
“Leveraging delayed antibiotic prescription may be an excellent way to combat antibiotic overuse in the outpatient setting, while avoiding provider and parental fear of the ‘no antibiotic’ approach,” Dr. Feghaly and Dr. Jackson said.
Karlyn Kinsella, MD, of Pediatric Associates of Cheshire, Conn., suggested that clinicians discuss these findings with parents who request antibiotics for “otitis, pharyngitis, bronchitis, or sinusitis.”
“We can cite this study that antibiotics have no effect on symptom duration or severity for these illnesses,” Dr. Kinsella said. “Of course, our clinical opinion in each case takes precedent.”
According to Dr. Kinsella, conversations with parents also need to cover reasonable expectations, as the study did, with clear time frames for each condition in which children should start to get better.
“I think this is really key in our anticipatory guidance so that patients know what to expect,” she said.
The study was funded by Instituto de Salud Carlos III, the European Union, and the Spanish Ministry of Health, Social Services, and Equality. The investigators and interviewees reported no conflicts of interest.
For pediatric patients with respiratory tract infections (RTIs), immediately prescribing antibiotics may do more harm than good, based on prospective data from 436 children treated by primary care pediatricians in Spain.
In the largest trial of its kind to date, children who were immediately prescribed antibiotics showed no significant difference in symptom severity or duration from those who received a delayed prescription for antibiotics, or no prescription at all; yet those in the immediate-prescription group had a higher rate of gastrointestinal adverse events, reported lead author Gemma Mas-Dalmau, MD, of the Sant Pau Institute for Biomedical Research, Barcelona, and colleagues.
“Most RTIs are self-limiting, and antibiotics hardly alter the course of the condition, yet antibiotics are frequently prescribed for these conditions,” the investigators wrote in Pediatrics. “Antibiotic prescription for RTIs in children is especially considered to be inappropriately high.”
This clinical behavior is driven by several factors, according to Dr. Mas-Dalmau and colleagues, including limited diagnostics in primary care, pressure to meet parental expectations, and concern for possible complications if antibiotics are withheld or delayed.
In an accompanying editorial, Jeffrey S. Gerber, MD, PhD and Bonnie F. Offit, MD, of Children’s Hospital of Philadelphia, noted that “children in the United States receive more than one antibiotic prescription per year, driven largely by acute RTIs.”
Dr. Gerber and Dr. Offit noted that some RTIs are indeed caused by bacteria, and therefore benefit from antibiotics, but it’s “not always easy” to identify these cases.
“Primary care, urgent care, and emergency medicine clinicians have a hard job,” they wrote.
According to the Centers for Disease Control and Prevention, delayed prescription of antibiotics, in which a prescription is filled upon persistence or worsening of symptoms, can balance clinical caution and antibiotic stewardship.
“An example of this approach is acute otitis media, in which delayed prescribing has been shown to safely reduce antibiotic exposure,” wrote Dr. Gerber and Dr. Offit.
In a 2017 Cochrane systematic review of both adults and children with RTIs, antibiotic prescriptions, whether immediate, delayed, or not given at all, had no significant effect on most symptoms or complications. Although several randomized trials have evaluated delayed antibiotic prescriptions in children, Dr. Mas-Dalmau and colleagues described the current body of evidence as “scant.”
The present study built upon this knowledge base by prospectively following 436 children treated at 39 primary care centers in Spain from 2012 to 2016. Patients were between 2 and 14 years of age and presented for rhinosinusitis, pharyngitis, acute otitis media, or acute bronchitis. Inclusion in the study required the pediatrician to have “reasonable doubts about the need to prescribe an antibiotic.” Clinics with access to rapid streptococcal testing did not enroll patients with pharyngitis.
Patients were randomized in approximately equal groups to receive either immediate prescription of antibiotics, delayed prescription, or no prescription. In the delayed group, caregivers were advised to fill prescriptions if any of following three events occurred:
- No symptom improvement after a certain amount of days, depending on presenting complaint (acute otitis media, 4 days; pharyngitis, 7 days; acute rhinosinusitis, 15 days; acute bronchitis, 20 days).
- Temperature of at least 39° C after 24 hours, or at least 38° C but less than 39° C after 48 hours.
- Patient feeling “much worse.”
Primary outcomes were severity and duration of symptoms over 30 days, while secondary outcomes included antibiotic use over 30 days, additional unscheduled visits to primary care over 30 days, and parental satisfaction and beliefs regarding antibiotic efficacy.
In the final dataset, 148 patients received immediate antibiotic prescriptions, while 146 received delayed prescriptions, and 142 received no prescription. Rate of antibiotic use was highest in the immediate prescription group, at 96%, versus 25.3% in the delayed group and 12% among those who received no prescription upon first presentation (P < .001).
Although the mean duration of severe symptoms was longest in the delayed-prescription group, at 12.4 days, versus 10.9 days in the no-prescription group and 10.1 days in the immediate-prescription group, these differences were not statistically significant (P = .539). Median score for greatest severity of any symptom was also similar across groups. Secondary outcomes echoed this pattern, in which reconsultation rates and caregiver satisfaction were statistically similar regardless of treatment type.
In contrast, patients who received immediate antibiotic prescriptions had a significantly higher rate of gastrointestinal adverse events (8.8%) than those who received a delayed prescription (3.4%) or no prescription (2.8%; P = .037).
“Delayed antibiotic prescription is an efficacious and safe strategy for reducing inappropriate antibiotic treatment of uncomplicated RTIs in children when the doctor has reasonable doubts regarding the indication,” the investigators concluded. “[It] is therefore a useful tool for addressing the public health issue of bacterial resistance. However, no antibiotic prescription remains the recommended strategy when it is clear that antibiotics are not indicated, like in most cases of acute bronchitis.”
“These data are reassuring,” wrote Dr. Gerber and Dr. Offit; however, they went on to suggest that the data “might not substantially move the needle.”
“With rare exceptions, children with acute pharyngitis should first receive a group A streptococcal test,” they wrote. “If results are positive, all patients should get antibiotics; if results are negative, no one gets them. Acute bronchitis (whatever that is in children) is viral. Acute sinusitis with persistent symptoms (the most commonly diagnosed variety) already has a delayed option, and the current study ... was not powered for this outcome. We are left with acute otitis media, which dominated enrollment but already has an evidence-based guideline.”
Still, Dr. Gerber and Dr. Offit suggested that the findings should further encourage pediatricians to prescribe antibiotics judiciously, and when elected, to choose the shortest duration and narrowest spectrum possible.
In a joint comment, Rana El Feghaly, MD, MSCI, director of outpatient antibiotic stewardship at Children’s Mercy, Kansas City, and her colleague, Mary Anne Jackson, MD, noted that the findings are “in accordance” with the 2017 Cochrane review.
Dr. Feghaly and Dr. Jackson said that these new data provide greater support for conservative use of antibiotics, which is badly needed, considering approximately 50% of outpatient prescriptions are unnecessary or inappropriate .
Delayed antibiotic prescription is part of a multifaceted approach to the issue, they said, joining “communication skills training, antibiotic justification documentation, audit and feedback reporting with peer comparison, diagnostic stewardship, [and] the use of clinician education on practice-based guidelines.”
“Leveraging delayed antibiotic prescription may be an excellent way to combat antibiotic overuse in the outpatient setting, while avoiding provider and parental fear of the ‘no antibiotic’ approach,” Dr. Feghaly and Dr. Jackson said.
Karlyn Kinsella, MD, of Pediatric Associates of Cheshire, Conn., suggested that clinicians discuss these findings with parents who request antibiotics for “otitis, pharyngitis, bronchitis, or sinusitis.”
“We can cite this study that antibiotics have no effect on symptom duration or severity for these illnesses,” Dr. Kinsella said. “Of course, our clinical opinion in each case takes precedent.”
According to Dr. Kinsella, conversations with parents also need to cover reasonable expectations, as the study did, with clear time frames for each condition in which children should start to get better.
“I think this is really key in our anticipatory guidance so that patients know what to expect,” she said.
The study was funded by Instituto de Salud Carlos III, the European Union, and the Spanish Ministry of Health, Social Services, and Equality. The investigators and interviewees reported no conflicts of interest.
For pediatric patients with respiratory tract infections (RTIs), immediately prescribing antibiotics may do more harm than good, based on prospective data from 436 children treated by primary care pediatricians in Spain.
In the largest trial of its kind to date, children who were immediately prescribed antibiotics showed no significant difference in symptom severity or duration from those who received a delayed prescription for antibiotics, or no prescription at all; yet those in the immediate-prescription group had a higher rate of gastrointestinal adverse events, reported lead author Gemma Mas-Dalmau, MD, of the Sant Pau Institute for Biomedical Research, Barcelona, and colleagues.
“Most RTIs are self-limiting, and antibiotics hardly alter the course of the condition, yet antibiotics are frequently prescribed for these conditions,” the investigators wrote in Pediatrics. “Antibiotic prescription for RTIs in children is especially considered to be inappropriately high.”
This clinical behavior is driven by several factors, according to Dr. Mas-Dalmau and colleagues, including limited diagnostics in primary care, pressure to meet parental expectations, and concern for possible complications if antibiotics are withheld or delayed.
In an accompanying editorial, Jeffrey S. Gerber, MD, PhD and Bonnie F. Offit, MD, of Children’s Hospital of Philadelphia, noted that “children in the United States receive more than one antibiotic prescription per year, driven largely by acute RTIs.”
Dr. Gerber and Dr. Offit noted that some RTIs are indeed caused by bacteria, and therefore benefit from antibiotics, but it’s “not always easy” to identify these cases.
“Primary care, urgent care, and emergency medicine clinicians have a hard job,” they wrote.
According to the Centers for Disease Control and Prevention, delayed prescription of antibiotics, in which a prescription is filled upon persistence or worsening of symptoms, can balance clinical caution and antibiotic stewardship.
“An example of this approach is acute otitis media, in which delayed prescribing has been shown to safely reduce antibiotic exposure,” wrote Dr. Gerber and Dr. Offit.
In a 2017 Cochrane systematic review of both adults and children with RTIs, antibiotic prescriptions, whether immediate, delayed, or not given at all, had no significant effect on most symptoms or complications. Although several randomized trials have evaluated delayed antibiotic prescriptions in children, Dr. Mas-Dalmau and colleagues described the current body of evidence as “scant.”
The present study built upon this knowledge base by prospectively following 436 children treated at 39 primary care centers in Spain from 2012 to 2016. Patients were between 2 and 14 years of age and presented for rhinosinusitis, pharyngitis, acute otitis media, or acute bronchitis. Inclusion in the study required the pediatrician to have “reasonable doubts about the need to prescribe an antibiotic.” Clinics with access to rapid streptococcal testing did not enroll patients with pharyngitis.
Patients were randomized in approximately equal groups to receive either immediate prescription of antibiotics, delayed prescription, or no prescription. In the delayed group, caregivers were advised to fill prescriptions if any of following three events occurred:
- No symptom improvement after a certain amount of days, depending on presenting complaint (acute otitis media, 4 days; pharyngitis, 7 days; acute rhinosinusitis, 15 days; acute bronchitis, 20 days).
- Temperature of at least 39° C after 24 hours, or at least 38° C but less than 39° C after 48 hours.
- Patient feeling “much worse.”
Primary outcomes were severity and duration of symptoms over 30 days, while secondary outcomes included antibiotic use over 30 days, additional unscheduled visits to primary care over 30 days, and parental satisfaction and beliefs regarding antibiotic efficacy.
In the final dataset, 148 patients received immediate antibiotic prescriptions, while 146 received delayed prescriptions, and 142 received no prescription. Rate of antibiotic use was highest in the immediate prescription group, at 96%, versus 25.3% in the delayed group and 12% among those who received no prescription upon first presentation (P < .001).
Although the mean duration of severe symptoms was longest in the delayed-prescription group, at 12.4 days, versus 10.9 days in the no-prescription group and 10.1 days in the immediate-prescription group, these differences were not statistically significant (P = .539). Median score for greatest severity of any symptom was also similar across groups. Secondary outcomes echoed this pattern, in which reconsultation rates and caregiver satisfaction were statistically similar regardless of treatment type.
In contrast, patients who received immediate antibiotic prescriptions had a significantly higher rate of gastrointestinal adverse events (8.8%) than those who received a delayed prescription (3.4%) or no prescription (2.8%; P = .037).
“Delayed antibiotic prescription is an efficacious and safe strategy for reducing inappropriate antibiotic treatment of uncomplicated RTIs in children when the doctor has reasonable doubts regarding the indication,” the investigators concluded. “[It] is therefore a useful tool for addressing the public health issue of bacterial resistance. However, no antibiotic prescription remains the recommended strategy when it is clear that antibiotics are not indicated, like in most cases of acute bronchitis.”
“These data are reassuring,” wrote Dr. Gerber and Dr. Offit; however, they went on to suggest that the data “might not substantially move the needle.”
“With rare exceptions, children with acute pharyngitis should first receive a group A streptococcal test,” they wrote. “If results are positive, all patients should get antibiotics; if results are negative, no one gets them. Acute bronchitis (whatever that is in children) is viral. Acute sinusitis with persistent symptoms (the most commonly diagnosed variety) already has a delayed option, and the current study ... was not powered for this outcome. We are left with acute otitis media, which dominated enrollment but already has an evidence-based guideline.”
Still, Dr. Gerber and Dr. Offit suggested that the findings should further encourage pediatricians to prescribe antibiotics judiciously, and when elected, to choose the shortest duration and narrowest spectrum possible.
In a joint comment, Rana El Feghaly, MD, MSCI, director of outpatient antibiotic stewardship at Children’s Mercy, Kansas City, and her colleague, Mary Anne Jackson, MD, noted that the findings are “in accordance” with the 2017 Cochrane review.
Dr. Feghaly and Dr. Jackson said that these new data provide greater support for conservative use of antibiotics, which is badly needed, considering approximately 50% of outpatient prescriptions are unnecessary or inappropriate .
Delayed antibiotic prescription is part of a multifaceted approach to the issue, they said, joining “communication skills training, antibiotic justification documentation, audit and feedback reporting with peer comparison, diagnostic stewardship, [and] the use of clinician education on practice-based guidelines.”
“Leveraging delayed antibiotic prescription may be an excellent way to combat antibiotic overuse in the outpatient setting, while avoiding provider and parental fear of the ‘no antibiotic’ approach,” Dr. Feghaly and Dr. Jackson said.
Karlyn Kinsella, MD, of Pediatric Associates of Cheshire, Conn., suggested that clinicians discuss these findings with parents who request antibiotics for “otitis, pharyngitis, bronchitis, or sinusitis.”
“We can cite this study that antibiotics have no effect on symptom duration or severity for these illnesses,” Dr. Kinsella said. “Of course, our clinical opinion in each case takes precedent.”
According to Dr. Kinsella, conversations with parents also need to cover reasonable expectations, as the study did, with clear time frames for each condition in which children should start to get better.
“I think this is really key in our anticipatory guidance so that patients know what to expect,” she said.
The study was funded by Instituto de Salud Carlos III, the European Union, and the Spanish Ministry of Health, Social Services, and Equality. The investigators and interviewees reported no conflicts of interest.
FROM PEDIATRICS
Zika vaccine candidate shows promise in phase 1 trial
in a phase 1 study.
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.
in a phase 1 study.
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.
in a phase 1 study.
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.
FROM ANNALS OF INTERNAL MEDICINE