MDedge Pediatrics

Two recent observational studies suggest that myocarditis, at least on cardiac magnetic resonance (CMR) imaging, might be far less common in elite-level athletes recovering from COVID-19 than suggested in influential earlier reports.

AlexLMX/Getty Images

Both new studies documented a rate less than one-quarter as high as those previously reported from smaller cohorts, raising questions about the diagnostic yield of CMR in highly conditioned athletes with recent COVID-19 absent other evidence, such as from biomarker assays or electrocardiography (ECG).

That could have implications for some top-tier university athletics programs that mandate CMR imaging, biomarker assays, and other evaluations for myocarditis on all their players who test positive for SARS-CoV-2 before they can return to play.

The findings collectively point to CMR imaging features that might be a hallmark of an athlete’s heart, characterized by normal myocardial remodeling brought on by elite-level exercise training, which in athletes with recent COVID-19 could be misinterpreted as evidence of myocarditis. That may have thrown off prevalence estimates in the literature, the studies’ investigators speculated.

The two studies were retrospective takes on university athletes who underwent CMR imaging while recovering from COVID-19, who were either asymptomatic or with only mild to moderate symptoms and were generally without ECG or troponin evidence of myocarditis.

One of them showed a less than 2% incidence of myocarditis by CMR among 145 such cases, a low yield for imaging that is “raising doubt regarding its utility to evaluate athletes without a clinical presentation or abnormal ancillary tests to support the diagnosis of myocarditis,” argues a report published Jan. 14 in JAMA Cardiology, with lead author Jitka Starekova, MD, University of Wisconsin – Madison.

“Part of the problem is that occult myocarditis is, at least with other viruses, a risk factor for sudden death in competitive athletes. So you don’t want to let one slip through the cracks,” senior author Scott B. Reeder, MD, PhD, from the same institution, said in an interview.

Whether a policy of routine CMR imaging in elite athletes who test positive for the new coronavirus is better than more selective use driven by symptoms or other screening tests is unknown. But the more pressing issue, Dr. Reeder said, “is if they have a normal electrocardiogram and troponins, do they still need cardiac magnetic resonance imaging?”

The current study, he said, “certainly provides helpful evidence that maybe we don’t need as many.”

The other study, which featured two control groups, saw a similarly low incidence of myocarditis by CMR in athletes with recent COVID-19. One of the control groups included university athletes imaged prior to the advent of SARS-CoV-2 in the university’s region of the country. The other consisted of apparently healthy adult nonathletes.

Armed with two non-COVID-19 cohorts and two athlete cohorts, the researchers found comparable rates of myocarditis by CMR in both the COVID-19 athletes and the healthy athletes. And only 3% of the COVID-19 athletes had the tell-tale CMR signs, notes the report, published Dec. 17 in Circulation, with lead author Daniel E. Clark, MD, MPH, Vanderbilt University Medical Center, Nashville, Tenn.
 

Reassurance and concern

“The incidence is much lower than we feared, and so that’s reassuring,” Clark said in an interview. Still, the athletes with myocarditis by CMR “would have been completely missed by a protocol that did not include cardiac MR, and that’s concerning,” he said. “Both had active myocarditis.”

The study’s two non-COVID-19 control groups – elite athletes in one and nonathletes in the other – allowed them to tease out the potential contribution of athletic myocardial remodeling to CMR features that could be interpreted as scar tissue, which are characterized by late gadolinium enhancement (LGE).

As it turned out, focal regions of LGE located in the right ventricular (RV) septum on the scans were often seen in both athlete cohorts. “This kind of trivial nonischemic fibrosis in the mid RV septal insertion site was common among athletic control subjects. It was seen in 24% of them, which is almost identical to the percentage that we saw in the COVID-19 athletes, 22%,” Dr. Clark said.

The LGE finding, wrote Dr. Clark and coauthors, “may represent remodeling from athletic training, and should not be conflated with myocarditis.”

Of note, the other study saw a comparable incidence of the same or a very similar CMR feature in its athletes; 26% of the Wisconsin COVID-19 athlete cohort showed limited focal LGE in the inferior RV insertion site.

“And you get a little bit in the mid-septum, as well,” Dr. Reeder said. But the sign, in the absence of any corresponding T2 abnormalities, was not judged to represent myocarditis. “We interpreted all of these studies with this potential confounder in mind.”

Conceivably, Dr. Reeder proposed, the earlier studies may have “over-called” the prevalence of myocarditis in their cohorts. “I haven’t seen their images, but it’s possible there could be false-positives.”

It’s noteworthy that the Vanderbilt and Wisconsin reports saw closely similar incidences of the tell-tale CMR sign in all the athlete cohorts whether or not COVID-19 was involved, Aaron L. Baggish, MD, Massachusetts General Hospital, Boston, said in an interview.

“It looks very much like just an unrecognized part of athletic remodeling and isn’t in any way, shape, or form implicated as being a COVID-related issue,” said Dr. Baggish, who directs the cardiovascular performance program at his center and is unaffiliated with either study.

Still, that connection remains unproven given how little is yet known about the prevalence of clinically important myocarditis in milder cases of COVID-19, according to an accompanying editorial from Jonathan H. Kim, MD, MSc.

Although isolated LGE at the interventricular RV insertion site is “more commonly described among masters-level endurance athletes, the clinical significance and prevalence of this finding in youthful athletes is uncertain and should not be assumed to be a normal consequence of intense athletic training in young competitive athletes,” argued Dr. Kim, of Emory University, Atlanta.

There’s probably little about being a young competitive athlete that would render a person any more or less prone to COVID-19 cardiac involvement, Dr. Baggish said. Rather, “I think what we’re seeing, as the studies continue to come out, is that prevalence estimates are getting into the low single digits.”

The estimates are similar to those associated with influenza before the COVID-19 age; about 2% of patients showed cardiac involvement, Dr. Baggish said. “So the degree to which COVID is a special virus from this perspective, I think, is still a topic of some debate.”

The two current studies have limitations and neither is positioned to change practice, he said. “I would say that they are both kind of important, reassuring pieces of an unfinished jigsaw puzzle. But we still don’t know what the picture on the puzzle is.”
 

Routine CMR for positive cases

The University of Wisconsin group looked at all of the institution’s competitive athletes who underwent gadolinium-enhanced CMR imaging and other tests during recovery from COVID-19 from the beginning of the pandemic to the end of November 2020.

The imaging was performed on average about 2 weeks after a first positive SARS-CoV-2 assay result. About one-half and one-fourth of the cohort had experienced mild and moderate symptoms, respectively, and about 17% were asymptomatic; none had been hospitalized.

All CMR scans were reviewed by two experienced radiologists for, among other things, evidence of myocarditis according to modified Lake Louise criteria, the group wrote. Those criteria are based on CMR markers of fibrosis and other characteristics of scarring from myocarditis.

Such evidence was seen in only two members of the cohort, or 1.4%, one with elevated troponins but normal with respect to other biomarkers, and the other negative for all assays. Both were asymptomatic at the time of imaging, the report noted.

The Vanderbilt analysis from Dr. Clark and associates centered on 59 university athletes recently with COVID-19 who underwent CMR imaging along with other tests about 3 weeks after confirmation of SARS-CoV-2 infection. Symptoms had been mild in 78% of the group, and the remainder were asymptomatic.

They were compared with 60 retrospectively identified college athletes and elite-conditioned military personnel who had undergone CMR imaging prior to the advent of COVID-19, and to 27 apparently healthy nonathlete adults in whom CMR had been previously performed to define normal CMR imaging criteria at that center.

The only two post-COVID-19 athletes who met modified Lake Louise criteria for myocarditis showed no abnormalities on ECG or myocardial strain echocardiography, and had normal troponins, the group reported.

The COVID-19 athletes showed increased cardiac chamber volumes and myocardial mass “consistent with athletic remodeling,” compared with the healthy control subjects, the group wrote. But “most standard CMR parameters were similar” between the COVID-19 athletes and the control athletes, consistent with the 22% and 24% rates, respectively, for the finding of focal late LGE isolated to the inferoseptal RV insertion site.

At the end of the day, all published experiences on athletes with recent COVID-19 “are descriptive studies, without any hint of follow-up,” Dr. Baggish noted, so their clinical implications are unknown.

“We need time to sit and watch to see what happens to these individuals,” he said. “And if the answer is nothing, then that’s a very reassuring story. If the answer is that we start to see events, then that’s really important for us to take stock of.”

Dr. Starekova had no disclosures. Dr. Reeder reports that the University of Wisconsin receives research support from GE Healthcare and Bracco Diagnostics; and that he has ownership interests in Calimetrix, Reveal Pharmaceuticals, Cellectar Biosciences, Elucent Medical, and HeartVista; and has received grant support from Bayer Healthcare. Disclosures for the other coauthors are in the report. Dr. Clark and coauthors had no disclosures. Dr. Baggish reported no conflicts. Kim discloses receiving funding from the National Heart, Lung, and Blood Institute; compensation as team cardiologist for the Atlanta Falcons; and research stipends from the Atlanta Track Club.

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

Two recent observational studies suggest that myocarditis, at least on cardiac magnetic resonance (CMR) imaging, might be far less common in elite-level athletes recovering from COVID-19 than suggested in influential earlier reports.

AlexLMX/Getty Images

Both new studies documented a rate less than one-quarter as high as those previously reported from smaller cohorts, raising questions about the diagnostic yield of CMR in highly conditioned athletes with recent COVID-19 absent other evidence, such as from biomarker assays or electrocardiography (ECG).

That could have implications for some top-tier university athletics programs that mandate CMR imaging, biomarker assays, and other evaluations for myocarditis on all their players who test positive for SARS-CoV-2 before they can return to play.

The findings collectively point to CMR imaging features that might be a hallmark of an athlete’s heart, characterized by normal myocardial remodeling brought on by elite-level exercise training, which in athletes with recent COVID-19 could be misinterpreted as evidence of myocarditis. That may have thrown off prevalence estimates in the literature, the studies’ investigators speculated.

The two studies were retrospective takes on university athletes who underwent CMR imaging while recovering from COVID-19, who were either asymptomatic or with only mild to moderate symptoms and were generally without ECG or troponin evidence of myocarditis.

One of them showed a less than 2% incidence of myocarditis by CMR among 145 such cases, a low yield for imaging that is “raising doubt regarding its utility to evaluate athletes without a clinical presentation or abnormal ancillary tests to support the diagnosis of myocarditis,” argues a report published Jan. 14 in JAMA Cardiology, with lead author Jitka Starekova, MD, University of Wisconsin – Madison.

“Part of the problem is that occult myocarditis is, at least with other viruses, a risk factor for sudden death in competitive athletes. So you don’t want to let one slip through the cracks,” senior author Scott B. Reeder, MD, PhD, from the same institution, said in an interview.

Whether a policy of routine CMR imaging in elite athletes who test positive for the new coronavirus is better than more selective use driven by symptoms or other screening tests is unknown. But the more pressing issue, Dr. Reeder said, “is if they have a normal electrocardiogram and troponins, do they still need cardiac magnetic resonance imaging?”

The current study, he said, “certainly provides helpful evidence that maybe we don’t need as many.”

The other study, which featured two control groups, saw a similarly low incidence of myocarditis by CMR in athletes with recent COVID-19. One of the control groups included university athletes imaged prior to the advent of SARS-CoV-2 in the university’s region of the country. The other consisted of apparently healthy adult nonathletes.

Armed with two non-COVID-19 cohorts and two athlete cohorts, the researchers found comparable rates of myocarditis by CMR in both the COVID-19 athletes and the healthy athletes. And only 3% of the COVID-19 athletes had the tell-tale CMR signs, notes the report, published Dec. 17 in Circulation, with lead author Daniel E. Clark, MD, MPH, Vanderbilt University Medical Center, Nashville, Tenn.
 

Reassurance and concern

“The incidence is much lower than we feared, and so that’s reassuring,” Clark said in an interview. Still, the athletes with myocarditis by CMR “would have been completely missed by a protocol that did not include cardiac MR, and that’s concerning,” he said. “Both had active myocarditis.”

The study’s two non-COVID-19 control groups – elite athletes in one and nonathletes in the other – allowed them to tease out the potential contribution of athletic myocardial remodeling to CMR features that could be interpreted as scar tissue, which are characterized by late gadolinium enhancement (LGE).

As it turned out, focal regions of LGE located in the right ventricular (RV) septum on the scans were often seen in both athlete cohorts. “This kind of trivial nonischemic fibrosis in the mid RV septal insertion site was common among athletic control subjects. It was seen in 24% of them, which is almost identical to the percentage that we saw in the COVID-19 athletes, 22%,” Dr. Clark said.

The LGE finding, wrote Dr. Clark and coauthors, “may represent remodeling from athletic training, and should not be conflated with myocarditis.”

Of note, the other study saw a comparable incidence of the same or a very similar CMR feature in its athletes; 26% of the Wisconsin COVID-19 athlete cohort showed limited focal LGE in the inferior RV insertion site.

“And you get a little bit in the mid-septum, as well,” Dr. Reeder said. But the sign, in the absence of any corresponding T2 abnormalities, was not judged to represent myocarditis. “We interpreted all of these studies with this potential confounder in mind.”

Conceivably, Dr. Reeder proposed, the earlier studies may have “over-called” the prevalence of myocarditis in their cohorts. “I haven’t seen their images, but it’s possible there could be false-positives.”

It’s noteworthy that the Vanderbilt and Wisconsin reports saw closely similar incidences of the tell-tale CMR sign in all the athlete cohorts whether or not COVID-19 was involved, Aaron L. Baggish, MD, Massachusetts General Hospital, Boston, said in an interview.

“It looks very much like just an unrecognized part of athletic remodeling and isn’t in any way, shape, or form implicated as being a COVID-related issue,” said Dr. Baggish, who directs the cardiovascular performance program at his center and is unaffiliated with either study.

Still, that connection remains unproven given how little is yet known about the prevalence of clinically important myocarditis in milder cases of COVID-19, according to an accompanying editorial from Jonathan H. Kim, MD, MSc.

Although isolated LGE at the interventricular RV insertion site is “more commonly described among masters-level endurance athletes, the clinical significance and prevalence of this finding in youthful athletes is uncertain and should not be assumed to be a normal consequence of intense athletic training in young competitive athletes,” argued Dr. Kim, of Emory University, Atlanta.

There’s probably little about being a young competitive athlete that would render a person any more or less prone to COVID-19 cardiac involvement, Dr. Baggish said. Rather, “I think what we’re seeing, as the studies continue to come out, is that prevalence estimates are getting into the low single digits.”

The estimates are similar to those associated with influenza before the COVID-19 age; about 2% of patients showed cardiac involvement, Dr. Baggish said. “So the degree to which COVID is a special virus from this perspective, I think, is still a topic of some debate.”

The two current studies have limitations and neither is positioned to change practice, he said. “I would say that they are both kind of important, reassuring pieces of an unfinished jigsaw puzzle. But we still don’t know what the picture on the puzzle is.”
 

Routine CMR for positive cases

The University of Wisconsin group looked at all of the institution’s competitive athletes who underwent gadolinium-enhanced CMR imaging and other tests during recovery from COVID-19 from the beginning of the pandemic to the end of November 2020.

The imaging was performed on average about 2 weeks after a first positive SARS-CoV-2 assay result. About one-half and one-fourth of the cohort had experienced mild and moderate symptoms, respectively, and about 17% were asymptomatic; none had been hospitalized.

All CMR scans were reviewed by two experienced radiologists for, among other things, evidence of myocarditis according to modified Lake Louise criteria, the group wrote. Those criteria are based on CMR markers of fibrosis and other characteristics of scarring from myocarditis.

Such evidence was seen in only two members of the cohort, or 1.4%, one with elevated troponins but normal with respect to other biomarkers, and the other negative for all assays. Both were asymptomatic at the time of imaging, the report noted.

The Vanderbilt analysis from Dr. Clark and associates centered on 59 university athletes recently with COVID-19 who underwent CMR imaging along with other tests about 3 weeks after confirmation of SARS-CoV-2 infection. Symptoms had been mild in 78% of the group, and the remainder were asymptomatic.

They were compared with 60 retrospectively identified college athletes and elite-conditioned military personnel who had undergone CMR imaging prior to the advent of COVID-19, and to 27 apparently healthy nonathlete adults in whom CMR had been previously performed to define normal CMR imaging criteria at that center.

The only two post-COVID-19 athletes who met modified Lake Louise criteria for myocarditis showed no abnormalities on ECG or myocardial strain echocardiography, and had normal troponins, the group reported.

The COVID-19 athletes showed increased cardiac chamber volumes and myocardial mass “consistent with athletic remodeling,” compared with the healthy control subjects, the group wrote. But “most standard CMR parameters were similar” between the COVID-19 athletes and the control athletes, consistent with the 22% and 24% rates, respectively, for the finding of focal late LGE isolated to the inferoseptal RV insertion site.

At the end of the day, all published experiences on athletes with recent COVID-19 “are descriptive studies, without any hint of follow-up,” Dr. Baggish noted, so their clinical implications are unknown.

“We need time to sit and watch to see what happens to these individuals,” he said. “And if the answer is nothing, then that’s a very reassuring story. If the answer is that we start to see events, then that’s really important for us to take stock of.”

Dr. Starekova had no disclosures. Dr. Reeder reports that the University of Wisconsin receives research support from GE Healthcare and Bracco Diagnostics; and that he has ownership interests in Calimetrix, Reveal Pharmaceuticals, Cellectar Biosciences, Elucent Medical, and HeartVista; and has received grant support from Bayer Healthcare. Disclosures for the other coauthors are in the report. Dr. Clark and coauthors had no disclosures. Dr. Baggish reported no conflicts. Kim discloses receiving funding from the National Heart, Lung, and Blood Institute; compensation as team cardiologist for the Atlanta Falcons; and research stipends from the Atlanta Track Club.

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

Two recent observational studies suggest that myocarditis, at least on cardiac magnetic resonance (CMR) imaging, might be far less common in elite-level athletes recovering from COVID-19 than suggested in influential earlier reports.

AlexLMX/Getty Images

Both new studies documented a rate less than one-quarter as high as those previously reported from smaller cohorts, raising questions about the diagnostic yield of CMR in highly conditioned athletes with recent COVID-19 absent other evidence, such as from biomarker assays or electrocardiography (ECG).

That could have implications for some top-tier university athletics programs that mandate CMR imaging, biomarker assays, and other evaluations for myocarditis on all their players who test positive for SARS-CoV-2 before they can return to play.

The findings collectively point to CMR imaging features that might be a hallmark of an athlete’s heart, characterized by normal myocardial remodeling brought on by elite-level exercise training, which in athletes with recent COVID-19 could be misinterpreted as evidence of myocarditis. That may have thrown off prevalence estimates in the literature, the studies’ investigators speculated.

The two studies were retrospective takes on university athletes who underwent CMR imaging while recovering from COVID-19, who were either asymptomatic or with only mild to moderate symptoms and were generally without ECG or troponin evidence of myocarditis.

One of them showed a less than 2% incidence of myocarditis by CMR among 145 such cases, a low yield for imaging that is “raising doubt regarding its utility to evaluate athletes without a clinical presentation or abnormal ancillary tests to support the diagnosis of myocarditis,” argues a report published Jan. 14 in JAMA Cardiology, with lead author Jitka Starekova, MD, University of Wisconsin – Madison.

“Part of the problem is that occult myocarditis is, at least with other viruses, a risk factor for sudden death in competitive athletes. So you don’t want to let one slip through the cracks,” senior author Scott B. Reeder, MD, PhD, from the same institution, said in an interview.

Whether a policy of routine CMR imaging in elite athletes who test positive for the new coronavirus is better than more selective use driven by symptoms or other screening tests is unknown. But the more pressing issue, Dr. Reeder said, “is if they have a normal electrocardiogram and troponins, do they still need cardiac magnetic resonance imaging?”

The current study, he said, “certainly provides helpful evidence that maybe we don’t need as many.”

The other study, which featured two control groups, saw a similarly low incidence of myocarditis by CMR in athletes with recent COVID-19. One of the control groups included university athletes imaged prior to the advent of SARS-CoV-2 in the university’s region of the country. The other consisted of apparently healthy adult nonathletes.

Armed with two non-COVID-19 cohorts and two athlete cohorts, the researchers found comparable rates of myocarditis by CMR in both the COVID-19 athletes and the healthy athletes. And only 3% of the COVID-19 athletes had the tell-tale CMR signs, notes the report, published Dec. 17 in Circulation, with lead author Daniel E. Clark, MD, MPH, Vanderbilt University Medical Center, Nashville, Tenn.
 

Reassurance and concern

“The incidence is much lower than we feared, and so that’s reassuring,” Clark said in an interview. Still, the athletes with myocarditis by CMR “would have been completely missed by a protocol that did not include cardiac MR, and that’s concerning,” he said. “Both had active myocarditis.”

The study’s two non-COVID-19 control groups – elite athletes in one and nonathletes in the other – allowed them to tease out the potential contribution of athletic myocardial remodeling to CMR features that could be interpreted as scar tissue, which are characterized by late gadolinium enhancement (LGE).

As it turned out, focal regions of LGE located in the right ventricular (RV) septum on the scans were often seen in both athlete cohorts. “This kind of trivial nonischemic fibrosis in the mid RV septal insertion site was common among athletic control subjects. It was seen in 24% of them, which is almost identical to the percentage that we saw in the COVID-19 athletes, 22%,” Dr. Clark said.

The LGE finding, wrote Dr. Clark and coauthors, “may represent remodeling from athletic training, and should not be conflated with myocarditis.”

Of note, the other study saw a comparable incidence of the same or a very similar CMR feature in its athletes; 26% of the Wisconsin COVID-19 athlete cohort showed limited focal LGE in the inferior RV insertion site.

“And you get a little bit in the mid-septum, as well,” Dr. Reeder said. But the sign, in the absence of any corresponding T2 abnormalities, was not judged to represent myocarditis. “We interpreted all of these studies with this potential confounder in mind.”

Conceivably, Dr. Reeder proposed, the earlier studies may have “over-called” the prevalence of myocarditis in their cohorts. “I haven’t seen their images, but it’s possible there could be false-positives.”

It’s noteworthy that the Vanderbilt and Wisconsin reports saw closely similar incidences of the tell-tale CMR sign in all the athlete cohorts whether or not COVID-19 was involved, Aaron L. Baggish, MD, Massachusetts General Hospital, Boston, said in an interview.

“It looks very much like just an unrecognized part of athletic remodeling and isn’t in any way, shape, or form implicated as being a COVID-related issue,” said Dr. Baggish, who directs the cardiovascular performance program at his center and is unaffiliated with either study.

Still, that connection remains unproven given how little is yet known about the prevalence of clinically important myocarditis in milder cases of COVID-19, according to an accompanying editorial from Jonathan H. Kim, MD, MSc.

Although isolated LGE at the interventricular RV insertion site is “more commonly described among masters-level endurance athletes, the clinical significance and prevalence of this finding in youthful athletes is uncertain and should not be assumed to be a normal consequence of intense athletic training in young competitive athletes,” argued Dr. Kim, of Emory University, Atlanta.

There’s probably little about being a young competitive athlete that would render a person any more or less prone to COVID-19 cardiac involvement, Dr. Baggish said. Rather, “I think what we’re seeing, as the studies continue to come out, is that prevalence estimates are getting into the low single digits.”

The estimates are similar to those associated with influenza before the COVID-19 age; about 2% of patients showed cardiac involvement, Dr. Baggish said. “So the degree to which COVID is a special virus from this perspective, I think, is still a topic of some debate.”

The two current studies have limitations and neither is positioned to change practice, he said. “I would say that they are both kind of important, reassuring pieces of an unfinished jigsaw puzzle. But we still don’t know what the picture on the puzzle is.”
 

Routine CMR for positive cases

The University of Wisconsin group looked at all of the institution’s competitive athletes who underwent gadolinium-enhanced CMR imaging and other tests during recovery from COVID-19 from the beginning of the pandemic to the end of November 2020.

The imaging was performed on average about 2 weeks after a first positive SARS-CoV-2 assay result. About one-half and one-fourth of the cohort had experienced mild and moderate symptoms, respectively, and about 17% were asymptomatic; none had been hospitalized.

All CMR scans were reviewed by two experienced radiologists for, among other things, evidence of myocarditis according to modified Lake Louise criteria, the group wrote. Those criteria are based on CMR markers of fibrosis and other characteristics of scarring from myocarditis.

Such evidence was seen in only two members of the cohort, or 1.4%, one with elevated troponins but normal with respect to other biomarkers, and the other negative for all assays. Both were asymptomatic at the time of imaging, the report noted.

The Vanderbilt analysis from Dr. Clark and associates centered on 59 university athletes recently with COVID-19 who underwent CMR imaging along with other tests about 3 weeks after confirmation of SARS-CoV-2 infection. Symptoms had been mild in 78% of the group, and the remainder were asymptomatic.

They were compared with 60 retrospectively identified college athletes and elite-conditioned military personnel who had undergone CMR imaging prior to the advent of COVID-19, and to 27 apparently healthy nonathlete adults in whom CMR had been previously performed to define normal CMR imaging criteria at that center.

The only two post-COVID-19 athletes who met modified Lake Louise criteria for myocarditis showed no abnormalities on ECG or myocardial strain echocardiography, and had normal troponins, the group reported.

The COVID-19 athletes showed increased cardiac chamber volumes and myocardial mass “consistent with athletic remodeling,” compared with the healthy control subjects, the group wrote. But “most standard CMR parameters were similar” between the COVID-19 athletes and the control athletes, consistent with the 22% and 24% rates, respectively, for the finding of focal late LGE isolated to the inferoseptal RV insertion site.

At the end of the day, all published experiences on athletes with recent COVID-19 “are descriptive studies, without any hint of follow-up,” Dr. Baggish noted, so their clinical implications are unknown.

“We need time to sit and watch to see what happens to these individuals,” he said. “And if the answer is nothing, then that’s a very reassuring story. If the answer is that we start to see events, then that’s really important for us to take stock of.”

Dr. Starekova had no disclosures. Dr. Reeder reports that the University of Wisconsin receives research support from GE Healthcare and Bracco Diagnostics; and that he has ownership interests in Calimetrix, Reveal Pharmaceuticals, Cellectar Biosciences, Elucent Medical, and HeartVista; and has received grant support from Bayer Healthcare. Disclosures for the other coauthors are in the report. Dr. Clark and coauthors had no disclosures. Dr. Baggish reported no conflicts. Kim discloses receiving funding from the National Heart, Lung, and Blood Institute; compensation as team cardiologist for the Atlanta Falcons; and research stipends from the Atlanta Track Club.

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

The Step 2 Clinical Skills (CS) test for medical school students and graduates has been permanently canceled, cosponsors of the U.S. Medical Licensing Examination (USMLE) announced in a press release this afternoon.

As previously reported by this news organization, the USMLE cosponsors, the Federation of State Medical Boards and the National Board of Medical Examiners, had announced in May that they would take the following 12-18 months to revamp the required test.

COVID-19 had forced a suspension of the all-day test, which requires test takers to have physical contact with standardized patients. It’s designed to gauge how soon-to-be doctors gather information from patients, perform physical exams, and communicate their findings to patients and colleagues.

However, the cosponsors said today, “we have no plans to bring back Step 2 CS, but we intend to take this opportunity to focus on working with our colleagues in medical education and at the state medical boards to determine innovative ways to assess clinical skills.”

David Johnson, FSMB’s chief assessment officer, said in an interview that, after months of study, “it became clear that the relaunch of a modified Step 2 CS exam would not meet our expectations to be appreciably better than the prior exam.”
 

Only weeks ago, NBME was hiring for the revamp

The news came as a huge surprise. Just weeks earlier, NBME was advertising for a position key to modifying the exam. The description for the position read: “This role will focus on operational planning and coordination both within the NBME and with ECFMG [Educational Commission for Foreign Medical Graduates] to effectively deliver a modified Step 2 Clinical Skills exam.”

Bryan Carmody, MD, MPH, an assistant professor at Eastern Virginia Medical School, Norfolk, noted in a Jan. 15 tweet that the position requires extensive information technology experience, “suggesting plans for a virtual test remain intact.”

Dr. Johnson said that, although the opportunities for helping lead the revamp of the test were posted until the announcement, no one had been hired for the position.

Today’s announcement stated that the USMLE still believes independent standardized tests for medical knowledge and clinical skills are important; however, it now feels clinical reasoning and communication skills will be able to be assessed in other steps.

“Computer-based case simulations in Step 3 and communication content recently bolstered in Step 1 are examples of these efforts that will continue,” the press release stated. “While not a replacement for Step 2 CS, these formats continue to contribute positively, e.g., measuring critical knowledge of medical communication.”

Critics ‘thrilled’ by test termination

Lydia Flier, MD, from the department of internal medicine at Harvard Medical School, Boston – who wrote an editorial for this news organization in August 2020 advocating that Step 2 CS be changed completely or ended entirely – said in an interview that she was “surprised and thrilled” by the announcement.

She said the cosponsors hadn’t initially appeared to agree with the growing sentiment that disruption from the pandemic had “proven the test was unnecessary and it looked like they really were going to try and keep it.”

“I’m thrilled for future generations,” she said. “It is proof of what many people have known all along, which is that the test is a no-value-add proposition that did not actually help determine people’s clinical skills.”

The test “met a breaking point” during the pandemic, she said, “from which CS could not recover.”

She noted in her editorial that the test costs $1,300 plus travel fees, as the test had been offered at only five sites. She agreed that the skills assessed by the Step 2 CS are already covered in medical school and through other Steps.

“It seems as though they could not justify it anymore. It’s the obvious right answer,” said Dr. Flier, who in 2016 cofounded #EndStep2CS, a nationwide movement demanding an end to the exam.

Another cofounder in that movement, Christopher Henderson, MD, a staff physician with Kaiser Permanente in Seattle, said in an interview that “this decision represents tremendous progress in the fight to reduce unnecessary costs in medical education, and is a win for future students. Credit goes to the many women and men who organized and voiced their desire for change.” He added that his views are his own and “do not reflect or imply the views of my organization.”

For the FSMB’s part, Dr. Johnson acknowledged that “the consideration of cost and value were two of many important factors for the Step 2 CS revitalization work.”

Dr. Johnson, Dr. Flier, and Dr. Henderson have declared no relevant financial relationships.

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

The Step 2 Clinical Skills (CS) test for medical school students and graduates has been permanently canceled, cosponsors of the U.S. Medical Licensing Examination (USMLE) announced in a press release this afternoon.

As previously reported by this news organization, the USMLE cosponsors, the Federation of State Medical Boards and the National Board of Medical Examiners, had announced in May that they would take the following 12-18 months to revamp the required test.

COVID-19 had forced a suspension of the all-day test, which requires test takers to have physical contact with standardized patients. It’s designed to gauge how soon-to-be doctors gather information from patients, perform physical exams, and communicate their findings to patients and colleagues.

However, the cosponsors said today, “we have no plans to bring back Step 2 CS, but we intend to take this opportunity to focus on working with our colleagues in medical education and at the state medical boards to determine innovative ways to assess clinical skills.”

David Johnson, FSMB’s chief assessment officer, said in an interview that, after months of study, “it became clear that the relaunch of a modified Step 2 CS exam would not meet our expectations to be appreciably better than the prior exam.”
 

Only weeks ago, NBME was hiring for the revamp

The news came as a huge surprise. Just weeks earlier, NBME was advertising for a position key to modifying the exam. The description for the position read: “This role will focus on operational planning and coordination both within the NBME and with ECFMG [Educational Commission for Foreign Medical Graduates] to effectively deliver a modified Step 2 Clinical Skills exam.”

Bryan Carmody, MD, MPH, an assistant professor at Eastern Virginia Medical School, Norfolk, noted in a Jan. 15 tweet that the position requires extensive information technology experience, “suggesting plans for a virtual test remain intact.”

Dr. Johnson said that, although the opportunities for helping lead the revamp of the test were posted until the announcement, no one had been hired for the position.

Today’s announcement stated that the USMLE still believes independent standardized tests for medical knowledge and clinical skills are important; however, it now feels clinical reasoning and communication skills will be able to be assessed in other steps.

“Computer-based case simulations in Step 3 and communication content recently bolstered in Step 1 are examples of these efforts that will continue,” the press release stated. “While not a replacement for Step 2 CS, these formats continue to contribute positively, e.g., measuring critical knowledge of medical communication.”

Critics ‘thrilled’ by test termination

Lydia Flier, MD, from the department of internal medicine at Harvard Medical School, Boston – who wrote an editorial for this news organization in August 2020 advocating that Step 2 CS be changed completely or ended entirely – said in an interview that she was “surprised and thrilled” by the announcement.

She said the cosponsors hadn’t initially appeared to agree with the growing sentiment that disruption from the pandemic had “proven the test was unnecessary and it looked like they really were going to try and keep it.”

“I’m thrilled for future generations,” she said. “It is proof of what many people have known all along, which is that the test is a no-value-add proposition that did not actually help determine people’s clinical skills.”

The test “met a breaking point” during the pandemic, she said, “from which CS could not recover.”

She noted in her editorial that the test costs $1,300 plus travel fees, as the test had been offered at only five sites. She agreed that the skills assessed by the Step 2 CS are already covered in medical school and through other Steps.

“It seems as though they could not justify it anymore. It’s the obvious right answer,” said Dr. Flier, who in 2016 cofounded #EndStep2CS, a nationwide movement demanding an end to the exam.

Another cofounder in that movement, Christopher Henderson, MD, a staff physician with Kaiser Permanente in Seattle, said in an interview that “this decision represents tremendous progress in the fight to reduce unnecessary costs in medical education, and is a win for future students. Credit goes to the many women and men who organized and voiced their desire for change.” He added that his views are his own and “do not reflect or imply the views of my organization.”

For the FSMB’s part, Dr. Johnson acknowledged that “the consideration of cost and value were two of many important factors for the Step 2 CS revitalization work.”

Dr. Johnson, Dr. Flier, and Dr. Henderson have declared no relevant financial relationships.

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

The Step 2 Clinical Skills (CS) test for medical school students and graduates has been permanently canceled, cosponsors of the U.S. Medical Licensing Examination (USMLE) announced in a press release this afternoon.

As previously reported by this news organization, the USMLE cosponsors, the Federation of State Medical Boards and the National Board of Medical Examiners, had announced in May that they would take the following 12-18 months to revamp the required test.

COVID-19 had forced a suspension of the all-day test, which requires test takers to have physical contact with standardized patients. It’s designed to gauge how soon-to-be doctors gather information from patients, perform physical exams, and communicate their findings to patients and colleagues.

However, the cosponsors said today, “we have no plans to bring back Step 2 CS, but we intend to take this opportunity to focus on working with our colleagues in medical education and at the state medical boards to determine innovative ways to assess clinical skills.”

David Johnson, FSMB’s chief assessment officer, said in an interview that, after months of study, “it became clear that the relaunch of a modified Step 2 CS exam would not meet our expectations to be appreciably better than the prior exam.”
 

Only weeks ago, NBME was hiring for the revamp

The news came as a huge surprise. Just weeks earlier, NBME was advertising for a position key to modifying the exam. The description for the position read: “This role will focus on operational planning and coordination both within the NBME and with ECFMG [Educational Commission for Foreign Medical Graduates] to effectively deliver a modified Step 2 Clinical Skills exam.”

Bryan Carmody, MD, MPH, an assistant professor at Eastern Virginia Medical School, Norfolk, noted in a Jan. 15 tweet that the position requires extensive information technology experience, “suggesting plans for a virtual test remain intact.”

Dr. Johnson said that, although the opportunities for helping lead the revamp of the test were posted until the announcement, no one had been hired for the position.

Today’s announcement stated that the USMLE still believes independent standardized tests for medical knowledge and clinical skills are important; however, it now feels clinical reasoning and communication skills will be able to be assessed in other steps.

“Computer-based case simulations in Step 3 and communication content recently bolstered in Step 1 are examples of these efforts that will continue,” the press release stated. “While not a replacement for Step 2 CS, these formats continue to contribute positively, e.g., measuring critical knowledge of medical communication.”

Critics ‘thrilled’ by test termination

Lydia Flier, MD, from the department of internal medicine at Harvard Medical School, Boston – who wrote an editorial for this news organization in August 2020 advocating that Step 2 CS be changed completely or ended entirely – said in an interview that she was “surprised and thrilled” by the announcement.

She said the cosponsors hadn’t initially appeared to agree with the growing sentiment that disruption from the pandemic had “proven the test was unnecessary and it looked like they really were going to try and keep it.”

“I’m thrilled for future generations,” she said. “It is proof of what many people have known all along, which is that the test is a no-value-add proposition that did not actually help determine people’s clinical skills.”

The test “met a breaking point” during the pandemic, she said, “from which CS could not recover.”

She noted in her editorial that the test costs $1,300 plus travel fees, as the test had been offered at only five sites. She agreed that the skills assessed by the Step 2 CS are already covered in medical school and through other Steps.

“It seems as though they could not justify it anymore. It’s the obvious right answer,” said Dr. Flier, who in 2016 cofounded #EndStep2CS, a nationwide movement demanding an end to the exam.

Another cofounder in that movement, Christopher Henderson, MD, a staff physician with Kaiser Permanente in Seattle, said in an interview that “this decision represents tremendous progress in the fight to reduce unnecessary costs in medical education, and is a win for future students. Credit goes to the many women and men who organized and voiced their desire for change.” He added that his views are his own and “do not reflect or imply the views of my organization.”

For the FSMB’s part, Dr. Johnson acknowledged that “the consideration of cost and value were two of many important factors for the Step 2 CS revitalization work.”

Dr. Johnson, Dr. Flier, and Dr. Henderson have declared no relevant financial relationships.

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

The U.K.’s B117 variant is circulating in at least 24 states, according to new data from the Centers for Disease Control and Prevention COVID-19 variant surveillance. The CDC projects that the U.K. variant will become the dominant strain in the United States by March.

From any vantage point, the United Kingdom appears to be in the crosshairs of COVID-19: Weeks after a new, highly contagious variant emerged that fueled a surge in cases and fresh lockdowns, the United Kingdom was revealed to have the world’s highest coronavirus death rate.

But the United Kingdom also has a not-so-secret weapon of its own: A genomic sequencing program widely believed to be the most coordinated and advanced any nation has forged. In the vise grip of the virus, the Brits have gleaned key insights into the behavior and consequences of SARS-CoV-2.

But B117 is also notable for what it is missing: In this case, producing a negative result on certain polymerase chain reaction (PCR) tests in the spike protein, or S-gene.

One of the S-gene mutations specific to the variant deletes two amino acids, causing that portion of the PCR test to show up negative. The coincidental finding known as an S-gene target failure has become an integral proxy to help track where and when the variant is spreading in the United Kingdom, where about 5% of samples from COVID-19–infected patients are sequenced, said Sharon Peacock, PhD, executive director and chair of the COVID-19 Genomics U.K. Consortium.

That same tactic could prove valuable to clinicians similarly overwhelmed with cases and deaths but lacking high-level sequencing information on the virus, Dr. Peacock said in an interview. A British report released Friday stated that there is a “realistic possibility” that the variant has a higher death rate than other cases of SARS-CoV-2.

“In this particular variant, a deletion in the genome leads to one part of the diagnostic test failing,” Dr. Peacock explained. “Several targets are positive, but this is negative. In the U.K., this has been used as a surrogate marker.”
 

Targeting an invisible adversary

B117 is not the only variant that produces this result, Dr. Peacock cautioned, “but in screening for it, you can have this in mind.”

“Since the U.K. is sequencing about 5% of the cases they detect, this gives them really important clues about what’s happening there,” said Anderson Brito, PhD, a virologist and postdoctoral researcher at Yale University, New Haven, Conn., where investigators are creating custom PCR tests to detect the B117 variant.

Dr. Brito, who lived in the United Kingdom for 4 years while studying for his doctorate at Imperial College London, said a “major advantage” is the more unified process to collect and sequence samples. Crucial information – including the date and place of collection – comes with each sample, which fuels not only sequencing, but an epidemiologic perspective.

“They’re not in the dark at all,” Dr. Brito said in an interview. “I think no other country in the world knows better which virus lineages are circulating.”

The CDC launched the SPHERES consortium in May 2020 to coordinate the sequencing of SARS-CoV-2 genomes across the United States.

But American genomic efforts are “not as centralized,” said Dr. Brito, whose lab detected the first two cases of the U.K. variant in Connecticut on Jan. 6. “We struggle to get samples, because they’re decentralized to a level where there’s little coordination between hospitals and research centers. They’re not as connected as in the U.K. If we just get a sample and it has no date of collection and no origin information, for example, it’s basically useless.”

Global genomic collaborations include GISAID, an international database where researchers share new genomes from various coronaviruses. As of mid-January, the United States had submitted about 68,000 sequences to GISAID, adding about 3,000 new samples every week and expecting even more from commercial labs in coming days, according to the CDC.

“The U.K. is definitely much more on top of looking for variants as they pop up,” said Gigi Gronvall, PhD, an immunologist and senior scholar at Johns Hopkins Center for Health Security in Baltimore. “The U.S. has now turned that up.”
 

Warning from British scientists to the world

Despite these genomic accomplishments, some British scientists said they have regrets too, wishing they’d known just how rapidly SARS-CoV-2 was actually spreading a year ago, when it hit western Europe.

That information was crucial not only for preventive efforts, but because viruses inevitably mutate faster the more people who are infected, said Igor Rudan, MD, PhD, director of the Center for Global Health Research at University of Edinburgh.

“Italy showed us just how fast it was spreading and how deadly it is for the very old and people with multiple comorbidities,” said Dr. Rudan, who also editor in chief of the Journal of Global Health. “We wish we knew it was spreading so fast, and we wish we knew the threshold of cases we could allow to be infected before the virus would mutate.”

More mutations mean more new strains of SARS-CoV-2, Dr. Rudan said in an interview. “We’ve reached that threshold now and will see more of these mutations.”

Despite its current struggles, the United Kingdom is reaching beyond tracking its new variant’s spread and trying to identify new mutations that might change the way the virus behaves.

Three features of any emerging variant are particularly important, Dr. Peacock explained: Is it more transmissible? Is it more lethal? And does it cut the ability of natural- or vaccine-induced immunity to protect people from infection?

“We need to sequence people coming to the hospital who are sicker,” said Dr. Peacock, also a professor of public health and microbiology at the University of Cambridge (England). “Also, if anyone has the infection after they’ve already been sick or had the vaccine, we really want to know what that looks like” genomically.

SARS-CoV-2 has already logged more than 4,000 mutations, Dr. Peacock said. But “knowing that viruses mutate all the time is not sufficient reason not to look. We really want to know if mutations lead to changes in amino acids, and if that can lead to changes in functionality.”

For the moment, however, experts say they’re relieved that the U.K. strain doesn’t seem able to evade COVID-19 vaccines or render them less effective.

“Even though mutations are common, those able to change the viral coding are rare,” Dr. Brito explained. If necessary, vaccines could be tweaked to replace the spike gene sequence “within a matter of weeks. We already do this for flu vaccines. Every year, we have to monitor variants of the virus circulating to develop a vaccine that covers most of them. If we end up having to do it for SARS-CoV-2, I would not be surprised.”

But variant-fueled increases in infections will require more people to be vaccinated before herd immunity can be achieved, Dr. Rudan warned. “If it spreads faster, we’ll need to vaccinate probably 85% of people versus 70% to reach herd immunity.”

One lesson the COVID-19 pandemic has driven home “is to always be on your guard about what happens next,” Dr. Peacock said. Although confident about the genomic efforts in the United Kingdom to date, she and her colleagues feel they’re still reaching for a complete understanding of the evolutionary changes of the virus.

“We’re ahead of the curve right now, but we want to get in front of the curve,” Dr. Peacock said. “It’s essential to get ahead of what might be around the corner because we don’t know how the virus is going to evolve.”

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

The U.K.’s B117 variant is circulating in at least 24 states, according to new data from the Centers for Disease Control and Prevention COVID-19 variant surveillance. The CDC projects that the U.K. variant will become the dominant strain in the United States by March.

From any vantage point, the United Kingdom appears to be in the crosshairs of COVID-19: Weeks after a new, highly contagious variant emerged that fueled a surge in cases and fresh lockdowns, the United Kingdom was revealed to have the world’s highest coronavirus death rate.

But the United Kingdom also has a not-so-secret weapon of its own: A genomic sequencing program widely believed to be the most coordinated and advanced any nation has forged. In the vise grip of the virus, the Brits have gleaned key insights into the behavior and consequences of SARS-CoV-2.

But B117 is also notable for what it is missing: In this case, producing a negative result on certain polymerase chain reaction (PCR) tests in the spike protein, or S-gene.

One of the S-gene mutations specific to the variant deletes two amino acids, causing that portion of the PCR test to show up negative. The coincidental finding known as an S-gene target failure has become an integral proxy to help track where and when the variant is spreading in the United Kingdom, where about 5% of samples from COVID-19–infected patients are sequenced, said Sharon Peacock, PhD, executive director and chair of the COVID-19 Genomics U.K. Consortium.

That same tactic could prove valuable to clinicians similarly overwhelmed with cases and deaths but lacking high-level sequencing information on the virus, Dr. Peacock said in an interview. A British report released Friday stated that there is a “realistic possibility” that the variant has a higher death rate than other cases of SARS-CoV-2.

“In this particular variant, a deletion in the genome leads to one part of the diagnostic test failing,” Dr. Peacock explained. “Several targets are positive, but this is negative. In the U.K., this has been used as a surrogate marker.”
 

Targeting an invisible adversary

B117 is not the only variant that produces this result, Dr. Peacock cautioned, “but in screening for it, you can have this in mind.”

“Since the U.K. is sequencing about 5% of the cases they detect, this gives them really important clues about what’s happening there,” said Anderson Brito, PhD, a virologist and postdoctoral researcher at Yale University, New Haven, Conn., where investigators are creating custom PCR tests to detect the B117 variant.

Dr. Brito, who lived in the United Kingdom for 4 years while studying for his doctorate at Imperial College London, said a “major advantage” is the more unified process to collect and sequence samples. Crucial information – including the date and place of collection – comes with each sample, which fuels not only sequencing, but an epidemiologic perspective.

“They’re not in the dark at all,” Dr. Brito said in an interview. “I think no other country in the world knows better which virus lineages are circulating.”

The CDC launched the SPHERES consortium in May 2020 to coordinate the sequencing of SARS-CoV-2 genomes across the United States.

But American genomic efforts are “not as centralized,” said Dr. Brito, whose lab detected the first two cases of the U.K. variant in Connecticut on Jan. 6. “We struggle to get samples, because they’re decentralized to a level where there’s little coordination between hospitals and research centers. They’re not as connected as in the U.K. If we just get a sample and it has no date of collection and no origin information, for example, it’s basically useless.”

Global genomic collaborations include GISAID, an international database where researchers share new genomes from various coronaviruses. As of mid-January, the United States had submitted about 68,000 sequences to GISAID, adding about 3,000 new samples every week and expecting even more from commercial labs in coming days, according to the CDC.

“The U.K. is definitely much more on top of looking for variants as they pop up,” said Gigi Gronvall, PhD, an immunologist and senior scholar at Johns Hopkins Center for Health Security in Baltimore. “The U.S. has now turned that up.”
 

Warning from British scientists to the world

Despite these genomic accomplishments, some British scientists said they have regrets too, wishing they’d known just how rapidly SARS-CoV-2 was actually spreading a year ago, when it hit western Europe.

That information was crucial not only for preventive efforts, but because viruses inevitably mutate faster the more people who are infected, said Igor Rudan, MD, PhD, director of the Center for Global Health Research at University of Edinburgh.

“Italy showed us just how fast it was spreading and how deadly it is for the very old and people with multiple comorbidities,” said Dr. Rudan, who also editor in chief of the Journal of Global Health. “We wish we knew it was spreading so fast, and we wish we knew the threshold of cases we could allow to be infected before the virus would mutate.”

More mutations mean more new strains of SARS-CoV-2, Dr. Rudan said in an interview. “We’ve reached that threshold now and will see more of these mutations.”

Despite its current struggles, the United Kingdom is reaching beyond tracking its new variant’s spread and trying to identify new mutations that might change the way the virus behaves.

Three features of any emerging variant are particularly important, Dr. Peacock explained: Is it more transmissible? Is it more lethal? And does it cut the ability of natural- or vaccine-induced immunity to protect people from infection?

“We need to sequence people coming to the hospital who are sicker,” said Dr. Peacock, also a professor of public health and microbiology at the University of Cambridge (England). “Also, if anyone has the infection after they’ve already been sick or had the vaccine, we really want to know what that looks like” genomically.

SARS-CoV-2 has already logged more than 4,000 mutations, Dr. Peacock said. But “knowing that viruses mutate all the time is not sufficient reason not to look. We really want to know if mutations lead to changes in amino acids, and if that can lead to changes in functionality.”

For the moment, however, experts say they’re relieved that the U.K. strain doesn’t seem able to evade COVID-19 vaccines or render them less effective.

“Even though mutations are common, those able to change the viral coding are rare,” Dr. Brito explained. If necessary, vaccines could be tweaked to replace the spike gene sequence “within a matter of weeks. We already do this for flu vaccines. Every year, we have to monitor variants of the virus circulating to develop a vaccine that covers most of them. If we end up having to do it for SARS-CoV-2, I would not be surprised.”

But variant-fueled increases in infections will require more people to be vaccinated before herd immunity can be achieved, Dr. Rudan warned. “If it spreads faster, we’ll need to vaccinate probably 85% of people versus 70% to reach herd immunity.”

One lesson the COVID-19 pandemic has driven home “is to always be on your guard about what happens next,” Dr. Peacock said. Although confident about the genomic efforts in the United Kingdom to date, she and her colleagues feel they’re still reaching for a complete understanding of the evolutionary changes of the virus.

“We’re ahead of the curve right now, but we want to get in front of the curve,” Dr. Peacock said. “It’s essential to get ahead of what might be around the corner because we don’t know how the virus is going to evolve.”

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

The U.K.’s B117 variant is circulating in at least 24 states, according to new data from the Centers for Disease Control and Prevention COVID-19 variant surveillance. The CDC projects that the U.K. variant will become the dominant strain in the United States by March.

From any vantage point, the United Kingdom appears to be in the crosshairs of COVID-19: Weeks after a new, highly contagious variant emerged that fueled a surge in cases and fresh lockdowns, the United Kingdom was revealed to have the world’s highest coronavirus death rate.

But the United Kingdom also has a not-so-secret weapon of its own: A genomic sequencing program widely believed to be the most coordinated and advanced any nation has forged. In the vise grip of the virus, the Brits have gleaned key insights into the behavior and consequences of SARS-CoV-2.

But B117 is also notable for what it is missing: In this case, producing a negative result on certain polymerase chain reaction (PCR) tests in the spike protein, or S-gene.

One of the S-gene mutations specific to the variant deletes two amino acids, causing that portion of the PCR test to show up negative. The coincidental finding known as an S-gene target failure has become an integral proxy to help track where and when the variant is spreading in the United Kingdom, where about 5% of samples from COVID-19–infected patients are sequenced, said Sharon Peacock, PhD, executive director and chair of the COVID-19 Genomics U.K. Consortium.

That same tactic could prove valuable to clinicians similarly overwhelmed with cases and deaths but lacking high-level sequencing information on the virus, Dr. Peacock said in an interview. A British report released Friday stated that there is a “realistic possibility” that the variant has a higher death rate than other cases of SARS-CoV-2.

“In this particular variant, a deletion in the genome leads to one part of the diagnostic test failing,” Dr. Peacock explained. “Several targets are positive, but this is negative. In the U.K., this has been used as a surrogate marker.”
 

Targeting an invisible adversary

B117 is not the only variant that produces this result, Dr. Peacock cautioned, “but in screening for it, you can have this in mind.”

“Since the U.K. is sequencing about 5% of the cases they detect, this gives them really important clues about what’s happening there,” said Anderson Brito, PhD, a virologist and postdoctoral researcher at Yale University, New Haven, Conn., where investigators are creating custom PCR tests to detect the B117 variant.

Dr. Brito, who lived in the United Kingdom for 4 years while studying for his doctorate at Imperial College London, said a “major advantage” is the more unified process to collect and sequence samples. Crucial information – including the date and place of collection – comes with each sample, which fuels not only sequencing, but an epidemiologic perspective.

“They’re not in the dark at all,” Dr. Brito said in an interview. “I think no other country in the world knows better which virus lineages are circulating.”

The CDC launched the SPHERES consortium in May 2020 to coordinate the sequencing of SARS-CoV-2 genomes across the United States.

But American genomic efforts are “not as centralized,” said Dr. Brito, whose lab detected the first two cases of the U.K. variant in Connecticut on Jan. 6. “We struggle to get samples, because they’re decentralized to a level where there’s little coordination between hospitals and research centers. They’re not as connected as in the U.K. If we just get a sample and it has no date of collection and no origin information, for example, it’s basically useless.”

Global genomic collaborations include GISAID, an international database where researchers share new genomes from various coronaviruses. As of mid-January, the United States had submitted about 68,000 sequences to GISAID, adding about 3,000 new samples every week and expecting even more from commercial labs in coming days, according to the CDC.

“The U.K. is definitely much more on top of looking for variants as they pop up,” said Gigi Gronvall, PhD, an immunologist and senior scholar at Johns Hopkins Center for Health Security in Baltimore. “The U.S. has now turned that up.”
 

Warning from British scientists to the world

Despite these genomic accomplishments, some British scientists said they have regrets too, wishing they’d known just how rapidly SARS-CoV-2 was actually spreading a year ago, when it hit western Europe.

That information was crucial not only for preventive efforts, but because viruses inevitably mutate faster the more people who are infected, said Igor Rudan, MD, PhD, director of the Center for Global Health Research at University of Edinburgh.

“Italy showed us just how fast it was spreading and how deadly it is for the very old and people with multiple comorbidities,” said Dr. Rudan, who also editor in chief of the Journal of Global Health. “We wish we knew it was spreading so fast, and we wish we knew the threshold of cases we could allow to be infected before the virus would mutate.”

More mutations mean more new strains of SARS-CoV-2, Dr. Rudan said in an interview. “We’ve reached that threshold now and will see more of these mutations.”

Despite its current struggles, the United Kingdom is reaching beyond tracking its new variant’s spread and trying to identify new mutations that might change the way the virus behaves.

Three features of any emerging variant are particularly important, Dr. Peacock explained: Is it more transmissible? Is it more lethal? And does it cut the ability of natural- or vaccine-induced immunity to protect people from infection?

“We need to sequence people coming to the hospital who are sicker,” said Dr. Peacock, also a professor of public health and microbiology at the University of Cambridge (England). “Also, if anyone has the infection after they’ve already been sick or had the vaccine, we really want to know what that looks like” genomically.

SARS-CoV-2 has already logged more than 4,000 mutations, Dr. Peacock said. But “knowing that viruses mutate all the time is not sufficient reason not to look. We really want to know if mutations lead to changes in amino acids, and if that can lead to changes in functionality.”

For the moment, however, experts say they’re relieved that the U.K. strain doesn’t seem able to evade COVID-19 vaccines or render them less effective.

“Even though mutations are common, those able to change the viral coding are rare,” Dr. Brito explained. If necessary, vaccines could be tweaked to replace the spike gene sequence “within a matter of weeks. We already do this for flu vaccines. Every year, we have to monitor variants of the virus circulating to develop a vaccine that covers most of them. If we end up having to do it for SARS-CoV-2, I would not be surprised.”

But variant-fueled increases in infections will require more people to be vaccinated before herd immunity can be achieved, Dr. Rudan warned. “If it spreads faster, we’ll need to vaccinate probably 85% of people versus 70% to reach herd immunity.”

One lesson the COVID-19 pandemic has driven home “is to always be on your guard about what happens next,” Dr. Peacock said. Although confident about the genomic efforts in the United Kingdom to date, she and her colleagues feel they’re still reaching for a complete understanding of the evolutionary changes of the virus.

“We’re ahead of the curve right now, but we want to get in front of the curve,” Dr. Peacock said. “It’s essential to get ahead of what might be around the corner because we don’t know how the virus is going to evolve.”

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

Just as Brazil surpassed 200,000 deaths from COVID-19 on Jan. 7, news from Bahia added another layer of concern: A platform case report in a preprint detailed the first case of reinfection in that state, apparently caused by a new strain, one having the E484K mutation.

That variant, now called Brazil P.1, has migrated to the United States. The Minnesota Department of Health announced on Jan. 25 the nation’s first known COVID-19 case associated with it.

The mutation is located in the protein gene of the virus’ spike, which forms the crown structure of coronaviruses and is responsible for the virus’ binding to human cells. The E484K mutation is now the focus because it’s associated with mutations that escape the immune system’s neutralizing antibodies.

“This mutation is at the center of worldwide concern, and it is the first time that it has appeared in a reinfection,” the study’s first author, Bruno Solano de Freitas Souza, MD, a researcher at the Salvador regional unit of Instituto D’Or of Teaching and Research, based at Hospital São Rafael, Salvador, Brazil, explained in an interview.

“We will wait for the sample from Bahia to confirm the case from the perspective of the Ministry of Health’s surveillance network,” said Fernando Motta, PhD, deputy head of the Laboratory for Respiratory Virus and Measles at the Oswaldo Cruz Institute in Rio de Janeiro, which acts as a national reference center for respiratory viruses with the Brazilian Ministry of Health (MS) and as a reference for the World Health Organization.
 

A case of reinfection

The case patient that led to the alarm was a 45-year-old woman who is a health care executive. She had no comorbidities. The team had been following health care professionals and patients who had tested positive on reverse transcription–polymerase chain reaction (RT-PCR) testing more than once to understand whether they represented cases of prolonged viral persistence or new infections.

The woman had symptoms of viral infection on two occasions (May 26 and Oct. 26). On both occasions, results of RT-PCR testing for SARS-CoV-2 on nasopharyngeal samples were positive. In the first episode, the patient had diarrhea, myalgia, asthenia, and odynophagia for about 7 days. She returned to activities 21 days later. In the second episode, she had more severe symptoms that lasted longer, but she still did not require hospitalization.

“It was the first confirmed case of reinfection in Bahia, and in the second episode, we observed a mutation that could have an impact on the ability of antibodies to neutralize the virus,” Dr. Souza said. “The research continues with the investigation of cases in which the patient has a positive SARS-CoV-2 RT-PCR more than once in an interval greater than 45 days, to have a higher level of evidence.”

He stressed that “it is very important to reinforce measures to control the pandemic, social distance, use of masks, and speed up vaccination to be able to control the circulation of the virus, while monitoring the evolution of it.”
 

On alert for more cases

A person who twice tests positive for SARS-CoV-2 on real-time RT-PCR is suspected of having been reinfected, provided 90 or more days have elapsed between the two episodes, regardless of the condition observed. To confirm the suspected case, the samples must be sent to reference laboratories according to a plan established by the Ministry of Health in Brazil.

A health professional living in the Brazilian city of Natal represented the first confirmed case of reinfection by the new coronavirus in Brazil. That case was announced on Dec. 10, 2020.

“We communicated this case of reinfection to the MS in early December 2020. And the second sample already had the E484K mutation on the spike, as in the case of Bahia,” said Dr. Motta.

The first step in differentiating reinfection from persistence is to observe differences in the genotyping of the virus. For the technique to be successful, Dr. Souza said, researchers need a large amount of viral genetic material, which usually cannot be obtained.

“That is why there are many more suspected than confirmed cases,” Dr. Souza explained. He admitted that, although there are few cases, “it is increasingly clear that reinfection is a reality.”
 

Markers of mutations

What worried the researchers most was not only the possibility of reinfection but also the fact that preliminary analyses showed a specific mutation.

“The E484K mutation is present in a group of variants identified in South Africa that have been associated with increased infectivity and has been observed in a strain recently described in Brazil,” Dr. Souza said.

Mutations are expected, appear spontaneously, and in most cases have no effects on transmission or clinical outcome – they are simply used as markers and are useful for contact tracing or studying transmission routes. But some mutations can last because they provide an advantage for the pathogen, even if only momentary. In the case of SARS-CoV-2, mutations in the protein spike gene (S) are relevant because they may give clues to that advantage – as well as to changes in infectivity, transmission potential, antibodies, and response to vaccines.

A variant of the virus that has eight changes that affect the protein S gene – and several others in different genes – is behind the increase in the number of cases in London and southeastern England. Researchers from the University of São Paulo identified one of the factors that made this new variant – classified as B.1.1.7 – more infectious.

With bioinformatics tools, they found that the protein S gene in the new viral strain has a stronger molecular interaction with the ACE2 receptor, which is on the surface of human cells and to which the virus binds, making infection possible. The variant has already spread to the rest of the world, and the first two cases have been confirmed in Brazil by the Adolf Lutz Institute.

The alert for a new variant in Africa – similar to B.1.1.7 in the United Kingdom in that it carries nine changes in protein S at position 501 – was made by the Brazilian virologist Tulio de Oliveira, PhD.

“We found that this strain seems to be spreading much faster,” Dr. Oliveira, who is with the University of KwaZulu Natal, told the journal Science. His work first alerted British scientists to the importance of the position N501Y.

“The new variants just described in the United Kingdom and South Africa are slightly more transmissible and have already been identified in cases imported into Brazil,” Dr. Motta said. “Unfortunately, we believe it is only a matter of time before it becomes indigenous.”
 

The viral family grows

Viruses such as SARS-CoV-2 are classified into strains on the basis of small differences in their genetic material. Since Dec. 26, 2020, in addition to the British and South African variants, it appears the Carioca lineage also is a player.

In a preprint article, researchers analyzed the evolution of the epidemic in Rio de Janeiro from April 2020 until just before the new increase in incidence in December. They compared the complete sequences of the viral genome of 180 patients from different municipalities. The study, which is being jointly conducted by members of the Federal University of Rio de Janeiro and the National Laboratory for Scientific Computing, identified a new variant of SARS-CoV-2 that has five unique mutations (from one of the predominant strains). Concern arose because, in addition to those five genetic changes, many of the samples had a sixth – the well-known E484K mutation.

“The three lines – the U.K., South Africa, and Brazil – were almost synchronous publications, but there is no clear evidence that they have any kind of common ancestry,” Carolina M. Voloch, PhD, the article’s first author and a biologist and researcher at the Molecular Virology Laboratory and associate professor in the department of genetics at the Federal University of Rio de Janeiro, said in an interview.

Dr. Voloch’s research focuses on the use of bioinformatics tools to study the molecular, phylogenetic, and genomic evolution of viruses.

“The emergence of new strains is common for viruses,” she said. “It can be happening anywhere in the world at any time.”

She stressed that identifying when mutations emerge will help to define the new Brazilian lineage. Researchers are working to determine whether the neutralizing antibodies of patients who have been infected with other strains respond to this Rio de Janeiro strain.

“We hope to soon be sharing these results,” Dr. Voloch said.

The article’s authors estimated that the new strain likely appeared in early July. They say more analysis is needed to predict whether the changes have a major effect on viral infectivity, the host’s immune response, or the severity of the disease. Asked about the lineage that caused the reinfection in Bahia, Dr. Voloch said she hadn’t yet contacted the authors to conduct a joint analysis but added that the data disclosed in the preprint would not represent the same variant.

“There are only two of the five mutations that characterize the Rio de Janeiro lineage. However, it has the E484K mutation that is present in more than 94% of the samples of the new variant of Rio,” she said.

She added that there’s a possibility of reinfection by the lineage that’s circulating in Rio de Janeiro and in other states, as well as countries such as the United States, the United Kingdom, and Japan.

“The Carioca virus is being exported to the rest of the world,” Dr. Voloch said.
 

Virus’ diversity still unknown

Researchers now know that SARS-CoV-2 probably circulated silently in Brazil as early as February 2020 and reached all the nation’s regions before air travel was restricted. Since the first half of 2020, there have been two predominant strains.

“More than a dozen strains have been identified in Brazil, but more important than counting strains to identify the speed with which they arise – which is directly associated with the rate of infection, which is very high in the country,” said Dr. Motta.

The so-called variant of Rio de Janeiro, he said, has also been detected in other states in four regions of Brazil. The key to documenting variants is to get a more representative sample with genomes from other parts of the country.

As of Jan. 10, a total of 347,000 complete genome sequences had been shared globally through open databases since SARS-CoV-2 was first identified, but the contribution of countries is uneven. Although the cost and complexity of genetic sequencing has dropped significantly over time, effective sequencing programs still require substantial investments in personnel, equipment, reagents, and bioinformatics infrastructure.

According to Dr. Voloch, it will only be possible to combat the new coronavirus by knowing its diversity and understanding how it evolves. The Fiocruz Genomic Network has made an infographic available so researchers can track the strains circulating in Brazil. It›s the result of collaboration between researchers from Fiocruz and the GISAID Initiative, an international partnership that promotes rapid data sharing.

As of Jan. 5, researchers in Brazil had studied 1,897 genomes – not nearly enough.

“In Brazil, there is little testing and even less sequencing,” lamented Dr. Souza.

“In the U.K., 1 in 600 cases is sequenced. In Brazil it is less than 1 in 10 million cases,” Dr. Voloch added.

So far, no decisive factors for public health, such as greater virulence or greater transmissibility, have been identified in any of the strains established in Brazil. The million-dollar question is whether the emergence of new strains could have an impact on the effectiveness of vaccines being administered today.

“In one way or another, the vaccine is our best bet ever, even if in the future we identify escapist mutants and have to modify it,” Dr. Motta said. “It is what we do annually with influenza.”

Dr. Voloch, Dr. Motta, and Dr. Souza disclosed no relevant financial relationships.

A version of this article first appeared on the Portuguese edition of Medscape.com.

Just as Brazil surpassed 200,000 deaths from COVID-19 on Jan. 7, news from Bahia added another layer of concern: A platform case report in a preprint detailed the first case of reinfection in that state, apparently caused by a new strain, one having the E484K mutation.

That variant, now called Brazil P.1, has migrated to the United States. The Minnesota Department of Health announced on Jan. 25 the nation’s first known COVID-19 case associated with it.

The mutation is located in the protein gene of the virus’ spike, which forms the crown structure of coronaviruses and is responsible for the virus’ binding to human cells. The E484K mutation is now the focus because it’s associated with mutations that escape the immune system’s neutralizing antibodies.

“This mutation is at the center of worldwide concern, and it is the first time that it has appeared in a reinfection,” the study’s first author, Bruno Solano de Freitas Souza, MD, a researcher at the Salvador regional unit of Instituto D’Or of Teaching and Research, based at Hospital São Rafael, Salvador, Brazil, explained in an interview.

“We will wait for the sample from Bahia to confirm the case from the perspective of the Ministry of Health’s surveillance network,” said Fernando Motta, PhD, deputy head of the Laboratory for Respiratory Virus and Measles at the Oswaldo Cruz Institute in Rio de Janeiro, which acts as a national reference center for respiratory viruses with the Brazilian Ministry of Health (MS) and as a reference for the World Health Organization.
 

A case of reinfection

The case patient that led to the alarm was a 45-year-old woman who is a health care executive. She had no comorbidities. The team had been following health care professionals and patients who had tested positive on reverse transcription–polymerase chain reaction (RT-PCR) testing more than once to understand whether they represented cases of prolonged viral persistence or new infections.

The woman had symptoms of viral infection on two occasions (May 26 and Oct. 26). On both occasions, results of RT-PCR testing for SARS-CoV-2 on nasopharyngeal samples were positive. In the first episode, the patient had diarrhea, myalgia, asthenia, and odynophagia for about 7 days. She returned to activities 21 days later. In the second episode, she had more severe symptoms that lasted longer, but she still did not require hospitalization.

“It was the first confirmed case of reinfection in Bahia, and in the second episode, we observed a mutation that could have an impact on the ability of antibodies to neutralize the virus,” Dr. Souza said. “The research continues with the investigation of cases in which the patient has a positive SARS-CoV-2 RT-PCR more than once in an interval greater than 45 days, to have a higher level of evidence.”

He stressed that “it is very important to reinforce measures to control the pandemic, social distance, use of masks, and speed up vaccination to be able to control the circulation of the virus, while monitoring the evolution of it.”
 

On alert for more cases

A person who twice tests positive for SARS-CoV-2 on real-time RT-PCR is suspected of having been reinfected, provided 90 or more days have elapsed between the two episodes, regardless of the condition observed. To confirm the suspected case, the samples must be sent to reference laboratories according to a plan established by the Ministry of Health in Brazil.

A health professional living in the Brazilian city of Natal represented the first confirmed case of reinfection by the new coronavirus in Brazil. That case was announced on Dec. 10, 2020.

“We communicated this case of reinfection to the MS in early December 2020. And the second sample already had the E484K mutation on the spike, as in the case of Bahia,” said Dr. Motta.

The first step in differentiating reinfection from persistence is to observe differences in the genotyping of the virus. For the technique to be successful, Dr. Souza said, researchers need a large amount of viral genetic material, which usually cannot be obtained.

“That is why there are many more suspected than confirmed cases,” Dr. Souza explained. He admitted that, although there are few cases, “it is increasingly clear that reinfection is a reality.”
 

Markers of mutations

What worried the researchers most was not only the possibility of reinfection but also the fact that preliminary analyses showed a specific mutation.

“The E484K mutation is present in a group of variants identified in South Africa that have been associated with increased infectivity and has been observed in a strain recently described in Brazil,” Dr. Souza said.

Mutations are expected, appear spontaneously, and in most cases have no effects on transmission or clinical outcome – they are simply used as markers and are useful for contact tracing or studying transmission routes. But some mutations can last because they provide an advantage for the pathogen, even if only momentary. In the case of SARS-CoV-2, mutations in the protein spike gene (S) are relevant because they may give clues to that advantage – as well as to changes in infectivity, transmission potential, antibodies, and response to vaccines.

A variant of the virus that has eight changes that affect the protein S gene – and several others in different genes – is behind the increase in the number of cases in London and southeastern England. Researchers from the University of São Paulo identified one of the factors that made this new variant – classified as B.1.1.7 – more infectious.

With bioinformatics tools, they found that the protein S gene in the new viral strain has a stronger molecular interaction with the ACE2 receptor, which is on the surface of human cells and to which the virus binds, making infection possible. The variant has already spread to the rest of the world, and the first two cases have been confirmed in Brazil by the Adolf Lutz Institute.

The alert for a new variant in Africa – similar to B.1.1.7 in the United Kingdom in that it carries nine changes in protein S at position 501 – was made by the Brazilian virologist Tulio de Oliveira, PhD.

“We found that this strain seems to be spreading much faster,” Dr. Oliveira, who is with the University of KwaZulu Natal, told the journal Science. His work first alerted British scientists to the importance of the position N501Y.

“The new variants just described in the United Kingdom and South Africa are slightly more transmissible and have already been identified in cases imported into Brazil,” Dr. Motta said. “Unfortunately, we believe it is only a matter of time before it becomes indigenous.”
 

The viral family grows

Viruses such as SARS-CoV-2 are classified into strains on the basis of small differences in their genetic material. Since Dec. 26, 2020, in addition to the British and South African variants, it appears the Carioca lineage also is a player.

In a preprint article, researchers analyzed the evolution of the epidemic in Rio de Janeiro from April 2020 until just before the new increase in incidence in December. They compared the complete sequences of the viral genome of 180 patients from different municipalities. The study, which is being jointly conducted by members of the Federal University of Rio de Janeiro and the National Laboratory for Scientific Computing, identified a new variant of SARS-CoV-2 that has five unique mutations (from one of the predominant strains). Concern arose because, in addition to those five genetic changes, many of the samples had a sixth – the well-known E484K mutation.

“The three lines – the U.K., South Africa, and Brazil – were almost synchronous publications, but there is no clear evidence that they have any kind of common ancestry,” Carolina M. Voloch, PhD, the article’s first author and a biologist and researcher at the Molecular Virology Laboratory and associate professor in the department of genetics at the Federal University of Rio de Janeiro, said in an interview.

Dr. Voloch’s research focuses on the use of bioinformatics tools to study the molecular, phylogenetic, and genomic evolution of viruses.

“The emergence of new strains is common for viruses,” she said. “It can be happening anywhere in the world at any time.”

She stressed that identifying when mutations emerge will help to define the new Brazilian lineage. Researchers are working to determine whether the neutralizing antibodies of patients who have been infected with other strains respond to this Rio de Janeiro strain.

“We hope to soon be sharing these results,” Dr. Voloch said.

The article’s authors estimated that the new strain likely appeared in early July. They say more analysis is needed to predict whether the changes have a major effect on viral infectivity, the host’s immune response, or the severity of the disease. Asked about the lineage that caused the reinfection in Bahia, Dr. Voloch said she hadn’t yet contacted the authors to conduct a joint analysis but added that the data disclosed in the preprint would not represent the same variant.

“There are only two of the five mutations that characterize the Rio de Janeiro lineage. However, it has the E484K mutation that is present in more than 94% of the samples of the new variant of Rio,” she said.

She added that there’s a possibility of reinfection by the lineage that’s circulating in Rio de Janeiro and in other states, as well as countries such as the United States, the United Kingdom, and Japan.

“The Carioca virus is being exported to the rest of the world,” Dr. Voloch said.
 

Virus’ diversity still unknown

Researchers now know that SARS-CoV-2 probably circulated silently in Brazil as early as February 2020 and reached all the nation’s regions before air travel was restricted. Since the first half of 2020, there have been two predominant strains.

“More than a dozen strains have been identified in Brazil, but more important than counting strains to identify the speed with which they arise – which is directly associated with the rate of infection, which is very high in the country,” said Dr. Motta.

The so-called variant of Rio de Janeiro, he said, has also been detected in other states in four regions of Brazil. The key to documenting variants is to get a more representative sample with genomes from other parts of the country.

As of Jan. 10, a total of 347,000 complete genome sequences had been shared globally through open databases since SARS-CoV-2 was first identified, but the contribution of countries is uneven. Although the cost and complexity of genetic sequencing has dropped significantly over time, effective sequencing programs still require substantial investments in personnel, equipment, reagents, and bioinformatics infrastructure.

According to Dr. Voloch, it will only be possible to combat the new coronavirus by knowing its diversity and understanding how it evolves. The Fiocruz Genomic Network has made an infographic available so researchers can track the strains circulating in Brazil. It›s the result of collaboration between researchers from Fiocruz and the GISAID Initiative, an international partnership that promotes rapid data sharing.

As of Jan. 5, researchers in Brazil had studied 1,897 genomes – not nearly enough.

“In Brazil, there is little testing and even less sequencing,” lamented Dr. Souza.

“In the U.K., 1 in 600 cases is sequenced. In Brazil it is less than 1 in 10 million cases,” Dr. Voloch added.

So far, no decisive factors for public health, such as greater virulence or greater transmissibility, have been identified in any of the strains established in Brazil. The million-dollar question is whether the emergence of new strains could have an impact on the effectiveness of vaccines being administered today.

“In one way or another, the vaccine is our best bet ever, even if in the future we identify escapist mutants and have to modify it,” Dr. Motta said. “It is what we do annually with influenza.”

Dr. Voloch, Dr. Motta, and Dr. Souza disclosed no relevant financial relationships.

A version of this article first appeared on the Portuguese edition of Medscape.com.

Just as Brazil surpassed 200,000 deaths from COVID-19 on Jan. 7, news from Bahia added another layer of concern: A platform case report in a preprint detailed the first case of reinfection in that state, apparently caused by a new strain, one having the E484K mutation.

That variant, now called Brazil P.1, has migrated to the United States. The Minnesota Department of Health announced on Jan. 25 the nation’s first known COVID-19 case associated with it.

The mutation is located in the protein gene of the virus’ spike, which forms the crown structure of coronaviruses and is responsible for the virus’ binding to human cells. The E484K mutation is now the focus because it’s associated with mutations that escape the immune system’s neutralizing antibodies.

“This mutation is at the center of worldwide concern, and it is the first time that it has appeared in a reinfection,” the study’s first author, Bruno Solano de Freitas Souza, MD, a researcher at the Salvador regional unit of Instituto D’Or of Teaching and Research, based at Hospital São Rafael, Salvador, Brazil, explained in an interview.

“We will wait for the sample from Bahia to confirm the case from the perspective of the Ministry of Health’s surveillance network,” said Fernando Motta, PhD, deputy head of the Laboratory for Respiratory Virus and Measles at the Oswaldo Cruz Institute in Rio de Janeiro, which acts as a national reference center for respiratory viruses with the Brazilian Ministry of Health (MS) and as a reference for the World Health Organization.
 

A case of reinfection

The case patient that led to the alarm was a 45-year-old woman who is a health care executive. She had no comorbidities. The team had been following health care professionals and patients who had tested positive on reverse transcription–polymerase chain reaction (RT-PCR) testing more than once to understand whether they represented cases of prolonged viral persistence or new infections.

The woman had symptoms of viral infection on two occasions (May 26 and Oct. 26). On both occasions, results of RT-PCR testing for SARS-CoV-2 on nasopharyngeal samples were positive. In the first episode, the patient had diarrhea, myalgia, asthenia, and odynophagia for about 7 days. She returned to activities 21 days later. In the second episode, she had more severe symptoms that lasted longer, but she still did not require hospitalization.

“It was the first confirmed case of reinfection in Bahia, and in the second episode, we observed a mutation that could have an impact on the ability of antibodies to neutralize the virus,” Dr. Souza said. “The research continues with the investigation of cases in which the patient has a positive SARS-CoV-2 RT-PCR more than once in an interval greater than 45 days, to have a higher level of evidence.”

He stressed that “it is very important to reinforce measures to control the pandemic, social distance, use of masks, and speed up vaccination to be able to control the circulation of the virus, while monitoring the evolution of it.”
 

On alert for more cases

A person who twice tests positive for SARS-CoV-2 on real-time RT-PCR is suspected of having been reinfected, provided 90 or more days have elapsed between the two episodes, regardless of the condition observed. To confirm the suspected case, the samples must be sent to reference laboratories according to a plan established by the Ministry of Health in Brazil.

A health professional living in the Brazilian city of Natal represented the first confirmed case of reinfection by the new coronavirus in Brazil. That case was announced on Dec. 10, 2020.

“We communicated this case of reinfection to the MS in early December 2020. And the second sample already had the E484K mutation on the spike, as in the case of Bahia,” said Dr. Motta.

The first step in differentiating reinfection from persistence is to observe differences in the genotyping of the virus. For the technique to be successful, Dr. Souza said, researchers need a large amount of viral genetic material, which usually cannot be obtained.

“That is why there are many more suspected than confirmed cases,” Dr. Souza explained. He admitted that, although there are few cases, “it is increasingly clear that reinfection is a reality.”
 

Markers of mutations

What worried the researchers most was not only the possibility of reinfection but also the fact that preliminary analyses showed a specific mutation.

“The E484K mutation is present in a group of variants identified in South Africa that have been associated with increased infectivity and has been observed in a strain recently described in Brazil,” Dr. Souza said.

Mutations are expected, appear spontaneously, and in most cases have no effects on transmission or clinical outcome – they are simply used as markers and are useful for contact tracing or studying transmission routes. But some mutations can last because they provide an advantage for the pathogen, even if only momentary. In the case of SARS-CoV-2, mutations in the protein spike gene (S) are relevant because they may give clues to that advantage – as well as to changes in infectivity, transmission potential, antibodies, and response to vaccines.

A variant of the virus that has eight changes that affect the protein S gene – and several others in different genes – is behind the increase in the number of cases in London and southeastern England. Researchers from the University of São Paulo identified one of the factors that made this new variant – classified as B.1.1.7 – more infectious.

With bioinformatics tools, they found that the protein S gene in the new viral strain has a stronger molecular interaction with the ACE2 receptor, which is on the surface of human cells and to which the virus binds, making infection possible. The variant has already spread to the rest of the world, and the first two cases have been confirmed in Brazil by the Adolf Lutz Institute.

The alert for a new variant in Africa – similar to B.1.1.7 in the United Kingdom in that it carries nine changes in protein S at position 501 – was made by the Brazilian virologist Tulio de Oliveira, PhD.

“We found that this strain seems to be spreading much faster,” Dr. Oliveira, who is with the University of KwaZulu Natal, told the journal Science. His work first alerted British scientists to the importance of the position N501Y.

“The new variants just described in the United Kingdom and South Africa are slightly more transmissible and have already been identified in cases imported into Brazil,” Dr. Motta said. “Unfortunately, we believe it is only a matter of time before it becomes indigenous.”
 

The viral family grows

Viruses such as SARS-CoV-2 are classified into strains on the basis of small differences in their genetic material. Since Dec. 26, 2020, in addition to the British and South African variants, it appears the Carioca lineage also is a player.

In a preprint article, researchers analyzed the evolution of the epidemic in Rio de Janeiro from April 2020 until just before the new increase in incidence in December. They compared the complete sequences of the viral genome of 180 patients from different municipalities. The study, which is being jointly conducted by members of the Federal University of Rio de Janeiro and the National Laboratory for Scientific Computing, identified a new variant of SARS-CoV-2 that has five unique mutations (from one of the predominant strains). Concern arose because, in addition to those five genetic changes, many of the samples had a sixth – the well-known E484K mutation.

“The three lines – the U.K., South Africa, and Brazil – were almost synchronous publications, but there is no clear evidence that they have any kind of common ancestry,” Carolina M. Voloch, PhD, the article’s first author and a biologist and researcher at the Molecular Virology Laboratory and associate professor in the department of genetics at the Federal University of Rio de Janeiro, said in an interview.

Dr. Voloch’s research focuses on the use of bioinformatics tools to study the molecular, phylogenetic, and genomic evolution of viruses.

“The emergence of new strains is common for viruses,” she said. “It can be happening anywhere in the world at any time.”

She stressed that identifying when mutations emerge will help to define the new Brazilian lineage. Researchers are working to determine whether the neutralizing antibodies of patients who have been infected with other strains respond to this Rio de Janeiro strain.

“We hope to soon be sharing these results,” Dr. Voloch said.

The article’s authors estimated that the new strain likely appeared in early July. They say more analysis is needed to predict whether the changes have a major effect on viral infectivity, the host’s immune response, or the severity of the disease. Asked about the lineage that caused the reinfection in Bahia, Dr. Voloch said she hadn’t yet contacted the authors to conduct a joint analysis but added that the data disclosed in the preprint would not represent the same variant.

“There are only two of the five mutations that characterize the Rio de Janeiro lineage. However, it has the E484K mutation that is present in more than 94% of the samples of the new variant of Rio,” she said.

She added that there’s a possibility of reinfection by the lineage that’s circulating in Rio de Janeiro and in other states, as well as countries such as the United States, the United Kingdom, and Japan.

“The Carioca virus is being exported to the rest of the world,” Dr. Voloch said.
 

Virus’ diversity still unknown

Researchers now know that SARS-CoV-2 probably circulated silently in Brazil as early as February 2020 and reached all the nation’s regions before air travel was restricted. Since the first half of 2020, there have been two predominant strains.

“More than a dozen strains have been identified in Brazil, but more important than counting strains to identify the speed with which they arise – which is directly associated with the rate of infection, which is very high in the country,” said Dr. Motta.

The so-called variant of Rio de Janeiro, he said, has also been detected in other states in four regions of Brazil. The key to documenting variants is to get a more representative sample with genomes from other parts of the country.

As of Jan. 10, a total of 347,000 complete genome sequences had been shared globally through open databases since SARS-CoV-2 was first identified, but the contribution of countries is uneven. Although the cost and complexity of genetic sequencing has dropped significantly over time, effective sequencing programs still require substantial investments in personnel, equipment, reagents, and bioinformatics infrastructure.

According to Dr. Voloch, it will only be possible to combat the new coronavirus by knowing its diversity and understanding how it evolves. The Fiocruz Genomic Network has made an infographic available so researchers can track the strains circulating in Brazil. It›s the result of collaboration between researchers from Fiocruz and the GISAID Initiative, an international partnership that promotes rapid data sharing.

As of Jan. 5, researchers in Brazil had studied 1,897 genomes – not nearly enough.

“In Brazil, there is little testing and even less sequencing,” lamented Dr. Souza.

“In the U.K., 1 in 600 cases is sequenced. In Brazil it is less than 1 in 10 million cases,” Dr. Voloch added.

So far, no decisive factors for public health, such as greater virulence or greater transmissibility, have been identified in any of the strains established in Brazil. The million-dollar question is whether the emergence of new strains could have an impact on the effectiveness of vaccines being administered today.

“In one way or another, the vaccine is our best bet ever, even if in the future we identify escapist mutants and have to modify it,” Dr. Motta said. “It is what we do annually with influenza.”

Dr. Voloch, Dr. Motta, and Dr. Souza disclosed no relevant financial relationships.

A version of this article first appeared on the Portuguese edition of Medscape.com.

Seven days into his presidency, Joe Biden announced that he is taking new steps to speed vaccines to Americans.

The president said he would increase the supply of vaccines to states from 8.6 million doses to 10 million doses per week, a 16% increase, for at least the next 3 weeks.

He said he was working to give states more advanced notice of their allotments so they could better plan their campaigns. He also said doses would be doled out based on population.

“We will both increase the supply and give our state and local partners more certainty about when doses will arrive,” he said Tuesday.

Finally, Mr. Biden announced that the United States would “soon be able to confirm” the purchase of 200 million more doses of the Pfizer and Moderna vaccines – 100 million of each – to effectively double the nation’s supply by “early summer.” That would increase the nation’s supply enough to fully vaccinate 300 million Americans by fall.

Mr. Biden said he was also working to shift the focus to getting more doses to economically disadvantaged communities and rural areas, which have fallen further behind as the vaccine rollout has faltered.

Even with these steps, Mr. Biden stressed that it would take months for vaccines to curb infections and deaths. He said, for the time being, masks, not vaccines, are the best way to save lives.

“The brutal truth is its going to take months before we get the majority of Americans vaccinated. Months,” he said, adding that wearing masks until at least April could save to save 50,000 lives.

“Let me be clear,” Mr. Biden said, “Things are going to get worse before they get better.

“We didn’t get into this mess overnight. It’s going to take months for us to turn things around. But let me be equally clear we’re going to get through this. We will defeat this pandemic,” he said.

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

Seven days into his presidency, Joe Biden announced that he is taking new steps to speed vaccines to Americans.

The president said he would increase the supply of vaccines to states from 8.6 million doses to 10 million doses per week, a 16% increase, for at least the next 3 weeks.

He said he was working to give states more advanced notice of their allotments so they could better plan their campaigns. He also said doses would be doled out based on population.

“We will both increase the supply and give our state and local partners more certainty about when doses will arrive,” he said Tuesday.

Finally, Mr. Biden announced that the United States would “soon be able to confirm” the purchase of 200 million more doses of the Pfizer and Moderna vaccines – 100 million of each – to effectively double the nation’s supply by “early summer.” That would increase the nation’s supply enough to fully vaccinate 300 million Americans by fall.

Mr. Biden said he was also working to shift the focus to getting more doses to economically disadvantaged communities and rural areas, which have fallen further behind as the vaccine rollout has faltered.

Even with these steps, Mr. Biden stressed that it would take months for vaccines to curb infections and deaths. He said, for the time being, masks, not vaccines, are the best way to save lives.

“The brutal truth is its going to take months before we get the majority of Americans vaccinated. Months,” he said, adding that wearing masks until at least April could save to save 50,000 lives.

“Let me be clear,” Mr. Biden said, “Things are going to get worse before they get better.

“We didn’t get into this mess overnight. It’s going to take months for us to turn things around. But let me be equally clear we’re going to get through this. We will defeat this pandemic,” he said.

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

Seven days into his presidency, Joe Biden announced that he is taking new steps to speed vaccines to Americans.

The president said he would increase the supply of vaccines to states from 8.6 million doses to 10 million doses per week, a 16% increase, for at least the next 3 weeks.

He said he was working to give states more advanced notice of their allotments so they could better plan their campaigns. He also said doses would be doled out based on population.

“We will both increase the supply and give our state and local partners more certainty about when doses will arrive,” he said Tuesday.

Finally, Mr. Biden announced that the United States would “soon be able to confirm” the purchase of 200 million more doses of the Pfizer and Moderna vaccines – 100 million of each – to effectively double the nation’s supply by “early summer.” That would increase the nation’s supply enough to fully vaccinate 300 million Americans by fall.

Mr. Biden said he was also working to shift the focus to getting more doses to economically disadvantaged communities and rural areas, which have fallen further behind as the vaccine rollout has faltered.

Even with these steps, Mr. Biden stressed that it would take months for vaccines to curb infections and deaths. He said, for the time being, masks, not vaccines, are the best way to save lives.

“The brutal truth is its going to take months before we get the majority of Americans vaccinated. Months,” he said, adding that wearing masks until at least April could save to save 50,000 lives.

“Let me be clear,” Mr. Biden said, “Things are going to get worse before they get better.

“We didn’t get into this mess overnight. It’s going to take months for us to turn things around. But let me be equally clear we’re going to get through this. We will defeat this pandemic,” he said.

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

New COVID-19 cases in children fell by almost 46,000 last week, returning to the gradual decline that began in mid-December, according to new data from the American Academy of Pediatrics and the Children’s Hospital Association.

The 165,000 new cases reported during the week of Jan. 15-21 were down by almost 22% from the previous week’s 211,000, when the new-case count reached its highest point in the pandemic, the AAP and CHA said in their weekly COVID-19 report.

Cumulative cases in children now stand at just over 2.67 million, and children represent 12.7% of all COVID-19 cases reported by 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam. For the week of Jan. 15-21, children made up 14.8% of all new cases, the highest proportion since late September, the AAP/CHA data show.

The cumulative rate of infection among children is up to 3,556 per 100,000 nationally, with states ranging from 943 per 100,000 in Hawaii to 8,195 in North Dakota. California has the most reported cases at 383,000, while Vermont has the fewest at 1,820, the two organizations reported.

There were 14 more deaths among children in the last week, bringing the total to 205 in the 43 states (plus New York City and Guam) reporting such data. Children represent just 0.06% of all coronavirus-related deaths, and only 0.01% of all cases in children have resulted in death, the AAP and CHA said. There are still 10 states where no children have died from COVID-19.

Although severe illness appears to be rare in children, the AAP and CHA noted, “there is an urgent need to collect more data on longer-term impacts of the pandemic on children, including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects.”

[email protected]

New COVID-19 cases in children fell by almost 46,000 last week, returning to the gradual decline that began in mid-December, according to new data from the American Academy of Pediatrics and the Children’s Hospital Association.

The 165,000 new cases reported during the week of Jan. 15-21 were down by almost 22% from the previous week’s 211,000, when the new-case count reached its highest point in the pandemic, the AAP and CHA said in their weekly COVID-19 report.

Cumulative cases in children now stand at just over 2.67 million, and children represent 12.7% of all COVID-19 cases reported by 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam. For the week of Jan. 15-21, children made up 14.8% of all new cases, the highest proportion since late September, the AAP/CHA data show.

The cumulative rate of infection among children is up to 3,556 per 100,000 nationally, with states ranging from 943 per 100,000 in Hawaii to 8,195 in North Dakota. California has the most reported cases at 383,000, while Vermont has the fewest at 1,820, the two organizations reported.

There were 14 more deaths among children in the last week, bringing the total to 205 in the 43 states (plus New York City and Guam) reporting such data. Children represent just 0.06% of all coronavirus-related deaths, and only 0.01% of all cases in children have resulted in death, the AAP and CHA said. There are still 10 states where no children have died from COVID-19.

Although severe illness appears to be rare in children, the AAP and CHA noted, “there is an urgent need to collect more data on longer-term impacts of the pandemic on children, including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects.”

[email protected]

New COVID-19 cases in children fell by almost 46,000 last week, returning to the gradual decline that began in mid-December, according to new data from the American Academy of Pediatrics and the Children’s Hospital Association.

The 165,000 new cases reported during the week of Jan. 15-21 were down by almost 22% from the previous week’s 211,000, when the new-case count reached its highest point in the pandemic, the AAP and CHA said in their weekly COVID-19 report.

Cumulative cases in children now stand at just over 2.67 million, and children represent 12.7% of all COVID-19 cases reported by 49 states (excluding New York), the District of Columbia, New York City, Puerto Rico, and Guam. For the week of Jan. 15-21, children made up 14.8% of all new cases, the highest proportion since late September, the AAP/CHA data show.

The cumulative rate of infection among children is up to 3,556 per 100,000 nationally, with states ranging from 943 per 100,000 in Hawaii to 8,195 in North Dakota. California has the most reported cases at 383,000, while Vermont has the fewest at 1,820, the two organizations reported.

There were 14 more deaths among children in the last week, bringing the total to 205 in the 43 states (plus New York City and Guam) reporting such data. Children represent just 0.06% of all coronavirus-related deaths, and only 0.01% of all cases in children have resulted in death, the AAP and CHA said. There are still 10 states where no children have died from COVID-19.

Although severe illness appears to be rare in children, the AAP and CHA noted, “there is an urgent need to collect more data on longer-term impacts of the pandemic on children, including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects.”

[email protected]

According to Noreen Heer Nicol, PhD, RN, FNP, frustration still exists for patients, families, and health care providers regarding the lack of consensus that routine bathing is good for patients with atopic dermatitis.

monkeybusinessimages/Getty Images

During the Revolutionizing Atopic Dermatitis symposium, she said that conflicting and vague guidelines currently exist on the topic.

“This stems from the fact that we just don’t have good studies,” said Dr. Nicol, associate dean and associate professor of nursing at the University of Colorado at Denver, Aurora. “Particularly, we don’t have randomized, controlled trials on the effects of water and bathing. It’s not just parents that are frustrated, but health care providers are as well.”

In an observational analysis, researchers evaluated results from three online surveys of dermatologists, allergists, and immunologists, and primary care physicians regarding routine bathing frequency recommendations for children with AD. It found that PCPs recommended daily bathing less than 50% of the time, while specialists recommended daily bathing more than 50% of the time.

“It seems like the PCPs have embraced that old dermatology notion when bathing was avoided in patients with AD,” Dr. Nicol said. “This lack of consensus on the basic daily care steps in AD management causes a great deal of confusion amongst patients, families, and young health care providers, in particular,” she added.

She believes that this goes back to a century-long debate about the pros and cons of bathing in AD. “We used to say that bathing will dry the skin out if you take a bath or a shower without immediately applying something like a good moisturizer. That’s where the 3-minute rule came along from the National Eczema Association, meaning that bathing hydrates the stratum corneum if you take a bath or a shower and you immediately apply that good moisturizer within 3 minutes to retain that hydration and keep the barrier intact and flexible.”

Dr. Nicol presented a stepwise management model that she has published many times over the years (see Pediatr Nursing 2020;46[2]:92-8 and J Allergy Clin Immunol Pract 2019;7[1]:1-16).

Step 1 consists of basic care, including skin hydration/bathing, application of a daily moisturizer, avoiding irritants, and identifying and addressing specific triggers. “This is the foundation for every step as you go forward,” she explained. Soak and seal has been a mainstay of treatment at National Jewish Health, she noted. “By that, I mean taking a soaking 10-15 minute bath in warm water daily. Gently pat away excess water. Immediately apply skin medications or moisturizer within 3 minutes. Using a gentle fragrance-free, dye-free cleanser to clean skin is also important. Avoid scrubbing.”

A review article on bathing and associated treatments in AD was published in 2017 and includes 144 references to bathing studies. A separate recommendation known as the “AD Yardstick” published by Dr. Nicol’s colleague at National Jewish Health, Mark Boguniewicz, MD, and coauthors, elaborated on the definition of basic skin care for nonlesional AD. Besides recommending the liberal and frequent application of moisturizers, it suggests management with warm baths or showers using nonsoap cleansers, usually once per day, followed by application of a moisturizer, even on clear areas.

“This is now what people are thinking as the basis of skin care in patients with AD,” Dr. Nicol said. “Warm baths and showers don’t look so controversial anymore. This model nicely lays out what we want people to remember. In the past, many times we just skipped that important step of telling people about bathing.”

In a small 2009 study, researchers conducted a quantitative assessment of combination bathing and moisturizing regimens on skin hydration in AD. They found that bathing followed by application of a moisturizer provides modest hydration benefits, though less than that of simply applying moisturizer alone. “That has not been the case for most of us who are bathing advocates,” Dr. Nicol said. “We believe that there is an additional hydration that’s gained from bathing and moisturizers done properly.”

In an earlier retrospective study of 28 patients referred to a tertiary care center for refractory chronic pruritic eruptions, researchers found that a plain-water 20-minute soak followed by smearing of midstrength corticosteroid ointment led to clearing or dramatic improvement of the lesions (Arch Dermatol 2005;14:1556-9). The authors recommended prospective studies to confirm the findings.

In a separate review of medical literature, researchers explored the role of frequent bathing in the treatment of pediatric AD (Ann Allergy Asthma Immunol 2016;117[1]:9-13). They found that the weight of evidence suggests that the frequent soak and smear bathing is preferred to infrequent bathing in the management of AD. Frequent bathing was defined as bathing at least once a day, while infrequent bathing was defined as bathing less than once a day.

“Bleach baths have received much attention in recent years, and have been endorsed by multiple AD guidelines, though not to the same degree as regular bathing,” Dr. Nicol said. “Right now, you can find almost as much literature for this practice as against it. The populations that seem to value from beach baths the most, however, are those with frequent infections, particularly those who are methicillin resistant. Most people recommend a maximum of two to three times per week but only with an active infection. Care must be taken to avoid additional drying or irritation of the skin from bleach.”

Many bleach bath recipes call for adding one-eighth to one-half of a cup of bleach to a tub full or water.

Dr. Nicol disclosed that she has served as an advisory board member for Eli Lilly.

[email protected]

According to Noreen Heer Nicol, PhD, RN, FNP, frustration still exists for patients, families, and health care providers regarding the lack of consensus that routine bathing is good for patients with atopic dermatitis.

monkeybusinessimages/Getty Images

During the Revolutionizing Atopic Dermatitis symposium, she said that conflicting and vague guidelines currently exist on the topic.

“This stems from the fact that we just don’t have good studies,” said Dr. Nicol, associate dean and associate professor of nursing at the University of Colorado at Denver, Aurora. “Particularly, we don’t have randomized, controlled trials on the effects of water and bathing. It’s not just parents that are frustrated, but health care providers are as well.”

In an observational analysis, researchers evaluated results from three online surveys of dermatologists, allergists, and immunologists, and primary care physicians regarding routine bathing frequency recommendations for children with AD. It found that PCPs recommended daily bathing less than 50% of the time, while specialists recommended daily bathing more than 50% of the time.

“It seems like the PCPs have embraced that old dermatology notion when bathing was avoided in patients with AD,” Dr. Nicol said. “This lack of consensus on the basic daily care steps in AD management causes a great deal of confusion amongst patients, families, and young health care providers, in particular,” she added.

She believes that this goes back to a century-long debate about the pros and cons of bathing in AD. “We used to say that bathing will dry the skin out if you take a bath or a shower without immediately applying something like a good moisturizer. That’s where the 3-minute rule came along from the National Eczema Association, meaning that bathing hydrates the stratum corneum if you take a bath or a shower and you immediately apply that good moisturizer within 3 minutes to retain that hydration and keep the barrier intact and flexible.”

Dr. Nicol presented a stepwise management model that she has published many times over the years (see Pediatr Nursing 2020;46[2]:92-8 and J Allergy Clin Immunol Pract 2019;7[1]:1-16).

Step 1 consists of basic care, including skin hydration/bathing, application of a daily moisturizer, avoiding irritants, and identifying and addressing specific triggers. “This is the foundation for every step as you go forward,” she explained. Soak and seal has been a mainstay of treatment at National Jewish Health, she noted. “By that, I mean taking a soaking 10-15 minute bath in warm water daily. Gently pat away excess water. Immediately apply skin medications or moisturizer within 3 minutes. Using a gentle fragrance-free, dye-free cleanser to clean skin is also important. Avoid scrubbing.”

A review article on bathing and associated treatments in AD was published in 2017 and includes 144 references to bathing studies. A separate recommendation known as the “AD Yardstick” published by Dr. Nicol’s colleague at National Jewish Health, Mark Boguniewicz, MD, and coauthors, elaborated on the definition of basic skin care for nonlesional AD. Besides recommending the liberal and frequent application of moisturizers, it suggests management with warm baths or showers using nonsoap cleansers, usually once per day, followed by application of a moisturizer, even on clear areas.

“This is now what people are thinking as the basis of skin care in patients with AD,” Dr. Nicol said. “Warm baths and showers don’t look so controversial anymore. This model nicely lays out what we want people to remember. In the past, many times we just skipped that important step of telling people about bathing.”

In a small 2009 study, researchers conducted a quantitative assessment of combination bathing and moisturizing regimens on skin hydration in AD. They found that bathing followed by application of a moisturizer provides modest hydration benefits, though less than that of simply applying moisturizer alone. “That has not been the case for most of us who are bathing advocates,” Dr. Nicol said. “We believe that there is an additional hydration that’s gained from bathing and moisturizers done properly.”

In an earlier retrospective study of 28 patients referred to a tertiary care center for refractory chronic pruritic eruptions, researchers found that a plain-water 20-minute soak followed by smearing of midstrength corticosteroid ointment led to clearing or dramatic improvement of the lesions (Arch Dermatol 2005;14:1556-9). The authors recommended prospective studies to confirm the findings.

In a separate review of medical literature, researchers explored the role of frequent bathing in the treatment of pediatric AD (Ann Allergy Asthma Immunol 2016;117[1]:9-13). They found that the weight of evidence suggests that the frequent soak and smear bathing is preferred to infrequent bathing in the management of AD. Frequent bathing was defined as bathing at least once a day, while infrequent bathing was defined as bathing less than once a day.

“Bleach baths have received much attention in recent years, and have been endorsed by multiple AD guidelines, though not to the same degree as regular bathing,” Dr. Nicol said. “Right now, you can find almost as much literature for this practice as against it. The populations that seem to value from beach baths the most, however, are those with frequent infections, particularly those who are methicillin resistant. Most people recommend a maximum of two to three times per week but only with an active infection. Care must be taken to avoid additional drying or irritation of the skin from bleach.”

Many bleach bath recipes call for adding one-eighth to one-half of a cup of bleach to a tub full or water.

Dr. Nicol disclosed that she has served as an advisory board member for Eli Lilly.

[email protected]

According to Noreen Heer Nicol, PhD, RN, FNP, frustration still exists for patients, families, and health care providers regarding the lack of consensus that routine bathing is good for patients with atopic dermatitis.

monkeybusinessimages/Getty Images

During the Revolutionizing Atopic Dermatitis symposium, she said that conflicting and vague guidelines currently exist on the topic.

“This stems from the fact that we just don’t have good studies,” said Dr. Nicol, associate dean and associate professor of nursing at the University of Colorado at Denver, Aurora. “Particularly, we don’t have randomized, controlled trials on the effects of water and bathing. It’s not just parents that are frustrated, but health care providers are as well.”

In an observational analysis, researchers evaluated results from three online surveys of dermatologists, allergists, and immunologists, and primary care physicians regarding routine bathing frequency recommendations for children with AD. It found that PCPs recommended daily bathing less than 50% of the time, while specialists recommended daily bathing more than 50% of the time.

“It seems like the PCPs have embraced that old dermatology notion when bathing was avoided in patients with AD,” Dr. Nicol said. “This lack of consensus on the basic daily care steps in AD management causes a great deal of confusion amongst patients, families, and young health care providers, in particular,” she added.

She believes that this goes back to a century-long debate about the pros and cons of bathing in AD. “We used to say that bathing will dry the skin out if you take a bath or a shower without immediately applying something like a good moisturizer. That’s where the 3-minute rule came along from the National Eczema Association, meaning that bathing hydrates the stratum corneum if you take a bath or a shower and you immediately apply that good moisturizer within 3 minutes to retain that hydration and keep the barrier intact and flexible.”

Dr. Nicol presented a stepwise management model that she has published many times over the years (see Pediatr Nursing 2020;46[2]:92-8 and J Allergy Clin Immunol Pract 2019;7[1]:1-16).

Step 1 consists of basic care, including skin hydration/bathing, application of a daily moisturizer, avoiding irritants, and identifying and addressing specific triggers. “This is the foundation for every step as you go forward,” she explained. Soak and seal has been a mainstay of treatment at National Jewish Health, she noted. “By that, I mean taking a soaking 10-15 minute bath in warm water daily. Gently pat away excess water. Immediately apply skin medications or moisturizer within 3 minutes. Using a gentle fragrance-free, dye-free cleanser to clean skin is also important. Avoid scrubbing.”

A review article on bathing and associated treatments in AD was published in 2017 and includes 144 references to bathing studies. A separate recommendation known as the “AD Yardstick” published by Dr. Nicol’s colleague at National Jewish Health, Mark Boguniewicz, MD, and coauthors, elaborated on the definition of basic skin care for nonlesional AD. Besides recommending the liberal and frequent application of moisturizers, it suggests management with warm baths or showers using nonsoap cleansers, usually once per day, followed by application of a moisturizer, even on clear areas.

“This is now what people are thinking as the basis of skin care in patients with AD,” Dr. Nicol said. “Warm baths and showers don’t look so controversial anymore. This model nicely lays out what we want people to remember. In the past, many times we just skipped that important step of telling people about bathing.”

In a small 2009 study, researchers conducted a quantitative assessment of combination bathing and moisturizing regimens on skin hydration in AD. They found that bathing followed by application of a moisturizer provides modest hydration benefits, though less than that of simply applying moisturizer alone. “That has not been the case for most of us who are bathing advocates,” Dr. Nicol said. “We believe that there is an additional hydration that’s gained from bathing and moisturizers done properly.”

In an earlier retrospective study of 28 patients referred to a tertiary care center for refractory chronic pruritic eruptions, researchers found that a plain-water 20-minute soak followed by smearing of midstrength corticosteroid ointment led to clearing or dramatic improvement of the lesions (Arch Dermatol 2005;14:1556-9). The authors recommended prospective studies to confirm the findings.

In a separate review of medical literature, researchers explored the role of frequent bathing in the treatment of pediatric AD (Ann Allergy Asthma Immunol 2016;117[1]:9-13). They found that the weight of evidence suggests that the frequent soak and smear bathing is preferred to infrequent bathing in the management of AD. Frequent bathing was defined as bathing at least once a day, while infrequent bathing was defined as bathing less than once a day.

“Bleach baths have received much attention in recent years, and have been endorsed by multiple AD guidelines, though not to the same degree as regular bathing,” Dr. Nicol said. “Right now, you can find almost as much literature for this practice as against it. The populations that seem to value from beach baths the most, however, are those with frequent infections, particularly those who are methicillin resistant. Most people recommend a maximum of two to three times per week but only with an active infection. Care must be taken to avoid additional drying or irritation of the skin from bleach.”

Many bleach bath recipes call for adding one-eighth to one-half of a cup of bleach to a tub full or water.

Dr. Nicol disclosed that she has served as an advisory board member for Eli Lilly.

[email protected]

As mutated strains of the coronavirus represent new threats in the pandemic, vaccine makers are racing to respond.

Moderna, whose two-dose vaccine has been authorized for use in the United States since Dec. 18, said on Jan. 25 that it is now investigating whether a third dose of the vaccine will better prevent the spread of a variant first seen in South Africa, while it also tests a new vaccine formula for the same purpose.

“Out of an abundance of caution and leveraging the flexibility of our mRNA platform, we are advancing an emerging variant booster candidate against the variant first identified in the Republic of South Africa into the clinic to determine if it will be more effective … against this and potentially future variants,” Moderna CEO Stéphane Bancel said in a statement. Pfizer and BioNTech, whose vaccine was also authorized in December, announced on Jan. 20 that their COVID-19 vaccine creates antibodies that could protect vaccine recipients from the U.K. variant B.1.1.7.

Moderna on Jan. 25 said laboratory tests have shown its COVID-19 vaccine could protect against the U.K. strain but that it is less effective – while still meeting efficacy benchmarks – against the strain identified in South Africa. Data from the study were submitted to a preprint server on Jan. 25 but have not yet been peer reviewed.

“This is not a problem yet,” Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNBC.

“Prepare for it. Sequence these viruses,” he said. “Get ready just in case a variant emerges, which is resistant.”

There were at least 195 confirmed cases of patients infected with the U.K. variant, which is believed to be as much as 70% more transmissible, in the United States as of Jan. 22, according to the Centers for Disease Control and Prevention. No cases from the South African variant have been confirmed in the United States. To try to prevent the variant from entering the country, President Joe Biden plans to ban travel from South Africa, except for American citizens and permanent residents.

The U.S. has reported more than 25 million total COVID-19 cases, according to data from Johns Hopkins University, marking another major milestone during the pandemic.

That means about 1 in 13 people have contracted the virus, or about 7.6% of the U.S. population.

“Twenty-five million cases is an incredible scale of tragedy,” Caitlin Rivers, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told The New York Times. She called the pandemic one of the worst public health crises in history.

After the first U.S. case was reported in January 2020, it took more than 9 months to reach 10 million cases in early November. Numbers rose during the holidays, and 10 million more cases were reported by the end of the year.

Following a major surge throughout January 2021, with a peak of more than 300,000 daily cases on some days, the U.S. reached 25 million in about 3 weeks.

Hospitalizations also peaked in early January, with more than 132,000 COVID-19 patients in hospitals across the country, according to the COVID Tracking Project. On Jan. 24, about 111,000 patients were hospitalized, which is the lowest since mid-December.

The U.S. has also reported nearly 420,000 deaths. As recently as the week starting Jan. 17, more than 4,400 deaths were reported in a single day, according to the COVID Tracking Project. Deaths are beginning to drop but still remain above 3,000 daily.

The University of Washington’s Institute for Health Metrics and Evaluation released a new projection Jan. 22 that said new cases would decline steadily in coming weeks. New COVID-19 cases had fallen about 21% in 2 weeks prior to Jan. 25, according to an analysis by The New York Times.

“We’ve been saying since summer that we thought we’d see a peak in January, and I think that, at the national level, we’re around the peak,” Christopher J.L. Murray, MD, director of the institute, told the newspaper.

At the same time, public health officials are concerned that new coronavirus variants could lead to an increase again. Dr. Murray said the variants could “totally change the story.” If the more transmissible strains spread quickly, cases and deaths will surge once more.

“We’re definitely on a downward slope, but I’m worried that the new variants will throw us a curveball in late February or March,” Ms. Rivers told the newspaper.
 

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

As mutated strains of the coronavirus represent new threats in the pandemic, vaccine makers are racing to respond.

Moderna, whose two-dose vaccine has been authorized for use in the United States since Dec. 18, said on Jan. 25 that it is now investigating whether a third dose of the vaccine will better prevent the spread of a variant first seen in South Africa, while it also tests a new vaccine formula for the same purpose.

“Out of an abundance of caution and leveraging the flexibility of our mRNA platform, we are advancing an emerging variant booster candidate against the variant first identified in the Republic of South Africa into the clinic to determine if it will be more effective … against this and potentially future variants,” Moderna CEO Stéphane Bancel said in a statement. Pfizer and BioNTech, whose vaccine was also authorized in December, announced on Jan. 20 that their COVID-19 vaccine creates antibodies that could protect vaccine recipients from the U.K. variant B.1.1.7.

Moderna on Jan. 25 said laboratory tests have shown its COVID-19 vaccine could protect against the U.K. strain but that it is less effective – while still meeting efficacy benchmarks – against the strain identified in South Africa. Data from the study were submitted to a preprint server on Jan. 25 but have not yet been peer reviewed.

“This is not a problem yet,” Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNBC.

“Prepare for it. Sequence these viruses,” he said. “Get ready just in case a variant emerges, which is resistant.”

There were at least 195 confirmed cases of patients infected with the U.K. variant, which is believed to be as much as 70% more transmissible, in the United States as of Jan. 22, according to the Centers for Disease Control and Prevention. No cases from the South African variant have been confirmed in the United States. To try to prevent the variant from entering the country, President Joe Biden plans to ban travel from South Africa, except for American citizens and permanent residents.

The U.S. has reported more than 25 million total COVID-19 cases, according to data from Johns Hopkins University, marking another major milestone during the pandemic.

That means about 1 in 13 people have contracted the virus, or about 7.6% of the U.S. population.

“Twenty-five million cases is an incredible scale of tragedy,” Caitlin Rivers, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told The New York Times. She called the pandemic one of the worst public health crises in history.

After the first U.S. case was reported in January 2020, it took more than 9 months to reach 10 million cases in early November. Numbers rose during the holidays, and 10 million more cases were reported by the end of the year.

Following a major surge throughout January 2021, with a peak of more than 300,000 daily cases on some days, the U.S. reached 25 million in about 3 weeks.

Hospitalizations also peaked in early January, with more than 132,000 COVID-19 patients in hospitals across the country, according to the COVID Tracking Project. On Jan. 24, about 111,000 patients were hospitalized, which is the lowest since mid-December.

The U.S. has also reported nearly 420,000 deaths. As recently as the week starting Jan. 17, more than 4,400 deaths were reported in a single day, according to the COVID Tracking Project. Deaths are beginning to drop but still remain above 3,000 daily.

The University of Washington’s Institute for Health Metrics and Evaluation released a new projection Jan. 22 that said new cases would decline steadily in coming weeks. New COVID-19 cases had fallen about 21% in 2 weeks prior to Jan. 25, according to an analysis by The New York Times.

“We’ve been saying since summer that we thought we’d see a peak in January, and I think that, at the national level, we’re around the peak,” Christopher J.L. Murray, MD, director of the institute, told the newspaper.

At the same time, public health officials are concerned that new coronavirus variants could lead to an increase again. Dr. Murray said the variants could “totally change the story.” If the more transmissible strains spread quickly, cases and deaths will surge once more.

“We’re definitely on a downward slope, but I’m worried that the new variants will throw us a curveball in late February or March,” Ms. Rivers told the newspaper.
 

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

As mutated strains of the coronavirus represent new threats in the pandemic, vaccine makers are racing to respond.

Moderna, whose two-dose vaccine has been authorized for use in the United States since Dec. 18, said on Jan. 25 that it is now investigating whether a third dose of the vaccine will better prevent the spread of a variant first seen in South Africa, while it also tests a new vaccine formula for the same purpose.

“Out of an abundance of caution and leveraging the flexibility of our mRNA platform, we are advancing an emerging variant booster candidate against the variant first identified in the Republic of South Africa into the clinic to determine if it will be more effective … against this and potentially future variants,” Moderna CEO Stéphane Bancel said in a statement. Pfizer and BioNTech, whose vaccine was also authorized in December, announced on Jan. 20 that their COVID-19 vaccine creates antibodies that could protect vaccine recipients from the U.K. variant B.1.1.7.

Moderna on Jan. 25 said laboratory tests have shown its COVID-19 vaccine could protect against the U.K. strain but that it is less effective – while still meeting efficacy benchmarks – against the strain identified in South Africa. Data from the study were submitted to a preprint server on Jan. 25 but have not yet been peer reviewed.

“This is not a problem yet,” Paul Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told CNBC.

“Prepare for it. Sequence these viruses,” he said. “Get ready just in case a variant emerges, which is resistant.”

There were at least 195 confirmed cases of patients infected with the U.K. variant, which is believed to be as much as 70% more transmissible, in the United States as of Jan. 22, according to the Centers for Disease Control and Prevention. No cases from the South African variant have been confirmed in the United States. To try to prevent the variant from entering the country, President Joe Biden plans to ban travel from South Africa, except for American citizens and permanent residents.

The U.S. has reported more than 25 million total COVID-19 cases, according to data from Johns Hopkins University, marking another major milestone during the pandemic.

That means about 1 in 13 people have contracted the virus, or about 7.6% of the U.S. population.

“Twenty-five million cases is an incredible scale of tragedy,” Caitlin Rivers, an epidemiologist at the Johns Hopkins Bloomberg School of Public Health, told The New York Times. She called the pandemic one of the worst public health crises in history.

After the first U.S. case was reported in January 2020, it took more than 9 months to reach 10 million cases in early November. Numbers rose during the holidays, and 10 million more cases were reported by the end of the year.

Following a major surge throughout January 2021, with a peak of more than 300,000 daily cases on some days, the U.S. reached 25 million in about 3 weeks.

Hospitalizations also peaked in early January, with more than 132,000 COVID-19 patients in hospitals across the country, according to the COVID Tracking Project. On Jan. 24, about 111,000 patients were hospitalized, which is the lowest since mid-December.

The U.S. has also reported nearly 420,000 deaths. As recently as the week starting Jan. 17, more than 4,400 deaths were reported in a single day, according to the COVID Tracking Project. Deaths are beginning to drop but still remain above 3,000 daily.

The University of Washington’s Institute for Health Metrics and Evaluation released a new projection Jan. 22 that said new cases would decline steadily in coming weeks. New COVID-19 cases had fallen about 21% in 2 weeks prior to Jan. 25, according to an analysis by The New York Times.

“We’ve been saying since summer that we thought we’d see a peak in January, and I think that, at the national level, we’re around the peak,” Christopher J.L. Murray, MD, director of the institute, told the newspaper.

At the same time, public health officials are concerned that new coronavirus variants could lead to an increase again. Dr. Murray said the variants could “totally change the story.” If the more transmissible strains spread quickly, cases and deaths will surge once more.

“We’re definitely on a downward slope, but I’m worried that the new variants will throw us a curveball in late February or March,” Ms. Rivers told the newspaper.
 

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

A systematic review suggests at least one-third of SARS-CoV-2 infections occur in people who never develop symptoms, providing strong evidence for the prevalence of asymptomatic infections.

The finding that nearly one in three infected people remain symptom free suggests testing should be changed, the investigators noted.

“To reduce transmission from people who are presymptomatic or asymptomatic, we need to shift our testing focus to at-home screening,” lead author Daniel Oran, AM, said in an interview. “Inexpensive rapid antigen tests, provided to millions of people for frequent use, could help us significantly reduce the spread of the virus.”

The systematic review was published online Jan. 22 in Annals of Internal Medicine.

The findings come at a dire time when the official number of COVID-19 cases in the United States exceeds 25 million for the first time. Public health officials have raised concerns about more transmissible, and possibly more deadly, variants of SARS-CoV-2, while a new presidential administration tries to meet the challenge of improving vaccine distribution and acceptance rates.

The results also build on earlier findings from the same research team – Mr. Oran and senior author Eric Topol, MD – that published a review article looking at asymptomatic COVID-19 cases. Even though initial data were more limited, they likewise suggested a broader scope of testing is warranted, pointing out that asymptomatic individuals can transmit SARS-CoV-2 for up to 14 days. Dr. Topol is also editor in chief of Medscape.

In the current systematic review, the highest-quality evidence comes from large studies in England and Spain. The nationally representative evidence included serologic surveys from more than 365,000 people in England and more than 61,000 in Spain. When analyzed separately, about the same proportion of asymptomatic cases emerged: 32.4% in England and 33% in Spain.

“It was really remarkable to find that nationwide antibody testing studies in England and Spain – including hundreds of thousands of people – produced nearly identical results: About one-third of the SARS-CoV-2 infections were completely asymptomatic,” said Mr. Oran, a researcher at Scripps Research Translational Institute in La Jolla, Calif.

The systematic review included 43 studies with PCR testing for active SARS-CoV-2 infection and another 18 with antibody results that indicated present or previous infection. The studies were published up until Nov. 17, 2020.

An appreciation for asymptomatic transmission of SARS-CoV-2 infection has come a long way from initial dismissals about its importance, Dr. Topol noted via Twitter. “When Dr. @camilla_rothe reported an asymptomatic transmission a year ago, the @NEJM report was refuted and disparaged. She was later named a TIME 100 Person of the Year.”
 

Not symptomatic vs. never symptomatic

The term “asymptomatic” could be misleading because some people in this group do progress to develop signs of infection. This “presymptomatic” group of patients is likely a minority, the authors noted. Longitudinal studies indicate that about three-quarters of people who are asymptomatic with SARS-CoV-2 remain so.

Dr. Topol anticipated the one-third asymptomatic finding could draw some feedback about distinguishing asymptomatic from presymptomatic individuals. He tweeted, “Some will argue that there is admixture with presymptomatic cases, but review of all the data supports this estimate as being a conservative one.”

The heterogeneity of the settings, populations and other features of the studies prevented the authors from performing a meta-analysis of the findings.
 

Home is where the test is

Based on their findings, Mr. Oran and Dr. Topol believe “that COVID-19 control strategies must be altered, taking into account the prevalence and transmission risk of asymptomatic SARS-CoV-2 infection.” They suggested frequent use of inexpensive, rapid home tests to identify people who are asymptomatic or presymptomatic, along with programs and housing provided by the government to offer financial assistance and allow this group of people to isolate themselves.

Further research is warranted to determine if and how well vaccines for SARS-CoV-2 prevent asymptomatic infection.

Dr. Topol and Mr. Oran created a short video to highlight the findings from their systematic review.

The study was supported by a grant from the National Institutes of Health.

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

A systematic review suggests at least one-third of SARS-CoV-2 infections occur in people who never develop symptoms, providing strong evidence for the prevalence of asymptomatic infections.

The finding that nearly one in three infected people remain symptom free suggests testing should be changed, the investigators noted.

“To reduce transmission from people who are presymptomatic or asymptomatic, we need to shift our testing focus to at-home screening,” lead author Daniel Oran, AM, said in an interview. “Inexpensive rapid antigen tests, provided to millions of people for frequent use, could help us significantly reduce the spread of the virus.”

The systematic review was published online Jan. 22 in Annals of Internal Medicine.

The findings come at a dire time when the official number of COVID-19 cases in the United States exceeds 25 million for the first time. Public health officials have raised concerns about more transmissible, and possibly more deadly, variants of SARS-CoV-2, while a new presidential administration tries to meet the challenge of improving vaccine distribution and acceptance rates.

The results also build on earlier findings from the same research team – Mr. Oran and senior author Eric Topol, MD – that published a review article looking at asymptomatic COVID-19 cases. Even though initial data were more limited, they likewise suggested a broader scope of testing is warranted, pointing out that asymptomatic individuals can transmit SARS-CoV-2 for up to 14 days. Dr. Topol is also editor in chief of Medscape.

In the current systematic review, the highest-quality evidence comes from large studies in England and Spain. The nationally representative evidence included serologic surveys from more than 365,000 people in England and more than 61,000 in Spain. When analyzed separately, about the same proportion of asymptomatic cases emerged: 32.4% in England and 33% in Spain.

“It was really remarkable to find that nationwide antibody testing studies in England and Spain – including hundreds of thousands of people – produced nearly identical results: About one-third of the SARS-CoV-2 infections were completely asymptomatic,” said Mr. Oran, a researcher at Scripps Research Translational Institute in La Jolla, Calif.

The systematic review included 43 studies with PCR testing for active SARS-CoV-2 infection and another 18 with antibody results that indicated present or previous infection. The studies were published up until Nov. 17, 2020.

An appreciation for asymptomatic transmission of SARS-CoV-2 infection has come a long way from initial dismissals about its importance, Dr. Topol noted via Twitter. “When Dr. @camilla_rothe reported an asymptomatic transmission a year ago, the @NEJM report was refuted and disparaged. She was later named a TIME 100 Person of the Year.”
 

Not symptomatic vs. never symptomatic

The term “asymptomatic” could be misleading because some people in this group do progress to develop signs of infection. This “presymptomatic” group of patients is likely a minority, the authors noted. Longitudinal studies indicate that about three-quarters of people who are asymptomatic with SARS-CoV-2 remain so.

Dr. Topol anticipated the one-third asymptomatic finding could draw some feedback about distinguishing asymptomatic from presymptomatic individuals. He tweeted, “Some will argue that there is admixture with presymptomatic cases, but review of all the data supports this estimate as being a conservative one.”

The heterogeneity of the settings, populations and other features of the studies prevented the authors from performing a meta-analysis of the findings.
 

Home is where the test is

Based on their findings, Mr. Oran and Dr. Topol believe “that COVID-19 control strategies must be altered, taking into account the prevalence and transmission risk of asymptomatic SARS-CoV-2 infection.” They suggested frequent use of inexpensive, rapid home tests to identify people who are asymptomatic or presymptomatic, along with programs and housing provided by the government to offer financial assistance and allow this group of people to isolate themselves.

Further research is warranted to determine if and how well vaccines for SARS-CoV-2 prevent asymptomatic infection.

Dr. Topol and Mr. Oran created a short video to highlight the findings from their systematic review.

The study was supported by a grant from the National Institutes of Health.

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

A systematic review suggests at least one-third of SARS-CoV-2 infections occur in people who never develop symptoms, providing strong evidence for the prevalence of asymptomatic infections.

The finding that nearly one in three infected people remain symptom free suggests testing should be changed, the investigators noted.

“To reduce transmission from people who are presymptomatic or asymptomatic, we need to shift our testing focus to at-home screening,” lead author Daniel Oran, AM, said in an interview. “Inexpensive rapid antigen tests, provided to millions of people for frequent use, could help us significantly reduce the spread of the virus.”

The systematic review was published online Jan. 22 in Annals of Internal Medicine.

The findings come at a dire time when the official number of COVID-19 cases in the United States exceeds 25 million for the first time. Public health officials have raised concerns about more transmissible, and possibly more deadly, variants of SARS-CoV-2, while a new presidential administration tries to meet the challenge of improving vaccine distribution and acceptance rates.

The results also build on earlier findings from the same research team – Mr. Oran and senior author Eric Topol, MD – that published a review article looking at asymptomatic COVID-19 cases. Even though initial data were more limited, they likewise suggested a broader scope of testing is warranted, pointing out that asymptomatic individuals can transmit SARS-CoV-2 for up to 14 days. Dr. Topol is also editor in chief of Medscape.

In the current systematic review, the highest-quality evidence comes from large studies in England and Spain. The nationally representative evidence included serologic surveys from more than 365,000 people in England and more than 61,000 in Spain. When analyzed separately, about the same proportion of asymptomatic cases emerged: 32.4% in England and 33% in Spain.

“It was really remarkable to find that nationwide antibody testing studies in England and Spain – including hundreds of thousands of people – produced nearly identical results: About one-third of the SARS-CoV-2 infections were completely asymptomatic,” said Mr. Oran, a researcher at Scripps Research Translational Institute in La Jolla, Calif.

The systematic review included 43 studies with PCR testing for active SARS-CoV-2 infection and another 18 with antibody results that indicated present or previous infection. The studies were published up until Nov. 17, 2020.

An appreciation for asymptomatic transmission of SARS-CoV-2 infection has come a long way from initial dismissals about its importance, Dr. Topol noted via Twitter. “When Dr. @camilla_rothe reported an asymptomatic transmission a year ago, the @NEJM report was refuted and disparaged. She was later named a TIME 100 Person of the Year.”
 

Not symptomatic vs. never symptomatic

The term “asymptomatic” could be misleading because some people in this group do progress to develop signs of infection. This “presymptomatic” group of patients is likely a minority, the authors noted. Longitudinal studies indicate that about three-quarters of people who are asymptomatic with SARS-CoV-2 remain so.

Dr. Topol anticipated the one-third asymptomatic finding could draw some feedback about distinguishing asymptomatic from presymptomatic individuals. He tweeted, “Some will argue that there is admixture with presymptomatic cases, but review of all the data supports this estimate as being a conservative one.”

The heterogeneity of the settings, populations and other features of the studies prevented the authors from performing a meta-analysis of the findings.
 

Home is where the test is

Based on their findings, Mr. Oran and Dr. Topol believe “that COVID-19 control strategies must be altered, taking into account the prevalence and transmission risk of asymptomatic SARS-CoV-2 infection.” They suggested frequent use of inexpensive, rapid home tests to identify people who are asymptomatic or presymptomatic, along with programs and housing provided by the government to offer financial assistance and allow this group of people to isolate themselves.

Further research is warranted to determine if and how well vaccines for SARS-CoV-2 prevent asymptomatic infection.

Dr. Topol and Mr. Oran created a short video to highlight the findings from their systematic review.

The study was supported by a grant from the National Institutes of Health.

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

Both patients in contact with primary care physicians and patient contact with these physicians in any form – including in office or over the phone – declined over 2-year periods occurring from 2002 to 2017.

The reasons for this less frequent contact and the ramifications for patients and doctors practicing primary care are unclear, according to various experts. But some offered possible explanations for the changes, with patients’ increased participation in high deductible plans and shortages in primary care physicians (PCPs) being among the most often cited.

The findings, which were published online Jan. 11 in Annals of Family Medicine, were derived from researchers using a repeated cross-sectional study of the 2002-2017 Medical Expenditure Panel Survey to characterize trends in primary care use. This survey, which collected information about medical care utilization from individuals and families, included 243,919 participants who were interviewed five times over 2 years. The authors defined primary care physician contact as “in-person visit or contact with a primary care physician (primarily telephone calls) with a reported specialty of family medicine, general internal medicine, geriatrics, general pediatrics, or general practice physician.” According to the paper, “the proportion of individuals with any primary care physician contact was determined for both the population and by age group using logistic regression models,” and negative binomial regression models were used to determine the number of contacts among people with visits during 2-year periods.

The study authors, Michael E. Johansen, MD, MS, and Joshua D. Niforatos, MD, MTS, said their study suggests that previously reported decreases in primary care contact was caused by fewer contacts per patient “as opposed to an absolute decrease in the number of patients in contact with primary care.”

Harold B. Betton, MD, PhD, who practices family medicine in Little Rock, Ark., questioned this claim.

"The paper draws observational conclusions and I fail to see the merit in the observation without knowing what the respondents were asked and not asked," he added. 

Other primary care physicians suggested patients’ participation in alternative pay models and high-deductible plans have played a factor in the declines.

Courtesy of Ada Stewart, MD

“Most of us have gone from fee-for-service, volume-based care to more value-based care,” Ada D. Stewart, MD, president of the American Academy of Family Physicians, said in an interview. The data reflect that trend, “whereas we were rewarded more for the number of people we were seeing, now we are trying to get towards more of the value that we provide,” suggested Dr. Stewart, who also practices family medicine with Cooperative Health in Columbia, S.C.

“Given the rise of high-deductible plans and copays, it is not surprising that younger patients, a generally healthier population, might well decrease their visits to a primary care physician. I would suspect that data for patients over 50 might well be different,” William E. Golden, MD, who is medical director at the Arkansas Department of Health & Human Services, noted in an interview.

Eileen Barrett, MD, MPH, also cited greater participation in high-deductible plans as a possible factor that could be leading some patients to forgo visits, as well as increased financial insecurity, rendering it expensive to have the visit and also to take time from work for the visit.

“I would wonder if some of this is also due to how overloaded most primary care offices are so that instead of stopping accepting new patients or shedding patients, it is just harder for existing patients to be seen,” said Dr. Barrett, who is a general internist and associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque. “Some of this could be from administrative burden – 2 hours per hour of clinic – and consequently reducing clinical time,” continued Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, which is affiliated with Family Practice News.

Other experts pointed to data showing an insufficient supply of PCPs as a potential explanation for the new study’s findings. The Health Resources and Services Organization, for example, reported that 83 million Americans live in primary care “health professional shortage areas,” as of Jan. 24, 2021, on their website.
 

New data

“The rate of any contact with a [PCP] for patients in the population over multiple 2-year periods decreased by 2.5% over the study period (adjusted odds ratio, 0.99 per panel; 95% [confidence interval], 0.98-0.99; P < .001),” wrote Dr. Johansen and Dr. Niforatos. The rate of contact for patients aged 18-39 years (aOR, 0.99 per panel; 95% CI, 0.98-0.99; P < .001) and patients aged 40-64 years (aOR, 0.99 per panel; 95% CI, 0.99-1.00; P = .002), specifically, also fell. These decreased contact rates correspond “to a predicted cumulative 5% absolute decrease for the younger group and a 2% absolute decrease for the older group,” the authors added.

“The number of contacts with a [PCP] decreased among individuals with any contact by 0.5 contacts over 2 years (P < .001). A decrease in the number of [PCP] contacts was observed across all age groups (P < .001 for all), with the largest absolute decrease among individuals with higher contact rates (aged less than 4 years and aged greater than 64 years),” according to the paper.

Outlook for PCPs

Physicians questioned about how concerning these data are for the future of PCPs and their ability to keep their practices running were hesitant to speculate, because of uncertainty about the causes of the study findings.

“A quote from the paper indicates that the respondents were interviewed five times over 2 years; however, without a copy of the questionnaire it is impossible to know what they were asked and not asked,” said Dr. Betton, who also serves on the editorial advisory board of Family Practice News and runs his own private practice. “In addition, it is impossible for the reader to know whether they understood what a primary care physician was to do.

“To draw a conclusion that PCP visits are falling off per patient per provider is only helpful if patients are opting out of the primary care model of practice and opting in for point-of-care [urgent] care,” Dr. Betton added.

Internist Alan Nelson, MD, said he was also undecided about whether the findings of the study are good or bad news for the physician specialty of primary care.

“Similar findings have been reported by the Medicare Payment Advisory Commission. They certainly merit further investigation,” noted Dr. Nelson, who is a member of the editorial advisory board of Internal Medicine News. “Is it because primary care physicians are too busy to see additional patients? Is it because nonphysician practitioners seem to be more caring? Should residency training be modified, and if so, how? In the meantime, I would not be surprised if the trend continues, at least in the short term.”

Ann Greiner, president and CEO of the Primary Care Collaborative, a nonprofit organization that advocates to strengthen primary care and make it more responsive to patient needs and preferences, on the other hand, reacted with a concerned outlook for primary care.

This study and others show that “the U.S. health care system is moving away from a primary care orientation, and that is concerning,” Ms. Greiner said in an interview. “Health systems that are more oriented toward primary care have better population health outcomes, do better on measures of equity across different population groups, and are less costly.”
 

Authors’ take

“Future research is needed to determine whether fewer contacts per patient resulted in clinically meaningful differences in outcomes across disease processes,” wrote Dr. Johansen, who is a family medicine doctor affiliated with OhioHealth Family Medicine Grant in Columbus and with the Heritage College of Osteopathic Medicine at Ohio University, Dublin, and Dr. Niforatos, who is affiliated with the department of emergency medicine at Johns Hopkins University, Baltimore.

The study’s limitations included reliance on self-reported categorization of PCP versus specialty care physician contact, insufficient accounting for nurse practitioner and physician assistant contact, and improved contact reporting having started in 2013, they said.
 

How to grow patient contact

For those PCPs looking to grow their visits and patient contact, Dr. Golden suggested they strengthen their medical home model in their practice.

“Medical home models help and transform practice operations. The Arkansas model is a multipayer model – private, Medicaid and CPC+ (Medicare),” said Dr. Golden, who also serves on the editorial advisory board of Internal Medicine News. It includes community-based doctors, not Federally Qualified Health Centers, and “requires 24/7 live voice access that promotes regular contact with patients and can reduce dependency on ER and urgent care center visits.”

“Greater use of patient portals and email communications facilitate access and patient engagement with their PCP,” Dr. Golden explained.

 “Over the last 6 years, the Arkansas [patient-centered medical home] initiatives have altered culture and made our practice sites stronger to withstand COVID and other challenges. As our sites became more patient centered and incorporated behavioral health options, patients perceived greater value in the functionality of primary care” he said.

Dr. Barrett proposed PCPs participate in team-based care “for professional sustainability and also for patients to continue to experience high-quality, person-centered care.” She added that “telemedicine can also help practices maintain and increase patients, as it can lessen burden on patients and clinicians – if it is done right.”

“More flexible clinic hours is also key – after usual business hours and on weekends – but I would recommend in lieu of usual weekday hours and for those who can make it work with their family and other duties,” Dr. Barrett said. “Evening or Saturday morning clinic isn’t an option for everyone, but it is an option for many some of the time, and it would be great for access to care if it were available in more locations.”
 

Pandemic effect

The data examined by Dr. Johansen and Dr. Niforatos predates the pandemic, but PCPs interviewed by this news organization have seen declining patient contact occur in 2020 as well.

In fact, a survey of 1,485 mostly physician primary care practitioners that began after the pandemic onset found that 43% of participants have fewer in-person visits, motivated largely by patient preferences (66%) and safety concerns (74%). This ongoing survey, which was conducted by the Larry Green Center in partnership with the Primary Care Collaborative, also indicated that, while 25% of participants saw a total increase in patient volume, more than half of primary care practitioners reported that chronic and wellness visits are down, 53% and 55%, respectively.

“Sometimes we have to go looking for our patients when we have not seen them in a while,” Dr. Stewart noted. “We saw that with COVID because people were fearful of coming into our offices, and we had to have some outreach.”

The study authors had no conflicts of interest. Dr. Barrett, Dr. Betton, Dr. Golden, Dr. Nelson, and Dr. Stewart had no relevant disclosures.

Jake Remaly contributed to this article.

[email protected]

Both patients in contact with primary care physicians and patient contact with these physicians in any form – including in office or over the phone – declined over 2-year periods occurring from 2002 to 2017.

The reasons for this less frequent contact and the ramifications for patients and doctors practicing primary care are unclear, according to various experts. But some offered possible explanations for the changes, with patients’ increased participation in high deductible plans and shortages in primary care physicians (PCPs) being among the most often cited.

The findings, which were published online Jan. 11 in Annals of Family Medicine, were derived from researchers using a repeated cross-sectional study of the 2002-2017 Medical Expenditure Panel Survey to characterize trends in primary care use. This survey, which collected information about medical care utilization from individuals and families, included 243,919 participants who were interviewed five times over 2 years. The authors defined primary care physician contact as “in-person visit or contact with a primary care physician (primarily telephone calls) with a reported specialty of family medicine, general internal medicine, geriatrics, general pediatrics, or general practice physician.” According to the paper, “the proportion of individuals with any primary care physician contact was determined for both the population and by age group using logistic regression models,” and negative binomial regression models were used to determine the number of contacts among people with visits during 2-year periods.

The study authors, Michael E. Johansen, MD, MS, and Joshua D. Niforatos, MD, MTS, said their study suggests that previously reported decreases in primary care contact was caused by fewer contacts per patient “as opposed to an absolute decrease in the number of patients in contact with primary care.”

Harold B. Betton, MD, PhD, who practices family medicine in Little Rock, Ark., questioned this claim.

"The paper draws observational conclusions and I fail to see the merit in the observation without knowing what the respondents were asked and not asked," he added. 

Other primary care physicians suggested patients’ participation in alternative pay models and high-deductible plans have played a factor in the declines.

Courtesy of Ada Stewart, MD

“Most of us have gone from fee-for-service, volume-based care to more value-based care,” Ada D. Stewart, MD, president of the American Academy of Family Physicians, said in an interview. The data reflect that trend, “whereas we were rewarded more for the number of people we were seeing, now we are trying to get towards more of the value that we provide,” suggested Dr. Stewart, who also practices family medicine with Cooperative Health in Columbia, S.C.

“Given the rise of high-deductible plans and copays, it is not surprising that younger patients, a generally healthier population, might well decrease their visits to a primary care physician. I would suspect that data for patients over 50 might well be different,” William E. Golden, MD, who is medical director at the Arkansas Department of Health & Human Services, noted in an interview.

Eileen Barrett, MD, MPH, also cited greater participation in high-deductible plans as a possible factor that could be leading some patients to forgo visits, as well as increased financial insecurity, rendering it expensive to have the visit and also to take time from work for the visit.

“I would wonder if some of this is also due to how overloaded most primary care offices are so that instead of stopping accepting new patients or shedding patients, it is just harder for existing patients to be seen,” said Dr. Barrett, who is a general internist and associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque. “Some of this could be from administrative burden – 2 hours per hour of clinic – and consequently reducing clinical time,” continued Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, which is affiliated with Family Practice News.

Other experts pointed to data showing an insufficient supply of PCPs as a potential explanation for the new study’s findings. The Health Resources and Services Organization, for example, reported that 83 million Americans live in primary care “health professional shortage areas,” as of Jan. 24, 2021, on their website.
 

New data

“The rate of any contact with a [PCP] for patients in the population over multiple 2-year periods decreased by 2.5% over the study period (adjusted odds ratio, 0.99 per panel; 95% [confidence interval], 0.98-0.99; P < .001),” wrote Dr. Johansen and Dr. Niforatos. The rate of contact for patients aged 18-39 years (aOR, 0.99 per panel; 95% CI, 0.98-0.99; P < .001) and patients aged 40-64 years (aOR, 0.99 per panel; 95% CI, 0.99-1.00; P = .002), specifically, also fell. These decreased contact rates correspond “to a predicted cumulative 5% absolute decrease for the younger group and a 2% absolute decrease for the older group,” the authors added.

“The number of contacts with a [PCP] decreased among individuals with any contact by 0.5 contacts over 2 years (P < .001). A decrease in the number of [PCP] contacts was observed across all age groups (P < .001 for all), with the largest absolute decrease among individuals with higher contact rates (aged less than 4 years and aged greater than 64 years),” according to the paper.

Outlook for PCPs

Physicians questioned about how concerning these data are for the future of PCPs and their ability to keep their practices running were hesitant to speculate, because of uncertainty about the causes of the study findings.

“A quote from the paper indicates that the respondents were interviewed five times over 2 years; however, without a copy of the questionnaire it is impossible to know what they were asked and not asked,” said Dr. Betton, who also serves on the editorial advisory board of Family Practice News and runs his own private practice. “In addition, it is impossible for the reader to know whether they understood what a primary care physician was to do.

“To draw a conclusion that PCP visits are falling off per patient per provider is only helpful if patients are opting out of the primary care model of practice and opting in for point-of-care [urgent] care,” Dr. Betton added.

Internist Alan Nelson, MD, said he was also undecided about whether the findings of the study are good or bad news for the physician specialty of primary care.

“Similar findings have been reported by the Medicare Payment Advisory Commission. They certainly merit further investigation,” noted Dr. Nelson, who is a member of the editorial advisory board of Internal Medicine News. “Is it because primary care physicians are too busy to see additional patients? Is it because nonphysician practitioners seem to be more caring? Should residency training be modified, and if so, how? In the meantime, I would not be surprised if the trend continues, at least in the short term.”

Ann Greiner, president and CEO of the Primary Care Collaborative, a nonprofit organization that advocates to strengthen primary care and make it more responsive to patient needs and preferences, on the other hand, reacted with a concerned outlook for primary care.

This study and others show that “the U.S. health care system is moving away from a primary care orientation, and that is concerning,” Ms. Greiner said in an interview. “Health systems that are more oriented toward primary care have better population health outcomes, do better on measures of equity across different population groups, and are less costly.”
 

Authors’ take

“Future research is needed to determine whether fewer contacts per patient resulted in clinically meaningful differences in outcomes across disease processes,” wrote Dr. Johansen, who is a family medicine doctor affiliated with OhioHealth Family Medicine Grant in Columbus and with the Heritage College of Osteopathic Medicine at Ohio University, Dublin, and Dr. Niforatos, who is affiliated with the department of emergency medicine at Johns Hopkins University, Baltimore.

The study’s limitations included reliance on self-reported categorization of PCP versus specialty care physician contact, insufficient accounting for nurse practitioner and physician assistant contact, and improved contact reporting having started in 2013, they said.
 

How to grow patient contact

For those PCPs looking to grow their visits and patient contact, Dr. Golden suggested they strengthen their medical home model in their practice.

“Medical home models help and transform practice operations. The Arkansas model is a multipayer model – private, Medicaid and CPC+ (Medicare),” said Dr. Golden, who also serves on the editorial advisory board of Internal Medicine News. It includes community-based doctors, not Federally Qualified Health Centers, and “requires 24/7 live voice access that promotes regular contact with patients and can reduce dependency on ER and urgent care center visits.”

“Greater use of patient portals and email communications facilitate access and patient engagement with their PCP,” Dr. Golden explained.

 “Over the last 6 years, the Arkansas [patient-centered medical home] initiatives have altered culture and made our practice sites stronger to withstand COVID and other challenges. As our sites became more patient centered and incorporated behavioral health options, patients perceived greater value in the functionality of primary care” he said.

Dr. Barrett proposed PCPs participate in team-based care “for professional sustainability and also for patients to continue to experience high-quality, person-centered care.” She added that “telemedicine can also help practices maintain and increase patients, as it can lessen burden on patients and clinicians – if it is done right.”

“More flexible clinic hours is also key – after usual business hours and on weekends – but I would recommend in lieu of usual weekday hours and for those who can make it work with their family and other duties,” Dr. Barrett said. “Evening or Saturday morning clinic isn’t an option for everyone, but it is an option for many some of the time, and it would be great for access to care if it were available in more locations.”
 

Pandemic effect

The data examined by Dr. Johansen and Dr. Niforatos predates the pandemic, but PCPs interviewed by this news organization have seen declining patient contact occur in 2020 as well.

In fact, a survey of 1,485 mostly physician primary care practitioners that began after the pandemic onset found that 43% of participants have fewer in-person visits, motivated largely by patient preferences (66%) and safety concerns (74%). This ongoing survey, which was conducted by the Larry Green Center in partnership with the Primary Care Collaborative, also indicated that, while 25% of participants saw a total increase in patient volume, more than half of primary care practitioners reported that chronic and wellness visits are down, 53% and 55%, respectively.

“Sometimes we have to go looking for our patients when we have not seen them in a while,” Dr. Stewart noted. “We saw that with COVID because people were fearful of coming into our offices, and we had to have some outreach.”

The study authors had no conflicts of interest. Dr. Barrett, Dr. Betton, Dr. Golden, Dr. Nelson, and Dr. Stewart had no relevant disclosures.

Jake Remaly contributed to this article.

[email protected]

Both patients in contact with primary care physicians and patient contact with these physicians in any form – including in office or over the phone – declined over 2-year periods occurring from 2002 to 2017.

The reasons for this less frequent contact and the ramifications for patients and doctors practicing primary care are unclear, according to various experts. But some offered possible explanations for the changes, with patients’ increased participation in high deductible plans and shortages in primary care physicians (PCPs) being among the most often cited.

The findings, which were published online Jan. 11 in Annals of Family Medicine, were derived from researchers using a repeated cross-sectional study of the 2002-2017 Medical Expenditure Panel Survey to characterize trends in primary care use. This survey, which collected information about medical care utilization from individuals and families, included 243,919 participants who were interviewed five times over 2 years. The authors defined primary care physician contact as “in-person visit or contact with a primary care physician (primarily telephone calls) with a reported specialty of family medicine, general internal medicine, geriatrics, general pediatrics, or general practice physician.” According to the paper, “the proportion of individuals with any primary care physician contact was determined for both the population and by age group using logistic regression models,” and negative binomial regression models were used to determine the number of contacts among people with visits during 2-year periods.

The study authors, Michael E. Johansen, MD, MS, and Joshua D. Niforatos, MD, MTS, said their study suggests that previously reported decreases in primary care contact was caused by fewer contacts per patient “as opposed to an absolute decrease in the number of patients in contact with primary care.”

Harold B. Betton, MD, PhD, who practices family medicine in Little Rock, Ark., questioned this claim.

"The paper draws observational conclusions and I fail to see the merit in the observation without knowing what the respondents were asked and not asked," he added. 

Other primary care physicians suggested patients’ participation in alternative pay models and high-deductible plans have played a factor in the declines.

Courtesy of Ada Stewart, MD

“Most of us have gone from fee-for-service, volume-based care to more value-based care,” Ada D. Stewart, MD, president of the American Academy of Family Physicians, said in an interview. The data reflect that trend, “whereas we were rewarded more for the number of people we were seeing, now we are trying to get towards more of the value that we provide,” suggested Dr. Stewart, who also practices family medicine with Cooperative Health in Columbia, S.C.

“Given the rise of high-deductible plans and copays, it is not surprising that younger patients, a generally healthier population, might well decrease their visits to a primary care physician. I would suspect that data for patients over 50 might well be different,” William E. Golden, MD, who is medical director at the Arkansas Department of Health & Human Services, noted in an interview.

Eileen Barrett, MD, MPH, also cited greater participation in high-deductible plans as a possible factor that could be leading some patients to forgo visits, as well as increased financial insecurity, rendering it expensive to have the visit and also to take time from work for the visit.

“I would wonder if some of this is also due to how overloaded most primary care offices are so that instead of stopping accepting new patients or shedding patients, it is just harder for existing patients to be seen,” said Dr. Barrett, who is a general internist and associate professor in the division of hospital medicine, department of internal medicine, at the University of New Mexico, Albuquerque. “Some of this could be from administrative burden – 2 hours per hour of clinic – and consequently reducing clinical time,” continued Dr. Barrett, who also serves on the editorial advisory board of Internal Medicine News, which is affiliated with Family Practice News.

Other experts pointed to data showing an insufficient supply of PCPs as a potential explanation for the new study’s findings. The Health Resources and Services Organization, for example, reported that 83 million Americans live in primary care “health professional shortage areas,” as of Jan. 24, 2021, on their website.
 

New data

“The rate of any contact with a [PCP] for patients in the population over multiple 2-year periods decreased by 2.5% over the study period (adjusted odds ratio, 0.99 per panel; 95% [confidence interval], 0.98-0.99; P < .001),” wrote Dr. Johansen and Dr. Niforatos. The rate of contact for patients aged 18-39 years (aOR, 0.99 per panel; 95% CI, 0.98-0.99; P < .001) and patients aged 40-64 years (aOR, 0.99 per panel; 95% CI, 0.99-1.00; P = .002), specifically, also fell. These decreased contact rates correspond “to a predicted cumulative 5% absolute decrease for the younger group and a 2% absolute decrease for the older group,” the authors added.

“The number of contacts with a [PCP] decreased among individuals with any contact by 0.5 contacts over 2 years (P < .001). A decrease in the number of [PCP] contacts was observed across all age groups (P < .001 for all), with the largest absolute decrease among individuals with higher contact rates (aged less than 4 years and aged greater than 64 years),” according to the paper.

Outlook for PCPs

Physicians questioned about how concerning these data are for the future of PCPs and their ability to keep their practices running were hesitant to speculate, because of uncertainty about the causes of the study findings.

“A quote from the paper indicates that the respondents were interviewed five times over 2 years; however, without a copy of the questionnaire it is impossible to know what they were asked and not asked,” said Dr. Betton, who also serves on the editorial advisory board of Family Practice News and runs his own private practice. “In addition, it is impossible for the reader to know whether they understood what a primary care physician was to do.

“To draw a conclusion that PCP visits are falling off per patient per provider is only helpful if patients are opting out of the primary care model of practice and opting in for point-of-care [urgent] care,” Dr. Betton added.

Internist Alan Nelson, MD, said he was also undecided about whether the findings of the study are good or bad news for the physician specialty of primary care.

“Similar findings have been reported by the Medicare Payment Advisory Commission. They certainly merit further investigation,” noted Dr. Nelson, who is a member of the editorial advisory board of Internal Medicine News. “Is it because primary care physicians are too busy to see additional patients? Is it because nonphysician practitioners seem to be more caring? Should residency training be modified, and if so, how? In the meantime, I would not be surprised if the trend continues, at least in the short term.”

Ann Greiner, president and CEO of the Primary Care Collaborative, a nonprofit organization that advocates to strengthen primary care and make it more responsive to patient needs and preferences, on the other hand, reacted with a concerned outlook for primary care.

This study and others show that “the U.S. health care system is moving away from a primary care orientation, and that is concerning,” Ms. Greiner said in an interview. “Health systems that are more oriented toward primary care have better population health outcomes, do better on measures of equity across different population groups, and are less costly.”
 

Authors’ take

“Future research is needed to determine whether fewer contacts per patient resulted in clinically meaningful differences in outcomes across disease processes,” wrote Dr. Johansen, who is a family medicine doctor affiliated with OhioHealth Family Medicine Grant in Columbus and with the Heritage College of Osteopathic Medicine at Ohio University, Dublin, and Dr. Niforatos, who is affiliated with the department of emergency medicine at Johns Hopkins University, Baltimore.

The study’s limitations included reliance on self-reported categorization of PCP versus specialty care physician contact, insufficient accounting for nurse practitioner and physician assistant contact, and improved contact reporting having started in 2013, they said.
 

How to grow patient contact

For those PCPs looking to grow their visits and patient contact, Dr. Golden suggested they strengthen their medical home model in their practice.

“Medical home models help and transform practice operations. The Arkansas model is a multipayer model – private, Medicaid and CPC+ (Medicare),” said Dr. Golden, who also serves on the editorial advisory board of Internal Medicine News. It includes community-based doctors, not Federally Qualified Health Centers, and “requires 24/7 live voice access that promotes regular contact with patients and can reduce dependency on ER and urgent care center visits.”

“Greater use of patient portals and email communications facilitate access and patient engagement with their PCP,” Dr. Golden explained.

 “Over the last 6 years, the Arkansas [patient-centered medical home] initiatives have altered culture and made our practice sites stronger to withstand COVID and other challenges. As our sites became more patient centered and incorporated behavioral health options, patients perceived greater value in the functionality of primary care” he said.

Dr. Barrett proposed PCPs participate in team-based care “for professional sustainability and also for patients to continue to experience high-quality, person-centered care.” She added that “telemedicine can also help practices maintain and increase patients, as it can lessen burden on patients and clinicians – if it is done right.”

“More flexible clinic hours is also key – after usual business hours and on weekends – but I would recommend in lieu of usual weekday hours and for those who can make it work with their family and other duties,” Dr. Barrett said. “Evening or Saturday morning clinic isn’t an option for everyone, but it is an option for many some of the time, and it would be great for access to care if it were available in more locations.”
 

Pandemic effect

The data examined by Dr. Johansen and Dr. Niforatos predates the pandemic, but PCPs interviewed by this news organization have seen declining patient contact occur in 2020 as well.

In fact, a survey of 1,485 mostly physician primary care practitioners that began after the pandemic onset found that 43% of participants have fewer in-person visits, motivated largely by patient preferences (66%) and safety concerns (74%). This ongoing survey, which was conducted by the Larry Green Center in partnership with the Primary Care Collaborative, also indicated that, while 25% of participants saw a total increase in patient volume, more than half of primary care practitioners reported that chronic and wellness visits are down, 53% and 55%, respectively.

“Sometimes we have to go looking for our patients when we have not seen them in a while,” Dr. Stewart noted. “We saw that with COVID because people were fearful of coming into our offices, and we had to have some outreach.”

The study authors had no conflicts of interest. Dr. Barrett, Dr. Betton, Dr. Golden, Dr. Nelson, and Dr. Stewart had no relevant disclosures.

Jake Remaly contributed to this article.

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